Alosetron relieves pain and improves bowel function compared with mebeverine in female nonconstipated irritable bowel syndrome patients.
BACKGROUND
Irritable bowel syndrome is one of the most common gastrointestinal disorders, yet no therapy convincingly controls the multiple symptoms of this syndrome.


OBJECTIVE
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.
Jones
R H
RH
Department of General Practice, Guy's, King's and St Thomas' School of Medicine, London, UK.
Holtmann
G
G
Rodrigo
L
L
Ehsanullah
R S
RS
Crompton
P M
PM
Jacques
L A
LA
Mills
J G
JG
D000293:Adolescent; D000328:Adult; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D003109:Colonic Diseases, Functional / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D010146:Pain / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D010276:Parasympatholytics / Q000009:adverse effects / Q000627:therapeutic use*; D010627:Phenethylamines / Q000009:adverse effects / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000009:adverse effects / Q000627:therapeutic use*
D002243:Carbolines; D010276:Parasympatholytics; D010627:Phenethylamines; D012702:Serotonin Antagonists; C090840:alosetron; C005096:mebeverine