Dyspepsiagord Nice Guideline2
Dyspepsiagord Nice Guideline2
Dyspepsiagord Nice Guideline2
NICE guideline
Draft for consultation, April 2014
If you wish to comment on this version of the guideline, please be aware that
all the supporting information and evidence is contained in the full version.
Contents
Introduction ...................................................................................................... 3
Patient-centred care......................................................................................... 5
Strength of recommendations .......................................................................... 6
Update information........................................................................................... 8
Key priorities for implementation .................................................................... 10
1 Recommendations .................................................................................. 12
Terms used in this guideline ....................................................................... 12
1.1 The community pharmacist ............................................................... 12
1.2 Common elements of care ................................................................ 12
1.3 Referral guidance for endoscopy ...................................................... 13
1.4 Interventions for uninvestigated dyspepsia ....................................... 14
1.5 Reviewing patient care...................................................................... 14
1.6 Interventions for gastro-oesophageal reflux disease (GORD) .......... 15
1.7 Interventions for peptic ulcer disease................................................ 16
1.8 Interventions for functional dyspepsia ............................................... 18
1.9 Helicobacter pylori testing and eradication ....................................... 18
1.10 Laparoscopic fundoplication .......................................................... 21
1.11 Referral to a specialist service ....................................................... 21
1.12 Surveillance for people with Barrett’s oesophagus ........................ 21
2 Research recommendations.................................................................... 23
3 Other information..................................................................................... 25
4 The Guideline Development Group, NICE Internal Clinical Guidelines
Programme team and NICE project team ...................................................... 29
Appendix A: Dosage information on proton pump inhibitors .......................... 32
Appendix B: Recommendations from NICE clinical guideline 17 (2004) that
have been deleted or changed……………………………………………………34
Introduction
Dyspepsia describes a range of symptoms arising from the upper
gastrointestinal (GI) tract, but it has no universally accepted definition. The
British Society of Gastroenterology (BSG) defines dyspepsia as a group of
symptoms that alert doctors to consider disease of the upper GI tract, and
states that dyspepsia itself is not a diagnosis. These symptoms, which
typically are present for 4 weeks or more, include upper abdominal pain or
discomfort, heartburn, gastric reflux, nausea or vomiting.
Some of the costs associated with treating dyspepsia are decreasing, but the
overall use of treatments is increasing. As a result, the management of
dyspepsia continues to have potentially significant costs to the NHS.
The use of endoscopy has increased considerably over the past decade, as
awareness of its value in investigating dyspepsia and gastro-oesophageal
reflux disease (GORD) has grown.
This guideline update covers adults (18 years and older) with symptoms of
dyspepsia, symptoms suggestive of GORD, or both. It also covers endoscopic
Drug recommendations
The guideline will assume that prescribers will use a drug’s summary of
product characteristics to inform decisions made with individual patients.
This guideline recommends some drugs for indications for which they do not
have a UK marketing authorisation at the date of publication, if there is good
evidence to support that use. The prescriber should follow relevant
professional guidance, taking full responsibility for the decision. The patient
(or those with authority to give consent on their behalf) should provide
informed consent, which should be documented. See the General Medical
Council’s Good practice in prescribing and managing medicines and devices
for further information. Where recommendations have been made for the use
of drugs outside their licensed indications (‘off-label use’), these drugs are
marked with a footnote in the recommendations.
Patient-centred care
This guideline offers best practice advice on the care of adults (18 years and
older) with symptoms of dyspepsia or symptoms suggestive of GORD, or
both.
Strength of recommendations
Some recommendations can be made with more certainty than others. The
Guideline Development Group makes a recommendation based on the trade-
off between the benefits and harms of an intervention, taking into account the
quality of the underpinning evidence. For some interventions, the Guideline
Development Group is confident that, given the information it has looked at,
most patients would choose the intervention. The wording used in the
recommendations in this guideline denotes the certainty with which the
recommendation is made (the strength of the recommendation).
For all recommendations, NICE expects that there is discussion with the
patient about the risks and benefits of the interventions, and their values and
preferences. This discussion aims to help them to reach a fully informed
decision (see also ‘Patient-centred care’).
Update information
This guidance is an update of NICE clinical guideline 17 (published in
April 2004) and will replace it.
You are invited to comment on the new and updated recommendations in this
guideline. These are marked as:
[new 2014] if the evidence has been reviewed and the recommendation
has been added or updated
[2014] if the evidence has been reviewed but no change has been made to
the recommended action.
