Efficacy of alosetron in irritable bowel syndrome: a meta-analysis of randomized controlled trials

Neurogastroenterol Motil. 2003 Feb;15(1):79-86. doi: 10.1046/j.1365-2982.2003.00389.x.


The 5HT3 receptor antagonist alosetron has been tested in several trials on irritable bowel syndrome (IBS) patients. The aim of the present meta-analysis was to determine its effect on adequate relief of pain or global improvement of symptoms in IBS patients. Six large, multicentre, randomized, placebo-controlled trials fulfilled pre-set criteria for high quality and were included in the meta-analysis; 1762 patients were randomized to alosetron treatment and 1356 to placebo. Seventy-five per cent of the patients experienced diarrhoea-predominant IBS and 93% were females. The pooled odds ratio for adequate relief of pain or global symptoms improvement was 1.81 [95% confidence interval (CI) 1.57-2.10). The average number of patients needed to treat with alosetron for one patient to achieve improvement over placebo treatment was seven (95% CI 5.74-9.43). The present analysis shows that alosetron 1 mg b.i.d. positively impacts global symptoms, and pain and discomfort in non-constipated IBS female patients. One in four patients treated with alosetron may develop constipation. The efficacy of alosetron is unclear in male patients.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Carbolines / adverse effects
  • Carbolines / pharmacology*
  • Colonic Diseases, Functional / drug therapy*
  • Diarrhea / drug therapy
  • Female
  • Humans
  • Male
  • Randomized Controlled Trials as Topic
  • Serotonin Antagonists / adverse effects
  • Serotonin Antagonists / pharmacology*
  • Sex Factors
  • Treatment Outcome


  • Carbolines
  • Serotonin Antagonists
  • alosetron