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Otilonium bromide in irritable bowel syndrome: a double-blind, placebo-controlled, 15-week study.
Aliment Pharmacol Ther. 1998 Oct; 12(10):1003-10.AP

Abstract

AIM

To evaluate the efficacy of otilonium bromide, a spasmolytic agent, in the treatment of irritable bowel syndrome using modern and validated diagnostic criteria.

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

Otilonium bromide may represent an effective treatment for irritable bowel syndrome because it reduces its predominant symptom (abdominal pain/ discomfort) more than placebo does.

Authors+Show Affiliations

Unit of Gastroenterology, Hospital SS Giovanni e Paolo, Venice, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9798806

Citation

Battaglia, G, et al. "Otilonium Bromide in Irritable Bowel Syndrome: a Double-blind, Placebo-controlled, 15-week Study." Alimentary Pharmacology & Therapeutics, vol. 12, no. 10, 1998, pp. 1003-10.
Battaglia G, Morselli-Labate AM, Camarri E, et al. Otilonium bromide in irritable bowel syndrome: a double-blind, placebo-controlled, 15-week study. Aliment Pharmacol Ther. 1998;12(10):1003-10.
Battaglia, G., Morselli-Labate, A. M., Camarri, E., Francavilla, A., De Marco, F., Mastropaolo, G., & Naccarato, R. (1998). Otilonium bromide in irritable bowel syndrome: a double-blind, placebo-controlled, 15-week study. Alimentary Pharmacology & Therapeutics, 12(10), 1003-10.
Battaglia G, et al. Otilonium Bromide in Irritable Bowel Syndrome: a Double-blind, Placebo-controlled, 15-week Study. Aliment Pharmacol Ther. 1998;12(10):1003-10. PubMed PMID: 9798806.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Otilonium bromide in irritable bowel syndrome: a double-blind, placebo-controlled, 15-week study. AU - Battaglia,G, AU - Morselli-Labate,A M, AU - Camarri,E, AU - Francavilla,A, AU - De Marco,F, AU - Mastropaolo,G, AU - Naccarato,R, PY - 1998/11/3/pubmed PY - 1998/11/3/medline PY - 1998/11/3/entrez SP - 1003 EP - 10 JF - Alimentary pharmacology & therapeutics JO - Aliment Pharmacol Ther VL - 12 IS - 10 N2 - AIM: To evaluate the efficacy of otilonium bromide, a spasmolytic agent, in the treatment of irritable bowel syndrome using modern and validated diagnostic criteria. 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: Otilonium bromide may represent an effective treatment for irritable bowel syndrome because it reduces its predominant symptom (abdominal pain/ discomfort) more than placebo does. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/9798806/Otilonium_bromide_in_irritable_bowel_syndrome:_a_double_blind_placebo_controlled_15_week_study_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0269-2813&amp;date=1998&amp;volume=12&amp;issue=10&amp;spage=1003 DB - PRIME DP - Unbound Medicine ER -