Mesalazine treatment for Irritable Bowel Syndrome – effects on bowel habits and specific gastrointestinal symptoms
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Background: There is accumulating evidence for low-grade intestinal inflammation in the pathogenesis of Irritable Bowel Syndrome (IBS), which led to studies of mesalazine for IBS. These previous studies indicated that a subgroup of patients may benefit from this treatment. Warranting further study to characterize these patients. Aims: This project investigated the effect of mesalazine treatment on individual IBSsymptoms as part of a randomised, double blind, placebo-controlled intervention trial of mesalazine treatment in patients with moderate to severe IBS. Methods: Participants received 2400 mg mesalazine or placebo for 8 weeks. Bowel movements and specific IBS symptoms were registered daily in a validated IBS diary during 2 weeks prior to treatment, and 2 weeks at end of treatment. Data from the 2 IBS diaries were compared in a between-group analysis and in a within-group analysis. The efficacy endpoints were improvement in bowel movements, stool form, abdominal pain, nausea, and bloating. Results: 45 participants were included in the analysis. In both the mesalazine group and the placebo group, there was a statistically significant reduction in abdominal pain and bloating on a within-group level. No significant changes were seen in the other endpoints, neither on a within-group level or in a between-group comparison. However, it is noteworthy that there was a larger numerical reduction of abdominal pain duration and bloating in the mesalazine group compared to the placebo group. Conclusions: In this project, there was no benefit from treatment with mesalazine compared to placebo regarding bowel habits and specific IBS symptoms. However, results indicate that the limited sample size included in the analysis may have masked potential positive treatment effects. Data from another 113 participants was available but could not be included in the analysis due to time restraints. A next step would therefore be an analysis of the entire study database.
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