Korean J Gastroenterol.  2013 Nov;62(5):278-287. 10.4166/kjg.2013.62.5.278.

Efficacy of Fenoverine and Trimebutine in the Management of Irritable Bowel Syndrome: Multicenter Randomized Double-blind Non-inferiority Clinical Study

• Kang SH
• Jeen YT
• Koo JS
• Koo YS
• Kim KO
• Kim YS
• Kim SY
• Moon JS
• Park JJ
• Baek IH
• Park SC
• Lee SJ
• Lee JH
• Choung RS
• Choi SC

• KMID: 1775735
• DOI: http://doi.org/10.4166/kjg.2013.62.5.278

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.

Keyword

Fenoverine; Trimebutine; Irritable bowel syndrome; Clinical study

MeSH Terms

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
Parasympatholytics
Phenothiazines
Trimebutine

Figure

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  Fig. 1. Flow chart of patient disposition.

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  Fig. 2. Comparison of symptoms at baseline, week 4, and week 8 (intention-to-treat analysis) between the fenoverine group and the trimebutine group. Bowel symptom scale (BSS) scores (by visual analogue scale [VAS]) are mean values. *p＜0.0001 for comparison among.

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