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

Authors

  • F. Cremonini,

    1. Clinical Enteric Neuroscience, Translational & Epidemiological Research Program (CENTER), Mayo Clinic and Mayo Foundation, Rochester, MN, USA
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  • S. Delgado-Aros,

    1. Clinical Enteric Neuroscience, Translational & Epidemiological Research Program (CENTER), Mayo Clinic and Mayo Foundation, Rochester, MN, USA
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  • M. Camilleri

    1. Clinical Enteric Neuroscience, Translational & Epidemiological Research Program (CENTER), Mayo Clinic and Mayo Foundation, Rochester, MN, USA
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Address for correspondence
Michael Camilleri, MD, Mayo Clinic, Charlton 8-110, 200 First Street S.W., Rochester, MN 55905, USA. Tel.: + 1 507 266 2305; e-mail: camilleri.michael@mayo.edu

Abstract

Abstract 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.

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