A double‐blind, randomized, placebo‐controlled dose‐ranging study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome

• Published in: Alimentary pharmacology & therapeutics 2000-01, Vol.14 (1), p.23-34
• Main Authors: Bardhan, Bodemar, Geldof, Schütz, Heath, Mills, Jacques
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Biological and medical sciences; Carbolines - administration & dosage; Carbolines - adverse effects; Carbolines - therapeutic use; Colonic Diseases, Functional - drug therapy; Digestive system; Double-Blind Method; Female; Humans; Male; Medical sciences; MEDICIN; MEDICINE; Middle Aged; Pain - etiology; Pain - prevention & control; Pain Measurement; Pharmacology. Drug treatments; Receptors, Serotonin - drug effects; Receptors, Serotonin, 5-HT3; Serotonin Antagonists - administration & dosage; Serotonin Antagonists - adverse effects; Serotonin Antagonists - therapeutic use; Sex Characteristics; Time Factors
• ISSN: 0269-2813; 1365-2036; 1365-2036
• DOI: 10.1046/j.1365-2036.2000.00684.x

Background: 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. Aims: 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. Methods: 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. Results: 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. Conclusion: Alosetron at a dose of 2 mg b.d. is an effective treatment for female patients with irritable bowel syndrome.