Swallowing Therapy For Dysphagia in Acute and Subacute Stroke

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Swallowing therapy for dysphagia in acute and subacute stroke
(Review)
Bath PM, Lee HS, Everton LF
Bath PM, Lee HS, Everton LF.

Swallowing therapy for dysphagia in acute and subacute stroke.
Cochrane Database of Systematic Reviews 2018, Issue 10. Art. No.: CD000323.
DOI: 10.1002/14651858.CD000323.pub3.
www.cochranelibrary.com

Swallowing therapy for dysphagia in acute and subacute stroke (Review)
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.

Library Better health. Cochrane Database of Systematic Reviews
TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 3
BACKGROUND.............................................................................................................................................................................................. 5
OBJECTIVES.................................................................................................................................................................................................. 5
METHODS..................................................................................................................................................................................................... 5
RESULTS........................................................................................................................................................................................................ 8
Figure 1.................................................................................................................................................................................................. 9
Figure 2.................................................................................................................................................................................................. 11
DISCUSSION.................................................................................................................................................................................................. 15
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 16
ACKNOWLEDGEMENTS................................................................................................................................................................................ 17
REFERENCES................................................................................................................................................................................................ 18
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 32
DATA AND ANALYSES.................................................................................................................................................................................... 124
Analysis 1.1. Comparison 1 Swallowing therapy, Outcome 1 Functional outcome - death or dependency, death or disability at 127
end of trial.............................................................................................................................................................................................
Analysis 1.2. Comparison 1 Swallowing therapy, Outcome 2 Case fatality at end of trial................................................................ 128
Analysis 1.3. Comparison 1 Swallowing therapy, Outcome 3 Length of inpatient stay (days)......................................................... 129
Analysis 1.4. Comparison 1 Swallowing therapy, Outcome 4 Proportion of participants with dysphagia at end of trial................ 129
Analysis 1.5. Comparison 1 Swallowing therapy, Outcome 5 Swallowing ability............................................................................. 131
Analysis 1.6. Comparison 1 Swallowing therapy, Outcome 6 Penetration aspiration score............................................................. 132
Analysis 1.7. Comparison 1 Swallowing therapy, Outcome 7 Chest infection or pneumonia.......................................................... 133
Analysis 1.8. Comparison 1 Swallowing therapy, Outcome 8 Pharyngeal transit time (seconds).................................................... 134
Analysis 1.9. Comparison 1 Swallowing therapy, Outcome 9 Institutionalisation............................................................................ 135
Analysis 1.10. Comparison 1 Swallowing therapy, Outcome 10 Nutritional (albumin).................................................................... 135
APPENDICES................................................................................................................................................................................................. 136
WHAT'S NEW................................................................................................................................................................................................. 141
HISTORY........................................................................................................................................................................................................ 141
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 141
DECLARATIONS OF INTEREST..................................................................................................................................................................... 142
SOURCES OF SUPPORT............................................................................................................................................................................... 142
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 142
INDEX TERMS............................................................................................................................................................................................... 143
Swallowing therapy for dysphagia in acute and subacute stroke (Review) i

Informed decisions.

[Intervention Review]
Swallowing therapy for dysphagia in acute and subacute stroke
Philip M Bath1, Han Sean Lee1, Lisa F Everton1
1Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, UK
Contact address: Philip M Bath, Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital,
Nottingham, NG5 1PB, UK. [email protected].
Editorial group: Cochrane Stroke Group

Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 10, 2018.
Citation: Bath PM, Lee HS, Everton LF. Swallowing therapy for dysphagia in acute and subacute stroke. Cochrane Database of Systematic
Reviews 2018, Issue 10. Art. No.: CD000323. DOI: 10.1002/14651858.CD000323.pub3.
ABSTRACT
Background
Dysphagia (swallowing problems), which is common after stroke, is associated with increased risk of death or dependency, occurrence of
pneumonia, poor quality of life, and longer hospital stay. Treatments provided to improve dysphagia are aimed at accelerating recovery
of swallowing function and reducing these risks. This is an update of the review first published in 1999 and updated in 2012.
Objectives
To assess the effects of swallowing therapy on death or dependency among stroke survivors with dysphagia within six months of stroke
onset.
Search methods
We searched the Cochrane Stroke Group Trials Register (26 June 2018), the Cochrane Central Register of Controlled Trials (CENTRAL;
2018, Issue 6) in the Cochrane Library (searched 26 June 2018), MEDLINE (26 June 2018), Embase (26 June 2018), the Cumulative Index to
Nursing and Allied Health Literature (CINAHL) (26 June 2018), Web of Science Core Collection (26 June 2018), SpeechBITE (28 June 2016),
ClinicalTrials.Gov (26 June 2018), and the World Health Organization International Clinical Trials Registry Platform (26 June 2018). We also
searched Google Scholar (7 June 2018) and the reference lists of relevant trials and review articles.
Selection criteria
We sought to include randomised controlled trials (RCTs) of interventions for people with dysphagia and recent stroke (within six months).
Data collection and analysis

Two review authors independently applied the inclusion criteria, extracted data, assessed risk of bias, used the GRADE approach to assess
the quality of evidence, and resolved disagreements through discussion with the third review author (PB). We used random-effects models
to calculate odds ratios (ORs), mean differences (MDs), and standardised mean differences (SMDs), and provided 95% confidence intervals
(CIs) for each.
The primary outcome was functional outcome, defined as death or dependency (or death or disability), at the end of the trial. Secondary
outcomes were case fatality at the end of the trial, length of inpatient stay, proportion of participants with dysphagia at the end of the trial,
swallowing ability, penetration aspiration score, or pneumonia, pharyngeal transit time, institutionalisation, and nutrition.
Main results
We added 27 new studies (1777 participants) to this update to include a total of 41 trials (2660 participants).
Swallowing therapy for dysphagia in acute and subacute stroke (Review) 1

Informed decisions.

We assessed the efficacy of swallowing therapy overall and in subgroups by type of intervention: acupuncture (11 studies), behavioural
interventions (nine studies), drug therapy (three studies), neuromuscular electrical stimulation (NMES; six studies), pharyngeal electrical
stimulation (PES; four studies), physical stimulation (three studies), transcranial direct current stimulation (tDCS; two studies), and
transcranial magnetic stimulation (TMS; nine studies).
Swallowing therapy had no effect on the primary outcome (death or dependency/disability at the end of the trial) based on data from one
trial (two data sets) (OR 1.05, 95% CI 0.63 to 1.75; 306 participants; 2 studies; I2 = 0%; P = 0.86; moderate-quality evidence). Swallowing
therapy had no effect on case fatality at the end of the trial (OR 1.00, 95% CI 0.66 to 1.52; 766 participants; 14 studies; I2 = 6%; P = 0.99;
moderate-quality evidence). Swallowing therapy probably reduced length of inpatient stay (MD -2.9, 95% CI -5.65 to -0.15; 577 participants;
8 studies; I2 = 11%; P = 0.04; moderate-quality evidence). Researchers found no evidence of a subgroup effect based on testing for subgroup
differences (P = 0.54). Swallowing therapy may have reduced the proportion of participants with dysphagia at the end of the trial (OR 0.42,
95% CI 0.32 to 0.55; 1487 participants; 23 studies; I2 = 0%; P = 0.00001; low-quality evidence). Trial results show no evidence of a subgroup
effect based on testing for subgroup differences (P = 0.91). Swallowing therapy may improve swallowing ability (SMD -0.66, 95% CI -1.01
to -0.32; 1173 participants; 26 studies; I2 = 86%; P = 0.0002; very low-quality evidence). We found no evidence of a subgroup effect based
on testing for subgroup differences (P = 0.09). We noted moderate to substantial heterogeneity between trials for these interventions.
Swallowing therapy did not reduce the penetration aspiration score (i.e. it did not reduce radiological aspiration) (SMD -0.37, 95% CI -0.74 to
-0.00; 303 participants; 11 studies; I2 = 46%; P = 0.05; low-quality evidence). Swallowing therapy may reduce the incidence of chest infection
or pneumonia (OR 0.36, 95% CI 0.16 to 0.78; 618 participants; 9 studies; I2 = 59%; P = 0.009; very low-quality evidence).
Authors' conclusions
Moderate- and low-quality evidence suggests that swallowing therapy did not have a significant effect on the outcomes of death or
dependency/disability, case fatality at the end of the trial, or penetration aspiration score. However, swallowing therapy may have reduced
length of hospital stay, dysphagia, and chest infections, and may have improved swallowing ability. However, these results are based on
evidence of variable quality, involving a variety of interventions. Further high-quality trials are needed to test whether specific interventions
are effective.
PLAIN LANGUAGE SUMMARY
Swallowing therapy for difficulties with swallowing in stroke survivors who have had a recent stroke
Question
We wanted to assess the effectiveness of swallowing therapy for stroke survivors with dysphagia (difficulty in swallowing). We looked at
swallowing therapy in survivors up to six months after stroke.
Background
Stroke often results in difficulty swallowing. This can lead to choking, chest infections, poorer quality of life, longer hospital stay, and
increased risk of death or discharge to a care home. Therapy to improve swallowing aims to speed up recovery of swallowing function
and reduce these risks.
Study characteristics
This is an update of the review originally published in 1999 and previously updated in 2012. We have now included a total of 41 studies (2660
participants), and the evidence is current to June 2018. Swallowing therapy comprises several different treatment types, and we looked at
eight of these: acupuncture (11 studies), behavioural interventions (nine studies), drug therapy (three studies), neuromuscular electrical
stimulation (NMES; six studies), pharyngeal electrical stimulation (PES; four studies), physical stimulation (three studies), transcranial
direct current stimulation (tDCS; two studies), and transcranial magnetic stimulation (TMS; nine studies).
Key results
Swallowing therapy did not result in less death or disability among stroke survivors, nor did it lead to a safer swallow after treatment.
However, some individual swallowing therapies seemed to reduce hospital length of stay, lessen the chance of getting a chest infection or
pneumonia, or improve swallowing ability and recovery from swallowing problems. Many of the swallowing therapies involved different
methods of delivery, so it is still not clear which approach is most effective for each type of therapy.
Quality of the evidence
The quality of the evidence was generally very low, low, or moderate. Additional high-quality studies are needed.

SUMMARY OF FINDINGS

Summary of findings for the main comparison. Swallowing therapy compared to placebo for dysphagia in acute and subacute stroke
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Swallowing therapy compared to placebo for dysphagia in acute and subacute stroke
Patient or population: dysphagia in acute and subacute stroke

Setting: in hospital
Intervention: swallowing therapy
Better health.
Informed decisions.
Trusted evidence.
Comparison: placebo
Outcomes Anticipated absolute effects* (95% CI) Relative ef- No. of partici- Certainty of Comments
fect pants the evidence
Risk with placebo Risk with swallowing (95% CI) (studies) (GRADE)
therapy
Death or dependency at end of trial Study population OR 1.05 306 ⊕⊕⊕⊝ a

(0.63 to 1.75) (2 RCTs) Moderate
693 per 1000 703 per 1000
(587 to 798)
Case fatality at end of trial Study population OR 1.00 766 ⊕⊕⊕⊝ b

(0.66 to 1.52) (14 RCTs) Moderate
197 per 1000 197 per 1000
(140 to 272)
Length of inpatient stay (days) Mean length of inpatient stay MD 2.9 lower - 577 ⊕⊕⊕⊝ c
(days) ranged from 19 to 119 (5.65 lower to 0.15 low- (8 RCTs) Moderate
er)
Proportion of participants with Study population OR 0.42 1487 ⊕⊕⊝⊝ d

dysphagia at end of trial (0.32 to 0.55) (23 RCTs) Low

570 per 1000 357 per 1000
(298 to 421)
Swallowing ability Mean swallowing ability was 0 SMD 0.66 lower - 1173 ⊕⊝⊝⊝ e
(1.01 lower to 0.32 low- (26 RCTs) Very low
er)
Penetration aspiration score Mean penetration aspiration SMD 0.37 lower - 303 ⊕⊕⊝⊝ f
score was 0 (0.74 lower to 0 ) (11 RCTs) Low
Adverse event: chest infection or Study population OR 0.34 676 ⊕⊝⊝⊝ g

pneumonia (0.17 to 0.71) (10 RCTs) Very low
3

343 per 1000 151 per 100
(82 to 271)
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*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and
its 95% CI).
CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial.
GRADE Working Group grades of evidence.
Better health.
Informed decisions.
Trusted evidence.
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is
substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
aDowngraded by one level due to lack of precision (one study split into two trials).
bDowngraded by one level for indirectness of the evidence (i.e. multiple different interventions).
cDowngraded by one level due to indirectness of the evidence (i.e. multiple different interventions). Note also that two studies had unclear blinding.
dDowngraded by two levels due to indirectness of the evidence and blinding - a large number of studies did not clarify blinding status.
eDowngraded by three levels due to indirectness of the evidence (i.e. multiple different interventions), considerable heterogeneity, and fair number of studies did not clarify
blinding status.
fDowngraded by two levels due to indirectness of the evidence (i.e. multiple different interventions) and moderate heterogeneity.
gDowngraded by three levels due to indirectness of the evidence (i.e. multiple different interventions), substantial heterogeneity, and fair number of studies did not clarify blinding
status.


4

Informed decisions.

BACKGROUND studies have demonstrated that recovery from dysphagia is

associated with improved function of the non-lesioned hemisphere
Description of the condition (Hamdy 1998). The aim of most of the interventions described in
this review is to accelerate this process of plasticity in acute and
Dysphagia after stroke is common, affecting 27% to 64% of stroke
sub-acute stroke patients with dysphagia. The exact process by
survivors (Gordon 1987; Wolfe 1993; Odderson 1995; Smithard
which this is achieved is not fully understood, although it is thought
1996; Mann 2000; Singh 2006a; Rofes 2013). Although dysphagia
that some interventions specifically aim to improve swallowing by
improves spontaneously in many people with stroke (by two
enhancing sensory drive to the brain, causing increased activity in
weeks in about half), some will die and 15% of stroke survivors
motor swallowing areas.
will still have swallowing problems at one month (Smithard
1993); many of these individuals require long-term feeding with Why it is important to do this review
significant impairment of function, recovery, and quality of life
(Barer 1989; Smithard 1997; Mann 1999; Perry 2004). Complications Dysphagia post stroke affects quality of life, carries increased
of dysphagia include aspiration leading to chest infection and risks of mortality and dependency (Smithard 1996; Arnold 2016),
pneumonia, malnutrition, inability to rehabilitate, increased risk prolongs hospital stay (Smithard 1996; Smithard 1997; Arnold
of infection, prolonged length of stay in hospital, and increased 2016), increases healthcare costs, and often leads to discharge from
risk of death (Smithard 1993; Odderson 1995; Finestone 1996; hospital to a care home (Smithard 1996; Arnold 2016). Despite
Smithard 1996; Sharma 2001; Martino 2005; Arnold 2016). Early all of this, the previous two versions of this review concluded in
identification and management of dysphagia have been shown to 1999 and 2012 that overall, current evidence for interventions was
reduce pneumonia rates (Odderson 1995; Ramsey 2003; Hinchey insufficient, and that no definitive treatments for dysphagia were
2005; Lakshminarayan 2010). Cohen 2016 recently reviewed this available (Bath 1999; Geeganage 2012).
topic.
An updated version of this review is therefore needed to appraise
Description of the intervention current evidence regarding the effectiveness of interventions for
dysphagia post stroke. This information will provide support
Speech and language therapists (SLTs) often administer for clinical practice; will inform stroke survivors, clinicians,
interventions for treating dysphagia. These interventions and healthcare funders regarding which interventions are most
involve behavioural approaches that may be compensatory effective; and may help guide policy and funding decisions.
or rehabilitative in nature. Compensatory approaches include This review assesses the effectiveness of swallowing therapy for
modification of fluid and food consistencies, postural techniques treatment of dysphagia in stroke survivors with acute or subacute
such as adopting a chin tuck position, and swallow strategies stroke.
such as a supraglottic swallow. Rehabilitative methods include
swallowing exercises that focus on muscle strength; resistance or OBJECTIVES
skill training, or both, such as tongue exercises, effortful swallow,
and Mendelsohn’s manoeuvre (Mendelsohn 1987); and the Shaker To assess the effects of swallowing therapy on death or dependency
exercise (Shaker 2002). Rehabilitative methods also include among stroke survivors with dysphagia within six months of stroke
peripheral sensory stimulation, such as physical stimulation with onset.
tactile, thermal, or sour stimulation (Lazarra 1986; Logemann 1991;
Logemann 1993; Rosenbek 1996; U1111-1188-0335); carbonation METHODS
(Krival 2008); electrical stimulation (Power 2006); and air pulses
(Theurer 2013). Researchers have also studied chemical and Criteria for considering studies for this review
pharmacological agents, including capsaicin, black pepper oil, Types of studies
cabergoline, angiotensin-converting enzyme (ACE) inhibitors, and
nifedipine (Arai 2003; Ebihira 2004; Ebihira 2005). We identified randomised controlled trials (RCTs) of swallowing
therapy for stroke survivors with acute or subacute stroke and
Practitioners in China routinely use acupuncture techniques to dysphagia.
treat dysphagia (Wong 2012).
We excluded trials if they compared two or more active treatments
Several other stimulation methods to promote recovery from (i.e. treatment was confounded), recruited participants after six
dysphagia post stroke have emerged in recent years, in particular months following stroke onset, involved a large proportion of
peripheral and central stimulation methods. Peripheral methods participants with non-stroke causes of dysphagia, or used a cross-
include pharyngeal electrical stimulation (PES), as reported in Scutt over design by which we could not just use data from the first
2015, and neuromuscular surface electrical stimulation (NMES), as treatment phase.
described in Chen 2016. Central stimulation methods, also known
as non-invasive brain stimulation, include transcranial magnetic For this third version of the review, we removed most trials
stimulation (TMS) (Momosaki 2016; Pisegna 2016), as well as examining postural studies and all trials examining modified fluids
transcranial direct current stimulation (tDCS) (Momosaki 2016; because they lacked a true control group. We also excluded trials
Pisegna 2016). of free water protocols, oral hygiene, cough reflex testing, and
swallow screening, as we do not consider these to be interventions
How the intervention might work for dysphagia per se. We also excluded trials involving the use of
antibiotics.
The swallowing network is asymmetrically represented in both
cerebral hemispheres, with one hemisphere showing dominance
for swallowing (Hamdy 1998). Following unilateral stroke, TMS
Informed decisions.

Types of participants Secondary outcomes

Definitions • Case fatality at the end of the trial
Acute or subacute stroke • Length of inpatient stay
• Proportion of patients with dysphagia at the end of the trial
Participants recruited with a clinical diagnosis of stroke within six
months of onset. • Swallowing ability based on assessments of dysphagia
impairment using the dysphagia severity rating scale (DSRS), the
Stroke type functional oral intake scale (FOIS), the dysphagia outcome and
severity scale (DOSS), or water swallowing tests
Ischaemic or haemorrhagic.
• Penetration Aspiration score determined by VFSS and FEES and
Dysphagia quantified on a scale such as the Penetration Aspiration Scale
(PAS)
Diagnosed clinically (water swallow tests, modified diet or fluid
assessments, swallowing test scores) by a clinician (typically a • Chest infection or pneumonia, determined clinically or
nurse or SLT), or by a videofluoroscopy swallow study (VFSS) or radiologically
fibreoptic endoscopic evaluation of swallowing (FEES). • Swallow timings from VFSS measurements (e.g. pharyngeal
transit time (PTT))
Types of interventions • Nutritional measure based on blood albumin
• Acupuncture versus no acupuncture or routine acupuncture or • Institutionalisation with discharge to a residential, care, or
sham acupuncture nursing home, or to an extended care facility
• Behavioural interventions such as swallowing exercises, or • Neurological impairment within four weeks (e.g. using National
positioning versus limited, usual, or no treatment Institutes of Health Stroke Scale (NIHSS) or Scandinavian Stroke
• Drug intervention versus none or placebo Scale)
• Neuromuscular electrical stimulation (NMES) versus none or • Quality of life (e.g. using Short Form-36 (SF-36) or EuroQoL
sham stimulation (measure of health-related quality of life))
• Pharyngeal electrical stimulation (PES) versus none or sham Search methods for identification of studies
stimulation
• Physical stimulation such as thermal or tactile versus limited, See the Cochrane Stroke Group search methods. We searched
usual, or no treatment for trials in all languages and arranged translation of relevant
articles published in languages other than English. We have listed
• Transcranial direct current stimulation (tDCS) versus none or
publications requiring translation in the Characteristics of studies
sham stimulation
awaiting classification section.
• Transcranial magnetic stimulation (TMS) versus none or sham
stimulation Electronic searches
We combined different interventions, collectively referred to as We searched the Cochrane Stroke Group Trials Register (last
'swallowing therapy', for the purpose of analysing their effects searched on 26 June 2018). In addition, we searched:
on the main outcomes. Given that the science of intervention
development for dysphagia is at an early stage, it is reasonable • Cochrane Central Register of Controlled Trials (CENTRAL; 2018,
to ask the question whether any intervention is better than no Issue 6) (Appendix 1) in the Cochrane Library (searched 26 June
intervention, and to try to establish where the most positive effects 2018);
are seen and for what topics more research is needed. • MEDLINE Ovid (1946 to 26 June 2018) (Appendix 2);
• Embase (1974 to 26 June 2018) (Appendix 3);
Types of outcome measures • Cumulative Index to Nursing and Allied Health Literature
We obtained information on the following outcome measures, as (CINAHL EBSCO) (1982 to 26 June 2018) (Appendix 4);
available, for each trial. • Science Citation Index Expanded, Social Sciences Citation Index,
Conference Proceedings Citation Index- Science (Web of Science
Primary outcomes Core Collection; 1900 to 26 June 2018) (Appendix 5); and
• Functional outcome assessed as death or dependency (modified • SpeechBITE (searched 28 June 2018) (Appendix 6).
Rankin Scale: mRS > 2), or death or disability (Barthel Index: BI
< 60), at the end of the trial In an effort to identify further published, unpublished, and ongoing
trials, we searched:
We chose functional outcome (i.e. death or dependency/disability)
as the primary outcome because dysphagia is associated with • US National Institutes of Health Ongoing Trials Register
increased risk of death or dependency in acute and subacute ClinicalTrials.gov (www.clinicaltrials.gov; searched 26 June
stroke. Whilst swallowing therapy aims to reduce dysphagia, we 2018; Appendix 7);
needed to assess whether evidences shows that people receiving • World Health Organization International Clinical Trials Registry
swallowing therapy are less likely to die or remain dependent. We Platform (apps.who.int/trialsearch; searched 26 June 2018;
listed other important outcomes relevant to swallowing function as Appendix 8); and
secondary outcomes. • Google Scholar (searched 7 June 2018; Appendix 9).

Informed decisions.

Searching other resources treatment groups to prevent control participants from being
counted more than once, and thereby artificially narrowing the CIs.
Additionally, we searched the reference lists of relevant trials and
We entered each set of data as a separate trial.
review articles and our own reference lists.
Dealing with missing data
For a previous version of this review (Geeganage 2012), we
contacted researchers and the UK Royal College of Speech and If a trial publication did not provide relevant data or if data were
Language Therapists Special Interest Group for information on missing but we felt it appropriate otherwise, we placed studies into
adult-acquired dysphagia trials. Characteristics of studies awaiting classification.
Data collection and analysis Assessment of heterogeneity

Selection of studies We used the random-effects model to assess heterogeneity by
looking at forest plots to see how CIs overlapped (non-overlapping
For this update, two review authors (HSL, LE) scanned the titles studies are exhibiting statistical heterogeneity) along with the I2
and abstracts of records identified through searches of electronic statistic (Higgins 2011). We defined thresholds for interpreting
bibliographic databases and excluded obviously irrelevant articles. heterogeneity according to the Cochrane Handbook for Systematic
We independently reviewed the full text of remaining studies and Reviews of Interventions, whereby 0% to 40% might not be
selected relevant trials according to the listed inclusion criteria; we important; 30% to 60% may represent moderate heterogeneity;
resolved disagreements through discussion with the third review 50% to 90% may represent substantial heterogeneity, and 75% to
author (PB). 100% represents considerable heterogeneity (Higgins 2011).
Data extraction and management Assessment of reporting biases
For this update, two review authors (HSL, LE) extracted data We assessed selective outcome reporting as reported in the 'Risk of
using a predefined proforma, and entered the data into RevMan bias' table (Characteristics of included studies).
5 (RevMan 2014); we resolved disagreements through discussion
and consultation with the third review author (PB). We assessed Data synthesis
information on randomisation, blinding, numbers of participants
randomised, timing of treatment from stroke, types of dysphagia We performed meta-analysis using functionality within RevMan 5
therapy, participant withdrawals and losses to follow-up, and (RevMan 2014): we used random-effects models (Mantel-Haenszel
relevant outcomes (Types of outcome measures). We aggregated method) and presented data as number (%) or mean (standard
outcome data from dose escalation or dose comparison trials into deviation), with OR, MD, or SMD. We used random-effects models
one active treatment group. because we expected that trials would be heterogeneous in
design and delivery, including different types of participants and
Assessment of risk of bias in included studies interventions.
We assessed potential for bias using the 'Risk of bias' tool as Grade and 'Summary of findings' table
recommended in the Cochrane Handbook for Systematic Reviews
of Interventions (Higgins 2011). This assessment includes sequence We assessed the quality of the evidence using the five
generation, allocation concealment, blinding of participants and GRADE considerations (study limitations, consistency of effect,
personnel, blinding of outcome assessment, incomplete outcome imprecision, indirectness, and publication bias), as described in the
data, selective outcome reporting, and other issues. Cochrane Handbook for Systematic Reviews of Interventions (Higgins
2011), for the following main outcomes of analysis.
Measures of treatment effect
• Death or dependency/disability at the end of the trial.
We assessed weighted estimate of the typical treatment effect • Case fatality at the end of the trial.
across trials using odds ratios (ORs) and 95% confidence intervals
• Length of inpatient stay.
(CIs) for binary data, mean differences (MDs) and 95% CIs for
continuous data, and standardised mean differences (SMDs) and • Proportion of participants with dysphagia at the end of the trial.
95% CIs for continuous data based on different scales. We • Swallowing ability.
performed analyses using RevMan 5 (RevMan 2014). We calculated • Penetration aspiration score.
OR using the Mantel-Haenszel method, and MDs using the inverse • Adverse event: chest infection or pneumonia.
variance method.
We have presented in Summary of findings for the main comparison
Unit of analysis issues key findings of the review, including a summary of the quantity
When outcome measures included different scores, we converted of data, the magnitude of effect size, and the overall quality of
these to grades in the same direction of mild to severe and evidence.
analysed them using MDs. When studies compared graduations
Subgroup analysis and investigation of heterogeneity
of therapy (high-medium-low intensity), we divided the middle-
intensity group in two and analysed study data by comparing high We performed subgroup analyses on the eight different types
intensity versus medium intensity, and medium intensity versus of swallowing therapy to provide more specific information
low intensity or no treatment. Similarly, if a trial compared high- pertaining to the different interventions. We assessed for significant
versus low-frequency stimulation or unilateral versus bilateral subgroup interactions by testing for subgroup differences for each
stimulation, we divided control group participants equally between main outcome.

Informed decisions.

Sensitivity analysis 168 records. After full-text review, we excluded 41 studies. We added
these newly excluded studies to the existing list of 39 excluded
We did not perform sensitivity analyses due to the small number of
studies, for a total of 80 (Excluded studies). We added 22 studies
studies.
into the ongoing studies section (Ongoing studies). We also added
RESULTS 78 new studies to the eight existing studies awaiting classification,
yielding a total of 86 (Studies awaiting classification); these studies
Description of studies have been completed and are awaiting publication or are awaiting
translation, or we are seeking full-text articles. External assessment
We identified 27 new RCTs involving a total of 1777 acute or of this review led to a request to further update the searches; an
subacute stroke survivors with dysphagia. updated search revealed further potentially relevant studies, and
we have added these to the Studies awaiting classification section;
Results of the search we will assess these when we prepare the next update of this review.
We have presented the PRISMA study flow diagram in Figure 1. In Finally, we added 27 new studies to the existing 14 studies, yielding
total, we identified 2902 references, removed 860 duplicates, and a total of 41 included studies (47 data sets) (Included studies). This
screened 2042 records. We excluded 1874 records, leaving a total of resulted in the addition of 1777 participants to the existing 883, for
a total of 2660 participants.


Informed decisions.

Figure 1. Study Flow Diagram, *86 studies awaiting classification.


Informed decisions.

Figure 1. (Continued)

Included studies them using mean differences (MDs). Two studies compared
graduations of therapy (high-medium-low intensity) (Yuan 2003i;
We included 41 trials in this updated review (mean participant
Yuan 2003ii; Carnaby 2006i; Carnaby 2006ii;); here, we divided the
age 67.8 years). These trials looked at various forms of swallowing
middle-intensity group in two and analysed the study data by
therapy after stroke.
comparing high intensity versus medium intensity, and medium
When outcome measures included different scores, we converted intensity versus low intensity or no treatment. Similarly, one trial of
these to grades in the same direction of mild to severe and analysed TMS compared high- versus low-frequency stimulation or unilateral

Informed decisions.

versus bilateral stimulation (Kim 2012i; Kim 2012ii; Du 2016i; Du compared NMES versus traditional dysphagia therapy. One study
2016ii; Park 2016 (a) i; Park 2016 (a) ii); here, we divided control combined NMES and effortful swallow (Park 2012).
group participants equally between treatment groups to prevent
control participants from being counted more than once and Pharyngeal electrical stimulation (PES)
thereby artificially narrowing the confidence intervals (CIs). We Four studies involving 214 participants assessed PES (Jayasekeran
entered each set of data as a separate trial; hence, although the 2010a; Jayasekeran 2010b; STEPS 2016; Vasant 2016).
total number of included studies was 41, the total number of data
sets entered for analysis was 47. Physical stimulation (thermal, tactile)
Acupuncture Three studies enrolled 155 participants. Types of stimulation

included tactile stimulation (Bath 1997), electrical stimulation
Eleven studies tested acupuncture in 998 participants (Liu 2000; (Power 2006), and Tongyan spray (Feng 2012).
Han 2004; Liu 2004; Wei 2005; Jia 2006a; Bai 2007i; Bai 2007ii; Huang
2010; Chan 2012; Chen 2016a; Xia 2016a). Transcranial direct current stimulation (tDCS)
Behavioural interventions Two studies assessed tDCS in 34 participants (Kumar 2011;

Shigematsu 2013).
Nine studies investigated behavioural interventions in 632
participants (Yuan 2003i; Yuan 2003ii; Song 2004; Carnaby 2006i; Transcranial magnetic stimulation (TMS)
Carnaby 2006ii; Kang 2012; Zheng 2014; Heo 2015; Park 2016b).
Behavioural interventions consisted of swallowing exercises, Nine studies involving 167 participants investigated TMS (Khedr
environmental modifications such as upright positioning for 2009; Khedr 2010; Kim 2012i; Kim 2012ii; Park 2013; Du 2016i; Du
feeding, safe swallowing advice, dietary modifications, kinesio- 2016ii; Park 2016a (i); Park 2016a (ii).
taping, and expiratory muscle strength training. Excluded studies
Drug therapy We excluded 80 studies from this updated review, most
Three studies assessed several different drugs in 148 participants commonly because investigators compared two active treatments
(Perez 1997; Lee 2015; Warusevitane 2015). Drug interventions (confounded) or because the trials were not RCTs. We excluded
included nifedipine in 17 participants (Perez 1997), lisinopril in 71 10 studies as reported outcomes were not relevant to this review.
participants (Lee 2015), and metoclopramide in 60 participants We excluded 11 studies because of lack of outcome data; some of
(Warusevitane 2015). these might be relevant to this review should outcome data become
available (Characteristics of excluded studies).
Neuromuscular electrical stimulation (NMES)
Risk of bias in included studies
Six studies tested NMES in 312 participants (Lim 2009; Xia 2011;
Park 2012; Lee 2014; Li 2014; Terre 2015). Researchers most often Key sources of bias follow; we have summarised risk of bias in
Figure 2.

Figure 2. 'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages
across all included studies.

Informed decisions.

