Efficacy of otilonium bromide in irritable bowel syndrome: a pooled analysis
| Title: | Efficacy of otilonium bromide in irritable bowel syndrome: a pooled analysis |
|---|---|
| Authors: | Pere Clavé, Jan Tack |
| Source: | Therapeutic Advances in Gastroenterology, Vol 10 (2017) |
| Publisher Information: | SAGE Publishing, 2017. |
| Publication Year: | 2017 |
| Collection: | LCC:Diseases of the digestive system. Gastroenterology |
| Subject Terms: | Diseases of the digestive system. Gastroenterology, RC799-869 |
| More Details: | Background: Otilonium bromide (OB) is a spasmolytic agent acting as an L-type calcium channel antagonist in intestinal and colonic smooth muscle cells (SMCs). We analyzed three independent clinical trials with homogeneous design on patients with irritable bowel syndrome (IBS). After 2 weeks receiving placebo, patients were randomized to receive OB (3 × 40 mg daily) or placebo for 15 weeks. We aimed to perform a pooled analysis of the data from these homogeneous clinical trials to evaluate the efficacy of OB treatment on symptoms and global response of patients. Methods: A total of 883 patients with IBS (69.8% women, mean age 46.2 years, 43.8% mixed type) were included, 442 treated with OB and 441 with placebo. The efficacy results from the three studies at weeks 5, 10 and 15 were pooled in an intention-to-treat (ITT) strategy, analyzed with a logistic regression model and described by forest plots. Results: Despite a placebo effect in all efficacy variables, a significant therapeutic effect of OB was observed at weeks 10 and 15 with reference to: (a) intensity and frequency of abdominal pain; (b) rate of responders as evaluated by patients (71.8% at week 10 and 77.2% at week 15); (c) severity of bloating; (d) rate of responders as evaluated by physicians (55% at week 10 and 63.9% at week 15). No significant OB effect was observed in stool frequency and consistency. Conclusions: OB is more effective than placebo in IBS treatment. Therapeutic benefits are significant after 10 weeks and are maximal after 15 weeks of treatment. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1756-283X 1756-2848 1756283X |
| Relation: | https://doaj.org/toc/1756-283X; https://doaj.org/toc/1756-2848 |
| DOI: | 10.1177/1756283X16681708 |
| Access URL: | https://doaj.org/article/c8661298665c43c0b905637e94d0e0f2 |
| Accession Number: | edsdoj.8661298665c43c0b905637e94d0e0f2 |
| Database: | Directory of Open Access Journals |
| ISSN: | 1756283X 17562848 |
|---|---|
| DOI: | 10.1177/1756283X16681708 |
| Published in: | Therapeutic Advances in Gastroenterology |
| Language: | English |