Octatropine methyl bromide and diazepam combination (Valpinax) in patients with irritable bowel syndrome: a multicentre, randomized, placebo-controlled trial.
OBJECTIVE
To investigate the efficacy and tolerability of octatropine methyl bromide plus diazepam (Valpinax) in patients with irritable bowel syndrome (IBS).


METHODS
We conducted a randomized, double-blind, multicentre study in 186 patients aged 18-65 years with IBS diagnosed according to Rome II criteria. Following a 2-week washout period, patients received octatropine plus diazepam 40 mg/2.5 mg twice daily or placebo for 6 weeks. The primary efficacy endpoint was response to a weekly question: "did you have satisfactory relief of your abdominal pain and discomfort during the last week?" Other endpoints included abdominal swelling, abdominal pain and discomfort, symptom severity, and the number of bowel movements. A prespecified subgroup analysis was conducted in patients with an abdominal pain and discomfort score > or = 3.


RESULTS
The primary efficacy endpoint showed a tendency towards a statistically significant benefit for octatropine plus diazepam over placebo among patients with a baseline abdominal pain and discomfort score of > or = 3 (3 vs. 0 patients; p = 0.059). Octatropine plus diazepam demonstrated significant improvements from baseline in all parameters assessed, but not compared with placebo. Adverse events were reported in 15.1% of patients receiving octatropine plus diazepam.


CONCLUSIONS
Patients with IBS and an abdominal pain and discomfort score of > or = 3, who may be considered in the active phase of the disease, may derive some benefits from octatropine plus diazepam. This study highlights that Rome II criteria should be considered with particular care in the design of a clinical trial, since it does not consider disease activity level on admission.
Pace
F
F
lnstitute of Gastroenterology, School of Medicine, "Luigi Sacco" Hospital, University of Milan, Italy. fabio.pace@unimi.it
Maurano
A
A
Ciacci
C
C
Savarino
V
V
Attili
A
A
Iaquinto
G
G
Magni
E
E
Porro
G Bianchi
GB
D015746:Abdominal Pain / Q000188:drug therapy / Q000209:etiology; D000293:Adolescent; D000328:Adult; D000368:Aged; D003672:Defecation / Q000187:drug effects; D003975:Diazepam / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D007558:Italy; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014326:Tropanes / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D004338:Drug Combinations; D005765:Gastrointestinal Agents; D014326:Tropanes; C009642:valpinax; D003975:Diazepam