Where recommendations are shaded in grey and end [2004], the evidence
has not been reviewed since the original guideline. We will not be able to
accept comments on these recommendations. Yellow shading in these
recommendations indicates wording changes that have been made for the
purposes of clarification only.
Where recommendations are shaded in grey and end [2004, amended 2014],
the evidence has not been reviewed but changes have been made to the
recommendation wording that change the meaning (for example, because of
equalities duties or a change in the availability of drugs, or incorporated
guidance has been updated). These changes are marked with yellow shading,
and explanations of the reasons for the changes are given in appendix B for
information. We will not be able to accept comments on these
recommendations.
The original NICE guideline and supporting documents are available here.
Leave a 2-week washout period after proton pump inhibitor (PPI) use
before testing for Helicobacter pylori (hereafter referred to as H pylori) with
a breath test or a stool antigen test. [2004, amended 2014]
[Recommendation 1.4.2]
Offer people a full-dose PPI (see table 2 in appendix A) for 8 weeks to heal
severe oesophagitis, taking into account the person’s preference and
clinical circumstances (for example, underlying health conditions and
possible interactions with other drugs). [new 2014] [Recommendation
1.6.7]
Offer H pylori eradication therapy to people who have tested positive for
H pylori and who have peptic ulcer disease. Also see 'H pylori testing and
eradication'. [2004] [Recommendation 1.7.1]
For people using NSAIDs with diagnosed peptic ulcer, stop the use of
NSAIDs where possible. Offer full-dose PPI (see table 1 in appendix A) or
H2RA therapy for 8 weeks and, if H pylori is present, subsequently offer
eradication therapy. [2004] [Recommendation 1.7.2]
Offer people with peptic ulcer (gastric or duodenal) and H pylori retesting
for H pylori 6 to 8 weeks after beginning treatment, depending on the size
of lesion. [2004, amended 2014] [Recommendation 1.7.4]
1
In Referral guidelines for suspected cancer (NICE clinical guideline 27), ‘unexplained’ is
defined as ‘a symptom(s) and/or sign(s) that has not led to a diagnosis being made by the
primary care professional after initial assessment of the history, examination and primary care
investigations (if any)’. (Please note that an update is in progress; publication expected May
2015. For more information see http://guidance.nice.org.uk/CG/Wave0/618.)
1 Recommendations
The following guidance is based on the best available evidence. The full
guideline [hyperlink to be added for final publication] gives details of the
methods and the evidence used to develop the guidance.
1.2.2 Advise people to avoid known precipitants they associate with their
dyspepsia where possible. These include smoking, alcohol, coffee,
chocolate, fatty foods and being overweight. Raising the head of
the bed and having a main meal well before going to bed may help
some people. [2004]
1.3.4 If people have had a previous endoscopy and do not have any new
alarm signs2, consider continuing management according to
previous endoscopic findings. [2004]
For more information about when to refer people to specialists when they
present with symptoms that could be caused by cancer, see Referral for
suspected cancer (NICE clinical guideline 27 [update in progress; publication
expected May 2015: http://guidance.nice.org.uk/CG/Wave0/618]).
2
For more information about alarm signs please see Referral for suspected cancer (NICE
clinical guideline 27 [update in progress; publication expected May 2015. For more
information see http://guidance.nice.org.uk/CG/Wave0/618]).
1.4.2 Leave a 2-week washout period after proton pump inhibitor (PPI)
use before testing for Helicobacter pylori (hereafter referred to as
H pylori) with a breath test or a stool antigen test. [2004, amended
2014]
1.4.3 Offer empirical full-dose PPI therapy (see table 1 in appendix A) for
4 weeks to people with dyspepsia. [2004]
1.4.4 Offer H pylori 'test and treat' to people with dyspepsia. [2004]
1.4.5 If symptoms return after initial care strategies, step down PPI
therapy to the lowest dose needed to control symptoms. Discuss
using the treatment on an ‘as-needed’ basis with people to manage
their own symptoms. [2004]
1.6.2 Offer people with GORD a full-dose PPI (see table 1 in appendix A)
for 4 or 8 weeks. [2004]
1.6.3 If symptoms recur after initial treatment, offer a PPI at the lowest
dose possible to control symptoms. [2004, amended 2014]
1.6.4 Discuss with people how they can manage their own symptoms by
using the treatment when they need it. [2004]
1.6.7 Offer people a full-dose PPI (see table 2 in appendix A) for 8 weeks
to heal severe oesophagitis, taking into account the person’s
preference and clinical circumstances (for example, underlying
health conditions and possible interactions with other drugs). [new
2014]
1.7.2 For people using NSAIDs with diagnosed peptic ulcer, stop the use
of NSAIDs where possible. Offer full-dose PPI (see table 1 in
appendix A) or H2RA therapy for 8 weeks and, if H pylori is present,
subsequently offer eradication therapy. [2004]
1.7.3 Offer people with gastric ulcer and H pylori repeat endoscopy 6 to
8 weeks after beginning treatment, depending on the size of lesion.
