Alverine citrate fails to relieve the symptoms of irritable bowel syndrome: results of a double-blind, randomized, placebo-controlled trial.
BACKGROUND
Alverine citrate has been used in the treatment of irritable bowel syndrome for many years.


OBJECTIVE
To compare the efficacy and safety of a new formulation of alverine citrate, a 120-mg capsule, with placebo given three times daily for 12 weeks.


METHODS
One hundred and seven patients with irritable bowel syndrome were entered into this three-centre, double-blind, randomized, placebo-controlled, parallel group trial. The primary end-point was relief of abdominal pain indicated by improvement in the scores for severity and frequency. Secondary efficacy variables included scores for other clinical symptoms and for overall well-being.


RESULTS
The severity and frequency of abdominal pain improved in 66% and 68% of patients treated with alverine citrate vs. 58% and 69% of the placebo group, but these differences were not significant. The mean percentage reduction in the scores for abdominal pain from baseline to the final assessment, although greater in the alverine citrate group (43.7%) compared with the placebo group (33.3%), was not statistically significant.


CONCLUSIONS
Alverine citrate is no better than placebo at relieving the symptoms of irritable bowel syndrome. Future trials should be designed to take into account the high and persistent placebo response seen in this condition.
Mitchell
S A
SA
Departments of Gastroenterology, Oxford Radcliffe Hospital, Oxford OX3 9DU, UK.
Mee
A S
AS
Smith
G D
GD
Palmer
K R
KR
Chapman
R W
RW
D000005:Abdomen; D015746:Abdominal Pain / Q000188:drug therapy / Q000209:etiology*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D003109:Colonic Diseases, Functional / Q000150:complications* / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011437:Propylamines / Q000494:pharmacology*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D011437:Propylamines; C010846:alverine