title: Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine.
abstract: BACKGROUND
  The 5-HT(3) receptor antagonists are known to be effective for the treatment of diarrhea-predominant irritable bowel syndrome (IBS), but not widely used yet. The aim of this study was to compare the efficacy and safety of ramosetron, a 5-HT(3) receptor antagonist, and mebeverine in male patients with IBS with diarrhea (IBS-D).
  
  
  METHODS
  This study was performed in a multicenter, randomized, open-label design. Data of 343 male patients with IBS-D who were randomized to either a 4-week treatment of ramosetron 5μg once daily or a 4-week treatment of mebeverine 135 mg three times daily were analyzed by the intent-to-treat analysis. The primary efficacy parameter was the proportion of patients with adequate relief of IBS symptoms at the last week of treatment. The secondary endpoints were changes in each symptom score and the safety profiles.
  
  
  RESULTS
  The responder rates for global IBS symptoms, abdominal pain/discomfort and abnormal bowel habits in the ramosetron and mebeverine groups significantly increased during the treatment period. The severity scores of abdominal pain/discomfort and urgency, the stool form score, and the stool frequency in both treatment arms were significantly reduced, compared with the baselines. There were no significant differences in the responder rates (37%vs 38% on ITT analysis) and adverse event profiles between the ramosetron and mebeverine groups. Neither severe constipation nor ischemic colitis was reported by ramosetron-treated patients.
  
  
  CONCLUSIONS
  Ramosetron 5μg once daily is as effective as mebeverine three times daily in male patients with IBS-D.
authors.affiliation: Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.
authors.forename: K J
authors.initials: KJ
authors.lastname: Lee
authors.forename: N Y
authors.initials: NY
authors.lastname: Kim
authors.forename: J K
authors.initials: JK
authors.lastname: Kwon
authors.forename: K C
authors.initials: KC
authors.lastname: Huh
authors.forename: O Y
authors.initials: OY
authors.lastname: Lee
authors.forename: J S
authors.initials: JS
authors.lastname: Lee
authors.forename: S C
authors.initials: SC
authors.lastname: Choi
authors.forename: C I
authors.initials: CI
authors.lastname: Sohn
authors.forename: S J
authors.initials: SJ
authors.lastname: Myung
authors.forename: H J
authors.initials: HJ
authors.lastname: Park
authors.forename: M K
authors.initials: MK
authors.lastname: Choi
authors.forename: Y T
authors.initials: YT
authors.lastname: Bak
authors.forename: P L
authors.initials: PL
authors.lastname: Rhee
mesh_terms: D000293:Adolescent; D000328:Adult; D001562:Benzimidazoles / Q000627:therapeutic use*; D003967:Diarrhea / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010276:Parasympatholytics / Q000627:therapeutic use*; D010627:Phenethylamines / Q000627:therapeutic use*; D056910:Republic of Korea; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001562:Benzimidazoles; D010276:Parasympatholytics; D010627:Phenethylamines; D058831:Serotonin 5-HT3 Receptor Antagonists; C005096:mebeverine; C071315:ramosetron