Allocation • Participants were blinded in nine studies (low risk of bias) (Khedr
2009; Chan 2012; Park 2012; Park 2013; Terre 2015; Du 2016i; Du
Random sequence generation
2016ii; STEPS 2016; Vasant 2016).
• Randomisation by computer occurred in 15 studies (low risk • Both participants and investigators were unblinded in five
of bias) (Bath 1997; Perez 1997; Carnaby 2006i; Carnaby 2006ii; studies (high risk of bias) (Carnaby 2006i; Carnaby 2006ii; Chen
Jayasekeran 2010a; Jayasekeran 2010b; Park 2012; Park 2013; 2016a; Park 2016a (i); Park 2016a (ii)).
Lee 2014; Li 2014; Lee 2015; Terre 2015; Chen 2016a; STEPS 2016; • Blinding of participants and investigators was uncertain in 14
Vasant 2016). studies (unclear risk of bias) (Bath 1997; Han 2004; Bai 2007i; Bai
• Randomisation via random number tables occurred in 10 2007ii; Lim 2009; Jayasekeran 2010a; Jayasekeran 2010b; Khedr
studies (low risk of bias) (Song 2004; Bai 2007i; Bai 2007ii; Chan 2010; Xia 2011; Shigematsu 2013; Li 2014; Lee 2015; Park 2016b;
2012; Feng 2012; Shigematsu 2013; Warusevitane 2015; Du 2016i; Xia 2016a).
Du 2016ii; Xia 2016a).
• Simple randomisation occurred in four studies (low risk of bias) Detection bias
(Han 2004; Kumar 2011; Heo 2015; Park 2016b). • Outcomes were blinded in 28 studies (low risk of bias) (Perez
• Method of randomisation was unclear in 16 studies (unclear risk 1997; Han 2004; Wei 2005; Carnaby 2006i; Carnaby 2006ii; Khedr
of bias) (Liu 2000; Yuan 2003i; Yuan 2003ii; Liu 2004; Wei 2005; 2009; Lim 2009; Jayasekeran 2010a; Jayasekeran 2010b; Khedr
Power 2006; Khedr 2009; Huang 2010; Khedr 2010; Xia 2011; 2010; Xia 2011; Chan 2012; Park 2012; Park 2013; Shigematsu
Kang 2012; Kim 2012i; Kim 2012ii; Zheng 2014; Park 2016a (i); 2013; Li 2014; Lee 2015; Terre 2015; Warusevitane 2015; Chen
Park 2016a (ii)). 2016a; Du 2016i; Du 2016ii; Park 2016a (i); Park 2016a (ii); Park
• Two studies used non-randomised methods (high risk of bias) 2016b; STEPS 2016; Vasant 2016; Xia 2016a).
(Jia 2006a; Lim 2009). • Outcomes were not blinded in three studies (high risk of bias)
(Bath 1997; Bai 2007i; Bai 2007ii).
Allocation concealment
Overall, 16 studies did not report on any blinding procedures (i.e.
• Researchers ensured allocation concealment in 17 studies (low
for participants, investigators, or outcome assessors) (unclear risk
risk of bias) (Han 2004; Carnaby 2006i; Carnaby 2006ii; Khedr
of bias) (Liu 2000; Yuan 2003i; Yuan 2003ii; Liu 2004; Song 2004; Wei
2009; Chan 2012; Feng 2012; Park 2012; Park 2013; Shigematsu
2005; Jia 2006a; Power 2006; Huang 2010; Feng 2012; Kang 2012;
2013; Li 2014; Lee 2015; Warusevitane 2015; Chen 2016a; Du
Kim 2012i; Kim 2012ii; Lee 2014; Zheng 2014; Heo 2015).
2016i; Du 2016ii; Park 2016b; Vasant 2016).
• Allocation concealment was unclear in 28 studies (unclear risk Incomplete outcome data
of bias) (Bath 1997; Perez 1997; Liu 2000; Yuan 2003i; Yuan
2003ii; Liu 2004; Song 2004; Wei 2005; Power 2006; Bai 2007i; • Ten studies reported no loss of participants during follow-up
Bai 2007ii; Huang 2010; Jayasekeran 2010a; Jayasekeran 2010b; (low risk of bias) (Han 2004; Jayasekeran 2010a; Chan 2012; Kang
Khedr 2010; Kumar 2011; Xia 2011; Kang 2012; Kim 2012i; Kim 2012; Kim 2012i; Kim 2012ii; Park 2013; Shigematsu 2013; Lee
2012ii; Lee 2014; Zheng 2014; Heo 2015; Terre 2015; Park 2016a 2014; Warusevitane 2015).
(i); Park 2016a (ii); STEPS 2016; Xia 2016a). • Twelve studies reported loss of participants during follow-up,
• Two studies did not ensure allocation concealment (high risk of but we judged them to be at low risk of bias (Perez 1997; Carnaby
bias) (Jia 2006a; Lim 2009). 2006i; Carnaby 2006ii; Khedr 2009; Khedr 2010; Feng 2012; Park
2012; Du 2016i; Du 2016ii; Park 2016a (i); Park 2016a (ii); Vasant
Baseline prognostic factors matching between intervention and 2016).
control groups • We judged seven studies to be at high risk of bias due to
incomplete outcome data (Lim 2009; Jayasekeran 2010b; Li
• Baseline factors were similar in 34 studies (low risk of bias)
2014; Lee 2015; Chen 2016a; Park 2016b; STEPS 2016).
(Perez 1997; Song 2004; Carnaby 2006i; Carnaby 2006ii; Bai
2007i; Bai 2007ii; Khedr 2009; Jayasekeran 2010b; Khedr 2010; • Loss of participants during follow-up was unclear in 18 studies
Xia 2011; Chan 2012; Feng 2012; Kang 2012; Kim 2012i; Kim (unclear risk of bias) (Bath 1997; Liu 2000; Yuan 2003i; Yuan
2012ii; Park 2012; Park 2013; Shigematsu 2013; Lee 2014; Li 2014; 2003ii; Liu 2004; Song 2004; Wei 2005; Jia 2006a; Power 2006; Bai
Zheng 2014; Heo 2015; Lee 2015; Terre 2015; Warusevitane 2015; 2007i; Bai 2007ii; Huang 2010; Kumar 2011; Xia 2011; Zheng 2014;
Chen 2016a; Du 2016i; Du 2016ii; Park 2016a (i); Park 2016a (ii); Heo 2015; Terre 2015; Xia 2016a).
Park 2016b; STEPS 2016; Vasant 2016; Xia 2016a). • Data were not available for quality of life.
• Baseline factor matching was unclear in 13 studies (unclear risk
Selective reporting
of bias) (Bath 1997; Liu 2000; Yuan 2003i; Yuan 2003ii; Han 2004;
Liu 2004; Wei 2005; Jia 2006a; Power 2006; Lim 2009; Huang • We judged 34 studies to be at low risk of reporting bias (Perez
2010; Jayasekeran 2010a; Kumar 2011). 1997; Carnaby 2006i; Carnaby 2006ii; Power 2006; Khedr 2009;
Jayasekeran 2010a; Jayasekeran 2010b; Khedr 2010; Kumar
Blinding 2011; Xia 2011; Chan 2012; Feng 2012; Kang 2012; Kim 2012i; Kim
Performance bias 2012ii; Park 2012; Park 2013; Shigematsu 2013; Lee 2014; Li 2014;
Zheng 2014; Heo 2015; Lee 2015; Terre 2015; Warusevitane 2015;
• Both participants and investigators were blinded in three studies Chen 2016a; Du 2016i; Du 2016ii; Park 2016a (i); Park 2016a (ii);
(low risk of bias) (Perez 1997; Kumar 2011; Warusevitane 2015). Park 2016b; STEPS 2016; Vasant 2016; Xia 2016a).

Informed decisions.

• In the remaining 13 studies, it was unclear if reported data were interval (CI) 0.63 to 1.75; 306 participants; 2 studies; I2 = 0%; P = 0.86:
complete (unclear risk of bias) (Bath 1997; Liu 2000; Yuan 2003i; moderate-quality evidence; Analysis 1.1). One trial (two data sets)
Yuan 2003ii; Han 2004; Liu 2004; Song 2004; Wei 2005; Jia 2006a; of behavioural interventions reported on this outcome.
Bai 2007i; Bai 2007ii; Lim 2009; Huang 2010).
Secondary outcomes
Other potential sources of bias
Case fatality at end of trial
We assessed seven studies based on translations of the original text Swallowing therapy had no effect on case fatality at end of trial
(Yuan 2003i; Yuan 2003ii; Song 2004; Wei 2005; Bai 2007i; Bai 2007ii; (OR 1.00, 95% CI 0.66 to 1.52; 766 participants; 14 studies; I2
Huang 2010). Native Chinese speakers performed translations from = 6%; P = 0.99: moderate-quality evidence; Analysis 1.2). Trials
Chinese to English. of behavioural interventions, drug therapy, pharyngeal electrical
We aggregated outcome data from dose escalation or comparison stimulation, physical stimulation, and transcranial magnetic
trials to form one active treatment group in one trial (Jayasekeran stimulation reported on this outcome.
2010b). Length of inpatient stay
Effects of interventions Swallowing therapy probably reduced length of inpatient stay

(mean difference (MD) -2.90, 95% CI -5.65 to -0.15; 577 participants;
See: Summary of findings for the main comparison Swallowing 8 studies; I2 = 11%; P = 0.04: moderate-quality evidence; Analysis
therapy compared to placebo for dysphagia in acute and subacute 1.3). Trials of behavioural interventions and PES reported on this
stroke outcome. Subgroup analysis showed that the interventions did not
Summary of findings for main outcomes of swallowing therapy differ (Analysis 1.3).
in general Proportion of participants with dysphagia at end of trial
We entered the important outcomes in this review into Summary Swallowing therapy probably reduced the proportion of
of findings for the main comparison, and we reported outcomes participants with dysphagia at end of trial (OR 0.42, 95% CI 0.32
for 'swallowing therapy' versus 'no swallowing therapy'. This to 0.55; 1487 participants; 23 studies; I2 = 0%; P = 0.00001: low-
means that overall, for each outcome (e.g. length of inpatient quality evidence; Analysis 1.4). Trials of acupuncture, behavioural
stay), we combined several different interventions to test for interventions, drug therapy, NMES, PES, physical stimulation, and
efficacy. In this way, we have provided information on the tDCS reported on this outcome. Subgroup analysis showed that
effectiveness of swallowing therapy as a whole for each outcome. acupuncture (OR 0.31, 95% CI 0.20 to 0.49; 676 participants; 8
We assessed three additional outcomes (pharyngeal transit time, studies; I2 = 0%; P < 0.00001) and behavioural interventions (OR
institutionalisation, and nutrition) but did not include them in 0.45, 95% CI 0.28 to 0.74; 511 participants; 6 studies; I2 = 28%; P =
Summary of findings for the main comparison (a maximum of seven 0.001) each reduced dysphagia but did not differ from each other (P
outcomes are allowed); therefore, we did not assess the quality of = 0.91; Analysis 1.4).
studies for these outcomes using the GRADE approach, and we have
not reported their outcomes in the main findings. Swallowing ability
We also undertook subgroup analysis for each different type of Swallowing therapy probably improved swallowing ability
intervention. (standardised mean difference (SMD) -0.66, 95% CI -1.01 to -0.32;
1173 participants; 26 studies; I2 = 86%; P = 0.0002: very low-
The number of outcomes reported varied considerably across quality evidence; Analysis 1.5). Trials of acupuncture, behavioural
studies. interventions, drug therapy, NMES, PES, physical stimulation, tCDS,
and TMS reported on this outcome. Subgroup analysis showed that
• Primary outcome of death or dependency/disability at end of behavioural interventions (SMD -0.56, 95% CI -1.07 to -0.05; 121
trial in one trial (split into two data sets). participants; 3 studies; I2 = 47%; P = 0.03) and TMS (SMD -1.29, 95%
• Case fatality at end of trial in 14 trials. CI -2.37 to -0.21; 141 participants; 8 studies; I2 = 85%; P = 0.02) each
• Length of inpatient stay in eight trials. improved swallowing ability but did not differ from each other (P =
0.09; Analysis 1.5). Review authors noted moderate to substantial
• Proportion of patients with dysphagia at end of trial in 23 trials.
heterogeneity between trials (Analysis 1.5).
• Swallowing ability in 26 trials.
• Penetration aspiration score (PAS) in 11 trials. Penetration aspiration score
• Chest infections or pneumonia in nine trials. Swallowing therapy did not significantly reduce aspiration
• Swallow timing in six trials. assessed as penetration aspiration score (SMD -0.37, 95% CI -0.74
• Nutrition in three trials. to -0.00; 303 participants; 11 studies; I2 = 46%; P = 0.05: low-quality
• Institutionalisation in three trials. evidence; Analysis 1.6). Trials of behavioural interventions, NMES,
PES, and TMS reported on this outcome. However, given that results
Primary outcome show no overall benefit, we have not commented on subgroup
analysis (Analysis 1.6).
Functional outcome: death or dependency or death or disability at end
of trial Chest infection or pneumonia
Swallowing therapy had no effect on death or dependency, or death Swallowing therapy probably reduced the incidence of chest
or disability, at end of trial (odds ratio (OR) 1.05, 95% confidence infection or pneumonia (OR 0.36, 95% CI 0.16 to 0.78; 618

Informed decisions.

participants; 9 studies; I2 = 59%; P = 0.009: very low-quality yield significant results. Although behavioural interventions also
evidence; Analysis 1.7). Trials of behavioural interventions, drug reduced penetration aspiration score (i.e. < 1.0), results show
therapy, NMES, and PES reported on this outcome. Subgroup no overall benefit for this outcome and this finding is likely
analysis showed that drug therapy (OR 0.06, 95% CI 0.01 to 0.21; due to chance. Behavioural interventions did not reduce length
60 participants; 1 study; I2 not applicable; P < 0.0001) significantly of inpatient stay, chest infection or pneumonia, case fatality
reduced the incidence of chest infection or pneumonia at end of at end of trial, functional outcome, institutionalisation, or
trial - a result that differed significantly from other interventions (P nutrition. Behavioural interventions addressed more outcomes
= 0.008; Analysis 1.7). when compared with most interventions.
Pharyngeal transit time (PTT) • Swallowing ability (SMD -0.56, 95% CI -1.07 to -0.05; 121
Swallowing therapy may have reduced PTT (MD -0.23, 95% CI -0.32 participants; 3 studies; I2 = 47%; P = 0.03; Analysis 1.5).
to -0.15; 187 participants; 6 studies; I2 = 29%; P < 0.00001; Analysis • Proportion of participants with dysphagia at end of trial (OR
1.8). Trials of drug therapy, NMES, PES, and physical stimulation 0.45, 95% CI 0.28 to 0.74; 511 participants; 6 studies; I2 = 28%; P
reported on this outcome. Subgroup analysis showed that NMES = 0.001; Analysis 1.4).
(MD -0.23, 95% CI -0.39 to -0.08; 126 participants; 3 studies; I2 = • Penetration aspiration score (SMD -0.88, 95% CI -1.68 to -0.08; 27
63%; P = 0.003; Analysis 1.8) and physical stimulation in one small participants; 1 study; I2 not applicable; P = 0.03; Analysis 1.6).
study (MD -0.19; 95% CI -0.34 to -0.04; 16 participants; 1 study; I2 not • Length of inpatient stay (MD -2.70, 95% CI -5.68 to 0.28; 370
applicable; P = 0.01) each reduced PTT but did not differ from each participants; 4 studies; I2 = 19%; P = 0.08; Analysis 1.3).
other, i.e. these findings are likely due to chance and not-significant. • Chest infection or pneumonia (OR 0.56, 95% CI 0.31 to 1.00; 473
(P = 0.98; Analysis 1.8). participants; 6 studies; I2 = 21%; P = 0.05; Analysis 1.7).
Institutionalisation • Case fatality at end of trial (OR 0.83, 95% CI 0.46 to 1.51; 306
participants; 2 studies; I2 = 0%; P = 0.54; Analysis 1.2).
Swallowing therapy did not reduce the incidence of
• Functional outcome (OR 1.05, 95% CI 0.63 to 1.75; 306
institutionalisation (OR 0.75, 95% CI 0.47 to 1.19; 447 participants;
3 studies; I2 = 0%; P= 0.22; Analysis 1.9). Trials of behavioural
interventions and pharyngeal electrical stimulation reported on • Institutionalisation (OR 0.76, 95% CI 0.39 to 1.48; 306
this outcome. participants; 2 studies; I2 = 12%; P = 0.42; Analysis 1.9).
• Nutrition (albumin) (MD 0.20, 95% CI -4.77 to 5.17; 64
Nutrition (albumin) participants; 2 studies; I2 = 0%; P = 0.94; Analysis 1.10).
Swallowing therapy did not reduce nutrition (MD 0.37, 95% CI -1.5
Drug therapy
to 2.24; 169 participants; 3 studies; I2 = 0%; P = 0.70; Analysis
1.10). Trials of behavioural interventions and pharyngeal electrical Drug therapy was probably effective for reducing chest infection or
stimulation reported on this outcome. pneumonia in one study - a result that differed from those of other
interventions. Drug therapy did not improve swallowing ability, nor
Detailed subgroup analysis: summary of findings per type of did it reduce case fatality, proportion of participants with dysphagia
intervention at end of trial, or pharyngeal transit time. Data on effects of drug
Not all interventions addressed all outcomes. We have reported therapy on other outcomes were not available.
available data.
• Chest infection or pneumonia (OR 0.06, 95% CI 0.01 to 0.21; 60
Acupuncture participants; 1 study; I2 not applicable; P < 0.0001; Analysis 1.7).
• Swallowing ability (SMD -0.46, 95% CI -0.93 to 0.01; 71
Acupuncture resulted in significant results (i.e. < 1.0) for reducing participants; 1 study; I2 not applicable; P = 0.06; Analysis 1.5).
the proportion of participants with dysphagia at end of trial.
• Case fatality (OR 1.40, 95% CI 0.31 to 6.28; 148 participants; 3
However, these findings may be due to chance, given that
studies; I2 = 70%; P = 0.66; Analysis 1.2).
testing for subgroup differences did not yield significant results.
Acupuncture did not reduce swallowing ability. Data on the effects • Proportion of participants with dysphagia at end of trial (OR
of acupuncture on other outcomes were not available. 0.48, 95% CI 0.07 to 3.35; 17 participants; 1 study; I2 not
applicable; P = 0.46; Analysis 1.4).
• Proportion of participants with dysphagia at end of trial (OR • Pharyngeal transit time (MD -0.21, 95% CI -0.91 to 0.49; 17
0.31, 95% CI 0.20 to 0.49; 676 participants; 8 studies; I2 = 0%; P < participants; 1 study; I2 not applicable; P = 0.56; Analysis 1.8).
0.00001; Analysis 1.4).
• Swallowing ability (SMD -0.55, 95% CI -1.20 to 0.11; 496 Neuromuscular electrical stimulation (NMES)
participants; 6 studies; I2 = 91%; P = 0.10). We noted significant NMES was probably effective for reducing pharyngeal transit time
heterogeneity (Analysis 1.5). (i.e. < 1.0). NMES did not reduce the proportion of participants with
dysphagia at end of trial or penetration aspiration score, and did
Behavioural interventions
not improve swallowing ability.
Behavioural interventions produced significant results (i.e. < 1.0)
for improving swallowing ability and reducing the proportion of • Pharyngeal transit time (MD -0.23, 95% CI -0.39 to -0.08; 126
participants with dysphagia at the end of the trial. However, participants; 3 studies; I2 = 63%; P = 0.003; Analysis 1.8).
both of these findings may be due to chance, given that
testing for subgroup differences for each outcome did not

Informed decisions.

• Proportion of participants with dysphagia at end of trial (OR • Proportion of participants with dysphagia at end of trial (OR
0.51, 95% CI 0.18 to 1.49; 76 participants; 2 studies; I2 = 7%; P = 0.29, 95% CI 0.01 to 8.39; 14 participants; 1 study; I2 not
0.22; Analysis 1.4). applicable; P = 0.47; Analysis 1.4).
• Penetration aspiration score (SMD 0.57, 95% CI -0.38 to 1.52; 18 • Swallowing ability (SMD -0.33, 95% CI -2.22 to 1.56; 34
participants; 1 study; I2 not applicable; P = 0.24; Analysis 1.6). participants; 2 studies; I2 = 85%; P = 0.73; Analysis 1.5).
• Swallowing ability (SMD -1.34, 95% CI -3.39 to 0.71; 100
participants; 2 studies; I2 = 93%; P = 0.20; Analysis 1.5). Transcranial magnetic stimulation (TMS)
TMS improved swallowing ability at end of trial (i.e. < 1.0),
Pharyngeal electrical stimulation (PES) although this finding may be due to chance, given that testing for
PES studies addressed many outcomes but did not show an effect subgroup differences did not yield significant results. We also noted
for case fatality, length of inpatient stay, proportion of participants considerable heterogeneity. TMS did not alter case fatality at end of
with dysphagia at end of trial, swallowing ability, penetration trial nor penetration aspiration score. Data on other outcomes were
aspiration score, chest infection or pneumonia, pharyngeal transit not available.
time, institutionalisation, or nutrition.
• Swallowing ability (SMD -1.29, 95% CI -2.37 to -0.21; 141
• Case fatality (OR 0.92, 95% CI 0.38 to 2.26; 215 participants; 4 participants; 8 studies = 8; I2 = 85%; P = 0.02; Analysis 1.5).
studies; I2 = 0%; P = 0.86; Analysis 1.2). • Case fatality at end of trial (OR 0.28, 95% CI 0.03 to 2.93; 78
• Length of inpatient stay (MD -6.05, 95% CI -16.40 to 4.31; 207 participants; 4 studies; I2 = 0%; P = 0.29; Analysis 1.2).
participants; 4 studies; I2 = 27%; P = 0.25; Analysis 1.3). • Penetration aspiration score (SMD -0.53, 95% CI -1.22 to 0.16; 81
• Proportion of participants with dysphagia at end of trial (OR participants; 5 studies; I2 = 51%; P = 0.13; Analysis 1.6).
0.55, 95% CI 0.15 to 2.11; 66 participants; 3 studies; I2 = 0%; P =
0.39; Analysis 1.4). In summary, acupuncture, behavioural interventions, and TMS
appeared to be individually effective for reducing some outcomes.
• Swallowing ability (SMD 0.06, 95% CI -0.22 to 0.34; 194 However, as results of testing for subgroup differences were not
significant, none of these interventions are convincingly different
• Penetration aspiration score (SMD -0.17, 95% CI -0.53 to 0.19; 177 from the summary result. Drug therapy was the only intervention
participants; 4 studies; I2 = 12%; P = 0.35; Analysis 1.6). that was significantly less than 1.0, and findings were significantly
• Chest infection (OR 0.43, 95% CI 0.06 to 3.09; 28 participants; 1 different for testing of subgroup differences, although this result
study; I2 not applicable; P = 0.40; Analysis 1.7). was based on very low-quality evidence.
• Pharyngeal transit time (MD -0.15, 95% CI -0.67 to 0.37; 28
participants; 1 study; I2 not applicable; P = 0.56; Analysis 1.8). DISCUSSION
• Institutionalisation (OR 0.73, 95% CI 0.36 to 1.48; 141
Summary of main results
participants; 1 study; I2 not applicable; P = 0.38; Analysis 1.9).
• Nutrition (MD 0.40; 95% CI-1.62 to 2.42; 105 participants; 1 study; We included 41 studies in this updated review of swallowing
I2 not applicable; P = 0.70; Analysis 1.10). therapy in people with stroke. We identified 22 additional studies
that are ongoing (Characteristics of ongoing studies), along with 86
Physical stimulation (thermal, tactile) studies that are awaiting classification (Characteristics of studies
awaiting classification).
Physical stimulation reduced pharyngeal transit time in one small
study (i.e. < 1.0). However, these findings may be due to chance, Researchers assessed eight types of stimulatory techniques -
given that testing for subgroup differences did not yield significant acupuncture, behavioural therapy, drug therapy, neuromuscular
findings. electrical stimulation (NMES), pharyngeal electrical stimulation
(PES), physical stimulation, transcranial direct current stimulation
Physical stimulation had no effect on case fatality at end of trial nor
(tDCS), and transcranial magnetic stimulation (TMS). Swallowing
on proportion of participants with dysphagia at end of trial and did
therapy had no effect on functional outcomes (death or
not improve swallowing ability.
dependency, or death or disability), although only one trial
• Pharyngeal transit time (MD -0.19, 95% CI -0.34 to -0.04; 16 reported this outcome (two data sets). Swallowing therapy also
participants; 1 study; I2 not applicable; P = 0.01; Analysis 1.8). had no effect on case fatality at end of trial, nor on penetration
aspiration score. However, swallowing therapy probably reduced
• Case fatality at end of trial (OR 1.05, 95% CI 0.16 to 6.92; 19
length of inpatient stay, the proportion of participants with
participants; 1 study; I2 not applicable; P = 0.96; Analysis 1.2).
dysphagia at end of trial, and the incidence of chest infection or
• Proportion of participants with dysphagia at end of trial (OR pneumonia (with one study reporting significant effects for drug
0.65, 95% CI 0.07 to 5.85; 127 participants; 2 studies; I2 = 0%; P therapy). Swallowing therapy also probably improved swallowing
= 0.70; Analysis 1.4). ability. In the absence of significant effects on the primary outcome,
• Swallowing ability (SMD -0.30, 95% CI -1.29 to 0.68; 16 statistically significant findings in secondary and explanatory
participants; 1 study; I2 not applicable; P = 0.55; Analysis 1.5). outcomes are hypothesis-generating and might reflect chance, for
example, due to multiple-comparison testing. Hence, further trials
Transcranial direct current stimulation (tDCS) are needed to test these observations.
tDCS did not alter the proportion of participants with dysphagia at
end of trial and did not improve swallowing ability. Data on other
outcomes were not available.

Informed decisions.

Overall completeness and applicability of evidence acupuncture in stroke (Xie 2008; Long 2012; Wong 2012),
behavioural interventions in neurogenic dysphagia (Ashford 2009),
Results of this review are incomplete at this time because of TMS in stroke and acquired brain injury (Yang 2015; Liao 2016;
the significant number of ongoing studies and those awaiting Momosaki 2016; Pisegna 2016), tDCS in stroke and acquired brain
classification identified by review authors. Nevertheless, the injury (Yang 2015; Momosaki 2016; Pisegna 2016), NMES in stroke
addition of new studies to this version of the review has and neurological impairment (Chen 2016; Ding 2016), and PES in
tightened confidence intervals, although the overall conclusion stroke (Scutt 2015). However, these reviews have examined the
that dysphagia treatment does not alter functional outcome has efficacy of individual interventions, whereas the current review has
not changed. examined the efficacy of swallowing therapy overall; hence direct
comparisons are difficult to make.
Quality of the evidence
The quality of evidence ranged from very low and low through AUTHORS' CONCLUSIONS
moderate to high, as presented in Summary of findings for the
main comparison. The most common reasons for reduced quality Implications for practice
of evidence were lack of blinding, moderate to considerable Information on effects of swallowing therapy on the primary
heterogeneity between trials, and lack of precision (i.e. inclusion of outcome of death or dependency/disability continues to be
multiple different interventions). insufficient. Although some swallowing therapies appear to have
a beneficial effect on some outcomes, these results are based on
Potential biases in the review process lower-quality evidence. At present, clinical decisions cannot be
Results of the present analysis are subject to several caveats. based on reliable evidence from clinical trials.
First, we combined different interventions together for analysis,
to assess whether trial results show any effect of swallowing Implications for research
therapy as a whole as opposed to no intervention or usual On the basis of existing studies and the need to exclude many
care. This means that decisions on which specific types of others, future trials should consider the following design issues.
interventions are effective cannot be made upon analysis of these
data. Future reviews will focus on assessing effects of specific • Patients: include only those who have post-stroke dysphagia,
interventions on main outcomes. Second, we excluded 80 studies and limit recruitment to a particular temporal phase after stroke.
from the analysis. One common reason for exclusion is that studies Researchers must specify clearly the time from stroke onset to
compared two active treatments without including a control or randomisation when reporting trials. Trialists should aim for
placebo group. We also excluded trials due to lack of uniformity larger numbers of participants, ideally from multiple centres.
in usage of outcome measures and lack of data on clinical • Comparator: in the absence of any proven treatment, the control
outcomes, such as dependency, mortality, institutionalisation, group should receive only standard care, with the treatment
and chest infection or pneumonia. Further, included trials used group receiving standard care plus the intervention being
various swallowing assessment techniques, cortical excitability tested.
techniques, and videofluoroscopic measurements. So, trialists
• Outcomes: studies need to ensure that standardised outcome
are encouraged to design future trials that include a control or
measures are used to allow comparison of trials. Functional
placebo group, and to incorporate standard outcome measures.
outcome (death or dependency) should be included in future
Third, a further 86 studies are awaiting assessment, subject to
trials, as should the number of participants who develop chest
the availability of full-text articles; such omission of multiple
infection or pneumonia, or who have signs of aspiration. Trials
studies will inevitably bias review results. Fourth, with regard to
should include outcomes of relevance to health economics, such
acupuncture, data from three studies may have been confounded
as length of inpatient stay and discharge to an institution, as
due to use of 'routine' acupuncture or a different type of
well as quality of life outcomes (e.g. EuroQoL Group Quality
acupuncture as control, variation in delivery of therapy, and risk
of Life Questionnaire based on five dimensions (EuroQoL-5D),
of language bias, in that some of the acupuncture literature is
Swallowing Quality of Life Questionnaire (SWAL-QOL)).
available in full only in Chinese language journals. Similarly, we
included data from an NMES study (Park 2012), which considered • Methods: researchers should endeavour to examine common
sensory stimulation as a control; therefore we cannot be certain parameters (i.e. use similar methods), so that results can be
that this trial is not confounded. Last, the present analysis included compared more readily across different studies.
only studies up to six months from stroke onset, and the effects of • Quality of research: trialists must report full information on
later treatments for post-stroke dysphagia remain unclear. randomisation, allocation concealment, blinding of treatment
and outcome assessment, and attrition.
It is important to note that many trials are ongoing and should add • Future research: further research is needed to discover which
substantially to the existing data once complete. components of swallowing therapy are beneficial. A number
of studies assessing interventions for dysphagia are ongoing
Agreements and disagreements with other studies or (22 studies), and findings of these studies will add further
reviews information on this topic (Characteristics of ongoing studies).
This is the largest, most inclusive, and most up-to-date review Several studies of mixed groups of chronic dysphagia have
on this topic. It combines all current interventions for dysphagia been done or are ongoing: a systematic review of these studies
in the acute and subacute phases of stroke. A number of may further inform the management of acute and subacute
separate systematic reviews exploring individual interventions for dysphagia post stroke.
stroke survivors have been published, including some examining

Informed decisions.

ACKNOWLEDGEMENTS We thank the Cochrane Stroke Group for assistance in identifying

trials and conducting searches, and their editors and external
We thank the following people who were review authors in previous assessor for comments on the review. Several trialists and other
versions of this review. interested healthcare staff reviewed the draft of the first version
and made comments - we thank each of them: CGMI Baeten
• Version 1 (1999): Jean Kerr, Morwenna Collins, Cameron Sellars, (Netherlands), MS Dennis (UK), BR Garon (USA), GJ Hankey
and David Smithard; they variously contributed to searches, (Australia), GKT Holmes (UK), PR Mills (UK), B Norton (UK), C
data extraction, analysis and interpretation of data, and Ormiston (USA), J Rosenbek (USA), and G Vanhooren (Belgium).
updating of the review. We also thank D Luo and G Lan, who translated five of the papers
• Version 2 (2012): Jessica Beavan, Sharon Ellendar, and Chamilla from Chinese into English. Finally, we are grateful to the funding
Geeganage; they variously undertook searches, data extraction, bodies that supported this research. Naturally any mistakes are our
and analysis and interpretation of data, and updated the review. own. We would be very grateful to be informed of any completed
or ongoing trials that are not listed in the review, and to know of
outcome data from existing trials that have not been included.

Informed decisions.

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Informed decisions.

Terre 2015 {published data only} References to studies excluded from this review
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neuromuscular electrical stimulation in oropharyngeal
Akamatsu C, Ebihara T, Ishizuka S, Fujii M, Seki K, Arai H, et al.
dysphagia secondary to acquired brain injury. European Journal
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to lower leg acupoints in patients after stroke. Journal of the
Vasant 2016 {published data only} American Geriatric Society 2009;57(10):1959-60.
Vasant D, Michou E, Tyrrell P, Jayasekeran V, Mistry S, O'Leary N, Aoki 2016 {published data only}
et al. Pharyngeal electrical stimulation (PES) In dysphagia
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decreases pneumonia onset in acute stroke patients. PLOS ONE
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Informed decisions.

electroacupuncture integrated rehabilitation. Chinese Journal of Freed 2001 {published data only}
Clinical Rehabilitation 2003;7(3):430-1. Freed ML, Freed L, Chatburn RL, Christian M. Electrical
stimulation for swallowing disorders caused by stroke.
ChiCTR-ONC-17012326 {published data only}
Respiratory Care 2001;46(5):466-74.
ChiCTR-ONC-17012326. Therapeutic effect of acupuncture
and rTMS for dysphagia after unilateral hemispheric Hagg 2015 {published data only}
stroke of pharyngeal stage: a multi-center cohort study. Hagg M, Tibbling L. Effect of oral IQoro® and palatal plate
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ChiCTR-TRC-14005233 {published data only}
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stroke rehabilitation. www.chictr.org.cn/showprojen.aspx? Inui Y, Kamakuyra Y, Fukada J, Yoneda M, Kataoka E, Usami Y,
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aspiration pneumonia prevention during the acute stroke.
DePippo 1994 {published data only}
Dysphagia 2017;32:767-76.
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stroke: a controlled trial. Neurology 1993;43:A234-5. ISRCTN18137204 {published data only}
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DePippo KL, Holas MA, Reding MJ, Lesser ML, Mandel FS.
for early de-cannulation in TRACheotomised stroke patients
Dysphagia therapy following stroke: a controlled trial.
with neurogenic dysphagia: a prospective randomized
Neurology 1992;42:249.
single-blinded interventional study (PHAST TRAC study).
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a prospective randomised single-blinded interventional study
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Ebihira 2005 {published data only} in chronic stage treated with magnetic-ball sticking therapy at
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Watando A. Capsaicin trouche for swallowing dysfunction
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with cerebrovascular disease: a randomized double-blind
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associated with improved motor function after brain injury.
Neuron 2002;34(5):831-40. Kobayashi 1996 {published data only}
Freed 1996 {published data only} Kobayashi H, Nakagawa T, Sekizawa K, Arai H, Sasaki H.
Levodopa and swallowing reflex. Lancet 1996;348:1320-1.
Freed M, Christian MO, Beytas EM, Tucker H, Kotton B.
Electrical stimulation of the neck: a new effective treatment for
dysphagia. Dysphagia 1996;11:159.

Informed decisions.

