OTILONIUM BROMIDE IN IRRITABLE-BOWEL-SYNDROME - A DOUBLE-BLIND, PLACEBO-CONTROLLED, 15-WEEK STUDY

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.