G. Battaglia et al., OTILONIUM BROMIDE IN IRRITABLE-BOWEL-SYNDROME - A DOUBLE-BLIND, PLACEBO-CONTROLLED, 15-WEEK STUDY, Alimentary pharmacology & therapeutics, 12(10), 1998, pp. 1003-1010
Aim: To evaluate the efficacy of otilonium bromide, a spasmolytic agen
t, in the treatment of irritable bowel syndrome using modern and valid
ated diagnostic criteria. Methods: Three hundred and seventy-eight pat
ients with irritable bowel syndrome were enrolled in the study. At ent
ry, endoscopy/barium enema, clinical examination and laboratory tests
were used to rule out organic diseases. After a 2-week placebo run-in,
325 patients were randomly assigned to receive either otilonium bromi
de 40 mg t.d.s. or placebo for 15 weeks. Abdominal pain, abdominal dis
tension and disturbed defecation were scored at the beginning of the s
tudy and every 5 weeks. A global determination of well-being by visual
analogue scale and the tenderness of the sigmoid colon were also scor
ed. Results: The reduction in the number of abdominal pain episodes wa
s significantly higher (P < 0.01) in otilonium bromide patients (55.3%
) than in those taking placebo (39.9%) as was the severity of abdomina
l distension (42.0% vs. 30.2%; P < 0.05). Bowel disturbance improved i
n both groups, but without any statistically significant difference. T
he visual analogue scale of well-being revealed a significant improvem
ent (P < 0.05) in patients taking otilonium bromide. The investigators
' global positive assessment was in favour of otilonium bromide (65.2%
) compared with placebo (49.6%) (P < 0.01). Conclusions: Otilonium bro
mide may represent an effective treatment for irritable bowel syndrome
because it reduces its predominant symptom (abdominal pain/discomfort
) more than placebo does.