Colon to Rectum
Gut. 2024;73(3):459–69
Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: A randomized, double-blind, placebo-controlled trial
Objective: The authors evaluated the histamine 1 receptor antagonist ebastine as a potential treatment for patients with non-constipated irritable bowel syndrome (IBS) in a randomized, 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% versus baseline. The primary end points 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 end point) 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: This study shows that ebastine is superior to placebo and should be further evaluated as novel treatment for patients with non-constipated irritable bowel syndrome.