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Minesapride = placebo to reduce constipation in patients with irritable bowel syndrome with predominant constipation
Clinical Question
Is minesapride more effective than placebo to increase spontaneous bowel movements in patients with irritable bowel syndrome with predominant constipation?
Bottom line
Minesapride, an investigational treatment for irritable bowel syndrome with predominant constipation (IBS-C), is no more effective than placebo in affecting the composite outcome of reducing abdominal pain and increasing spontaneous bowel movements in patients with severe symptoms. 1b-
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (specialty)
Synopsis
These investigators enrolled 411 patients (86% women) with a history of severe IBS-C (Rome IV) with an average daily abdominal pain score of 5.6 out of a possible 10, an average of less than 3 spontaneous bowel movements per week, and an average of 0.34 complete spontaneous bowel movements per week. After 2 weeks of placebo treatment to establish a baseline, the patients were randomized, allocation concealment uncertain, to receive placebo or minesapride 10 mg, 20 mg, or 40 mg daily for 3 months. The primary endpoint—an increase in one or more complete spontaneous bowel movements plus an improvement of 30% or more from baseline in the weekly average worst abdominal pain score—was not different with treatment or placebo after 6 or 12 weeks of treatment (13.6% - 19.2%), regardless of dose. More than 94% of patients completed the study. Analysis was by modified intention to treat.
Reviewer
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA
Comments
minesapride
a patient of mine with IBS/constipation, sought out this preparation while in USA, and found irritating diarrhoea, with no relief of the pain. Our trial of 1 indicates failure. I suppose in the target endpoint, he would be a success, as his bowel movements were increased, but his conclusion: he would not tolerate again.
IBS
The treatment involves things other than medications