[2004, amended 2014]
1.7.4 Offer people with peptic ulcer (gastric or duodenal) and H pylori
retesting for H pylori 6 to 8 weeks after beginning treatment,
depending on the size of lesion. [2004, amended 2014]
1.7.5 Offer full-dose PPI (see table 1 in appendix A) or H2RA therapy for
4 to 8 weeks to people who have tested negative for H pylori who
are not taking NSAIDs. [2004]
1.7.6 For people continuing to take NSAIDs after a peptic ulcer has
healed, discuss the potential harm from NSAID treatment. Review
the need for NSAID use regularly (at least every 6 months) and
offer a trial of use on a limited, ‘as-needed’ basis. Consider
reducing the dose, substituting an NSAID with paracetamol, or
using an alternative analgesic or low-dose ibuprofen (1.2 g daily).
[2004]
1.7.7 In people at high risk (previous ulceration) and for whom NSAID
continuation is necessary, offer gastric protection or consider
substitution with a cyclooxygenase (COX)-2-selective NSAID.
[2004]
1.8.4 If H pylori has been excluded and symptoms persist, offer either a
low-dose PPI (see table 1 in appendix A) or an H2RA for 4 weeks.
[2004, amended 2014]
1.8.7 Avoid long-term, frequent dose, continuous antacid therapy (it only
relieves symptoms in the short term rather than preventing them).
[2004, amended 2014]
Testing
1.9.1 Test for H pylori using a carbon-13 urea breath test or a stool
antigen test, or laboratory-based serology where its performance
has been locally validated. [2004, amended 2014]
1.9.2 Perform re-testing for H pylori using a carbon-13 urea breath test.
(There is currently insufficient evidence to recommend the stool
antigen test as a test of eradication3.) [2004]
Eradication
First-line treatment
1.9.4 Offer people who test positive for H pylori a 7-day, twice-daily
course of treatment with:
1.9.5 Offer people who are allergic to penicillin and who have had
previous exposure to clarithromycin and a quinolone a 7-day,
twice-daily course of treatment with:
1.9.6 Offer people who are allergic to penicillin and who have had
previous exposure to clarithromycin a 7-day, twice-daily course of
treatment with:
3
This refers to evidence reviewed in 2004.
metronidazole and
tetracycline. [new 2014]
1.9.7 Discuss treatment adherence with the person and emphasise its
importance. For more information about supporting adherence, see
Medicines adherence (NICE clinical guideline 76). [new 2014]
Second-line treatment
1.9.8 Offer people who still have symptoms after first-line eradication
treatment a 7-day, twice-daily course of treatment with:
1.9.10 Offer people who are allergic to penicillin (or who have had
previous exposure to clarithromycin but not a quinolone) a 7-day,
twice-daily course of treatment with:
1.9.11 Offer people who are allergic to penicillin and who have had
previous exposure to clarithromycin and a quinolone:
metronidazole and
a tetracycline. [new 2014]
4
In Referral guidelines for suspected cancer (NICE clinical guideline 27), ‘unexplained’ is
defined as ‘a symptom(s) and/or sign(s) that has not led to a diagnosis being made by the
primary care professional after initial assessment of the history, examination and primary care
investigations (if any)’. (Please note that an update is in progress; publication expected May
2015. For more information, see http://guidance.nice.org.uk/CG/Wave0/618.)
2 Research recommendations
The Guideline Development Group has made the following recommendations
for research, based on its review of evidence, to improve NICE guidance and
patient care in the future.
3 Other information
The methods and processes for developing NICE clinical guidelines are
described in The guidelines manual.