Kulnik 2015 {published data only} Mepani 2009 {published data only}
Kulnik ST, Birring SS, Moxham J, Rafferty GF, Klara L. Does Mepani R, Antonik S, Massey B, Kern M, Logemann J, Pauloski B,
respiratory muscle training improve cough flow in acute stroke? et al. Augmentation of deglutitive thyrohyoid muscle shortening
Pilot randomized controlled trial. Stroke 2015;46:447-53. by the shaker exercise. Dysphagia 2009;24:26-31.
Kushner 2013 {published data only} Messaggi-Sartor 2015 {published data only}
Kushner DS, Peters K, Eroglu ST, Perless-Carroll M, Johnson- Messaggi-Sartor M, Guillen-Solà A, Depolo M, Duarte E,
Greene D. Neuromuscular electrical stimulation efficacy Rodríguez DA, Barrera M, et al. Inspiratory and expiratory
in acute stroke feeding tube-dependent dysphagia during muscle training in subacute stroke - a randomized clinical trial.
inpatient rehabilitation. American Journal of Physical Medicine American Academy of Neurology 2015;85:564-72.
and Rehabilitation 2013;92(6):486-95.
Michou 2010 {published data only}
Lan 2013 {published data only} * Michou E, Mistry S, Jefferson S, Singh S, Rothwell J, Hamdy S.
Lan Y, Xu G, Dou Z, Wan G, Yu F, Lin T. Biomechanical changes Addressing oropharyngeal dysphagia post stroke with
in the pharynx and upper sphincter after modified balloon neurostimulation interventions: a pilot study. International
dilatation in brainstem stroke patients with dysphagia. Journal of Stroke 2010;5 Suppl 3:61-2.
Neurogastroenterology and Motility 2013;25:821-9.
Michou E, Mistry S, Jefferson S, Singh S, Hamdy SA. Preliminary
Logemann 2009 {published data only} study of neurostimulation based interventions in the treatment
Logemann JA, Rademaker A, Pauloski BR, Kelly A, Stangl- of chronic dysphagia post stroke. Gut 2010;59(1):A27.
McBreen C, Antinoja J, et al. A randomized study comparing the
Michou 2011 {published data only}
Shaker exercise with traditional therapy: a preliminary study.
Dysphagia 2009;24(4):403-11. Michou E, Mistry S, Jefferson S, Singh S, Rothwell J, Tyrrell P,
et al. Neurostimulation techniques benefit stroke patients
Ma 2014 {published data only} with chronic oropharyngeal dysphagia: preliminary results
Ma FX, Cao GP, Li WL. Post-stroke dysphagia treated with from a randomised controlled study. Cerebrovascular Diseases
acupoint injection combined with neural electrical stimulation. 2011;31(Suppl 2):58.
Zhongguo Zhenjiu 2014;34(12):1169-73.
Nakamura 2013 {published data only}
Ma 2015 {published data only} Nakamura T, Fujishima I. Usefulness of ice massage in triggering
Ma JN, Wang ZL, Ning LN, Yang H, Xiong J. Observation the swallow reflex. Journal of Stroke and Cerebrovascular
on therapeutic effects of acupuncture combined with Diseases 22;4:378-82.
cutaneous electrical stimulation for dysphagia in patients with
Nakayama 1998 {published data only}
cerebral infarction. Chen Tzu Yen Chiu Acupuncture Research
2015;40(3):238-41. Nakayama K, Sekizawa K, Sasaki H. ACE inhibitor and
swallowing reflex. Chest 1998;113(5):1425.
Maeda 2017 {published data only}
Nam 2012 {published data only}
Maeda K, Koga T, Akagi J. Interferential current sensory
stimulation, through the neck skin, improves airway defense Nam H, Beom J, Oh BM, Han BR. Kinematic analysis of hyoid
and oral nutrition intake in patients with dysphagia: a double- bone and vocal cord after laryngeal electrical stimulation
blind randomized controlled trial. Clinical Interventions in Aging therapy in dysphagia. Neurorehabilitation and Neural Repair
2017;12:1879-86. 2012;26(4):433.
Mao 2016 {published data only} NCT00376506a {published data only}

Mao L, Li L, Mao Z, Han Y, Zhang X, Yao J, Li M. Therapeutic effect NCT00376506. A comparison of an implanted neuroprosthesis
of acupuncture combining standard swallowing training for with sensory training for improving airway protection in chronic
post-stroke dysphagia: a prospective cohort study. Chinese dysphagia. https://clinicaltrials.gov/ct2/show/NCT00376506
Journal of Integrative Medicine 2016;22(7):525-31. (first received 15 September 2006).
McCullough 2012 {published data only} NCT00376506b {published data only}

McCullough GH, Kamarunas E, Mann GC, Schmidley JW, NCT00376506. A comparison of an implanted neuroprosthesis
Robbins JA, Crary MA. Effects of Mendelsohn maneuver on with sensory training for improving airway protection in chronic
measures of swallowing duration post-stroke. Topics in Stroke dysphagia. clinicaltrials.gov/ct2/show/NCT00376506 (first
Rehabilitation 2012;19(3):234-43. received 15 September 2006).
McCullough 2013 {published data only} NCT01971320 {published data only}

McCullough GH, Kim Y. Effects of the Mendelsohn maneuver NCT01971320. Evaluation of transcutaneous electrical
on extent of hyoid movement and UES opening post-stroke. stimulation in post stroke dysphagia. clinicaltrials.gov/show/
Dysphagia 2013;28:511-9. NCT01971320 (first received 29 October 2013).

Informed decisions.

Nishiyama 2010 {published data only} Sdravou 2012 {published data only}
Nishiyama Y, Abe A, Ueda M, Katsura K, Katayama Y. Nicergoline Sdravou K, Walshe M. Effects of carbonated liquids on
increases serum substance P levels in patients with an oropharyngeal swallowing measures in people with neurogenic
ischaemic stroke. Cerebrovascular Diseases 2010;29(2):194-8. dysphagia. Dysphagia 2012;27:240-50.
Ortega 2016 {published data only} Seki 2005 {published data only}
Ortega O, Rofes L, Martin A, Arreola V, Lo I, Clave P. A Seki T, Iwasaki K, Arai H, Sasaki H, Hayashi H, Yamada S, et al.
comparative study between two sensory stimulation Acupuncture for dysphagia in post stroke patients: a video
strategies after two weeks treatment on older patients with fluoroscopic study. Journal of the American Geriatrics Society
oropharyngeal dysphagia. Dysphagia 2016;31:706-16. 2005;53(6):1083-4.
Permsirivanich 2009 {published data only} Shaker 2002a {published data only}
Permsirivanich W, Tipchatyotin S, Wongchai M, Leelamanit V, Easterling C, Kern M, Nitschke T, Grande B, Kazandijan M,
Setthawatcharawanich S, Sathirapanya P, et al. Comparing the Dikeman K, et al. Restoration of oral feeding in 17 tube fed
effects of rehabilitation swallowing therapy vs. neuromuscular patients by the Shaker exercise. Dysphagia 2000;15(2):105.
electrical stimulation therapy among stroke patients with
persistent pharyngeal dysphagia: a randomized controlled * Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S,
study. Journal of the Medical Association of Thailand et al. Rehabilitation of swallowing by exercise in tube-fed
2009;92(2):259-65. patients with pharyngeal dysphagia secondary to abnormal
UES opening. Gastroenterology 2002;122:1314-21.
Pownall 2008 {published data only}
She 2014 {published data only}
Pownall S, Enderby P, Hendra T, Marshall M. Are thickened fluids
worth the trouble? A pilot RCT of dysphagia management. She RP, Ge CH. Clinical observation on medulla oblongata palsy
Proceedings of the 3rd UK Stroke Forum Conference. Harrogate, after brainstem infarction treated with electroacupuncture
UK: The Stroke Association, 2008:86-7. at eight-neck-occiput points. Zhongguo Zhen Jiu
2014;34(6):539-42.
Pryor 2011 {published data only}
SQACU01 2001 {published data only}
Pryor J, Leonard R, Belafsky P. A prospective, randomized
trial of two dysphagia therapies: neuromuscular electrical Heng D. SQACU01 - a randomised trial of acupuncture as
stimulation and vibrotactile stimulation. Dysphagia adjuvant therapy for dysphagia due to recent stroke. Clinical
2011;26(4):466. Trials and Epidemiology Research Unit Annual Report.
Singapore: Clinical Trials and Epidemiology Research Unit,
Reidnauer 2006 {published data only} 2001:41.
Reidnauer S, Repsher S, Stryker D, Segal M. Vital stimulation
Steele 2016 {published data only}
may be more effective than traditional treatment in improving
swallowing after stroke. Stroke 2006;37(2):737. Steele CM. Tongue pressure profile training for dysphagia post
stroke (TPPT): study protocol for an exploratory randomized
Rofes 2014 {published data only} controlled trial. Trials 2013; Vol. 14:126.
Rofes L, Arreola V, Martin A, Clave P. Effect of oral piperine
* Steele CM, Bayley MT, Peladeau-Pigeon M, Nagy A,
on the swallow response of patients with oropharyngeal
Namasivayam AM, Stokely S, et al. A randomized trial
dysphagia. Journal of Gastroenterology 2014;29:1517-23.
comparing two tongue-pressure resistance training protocols
Rosenbek 1991 {published data only} for post-stroke dysphagia. Dysphagia 2016;31:452-61.
Rosenbek JC, Robbins J, Fishback B, Levine RL. Effects of Sukthankar 1994 {published data only}
thermal application on dysphagia after stroke. Journal Speech
Sukthankar SM, Reddy NP, Canilang EP, Stephenson L,
and Hearing Research 1991;34:1257-68.
Thomas R. Design and development of portable biofeedback
Rosenbek 1996 {published data only} systems for use in oral dysphagia rehabilitation. Medical
Engineering and Physics 1994;16:430-5.
Rosenbek JC. Effects of thermal stimulation on dysphagia after
stroke. Journal of Rehabilitation Research and Development Suntrup 2015 {published data only}
1990;28(1):151.
DRKS00005509. A single-centre, double blind, randomised
* Rosenbek JC, Roecker EB, Wood JL, Robbins J. Thermal controlled clinical trial to evaluate the effect of electrical
application reduces the duration of stage transition in pharyngeal stimulation as a treatment for stroke-related
dysphagia after stroke. Dysphagia 1996;11:225-33. dysphagia in tracheotomized stroke patients. www.drks.de/
DRKS00005509 (first received 15 January 2014).
Rosenbek 1998 {published data only}
* Suntrup S, Marian T, Schröder JB, Suttrup I, Muhle P,
Rosenbek JC, Robbins JA, Willford WO, Kirk G, Schiltz A,
Oelenberg S, et al. Electrical pharyngeal stimulation for
Sowell TW, et al. Comparing treatment intensities of tactile-
dysphagia treatment in tracheotomized stroke patients:
thermal application. Dysphagia 1998;13:1-9.
a randomized controlled trial. Intensive Care Medicine
2015;41(9):1629-37.
Informed decisions.

Suzuki 2012 {published data only} Zhang 2011 {published data only}
Suzuki H, Takeda S, Nakazaki M, Sone S, Mori T. The appropriate Zhang ZL, Zhao SH, Chen GH, Ji XQ, Xue L, Yang YQ, et al.
body position during nasal-gastric tube feeding to prevent the Randomized controlled study on dysphagia after stroke
aspiration pneumonia in acute stroke patients. Cerebrovascular treated with deep insertion of Chonggu (EX-HN 27) by
Diseases 2012;33(2):464. electroacupuncture. Zhongguo Zhen Jiu 2011;31(5):385-90.
Tai 2014 {published data only} Zhang 2018a {published data only}
* Tai S, Chang Y, Chang L. On the use of the chin-down posture Zhang L, Xu N, Li R, Wang L. Clinical study of electroacupuncture
for dysphagia in stroke patients. Cerebrovascular Diseases with different frequencies at Lianquan (CV 23) and Fengfu (GV
2014;38:105. 16) for stroke dysphagia. Chinese Acupuncture and Moxibustion
2018;38(2):115-9.
Tai S, Huang HM. The effectiveness of the chin-down posture
in the improvement of dysphagia in stroke patients. http:// Zhang 2018b {published data only}
hdl.handle.net/10755/602716 (first received 21 March 2016). Zhang R, Ju X. Clinical improvement of nursing intervention in
swallowing dysfunction of elderly stroke patients. Biomedical
Teramoto 2008 {published data only}
Research 2018;29(6):1099-102.
Teramoto S, Yamamoto H, Yamaguchi Y, Ishii M, Hibi S,
Kume H. Antiplatelet cilostazol, an inhibitor of type III Zhao 2015 {published data only}
phosphodiesterase, improves swallowing function in patients Zhao K, Wang Z, Cao W, Zhang Y, Song S, Kang W, et al.
with a history of stroke. Journal of the American Geriatrics Therapeutic efficacy of swallowing neuromuscular electrical
Society 2008;56(6):1153-4. stimulation combined with acupuncture for post-stroke
dysphagia. World Journal of Acupuncture-Moxibustion
Terre 2012 {published data only}
2015;25(1):19-23.
Terre R, Mearin F. Effectiveness of chin-down posture to prevent
tracheal aspiration in dysphagia secondary to acquired brain
injury. A videofluoroscopy study. Neurogastroenterology and References to studies awaiting assessment
Motility 2012;24:414.
Azimov 2017 {published data only}
Toyama 2014 {published data only} Azimov A, Sadykov R, Rakhimbaeva G. Dopaminergic medicines
* Toyama K, Matsumoto S, Kurasawa M, Setoguchi H, Noma T, can treat dysphagia in ischemic stroke. Journal of the
Takenaka K, et al. Novel neuromuscular electrical stimulation Neurological Sciences 2017;381 Suppl 1:396.
system for treatment of dysphagia after brain injury. Neurologia
Carnaby 2012 {published data only}
Medico-Chirurgica 2014;54:521-8.
Carnaby G, LaGorio L, Crary M, Miller D. A randomized double
UMIN000015406. Effect of electrical stimulation in post- blind trial of neuromuscular electrical stimulation + McNeill
stroke patients with dysphagia: a feasibility study. https:// dysphagia therapy (MDTP) after stroke (ANSRS). Dysphagia
upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? 2012;27:569-620.
recptno=R000017918 (first received 10 October 2014).
Chang 2014 {published data only}
Ueda 2004 {published data only} Chang L, He PL, Zhou ZZ, Li YH. Efficacy observation of
Ueda K, Yamada Y, Toyosata A, Nomura S, Saitho E. Effects of dysphagia after acute stroke treated with acupuncture
functional training of dysphagia to prevent pneumonia for and functional electric stimulation. Zhongguo Zhenjiu
patients on tube feeding. Gerontology 2004;21:108-11. 2014;34(8):737-40.
Varma 2006 {published data only} Chaudhuri 2008 {published data only}
Varma AK. The effect of motor control on oro-facial dysfunctions Chaudhuri G, Brady S, Caldwell R, Wesling M, Quill A.
in stroke patients under Indian conditions; 5th World Stroke Neuromuscular electrical stimulation (NMES) for dysphagia
Congress; 2004 Jun 23-26; Vancouver, Canada. 2006;e319. treatment following acute ischaemic stroke. Dysphagia
2008;23(4):441.
Wang 2016 {published data only}
Wang Z, Ma J, Ning L. Clinical observation of dysphagia after Chen 2017 {published data only}
cerebral infarction treated with awn-like needle at Tiantu (CV Chen D, Xing H Jiang Q, Xiang Y, Guo H. Role of levetiracetam
22). Chinese Acupuncture and Moxibustion 2016;36(10):1019-22. in the rehabilitation of dysphagia due to stroke. International
Journal of Pharmacology 2017;13(6):603-11.
Xia W, Zheng C, Xia J, Zhang Y. Post-stroke dysphagia treated Cheng 2005 {published data only}
with acupuncture of meridian differentiation: a randomized Cheng XL, Zhao CS, Wang H, Ma L. Effects of early throat muscle
controlled trial. Chinese Acupuncture and Moxibustion training on vertebral-basilar artery blood flow in patients with
2016;36(7):673-8. pseudobulbar palsy. Chinese Journal of Clinical Rehabilitation
2005;9(25):17-9.

Informed decisions.

Cheng 2014 {published data only} Fan 2007 {published data only}
Cheng FX, Chen T. Efficacy observation of post-stroke dysphagia Fan C, Jiang H, Wu L. Clinical observations on acupuncture
treated with acupuncture at Lianquan (CV 23). Zhongguo Zhen treatment of postapoplectic dysphagia. Shanghai Journal of
Jiu 2014;34(7):627-30. Acupuncture and Moxibustion 2007;26:6-7.
ChiCTR-TRC-07000010 {published data only} Feng 2016 {published data only}

ChiCTR-TRC-07000010. Randomized controlled study on the Feng S, Cao S, Du S, Yin T, Mai F, Chen X, et al. Acupuncture
acupuncture for dysphagia in convalescence phase of apoplexy. combined with swallowing training for post-stroke
http://www.chictr.org.cn/showprojen.aspx?proj=9515 (first dysphagia: a randomized controlled trial. Zhongguo Zhen Jiu
received 6 February 2007). 2016;36(4):347-50.
ChiCTR-TRC-08000463 {published data only} Gao 2016 {published data only}

ChiCTR-TRC-08000463. Clinical evaluation of dysphagia Gao J, Zhang HJ. Effects of chin tuck against resistance exercise
therapeutic apparatus on cerebrovascular disease. Chinese versus Shaker exercise on dysphagia and psychological state
Clinical Trial Registry (ChiCTR) www.chictr.org/ (first received 3 after cerebral infarction. European Journal of Physical and
November 2008). Rehabilitation Medicine 2016;53(3):426-32.
ChiCTR-TRC-14004235 {published data only} Guillen-Sola 2017 {published data only}

ChiCTR-TRC-14004235. Clinical research of modified Dihuang * Guillén-Solà A, Messagi Sartor M, Bofill-Soler N, Duarte E,
Yinzi Decoction combined swallowing rehabilitation and Barrera MC, Marco E. Respiratory muscle strength training and
videofluoroscopy on post-stroke dysphagia patients: a pilot neuromuscular electrical stimulation in subacute dysphagic
trial. www.chictr.org/en/proj/show.aspx?proj=6601 (first stroke patients: a randomized controlled trial. Clinical
received 20 January 2014). Rehabilitation 2017;31(6):761-71.
ChiCTR-TRC-14004955 {published data only} Guillen-Sola A, Messagi-Sartor M, Barrera De Paz C, Bofill-

ChiCTR-TRC-14004955. Effect of transcranial direct current Soler N, Rodriguez DA, Duarte E, et al. Effects of neuromuscular
stimulation on dysphagia after stroke. http://www.chictr.org.cn/ electrostimulation and respiratory muscle training in acute/
showproj.aspx?proj=4618 (first received 16 July 2014). subacute dysphagic stroke patients. Retornus: a randomized
control trial. Dysphagia 2015;30(2):236-7.
Choi 2017 {published data only}
Hamada 2017 {published data only}
Choi J-B, Shim S-H, Yang J-E, Kim H-D, Lee D-H, Park J-S. Effects
of Shaker exercise in stroke survivors with oropharyngeal Hamada S, Yamaguchi H, Hiroyoshi H. Does sensory
dysphagia. NeuroRehabilitation 2017;41(4):753-7. transcutaneous electrical stimulation prevent pneumonia in the
acute stage of stroke? A preliminary study. International Journal
Chu 2017 {published data only} of Rehabilitation Research 2017;40(1):94-6.
Chu J, Liu X, Chen F, Hong F, Bao Y. Effects of GAO's neck
Hong 2011 {published data only}
acupuncture on swallowing function and quality of life in
patients with post-stroke pseudobulbar palsy: a randomized Hong Z, Yulin W, Qin Y. Influence of diet nursing care on the
controlled trial. Chinese Acupuncture and Moxibustion prognosis of patients with poststroke dysphagia. Chinese
2017;37(7):691-5. Nursing Research 2011;25(1C):211-3.
de Fraga 2017 {published data only} Huang 2008 {published data only}
de Fraga BFD, Almeida STD, Santana MG, Cassol M. Efficacy Huang YL, Liang FR, Chang HS, Hu KM, He J, Li N, et al. Effect
of myofunctional therapy associated with voice therapy in of acupuncture on quality of life in post-ischemic stroke
the rehabilitation of neurogenic oropharyngeal dysphagia: patients with dysphagia. Zhongguo Zhong Xi Yi Jie He Za Zhi
a pilot study. International Archives of Otorhinolaryngology 2008;28:505-8.
2017;DOI:10.1055/s-0037-1605597:[Ref 27900].
Huang 2014 {published data only}
Eom 2017 {published data only} * Huang K, Liu T, Huang Y, Leong C, Lin W, Pong Y. Functional
Eom M, Chang M, Oh D, Kim H, Han N, Park J. Effects of outcome in acute stroke patients with oropharyngeal dysphagia
resistance expiratory muscle strength training in elderly after swallowing therapy. Journal of Stroke and Cerebrovascular
patients with dysphagic stroke. Neuro Rehabilitation Diseases 2014;23(10):2547-53.
2017;41(4):747-52.
NCT03048916. Dysphagia after different swallowing therapies.
Erfmann 2017 {published data only} https://www.clinicaltrials.gov/ct2/show/record/NCT03048916
(first received 1 August 2010).
Erfmann, K. Effects of expiratory muscle strength training
(EMST) on oropharyngeal dysphagia in subacute stroke Huimin 2015 {published data only}
patients: a randomised controlled trial. Journal of Clinical
Huimin Z, Yongchao Y, Jiang R, Li L, Yao W, Weibo S, Jie Z. Effect
Practice in Speech-Language Pathology 2017;19(2):111.
of surface electromyographic biofeedback on the pharyngeal

Informed decisions.

phase activities in patients with dysphagia after stroke. Chinese Li 2008 {published data only}
Journal of Cerebrovascular Diseases 2015;12(11):572-6. Li J, Li J. Acupuncture used to treat dysphagia induced by
ischemic stroke. Journal of Beijing University of Traditional
Jefferson 2008 {published data only}
Chinese Medicine 2008;15:17-9.
Jefferson S, Hamdy S, Michou E, Mistry S, Singh S.
Neurostimulation is able to increase cortical bulbar excitability Li 2009 {published data only}
following dysphagic stroke. Proceedings of the 3rd UK Stroke Li H, Yue G, Liu D, Zhou H. Clinical observations on acupuncture
Forum Conference; 2008 Dec 2-4. Harrogate: The Stroke plus rehabilitation training for improving postapoplectic
Association, 2008. dysphagia. Shanghai Journal of Acupuncture and Moxibustion
2009;28:388-9.
Jia 2006 {published data only}
Jia H-L, Zhang Y-C. Treatment of 40 cases of post-apoplectic Li 2016 {published data only}
dysphagia by acupuncture plus rehabilitation exercise. Journal Li Y, Ren K, Xing R, Peng J, Zhang Z, Zhao J. Clinical research
of Acupuncture and Tuina Science 2006;4(6):336-8. of the five needles combined with rehabilitation training
treatment dysphagia after stroke. Pakistan Journal of
Jiang 2014 {published data only}
Pharmaceutical Sciences 2016;29(5 Suppl):1745-8.
Jiang W, Tan B, Zhou Y, Jia G, Wu X, Jia L, et al. Clinical study on
treatment of patients with dysphagia after stroke by improved Liu 2018 {published data only}
Vitalstim electroacupuncture. Journal of Shanghai Jiaotong Liu XP, Chen FY, Chu JM, Bao YH. Effects of nape acupuncture
University (Medical Science) 2014;34(9):1361-4. combined with swallowing rehabilitation on dysphagia in
pseudobulbar palsy. Journal of Traditional Chinese Medicine
Jing 2016 {published data only}
2018;38(1):117-24.
Jing Q, Yang X, Reng Q. Effect of neuromuscular electrical
stimulation in patients with post-stroke dysphagia. Medical Ma 2016 {published data only}
Science Technology 2016;57:1-5. Ma P, Xu S, Tian W, Duan H, Wang C, Shan Y, et al. Efficacy
observation of post-stroke pseudo-bulbar palsy treated
Ji-Ye 2017 {published data only}
with quick needle insertion therapy at Aqiang point. Chinese
Ji-Ye L. Influence of acupoint-injection on TXB2 and 6-keto- Acupuncture and Moxibustion 2016;36(10):1027-30.
PGF1a in patients with pseudobulbar palsy: a randomized
controlled trial. Journal of Acupuncture and Tuina Medicine Malik 2017 {published data only}
2017;1:22-6. Malik SN, Khan MSG, Ehsaan F, Tul-Ain Q. Effectiveness of
swallow maneuvers, thermal stimulation and combination
Kim 2017 {published data only}
both in treatment of patients with dysphagia using functional
Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue- outcome swallowing scale. Biomedical Research (India)
to-palate resistance training improves tongue strength and 2017;28(4):1479-82.
oropharyngeal swallowing function in subacute stroke survivors
with dysphagia. Journal of Oral Rehabilitation 2017;44:59–64. Mehndiratta 2017 {published data only}
Mehndiratta MM, Gupta P, Kaur M. The effect of sensory-level
Koch 2015 {published data only}
electrical stimulation of the masseter muscle in early stroke
Koch I, Meneghello F, Piccione F. Preliminary data of swallowing patients with dysphagia. Neurology India 2017;65(4):743-5.
training using sEMG as biofeedback. Journal of the Neurological
Sciences 2015;357:e353. Meng 2015 {published data only}
Meng Y, Wang C, Shang S, Ning L, Zhou L, Han K. Effects of
Konecny 2018 {published data only}
different acupuncture depths of Lianquan (CV 23) for dysphagia
Konecny P, Elfmark M. Electrical stimulation of hyoid muscles after stroke: a randomized controlled trial. Zhongguo Zhen Jiu
in post-stroke dysphagia. Biomedical Papers of the Medical 2015;35(10):990-4.
Faculty of the University Palacky Olomouc Czechoslovakia
2018;162(1):40-2. Meng 2018 {published data only}
Meng P, Zhang S, Wang Q, Wang P, Han C, Gao J, Yue S. The
Koyama 2017 {published data only}
effect of surface neuromuscular electrical stimulation on
Koyama Y, Sugimoto A, Hamano T, Kasahara T, Toyokura M, patients with post-stroke dysphagia. Journal of Back &
Masakado Y. Proposal for a modified jaw opening exercise for Musculoskeletal Rehabilitation 2018;31(2):363-70.
dysphagia: a randomized, controlled trial. Tokai Journal of
Experimental and Clinical Medicine 2017;42(2):71-8. Moon 2017 {published data only}
Moon JH, Jung J, Won YS, Cho H, Cho K. Effects of expiratory
Lee 2015b {published data only}
muscle strength training on swallowing function in acute stroke
Lee JH, Kim SB, Lee KW, Lee SJ, Lee JU. Effect of repetitive patients with dysphagia. Journal of Physical Therapy Science
transcranial magnetic stimulation according to the stimulation 2017;29:609-12.
site in stroke patients with dysphagia. Annals of Rehabilitation
Medicine 2015;39(3):432-9.

Informed decisions.

Moon 2018 {published data only} Park 2017 {published data only}
Moon JH, Hahm SC, Won YS, Cho HY. The effects of tongue * Park JS, Hwang NK, Oh DH, Chang MY. Effect of head lift
pressure strength and accuracy training on tongue pressure exercise on kinematic motion of the thyolaryngeal complex and
strength, swallowing function, and quality of life in subacute aspiration in patients with dysphagic stroke. Journal of Oral
stroke patients with dysphagia: a preliminary randomized Rehabilitation 2017;44:385–91.
clinical trial. International Journal of Rehabilitation
Research 2018; Vol. 41, issue 3:204-10. [DOI: 10.1097/ KCT0001901. Effect of shaker exercise on motion of
MRR.0000000000000282] hyolaryngeal complex and aspiration in stroke patients with
oropharyngeal dysphagia. http://cris.nih.go.kr/cris/en/search/
NCT00722111 {published data only} search_result_st01.jsp?seq=6221 (first received 30 October
NCT00722111. Exercise for swallowing problems after stroke. 2015).
https://clinicaltrials.gov/ct2/show/NCT00722111 (first received
Park 2018 {published data only}
25 July 2008).
Park J, An D, Oh D, Chang M. Effect of chin tuck against
NCT01081444 {published data only} resistance exercise on patients with dysphagia following stroke:
NCT01081444. Repetitive transcranial stimulation (rTMS) in a randomized pilot study. NeuroRehabilitation 2018;42(2):191-7.
post stroke dysphagia. clinicaltrials.gov/ct2/show/record/
Shao 2017 {published data only}
NCT01081444?term=NCT01081444&rank=1 (first received 5
March 2010). Shao W-B, Wang Y, Jiang W-W, Tian L, Zhang J. Clinical study
of columnar balloon dilatation therapy for severe dysphagia
NCT01085903 {published data only} caused by upper esophageal sphincter achalasia after stroke.
NCT01085903. Identifying and treating arousal related deficits Chinese Journal of Contemporary Neurology and Neurosurgery
in neglect and dysphagia. https://clinicaltrials.gov/ct2/show/ 2017;17(3):185-91.
NCT01085903 (first received 12 March 2010).
Su 2010 {published data only}
NCT01777672 {published data only} Su X, Lai X. The clinical study on "tongdutiaoshen" (an
NCT01777672. Effect of afferent oropharyngeal pharmacological acupuncture treatment) for treatment of dysphagia after stroke.
and electrical stimulation on swallow response and Journal of Clinical Acupuncture and Moxibustion 2010;26:3-6.
on activation of human cortex in stroke patients with
Sun 2008 {published data only}
oropharyngeal dysphagia (OD). A randomized controlled trial.
clinicaltrials.gov/show/NCT01777672 (first received 29 January Sun J, Mi Z, Wang H, Xu D, Chen H. Study on therapeutic effect of
2013). acupuncture on dysphagia after stroke. Journal of Rehabilitation
Medicine 2008;169 Suppl 46:Abstract PP003-139.
NCT02090231 {published data only}
Sun 2018 {published data only}
NCT02090231. The effect of repetitive transcranial magnetic
stimulation for post-stroke dysphagia recovery. https:// Sun D, Xu W, Chen N, Li S-M, Fu T. Clinical effectiveness of
clinicaltrials.gov/ct2/show/NCT02090231 (first received 18 intradermal needle-embedding therapy for swallowing function
March 2014). in stroke patients with dysphagia. Acupuncture Research
2018;43(2):118-22.
Suntrup-Krueger 2018 {published data only}
NCT02379182. Randomized controlled trial to evaluate
the effect of vitalstim in patients with chronic post-stroke NCT01970384. Transcranial direct current stimulation
oropharyngeal dysphagia. clinicaltrials.gov/show/NCT02379182 for dysphagia therapy in acute stroke patients. https://
(first received 4 March 2015). clinicaltrials.gov/ct2/show/NCT01970384 (first received 28
October 2013).
Nowicki 2003 {published data only}
* Suntrup-Krueger S, Ringmaier C, Muhle P, Wollbrink A,
Nowicki NC, Averill A. Acupuncture for dysphagia following
Kemmling A, Hanning U, et al. Randomized trial of transcranial
stroke. Medical Acupuncture 2003;14(3):17-9.
direct current stimulation for poststroke dysphagia. Annals of
Oshima 2009 {published data only} Neurology 2018;83(2):328-40.
Oshima F, Takezawa H, Hamanaka M, Imai K, Makino M, Oda K, Tageldin 2017 {published data only}
et al. Usefulness of nutritional management and swallowing
Tageldin E, Khalil M, Bahnasy W, Fouda B. Evaluation of
training during the acute phase of cerebral infarction and the
possible role of repetitive transcranial magnetic stimulation
incidence rate of infection. Dysphagia 2009;24:453.
for dysphagic patients with brain stem infarction. Neurology
Pan 2015 {published data only} 2017;88(16 Suppl 1):P5.156.
Pan MZ, Chen J, Lin L. Effect of traditional Chinese medicine Umay 2017 {published data only}
rehabilitation nursing on functional rehabilitation of dysphagia
Umay EK, Yaylaci A, Saylam G, Gundogdu I, Gurcay E,
in stroke patients. Chinese Medicine Modern Distance Education
Akcapinar D, et al. The effect of sensory level electrical
of China 2015;13(23):107-9.
stimulation of the masseter muscle in early stroke patients with

Informed decisions.

dysphagia: a randomized controlled study. Neurology India Yifeng Acupoints. Journal of Zhejiang University of Traditional
2017;65(4):734-42. Chinese Medicine 2013;37(9):1117-8, 1132.
Wang 2010 {published data only} Xue 2004 {published data only}
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Xu 2013 {published data only} Zhong 2003 {published data only}

Xu JY, Zhou ZL, Wu J. Clinical observation on the treatment Zhong C-M, Rong G, He F-Z, Jin H-Y. Comparison of head and
of post-stroke dysphagia by Tiaoshen Tongluo Acupuncture body acupuncture in the treatment of deglutition disorders
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Informed decisions.

Zhu 2015a {published data only} www.isrctn.com/ISRCTN14124645 (first received 10 October

Zhu H, Yang Y, Rao J, Liu L, Wang Y, Shao W, Zhang J. Effect of 2016).
surface electromyographic biofeedback on the pharyngeal
ISRCTN68981054 {published data only}
phase activities in patients with dysphagia after stroke. Chinese
Journal of Cerebrovascular Diseases 2015;11:572-6. ISRCTN68981054. Treatment of dysphagia after stroke with He's
santong needling method: a prospective randomized controlled
Zhu 2015b {published data only} study. http://www.isrctn.com/ISRCTN68981054 (first received
Zhu Z Z, Cui LL, Yin MM, Yu Y, Wang HT. Effects of swallowing 25 September 2017).
training combined with low -frequency electrical stimulation
on dysphagia after ischemic stroke. Chinese Journal of
Contemporary Neurology and Neurosurgery 2015;15(4):285-9. NCT01758991. Improving swallowing after stroke with
transcranial direct current stimulation (iSWAT). https://
clinicaltrials.gov/ct2/show/NCT01758991 (first received 1
References to ongoing studies January 2013).
ChiCTR1800014337 {published data only} NCT01919112 {published data only}
ChiCTR1800014337. High frequency repetitive transcranial NCT01919112. Fostering eating after stroke with transcranial
magnetic stimulation in the rehabilitation of post- direct current stimulation. https://clinicaltrials.gov/ct2/show/
stroke swallowing disorder. http://www.chictr.org.cn/ record/NCT01919112 (first received 8 August 2013).
showprojen.aspx?proj=23332 (first received 6 January 2018).
ChiCTR1800015837 {published data only}
NCT02322411. Effects of device-facilitated isometric progressive
ChiCTR1800015837. A randomized controlled clinical resistance oropharyngeal (I-PRO) therapy on dysphagia
study on stroke with dysphagia with treatment of related outcomes in patients post-stroke (StrokeStrong).
combined of traditional Chinese and West medicine. http:// clinicaltrials.gov/show/NCT02322411 (first received 23
www.chictr.org.cn/showprojen.aspx?proj=20656 (first received December 2014).
24 April 2018).
ChiCTR-ICR-15006004 {published data only}
NCT02470078. Pharyngeal electrical stimulation for the
ChiCTR-ICR-15006004. Clinical observation of YiShen-TongQiao treatment of post-extubation dysphagia in acute stroke. https://
acupuncture on pharyngeal dysphagia after stroke. http:// clinicaltrials.gov/ct2/show/NCT02470078 (first posted 12 June
www.chictr.org.cn/showproj.aspx?proj=10470 (first received 25 2015).
February 2015).
ChiCTR-IOR-17010505 {published data only}
Humbert IA, Vose A. Kinematic visual biofeedback is best when
ChiCTR-IOR-17010505. Fire needle for patients with training novel swallowing behaviors in dysphagic patients after
dysphagia caused by post-stroke pseudobulbar palsy: a stroke. Stroke 2018;49:ATP150.
randomized controlled clinical trial. http://www.chictr.org.cn/
showprojen.aspx?proj=17738 (first received 23 January 2017). * NCT02576470. Applying motor learning principles to
dysphagia rehabilitation. https://clinicaltrials.gov/ct2/show/
ChiCTR-IOR-17011359 {published data only} NCT02576470 (first received 15 October 2015).
ChiCTR-IOR-17011359. The study on the effect of electro-
acupuncture at Lianquan and Fengfu on one side of brain NCT02960737 {published data only}
swallowing function. http://www.chictr.org.cn/showproj.aspx? NCT02960737. Dysphagia evaluation after stroke - incidence and
proj=19078 (first received 11 May 2017). effect of oral screen intervention on swallowing dysfunction.
clinicaltrials.gov/show/NCT02960737 (first received 10
ChiCTR-IPC-14005435 {published data only} November 2016).
ChiCTR-IPC-14005435. Research on mechanism of central
regulation of transcranial magnetic stimulation on post-stroke NCT03021252 {published data only}
dysphagia patients. http://www.chictr.org.cn/showproj.aspx? NCT03021252. Respiratory muscle training in stroke swallowing
proj=9785 (first received 17 October 2017). disorders RETORNUS-2. https://clinicaltrials.gov/ct2/show/
NCT03021252 (first received 13 January 2017).
ChiCTR-ROC-17011673 {published data only}
ChiCTR-ROC-17011673. Neuromodulation on post-stroke NCT03247374 {published data only}
patients: a clinical control trial based on mapping swallowing NCT03247374. Bio-feedback treatment versus standard
musculature motor cortex. www.chictr.org.cn/showproj.aspx? treatment for dysphagic post-stroke patients: a randomized
proj=19921 (first received 16 June 2017). controlled trial (bio-feedback treatment for dysphagic post-
stroke patients (BIO_DYS)). https://clinicaltrials.gov/ct2/show/
ISRCTN14124645 {published data only} NCT03247374 (first received 11 August 2017).
ISRCTN14124645. Metoclopramide and selective oral
decontamination for avoiding pneumonia after stroke. http://

Informed decisions.

