Abstract | AIM: METHODS: Three hundred and seventy-eight patients with irritable bowel syndrome were enrolled in the study. At entry, 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 bromide 40 mg t.d.s. or placebo for 15 weeks. Abdominal pain, abdominal distension and disturbed defecation were scored at the beginning of the study and every 5 weeks. A global determination of well-being by visual analogue scale and the tenderness of the sigmoid colon were also scored. RESULTS: The reduction in the number of abdominal pain episodes was significantly higher (P < 0.01) in otilonium bromide patients (55.3%) than in those taking placebo (39.9%) as was the severity of abdominal distension (42.0%, vs. 30.2%; P < 0.05). Bowel disturbance improved in both groups. but without any statistically significant difference. The visual analogue scale of well-being revealed a significant improvement (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:
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Authors | G Battaglia, A M Morselli-Labate, E Camarri, A Francavilla, F De Marco, G Mastropaolo, R Naccarato |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 12
Issue 10
Pg. 1003-10
(Oct 1998)
ISSN: 0269-2813 [Print] England |
PMID | 9798806
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Parasympatholytics
- Placebos
- Quaternary Ammonium Compounds
- octylonium
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Topics |
- Colonic Diseases, Functional
(drug therapy)
- Double-Blind Method
- Female
- Health Status
- Humans
- Male
- Middle Aged
- Pain
(drug therapy)
- Parasympatholytics
(therapeutic use)
- Placebos
- Quaternary Ammonium Compounds
(adverse effects, therapeutic use)
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