title: Randomised clinical trial: otilonium bromide improves frequency of abdominal pain, severity of distention and time to relapse in patients with irritable bowel syndrome.
abstract: BACKGROUND
  Otilonium bromide (OB) is a spasmolytic agent that blocks L-Type Calcium channels in human colonic smooth muscle.
  
  
  OBJECTIVE
  To study the efficacy of OB in symptom control in irritable bowel syndrome (IBS).
  
  
  METHODS
  A total of 356 patients (46.16±19years, 71% female) with IBS participated in a double-blind, randomised, parallel placebo-controlled phase IV study. OB (40mg t.d.s.) or placebo was administered for 15weeks, and follow-up was extended 10 additional weeks.
  
  
  RESULTS
  Otilonium bromide (n=179) and placebo (n=177) groups had comparable demographics, symptom severity and IBS subtype. Both OB and placebo reduced abdominal pain and IBS symptoms. The effect of OB was significantly greater than placebo in the reduction of weekly frequency of episodes of abdominal pain at the end of treatment period (primary endpoint, -0.90±0.88 vs. -0.65±0.91, P=0.03), reduction of abdominal bloating (-1.2±1.2 vs. -0.9±1.1, P=0.02) and global efficacy by patient assessment (1.3±1.1 vs. 1.0±1.1, P=0.047). Intensity of abdominal pain, proportion of patient responders, safety and quality of life scores were similarly affected by OB and placebo. During follow-up, the therapeutic effect of OB remained greater than placebo in terms of withdrawal rate due to symptom relapse (10% vs. 27%, P=0.009), global efficacy of treatment and relapse-free probability (P=0.038).
  
  
  CONCLUSIONS
  This placebo-controlled double-blind study shows that otilonium bromide is safe, well tolerated and superior to placebo in reducing the frequency of abdominal pain, severity of abdominal bloating and protecting from symptom relapse in IBS. These results further confirm that patients with IBS can improve during and following treatment with otilonium bromide.
authors.affiliation: Department of Surgery, Hospital de Mataró, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Clavé
authors.forename: M
authors.initials: M
authors.lastname: Acalovschi
authors.forename: J K
authors.initials: JK
authors.lastname: Triantafillidis
authors.forename: Y P
authors.initials: YP
authors.lastname: Uspensky
authors.forename: C
authors.initials: C
authors.lastname: Kalayci
authors.forename: V
authors.initials: V
authors.lastname: Shee
authors.forename: J
authors.initials: J
authors.lastname: Tack
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy* / Q000503:physiopathology; D000328:Adult; D000368:Aged; D020746:Calcium Channels, L-Type / Q000627:therapeutic use*; D004108:Dilatation, Pathologic; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009130:Muscle, Smooth / Q000187:drug effects*; D000644:Quaternary Ammonium Compounds / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013223:Statistics as Topic; D011795:Surveys and Questionnaires; D013997:Time Factors
chemical_list: D020746:Calcium Channels, L-Type; D000644:Quaternary Ammonium Compounds; C013934:octylonium