NCT03274947 {published data only} stroke dysphagia: a systemic review and meta-analysis. Clinical
NCT03274947. The utility of cerebellar transcranial magnetic Rehabilitation 2016;30(1):24-35.
stimulation in the neurorehabilitation of dysphagia after stroke.
Cohen 2016
https://clinicaltrials.gov/ct2/show/NCT03274947 (first received
7 September 2017). Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S,
et al. Post stroke dysphagia: a review and design considerations
NCT03358810 {published data only} for future trials. International Journal Stroke 2016;11(4):399-411.
NCT03358810. Pharyngeal electrical stimulation evaluation for
Ding 2016
dysphagia after stroke (PhEED). https://clinicaltrials.gov/ct2/
show/NCT03358810 (first received 2 December 2017). Ding R, Ma F. Effectiveness of neuromuscular electrical
stimulation on dysphagia treatment in patients with
NCT03499574 {published data only} neurological impairments – a systematic review and
NCT03499574. Feasibility study of biofeedback in dysphagia metaanalysis. Annals of Otolaryngology and Rhinology
therapy post stroke. https://www.clinicaltrials.gov/ct2/show/ 2016;3(12):1151.
record/NCT03499574?id=NCT03499574&rank=1 (first received
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CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Bai 2007i
Methods Random numbers table
Outcomes not blinded

(medium-intensity vs low-intensity data set)
Participants 1 centre in China

111 participants within 2 weeks of stroke
Baseline characteristics similar
No cross-overs or dropouts identified

Dysphagia defined by Watian swallow test
Interventions A1: shallow needling (control) (n = 35) = low intensity

A2: single deep needling (n = 18) = medium intensity
B: deep multi-needling
Outcomes Watian drinking test grade

Return to normal diet
Notes Exclusions: needle phobia, infection risk, dementia, inability to co-operate with treatment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence genera- High risk Randomisation via a random numbers table
tion (selection bias)
Allocation concealment Unclear risk Unclear

(selection bias)

Informed decisions.

Bai 2007i (Continued)
Blinding (performance Unclear risk Unclear
bias and detection bias)
All outcomes
Blinding of participants Unclear risk Unclear

and personnel (perfor-
mance bias)
All outcomes
Blinding of outcome as- High risk Outcomes not blinded

sessment (detection bias)
All outcomes
Incomplete outcome data Unclear risk Unclear

(attrition bias)
All outcomes
Selective reporting (re- Unclear risk Unclear

porting bias)
Other bias Unclear risk Translated from Chinese language

Bai 2007ii
Methods (High vs medium data set)
Participants As data set 1
Interventions A1: shallow needling (control)

A2: single deep needling (n = 17) = medium intensity
B: deep multi-needling (n = 40) = high intensity
Outcomes As data set 1
Notes -
Risk of bias
Random sequence genera- High risk Randomisation via a random numbers table

(selection bias)

All outcomes

mance bias)
All outcomes

Informed decisions.

Bai 2007ii (Continued)
Blinding of outcome as- High risk Outcomes not blinded
All outcomes

(attrition bias)
All outcomes

porting bias)
Other bias Unclear risk Translated from Chinese

Bath 1997
Methods Computerised randomisation by minimisation
Unblinded outcome assessment
Analysis by ITT
Cross-overs: 3 NGT to PEG, 0 PEG to NGT
Balancing of baseline prognostic factors between treatment groups unclear
Participants 1 centre in UK
19 participants: 8 male
Mean age 77 (SD 11) years
13 ischaemic stroke, 6 haemorrhagic stroke
100% CT
Enrolment within 2 weeks of stroke onset
Interventions Factorial trial: PEG vs NGT; intensive vs conservative swallowing therapy

PEG: NGT: up to 3 NGTs
Intensive swallowing therapy: as for conservative, plus voluntary control (tongue-holding), sensory
stimulation (tactile, oromotor exercises, swallow practice)
Conservative swallowing therapy: review, advice regarding feeding route, postural/dietary modifica-
tion, safe swallowing methods
Outcomes Primary outcomes: resumption of safe feeding at 12 weeks, weight loss < 5% at 6 weeks, discharge by 6
weeks
Secondary outcomes: impairment, disability, handicap, quality of life, tube failures, chest infection,
oropharyngeal delay time (by videofluoroscopy) at 4 weeks
Notes Exclusions: oro-gastrointestinal disease, concurrent severe illness, coagulopathy, premorbid depen-
dency, severe dementia, psychiatric illness
Follow-up: 3 months
Risk of bias
Random sequence genera- Low risk Computerised randomisation by minimisation


(selection bias)


Informed decisions.

Bath 1997 (Continued)
All outcomes

mance bias)
All outcomes
Blinding of outcome as- High risk Unblinded outcome assessment

All outcomes

(attrition bias)
All outcomes

porting bias)
Other bias Low risk None identified

Carnaby 2006i
Methods Computerised randomisation
Blinded outcome assessments by SLT
ITT
(Control vs low-intensity data set)
Baseline prognostic factors balanced between treatment groups
Participants 1 centre in Australia
306 participants; baseline characteristics similar
Enrolment within 2 weeks of stroke onset: mean/median 2 days, range 0 to 12 days
Clinical and videofluoroscopic evidence of dysphagia
Interventions Rx 1: standardised high-intensity swallowing therapy (n = 102)

Rx 2: standardised low-intensity swallowing therapy (n = 102); split into (n = 51) for each data set
C: usual care (n = 102)
Treatment for up to 1 month
Outcomes Outcomes: time to return to normal diet; aspiration pneumonia; dysphagia (PHAD score < 85)
Notes Trial completed and published 2006

Exclusions: previous swallowing therapy, head and neck surgery, inability to consent
Follow-up: 6 months
Risk of bias
Random sequence genera- Low risk Treatment allocation based on a computer-generated random numbers list
tion (selection bias) generated via the SPSS statistical package

Informed decisions.

Carnaby 2006i (Continued)
Allocation concealment Low risk Randomisation schedule held at the trial office, remote from the study envi-
(selection bias) ronment; assignment to 1 of 3 treatment options by a telephone call to the tri-
al office made by the study speech pathologist
Blinding (performance High risk All people involved in the study unaware of treatment allocation, apart from
bias and detection bias) participants and the study speech pathologist who treated participants
All outcomes Assigned to high-intensity and low-intensity groups
Blinding of participants High risk Participants and speech pathologist aware of treatment allocation
mance bias)
All outcomes
Blinding of outcome as- Low risk Outcome assessed by an independent speech pathologist, who was unaware
sessment (detection bias) of treatment allocation, every month for 6 months after randomisation
All outcomes
Incomplete outcome data Low risk 3 participants lost to follow-up before 6-month analysis
(attrition bias)
All outcomes
Selective reporting (re- Low risk All outcomes reported

porting bias)

Carnaby 2006ii
Methods (High-intensity vs low-intensity data set)
Interventions High intensity (n = 102)

Low intensity (n = 51)
Notes -
Risk of bias
Random sequence genera- Low risk Treatment allocation based on a computer-generated random numbers list
tion (selection bias) obtained via the SPSS statistical package
Allocation concealment Low risk Randomisation schedule held at trial office, remote from the study environ-
(selection bias) ment; assignment to 1 of 3 treatment options by a telephone call to the trial of-
fice made by the study speech pathologist
Blinding (performance High risk All people involved in the study unaware of treatment allocation, apart from
bias and detection bias) participants and the study speech pathologist who treated participants
All outcomes Assigned to high-intensity and low-intensity groups

Informed decisions.

Carnaby 2006ii (Continued)
Blinding of participants High risk As above
mance bias)
All outcomes
Blinding of outcome as- Low risk Outcome assessed by an independent speech pathologist, who was unaware
sessment (detection bias) of treatment allocation, every month for 6 months after randomisation
All outcomes
Incomplete outcome data Low risk 3 participants lost to follow-up before 6-month analysis
(attrition bias)
All outcomes

porting bias)
Other bias Unclear risk None identified

Chan 2012
Methods Randomisation by random sequences on black paper
Single-blind (participants blinded): outcome assessors blinded
Participants 1 centre in Hong Kong
87 participants with neurogenic dysphagia with similar baseline characteristics
60 (69%) participants with dysphagia due to cerebral infarct < 6 months; other causes of neurogenic
dysphagia include intracranial haemorrhage, vascular dementia, Parkinson's disease
Clinical evidence of dysphagia
Interventions All groups given routine swallowing therapy
Rx 1: true acupuncture (n = 20)

Rx 2: sham acupuncture that did not puncture true acupoints lying on a meridian (n = 19)
C: routine swallowing therapy only (n = 48)
Treatment for up to 4 weeks
Outcomes Outcomes: Royal Brisbane Hospital Outcome Measure Scale (RBHOMS), swallow function by consisten-
cies of ingested food and fluid
Notes Exclusions: structural oral, pharyngeal, or oesophageal disease; severe primary disease of the liver, kid-
neys, hematopoietic system, or endocrine system; malignant tumour or infectious disease; inability to
follow commands
Follow-up: 3 months
Risk of bias
Random sequence genera- Low risk Randomisation by random sequences

Allocation concealment Low risk Allocation concealed in opaque envelopes

(selection bias)

Informed decisions.

Chan 2012 (Continued)
Blinding (performance Low risk Single (participants) blinded
All outcomes
Blinding of participants Low risk Single (participants) blinded

mance bias)
All outcomes
Blinding of outcome as- Low risk Outcome assessors blinded

All outcomes
Incomplete outcome data Low risk No losses to follow-up reported

(attrition bias)
All outcomes

porting bias)

Chen 2016a
Methods Computer-generated random numbers by independent research staff
Assessors blinded
Participants Multi-centre trial in China
250 participants; 148 male
100% stroke within 2 to 7 days
Dysphagia identified by bedside swallowing assessment and videofluoroscopic swallowing study
Baseline characteristics and prognostic values similar between both groups
Interventions Rx: acupuncture and conventional stroke rehabilitation care
C: conventional stroke rehabilitation care only
Duration: 3 weeks
Follow-up: 7 weeks
Outcomes Primary outcome: NIHSS index
Secondary outcomes: FMA for motor function, rate of recovery based on BSA, VFSS, MMSE, and MoCA
Notes Exclusions: serious heart, liver, and kidney-related diseases; blood coagulation dysfunction; inability
to complete the MMSE test or bedside swallowing assessment; congenital disabilities; posterior circula-
tion infarcts; receiving thrombolytic; participated in other clinical trials within previous 3 months; preg-
nant or breastfeeding
Risk of bias

Informed decisions.

Chen 2016a (Continued)
Random sequence genera- Low risk Computer-generated random numbers provided by independent research
tion (selection bias) staff
Allocation concealment Low risk Random numbers placed into sequentially numbered, opaque, sealed en-
(selection bias) velopes
Blinding (performance High risk Participants and acupuncturist aware of treatment allocations. All allopathic
bias and detection bias) medical staff and rehabilitation therapists blinded
All outcomes
Blinding of participants High risk Participants and acupuncturist not blinded

mance bias)
All outcomes

All outcomes
Incomplete outcome data High risk 5 participants lost to follow-up; 4 discontinued intervention. Not all partici-
(attrition bias) pants given VFSS examination
All outcomes

porting bias)

Du 2016i
Methods Randomisation by sequentially numbered sealed envelopes
Blinded outcome assessments by trained neurologist

(Sham vs low-frequency (1 Hz) data set)
Enrolment within 2 months of stroke onset confirmed by CT or MRI scan
Interventions Rx 1: 1 Hz rTMS to unaffected hemisphere (n = 13)

Rx 2: 3 Hz rTMS to affected hemisphere (n = 13)
C: sham rTMS (n = 12), split into n = 6 for each data set
Treatment for up to 5 days
Outcomes Outcomes: swallow score using Standardised Swallow Assessment (SSA), BI, mRS, and measures of my-
lohyoid MEPs
Notes Exclusions: other concomitant neurological diseases, fever, infection, prior administration of tranquil-
liser, severe aphasia or cognitive impairment, inability to complete the follow-up, and other contraindi-
cations for rTMS
Follow-up: up to 3 months

Informed decisions.

Du 2016i (Continued)
Risk of bias
Random sequence genera- Low risk Randomisation by sequentially numbered sealed envelopes
Allocation concealment Low risk Allocation concealed by sealed envelopes

(selection bias)
Blinding (performance Low risk Participant blinded; outcome assessor blinded

All outcomes
Blinding of participants Low risk Participant blinded

mance bias)
All outcomes
Blinding of outcome as- Low risk Outcome assessor blinded - measures evaluated by a trained neurologist who
sessment (detection bias) was blinded to participants' group allocation throughout
All outcomes
Incomplete outcome data Low risk 2 participants lost to follow-up

(attrition bias)
All outcomes
Selective reporting (re- Low risk Only NIHSS not recorded at the end; all other measures reported on for all 3
porting bias) time points

Du 2016ii
Methods (High-frequency vs sham data set)
Interventions High = 102 (high intensity)

Sham = 51 (low intensity)
Notes -
Risk of bias
Random sequence genera- Low risk Randomisation by sequentially numbered sealed envelopes
Allocation concealment Low risk Allocation concealed by sealed envelopes

(selection bias)

Informed decisions.

Du 2016ii (Continued)
Blinding (performance Low risk Participant blinded; outcome assessor blinded
All outcomes
Blinding of participants Low risk Participant blinded

mance bias)
All outcomes
Blinding of outcome as- Low risk Outcome assessor blinded - measures evaluated by a trained neurologist who
sessment (detection bias) was blinded to participants' group allocation throughout
All outcomes
Incomplete outcome data Low risk 2 participants lost to follow-up

(attrition bias)
All outcomes
Selective reporting (re- Low risk Only NIHSS not recorded at the end; all other measures reported on for all 3
porting bias) time points

Feng 2012
Methods Randomisation by random numbers table
Blinding unclear
Enrolment within 2 weeks to 6 months of stroke onset
2 participants lost to follow-up
Interventions Rx: tongyan spray (n = 60)

C: placebo (n = 60)
Treatment for up to 28 days
Outcomes Outcomes: swallow safety and function using the SSA
Notes Exclusions: consciousness disorder; unstable life sign and accompanied by serious diseases (heart, kid-
ney, etc.), non-compliance with examination and treatment
Risk of bias
Random sequence genera- Low risk Random numbers table


Informed decisions.

Feng 2012 (Continued)
Allocation concealment Low risk Concealed via sealed envelopes
(selection bias)
Blinding (performance Unclear risk Blinding unclear

All outcomes
Blinding of participants Unclear risk Blinding unclear

mance bias)
All outcomes
Blinding of outcome as- Unclear risk Blinding unclear

All outcomes
Incomplete outcome data Low risk 2 participant dropouts (1 from each group)
(attrition bias)
All outcomes
Selective reporting (re- Low risk All outcomes listed reported

porting bias)

Han 2004
Methods Randomisation by sealed opaque envelope. Assessors blinded
Participants People with acute stroke, dysphagia, and dysarthria
1 centre in China
66 participants
100% with stroke within 30 days of onset. Degrees of dysphagia not stated
Interventions Rx: scalp and neck acupuncture with electroacupuncture with standard Western medical treatment
C: standard Western medical treatment only
Outcomes Dysphagia at end of trial after 3 treatment sessions
Notes Exclusions: reduced consciousness, poor compliance, infections at acupoints
Risk of bias
Random sequence genera- Low risk Randomisation by sealed opaque envelopes

Allocation concealment Low risk Allocations concealed by opaque envelopes

(selection bias)

Informed decisions.

Han 2004 (Continued)
All outcomes

mance bias)
All outcomes
Blinding of outcome as- Low risk Assessors blinded

All outcomes
Incomplete outcome data Low risk None lost to follow-up

(attrition bias)
All outcomes

porting bias)

Heo 2015
Methods Participants were randomly allocated for radiographic inspection and treatment with or without kine-
siotaping by drawing lots
Blinding unknown
Participants 1 centre in Republic of Korea
44 participants
100% with dysphagia and stroke within 3 months of diagnosis
Interventions Rx: kinesiotaping
C: no kinesiotaping
Outcomes Kinematic analysis of movement of the hyoid bone (movements measured in both horizontal and verti-
cal sections)
Angular variation of the epiglottis using human anatomy-based co-ordinates
Swallow score: FDS
Notes Exclusions: none
Risk of bias
Random sequence genera- Low risk Participants randomly allocated by drawing lots

(selection bias)

Informed decisions.

Heo 2015 (Continued)
All outcomes

mance bias)
All outcomes
Blinding of outcome as- Unclear risk Unclear

All outcomes

(attrition bias)
All outcomes

porting bias)

Huang 2010
Methods Method of randomisation unknown
Blinding unknown
Only data for groups 2 and 3 included
97 participants with post-stroke dysphagia
Interventions Group 1: electrical stimulation (n = 35)
Group 2: rehabilitation training (n = 30)
Group 3: acupuncture (n = 32)
Outcomes Swallowing function
Notes -
Risk of bias
Random sequence genera- Unclear risk Method of randomisation unknown


(selection bias)
Blinding (performance Unclear risk Blinding unknown


Informed decisions.

Huang 2010 (Continued)
All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)

Jayasekeran 2010a
Methods Dose comparison protocol (only data from the group that were stimulated once a day over 3 days were
included)
Computerised randomisation by minimisation
Blinded outcome measures
Balancing of prognostic baseline factors between treatment groups unclear
10 participants with acute anterior circulation cerebral infarct (< 3 weeks)
Mean age 73 years
Interventions Rx: bedside pharyngeal electrical stimulation
C: sham stimulation
Duration: once daily for 3 consecutive days
Outcomes Airway aspiration at 2 weeks' post intervention
Notes Exclusion: dementia, pacemaker or implantable cardiac defibrillator, severe receptive aphasia, un-
stable cardiopulmonary status, distorted oropharyngeal anatomy (e.g. pharyngeal pouch), brainstem
stroke, dysphagia resulting from conditions other than hemispheric stroke
Risk of bias

Allocation concealment Unclear risk Not reported

(selection bias)

Informed decisions.

Jayasekeran 2010a (Continued)
All outcomes

mance bias)
All outcomes
Blinding of outcome as- Low risk Blinded outcome measures

All outcomes

(attrition bias)
All outcomes

porting bias)

Jayasekeran 2010b
Methods Parallel-group design protocol
Computerised randomisation by minimisation
Blinded outcome measures
Prognostic baseline factors between treatment groups similar
Participants 2 centres in UK
28 participants with acute anterior circulation cerebral infarct or haemorrhage (< 3 weeks)
Mean age 75 years
Interventions Rx: bedside pharyngeal electrical stimulation
C: sham stimulation
Duration: once daily for 3 consecutive days
Outcomes Airway aspiration at 2 weeks post intervention
Notes Exclusion: dementia, pacemaker or implantable cardiac defibrillator, severe receptive aphasia, un-
stable cardiopulmonary status, distorted oropharyngeal anatomy (e.g. pharyngeal pouch), brainstem
stroke, dysphagia resulting from conditions other than hemispheric stroke
Risk of bias


Informed decisions.

Jayasekeran 2010b (Continued)
(selection bias)

All outcomes

mance bias)
All outcomes
Blinding of outcome as- Low risk Blinded outcome measures

All outcomes
Incomplete outcome data High risk 3 participants lost to follow-up

(attrition bias)
All outcomes

porting bias)

Jia 2006a
Methods Randomisation: participants randomised in visiting sequence
Blinding: unclear
ITT: unclear
Balancing of all prognostic factors not reported; only for age, gender, and stroke duration
72 inpatients, stroke confirmed by CT or MRI scan but unclear patient inclusion criteria - 2 out of
5 symptoms as hemiplegia, coma, slurred speech, unilateral sensory disturbance, wry mouth and
tongue; difficulty in swallowing
Mean age: treatment group = 55.4 years, control = 54.8 years
Interventions Group 1: acupuncture + rehabilitation training
Group 2: rehabilitation training only
Outcomes Primary outcomes: therapeutic assessment of swallowing function using 1 to 10 point scale with cate-
gories basic cure; marked improvement; improvement and failure
Notes Not having above symptoms; cannot co-operate to do chemical examination and treatment; severe pri-
mary disease in the liver, kidneys, hematopoietic system, and endocrine system
Risk of bias

Informed decisions.

Jia 2006a (Continued)
Random sequence genera- High risk Participants randomised in visiting sequence
Allocation concealment High risk Allocation not concealed

(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Unclear risk Only 1 outcome chosen and reported - improvement in swallowing at end of
porting bias) trial
Other bias Unclear risk Unclear

Kang 2012
Methods Method of randomisation unclear
Participants 1 centre in Korea
Enrolment within 6 weeks of stroke onset
Interventions Rx: additional exercise programme for dysphagia with thermal-tactile stimulation
C: thermal-tactile stimulation only
Treatment for up to 2 months
Outcomes Videofluoroscopy, Functional Oral Intake Scale, transition from tube to oral feeding, incidence of aspi-
ration pneumonia
Notes Exclusions: previous history of other diseases, which may have caused dysphagia; severe cognitive dis-
order, such as dementia; inability to carry out videofluoroscopy due to incapability of sitting posture;
inability to follow study instructions
Risk of bias

Informed decisions.

Kang 2012 (Continued)
Random sequence genera- Unclear risk Randomisation unclear
Allocation concealment Unclear risk Blinding unclear

(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes
Incomplete outcome data Low risk None reported

(attrition bias)
All outcomes

porting bias)

Khedr 2009
Methods Method of randomisation unclear: participants were assigned randomly to receive real or sham rTMS
using closed envelopes
Blinded outcome assessment
Allocation sequence concealed from participants
Participants 1 centre in Egypt
26 participants between 5th and 10th days post stroke (monohemispheric)
Mean age 56 years
Interventions Rx: repetitive transcranial magnetic stimulation of the affected motor cortex (n = 14)
C: sham stimulation (n = 12)
Outcomes Primary outcome: score on the dysphagia rating scale
Secondary outcomes: motor power of hand grip, BI, measures of oesophageal motor evoked potentials
from both hemispheres before and 1 month after sessions
Notes Exclusion: head injury or neurological disease other than stroke, unstable cardiac dysrhythmia, fever,
infection, hyperglycaemia, prior administration of tranquilliser

Informed decisions.

Khedr 2009 (Continued)
Risk of bias
Random sequence genera- Unclear risk Method of randomisation unclear

Allocation concealment Low risk Allocation sequence concealed from participants

(selection bias)
Blinding (performance Low risk Participants and outcome assessors not aware of allocation
All outcomes
Blinding of participants Low risk Participants informed of which group they had been allocated to at the end of
and personnel (perfor- the last assessment
mance bias)
All outcomes
Blinding of outcome as- Low risk Blinded outcome assessment

All outcomes
Incomplete outcome data Low risk All participants apart from 1 in the sham treatment group who died completed
(attrition bias) the trial and follow-up periods
All outcomes

porting bias)

Khedr 2010
Methods Method of randomisation unclear: participants from both the lateral medullary infarction (LMI) group
and the other brainstem infarction group were each randomly classified into 2 groups - to receive real
or sham repetitive transcranial magnetic stimulation
Blinded primary outcome assessment
Participants 1 centre in Egypt
Total of 22 participants with hemispheric stroke split into having lateral medullary infarction or other
brainstem infarction
Mean age 58 years
Interventions Rx: repetitive transcranial magnetic stimulation of the affected motor cortex (n = 11)
C: sham stimulation (n = 11)
Outcomes Primary outcome: score on the dysphagia rating scale
Secondary outcomes: motor power of hand grip, BI, NIHSS

Informed decisions.

Khedr 2010 (Continued)
Notes Exclusion: head injury or neurological disease other than stroke, unstable cardiac dysrhythmia, fever,
infection, hyperglycaemia, epilepsy, prior administration of tranquilliser
Risk of bias


(selection bias)

All outcomes

mance bias)
All outcomes
Blinding of outcome as- Low risk Blinded outcome assessment

All outcomes
Incomplete outcome data Low risk All participants apart from 2 in the sham treatment group who died completed
(attrition bias) the trial and follow-up periods
All outcomes

porting bias)

Kim 2012i
Blinding unclear
(High frequency data set vs control)
30 participants with acute brain injury; baseline characteristics similar
Interventions Rx 1: high-frequency (5 Hz) rTMS (n = 10)

Rx 2: low-frequency (1 Hz) rTMS (n = 10)
(Using high frequency data set)

C: sham stimulation. (n = 10); control = 5
Treatment for 2 weeks

Informed decisions.

Kim 2012i (Continued)
Outcomes Functional Dysphagia Scale and Penetration Aspiration Scale
Notes Exclusions: prior diagnosis of another neurological disease, unstable medical condition, severe cogni-
tive impairment, severe aphasia, history of seizure
Risk of bias


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)

Kim 2012ii
Methods (Low-frequency data set vs control)
Interventions Low-frequency rTMS = 10

Control (sham stimulation) = 5
Notes
Risk of bias

Informed decisions.

Kim 2012ii (Continued)

(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)

Kumar 2011
Methods Randomisation via simple randomisation
Double-blind
Analysis by ITT unclear
Participants 1 centre in USA
14 participants with subacute (24 to 168 hours) unilateral hemispheric infarction
Mean age 75 years
Interventions Rx: anodal transcranial direct current stimulation
C: sham stimulation
For 5 consecutive days
Outcomes Swallowing impairment using dysphagia outcome and severity scale
Notes Exclusions: difficulty following instructions because of obtundation or cognitive impairment, pre-exist-
ing swallowing problems; other contraindications to transcranial direct current stimulation
Risk of bias

Informed decisions.

Kumar 2011 (Continued)
Random sequence genera- Unclear risk Randomisation via simple randomisation


(selection bias)
Blinding (performance Low risk Double-blind

All outcomes
Blinding of participants Low risk Double-blind

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Low risk All outcomes reported and explained
porting bias)

Lee 2014
Methods Randomisation via computer-generated block randomisation
Blinding unclear
Prognostic baseline factors between treatment groups similar
57 participants with dysphagic stroke within 10 days of onset (men 42, women 15)
Mean age 65 years
Interventions Rx: NMES combined with traditional dysphagia therapy (n = 31)
C: traditional dysphagia therapy only (n = 26)
5 days per week for 3 weeks
Outcomes Swallowing function, Functional Oral Intake Scale
Notes Exclusion: presence of dysphagia before stroke, previous history, unstable cardiopulmonary status, se-
rious psychological disorder or epilepsy, tumour or radiotherapy of the head and neck region, swallow-

Informed decisions.

Lee 2014 (Continued)
ing therapy before participation in the present study, unstable medical conditions that may interfere
with VFSS
Risk of bias
Random sequence genera- Low risk Computer-generated block randomisation


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes
Incomplete outcome data Low risk All participants appeared to have been followed up at 12 weeks
(attrition bias)
All outcomes

porting bias)

Lee 2015
Methods Randomisation by computer-generated random sequence
Outcome assessors blinded
Participants Multi-centre trial in Hong Kong
93 participants with cerebrovascular disease; onset unclear although study states recent hospitalisa-
tion in the previous 3 months
Baseline characteristics and prognostic factors similar
Interventions Rx: lisinopril 2.5 mg once daily at bedtime
C: placebo
Outcomes Incidence of pneumonia, mortality, and Royal Brisbane Hospital Outcome Measure Scale score
Notes Exclusion: life expectancy < 6 months, baseline systolic blood pressure less than 100 mm Hg, known in-
tolerance to ACE inhibitors, current use of ACE inhibitor or angiotensin receptor blockers, symptomatic

Informed decisions.

Lee 2015 (Continued)
chronic lung disease or cardiac failure, frequent withdrawal of enteral tube by patients, serum creati-
nine > 150 mmol/L, serum potassium > 5.1 mmol/L
Risk of bias
Random sequence genera- Low risk Computer-generated random sequence

Allocation concealment Low risk Allocations concealed by coding files kept confidential to all parties involved
(selection bias) until the end of the trial
Blinding (performance Low risk All parties involved not aware of allocation
All outcomes
Blinding of participants Low risk All parties involved not aware of allocation
mance bias)
All outcomes
Blinding of outcome as- Low risk Outcome assessor blinded

All outcomes
Incomplete outcome data High risk 22 participants did not complete trial
(attrition bias)
All outcomes

porting bias)

Li 2014
Methods Randomisation via minimisation software
Single-blind - assessors blinded
No significant differences in baseline comparability tests in all groups of participants
Participants Recruitment through newspaper advertisements and flyers in China
118 participants with dysphagia and hemispheric stroke
Interventions Rx 1: neuromuscular electrical stimulation (VitalStim)
Rx 2: combined NMES and traditional swallowing therapy
C: traditional swallowing therapy
(Data from Rx 2 vs control used in this review)
Outcomes Swallow score, oral transit time, pharyngeal transit time, laryngeal closure duration, PAS

Informed decisions.

Li 2014 (Continued)
Notes Exclusion: progressive stroke, other neurological disease, neoplastic disease, previous surgery to swal-
lowing apparatus, nasogastric tube
Risk of bias
Random sequence genera- Low risk Computer randomisation via minimisation software
Allocation concealment Low risk Allocation concealed by sealed envelope

(selection bias)
Blinding (performance Low risk Outcome assessor blinded

All outcomes
Blinding of participants High risk Participants and technicians not blinded

mance bias)
All outcomes
Blinding of outcome as- Low risk As above

All outcomes
Incomplete outcome data High risk 17 participant dropouts

(attrition bias)
All outcomes

porting bias)

Lim 2009
Methods Method of randomisation unclear: participants divided into 2 groups according to order of enrolment
Blinding of outcomes unclear
Balancing of prognostic baseline factors between treatment groups - not reported for dysphagia severi-
ty, only for previous treatment of pneumonia
22 participants with CT or MRI confirmed stroke < 6 months from onset
Mean age 64 years
Interventions Rx: neuromuscular electrical stimulation + thermal-tactile stimulation (n = 13)
C: thermal-tactile stimulation (n = 9)
Outcomes Swallow function scoring system, PAS and PTT

Informed decisions.

Lim 2009 (Continued)
Notes Exclusions: inability to receive treatment for 1 hour, neurological disease other than stroke, combined
behavioural disorder that interfered with administration of therapy, current illness or upper gastroin-
testinal disease, inability to give informed consent because of cognitive impairment or receptive apha-
sia
Risk of bias
Random sequence genera- High risk Participants divided into 2 groups according to order of enrolment
Allocation concealment High risk Not concealed

(selection bias)
Blinding (performance Unclear risk No details available

All outcomes
Blinding of participants Unclear risk No details available

mance bias)
All outcomes
Blinding of outcome as- Low risk Doctor blinded to groups performed videofluoroscopic examination; mea-
sessment (detection bias) sured PTT as well as swallow function scoring system and Rosenbek penetra-
All outcomes tion aspiration scale.
Incomplete outcome data High risk 36 enrolled to the study. Only 28 participants completed the study (16 in the
(attrition bias) experimental group and 12 in the control group)
All outcomes
Selective reporting (re- Unclear risk Swallow scores not fully reported (unclear on the range of median values)
porting bias)

Liu 2000
Blinding of outcomes unclear
84 participants with bulbar palsy and CT/MRI-documented stroke: 54 men, 30 women
Age 50 to 78 years
Infarct 56, haemorrhage 28
Enrolment within 2 months of stroke onset
Interventions Rx: acupuncture - Tiantu (CV 22), Lieque (LU 7), Zhaohai (KI 6) - once daily for 10 days (n = 54)
Informed decisions.

Liu 2000 (Continued)
C: (n = 30)
Outcomes Outcome: bulbar function (phonation, swallowing, cough reflex)
Timing unclear
Notes Exclusions: not given
Risk of bias


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Unclear risk Unclear - no clear aim of study

porting bias)

Liu 2004
Methods RCT
82 participants with cerebral infarction or haemorrhage and CT/MRI-documented stroke: 49 men, 33

women
Age 40 to 80 years
Infarct 72, haemorrhage 10
Enrolment within 6 months of stroke onset
Interventions Rx: scalp acupuncture + sublingual needling (n = 44)

Informed decisions.

Liu 2004 (Continued)
C: scalp acupuncture + control needling (n = 38)
Outcomes Recovery of function (swallowing food and water, movement of the tongue, disappearance of dyslalia
and hoarseness)
Notes Exclusion: severe arrhythmia, coma, asthma, dilating myocardiopathy
Risk of bias


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Unclear risk Unclear aim of study - only 1 outcome reported
porting bias)

Park 2012
Methods Computer-generated randomisation sequence
Outcomes and participants blinded
Participants Study in Korea
20 participants with stroke > 1 month
Baseline characteristics similar, except stimulation intensities. Unclear baseline degree of dysphagia
between groups
Dysphagia defined by videofluoroscopy
Interventions Rx: effortful swallow with infrahyoid motor electrical stimulation
C: effortful swallow with infrahyoid sensory electrical stimulation (placebo stimulation)

Informed decisions.

