Alosetron relieves pain and improves bowel function compared with mebeverine in female nonconstipated irritable bowel syndrome patients

Aliment Pharmacol Ther. 1999 Nov;13(11):1419-27. doi: 10.1046/j.1365-2036.1999.00678.x.


Background: Irritable bowel syndrome is one of the most common gastrointestinal disorders, yet no therapy convincingly controls the multiple symptoms of this syndrome.

Aim: To compare the efficacy and tolerability of the new 5-HT3-receptor antagonist alosetron and the smooth muscle relaxant mebeverine in a double-blind, multicentre, randomized trial.

Methods: Six hundred and twenty-three nonconstipated females with irritable bowel syndrome were randomized to receive alosetron 1 mg twice daily (n=319) or mebeverine 135 mg three times daily (n=304) for 12 weeks, followed by a 4-week post-treatment period. The primary efficacy end-point was monthly responders for adequate relief of irritable bowel syndrome related abdominal pain and discomfort (defined as patients reporting adequate relief on at least 2 out of 4 weeks). Secondary end-points included assessments of bowel function, including urgency, stool frequency and stool consistency.

Results: There were significantly more responders in the alosetron group compared with mebeverine at months 2 and 3 (P < 0.01). Compared with mebeverine, the alosetron group experienced significant decreases in proportion of days with urgency and mean stool frequency, and had firmer stools within 1 week of starting treatment. A similar proportion of patients reported adverse events in the two treatment groups.

Conclusions: In nonconstipated female irritable bowel syndrome patients, alosetron is significantly more effective than mebeverine in improving symptoms.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Carbolines / adverse effects
  • Carbolines / therapeutic use*
  • Colonic Diseases, Functional / complications
  • Colonic Diseases, Functional / drug therapy*
  • Colonic Diseases, Functional / physiopathology
  • Double-Blind Method
  • Female
  • Humans
  • Pain / drug therapy*
  • Pain / etiology
  • Pain / physiopathology
  • Parasympatholytics / adverse effects
  • Parasympatholytics / therapeutic use*
  • Phenethylamines / adverse effects
  • Phenethylamines / therapeutic use*
  • Serotonin Antagonists / adverse effects
  • Serotonin Antagonists / therapeutic use*


  • Carbolines
  • Parasympatholytics
  • Phenethylamines
  • Serotonin Antagonists
  • alosetron
  • mebeverine