Effect of Otilonium Bromide in the Treatment of Irritable Bowel Syndrome: A Meta-Analysis

Abstract

Introduction: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits in the absence of organic causes. Antispasmodics have been studied in the management of IBS. The aim of our study is to update previous overviews of placebo controlled randomized trials assessing the efficacy and tolerance of otilonium bromide in irritable bowel syndrome. Methods: A systematic search of PubMed/Medline, CINAHL, Scopus, Cochrane data base of systematic reviews, and clinical trials.gov registry was performed. Two independent reviewers systematically identified prospective randomized controlled trials (RCTs) that compared the effect of otilonium bromide versus placebo in adults with IBS. Studies had to report either a global assessment of cure or improvement in symptoms, or improvement in abdominal pain after treatment. Meta-analysis was performed using a fixed effect model to assess the primary outcome (global improvement of symptoms) and secondary outcomes (improvement in abdominal pain and frequency of adverse events). Review Manager 5.2 software program was utilized for statistical analysis. Results: Seven RCTs met the inclusion criteria. A total of 1,188 patients were included in the meta-analysis. The mean percentage of patients with global improvement was 39% in the placebo group (n=522) and 53% in the OB group (n=521), in favor of otilonium bromide with an odds ratio of 1.84 (95% CI: 1.42-2.40; p<0.01). The percentage of patients with improvement of abdominal pain was 47% in the placebo group (n=350) and 62% in the otilonium bromide group (n=354) with an odds ratio of 1.94 (95% CI: 1.42-2.63; p<0.01). There was no significant difference for adverse events. Conclusion: Otilonium bromide was superior to placebo in the management of IBS, without any significant adverse effects. Disclosure - Dr. Bechtold - Consultant: Nestle Nutrition Institute.