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[Efficacy of fenoverine and trimebutine in the management of irritable bowel syndrome: multicenter randomized double-blind non-inferiority clinical study].

Authors
Kang S.H.Jeen Y.T.Koo J.S.Koo Y.S.Kim K.O.Kim Y.S.Kim S.Y.Moon J.S.Park J.J.Baek I.H.Park S.C.Lee S.J.Lee J.H.Choung R.S.Choi S.C.
Issue Date
2013
Keywords
Fenoverine; Trimebutine; Irritable bowel syndrome; Clinical study; 페노베린; 트리메뷰틴; 과민성 장 증후군; 임상시험
Citation
The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi, v.62, no.5, pp.278 - 287
Indexed
SCOPUS
KCI
Journal Title
The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi
Volume
62
Number
5
Start Page
278
End Page
287
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/11266
DOI
10.4166/kjg.2013.62.5.278
ISSN
1598-9992
Abstract
Antispasmodic agents have been used in the management of irritable bowel syndrome. However, systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome. Fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium. We compared fenoverine with trimebutine for the treatment of patients with IBS. A multicenter, randomized, double-blind, non-inferiority clinical study was conducted to compared fenoverine with trimebutine. Subjects were randomized to receive either fenoverine (100 mg three times a day) or trimebutine (150 mg three times a day) for 8 weeks. A total of 197 patients were analyzed by the intention-to-treat approach. The primary endpoint was the proportion of patients who had 30% reduction in abdominal pain or discomfort measured by bowel symptom scale (BSS) score at week 8 compared to the baseline. The secondary endpoints were changes of abdominal bloating, diarrhea, constipation, overall and total scores of BSS, and overall satisfaction. At week 8, fenoverine was shown to be non-inferior to trimebutine (treatment difference, 1.76%; 90% CI, -10.30-13.82; p=0.81); 69.23% (54 of 78 patients) of patients taking fenoverine and 67.47% (56 of 83 patients) of patients taking trimebutine showed 30% reduction in abdominal pain or discomfort compared to the baseline. There results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group. Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability.
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Park, Jong Jae
Guro Hospital (Department of Gastroenterology and Hepatology, Guro Hospital)
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