Published
General
Condition-specific
Under development
NICE is developing the following guidance (details available from the NICE
website):
Peter Barry
Chair, Consultant in Paediatric Intensive Care, Leicester Royal Infirmary
Hugh Barr
Consultant General and Upper Gastrointestinal Surgeon, Gloucestershire
Royal Hospital
John de Caestecker
Consultant Gastroenterologist, University Hospitals of Leicester
Mark Follows
Freelance GP, Yorkshire
Alex Ford
Consultant Gastroenterologist, Leeds Teaching Hospitals NHS Trust
Janusz Jankowski
Consultant Gastroenterologist, Leicester Royal Infirmary
Ann Harding
Patient and carer member
Mimi McCord
Patient and carer member
Marco Novelli
Consultant Histopathology, University College Hospitals NHS Trust
Mark Baker
Clinical Adviser (until March 2012)
Emma Banks
Project Manager
Steven Barnes
Technical Analyst (until December 2012)
Jenny Craven
Information Specialist (from January 2013)
Susan Ellerby
Clinical Adviser (from October 2012)
Nicole Elliott
Associate Director
Ruth Garnett
Medicines Evidence Senior Adviser
Kathryn Harrisson
Technical Analyst
Michael Heath
Programme Manager
Rachel Houten
Health Economist (from April 2013)
Emma McFarlane
Technical Analyst
Gabriel Rogers
Technical Adviser (Health Economist)
Claire Stevens
Medicines Evaluation Scientist
Lisa Stone
Medicines Evidence Senior Adviser
Toni Tan
Technical Adviser
Jonathan Underhill
Medicines Evidence Associate Director
Thomas Wilkinson
Health Economist (until February 2013)
Martin Allaby
Clinical Adviser
Ben Doak
Guideline Commissioning Manager
Joy Carvill
Guideline Coordinator
Beth Shaw
Technical Lead
Jasdeep Hayre
Technical Lead (Health Economics)
Sarah Palombella
Editor
During the update of this guideline (2014), the GDG have further defined the
PPI doses specifically for severe oesophagitis and H pylori eradication
therapy, in tables 2 and 3 below.
Table 2 PPI doses for severe oesophagitis in this guideline update (2014)
PPI Full/standard dose Low dose High/double dose
(on-demand dose)
Esomeprazole (40 mg1 once a day) (20 mg1once a day) (40 mg1 twice a day)
Lansoprazole 30 mg once a day 15 mg once a day 30 mg2 twice a day
Omeprazole (40 mg1 once a day) (20 mg1 once a day) (40 mg1 twice a day)
Pantoprazole 40 mg once a day 20 mg once a day 40 mg2 twice a day
Rabeprazole 20 mg once a day 10 mg once a day 20 mg2 twice a day
1
Change from the 2004 dose, specifically for severe oesophagitis, agreed by the GDG
during the update of CG17.
2
Off-label dose for GORD.
Recommendations to be deleted
The table shows recommendations from 2004 that NICE proposes deleting in
the 2014 update. The right-hand column gives the replacement
recommendation, or explains the reason for the deletion if there is no
replacement recommendation
1.5.3 Offer simple lifestyle advice, This recommendation has been deleted
including healthy eating, weight reduction as it is a duplicate of recommendation
and smoking cessation. 1.2.2.
1.5.4 Advise patients to avoid known This recommendation has been deleted
precipitants they associate with their as it is a duplicate of recommendation
dyspepsia where possible. These include 1.2.3.
smoking, alcohol, coffee, chocolate, fatty
foods and being overweight. Raising the
head of the bed and having a main meal
well before going to bed may help some
people.
1.6.6 Surgery cannot be recommended Replaced by:
for the routine management of persistent 1.11.1 Consider referral to a specialist
GORD although individual patients service for people:
whose quality of life remains significantly
of any age with gastro-oesophageal
impaired may value this form of
symptoms that are persistent, non-
treatment.
responsive to treatment or
unexplained1
with suspected GORD who are
thinking about surgery
with H pylori and persistent
symptoms that have not responded to
second-line eradication therapy. [new
2014]
1
In Referral guidelines for suspected cancer
(NICE clinical guideline 27), ‘unexplained’ is
defined as ‘a symptom(s) and/or sign(s) that has
not led to a diagnosis being made by the primary
care professional after initial assessment of the
history, examination and primary care
investigations (if any)’. (Please note that an update
is in progress; publication expected May 2015. For
more information, see
http://guidance.nice.org.uk/CG/Wave0/618).
1.9.4 For patients who test positive, Replaced by:
provide a 7-day, twice-daily course of 1.9.4 Offer people who test positive for
treatment consisting of a full-dose PPI, H pylori a 7-day, twice-daily course of
with either metronidazole 400 mg and treatment with:
clarithromycin 250 mg or amoxicillin 1 g
a PPI (see table 3 in appendix A) and
and clarithromycin 500 mg.
amoxicillin and
either clarithromycin or
metronidazole.
endoscopy and
retesting, however
just retesting for H
pylori was necessary
for people with
duodenal ulcers.