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

• Published in: Neurogastroenterology and motility Vol. 15; no. 1; pp. 79 - 86
• Main Authors: Cremonini, F., Delgado‐Aros, S., Camilleri, M.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.02.2003
• Subjects: 5‐HT3 antagonists; alosetron; Carbolines - adverse effects; Carbolines - pharmacology; Colonic Diseases, Functional - drug therapy; Diarrhea - drug therapy; Female; Humans; irritable bowel syndrome; Male; meta‐analysis; Randomized Controlled Trials as Topic; serotonin; Serotonin Antagonists - adverse effects; Serotonin Antagonists - pharmacology; Sex Factors; Treatment Outcome
• ISSN: 1350-1925; 1365-2982
• 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.