Publication
Title
Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine : a randomised, double-blind, placebo-controlled trial
Author
Abstract
ObjectiveWe evaluated the histamine 1 receptor antagonist ebastine as a potential treatment for patients with non-constipated irritable bowel syndrome (IBS) in a randomised, placebo-controlled phase 2 study.MethodsNon-constipated patients with IBS fulfilling the Rome III criteria were randomly assigned to 20 mg ebastine or placebo for 12 weeks. Subjects scored global relief of symptoms (GRS) and abdominal pain intensity (API). A subject was considered a weekly responder for GRS if total or obvious relief was reported and a responder for API if the weekly average pain score was reduced by at least 30% vs baseline. The primary endpoints were the proportion of subjects who were weekly responders for at least 6 out of the 12 treatment weeks for both GRS and API ('GRS+API', composite endpoint) and for GRS and API separately.Results202 participants (32 +/- 11 years, 68% female) were randomly allocated to receive ebastine (n=101) or placebo (n=101). Treatment with ebastine resulted in significantly more responders (12%, 12/92) for GRS+API compared with placebo (4%, 4/87, p=0.047) while the proportion of responders for GRS and API separately was higher for ebastine compared with placebo, although not statistically significant (placebo vs ebastine, GRS: 7% (6/87) vs 15% (14/91), p=0.072; API: 25% (20/85) vs 37% (34/92), p=0.081).ConclusionsOur study shows that ebastine is superior to placebo and should be further evaluated as novel treatment for patients with non-constipated IBS.Trial registration numberThe study protocol was approved by the local ethics committee of each study site (EudraCT number: 2013-001199-39; ClinicalTrials.gov identifier: NCT01908465).
Language
English
Source (journal)
Gut : the journal of the British Society for Gastroenterology / British Society for Gastroenterology. - London, 1960, currens
Publication
London : Bmj publishing group , 2024
ISSN
0017-5749
DOI
10.1136/GUTJNL-2023-331634
Volume/pages
(2024) , p. 1-11
ISI
001142650100001
Pubmed ID
38191268
Full text (Publisher's DOI)
Full text (publisher's version - intranet only)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identifier
Creation 01.02.2024
Last edited 08.02.2024
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