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Serotonin receptor modulation in irritable bowel syndrome: one step forwards and one step backwards.
Camilleri M, Northcutt AR, Kong S, et al. Efficacy and safety of alosetron in women with irritable bowel syndrome a randomised, placebo-controlled trial. Lancer 2000;355: 1035-40.
Question
Does alosetron, 5-[HT.sub.3], receptor antagonist, reduce symptoms in women with diarrhoea due to irritable bowel syndrome?
Design
Randomised, double blind controlled trial of 12 weeks' treatment.
Setting
One hundred nineteen sites in the USA consisting of outpatient clinics and clinical research centres.
Patients
A total of 647 of 1463 women screened, aged over 18 years, with at least six months of symptoms that fulfilled the Rome criteria for irritable bowel syndrome (IBS). Patients were classified as diarrhoea predominant or constipation predominant if one or the other was present for at least 75% of the time of active symptoms, and the remainder were classed as alternating IBS. Constipation predominant patients were excluded.
Intervention
After a two week screening period, patients were randomly allocated to 1 mg of alosetron or placebo to be taken orally twice daily before meals for 12 weeks followed by four weeks of post-treatment follow up. Patients were seen monthly by…
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