Efficacy of Fenoverine and Trimebutine in the Management of Irritable Bowel Syndrome: Multicenter Randomized Double-blind Non-inferiority Clinical Study.
10.4166/kjg.2013.62.5.278
- Author:
Seong Hee KANG
1
;
Yoon Tae JEEN
;
Ja Seol KOO
;
Yang Seo KOO
;
Kyoung Oh KIM
;
You Sun KIM
;
Seung Yeong KIM
;
Jeong Seop MOON
;
Jong Jae PARK
;
Il Hyun BAEK
;
Sung Chul PARK
;
Sung Joon LEE
;
Jong Hun LEE
;
Rok Seon CHOUNG
;
Suck Chei CHOI
Author Information
1. Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. ytjeen@korea.ac.kr
- Publication Type:Original Article ; English Abstract ; Multicenter Study ; Randomized Controlled Trial
- Keywords:
Fenoverine;
Trimebutine;
Irritable bowel syndrome;
Clinical study
- MeSH:
Abdominal Pain/etiology;
Adult;
Constipation/etiology;
Diarrhea/etiology;
Double-Blind Method;
Drug Administration Schedule;
Female;
Humans;
Irritable Bowel Syndrome/complications/*drug therapy;
Male;
Middle Aged;
Parasympatholytics/*therapeutic use;
Phenothiazines/*therapeutic use;
Severity of Illness Index;
Treatment Outcome;
Trimebutine/*therapeutic use
- From:The Korean Journal of Gastroenterology
2013;62(5):278-287
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
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.