Park 2012 (Continued)
Outcomes Vertical laryngeal and hyoid movements, maximum width of UES opening, PAS
Notes Exclusions: subarachnoid haemorrhage, carotid stenosis, inability to overcome stimulation, which was
determined by observation and palpation
Risk of bias
Random sequence genera- Low risk Computer-generated randomisation sequence

Allocation concealment Low risk Automated assignment system

(selection bias)
Blinding (performance Low risk Participants and outcome assessors blinded

All outcomes
Blinding of participants Low risk Participants blinded

mance bias)
All outcomes

All outcomes
Incomplete outcome data Low risk 2 participant dropouts (1 from each group)
(attrition bias)
All outcomes

porting bias)

Park 2013
Methods Computer-generated randomisation sequence
Outcomes and participants blinded
Participants Study in Korea

18 participants with stroke > 1 month

Dysphagia confirmed by videofluoroscopy
Interventions Rx: active high-frequency rTMS (5 Hz) at the contralesional intact cortex
C: sham rTMS
Outcomes VDS, PAS
Notes Exclusions: metal implants or a pacemaker in the body, history of seizures

Informed decisions.

Risk of bias
Random sequence genera- Low risk Computer-generated randomisation sequence

Allocation concealment Low risk Automated assignment system

(selection bias)
Blinding (performance Low risk Participants and outcome assessors blinded

All outcomes
Blinding of participants Low risk Participants blinded

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)

Park 2016a (i)
Methods Randomisation unclear
Outcome assessor blinded
(unilateral stimulation vs sham data set)
35 participants with subacute stroke defined as onset < 3 months
Swallowing dysfunction confirmed by videofluoroscopy
2 participants lost to follow-up
Interventions Rx 1: unilateral stimulation group with (10 Hz) rTMS on ipsilesional cortex and sham on contralesional
cortex (n = 11)
Rx 2: bilateral stimulation group with (10 Hz) rTMS on ipsilesional and contralesional cortex (n = 11)
C: sham rTMS over bilateral hemispheres (n = 11)
Control group split into n = 5 for data set 1 and n = 6 for data set 2

Informed decisions.

Park 2016a (i) (Continued)

Therefore for this data set, unilateral stimulation (n = 11) vs sham stimulation (n = 5)
Outcomes Clinical Dysphagia Scale, Dysphagia Outcome and Severity Scale, PAS, VDS
Notes Exclusion: history of swallowing problems caused by other underlying neurological diseases, such as
Parkinson’s disease, dementia, or motor neuron disease; history of intractable seizure; metallic im-
plants in the brain
Risk of bias
Random sequence genera- Unclear risk Blinding unclear


(selection bias)
Blinding (performance High risk Single-blinded (assessors only)

All outcomes
Blinding of participants High risk Reported only as single-blinded (assessors only)

mance bias)
All outcomes

All outcomes
Incomplete outcome data Low risk 2 lost to follow-up

(attrition bias)
All outcomes

porting bias)

Park 2016a (ii)
Methods As per Park 2016a
(bilateral stimulation vs sham data set)
Interventions Bilateral stimulation (n = 11) vs sham stimulation (n = 6)
Notes As data set 1
Risk of bias

Informed decisions.

Park 2016a (ii) (Continued)

Random sequence genera- Unclear risk Blinding unclear


(selection bias)
Blinding (performance High risk Single-blinded (assessors only)

All outcomes
Blinding of participants High risk Reported only as single-blinded (assessors only)

mance bias)
All outcomes

All outcomes
Incomplete outcome data Low risk 2 lost to follow-up

(attrition bias)
All outcomes

porting bias)

Park 2016b
Methods Randomisation by randomly selected envelopes containing a code specifying the group
Outcomes partially blinded (for VFSS only but not for sEMG evaluation)
33 participants with dysphagia (inclusion criteria states stroke onset within 6 months)
Dysphagia confirmed by videofluoroscopy
Baseline demographics and prognostic factors balanced
Interventions Rx: EMST with a 70% threshold value of maximal expiratory pressure, using an EMST device
C: training with sham device
Outcomes Swallow function using VFSS, PAS, Functional Oral Intake Scale
Notes Exclusion: stroke before that resulting in dysphagia; severe oro-facial pain including trigeminal neu-
ropathy; significant malocclusion or facial asymmetry; unstable breathing and pulse; tracheostomy; se-
vere communication disorder such as severe aphasia; inadequate lip closure
Risk of bias

Informed decisions.

Park 2016b (Continued)
Random sequence genera- Low risk Randomisation by randomly selected envelopes containing a code specifying
tion (selection bias) the group
Allocation concealment Low risk Concealed by coded envelopes

(selection bias)
Blinding (performance Unclear risk Participant blinding unclear

All outcomes

mance bias)
All outcomes
Blinding of outcome as- Low risk Outcomes partially blinded (surface EMG evaluation not blinded; however this
sessment (detection bias) outcome not relevant in this review)
All outcomes
Incomplete outcome data High risk 6 participants lost to follow-up

(attrition bias)
All outcomes

porting bias)

Perez 1997
Triple-blind trial; outcomes assessed by blinded therapist
Analysis by ITT
No cross-overs or losses to follow-up
1 participant withdrawn with heart failure (nifedipine group)
17 participants; 8 men
Mean age 77 (SD 7) years
All first ischaemic stroke
100% CT
Enrolment 2 weeks after stroke
Interventions Rx: nifedipine (30 mg orally daily, Bayer, UK) (n = 8)

Informed decisions.

Perez 1997 (Continued)
Pl: matching tablet; treatment for 4 weeks (n = 9)
Outcomes Primary outcome: clinical improvement in swallowing
Other outcomes: incidence of silent aspiration, pharyngeal transit time and response duration, swal-
lowing delay (all assessed by videofluoroscopy), death
Notes Exclusions: inability to sit, high clinical risk of aspiration, receptive dysphasia, cognitive impairment,
pre-stroke dysphagia, existing neurological or psychiatric disease, current treatment with calcium
channel blockers or aminophylline
Follow-up: 4 weeks. 1 participant withdrawn with heart failure
Risk of bias
Random sequence genera- Low risk Computerised randomisation

Allocation concealment Unclear risk Not stated

(selection bias)
Blinding (performance Low risk Triple-blind trial

All outcomes
Blinding of participants Low risk Triple-blind trial

mance bias)
All outcomes
Blinding of outcome as- Low risk Outcomes assessed by blinded therapist

All outcomes
Incomplete outcome data Low risk 1 participant withdrawn with heart failure (nifedipine group)
(attrition bias)
All outcomes No cross-overs

porting bias)

Power 2006
CT scans analysed by a neuroradiologist who was blinded to patients' clinical presentation and video-
fluoroscopic swallowing status
Baseline data not including dysphagia severity of baseline groups
16 participants

Informed decisions.

Power 2006 (Continued)
Interventions Rx: actual electrical stimulation following threshold setting exercise to faucial pillars
C: single episode of sham electrical stimulation following threshold setting exercise
Outcomes Changes on videofluoroscopy 60 minutes post intervention
Notes Exclusions: prior dysphagia, intercurrent illness, other neurological disease
Risk of bias


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)

Shigematsu 2013
Methods Participants randomised using code numbers issued by coauthor
Outcomes blinded
Participants 1 centre in Japan

20 participants with stroke > 4 weeks

Clinical, video endoscopic, and videofluoroscopic evidence of dysphagia
Interventions Rx: 1-mA anodal tDCS
C: sham tDCS (n = 10)
Treatment for 10 days

Informed decisions.

Shigematsu 2013 (Continued)
Outcomes Dysphagia Outcome and Severity Scale, PAS, VFSS, video endoscopic evaluation of dysphagia
Notes Exclusions: subarachnoid haemorrhage, history of epileptic seizures, severe consciousness distur-
bance, organic neck disease, history of surgery except for tracheotomy
Risk of bias
Random sequence genera- Low risk Randomised via code numbers issued by coauthor
Allocation concealment Low risk Allocation concealed by code numbers

(selection bias)
Blinding (performance Unclear risk Participant blinding unclear

All outcomes

mance bias)
All outcomes
Blinding of outcome as- Low risk Outcomes blinded (rehabilitation doctor and speech-language hearing thera-
sessment (detection bias) pists did not know participants' group allocation)
All outcomes

(attrition bias)
All outcomes
Selective reporting (re- Low risk Results of the Dysphagia Outcome and Severity Scale reported pre-, post-, and
porting bias) at 1-month follow-up

Song 2004
Methods Method of randomisation: random numbers table
Allocation method and concealment unclear
All dysphagia identified by water swallow test
Baseline characteristics reported as similar
Interventions Rx: nurse-led swallowing exercises, oral stimulation and oral care (n = 29)
C (n = 24)
Follow-up: 1 month
Outcomes Primary and secondary outcomes not defined

Informed decisions.

Song 2004 (Continued)
Resolution of dysphagia by water swallow test and dietary ability, pneumonia rates
Notes Exclusions and whether ITT not stated
Risk of bias
Random sequence genera- Low risk Method of randomisation: random numbers table

(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)

STEPS 2016
Single-blind; outcome assessor blinded
Analysis by ITT
Baseline characteristics balanced
Participants International, multi-centre trial
Mean age 74.4 years
Dysphagia identified clinically and by videofluoroscopy
Interventions Rx: active pharyngeal electrical stimulation
C: sham pharyngeal electrical stimulation

Informed decisions.

STEPS 2016 (Continued)
Follow-up: up to 12 weeks
Outcomes Primary: change in PAS at 2 weeks from baseline
Secondary: safety outcomes, clinical dysphagia (Dysphagia Severity Rating Scale, PAS at 12 weeks), de-
pendency (mRS), activities of daily living/disability (BI), impairment (NIHSS), health-related quality of
life (European Quality of Life-5 Dimensions (EQ-5D), nutritional measures (weight, mid-arm circumfer-
ence, and blood albumin))
Notes Exclusions: history of dysphagia, dysphagia from a condition other than stroke, advanced dementia,
implanted pacemaker or cardiac defibrillator in situ, unstable cardiopulmonary status or a condition
that compromised cardiac or respiratory status, distorted oropharyngeal anatomy, additional diagno-
sis of progressive neurological disorder, receiving continuous oxygen treatment, pregnant or nursing
mother
Risk of bias
Random sequence genera- Low risk Randomisation by computer-generated permuted blocks


(selection bias)
Blinding (performance Low risk Researcher delivering the intervention not blinded
All outcomes
Blinding of participants Low risk Assessor and participant blinded

mance bias)
All outcomes

All outcomes
Incomplete outcome data High risk 181 participants randomised; only 123 participants completed all 3 treatments
(attrition bias)
All outcomes

porting bias)

Terre 2015
Double-blinded study
Outcome assessors blinded
Participants Study completed in Spain

Informed decisions.

Terre 2015 (Continued)
20 participants with neurological oropharyngeal dysphagia (14 stroke participants in the posterior cir-
culation; 6 with traumatic brain injury)
Baseline characteristics similar between groups
All within 5 months of diagnosis
Dysphagia identified by videofluoroscopy and Functional Oral Intake Scale
Interventions Rx: active NMES with conventional therapy
C: sham NMES with conventional therapy
Outcomes Clinical, videofluoroscopic, and oesophageal manometric analyses of swallow; Functional Oral Intake
Scale
Notes Exclusion: previous stroke or traumatic brain injury, previous dysphagia secondary to any other etiolo-
gy, other metabolic or neurological disease
Risk of bias
Random sequence genera- Low risk Computerised randomisation


(selection bias)
Blinding (performance Low risk Double-blinded

All outcomes
Blinding of participants Low risk Participants and assessors blinded

mance bias)
All outcomes
Blinding of outcome as- Low risk Assessors blinded

All outcomes

(attrition bias)
All outcomes

porting bias)

Vasant 2016
Single-blind trial; outcomes assessed by blinded therapist

Informed decisions.

Vasant 2016 (Continued)
Analysis by ITT
Participants 3 centres in UK
All dysphagia identified by bedside screening swallow test and videofluoroscopy
Baseline characteristics reported as similar
1 participant withdrawn and lost to follow-up
Baseline prognostic factors similar between groups
Interventions Rx: pharyngeal electrical stimulation n = 18
C: sham n = 18
Duration: 3 days
Follow-up: 3 months
Outcomes Death, swallow function, dysphagia
Notes Exclusions: advanced dementia, other neurological conditions that may explain dysphagia, previous
history of dysphagia, presence of cardiac pacemaker or implanted cardiac defibrillator, diagnosis other
than stroke (e.g. brain tumour), significant structural abnormalities of the mouth or throat and requir-
ing continuous oxygen treatment
Risk of bias
Random sequence genera- Low risk Randomisation through a concealed computer programme
Allocation concealment Low risk Concealed via a computerised programme

(selection bias)
Blinding (performance Low risk Researcher delivering the intervention not blinded
All outcomes
Blinding of participants Low risk Participants and assessors blinded to group allocation
mance bias)
All outcomes

All outcomes
Incomplete outcome data Low risk 1 participant lost to follow-up (withdrawn), 2 participants (1 from each group)
(attrition bias) died before follow-up at 3 months
All outcomes

porting bias)

Informed decisions.


Warusevitane 2015
Methods Randomisation via a random numbers list generated by an independent statistician
Double-blind
60 participants within 7 days of acute ischaemic or haemorrhagic stroke confirmed by CT scan of the
brain who required nasogastric feeds for > 24 hours
Mean age: 78
No significant differences between baseline characteristics
Interventions Rx: 10 mg metoclopramide (10 mL)
C: 10 mL normal saline
Treatment duration: 21 days or until NGT no longer needed
Outcomes Swallowing impairment using dysphagia outcome and severity scale
Notes Exclusions: signs and symptoms of pneumonia after stroke onset, history of chronic neurodegenerative
disease that could affect swallowing (e.g. Parkinson disease, motor neuron disease), oesophageal dis-
orders, contraindications to metoclopramide.
Risk of bias
Random sequence genera- Low risk Randomisation by numbers list generated by an independent statistician
Allocation concealment Low risk Allocation sequence concealed from participants

(selection bias)
Blinding (performance Low risk Double-blind trial

All outcomes
Blinding of participants Low risk Double-blind trial

mance bias)
All outcomes
Blinding of outcome as- Low risk Researcher and medical team involved in participants' care blinded to treat-
sessment (detection bias) ment allocation
All outcomes
Incomplete outcome data Low risk All 60 participants analysed at end of trials (none excluded)
(attrition bias)
All outcomes

porting bias)

Informed decisions.

Warusevitane 2015 (Continued)

Wei 2005
Outcomes blinded

68 participants; timing post stroke unclear but suggests acute
Dysphagia defined by water swallow test
Interventions Rx: Shuiti acupoint injection with stellate ganglion block for 40 days of treatment (n = 32)
C: standard medical care, which included some acupuncture (n = 33)
Outcomes Resolution of dysphagia: water swallow test score

BI
Chinese Neurological Score
Fugl-Meyer Assessment
Notes Exclusions: needle phobia, organ failure, head and neck tumours
Exclusions and dropouts accounted for but not analysed by ITT
Risk of bias
Random sequence genera- Unclear risk Unclear


(selection bias)

All outcomes

mance bias)
All outcomes
Blinding of outcome as- Low risk Outcomes blinded

All outcomes

(attrition bias)
All outcomes

porting bias)

Informed decisions.


Xia 2011
Outcomes blinded

120 participants, timing post stroke unclear but suggests acute
Dysphagia defined by water swallow test
Interventions Rx 1: combined VitalStim therapy + conventional swallowing training (n = 40)
Rx 2: VitalStim therapy (n = 40)

C: conventional swallowing training (n = 40)
For the purpose of this review, treatment group Rx 1 used as the treatment arm only
Outcomes VFSS, Standardised Swallowing Assessment (SSA), surface EMG, Swallowing Quality of Life (SWAL-QOL)
Notes Exclusion criteria not specified
Risk of bias
Random sequence genera- Unclear risk Randomisation unclear


(selection bias)

All outcomes

mance bias)
All outcomes
Blinding of outcome as- Unclear risk Outcomes blinded

All outcomes

(attrition bias)
All outcomes

porting bias)


Informed decisions.

Xia 2016a
Methods Randomisation by random numbered tables
Outcomes blinded

124 participants, timing post stroke unclear but suggests acute based on mean days from onset of
stroke
Dysphagia identified by videofluoroscopy and Dysphagia Outcome Severity Scale
No significant differences in baseline characteristics between groups
Interventions Rx: combined acupuncture with standard swallowing training (n = 62)

C: standard swallowing training only (n = 62)
Outcomes Primary: Standardized Swallowing Assessment, Dysphagia Outcome Severity Scale
Secondary: Modified BI, Swallowing Quality of Life (SWAL-QOL)
Notes Exclusion: presence of serious diseases of the liver, kidney, hematological system, or endocrine system;
psychiatric disorders; severe cognitive impairment; severe aphasia; other diseases that potentially im-
paired swallowing function, such as head and neck tumours, oesophageal neoplasms, craniocerebral
injury, myasthenia gravis, and Guillain-Barre syndrome
Risk of bias
Random sequence genera- Low risk Randomisation by random numbers table


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes
Incomplete outcome data Low risk 4 participant dropouts from study in total
(attrition bias)
All outcomes

porting bias)

Informed decisions.


Yuan 2003i
Blinding unclear
(traditional liquid diet with swallowing therapy vs control)

64 participants; timing unclear
All dysphagia as defined by Watian Swallow Test
Interventions R1: enteral nutrition agent with thickener and swallowing therapy (n = 18)
R2: traditional liquid diet and swallowing therapy (n = 22). This data set was split (n= 11)*
C: liquid diet only and no swallowing therapy (n = 24)
(R1 and R2 had NGTs for an uncertain amount of time)
*Compared in data set 1
Outcomes Length of stay, pneumonia rates, nutritional measures, resolution of dysphagia (swallow test grade)
Notes Exclusions: terminal illness, organ failure

Unclear if any blinding of interventions or outcomes occurred
Risk of bias


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)


Informed decisions.

Yuan 2003ii
Methods (Enteral nutrition agent with thickener and swallowing therapy vs traditional liquid diet and swallow-
ing therapy data set)
Interventions R1: enteral nutrition agent with thickener and swallowing therapy (n = 18)
R2: traditional liquid diet and swallowing therapy (n = 22). This data set was split (n = 11)
Notes -
Risk of bias


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)

Zheng 2014
Methods Randomisation unclear
Blinding unclear

88 participants; onset of stroke within 2 weeks
Dysphagia identified by water swallow test

Informed decisions.

Zheng 2014 (Continued)
Interventions Rx: individualised multi-disciplinary rehabilitation programme (n = 44)
C: conventional rehabilitation programme (n = 44)
Outcomes Swallowing function by the water swallow test
Notes Exclusion: comprehension difficulty, such as Wernicke aphasia
Risk of bias


(selection bias)

All outcomes

mance bias)
All outcomes

All outcomes

(attrition bias)
All outcomes

porting bias)
ACE: angiotensin-converting enzyme

BI: Barthel Index
BSA: body surface area
C: control group
CT: computed tomography
EMG: electromyography
EMST: expiratory muscle strength training
EQ-5D: EuroQoL Group Quality of Life Questionnaire based on five dimensions
FDS: Functional Dysphagia Scale
FMA: Fugl-Meyer Assessment
Hz: Hertz
ITT: intention-to-treat analysis
LMI: lateral medullary infarction
MD: mean difference
MEPs: motor evoked potentials
MMSE: Mini Mental State Examination
MoCA: Montreal Cognitive Assessment

Informed decisions.

MRI: magnetic resonance imaging

mRS: modified Rankin Scale
NGT: nasogastric tube
NIHSS: National Institutes of Health Stroke Scale
NMES: neuromuscular electrical stimulation
OR: odds ratio
PAS: Penetration Aspiration Scale
PEG: percutaneous endoscopic gastrostomy
PHAD: Paramatta Hospital's Assessment for Dysphagia score
Pl: placebo group
PTT: pharyngeal transit time
RBHOMS: Royal Brisbane Hospital Outcome Measure Scale
rTMS: repetitive transcranial magnetic stimulation
Rx: treatment group
SD: standard deviation
sEMG: surface electromyography
SLT: speech and language therapy
SPSS: Statistical Package for the Social Sciences
SSA: Standardised Swallow Assessment
SWAL-QOL: Swallowing Quality of Life Questionnaire
tDCS: transcranial direct current stimulation
UES: upper oesophageal sphincter
VDS: videofluoroscopic dysphagia scale
VFSS: videofluoroscopy swallow study

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion
Akamatsu 2009 RCT assessing transcutaneous electrical stimulation vs control
12 participants with chronic stroke and episodes of choking while eating or drinking
Outcome: latency time in swallowing reflex
Excluded: no relevant outcome data
Aoki 2016 Study looking at effect of implementing multi-disciplinary swallowing team approach in lowering
the rate of pneumonia (between-team organisation vs after-team organisation)
Outcomes: rates of pneumonia
Excluded: not a true RCT
Arai 2003 RCT

Group 1: cabergoline (n = 13)
Group 2: amantadine (n = 14)
Group 3 : ACE inhibitor (n = 12)
Group 4: control
Excluded: (1) > 3 months post stroke; (2) definition of aspiration non-standard; (3) randomisation
unclear; (4) insufficient information
Beom 2011 Study comparing conventional dysphagia management (CDM) vs CDM with repetitive electrical
stimulation of the suprahyoid muscles
Outcomes: swallow score
Excluded: not true RCT - non-concurrent comparative design
Beom 2015 Randomised trial in dysphagic participants with stroke, traumatic brain injury, or brain tumour
NMES on suprahyoid (Stimplus) vs NMES on suprahyoid and infrahyoid (VitalStim)

Informed decisions.


Outcomes: swallow scores
Excluded: confounded - comparison between 2 treatment groups
Byeon 2016 Randomised trial comparing neuromuscular electrical stimulation vs thermal-tactile stimulation in
subacute stroke patients with dysphagia
Outcomes: swallow scores (Functional Dysphagia Scale using VFSS)
Excluded: confounded - comparing 2 active treatments
Bülow 2008 RCT assessing neuromuscular electrical stimulation vs traditional swallowing therapy in 25 stroke
patients with dysphagia
Outcomes: video radiographic swallowing evaluation, nutritional status, oral motor function test,
visual analogue scale for self-evaluation of complaints
Excluded: (1) no available outcome data, (2) confounded, comparing 2 direct treatments
Cai 2015 Randomised trial comparing tongue acupuncture vs conventional (neck and wrist) acupuncture in
post-stroke dysphagia patients
Outcomes: dysphagia at end of trial, NIHSS, pneumonia
Excluded: (1) confounded - both groups received active treatment
Chaudhuri 2006 RCT assessing effectiveness of electric stimulation vs traditional dysphagia therapy in participants
with acute stroke (< 6 weeks)
Outcomes: American Speech Language Hearing Association National outcome measurement sys-
tem swallowing level
Excluded: no available outcome data
Chen 2002 RCT assessing tongue acupuncture + ice massage + general medical treatment (n = 50) vs general
medical treatment (n = 46) in acute dysphagic stroke patients
Outcome: dysphagia recovery assessed by videofluoroscopy
Chen 2003 RCT assessing electroacupuncture + rehabilitation (n = 34) vs rehabilitation alone (n = 34) in dys-
phagia patients with pseudobulbar palsy including stroke
Treated for 10 days
Outcome: dysphagia recovery after stroke
ChiCTR-ONC-17012326 RCT examining effects of acupuncture and rTMS for acute patients - duration of stroke and dyspha-
gia between 1 and 6 months.
Outcomes: VFSS score
Excluded: confounded - comparing acupuncture and rTMS
ChiCTR-TRC-14005233 RCT comparing validity and safety of telerehabilitation (exercise rehabilitation and myoelectrical
feedback) vs conventional rehabilitation in dysphagic patients with ischaemic cerebral stroke
Outcomes: Barthel Index assessment; NIHSS assessment; water drinking test assessment; surface
electromyography

Informed decisions.


Excluded: confounded - comparing 2 active treatment groups
DePippo 1994 RCT comparing 3 active interventions in 115 dysphagic stroke patients taught compensatory swal-
lowing techniques
Group 1: patient/family choice of diet and food consistency (n = 38)
Group 2: therapist-prescribed diet and food consistency (n = 38)
Group 3: therapist-prescribed diet and food consistency, with daily reinforcement of compensatory
swallowing techniques (n = 39)
Outcomes: pneumonia, dehydration, caloric-nitrogen deficit, death
Excluded: 3 active treatment groups with no control group (confounded)
Dou 2012 Randomised trial comparing effects of active vs passive balloon dilatation therapy on swallowing
function in participants with cricopharyngeal dysfunction due to neurological disorders
Outcomes: swallow score, changes in upper oesophageal sphincter opening
Excluded: confounded - comparison between 2 active treatments
Ebihira 2004 RCT

Group 1: theophylline 200 mg once daily
Group 2: placebo
N = 85 with 'mild to moderate' dysphagia (definition unclear)
Outcome: latency of swallow
Excluded: (1) nursing home residents (not acute), proportion of stroke patients not stated; (2) > 3
months post stroke
Ebihira 2005 RCT

Group1: capsaicin troche 1.5 mcg (n = 34)
Group 2: placebo (blinded) (n = 33) for 4 weeks
Excluded: (1) 'predominantly' stroke (% not stated) nursing home-dependent residents; (2) defini-
tion of dysphagia unclear; (3) > 3 months post stroke; (4) outcomes: latency of swallow not relevant
to review
El-Tamawy 2015 RCT evaluating effects of a designed physical therapy programme that consists of therapeutic
physical exercises in addition to neuromuscular electrical stimulation on severe swallowing disor-
ders (oropharyngeal dysphagia) in people with acute ischaemic cerebrovascular stroke
Outcomes: oral transit time, hyoid/laryngeal elevation, oesophageal sphincter opening, incidence
of penetration and aspiration
Fraser 2002 RCT including 16 acute stroke (< 4 days from ictus) participants with dysphagia
TMS vs none
Outcome: pharyngeal electromyographic responses
Freed 1996 Controlled clinical trial comparing 3 active interventions in 112 participants with aspiration
Group 1: electrical stimulation
Group 2: thermal stimulation
Group 3: both - failed thermal stimulation followed by electrical stimulation
Outcome: regain oral intake
Excluded: (1) dysphagia of mixed aetiology (stroke ?%); (2) not an RCT; (3) 2 active treatment
groups with no control group (confounded)
Freed 2001 Quasi-RCT (alternate assignment) comparing electrical stimulation vs thermal-tactile stimulation
in 110 dysphagic stroke patients

Informed decisions.


Outcome: swallow score
Excluded: (1) 2 active treatment groups with no control group (confounded)
Hagg 2015 Prospective comparative study of 2 groups of post-stroke 4-quadrant facial dysfunction and dys-
phagic patients - palatal plate training (2005-2008) vs training with oral IQoro® (2009-2012)
Outcome: facial activity, swallow function
Excluded: (1) not a true RCT, (2) confounded - comparing 2 active treatment protocols
Inui 2017 Quasi-experimental study to compare the incidence of pneumonia as a dependent variable be-
tween before (control) and after (intervention group) intervention with pyriform sinus suctioning
as an independent variable
Outcomes: incidence of pneumonia
Excluded: (1) not an RCT - not randomised
ISRCTN18137204 RCT comparing electrical pharyngeal stimulation vs sham stimulation in severely dysphagic tra-
cheotomised stroke patients
Outcomes: intention to decannulate based on FEES performance; feeding status at discharge (dys-
phagia severity rating scale, functional oral intake scale); mRS; length of stay (ICU/hospital), time
from stimulation to discharge
Excluded: outcomes not relevant to the review
ISRCTN97286108 RCT assessing dose response of transcranial direct current stimulation for dysphagia after acute
stroke
Outcome: swallow safety
Excluded: trial terminated due to problems in recruitment (according to study author)
Jin 2014a RCT assessing effects of magnetic-ball sticking therapy at auricular points against acupuncture in
90 participants with chronic post-stroke dysphagia
Outcomes: swallow score (VFSS), PAS, pneumonia, malnutrition
Excluded: (1) confounded - all participants received treatment, (2) duration of stroke unknown
KCT0001907 Study looking at effects of NMES according to electrode placement in stroke patients with dyspha-
gia
Outcomes: videofluoroscopic dysphagia scale; PAS; functional oral intake scale
Excluded: (1) confounded (comparing electrode placement on suprahyoid vs infrahyoid), (2) time
post onset unclear
Kikuchi 2014 Double-blind RCT on participants > 65 years old with stroke and dysphagia from 2 hospitals and 2
nursing homes in Sendai, Japan
Group 1: press needles (Pyonex; Seirin Corporation, Shizuoka, Japan) at 2 points on the legs (ST36
and KI3)
Group 2: sham patches on acupuncture points

Group 3: press needles on sham points
Excluded: no relevant outcomes
Kobayashi 1996 Randomised crossover trial assessing levodopa in 27 participants with basal ganglia infarction and
20 healthy volunteers
Informed decisions.


Outcomes: swallowing latency
Excluded: (1) cross-over trial, (2) outcomes (swallowing latency) not relevant to this review, (3) <
50% stroke
Kulnik 2015 Single-blind RCT in acute stroke patients
Expiratory training vs inspiratory training vs sham training
Outcomes: peak expiratory cough flow of maximal voluntary cough, pneumonia
Excluded: most participants do not have clinical dysphagia
Kushner 2013 Case-control study comparing the efficacy of NMES in addition to traditional dysphagia therapy in-
cluding progressive resistance training vs that of traditional dysphagia therapy/progressive resis-
tance training alone in participants with acute post-stroke dysphagia
Outcomes: swallow score, dysphagia at end of trial
Excluded: non-randomised trial
Lan 2013 Single-blind clinical intervention trial comparing biomechanical properties of swallowing in brain-
stem stroke patients with dysphagia following modified balloon dilation therapy vs regular dyspha-
gia therapy
Outcomes: Functional Oral Intake Scale, pharyngeal maximum pressures and duration, and up-
per oesophageal sphincter residual pressure and duration during swallowing were measured using
high-resolution manometry
Excluded: non-randomised trial
Logemann 2009 RCT assessing traditional swallowing therapy or the Shaker exercise in participants with prolonged
oropharyngeal dysphagia and aspiration
Outcomes: occurrence of aspiration (preswallow, intraswallow, postswallow) at 6-week follow-up

period; occurrence of residue in the oral cavity, valleculae, or pyriform sinuses; Performance Status
Scale for Diet
Excluded: (1) head and neck cancer and stroke (< 50%); (2) no relevant outcome data
Ma 2014 Randomised trial comparing acupoint injection, neural electrical stimulation, combination of both
and swallowing training
Outcomes: swallow function using water swallow test
Ma 2015 Randomised trial comparing effects of acupuncture and neck-skin electrical stimulation on dys-
phagia in participants with cerebral infarction
Outcomes: swallow function using water swallow test and food-intake scale
Maeda 2017 RCT
43 participants who were prescribed in-hospital dysphagia rehabilitation (most with history of
stroke)
Sensory stimulation vs sham stimulation
Outcomes: cough latency times, functional oral intake scale scores, oral nutritional intake

Informed decisions.


Excluded: (1) majority of participants without stroke (48.8% stroke participants), (2) timing of
stroke unclear
Mao 2016 Non-randomised interventional study
Standard swallowing training vs standard swallowing training with acupuncture
All participants with post-stroke dysphagia
Excluded: not an RCT - not randomised
McCullough 2012 Cross-over study investigating effects of intensive exercise using Mendelsohn manoeuvre on swal-
lowing movement
All 18 participants with stroke and dysphagia
Outcomes: videofluoroscopic swallow assessment, swallow score
Excluded: (1) not a true RCT - cross-over design, (2) majority of participants chronic
McCullough 2013 Cross-over study assessing effect of Mendelsohn manoeuvre on hyoid movement
All 18 participants with post-stroke dysphagia
Outcomes: assessment of hyoid movements, upper oesophageal sphincter opening
Excluded: (1) not a true RCT - cross-over design, (2) no relevant outcomes
Mepani 2009 RCT comparing traditional swallowing therapy vs Shaker exercise in 6 stroke and 5 cancer patients
Outcome: deglutitive thyrohyoid shortening before and after completion of assigned therapy regi-
men
Excluded: (1) no time of onset for stroke patients, (2) no separate results for stroke, (3) no relevant
outcome data
Messaggi-Sartor 2015 RCT comparing effects of short-term inspiratory and expiratory muscle training on respiratory mus-
cle strength in subacute stroke patients
Outcomes: respiratory muscle strength (maximum inspiratory and expiratory pressures)
Excluded: (1) outcomes not relevant to review, (2) not all participants had dysphagia
Michou 2010 RCT comparing transcranial magnetic stimulation vs sham stimulation in 12 stoke participants with
dysphagia
Outcome: pharyngeal electromyographic responses
Michou 2011 RCT comparing transcranial magnetic stimulation vs pharyngeal electrical stimulation vs paired as-
sociative stimulation vs sham stimulation in 14 dysphagic stroke participants
Outcome: videofluoroscopic swallowing assessments
Nakamura 2013 Cross-over study assessing the effect of ice massage in triggering the swallow reflex
Outcomes: videofluoroscopic assessment of swallowing
Excluded: not a true RCT - cross-over design

Informed decisions.

