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KMID : 0614620130620050278
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Korean Journal of Gastroenterology
2013 Volume.62 No. 5 p.278 ~ p.287
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Efficacy of Fenoverine and Trimebutine in the Management of Irritable Bowel Syndrome: Multicenter Randomized Double-blind Non-inferiority Clinical Study
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Kang Seong-Hee
Jeen Yoon-Tae
Koo Ja-Seol
Koo Yang-Suh
Kim Kyoung-Oh
Kim You-Sun
Kim Seung-Young
Moon Jeong-Seop
Park Jong-Jae
Baek Il-Hyun
Park Sung-Chul
Lee Seong-Joon
Lee Jong-Hoon
Choung Rok-Seon
Choi Suck-Chei
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Abstract
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Background/Aims: 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.
Methods: 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.
Results: 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.
Conclusions: Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability.
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KEYWORD
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Fenoverine, Trimebutine, Irritable bowel syndrome, Clinical study
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