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QUESTION: What is the effectiveness and safety of alosetron in women with irritable bowel syndrome (IBS)?
Randomised (allocation concealed*), blinded (clinicians, patients, outcome assessors, and statisticians),* placebo controlled trial for 12 weeks with 1 month follow up.
119 centres in the US.
647 women ≥18 years of age (mean age 46 y, 93% white) who had IBS for ≥6 months, had normal colonic anatomy, were diarrhoea predominant or had alternating bowel patterns (diarrhoea and constipation), had a mean daily abdominal pain and discomfort score between 1.0 and 3.3 on a 5 point scale (0=none to 4=severe), and a mean daily stool consistency score ≥2.5 on a 5 point scale (1=very hard to 5=watery). Exclusion criteria were constipation predominant IBS; pregnancy, breast feeding, or potential for childbearing; unstable medical or other gastrointestinal disorder; major psychiatric disorder; substance abuse in the previous 2 years; abnormal aspartate aminotransferase, alanine aminotransferase, or serum creatinine concentrations; hyperthyroidism or hypothyroidism; non-skin malignancy in the previous 5 years; investigational drug use 30 days before study; or use of …