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

F. Cremonini, S. Delgado-Aros, Michael Camilleri

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184 Scopus citations


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 percent 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.

Original languageEnglish (US)
Pages (from-to)79-86
Number of pages8
JournalNeurogastroenterology and Motility
Issue number1
StatePublished - Feb 2003


  • 5-HT antagonists
  • Alosetron
  • Irritable bowel syndrome
  • Meta-analysis
  • Serotonin

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology


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