Nakayama 1998 RCT comparing 5 mg imidapril or placebo in randomised, double-blind, cross-over design. Partici-
pants were normotensive patients with at least 1 episode of aspiration and healthy volunteers
Outcome: swallowing reflex
Nam 2012 Randomised trial comparing 2 neuromuscular stimulation techniques (VitalStim vs Stimplus DP
200)
Outcomes: swallow function using videofluoroscopic swallowing studies
Excluded: confounded - comparison of 2 treatment groups
NCT00376506a Implanted neuroprosthesis (neuro control implantable receiver-stimulator) to stimulate the laryn-
geal nerve vs sensory training in dysphagic participants including stroke > 6 months post onset
Excluded: (1) no control group, 2 active groups compared, (2) no outcome data
NCT00376506b RCT assessing intramuscular stimulation device implanted in the neck vs vibrotactile stimulation of
the throat in 20 participants with dysphagia secondary to stroke or chronic neurological disease
Outcome: swallowing safety for 10 mL of thin liquid and 5 mL of pudding with and without stimula-
tion
Excluded: comparing 2 active treatments vs no control (confounded)
NCT01971320 Single-blind RCT comparing active vs fake Urostim I stimulation in hemispheric stroke patients with
oropharyngeal dysphagia
Outcomes: evaluation of oropharyngeal dysphagia symptoms
Excluded: no outcome data as trial terminated due to lack of recruitment
Nishiyama 2010 RCT comparing nicergoline (15 mg tds) vs control in 50 ischaemic stroke patients
Outcome: substance P level
Ortega 2016 RCT comparing 2 x 10-day treatment groups (transient receptor potential vanilloid 1 agonist vs
transcutaneous sensory electrical stimulation)
Outcomes: swallow function (videofluoroscopic), dysphagia at end of trial
Excluded: (1) < 50% participants with stroke - duration unknown, (2) confounded - comparing 2 ac-
tive treatments
Permsirivanich 2009 RCT
Group 1: NMES (n = 12)
Group 2: rehabilitation swallowing therapy (n = 11)
All stroke
Excluded: confounded, i.e. comparison of 2 active treatments
Pownall 2008 RCT assessing thickened fluids vs postural and/or swallowing strategies in 50 participants with
post-stroke dysphagia: a further group of participants who were not dysphagic for liquids and who
were given normal fluids compared with RCT

Informed decisions.


Outcome: development of chest infection and dehydration
Excluded: no control group - 2 interventional groups were compared in the RCT
Pryor 2011 RCT comparing NMSE vs vibrotactile stimulation in dysphagic participants
Outcomes: swallow function, PAS
Excluded: (1) mixed patient population, (2) confounded - comparison of 2 active interventions
Reidnauer 2006 RCT comparing vital stimulation (and electrotherapy intervention) vs traditional treatment in post-
stroke participants with dysphagia
Outcomes: swallow scores
Rofes 2014 Double-blind RCT comparing effects of 2 doses of piperine (dual TRPV1/TRPA1 agonist) on the
swallow response of dysphagic participants
Participants were randomised into 2 groups: 1 group received 150 lM piperine and the other group
received 1 mM
Outcome: PAS, swallowing analysis with videofluoroscopic images
Excluded: dose-response trial - all groups received treatment (either low or high dose of piperine)
Rosenbek 1991 Randomised cross-over trial assessing thermal stimulation in 7 male dysphagic participants with
multiple previous strokes
Outcome: duration of stage transition
Excluded: (1) cross-over trial, (2) most participants recruited > 3 months after stroke onset, (3) ran-
domisation status unclear
Rosenbek 1996 Randomised cross-over trial assessing thermal stimulation in 23 dysphagic participants with multi-
ple previous strokes
Outcome: duration of stage transition, total swallow duration
Excluded: (1) cross-over trial, (2) 14 participants recruited > 3 months after stroke onset
Rosenbek 1998 Dose comparison RCT of thermal stimulation (150, 300, 450, 600 trials per week) in 45 dysphagic
stroke participants recruited within 12 weeks
Outcome: number of trials delivered, treatment time, duration of stage transition, aspiration (PAS)
Excluded: no control group
Sdravou 2012 Interventional study comparing effects of carbonated thin liquids vs non-carbonated thin liquids
on oropharyngeal swallowing in adults with neurogenic dysphagia
Outcomes: oral transit time, pharyngeal transit time, PAS
Excluded: (1) non-RCT, (2) many participants with chronic stroke (> 6 months)
Seki 2005 Randomised trial

Group 1: acupuncture (n = 18)
Group 2: no intervention (n = 14)
Excluded: (1) incomplete outcome data, (2) time from stroke unclear
Shaker 2002a RCT comparing head-raising exercise vs sham exercise in 27 dysphagic participants
Outcomes: upper oesophageal sphincter function, functional swallow status
Excluded: (1) dysphagia of mixed aetiology (cerebrovascular disease 56%), (2) most participants
recruited > 3 months after stroke onset, (3) individual patient data unavailable, so not possible to
analyse subgroup of appropriate participants

Informed decisions.

She 2014 RCT comparing acupuncture in 8 neck-occiput points vs meridian points
Outcomes: speech and swallowing dysfunction at end of trial
Excluded: (1) confounded - comparing 2 different treatment groups
SQACU01 2001 RCT comparing acupuncture vs sham acupuncture for 16 sessions in participants with dysphagia
due to recent stroke
Outcomes: tube feeding, pneumonia, mortality, each at 6 months
Excluded: no outcome data
Steele 2016 RCT comparing 2 treatment protocols: tongue pressure profile training or tongue pressure
strength-and-accuracy training
Outcomes: swallow function
Excluded: confounded - comparison between 2 treatment protocols
Sukthankar 1994 RCT assessing swallowing therapy (biofeedback) in 9 participants with dysphagia secondary to
stroke or head injury
Group 1: regular therapy (n = 4)
Group 2: regular therapy and oral exercises (n = 2)
Group 3: regular therapy and oral exercises with visual and audio biofeedback (n = 3)
Excluded: (1) dysphagia of mixed aetiology, (2) outcome measures (tongue and lip motor force) not
relevant to this review
Suntrup 2015 RCT comparing electrical pharyngeal stimulation vs sham stimulation (control) in severely dys-
phagic tracheotomised stroke participants
Outcomes: ability to decannulate based on FEES performance; feeding status at discharge (FOIS);
mRS; length of stay (ICU/hospital) and time from stimulation to discharge
Excluded: outcomes (decannulation) not relevant to review (only data regarding decannulation
available before trial unblinded)
Suzuki 2012 Randomised trial investigating the relationship between body position during nasogastric feed and
aspiration pneumonia in acute stroke participants
Outcomes: aspiration pneumonia rates
Excluded: pseudo-randomised study; assessment of body position
Tai 2014 Quasi-experimental trial to investigate effectiveness of the chin-down swallowing technique in im-
provement of dysphagia in stroke participants
Outcomes: Dysphasia Assessment Scale and Swallow Self-assessment
Teramoto 2008 RCT assessing swallowing function using cilostazol vs placebo in 48 participants with dysphagia
secondary to stroke
Outcome: swallowing function
Excluded: (1) onset of stroke to randomisation, 1 to 6 months, (2) cross-over study, no access to da-
ta on the first phase

Informed decisions.

Terre 2012 Randomised, alternating, cross-over study assessing effectiveness of chin-down posture in pre-
venting aspiration in participants with neurogenic dysphagia secondary to acquired brain injury
Outcomes: aspiration prevention
Excluded: (1) pseudo-randomised study, (2) assessment of posture
Toyama 2014 Non-randomised interventional study comparing NMES and conventional treatment vs conven-
tional treatment only
Outcomes: swallow scores (VDS, FOIS), hyoid and laryngeal displacement
Ueda 2004 21 participants

Group 1: functional swallowing training (n = 11)
Group 2: oral care (n = 11) in nursing home residents (% stroke unknown) who are tube fed
Excluded: (1) < 50% stroke, (2) non-acute, (3) randomisation unclear
Varma 2006 Group 1: motor control programme (n = 30)

Group 2: home exercise programme (n = 30)
Randomisation method unclear
Excluded: (1) insufficient data, (2) outcome methods unclear
Wang 2016 Randomised interventional trial comparing differences in effects between awn-like needle at
Tiantu (CV 22) and filiform needle for dysphagia after cerebral infarction
Outcomes: standard swallowing assessment scale and modified Bathel index
Exlcuded: confounded - comparing 2 different treatment groups
Xia 2016 RCT with 130 participants with post-stroke dysphagia
In treatment group, acupuncture based on meridian differentiation was adopted. The main acu-
points were Neiguan (PC 6), Shuigou (GV 26), Sanyinjiao (SP 6), Fengchi (GB 20), Lianquan (CV 23),
Jialianquan (Extra), Jinjin (EX-HN 12), Yuye (EX-HN 13), etc.
Control group: points were selected 5 cm lateral to the acupoints used in the observation groups
and stimulated with shallow puncture
Outcomes: standardised swallowing assessment, VFSS, modified Barthel Index and swallowing-re-
lated quality of life (SWAL-QOL)
Excluded: confounded - comparing 2 treatments
Zhang 2011 RCT comparing different depth of Chonggu (EX-HN 27) by electroacupuncture in participants with
dysphagia after stroke
Chonggu (EX-HN 27) deep insertion group (n = 99)
Chonggu (EX-HN 27) shallow insertion group (n = 94)
Traditional acupuncture group (n = 90)
Outcomes: Kubota's Water Drinking Test Scale, standard swallowing function scale, and TCM Scale
of Dysphagia After Stroke
Zhang 2018a RCT comparing effects of electroacupuncture with different frequencies in participants with dys-
phagia after stroke

Informed decisions.


Low-frequency (2 Hz) electroacupuncture group vs high-frequency (100 Hz) electroacupuncture
group
Outcomes: VFSS, standardised swallowing assessment
Excluded: not an RCT - dose-response study (no control group)
Zhang 2018b Randomised interventional trial to assess clinical improvement of nursing intervention in swallow-
ing dysfunction of elderly stroke participants
Conventional nursing service vs nursing interventions (psychological intervention, health educa-

tion, rehabilitation exercises, diet intervention)
Outcomes: dysphagia at end of trial, functional outcomes (GQOL-74)
Excluded: confounded - comparing 2 different treatment groups
Zhao 2015 Randomised trial of participants with stroke and swallowing disorders
Group A: normal acupuncture
Group B: NMES combined with acupuncture with uniform reinforcing-reducing manipulation as

well as the piercing and blood-letting method
Outcomes: Kubota water test, dysphagia at end of trial
Excluded: confounded - comparison between 2 treatment groups
ACE: angiotensin-converting enzyme

CDM: conventional dysphagia management
CXR: chest x-ray
FEES: Fibreoptic Endoscopic Evaluation of Swallowing
FIM: Functional Independence Measure
FOIS: Functional Oral Intake Scale
GQOL-74: Generic Quality of Life Inventory
ICU: intensive care unit
IOro®: Orofacial device
NGT: nasogastric tube
PEG: percutaneous endoscopic gastrostomy
RCT: randomised controlled trial
SAH: subarachnoid haemorrhage
TCM: Traditional Chinese Medicine
TMS: transcranial magnetic stimulation
VDS: videofluoroscopic dysphagia scale

Characteristics of studies awaiting assessment [ordered by study ID]

Azimov 2017
Methods RCT although randomisation method unclear
Participants 34 participants with ischaemic stroke and dysphagia at onset 2 to 7 points of PAS Scale

Informed decisions.

Azimov 2017 (Continued)
Interventions Experimental group: amantadine (200 mg/d) and levodopa (125 mg/d) after standard treatment (n
= 17)
Control group: standard treatment, including citicoline and anticholinesterase (n = 17)
Outcomes PAS divided into group PAS score 2 to 4 and group PAS score 5 to 7; recheck after 2 months
Notes Study completed; awaiting full published data

Carnaby 2012
Methods RCT
Participants 53 stroke participants from a subacute rehabilitation facility
Interventions Group 1: usual care
Group 2: McNeill Dysphagia Therapy plus sham NMES

Group 3: McNeill Dysphagia Therapy plus active NMES
Outcomes Increase of 10 or more points on the Mann Assessment of Swallowing and improvement of 2 or
more scale points on the Functional Oral Intake Scale, without significant weight loss or complica-
tion
Notes In the process of retrieving full-text article and data

Chang 2014
Methods RCT
Participants 74 participants with dysphagia after stroke
Interventions Functional electrical stimulation vs a combination of electrical stimulation and acupuncture
Outcomes Swallow score, removal rate of nasogastric tube
Notes In the process of retrieving full-text article

Chaudhuri 2008
Methods RCT
Participants People with stroke and dysphagia
Interventions Traditional dysphagia treatment vs combined neuromuscular electrical stimulation and traditional
treatment
Outcomes Swallow score (ASHA NOMS)
Notes Awaiting published data (full text)

Informed decisions.


Chen 2017
Methods RCT
Participants People with dysphagia due to stroke (onset 2 to 7 days)
Interventions Levetiracetam (Keppra) vs carbidopa/levodopa (Sinemet) vs placebo
Outcomes Qualitative and quantitative swallow function
Notes Study published; in the process of extracting data

Cheng 2005
Methods RCT
Participants People with Ischaemic stroke with pseudobulbar palsy
Interventions Early throat muscle training vs control
Outcomes Effects on vertebral and basilar artery blood flow

Cheng 2014
Methods RCT
Participants 180 participants with post-stroke dysphagia
Interventions Group 1 (Acupuncture A): acupuncture at Lianquan (CV 23)
Group 2 (Acupuncture B): acupuncture at Hegu (LI 4) and Neiguan (PC 6)
Group 3 (Control): rehabilitation group
Outcomes NIHSS scores, VFSS scale, pneumonia, clinical efficacy

ChiCTR-TRC-07000010
Methods RCT
Participants People with dysphagia in the convalescence phase of stroke (2 and 6 months)
Interventions Combination of body acupuncture, scalp acupuncture, and electroacupuncture vs routine rehabili-
tation training
Outcomes Safety and tolerability of acupuncture

Informed decisions.

ChiCTR-TRC-07000010 (Continued)
Notes Study completed; awaiting published data

ChiCTR-TRC-08000463
Methods RCT
Participants People with stroke 2 to 60 days from onset
Interventions Dysphagia therapeutic apparatus on acupoints vs regular dysphagia rehabilitation vs both
Outcomes Swallowing function and mastication function

ChiCTR-TRC-14004235
Methods RCT
Participants People with dysphagia symptoms appearing within 1 to 6 months after stroke
Interventions Modified Dihuang Yinzi Decoction (herb treatment group) vs control
Outcomes Swallowing rehabilitation improvement diagnosed by videofluoroscopy, adverse events

ChiCTR-TRC-14004955
Methods Randomised parallel controlled trial
Participants 60 people with stroke; onset of stroke at least 2 times but occurrence of stroke at least 1 month be-
fore admission
Interventions Manipulation + sham tDCS
Manipulation + tDCS
Outcomes Lingual movement; buccofacial apraxia; Modified Assessment of Swallowing Ability; VFSS; EEG
non-linear analysis
Notes Study likely completed; website not updated; awaiting published data

Choi 2017
Methods RCT
Participants Stroke survivors with dysphagia
Interventions Experimental group: Shaker exercise + conventional therapy (n = 16)

Informed decisions.

Choi 2017 (Continued)
Control group: conventional therapy (n = 16)
Outcomes PAS and oral diet level

Chu 2017
Methods RCT
Participants Dysphagia patients with pseudobulbar palsy
Interventions Basic treatment vs GAO neck acupuncture at Fengchi (GB 20), Yiming (EX-HN 14), Gongxue (Extra),
Lianquan (CV 23), Wai Jinjin Yuye (Extra), Tunyan (Extra), Zhiqiang (Extra), Fayin (Extra) with basic
treatment
Outcomes Repetitive saliva-swallowing test, standardised swallowing assessment, swallow quality-of-life

questionnaire

de Fraga 2017
Methods RCT
Participants 10 participants with ischaemic stroke and speech therapy-diagnosed oropharyngeal dysphagia
Interventions Rx: myofunctional therapy plus voice therapy
C: myofunctional therapy only
Outcomes Swallow function

Eom 2017
Methods RCT
Participants Stroke patients with oropharyngeal dysphagia
Interventions Resistance expiratory muscle strength training vs sham expiratory muscle strength training
Outcomes Videofluoroscopic dysphagia scale, PAS


Informed decisions.

Erfmann 2017
Methods RCT
Participants Subacute stroke patients with oropharyngeal dysphagia
Interventions Expiratory muscle strength training; no further details available
Outcomes No further details available at the time
Notes In the process of retrieving text

Fan 2007
Methods RCT
Participants 60 post-stroke patients with dysphagia
Interventions Experimental group: acupuncture plus Western drugs
Control group: Western drugs
Outcomes Swallowing test

Feng 2016
Methods RCT
Participants 60 cases of post-stroke dysphagia
Interventions Rx: deep acupuncture at Lianquan (CV 23) and Yifeng (TE 17) with swallowing training
C: swallowing training only
Outcomes VFSS dysphagia evaluation scale and Watian water swallow test

Gao 2016
Methods RCT
Participants 90 patients with dysphagia after cerebral infarction
Interventions Chin tuck resistance vs Shaker exercise vs control
Outcomes VFSS, Self-Rating Depression Scale, PAS

Informed decisions.


Guillen-Sola 2017
Methods RCT
Participants Subacute ischaemic stroke (1 to 3 weeks) and dysphagia confirmed by videofluoroscopic study
with a score ≥ 3 on the 8-point PAS
Interventions Group I: standard swallow therapy
Group II: inspiratory and expiratory muscle training + standard swallow therapy
Group III: neuromuscular electrical stimulation of suprahyoid muscles, sham inspiratory and expi-
ratory muscle training, and standard swallow therapy
Outcomes Respiratory muscle function (baseline, 3 weeks, and 3 months), severity of dysphagia (PAS) (base-
line and 3 months), and occurrence of respiratory complications (chest x-ray, fever); also vol-
ume-viscosity swallow test (V-VST), Functional Oral Intake Scale, and Dysphagia Outcome and
Severity Scale (baseline, 3 weeks, and 3 months)

Hamada 2017
Methods Study design not clear
Participants 56 people with acute stroke and dysphagia
Interventions General dysphagia therapy vs combination of surface electrical stimulation and general dysphagia
therapy
Outcomes Pulmonary infection

Hong 2011
Methods RCT
Participants People with cerebral apoplexy and dysphagia
Interventions Strengthened diet nursing vs control
Outcomes Incidence of aspiration, malnutrition, dehydration

Huang 2008
Methods RCT
Participants 66 participants with dysphagia post-ischaemic stroke

Informed decisions.

Huang 2008 (Continued)
Interventions Group 1: electro-acupuncture group
Group 2: rehabilitation training combined with acupoint percutaneous electrical stimulation
Group 3: rehabilitation training combined with acupoint token puncturing
Outcomes Quality of life scale specified for dysphagia (name not stated)
Notes In process of retrieving full-text article

Huang 2014
Methods RCT
Participants People with acute stroke and dysphagia
Interventions Traditional swallowing vs oropharyngeal NMES vs combined NMES/traditional swallowing
Outcomes Swallow score, PAS, VFSS
Notes In process of retrieving relevant outcome data

Huimin 2015
Methods RCT
Participants 76 people with pharyngeal dysphagia after stroke
Interventions Surface electromyographic biofeedback with conventional therapy vs conventional therapy only
Outcomes Degree of openness of upper oesophageal sphincter, pharyngeal transit time, maximum displace-
ment of the hyoid bone

Jefferson 2008
Methods RCT
Participants People with chronic stroke and dysphagia
Interventions Repetitive transcranial magnetic stimulation vs sham stimulation over the unaffected pharyngeal
motor cortex
Outcomes Measurements of cortico-pharyngeal excitability


Informed decisions.

Ji-Ye 2017
Methods RCT
Participants Dysphagia patients with ischaemic stroke and pseudobulbar palsy
Interventions Oral aspirin vs acupuncture (XNJ-AI at Fengchi (GB 20)) with oral aspirin
Outcomes Water-swallowing test, plasma thromboxane B2 and 6-keto-prostaglandin F1a levels

Jia 2006
Methods RCT
Participants 40 cases of post-apoplectic dysphagia with 2 out of 5 symptoms such as hemiplegia, coma, slurred
speech, unilateral sensory disturbance, dry mouth and tongue, difficulty in swallowing
Interventions Treatment group was treated by acupuncturing points Fengchi (GB 20), Tianzhu (BL 10), Tongli (HT
5), and Lianquan (CV 23) plus rehabilitation exercises
Control group only by rehabilitation exercise
Outcomes Therapeutic effect assessed by 1 to 10 point scale

Jiang 2014
Methods RCT
Interventions Electroacupuncture group vs VitalStim group vs combined group
Outcomes Water swallow test, swallow score

Jing 2016
Methods RCT
Participants 60 people with dysphagia after stroke
Interventions NMES with conventional therapy vs conventional therapy only
Outcomes Curative effects, swallowing function, aspiration, laryngeal elevation, food residue, food intake
scores

Informed decisions.


Kim 2017
Methods RCT
Participants People with post-stroke oropharyngeal dysphagia confirmed by VFSS
Interventions Tongue-to-palate resistance training vs control
Outcomes Swallowing function - videofluoroscopic dysphagia scale and PAS

Koch 2015
Methods RCT
Interventions Swallowing training using surface electromyography as biofeedback vs standard treatment
Outcomes Swallow score

Konecny 2018
Methods RCT
Participants 54 people with early-stage stroke and dysphagia
Interventions Transcutaneous electrical nerve stimulation of suprahyoid muscles vs control
Outcomes Swallow function - videofluoroscopic study, oral transit time, pharyngeal transit time

Koyama 2017
Methods RCT
Participants 16 participants with stroke-related dysphagia
Interventions Modified jaw opening exercise vs control
Outcomes Swallow function - videofluorographic swallowing study, distance between the mental spine and
the hyoid bone, hyoid displacement

Informed decisions.


Lee 2015b
Methods RCT
Participants 24 people with dysphagia after ischaemic stroke
Interventions Treatment: 10 Hz rTMS over the brain cortex where motor evoked potential was obtained from the
suprahyoid muscle
Control: 10 Hz rTMS over the brain cortex where motor evoked potential was obtained from the ab-
ductor pollicis brevis muscle
Outcomes Functional Dysphagia Scale, PAS, Dysphagia Outcome and Severity Scale

Li 2008
Methods RCT
Participants 60 people with ischaemic stroke and dysphagia
Interventions Group 1: acupuncture group and routine treatment and rehabilitation training
Group 2: routine treatment and rehabilitation training
Outcomes Not stated

Li 2009
Methods RCT
Participants 60 people post stroke with dysphagia
Interventions Experimental group: acupuncture plus feeding and swallowing rehabilitation training
Control group: swallowing and feeding rehabilitation training
Outcomes Swallowing test

Li 2016
Methods RCT
Participants 60 people with pseudobulbar palsy paralysis dysphagia
Interventions Treatment: 5 needles of the Nape acupuncture
Informed decisions.

Li 2016 (Continued)
Control: routine acupuncture (Lian Quan, Tong Li, Zhao Hai)
Outcomes Curative effect dysphagia (unclear)

Liu 2018
Methods RCT
Participants 100 people with dysphagia caused by pseudobulbar palsy
Interventions Nape acupuncture with rehabilitative swallowing training vs rehabilitative swallowing training only
Outcomes Repetitive saliva-swallowing test, water swallow test, standardised swallowing assessment, swal-
low quality-of-life questionnaire (SWAL-QOL)

Ma 2016
Methods RCT
Participants 80 people with dysphagia and pseudobulbar palsy
Interventions Quick needle insertion at Aqiang point vs routine acupuncture at Lianquan (CV 23)
Outcomes Water swallow test, curative rate

Malik 2017
Methods RCT
Participants People with dysphagia (95% of patients with stroke aetiology)
Interventions Thermal stimulation vs swallowing manoeuvres vs combination of both
Outcomes Function Outcome Swallowing Scale

Mehndiratta 2017
Methods RCT
Participants 98 people with dysphagia within the first month after ischaemic stroke
Informed decisions.

Mehndiratta 2017 (Continued)
Interventions Sensory-level electrical stimulation to bilateral masseter muscles vs sham stimulation
Outcomes Bedside Dysphagia Score, Neurological Examination Dysphagia Score, Total Dysphagia Score,
Mann Assessment of Swallowing Ability test, flexible fibreoptic endoscopic evaluation of swallow-
ing

Meng 2015
Methods RCT
Interventions Group 1: deep acupuncture with conventional glossopharyngeum acupuncture
Group 2: shallow acupuncture with conventional glossopharyngeum acupuncture
Group 3: conventional glossopharyngeum acupuncture only (control)
Outcomes Water swallowing test evaluation scale

Meng 2018
Methods RCT
Participants 30 people with post-stroke dysphagia
Interventions 2 groups given surface NMES at different sites of patients' neck vs control
Outcomes Water swallow test, repetitive saliva swallowing test, dysphagia outcome and severity scale

Moon 2017
Methods RCT
Participants 18 people with stroke and dysphagia
Interventions Expiratory muscle strength training vs control
Outcomes Functional dysphagia scale, PAS, vallecular residue, pyriform sinuses residue

Informed decisions.

Moon 2018
Methods RCT
Participants 16 people with subacute stroke and dysphagia
Interventions Tongue pressure strength and accuracy training vs control
Outcomes Maximum isometric tongue pressures of the anterior and posterior tongue, Mann Assessment of
Swallowing Ability, Swallowing-Quality of Life

NCT00722111
Methods Randomised, open label
Participants 200 people post stroke
Interventions Group 1: lingual press (high-intensity, oral, non-swallowing)
Group 2: effortful swallowing (high-intensity swallowing)
Group 3: natural swallowing (high-frequency, low-intensity swallowing)
Group 4: non-oral sham (control) exercise
Outcomes Composite score of PAS and Residue Scale with no worsening of either at baseline, week 4, and
week 8

NCT01081444
Methods RCT
Participants People with dysphagia and first episode of stroke
Interventions Active vs sham rTMS
Outcomes Videofluoroscopy and high-resolution manometry

NCT01085903
Methods Randomised, double-blind (participant, investigator), cross-over assignment
Participants People with stroke, neglect, dysphagia
Interventions Modafinil 200 mg once daily vs placebo for 3 days
Outcomes Predicting response to modafinil among participants with neglect, dysphagia
Informed decisions.

NCT01085903 (Continued)

NCT01777672
Methods RCT
Participants 100 people with oropharyngeal dysphagia due to stroke episode within last 3 months
Interventions Control group: recommendations from patient healthcare providers
Experimental group 1: oral TRPV1 (natural capsaicin) plus recommendations from patient health-
care providers
Experimental group 2: pharyngeal electrical stimulation plus recommendations from patient

healthcare providers
Experimental group 3: transcutaneous electrical stimulation plus recommendations from patient

healthcare providers
Outcomes VFSS-PAS, oropharyngeal reconfiguration, timing and extent of hyoid motion, bolus propulsion
force of tongue
Episodes of aspiration pneumonia and lower respiratory tract infection
Clinical outcomes of nutritional status, complications and clinical symptoms, mortality rates,
cause of death

NCT02090231
Methods RCT
Participants Post-stroke dysphagia more than 3 months
Interventions Real 5 Hz rTMS vs sham 5 Hz rTMS
Outcomes Dysphagia severity, swallow function

NCT02379182
Methods RCT
Participants 90 people with stroke > 3 months
Interventions Control group: standard clinical care
Sensory group: transcutaneous electrical stimulation at sensory level
Motor group: transcutaneous electrical stimulation at motor level
Informed decisions.

Outcomes PAS; incidence of all adverse events; change in pharyngeal residue prevalence; change in Eating As-
sessment Tool-10 scores; frequency of chest infection; time from randomisation to death

Nowicki 2003
Methods RCT
Interventions Manual + electro-acupuncture (6 to 8 treatments 2 to 3 times per week for 3 weeks) vs control
Outcomes Not available in the study summary

Oshima 2009
Methods Unclear design (not stated in abstract)
Participants 218 people with stroke complicated by dysphagia
Interventions Group 1: swallowing training with nutritional and high-risk management
Group 2: control (none of the above)
Outcomes Time taken to oral intake, nutritional status, incidence rate of infection, activities of daily living

Pan 2015
Methods RCT
Participants 70 people with post-stroke dysphagia
Interventions Acupoint massage vs control
Outcomes Improvement rate in swallow function

Park 2017
Methods RCT
Participants 40 participants with dysphagia after stroke 6 months < stroke onset
Informed decisions.

Interventions Group 1: head lift exercise and conventional dysphagia therapy
Group 2: conventional dysphagia therapy
Outcomes Movement of hyolaryngeal complex; PAS
Notes Study completed; in the process of retrieving data

Park 2018
Methods RCT
Participants People with dysphagia following subacute stroke
Interventions Chin tuck against resistance exercise vs control
Outcomes Functional dysphagia scale, PAS

Shao 2017
Methods RCT
Participants 64 people with post-stroke upper oesophageal sphincter dystrophy and severe dysphagia
Interventions Drug therapy and conventional swallowing rehabilitation training vs columnar balloon dilatation
combined with drug therapy and conventional swallowing rehabilitation training
Outcomes Upper sphincter dynamics and dysphagia scores

Su 2010
Methods RCT
Interventions Group 1: electroacupuncture
Group 2: swallowing training
Outcomes VFSS and Kubota water swallowing function test

Informed decisions.

Sun 2008
Methods RCT
Participants People with dysphagia after stroke
Interventions Acupuncture at Lianquan, Yamen, and Tian Zhu acupoints vs VitalStim therapy

Sun 2018
Methods RCT
Interventions Treatment group treated by intradermal needle-embedding at Lianquan (CV 23), Jialian-
quan-point, Yifeng (TE 17), Ashi-point, etc. (once every other day for 20 days) on the basis of treat-
ments used in the control group
Control group was treated with conventional medicines, NMES of the bilateral midlines of the neck,
and swallowing function training
Outcomes Swallowing function (0 to 10 point scaling), surface electromyography

Suntrup-Krueger 2018
Methods RCT
Participants People with dysphagia due to stroke
Interventions Experimental group: transcranial direct current stimulation vs sham group: sham stimulation
Outcomes Fibreoptic Endoscopic Dysphagia Severity Scale, diet at discharge, dysphagia severity rating score,
endoscopically assessed swallow function
Notes Study completed; in the process of retrieving data

Tageldin 2017
Methods RCT
Participants 30 people with dysphagia following brain stem infarction
Interventions rTMS vs sham rTMS on bilateral supratentorial motor area
Outcomes Modified dysphagia outcome and severity scale
Informed decisions.

Tageldin 2017 (Continued)

Umay 2017
Methods RCT
Participants 98 people with dysphagia within the first month after ischaemic stroke
Interventions Sensory-level electrical stimulation vs sham sensory-level electrical stimulation to bilateral mas-
seter muscles
Outcomes Bedside Dysphagia Score, Neurological Examination Dysphagia Score, Total Dysphagia Score, and
Mann Assessment of Swallowing Ability test, flexible fibreoptic endoscopic evaluation of swallow-
ing

Wang 2010
Methods RCT
Participants 84 people with cerebral stroke and dysphagia
Interventions Group 1: routine therapy and acupuncture
Group 2: routine therapy
Outcomes Not stated

Wang 2014
Methods RCT
Participants 54 nasal feeding patients with pseudobulbar palsy or bulbar palsy after acute ischaemic stroke
Interventions Integrated swallowing function rehabilitation training vs routine treatment
Outcomes Swallow score, oral intake function

Wang 2015
Methods RCT
Participants 91 people with post-stroke deglutition disorders
Informed decisions.

Wang 2015 (Continued)
Interventions Acupuncture using the Tong Guan Li Qiao needling method vs control
Outcomes Standard Swallowing Assessment (Modified Barthel Index), Swallowing-related Quality of Life,
Hamilton Depression Scale

Wang 2017
Methods RCT
Participants 96 people with dysphagic stroke
Interventions Observation group to receive Rood intervention; control group to receive routine oral intervention
Outcomes Swallowing function, nutritional status and interventional effect - no further details

Wei 2017
Methods RCT
Participants 30 people with upper oesophageal sphincter dysfunction due to unilateral brainstem stroke
Interventions Modified balloon dilatation therapy vs control
Outcomes Amplitude of bilateral submental motor evoked potentials induced by transcranial magnetic stim-
ulations over bilateral motor cortex, diameters of upper oesophageal sphincter opening, maximal
displacement of hyoid

Wu 2011
Methods RCT
Interventions Group 1: acupuncture
Group 2: acupuncture and rehabilitation training
Group 3: control group with rehabilitation training
Outcomes Traditional Chinese medicine swallowing assessment, swallowing test, Swallowing Quality of Life
Scale - SWAL-QOL
Informed decisions.


Wu 2013
Methods RCT
Interventions Group 1: routine acupuncture group + routine treatment and swallowing training
Group 2: acupuncture kinesitherapy simultaneously at ezhongxian, lianquan (RN23), jialianquan

points + routine treatment, and swallowing training
Group 3: routine treatment and swallowing training
Outcomes Water drinking test and brainstem auditory evoked potential

Xia 2010
Methods RCT
Interventions Experimental group: feeding-swallowing training and acupuncture treatment
Control group: feeding-swallowing training
Outcomes Standardised Swallowing Assessment, VFSS, Modified Barthel Index, Swallowing Quality of LIfe
Scale - SWAL-QOL

Xie 2011
Methods RCT
Interventions Acupuncture group (body acupuncture, electrical acupuncture, and scalp acupuncture) vs rehabili-
tation group
Outcomes Intention-to-treat analysis and on-treatment/per-protocol analysis, Watian swallowing ability, pul-
monary infection rate, mortality

Xu 2013
Methods RCT
Participants 140 people with stroke
Informed decisions.

Xu 2013 (Continued)
Interventions Experimental group: acupuncture and Western medicine
Control group: Western medicine
Outcomes Water drinking test

Xue 2004
Methods RCT
Participants People with post-stroke dysphagia
Interventions Early rehabilitation + acupuncture vs control

Yang 2008
Methods RCT
Participants People with post-stroke dysphagia
Interventions Functional electrical stimulation 40 minutes/d vs functional electrical stimulation 40 minutes twice
daily

Yang 2012
Methods RCT
Participants People with post-stroke dysphagia diagnosed using VFSS
Interventions Anodal tDCS group (1 mA for 20 minutes) vs sham group (1 mA for 30 seconds)
Outcomes Functional dysphagia scale

Zeng 2017
Methods RCT
Informed decisions.

Zeng 2017 (Continued)
Participants 112 people with cerebral infarction and dysphagia
Interventions NMES vs control
Outcomes Water-drinking test, Hamilton Anxiety Scale test, Hamilton Depression Scale

Zhang 2007
Methods RCT
Participants People with stroke, dysphagia, and poor elevation of the larynx
Interventions Comparison of 2 methods of larynx elevation (15 minutes, 5 × day for 4 weeks)

Zhang 2015
Methods RCT
Interventions Huoshe Liyan Decoction vs control
Outcomes Efficacy rate, swallow function (unclear)

Zhang 2016
Methods RCT
Participants People with dysphagia with medullary infarction
Interventions Traditional swallowing therapy vs sensory approach combined with traditional swallowing therapy
vs motor approach combined with traditional swallowing therapy
Outcomes Swallow function, quality of life, cognition
Notes In the process of retrieving relevant data

Zhang 2017
Methods RCT
Informed decisions.

