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International Journal of Medical and Biomedical Studies

Available Online at www.ijmbs.info
PubMed (National Library of Medicine ID: 101738825)
Index Copernicus Value 2018: 75.71
Original Research Article Volume 4, Issue 5; May: 2020; Page No. 131-132

DETERMINE THE EFFICACY AND SAFETY OF BETAHISTINE IN TREATING VERTIGO AMONG PATIENTS AT
TERTIARY CARE HOSPITAL.
Dr. Amit Kumar1, Dr. Satyendra Sharma2
1
Assistant Professor, Department of ENT, Nalanda Medical College and Hospital, Patna, Bihar, India
2
Associate Professor, Department of ENT, Nalanda Medical College and Hospital, Patna, Bihar, India.
Article Info: Received 08 April 2020; Accepted 25 May 2020
DOI: https://doi.org/10.32553/ijmbs.v4i5.1238
Corresponding author: Dr. Satyendra Sharma
Conflict of interest: No conflict of interest.
Abstract
Aim: to determine the efficacy and safety of betahistine in treating vertigo among patients at tertiary care hospital.
Materials and Methods: the present open label interventional study was conducted on 50 patients of confirmed peripheral
vertigo visited the department of ENT, Nalanda Medical College and Hospital, Patna, Bihar, India. Patients received 48mg
betahistine (16mg, TDS) for 21 days, and were followed up on day 0, 7 and 21. Safety and effectiveness were assessed
based on clinical response (scale for vestibular vertigo severity level and clinical response evaluation (SVVSLCRE).
Results: mean age of the study population was 42.16 years and majority of them were females. Betahistine was found to be
effective at 16mg TDS, given up to 21days, by demonstrating a significant reduction in vertigo severity (p<0.0001),
as assessed by changes in score of vestibular vertigo severity level and clinical response evaluation (SVVSLCRE) level.
Conclusions: Betahistine was found to be effective in controlling vertigo and easily tolerated in the study population with no
major adverse effect.
Keywords: Betahistine, Vertigo, Saftey, Nausea
other vertigo disorders of central and peripheral origin
Introduction
such as multiple sclerosis and motion sickness.vi,vii
Vertigo is one of the most common symptoms which
Betahistine has not been shown to be better than placebo
patients present to physicians. It has been estimated that
in many clinical studies.viii Hence, its clinical efficacy and
the annual prevalence of vertigo is 4.9% for the general
safety is still questionable. The present study was
population, and the lifetime prevalence of vertigo is ~ 20–
conceived with the aim to determine its efficacy and safety
30%.i,ii
in treating vertigo among patients at tertiary care hospital.
Vertigo is reported ~ 1.7-times more often by women than
Materials and Methods
by men, and visits to the doctor’s office because of vertigo
increase with age. Vertigo always reflects dysfunction at The present open label interventional study was conducted
some level of the vestibular system, and, according to the on patients visited the department of ENT, Nalanda
topographic origin of the disturbance, it may be classified Medical College and Hospital, Patna, Bihar, India.
as peripheral or central. iii
Inclusion Criteria:
The most common causes of vertigo are peripheral
1. Patients above 18 years of age of either sex
vestibular disorders, but central nervous system disorders
2. Patients diagnosed with vertigo
must be thoroughly assessed and excluded in each patient.
3. Those who give informed consent
Epidemiologic studies indicate peripheral causes of vertigo
are responsible for almost three-quarters of the Exclusion Criteria
vertiginous attacks experienced by patients, while one-
1. Patients who are medically unfit i.e. suffering from
quarter may be related to central or mixed causes.1-3
acute and chronic systemic illness
Betahistine is a histamine modulatory drug used for the 2. Patients already taking the drug understudy
treatment of vertigo and other disorders of vestibular 3. Patients who have not signed the informed consent
origin.iv It was first introduced for the symptomatic
The study protocol was reviewed by the Ethical Committee
treatment of vascular and vasomotor disorders such as
of the Hospital and granted ethical clearance. After
cluster headaches and vascular dementia.v Subsequently it
explaining the purpose and details of the study, a written
was used in Ménière's disease and has been explored in
informed consent was obtained.

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Sample selection Discussion

The sample size was calculated using a prior type of power The clinical efficacy of betahistine in the treatment of
analysis by G* Power Software Version 3.0.1.0 (Franz Faul, vertigo was evidenced in many studies where most of
Universitat Kiel, Germany). The minimum sample size was them were focused on subjective scales with vertigo
calculated, following these input conditions: power of 0.80 as the main symptom, and/or on questionnaires on
and P ≤ 0.05 and sample size arrived were 44 participants. self-evaluation of quality of life.ix
Final sample achieved was 50.
In the present study, betahistine was found to be effective
Methodology at 16mg TDS, given up to 21days, by demonstrating a
significant reduction in vertigo severity (p<0.0001),
After taking detailed history and recording demographic
as assessed by changes in score of vestibular vertigo
data and thorough clinical examination was carried out. All
severity level and clinical response evaluation (SVVSLCRE)
the eligible patients were advised to take 48 mg per day
level.
of oral betahistine (Vertin, Abbott India Ltd) 16mg three
times daily for 21 days. Similar results were obtained in multi-national,
observational review, where betahistine treatment was
Follow-up
given at a dose of 48mg/day, and a significant change in
x
All the patients were followed at Baseline- day-0, at day-7 vertigo severity was noted.
and day 21 following betahistine treatment to check its
A double-blind, multicentre and parallel-group
effectiveness using scale vestibular vertigo severity level
randomized study with 144 patients showed that
and clinical response evaluation (SVVSLCRE).
Betahistine had a significant effect on frequency,
Statistical Analysis intensity and duration of vertigo attacks.xi
The data was coded and entered into Microsoft Excel Present study reported few adverse effects like nausea
spreadsheet. Analysis was done using SPSS version 20 (IBM (6%) followed by headache of mild intensity (2%), dry
SPSS Statistics Inc., Chicago, Illinois, USA) Windows mouth (2%) and gastritis (2%) but no serious adverse
software program. The variables were assessed for effects were reported. This indicate the easily tolerable
normality using the Kolmogorov Smirnov test. Descriptive safety profile of betahistine at 16mg TDS. Similarly another
statistics included computation of percentages, means and study also reported no serious adverse effects.10 In another
standard deviations. Level of significance was set at study gastritis was reported in a patient receiving
p≤0.05. betahistine.xii Few more studies supported results of
current study that betahistine treatment has shown
Results
minimal side-effects and have a positive safety profile
xiii,xiv
Table 1: demographic profile of the study population in patients with vertigo.
Age (years) 42.16±6.61 Conclusion
Gender (M/F) 14 (28.0%) /36 (72.0%)
It can be concluded that betahistine therapy may be
BMI 26.21±2.01
considered for the treatment of acute peripheral
Table 2: mean change in score of vestibular vertigo vertigo in the Indian population. Betahistine was found to
severity level and clinical response evaluation over be effective in controlling vertigo and easily tolerated in
different time intervals the study population with no major adverse effect.
SVVSLCRE Day 0 Day 7 Day 21 References
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