title: [Efficacy of fenoverine and trimebutine in the management of irritable bowel syndrome: multicenter randomized double-blind non-inferiority clinical study].
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Korea University College of Medicine, Seoul.
authors.forename: Seong Hee
authors.initials: SH
authors.lastname: Kang
authors.forename: Yoon Tae
authors.initials: YT
authors.lastname: Jeen
authors.forename: Ja Seol
authors.initials: JS
authors.lastname: Koo
authors.forename: Yang Seo
authors.initials: YS
authors.lastname: Koo
authors.forename: Kyoung Oh
authors.initials: KO
authors.lastname: Kim
authors.forename: You Sun
authors.initials: YS
authors.lastname: Kim
authors.forename: Seung Yeong
authors.initials: SY
authors.lastname: Kim
authors.forename: Jeong Seop
authors.initials: JS
authors.lastname: Moon
authors.forename: Jong Jae
authors.initials: JJ
authors.lastname: Park
authors.forename: Il Hyun
authors.initials: IH
authors.lastname: Baek
authors.forename: Sung Chul
authors.initials: SC
authors.lastname: Park
authors.forename: Sung Joon
authors.initials: SJ
authors.lastname: Lee
authors.forename: Jong Hun
authors.initials: JH
authors.lastname: Lee
authors.forename: Rok Seon
authors.initials: RS
authors.lastname: Choung
authors.forename: Suck Chei
authors.initials: SC
authors.lastname: Choi
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D000328:Adult; D003248:Constipation / Q000209:etiology; D003967:Diarrhea / Q000209:etiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010276:Parasympatholytics / Q000627:therapeutic use*; D010640:Phenothiazines / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014287:Trimebutine / Q000627:therapeutic use*; D010879:Piperazines
chemical_list: D010276:Parasympatholytics; D010640:Phenothiazines; D014287:Trimebutine; C048314:fenoverine; D010879:Piperazines