Zhang 2017 (Continued)
Interventions Vitalstim Electroacupuncture of Fengchi (GB 20), Jinjin (EX-HN 12) and Yuye (EX-HN 13) with a Vital-
stim Electrostimulator, and manual acupuncture stimulation of Lianquan (CV 23), Tiantu (CV 22) vs
control. Both groups received conventional therapy
Outcomes Kubota swallowing ability test, dysphagia subscale (0 to 6 scores) of the neurological deficit de-
grees, videofluorography assessment, Medical Outcomes Study Item Short Form Health Survey
(SF-36)

Zhen 2014
Methods RCT
Participants 97 people with post-stroke deglutition dysfunction
Interventions Group A: acupuncture with conventional treatment
Group B: VitalStim electric stimulation with conventional treatment
Group C: conventional treatment only
Outcomes Swallow function (water-drinking test, stethocatharsis scoring, and fluoroscopic examination)

Zhong 2003
Methods RCT
Participants People with stroke and dysphagia 15 to 40 days post stroke
Interventions Head acupuncture vs body acupuncture vs control

Zhu 2015a
Methods RCT
Participants People with dysphagia after stroke
Interventions Conventional training vs surface electromyographic biofeedback treatment with conventional

training
Outcomes Upper oesophageal sphincter opening, pharyngeal transit time
Informed decisions.

Zhu 2015a (Continued)

Zhu 2015b
Methods RCT
Participants 68 people with dysphagia after ischaemic stroke
Interventions Combined treatment group (n = 34) receiving swallowing training, feeding strategies, and low-fre-
quency electrical stimulation
Control group (n = 34) receiving swallowing training and feeding strategies
Outcomes VFSS, Standardized Swallowing Assessment
ASHA-NOMS: American Speech-Language-Hearing Association National Outcomes Measurement System

EEG: electroencephalography
Hz: Hertz
TRPV1: transient receptor potential vanilloid 1
VFSS: videofluoroscopic swallow study
V-VST: volume-viscosity swallow test

Characteristics of ongoing studies [ordered by study ID]

ChiCTR-ICR-15006004
Trial name or title Clinical observation of YiShen-TongQiao acupuncture on pharyngeal dysphagia after stroke
Methods RCT
Participants 90 stroke patients with pharyngeal dysphagia
Interventions Observational group: YiShen-TongQiao acupuncture treatment
Control group: rehabilitation training
Outcomes Kubota drinking water test score; Swallow Quality of Life
Starting date 2015
Contact information Yu Chuan; [email protected]
Notes Funding: general planning project of BeiJing Municipal Science and Technology Project of Tradi-
tional Chinese Medicine

Informed decisions.


ChiCTR-IOR-17010505
Trial name or title Fire N needle for patients with dysphagia caused by post-stroke pseudobulbar palsy: a randomized
controlled clinical trial
Methods Randomised, parallel controlled trial
Participants 64 participants with dysphagia after stroke, 30 to 75 years old, onset time < 8 months
Interventions Group A: fire needle
Group B: rehabilitation treatment of dysphagia
Outcomes Watian water test evaluation, TengShi swallowing disorder evaluation, swallowing-related quality
of life, dysphagia assessment scale of Traditional Chinese Medicine, pulse oximetry
Starting date 2017, but not yet recruiting
Contact information Xiaolu Qian; [email protected]
Notes Funding: Shanghai Municipal Commission of Health and Family Planning

ChiCTR-IOR-17011359
Trial name or title The study on the effect of electroacupuncture at Lianquan and Fengfu on one side of brain swal-
lowing function
Participants 30 participants aged 18 to 65 years; inclusion criteria not clear
Interventions Electroacupuncture group
Sham acupuncture group
Outcomes MEP of mylohyoid muscle
Resting motion threshold of mylohyoid muscle
Starting date 2017
Contact information Lin Wang; [email protected]
Notes Funding: Education Department of Guangdong

ChiCTR-IPC-14005435
Trial name or title Research on mechanism of central regulation of transcranial magnetic stimulation on post-stroke
dysphagia patients
Methods Randomised parallel controlled trial, phase 1
Participants 20 virtual lesion group; 20 stroke patient group; 20 control
Interventions Virtual lesion group: continuous theta burst stimulation

Informed decisions.

ChiCTR-IPC-14005435 (Continued)
Patient group: transcranial magnetic stimulation
Control: conventional treatments
Outcomes MEP; pharyngeal pressure waveform; upper oesophageal sphincter pressure waveform; centre net-
work of swallowing
Starting date 2013
Contact information Yue Lan; [email protected]
Notes Funding: National Science Foundation of China

ChiCTR-ROC-17011673
Trial name or title Neuromodulation on post-stroke patients: a clinical control trial based on mapping swallowing
musculature motor cortex
Methods Clinical control (randomisation unclear)
Participants 120 participants with dysphagia post stroke
Interventions Experimental group: TMS
Control group: sham TMS
Outcomes Pharyngeal musculature MEP; MEP amplitude; latency of MEP; hotspot
Starting date 2017
Contact information Wanqi Li; [email protected]
Notes Funding: -

ChiCTR1800014337
Trial name or title High frequency repetitive transcranial magnetic stimulation in the rehabilitation of post-stroke
swallowing disorder
Participants 40 participants with acute stroke (> 2 weeks post onset) with dysphagia
Interventions High-frequency rTMS + routine swallow training vs routine swallow training alone
Outcomes Surface EMG; VFSS; Standardised Swallowing Study; VGF (no explanation provided on website);
PAS; water drinking test scale for depression
Starting date 2018
Contact information Zhu Qixiu; [email protected]
Notes Funding: Shandong Province Science and Technology Plan
Informed decisions.


ChiCTR1800015837
Trial name or title A randomized controlled clinical study on stroke with dysphagia with treatment of combined of
traditional Chinese and west medicine
Participants 242 stroke patients with dysphagia from 2 weeks to 6 months
Interventions Treatment: acupuncture treatment based on surface electromyography
Control: traditional acupuncture treatment
Outcomes Water swallow test rating scale of depression, Standardized Swallowing Assessment, videofluoro-
scopic swallowing study
Starting date 2016
Contact information Guoping Zhou; [email protected]
Notes Funding: Construction of High-level University Scientific Research Funding

ISRCTN14124645
Trial name or title Metoclopramide and selective oral decontamination for avoiding pneumonia after stroke (MAPS-2)
Trial
Methods 2 × 2 factorial double-blind randomised controlled trial (treatment)
Participants Acute stroke within 9 hours of clinical onset
Interventions Metoclopramide and placebo paste

Metoclopramide and antibiotic paste
Placebo metoclopramide and antibiotic paste
Placebo metoclopramide and placebo paste
Outcomes Mortality up to the end of the study (90 days), pneumonia within 14 days, number of days of an-
tibiotic treatment for pneumonia within the first 30 days, neurological recovery (NIHSS), disability
(mRS), quality of life (EuroQol)
Starting date 1 January 2017
Contact information Christine Roffe - Institute for Applied Clinical Sciences (IACS), Keele University Guy Hilton Research
Centre, Thornburrow Drive, Hartshill ST4 7QB, Stoke-on-Trent, United Kingdom
Notes Funding: Health Technology Assessment Programme

ISRCTN68981054
Trial name or title Treatment of dysphagia after stroke with He's santong needling method: a prospective randomized
controlled study
Methods RCT
Informed decisions.

ISRCTN68981054 (Continued)
Participants 60 stroke patients with oral and pharyngeal dysphagia
Interventions Experimental group: He's santong needling method acupuncture combined with swallowing reha-
bilitation
Control group: swallowing rehabilitation
Outcomes Dynamics of swallowing function measured using FEES and Caiteng 7 Rank
Swallowing Quality of Life - SWAL-QOL, Modified MASA, surface EMG
Starting date 2017
Contact information Bin Li; [email protected]
Notes Funding: Beijing Traditional Chinese Medicine Administration Administrative Project

NCT01758991
Trial name or title Therapeutic Impact of tDCS on dysphagia in the acute phase of stroke (improving swallowing after
stroke with transcranial direct current stimulation (iSWAT))
Methods RCT
Participants 100 acute stroke patients with dysphagia
Interventions Experimental group: tDCS
Control group: sham tDCS
Outcomes Videofluoroscopy; fiberoptic endoscopic evaluation of swallowing; NIHSS; clinical records; swal-
lowing quality of life - SWAL-QOL
Starting date 2013
Contact information Katalin de Fays; [email protected]
Notes Funding: University Hospital of Mont-Godinne; Université Catholique de Louvain

NCT01919112
Trial name or title Non-invasive brain stimulation for swallowing recovery after a dysphagic stroke
Methods RCT
Participants Moderate to severe dysphagic patients with acute stroke documented by imaging
Interventions High dose vs low dose vs sham (control) anodal tDCS
Outcomes Improvement in swallowing
Starting date 2013
Informed decisions.

Contact information Sandeep Kumar; Beth Israel Deaconess Medical Center; 617-632-8917; [email protected]
Notes Funding: Beth Israel Deaconess Medical Center

NCT02322411
Trial name or title Effects of device-facilitated isometric progressive resistance oropharyngeal (I-PRO) therapy on dys-
phagia related outcomes in patients post-stroke
Methods Randomised controlled pilot study
Participants 30 ischaemic stroke patients within 6 months of acute stroke diagnosis
Interventions Group 1: 12 weeks of Isometric Progressive Resistance Oropharyngeal Therapy plus compensatory
treatment
Group 2: compensatory treatment only
Outcomes Change in maximum isometric tongue pressures; bolus flow durational measures; swallowing-re-
lated pressures; swallowing quality of life - SWAL-QOL; functional oral intake scale; pneumonia di-
agnoses; hospital admissions
Starting date 2014
Contact information Nicole Pulia; [email protected]
Notes Sponsors and collaborators: University of Wisconsin, Madison

NCT02470078
Trial name or title Randomised controlled trial of pharyngeal electrical stimulation for the treatment of post-extuba-
tion dysphagia in acute stroke patients
Methods Randomised parallel assignment trial
Participants 60 stroke patients with severe dysphagia post extubation due to acute stroke
Interventions Pharyngeal electrical stimulation vs sham stimulation
Outcomes Pneumonia rate; reintubation rate; length of stay; PEG tube placement; swallowing function; time
until oral nutrition
Starting date 2015
Contact information Rainer Dziewas; [email protected]
Notes Funding: University Hospital Muenster

Informed decisions.

NCT02576470
Trial name or title Motor learning in dysphagia rehabilitation
Methods Randomised, parallel assignment trial
Participants 21 to 100 years with a swallowing problem
Interventions Investigating 3 forms of biofeedback for training swallowing manoeuvres or compensatory tech-
niques and pairing with adjuvant techniques - tDCS, TMS, and financial reward.
Group 1: VFSS biofeedback
Group 2: submental EMG biofeedback
Group 3: mixed VFSS and submental EMG biofeedback
Group 4: VFSS biofeedback with anodal tDCS and TMS
Group 5: submental EMG biofeedback with anodal tDCS and TMS
Group 6: mixed VFSS, submental EMG with anodal tDCS and TMS.
Group 7: VFSS with sham tDCS
Group 8: submental EMG with sham tDCS
Group 9: mixed VFSS and submental EMG with sham tDCS
Group 10: VFSS with financial reward
Group 11: submental EMG with financial reward
Group 12: mixed VFSS and submental EMG with financial reward
Outcomes PAS, targeted dysphagia training biofeedback using VFSS images, submental EMG measures and
both VFSS and submental EMG measures; dysphagia manoeuvres, kinematic analysis, financial re-
ward analysis
Starting date
Contact information

NCT02960737
Trial name or title Dysphagia evaluation after stroke-incidence and effect of oral screen intervention on swallowing
dysfunction (DESIRE)
Methods Interventional, randomised, parallel assignment. Double-blind (investigator, outcomes assessor)
Participants Acute stroke patients 6 (± 2) weeks after first-time transient ischaemic attack and stroke
Interventions Experimental group: intensive training with oral screen and traditional compensatory swallowing
training
Control group: no intervention; traditional compensatory swallowing training only
Informed decisions.

Outcomes Swallowing ability, swallowing function, lip force, swallowing quality of life, dysarthria, oral health,
activities of daily living, global disability, NIHSS
Starting date 2016
Contact information Patricia Hägglund, PhD Student; +46907850000; [email protected]
Notes Sponsor: Umeå University

NCT03021252
Trial name or title The RETORNUS-2 study: impact of respiratory muscle training on swallowing disorders in stroke
patients
Methods Interventional, randomised, parallel assignment; single-blind (outcomes assessor)
Participants Stroke onset 1 month
Interventions Experimental group: high-intensity inspiratory and expiratory muscle training (IEMT) (IEMT + stan-
dard swallow therapy) vs control
Sham IEMT
Sham IEMT + standard swallow therapy
Outcomes Change in dysphagia severity, change in respiratory muscle strength
Starting date 2017
Contact information Anna Guillen-Sola; [email protected]
Notes Funding: Parc de Salut Mar

NCT03247374
Trial name or title Bio-feedback treatment versus standard treatment for dysphagic post-stroke patients: a random-
ized controlled trial
Methods RCT
Participants 40 patients (> 6 weeks onset) with post-stroke dysphagia
Interventions Experimental group: biofeedback (visual and verbal feedback)
Control group: standard SLT (verbal feedback)
Outcomes Functional Oral Intake Scale; change in pooling score during endoscopic evaluation; PAS
Starting date 2017
Contact information Sara Nordio; [email protected]
Notes Funding: IRCCS San Camillo, Venezia, Italy
Informed decisions.


NCT03274947
Trial name or title The utility of cerebellar transcranial magnetic stimulation in the neurorehabilitation of dysphagia
after stroke
Methods RCT
Participants 72 participants with post-stroke dysphagia within 6 weeks of symptom onset
Interventions Protocol 1
Experimental group: cerebellar TMS
Control group: sham TMS
Protocol 2
Experimental group: low-level cerebellar TMS stimulation (once per day for 3 days) plus standard
SLT
Experimental group: high-level cerebellar TMS stimulation (twice per day for 5 days) plus standard
SLT
Control group: sham stimulation (twice per day for 5 days) plus standard SLT
Outcomes Protocol 1: videofluoroscopy before and at 1 hour
Protocol 2: videofluoroscopy; functional oral intake scale; dysphagia severity rating scale; feeding
status; mRS
Starting date 2017
Contact information Shaheen Hamdy; [email protected]
Notes Funding: University of Manchester, Medical Research Council University of Nottingham

NCT03358810
Trial name or title Pharyngeal electrical stimulation evaluation for dysphagia after stroke
Methods RCT
Participants 270 acute ischaemic or hemorrhagic cerebral stroke within 7 to 28 days of baseline VFSS
Interventions Experimental group: pharyngeal electrical stimulation
Control group: sham pharyngeal electrical stimulation
Outcomes PAS (based on VFSS); time to removal of NG/PEG tube/transition to oral feeding or first diet up-
grade; functional oral intake scale
Starting date 2017
Contact information Phagenesis Ltd.
Notes Funding: Phagenesis Ltd.; Regulatory and Clinical Research Institute; Cytel
Informed decisions.


NCT03499574
Trial name or title A randomized controlled feasibility trial of dysphagia therapy using biofeedback in patients with
acute stroke
Methods RCT
Participants Participants with new diagnosis of acute stroke and dysphagia
Interventions Experimental: biofeedback using surface EMG with usual care
Control: usual care only
Outcomes Dysphagia Severity Rating Scale, Functional Oral Intake Scale, PAS, Dysphagia Handicap Index,
modified Rankin Scale, NIHSS, mortality, incidence of pneumonia
Starting date 2018
Contact information Timothy England; [email protected]
Notes Funding: University of Nottingham

PACTR201710002724163
Trial name or title Effect of transcutaneous electrical nerve stimulation and conventional therapy in post-stroke dys-
phagic patients: a randomized controlled trial
Methods RCT
Participants Dysphagic patients following ischaemic stroke less than 1 month (aged 45 to 70 years)
Interventions TENS vs TENS + conventional treatment vs conventional treatment
Outcomes Swallow function
Starting date 2017
Contact information Rami Maged; [email protected]
Notes Funding: Taheal Rehabilitation Centre

U1111-1188-0335
Trial name or title Program of rehabilitation with therapeutic efficacy control in oropharyngeal dysphagia after stroke
Methods Randomised, parallel trial
Participants 20 participants with dysphagia after stroke
Interventions Group 1: neuromuscular electrical stimulation associated with sour taste swallowing and cold tem-
perature
Group 2: stimulation of swallowing sour taste and cold temperature
Informed decisions.

U1111-1188-0335 (Continued)
Outcomes Decreased episodes of penetration and aspiration (verified by objective examination of swallow-
ing), nasoendoscopy
Starting date 2015
Contact information Paula Cristina Cola, [email protected]
Notes Funding: Faculdade Filosofia e Ciências de Marília
C: control
EMG: electromyography
EuroQoL: European Quality of Life Scale
FEES: Fibreoptic Endoscopic Evaluation of Swallowing
MASA: Mann Assessment of Swallowing Ability
MEP: motor evoked potential
NG: nasogastric
PEG: percutaneous endoscopic gastroscopy
Rx: treatment
SD: standard deviation
SLT: speech and language therapy
TMS: transcranial magnetic stimulation
VGF: no explanation provided on website as to abbreviation

DATA AND ANALYSES

Comparison 1. Swallowing therapy
Outcome or subgroup title No. of No. of Statistical method Effect size

studies partici-
pants
1 Functional outcome - death or dependency, 2 306 Odds Ratio (M-H, Random, 1.05 [0.63, 1.75]
death or disability at end of trial 95% CI)
1.1 Behavioural interventions 2 306 Odds Ratio (M-H, Random, 1.05 [0.63, 1.75]
95% CI)
2 Case fatality at end of trial 14 766 Odds Ratio (M-H, Random, 1.00 [0.66, 1.52]
95% CI)
95% CI)
2.2 Drug therapy 3 148 Odds Ratio (M-H, Random, 1.40 [0.31, 6.28]
95% CI)
Informed decisions.


studies partici-
pants
2.3 Pharyngeal electrical stimulation 4 215 Odds Ratio (M-H, Random, 0.92 [0.38, 2.26]
95% CI)
2.4 Physical stimulation (thermal, tactile) 1 19 Odds Ratio (M-H, Random, 1.05 [0.16, 6.92]
95% CI)
2.5 Transcranial magnetic stimulation 4 78 Odds Ratio (M-H, Random, 0.28 [0.03, 2.93]
95% CI)
3 Length of inpatient stay (days) 8 577 Mean Difference (IV, Ran- -2.90 [-5.65, -0.15]
dom, 95% CI)
3.1 Behavioural interventions 4 370 Mean Difference (IV, Ran- -2.70 [-5.68, 0.28]
dom, 95% CI)
3.2 Pharyngeal electrical stimulation 4 207 Mean Difference (IV, Ran- -6.05 [-16.40, 4.31]
dom, 95% CI)
4 Proportion of participants with dysphagia at 23 1487 Odds Ratio (M-H, Random, 0.42 [0.32, 0.55]
end of trial 95% CI)
4.1 Acupuncture 8 676 Odds Ratio (M-H, Random, 0.31 [0.20, 0.49]
95% CI)
95% CI)
95% CI)
4.4 Neuromuscular electrical stimulation 2 76 Odds Ratio (M-H, Random, 0.51 [0.18, 1.49]
95% CI)
95% CI)
4.6 Physical stimulation (thermal, tactile) 2 127 Odds Ratio (M-H, Random, 0.65 [0.07, 5.85]
95% CI)
4.7 Transcranial direct current stimulation 1 14 Odds Ratio (M-H, Random, 0.29 [0.01, 8.39]
95% CI)
5 Swallowing ability 26 1173 Std. Mean Difference (IV, -0.66 [-1.01, -0.32]
Random, 95% CI)
5.1 Acupuncture 6 496 Std. Mean Difference (IV, -0.55 [-1.20, 0.11]
Random, 95% CI)
5.2 Behavioural intervention 3 121 Std. Mean Difference (IV, -0.56 [-1.07, -0.05]
Random, 95% CI)
5.3 Drug therapy 1 71 Std. Mean Difference (IV, -0.46 [-0.93, 0.01]
Random, 95% CI)
Informed decisions.


studies partici-
pants
5.4 Neuromuscular electrical stimulation 2 100 Std. Mean Difference (IV, -1.34 [-3.39, 0.71]
Random, 95% CI)
5.5 Pharyngeal electrical stimulation 3 194 Std. Mean Difference (IV, 0.06 [-0.22, 0.34]
Random, 95% CI)
5.6 Physical stimulation (thermal, tactile) 1 16 Std. Mean Difference (IV, -0.30 [-1.29, 0.68]
Random, 95% CI)
5.7 Transcranial direct current stimulation 2 34 Std. Mean Difference (IV, -0.33 [-2.22, 1.56]
Random, 95% CI)
5.8 Transcranial magnetic stimulation 8 141 Std. Mean Difference (IV, -1.29 [-2.37, -0.21]
Random, 95% CI)
6 Penetration aspiration score 11 303 Std. Mean Difference (IV, -0.37 [-0.74, -0.00]
Random, 95% CI)
6.1 Behavioural intervention 1 27 Std. Mean Difference (IV, -0.88 [-1.68, -0.08]
Random, 95% CI)
6.2 Neuromuscular electrical stimulation 1 18 Std. Mean Difference (IV, 0.57 [-0.38, 1.52]
Random, 95% CI)
6.3 Pharyngeal electrical stimulation 4 177 Std. Mean Difference (IV, -0.17 [-0.53, 0.19]
Random, 95% CI)
6.4 Transcranial magnetic stimulation 5 81 Std. Mean Difference (IV, -0.53 [-1.22, 0.16]
Random, 95% CI)
7 Chest infection or pneumonia 9 618 Odds Ratio (M-H, Random, 0.36 [0.16, 0.78]
95% CI)
95% CI)
95% CI)
7.3 Neuromuscular electrical stimulation 1 57 Odds Ratio (M-H, Random, 0.0 [0.0, 0.0]
95% CI)
95% CI)
8 Pharyngeal transit time (seconds) 6 187 Mean Difference (IV, Ran- -0.23 [-0.32, -0.15]
dom, 95% CI)
8.1 Drug therapy 1 17 Mean Difference (IV, Ran- -0.21 [-0.91, 0.49]
dom, 95% CI)
8.2 Neuromuscular electrical stimulation 3 126 Mean Difference (IV, Ran- -0.23 [-0.39, -0.08]
dom, 95% CI)
Informed decisions.


studies partici-
pants
8.3 Pharyngeal electrical stimulation 1 28 Mean Difference (IV, Ran- -0.15 [-0.67, 0.37]
dom, 95% CI)
8.4 Physical stimulation (thermal, tactile) 1 16 Mean Difference (IV, Ran- -0.19 [-0.34, -0.04]
dom, 95% CI)
9 Institutionalisation 3 447 Odds Ratio (M-H, Random, 0.75 [0.47, 1.19]

95% CI)
95% CI)
95% CI)
10 Nutritional (albumin) 3 169 Mean Difference (IV, Ran- 0.37 [-1.50, 2.24]
dom, 95% CI)
10.1 Behavioural interventions 2 64 Mean Difference (IV, Ran- 0.20 [-4.77, 5.17]
dom, 95% CI)
10.2 Pharyngeal electrical stimulation 1 105 Mean Difference (IV, Ran- 0.40 [-1.62, 2.42]
dom, 95% CI)

Analysis 1.1. Comparison 1 Swallowing therapy, Outcome 1 Functional
outcome - death or dependency, death or disability at end of trial.
Study or subgroup Treatment Control Odds Ratio Weight Odds Ratio
n/N n/N M-H, Random, 95% CI M-H, Random, 95% CI
1.1.1 Behavioural interventions
Carnaby 2006i 35/51 72/102 49.48% 0.91[0.44,1.89]
Carnaby 2006ii 72/102 34/51 50.52% 1.2[0.58,2.47]
Subtotal (95% CI) 153 153 100% 1.05[0.63,1.75]
Total events: 107 (Treatment), 106 (Control)
Heterogeneity: Tau2=0; Chi2=0.28, df=1(P=0.6); I2=0%
Test for overall effect: Z=0.18(P=0.86)

Total (95% CI) 153 153 100% 1.05[0.63,1.75]
Therapy better 0.2 0.5 1 2 5 Therapy worse

Informed decisions.

Analysis 1.2. Comparison 1 Swallowing therapy, Outcome 2 Case fatality at end of trial.
Carnaby 2006i 10/51 23/102 21.44% 0.84[0.36,1.93]
Carnaby 2006ii 17/102 10/51 20.07% 0.82[0.35,1.95]
Subtotal (95% CI) 153 153 41.52% 0.83[0.46,1.51]
Heterogeneity: Tau2=0; Chi2=0, df=1(P=0.97); I2=0%

1.2.2 Drug therapy
Lee 2015 19/33 10/38 15.59% 3.8[1.4,10.32]
Perez 1997 1/8 1/9 1.97% 1.14[0.06,21.87]
Warusevitane 2015 8/30 12/30 13.32% 0.55[0.18,1.62]
Subtotal (95% CI) 71 77 30.88% 1.4[0.31,6.28]
Heterogeneity: Tau2=1.13; Chi2=6.66, df=2(P=0.04); I2=69.98%

1.2.3 Pharyngeal electrical stimulation
Jayasekeran 2010a 0/4 0/6 Not estimable
Jayasekeran 2010b 2/16 0/12 1.76% 4.31[0.19,98.51]
STEPS 2016 9/78 9/63 15.84% 0.78[0.29,2.11]
Vasant 2016 1/18 1/18 2.11% 1[0.06,17.33]
Subtotal (95% CI) 116 99 19.71% 0.92[0.38,2.26]

1.2.4 Physical stimulation (thermal, tactile)
Bath 1997 7/11 5/8 4.73% 1.05[0.16,6.92]
Subtotal (95% CI) 11 8 4.73% 1.05[0.16,6.92]
Heterogeneity: Not applicable

1.2.5 Transcranial magnetic stimulation
Khedr 2009 0/14 1/12 1.59% 0.26[0.01,7.12]
Khedr 2010 0/11 1/11 1.57% 0.3[0.01,8.32]
Kim 2012i 0/10 0/5 Not estimable
Kim 2012ii 0/10 0/5 Not estimable
Subtotal (95% CI) 45 33 3.16% 0.28[0.03,2.93]
Heterogeneity: Tau2=0; Chi2=0, df=1(P=0.95); I2=0%

Total (95% CI) 396 370 100% 1[0.66,1.52]
Test for subgroup differences: Chi2=1.36, df=1 (P=0.85), I2=0%
Informed decisions.


Analysis 1.3. Comparison 1 Swallowing therapy, Outcome 3 Length of inpatient stay (days).
Study or subgroup Treatment Control Mean Difference Weight Mean Difference
N Mean(SD) N Mean(SD) Random, 95% CI Random, 95% CI
Carnaby 2006i 51 19.2 (13.3) 102 21.4 (12.4) 28.92% -2.2[-6.57,2.17]
Carnaby 2006ii 102 19.1 (10.5) 51 19.2 (13.3) 30.86% -0.1[-4.28,4.08]
Yuan 2003i 11 31 (9.4) 24 37 (14.7) 10.44% -6[-14.09,2.09]
Yuan 2003ii 18 24 (8.5) 11 31 (9.4) 14.19% -7[-13.8,-0.2]
Subtotal *** 182 188 84.4% -2.7[-5.68,0.28]

Jayasekeran 2010a 4 33.8 (18.6) 6 119.2 (125) 0.07% -85.42[-187.07,16.23]
Jayasekeran 2010b 16 43.2 (18.7) 12 54.9 (26.1) 2.44% -11.73[-29.14,5.68]
STEPS 2016 78 27.7 (22.7) 63 28.7 (23) 11.7% -1[-8.59,6.59]
Vasant 2016 14 56.1 (25.9) 14 66.4 (36) 1.39% -10.36[-33.57,12.85]
Subtotal *** 112 95 15.6% -6.05[-16.4,4.31]

Total *** 294 283 100% -2.9[-5.65,-0.15]
Therapy better -40 -20 0 20 40 Therapy worse

Analysis 1.4. Comparison 1 Swallowing therapy, Outcome
4 Proportion of participants with dysphagia at end of trial.
1.4.1 Acupuncture
Bai 2007i 13/18 32/35 2.89% 0.24[0.05,1.17]
Bai 2007ii 22/40 13/17 4.33% 0.38[0.1,1.36]
Chen 2016a 8/103 17/97 8.96% 0.4[0.16,0.97]
Han 2004 22/34 25/32 5.95% 0.51[0.17,1.53]
Huang 2010 1/32 10/30 1.57% 0.06[0.01,0.54]
Jia 2006a 27/40 28/32 4.64% 0.3[0.09,1.02]
Liu 2000 16/54 19/30 7.98% 0.24[0.09,0.63]
Liu 2004 1/44 3/38 1.34% 0.27[0.03,2.72]
Subtotal (95% CI) 365 311 37.65% 0.31[0.2,0.49]
Test for overall effect: Z=5.21(P<0.0001)

Carnaby 2006i 18/51 45/102 14.76% 0.69[0.34,1.38]
Carnaby 2006ii 31/102 19/51 14.23% 0.74[0.36,1.49]
Informed decisions.


Song 2004 6/29 10/24 4.86% 0.37[0.11,1.23]
Yuan 2003i 8/11 22/24 1.85% 0.24[0.03,1.73]
Yuan 2003ii 6/18 9/11 2.15% 0.11[0.02,0.68]
Zheng 2014 19/44 32/44 8.95% 0.28[0.12,0.7]
Subtotal (95% CI) 255 256 46.79% 0.45[0.28,0.74]
Test for overall effect: Z=3.18(P=0)

1.4.3 Drug therapy
Perez 1997 3/8 5/9 1.89% 0.48[0.07,3.35]
Subtotal (95% CI) 8 9 1.89% 0.48[0.07,3.35]

1.4.4 Neuromuscular electrical stimulation
Lee 2014 16/31 16/26 6.36% 0.67[0.23,1.92]
Lim 2009 6/12 6/7 1.24% 0.17[0.02,1.84]
Subtotal (95% CI) 43 33 7.59% 0.51[0.18,1.49]

Jayasekeran 2010a 4/4 6/6 Not estimable
Jayasekeran 2010b 13/16 12/12 0.76% 0.15[0.01,3.3]
Vasant 2016 6/14 7/14 3.21% 0.75[0.17,3.33]
Subtotal (95% CI) 34 32 3.97% 0.55[0.15,2.11]

Bath 1997 3/4 3/3 0.57% 0.33[0.01,11.34]
Feng 2012 59/60 59/60 0.91% 1[0.06,16.37]
Subtotal (95% CI) 64 63 1.48% 0.65[0.07,5.85]

1.4.7 Transcranial direct current stimulation
Kumar 2011 6/7 7/7 0.63% 0.29[0.01,8.39]
Subtotal (95% CI) 7 7 0.63% 0.29[0.01,8.39]

Total (95% CI) 776 711 100% 0.42[0.32,0.55]
Informed decisions.



Analysis 1.5. Comparison 1 Swallowing therapy, Outcome 5 Swallowing ability.
Study or subgroup Treatment Control Std. Mean Difference Weight Std. Mean Difference
1.5.1 Acupuncture
Bai 2007i 18 5.5 (1.2) 35 6 (1.4) 4.34% -0.41[-0.98,0.17]
Bai 2007ii 40 4.2 (1.4) 17 5.5 (1.2) 4.31% -0.91[-1.5,-0.32]
Chan 2012 48 5.6 (1) 20 5.8 (1) 4.43% -0.21[-0.73,0.31]
Chen 2016a 65 9.4 (0.8) 68 9.8 (0.5) 4.69% -0.67[-1.02,-0.32]
Wei 2005 32 5.5 (0.8) 33 5 (0.6) 4.47% 0.69[0.19,1.19]
Xia 2016a 60 3.7 (1.1) 60 5.8 (1.3) 4.59% -1.73[-2.15,-1.31]
Subtotal *** 263 233 26.84% -0.55[-1.2,0.11]
Heterogeneity: Tau2=0.61; Chi2=56.73, df=5(P<0.0001); I2=91.19%

1.5.2 Behavioural intervention
Heo 2015 22 25.7 (10) 22 26.7 (10.5) 4.31% -0.1[-0.69,0.5]
Kang 2012 25 3.6 (1.2) 25 4.6 (1) 4.33% -0.89[-1.47,-0.31]
Park 2016b 14 4.4 (0.8) 13 5.4 (1.7) 3.94% -0.74[-1.52,0.05]
Subtotal *** 61 60 12.58% -0.56[-1.07,-0.05]

1.5.3 Drug therapy
Lee 2015 38 3.5 (1.5) 33 4.2 (1.5) 4.52% -0.46[-0.93,0.01]
Subtotal *** 38 33 4.52% -0.46[-0.93,0.01]

Terre 2015 10 4.6 (2.5) 10 5.3 (2.5) 3.74% -0.27[-1.15,0.61]
Xia 2011 40 21.4 (3.5) 40 30.1 (3.8) 4.34% -2.36[-2.94,-1.78]
Subtotal *** 50 50 8.08% -1.34[-3.39,0.71]
Heterogeneity: Tau2=2.04; Chi2=15.13, df=1(P=0); I2=93.39%

Jayasekeran 2010b 16 6.3 (4.4) 12 5.6 (5.5) 4.01% 0.14[-0.61,0.89]
STEPS 2016 72 5.2 (4.1) 59 4.9 (3.6) 4.7% 0.08[-0.27,0.42]
Vasant 2016 18 4.3 (4) 17 4.6 (4.4) 4.18% -0.07[-0.74,0.59]
Subtotal *** 106 88 12.89% 0.06[-0.22,0.34]

Power 2006 8 24.9 (4.7) 8 26.3 (4.1) 3.53% -0.3[-1.29,0.68]
Informed decisions.

