A double-blind, randomized, placebo-controlled dose-ranging study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome
Article first published online: 24 DEC 2001
Alimentary Pharmacology & Therapeutics
Volume 14, Issue 1, pages 23–34, January 2000
How to Cite
Bardhan, Bodemar, Geldof, Schütz, Heath, Mills and Jacques (2000), A double-blind, randomized, placebo-controlled dose-ranging study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome. Alimentary Pharmacology & Therapeutics, 14: 23–34. doi: 10.1046/j.1365-2036.2000.00684.x
- Issue published online: 24 DEC 2001
- Article first published online: 24 DEC 2001
Irritable bowel syndrome is a common gastrointestinal disorder characterized by abdominal pain and discomfort and altered bowel habit. Antagonism at the 5-HT3 receptor may be of benefit in the treatment of irritable bowel syndrome.
To evaluate the effect of 12 weeks of treatment with alosetron, a 5-HT3 receptor antagonist at doses of 0.1 mg b.d., 0.5 mg b.d. and 2 mg b.d. in irritable bowel syndrome patients.
A double-blind, placebo-controlled, parallel-group study with a 2-week screening and a 12-week treatment period was conducted. A total of 462 patients (335 female) recorded details of the severity of their abdominal pain, and bowel function daily on a diary card throughout the study. At monthly clinic visits patients recorded the severity of their abdominal pain/discomfort and diarrhoea on a visual analogue scale.
In the total population and in the female subpopulation (but not in males) alosetron 2 mg b.d. significantly increased the proportion of pain-free days and decreased the visual analogue scale score for diarrhoea compared with placebo. Alosetron at doses of 0.5 mg b.d. and 2 mg b.d. led to a significant hardening of stool, and a reduction in stool frequency in the total population.
Alosetron at a dose of 2 mg b.d. is an effective treatment for female patients with irritable bowel syndrome.