Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: a randomised, double-blind, placebo-controlled trial.
Gut
; 73(3): 459-469, 2024 02 23.
Article
em En
| MEDLINE
| ID: mdl-38191268
ABSTRACT
OBJECTIVE:
We 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.METHODS:
Non-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.RESULTS:
202 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).CONCLUSIONS:
Our study shows that ebastine is superior to placebo and should be further evaluated as novel treatment for patients with non-constipated IBS. TRIAL REGISTRATION NUMBER The study protocol was approved by the local ethics committee of each study site (EudraCT number 2013-001199-39; ClinicalTrials.gov identifier NCT01908465).Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piperidinas
/
Síndrome do Intestino Irritável
Tipo de estudo:
Clinical_trials
/
Guideline
/
Prognostic_studies
Limite:
Female
/
Humans
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Male
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article