Subtotal *** 8 8 3.53% -0.3[-1.29,0.68]

1.5.7 Transcranial direct current stimulation
Kumar 2011 7 4.7 (1.7) 7 3.7 (1.1) 3.33% 0.65[-0.43,1.74]
Shigematsu 2013 10 3.5 (0.9) 10 4.7 (0.9) 3.54% -1.28[-2.26,-0.3]
Subtotal *** 17 17 6.86% -0.33[-2.22,1.56]

Du 2016i 13 18.9 (0.9) 6 22.7 (2.2) 2.83% -2.62[-3.96,-1.27]
Du 2016ii 13 18.5 (0.7) 6 22.7 (2.2) 2.65% -3.04[-4.49,-1.58]
Khedr 2010 11 1.4 (0.4) 11 3.7 (0.5) 2.17% -4.77[-6.54,-3.01]
Kim 2012i 10 9.2 (2.6) 5 11.1 (4.4) 3.3% -0.57[-1.66,0.53]
Kim 2012ii 10 8.4 (3.3) 5 11.1 (4.4) 3.28% -0.69[-1.8,0.42]
Park 2013 9 25.3 (9.8) 9 21.2 (15.6) 3.64% 0.3[-0.63,1.23]
Park 2016a (i) 5 3.8 (1.5) 11 3.1 (1.6) 3.35% 0.45[-0.62,1.52]
Park 2016a (ii) 6 3.8 (1.5) 11 4.4 (1.9) 3.49% -0.35[-1.35,0.66]
Subtotal *** 77 64 24.71% -1.29[-2.37,-0.21]

Total *** 620 553 100% -0.66[-1.01,-0.32]
Test for subgroup differences: Chi2=12.2, df=1 (P=0.09), I2=42.63%

Analysis 1.6. Comparison 1 Swallowing therapy, Outcome 6 Penetration aspiration score.
1.6.1 Behavioural intervention
Park 2016b 14 4.9 (0.5) 13 5.5 (0.8) 10.82% -0.88[-1.68,-0.08]
Subtotal *** 14 13 10.82% -0.88[-1.68,-0.08]
Heterogeneity: Tau2=0; Chi2=0, df=0(P<0.0001); I2=100%

Park 2012 9 3.2 (2.1) 9 2.2 (1.4) 8.94% 0.57[-0.38,1.52]
Subtotal *** 9 9 8.94% 0.57[-0.38,1.52]

Jayasekeran 2010a 4 3.7 (1.3) 6 4.8 (1.3) 5.61% -0.78[-2.12,0.56]
Jayasekeran 2010b 16 3.2 (1.5) 12 3.8 (1.3) 11.37% -0.41[-1.17,0.35]
Favours active -2 -1 0 1 2 Favours control
Informed decisions.

STEPS 2016 70 3.7 (2) 56 3.6 (1.9) 18.31% 0.05[-0.3,0.4]
Vasant 2016 6 2.6 (1.8) 7 4.3 (2.5) 7.08% -0.7[-1.84,0.43]
Subtotal *** 96 81 42.38% -0.17[-0.53,0.19]

Kim 2012i 10 3.7 (1) 5 3.8 (1.3) 7.64% -0.08[-1.15,1]
Kim 2012ii 10 2 (0.8) 5 3.8 (1.3) 5.81% -1.79[-3.1,-0.49]
Park 2013 9 1.4 (0.9) 9 3.1 (2.2) 8.41% -1.01[-2.01,-0.01]
Park 2016a (i) 11 5.8 (2.6) 5 4.8 (1.8) 7.69% 0.39[-0.68,1.46]
Park 2016a (ii) 11 3.8 (2.7) 6 4.8 (1.8) 8.32% -0.38[-1.38,0.63]
Subtotal *** 51 30 37.87% -0.53[-1.22,0.16]

Total *** 170 133 100% -0.37[-0.74,-0]
Favours active -2 -1 0 1 2 Favours control

Analysis 1.7. Comparison 1 Swallowing therapy, Outcome 7 Chest infection or pneumonia.
Carnaby 2006i 13/51 48/102 20.42% 0.38[0.18,0.81]
Carnaby 2006ii 28/102 13/51 20.16% 1.11[0.51,2.38]
Kang 2012 5/25 6/25 14.35% 0.79[0.21,3.03]
Song 2004 0/29 3/24 5.26% 0.1[0.01,2.12]
Yuan 2003i 0/18 1/11 4.58% 0.19[0.01,5.07]
Yuan 2003ii 2/11 10/24 11.17% 0.31[0.05,1.76]
Subtotal (95% CI) 236 237 75.93% 0.56[0.31,1]
Heterogeneity: Tau2=0.11; Chi2=6.33, df=5(P=0.28); I2=21%

1.7.2 Drug therapy
Warusevitane 2015 8/30 26/30 14.49% 0.06[0.01,0.21]
Subtotal (95% CI) 30 30 14.49% 0.06[0.01,0.21]

Lee 2014 0/31 0/26 Not estimable
Subtotal (95% CI) 31 26 Not estimable
Informed decisions.


Test for overall effect: Not applicable

Jayasekeran 2010b 2/16 3/12 9.58% 0.43[0.06,3.09]
Subtotal (95% CI) 16 12 9.58% 0.43[0.06,3.09]

Total (95% CI) 313 305 100% 0.36[0.16,0.78]

Analysis 1.8. Comparison 1 Swallowing therapy, Outcome 8 Pharyngeal transit time (seconds).
1.8.1 Drug therapy
Perez 1997 8 2.2 (0.6) 9 2.4 (0.8) 1.47% -0.21[-0.91,0.49]
Subtotal *** 8 9 1.47% -0.21[-0.91,0.49]

Li 2014 38 0.8 (0.1) 40 1.1 (0.1) 52.03% -0.3[-0.34,-0.26]
Lim 2009 16 0.9 (0.2) 12 1 (0.2) 20.29% -0.11[-0.27,0.05]
Terre 2015 10 1.2 (0.2) 10 1.5 (0.8) 2.81% -0.35[-0.85,0.15]
Subtotal *** 64 62 75.13% -0.23[-0.39,-0.08]

Jayasekeran 2010b 16 1.1 (0.7) 12 1.2 (0.7) 2.61% -0.15[-0.67,0.37]
Subtotal *** 16 12 2.61% -0.15[-0.67,0.37]

Power 2006 8 0.7 (0.1) 8 0.9 (0.2) 20.79% -0.19[-0.34,-0.04]
Subtotal *** 8 8 20.79% -0.19[-0.34,-0.04]

Total *** 96 91 100% -0.23[-0.32,-0.15]
Heterogeneity: Tau2=0; Chi2=7.04, df=5(P=0.22); I2=29.03%
Therapy better -1 -0.5 0 0.5 1 Therapy worse
Informed decisions.


Therapy better -1 -0.5 0 0.5 1 Therapy worse

Analysis 1.9. Comparison 1 Swallowing therapy, Outcome 9 Institutionalisation.
Carnaby 2006i 8/51 26/102 28.28% 0.54[0.23,1.31]
Carnaby 2006ii 19/102 9/51 28.32% 1.07[0.45,2.56]
Subtotal (95% CI) 153 153 56.6% 0.76[0.39,1.48]

STEPS 2016 49/78 44/63 43.4% 0.73[0.36,1.48]
Subtotal (95% CI) 78 63 43.4% 0.73[0.36,1.48]

Total (95% CI) 231 216 100% 0.75[0.47,1.19]

Analysis 1.10. Comparison 1 Swallowing therapy, Outcome 10 Nutritional (albumin).
Yuan 2003i 11 36.8 (10.3) 24 36.6 (9.8) 6.67% 0.2[-7.05,7.45]
Yuan 2003ii 18 37 (6.7) 11 36.8 (10.3) 7.52% 0.2[-6.63,7.03]
Subtotal *** 29 35 14.2% 0.2[-4.77,5.17]
Heterogeneity: Tau2=0; Chi2=0, df=1(P=1); I2=0%

STEPS 2016 63 37 (5.7) 42 36.6 (4.8) 85.8% 0.4[-1.62,2.42]
Subtotal *** 63 42 85.8% 0.4[-1.62,2.42]

Informed decisions.


Total *** 92 77 100% 0.37[-1.5,2.24]
Heterogeneity: Tau2=0; Chi2=0.01, df=2(P=1); I2=0%

APPENDICES
Appendix 1. CENTRAL search strategy

1. MeSH descriptor: [Cerebrovascular Disorders] this term only
2. MeSH descriptor: [Basal Ganglia Cerebrovascular Disease] this term only
3. MeSH descriptor: [Brain Ischemia] explode all trees
4. MeSH descriptor: [Carotid Artery Diseases] explode all trees
5. MeSH descriptor: [Cerebral Small Vessel Diseases] explode all trees
6. MeSH descriptor: [Intracranial Arterial Diseases] explode all trees
7. MeSH descriptor: [Intracranial Embolism and Thrombosis] explode all trees
8. MeSH descriptor: [Intracranial Hemorrhages] explode all trees
9. MeSH descriptor: [Stroke] explode all trees
10.MeSH descriptor: [Stroke, Lacunar] this term only
11.(stroke* or poststroke or apoplex* or cerebral vasc* or brain vasc* or cerebrovasc* or cva*):ti,ab,kw (Word variations have been searched)
12.((brain or cerebr* or cerebell* or vertebrobasil* or hemispher* or intracran* or intracerebral or infratentorial or supratentorial or middle
cerebral artery or MCA* or anterior circulation or posterior circulation or basilar artery or vertebral artery) near/5 (isch?emi* or infarct*
or thrombo* or emboli* or occlus*)):ti,ab,kw (Word variations have been searched)
13.((brain* or cerebr* or cerebell* or intracerebral or intracran* or parenchymal or intraparenchymal or intraventricular or infratentorial
or supratentorial or basal gangli* or putaminal or putamen or posterior fossa or hemispher*) near/5 (h?emorrhag* or h?ematoma* or
bleed*)):ti,ab,kw (Word variations have been searched)
14.{or #1-#13}
15.MeSH descriptor: [Deglutition] this term only
16.MeSH descriptor: [Deglutition Disorders] explode all trees
17.((swallow* or deglutit* or dysphag*) near/3 (disturbance* or disorder* or difficult* or dysfunction* or impair* or condition* or abnormal*
or damage* or injur*)):ti,ab,kw (Word variations have been searched)
18.MeSH descriptor: [Pharynx] this term only
19.MeSH descriptor: [Pharyngeal Muscles] this term only
20.((pharyn* or oropharyn*) near/3 (disturbance* or disorder* or difficult* or dysfunction* or impair* or condition* or abnormal* or
damage* or injur*)):ti,ab,kw (Word variations have been searched)
21.{or #15-#20}
22.#14 and #21
Appendix 2. MEDLINE search strategy

1. cerebrovascular disorders/ or basal ganglia cerebrovascular disease/ or exp brain ischemia/ or exp carotid artery diseases/ or exp
cerebral small vessel diseases/ or exp intracranial arterial diseases/ or exp "intracranial embolism and thrombosis"/ or exp intracranial
hemorrhages/ or stroke/ or stroke, lacunar/
2. (stroke$ or poststroke or apoplex$ or cerebral vasc$ or brain vasc$ or cerebrovasc$ or cva$).tw.
3. ((brain$ or cerebr$ or cerebell$ or vertebrobasil$ or hemispher$ or intracran$ or intracerebral or infratentorial or supratentorial or
middle cerebral artery or MCA$ or anterior circulation or posterior circulation or basilar artery or vertebral artery) adj5 (isch?emi$ or
infarct$ or thrombo$ or emboli$ or occlus$)).tw.
4. ((brain$ or cerebr$ or cerebell$ or intracerebral or intracran$ or parenchymal or intraparenchymal or intraventricular or infratentorial
or supratentorial or basal gangli$ or putaminal or putamen or posterior fossa or hemispher$) adj5 (h?emorrhag$ or h?ematoma$ or
bleed$)).tw.
Informed decisions.

5. or/1-4
6. Deglutition/
7. exp Deglutition Disorders/
8. ((swallow$ or deglutit$ or dysphag$) adj5 (disturbance$ or disorder$ or difficult$ or dysfunction$ or impair$ or condition$ or abnormal
$ or damage$ or injur$)).tw.
9. Pharynx/ or pharyngeal muscles/
10.((pharyn$ or oropharyn$) adj3 (disturbance$ or disorder$ or difficult$ or dysfunction$ or impair$ or condition$ or abnormal$ or damage
$ or injur$)).tw.
11.or/6-10
12.randomized controlled trial.pt.
13.controlled clinical trial.pt.
14.randomized.ab.
15.placebo.ab.
16.random$.ab.
17.trial.ab.
18.groups.ab.
19.or/12-18
20.5 and 11 and 19
Previous version of search strategy
1. stroke.mp.
2. infarction.mp.
3. exp cerebral infarction/
4. exp cerebrovascular disease/
5. cerebrovascular disease.mp.
6. hemorrhage.mp.
7. exp cerebral hemorrhage/
8. cerebral haemorrhage.mp.
9. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8
10.(dysphagia or deglutition or swallowing or deglutition disorders or swallowing disorders or malnutrition or undernutrition).mp.
11.(intervention or supplementation or feeding or nutrition or nutritional supplementation or therapy or swallowing therapy or tube
feeding or fluid or fluid supplementation or sip feeding or feeding route or timing or diet or hydration).mp.
12.10 or 11
13.9 and 12
14.(randomized controlled trial.pt. or controlled clinical trial.pt.or randomized.ab. or placebo.ab. or clinical trials as topic.sh. or
randomly.ab. or trial.ti.) and humans.sh.
15.13 and 14
Appendix 3. Embase search strategy

1. cerebrovascular disease/ or brain disease/ or exp basal ganglion hemorrhage/ or exp brain hematoma/ or exp brain hemorrhage/ or exp
brain infarction/ or exp brain ischemia/ or exp carotid artery disease/ or exp cerebral artery disease/ or exp cerebrovascular accident/
or exp intracranial aneurysm/ or exp occlusive cerebrovascular disease/ or exp vertebrobasilar insufficiency/
2. (stroke$ or poststroke or apoplex$ or cerebral vasc$ or brain vasc$ or cerebrovasc$ or cva$).tw.
3. ((brain or cerebr$ or cerebell$ or vertebrobasil$ or hemispher$ or intracran$ or intracerebral or infratentorial or supratentorial or middle
cerebral artery or MCA$ or anterior circulation or posterior circulation or basilar artery or vertebral artery) adj5 (isch?emi$ or infarct$
or thrombo$ or emboli$ or occlus$)).tw.
4. ((brain$ or cerebr$ or cerebell$ or intracerebral or intracran$ or parenchymal or intraparenchymal or intraventricular or infratentorial
or supratentorial or basal gangli$ or putaminal or putamen or posterior fossa or hemispher$) adj5 (h?emorrhag$ or h?ematoma$ or
bleed$)).tw.
5. or/1-4
6. dysphagia/
7. swallowing/
8. ((swallow$ or deglutit$ or dysphag$) adj3 (disturbance$ or disorder$ or difficult$ or dysfunction$ or impair$ or condition$ or abnormal
$ or damage$ or injur$)).tw.
Informed decisions.

9. exp pharynx/
10.((pharyn$ or oropharyn$) adj3 (disturbance$ or disorder$ or difficult$ or dysfunction$ or impair$ or condition$ or abnormal$ or damage
$ or injur$)).tw.
11.or/6-10
12.Randomized Controlled Trial/ or "randomized controlled trial (topic)"/
13.Randomization/
14.Controlled clinical trial/ or "controlled clinical trial (topic)"/
15.control group/ or controlled study/
16.clinical trial/ or "clinical trial (topic)"/ or phase 1 clinical trial/ or phase 2 clinical trial/ or phase 3 clinical trial/ or phase 4 clinical trial/
17.Crossover Procedure/
18.Double Blind Procedure/
19.Single Blind Procedure/ or triple blind procedure/
20.placebo/ or placebo effect/
21.(random$ or RCT or RCTs).tw.
22.(controlled adj5 (trial$ or stud$)).tw.
23.(clinical$ adj5 trial$).tw.
24.((control or treatment or experiment$ or intervention) adj5 (group$ or subject$ or patient$)).tw.
25.((control or experiment$ or conservative) adj5 (treatment or therapy or procedure or manage$)).tw.
26.((singl$ or doubl$ or tripl$ or trebl$) adj5 (blind$ or mask$)).tw.
27.(cross-over or cross over or crossover).tw.
28.(placebo$ or sham).tw.
29.trial.ti.
30.(assign$ or allocat$).tw.
31.controls.tw.
32.or/12-31
33.5 and 11 and 32
Previous version of search strategy
1. stroke.mp.
2. infarction.mp.
3. exp brain Infarction/
4. cerebrovascular disease.mp.
5. exp cerebrovascular disease/
6. hemorrhage.mp.
7. exp cerebral hemorrhage/
8. cerebral haemorrhage.mp.
9. 9. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8
10.(dysphagia or deglutition or swallowing or deglutition disorders or swallowing disorders or malnutrition or undernutrition).mp.
11.(intervention or supplementation or feeding or nutrition or nutritional supplementation or therapy or swallowing therapy or tube
feeding or fluid or fluid supplementation or sip feeding or feeding route or timing or diet or hydration).mp.
12.10 or 11
13.09 and 12
14.((RANDOMIZED-CONTROLLED-TRIAL/ or RANDOMIZATION/ or CONTROLLED-STUDY/ or MULTICENTER-STUDY/ or PHASE-3-CLINICAL-
TRIAL/ or PHASE-4-CLINICAL-TRIAL/ or DOUBLE-BLIND-PROCEDURE/ or SINGLE-BLIND-PROCEDURE/) or ((RANDOM* or CROSS?OVER*
or FACTORIAL* or PLACEBO* or VOLUNTEER*) or ((SINGL* or DOUBL* or TREBL* or TRIPL*) adj3 (BLIND* or MASK*))).ti,ab) and
human*.ec,hw,fs.
15.13 and 14
Appendix 4. CINAHL search strategy

1. S1 (MH "Cerebrovascular Disorders") OR (MH "Basal Ganglia Cerebrovascular Disease+") OR (MH "Carotid Artery Diseases+") OR (MH
"Cerebral Ischemia+") OR (MH "Cerebral Vasospasm") OR (MH "Intracranial Arterial Diseases+") OR ( (MH "Intracranial Embolism and
Thrombosis") ) OR (MH "Intracranial Hemorrhage+") OR (MH "Stroke") OR (MH "Vertebral Artery Dissections") OR (MH "Stroke Patients")
OR (MH "Stroke Units")
Informed decisions.

2. S2 TI ( stroke or poststroke or post-stroke or cerebrovasc* or brain vasc* or cerebral vasc or cva or apoplex ) or AB ( stroke or poststroke
or post-stroke or cerebrovasc* or brain vasc* or cerebral vasc or cva or apoplex )
3. S3 TI ((brain or cerebr* or cerebell* or vertebrobasil* or hemispher* or intracran* or intracerebral or infratentorial or supratentorial
or middle cerebral artery or MCA* or anterior circulation or posterior circulation or basilar artery or vertebral artery ) N5 ( ischemi*
or ischaemi* or infarct* or thrombo* or emboli* or occlus*)) OR AB ((brain or cerebr* or cerebell* or vertebrobasil* or hemispher*
or intracran* or intracerebral or infratentorial or supratentorial or middle cerebral artery or MCA* or anterior circulation or posterior
circulation or basilar artery or vertebral artery ) N5 ( ischemi* or ischaemi* or infarct* or thrombo* or emboli* or occlus*))
4. S4 TI (( brain* or cerebr* or cerebell* or intracerebral or intracran* or parenchymal or intraparenchymal or intraventricular or
infratentorial or supratentorial or basal gangli* or putaminal or putamen or posterior fossa or hemispher* ) N5 ( haemorrhage* or
hemorrhage* or haematoma* or hematoma* or bleed* )) OR AB (( brain* or cerebr* or cerebell* or intracerebral or intracran* or
parenchymal or intraparenchymal or intraventricular or infratentorial or supratentorial or basal gangli* or putaminal or putamen or
posterior fossa or hemispher* ) N5 ( haemorrhage* or hemorrhage* or haematoma* or hematoma* or bleed* ))
5. S5 S1 OR S2 OR S3 OR S4
6. S6 (MH "Deglutition") OR (MH "Gagging")
7. S7 (MH "Deglutition Disorders")
8. S8 TI ( (swallow* or deglutit* or dysphag*) N3 (disturbance* or disorder* or difficult* or dysfunction* or impair* or condition* or
abnormal* or damage* or injur*) ) OR AB ( (swallow* or deglutit* or dysphag*) N3 (disturbance* or disorder* or difficult* or dysfunction*
or impair* or condition* or abnormal* or damage* or injur*) )
9. S9 TI ((swallow* or deglutit* or dysphag*) N3 (scale* or screen* or checklist* or assess* or exam* or identif* or recogni* or evaluat* or
diagnos* or detect* or hazard or risk or test)) OR AB ((swallow* or deglutit* or dysphag*) N3 (scale* or screen* or checklist* or assess*
or exam* or identif* or recogni* or evaluat* or diagnos* or detect* or hazard or risk or test))
10.S10 S6 OR S7 OR S8 OR S9
11.S11 MH Random Assignment or MH Single-blind Studies or MH Double-blind Studies or MH Triple-blind Studies or MH Crossover design
or MH Factorial Design
12.S12 TI ("multicentre study" or "multicenter study" or "multi-centre study" or "multi-center study") or AB ("multicentre study" or
"multicenter study" or "multi-centre study" or "multi-center study") or SU ("multicentre study" or "multicenter study" or "multi-centre
study" or "multi-center study")
13.S13 TI random* or AB random*
14.S14 AB "latin square" or TI "latin square"
15.S15 TI (crossover or cross-over) or AB (crossover or cross-over) or SU (crossover or cross-over)
16.S16 MH Placebos
17.S17 TI ( ((singl* or doubl* or trebl* or tripl*) N3 (blind* or mask*)) ) OR AB ( ((singl* or doubl* or trebl* or tripl*) N3 (blind* or mask*)) )
18.S18 TI Placebo* or AB Placebo* or SU Placebo*
19.S19 MH Clinical Trials
20.S20 TI (Clinical AND Trial) or AB (Clinical AND Trial) or SU (Clinical AND Trial)
21.S21 S11 OR S12 OR S13 OR S14 OR S15 OR S16 OR S17 OR S18 OR S19 OR S20
22.S22 S5 AND S10 AND S21
Previous version of review search strategy
1. S1. stroke
2. S2. infarction
3. S3. brain Infarction
4. S4. cerebrovascular disease
5. S5. hemorrhage
6. S6. cerebral hemorrhage
7. S7. cerebral haemorrhage
8. S8. S1 or S2 or S3 or S4 or S5 or S6 or S7
9. S9. dysphagia or deglutition or swallowing or deglutition disorders or swallowing disorders or malnutrition or undernutrition
10.S10. intervention or supplementation or feeding or nutrition or nutritional supplementation or therapy or swallowing therapy or tube
feeding or fluid or fluid supplementation or sip feeding or feeding route or timing or diet or hydration
11.S11. S9 or S10
12.S12. S8 and S11
13.S13. randomised controlled trials or controlled clinical trial or randomized or clinical trials
14.S14. S12 and S13
Informed decisions.

Appendix 5. Web of Science search strategy

1. TS=(stroke* or poststroke or apoplex* or cerebral vasc* or brain vasc* or cerebrovasc* or cva*)
2. TS=((brain or cerebr* or cerebell* or vertebrobasil* or hemispher* or intracran* or intracerebral or infratentorial or supratentorial or

middle cerebral artery or MCA* or anterior circulation or posterior circulation or basilar artery or vertebral artery) NEAR/5 (isch?emi* or
infarct* or thrombo* or emboli* or occlus*))
3. TS=((brain* or cerebr* or cerebell* or intracerebral or intracran* or parenchymal or intraparenchymal or intraventricular or infratentorial
or supratentorial or basal gangli* or putaminal or putamen or posterior fossa or hemispher*) NEAR/5 (h?emorrhag* or h?ematoma* or
bleed*))
4. #3 OR #2 OR #1
5. TS=((swallow* or deglutit* or dysphag*) NEAR/3 (disturbance* or disorder* or difficult* or dysfunction* or impair* or condition* or
abnormal* or damage* or injur*))
6. TS=((pharyn* or oropharyn*) NEAR/3 (disturbance* or disorder* or difficult* or dysfunction* or impair* or condition* or abnormal* or
damage* or injur*))
7. #6 OR #5
8. TS=(random* or RCT or RCTs)
9. TS=(controlled NEAR/5 (trial* or stud*))

10. TS=(clinical* NEAR/5 trial*)
11. TS=((control or treatment or experiment* or intervention) NEAR/5 (group* or subject* or patient*))
12. TS=((control or experiment* or conservative) NEAR/5 (treatment or therapy or procedure or m.anage*))
13. TS=((singl* or doubl* or tripl* or trebl*) NEAR/5 (blind* or mask*))
14. TS=(cross-over or cross over or crossover)

15. TS=(placebo* or sham)
16. TS=trial
17. #16 OR #15 OR #14 OR #13 OR #12 OR #11 OR #10 OR #9 OR #8

18. #17 AND #7 AND #4
Previous version of review search strategy
1. stroke
2. infarction
3. brain infarction
4. cerebrovascular disease
5. hemorrhage
6. cerebral haemorrhage
7. cerebral hemorrhage
8. 1 or 2 or 3 or 4 or 5 or 6 or 7
9. dysphagia or deglutition or swallowing or deglutition disorders or swallowing disorders
10.randomized controlled trial or controlled clinical trial randomized or placebo or clinical trials or trial
11.8 and 9 and 10
Appendix 6. SpeechBITE search stategy

1. Speech Pathology Practice Area: Dysphagia
2. Type of intervention: Swallowing/ feeding
3. Within this population: Stroke/CVA
4. Research Design : Randomised Controlled Trial
5. Age group: Adults
1. Speech Pathology Practice Area: Dysphagia
2. Type of intervention: Swallowing/ feeding
3. Within this population: Stroke/CVA
4. Research Design: Non Randomised Controlled Trial
5. Age group: Adults
Informed decisions.

Appendix 7. US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (www.clinicaltrials.gov)

1. ( Dysphagia AND ( Brain Infarction OR Intracranial Hemorrhages OR Carotid Artery Diseases OR Brain Ischemia OR Cerebral Hemorrhage
OR Cerebrovascular Disorders OR Stroke ) ) [DISEASE]
Appendix 8. World Health Organization International Clinical Trials Registry Platform (apps.who.int/trialsearch)
1. stroke AND swallowing OR stroke AND dysphagia
Appendix 9. Google Scholar

1. Stroke
2. Dysphagia
3. Interventions
4. Randomised Controlled Trials
WHAT'S NEW

Date Event Description
28 March 2018 New citation required but conclusions More significant outcomes reported as compared to the 2012 re-
have not changed view, but largely based on moderate- to low-quality evidence.
Changes made to authorship
28 March 2018 New search has been performed New studies added. 14 studies (883 participants) included in the
2012 review. 27 studies (1777 participants) added to this updat-
ed review. Total number of included studies reported is 41 (2660
participants). Focus of this review is limited to treatment of dys-
phagia in acute and subacute stroke (nutritional, feeding, and
fluid support removed from this review and will become the fo-
cus of a separate review)

HISTORY
Protocol first published: Issue 1, 1997
Review first published: Issue 4, 1999

Date Event Description
14 March 2012 New citation required but conclusions Changes made to authorship. No changes made to conclusions
have not changed
14 March 2012 New search has been performed Results of 27 new studies involving 6567 participants added to
the review. Total of 33 studies involving 6779 participants now
included. 15 new ongoing studies also added. Modifications
made to analysis method, types of stroke patients included, and
outcome measures assessed (Differences between protocol and
review)
13 April 2008 Amended Review converted to new review format

CONTRIBUTIONS OF AUTHORS
Philip Bath: conceived and designed the review, undertook searches, analysed and interpreted data, wrote the original review, and updated
the review in 2007 (interim update), 2012, and 2018.
Informed decisions.

Han Sean Lee: undertook searches, extracted data, analysed and interpreted data, and updated the review in 2018.
Lisa Everton: undertook searches and data extraction, analysed and interpreted data, and updated the review in 2018.
DECLARATIONS OF INTEREST
PB was chief investigator of two included trials (Bath 1997, academic; STEPS 2016, commercial - funded by Phagenesis Ltd); he consults
for this company and receives honoraria and expenses for this work; he did not contribute to decisions on PES studies including deciding
which trials should be included and extracting outcome data. No pharmaceutical or device companies, or other commercial entities, were
involved in data analysis, data interpretation, writing of this review, or comments on it.
SL: none known.
LE: none known.
SOURCES OF SUPPORT
Internal sources
• King's College Hospital Audit Committee, UK.
• Division of Stroke, University of Nottingham, UK.
External sources
• South Thames NHS Executive, UK.
• Trent NHS Executive, UK.
• Wolfson Foundation, UK.
• The Stroke Association, UK.
• Royal College of Physicians, UK.
• Dunhill Medical Trust, UK.
• National Institutes of Health Research Stroke Research Network, UK.
Support for recruitment of patients into UK-based trials

• National Institutes of Health Research - Cochrane Incentive Scheme, UK.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW
Separation of dysphagia treatment from nutritional support

For this version of the review, we removed all trials related to nutritional support and feeding to allow focus on swallowing therapy for
post-stroke dysphagia.
Modification of analysis method

We changed the analysis method from fixed-effect to random-effects models (odds ratio (OR), mean difference (MD)) because we noted the
presence of significant trial and statistical heterogeneity. Two studies included more than one interventional group (Yuan 2003; Carnaby
2006), producing different treatment intensities. In these cases, we divided the low-intensity (middle) groups and entered data from the
study as two data sets (e.g. data set 1: medium (M), low (L), or none; and data set 2: high (H) or medium (M)). Similarly, in the case of
repetitive transcranial magnetic stimulation, when a trial compared high- versus low-frequency stimulation or unilateral versus bilateral
stimulation (Kim 2012i; Kim 2012ii; Du 2016i; Du 2016ii; Park 2016a (i); Park 2016a (ii)), we divided control group participants equally
between treatment groups to prevent counting control participants more than once, thereby artificially narrowing the confidence intervals
(CIs).
We combined different interventions, collectively referred to as 'swallowing therapy', for the purposes of analysing their effects on main
outcomes to evaluate whether any intervention is better than no intervention, and to try to establish where the most positive effects are
seen, and where more research is needed.
Modification of type of stroke patients

We excluded trials in which a majority of participants did not present with stroke, along with trials for which enrolment occurred after six
months.
Informed decisions.

Addition or modification of outcome measures

Modification of search strategies: we have revised and updated the search strategies used for this review to account for newly identified
relevant terms keywords and indexing terms. We have included both versions of each search strategy in the review appendices.
We divided swallowing therapy into subcategories: acupuncture, drug therapy, NMES, PES, physical stimulation (thermal, tactile), tDCS,
and TMS.
We added additional outcome measures, especially focusing on intermediate outcomes: chest infection or pneumonia rates and
penetration aspiration scores. We retained outcomes related to improvement of dysphagia as listed with proportion of participants with
dysphagia at end of trial. However, we also included changes in some measurements on videofluoroscopy (pharyngeal transit time)
and changes in swallowing ability as determined by change in swallow scores. We included discharge destination within the outcome
'institutionalisation': the number of participants discharged to long-term care.
INDEX TERMS
Medical Subject Headings (MeSH)

*Stroke Rehabilitation; Acupuncture Therapy [statistics & numerical data]; Acute Disease; Deglutition; Deglutition Disorders
[*etiology] [mortality] [*rehabilitation]; Electric Stimulation Therapy [statistics & numerical data]; Gastrostomy; Intubation,
Gastrointestinal; Length of Stay [statistics & numerical data]; Lisinopril [therapeutic use]; Metoclopramide [therapeutic use];
Nifedipine [therapeutic use]; Physical Stimulation [methods]; Pneumonia [epidemiology]; Randomized Controlled Trials as Topic;
Stroke [*complications] [mortality]; Time Factors; Transcranial Direct Current Stimulation [statistics & numerical data]
MeSH check words

Humans

Swallowing Therapy For Dysphagia in Acute and Subacute Stroke

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Bath PM, Lee HS, Everton LF

Bath PM, Lee HS, Everton LF.

Swallowing therapy for dysphagia in acute and subacute stroke (Review) i

Swallowing therapy for dysphagia in acute and subacute stroke

Philip M Bath1, Han Sean Lee1, Lisa F Everton1

Editorial group: Cochrane Stroke Group

Data collection and analysis

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 1

Quality of the evidence

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 2

Patient or population: dysphagia in acute and subacute stroke

Death or dependency at end of trial Study population OR 1.05 306 ⊕⊕⊕⊝ a

Case fatality at end of trial Study population OR 1.00 766 ⊕⊕⊕⊝ b

Proportion of participants with Study population OR 0.42 1487 ⊕⊕⊝⊝ d

Cochrane Database of Systematic Reviews

Adverse event: chest infection or Study population OR 0.34 676 ⊕⊝⊝⊝ g

GRADE Working Group grades of evidence.

Cochrane Database of Systematic Reviews

BACKGROUND studies have demonstrated that recovery from dysphagia is

Types of participants Secondary outcomes

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 6

Data collection and analysis Assessment of heterogeneity

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 7

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 8

Figure 1. Study Flow Diagram, *86 studies awaiting classification.

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 9

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 10

Acupuncture Three studies enrolled 155 participants. Types of stimulation

Behavioural interventions Two studies assessed tDCS in 34 participants (Kumar 2011;

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 11

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 12

Effects of interventions Swallowing therapy probably reduced length of inpatient stay

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 13

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 14

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 15

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 16

ACKNOWLEDGEMENTS We thank the Cochrane Stroke Group for assistance in identifying

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 17

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 19

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 20

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 21

Mao 2016 {published data only} NCT00376506a {published data only}

McCullough 2012 {published data only} NCT00376506b {published data only}

McCullough 2013 {published data only} NCT01971320 {published data only}

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 22

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 24

ChiCTR-TRC-07000010 {published data only} Feng 2016 {published data only}

ChiCTR-TRC-08000463 {published data only} Gao 2016 {published data only}

ChiCTR-TRC-14004235 {published data only} Guillen-Sola 2017 {published data only}

ChiCTR-TRC-14004955 {published data only} Guillen-Sola A, Messagi-Sartor M, Barrera De Paz C, Bofill-

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 25

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 26

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 27

Xu 2013 {published data only} Zhong 2003 {published data only}

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 28

Zhu 2015a {published data only} www.isrctn.com/ISRCTN14124645 (first received 10 October

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 29

U1111-1188-0335 {published data only} Hamdy 1998

Swallowing therapy for dysphagia in acute and subacute stroke (Review) 30