title: Efficacy and tolerability of two oral hyoscine butylbromide formulations in Chinese patients with recurrent episodes of self-reported gastric or intestinal spasm-like pain.
abstract: OBJECTIVE
  To compare the efficacy and tolerability of oral hyoscine butylbromide tablets and capsules in Chinese patients with recurrent episodes of self-reported gastric or intestinal spasm-like pain and to show non-inferiority of both formulations.
  
  
  METHODS
  302 patients were entered into a randomized, double-blind, double-dummy, active-controlled 2-arm parallel group study. They were randomized to 3 days of treatment with hyoscine butylbromide tablets or capsules. In patient diaries the pain intensity was assessed on 10 cm visual analogue scales on Day 1 (0, 30, 60, 90, 120, and 180 minutes after first dose), Days 2, and 3 (maximum pain intensity once daily). Pain frequency, overall efficacy, and tolerability were assessed on verbal rating scales.
  
  
  RESULTS
  In the per-protocol dataset 281 patients were analyzed. The change from baseline after 180 minutes was 59% in both treatment groups; the adjusted means of pain intensity on Day 1 were reduced by -2.36 cm (tablets) and -2.31 cm (capsules). Pain intensity decreased within 30 minutes by approximately 20%. The decrease of the peak pain intensity was approximately 55% after 3 days in both treatment groups; the adjusted means after 3 days were reduced by -2.48 cm (tablets) and by -2.45 cm (capsules). Abdominal pain frequency decreased by 50% (tablets) and 42% (capsules). Both treatments were well tolerated. Drug-related adverse events were infrequent (3.5%). No serious adverse event occurred.
  
  
  CONCLUSIONS
  Hyoscine butylbromide is effective in the treatment of recurrent gastric or intestinal spasm-like pain and well tolerated. Non-inferiority of tablets and capsules was demonstrated.
authors.affiliation: Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai.
authors.forename: Z
authors.initials: Z
authors.lastname: Ge
authors.forename: Y
authors.initials: Y
authors.lastname: Yuan
authors.forename: S
authors.initials: S
authors.lastname: Zhang
authors.forename: X
authors.initials: X
authors.lastname: Hou
authors.forename: J
authors.initials: J
authors.lastname: Wang
authors.forename: J
authors.initials: J
authors.lastname: Cai
authors.forename: R
authors.initials: R
authors.lastname: Shi
authors.forename: Y
authors.initials: Y
authors.lastname: Li
authors.forename: B
authors.initials: B
authors.lastname: Wang
authors.forename: F
authors.initials: F
authors.lastname: Ji
authors.forename: E
authors.initials: E
authors.lastname: Richter
authors.forename: E
authors.initials: E
authors.lastname: Schaefer
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002086:Butylscopolammonium Bromide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002214:Capsules; D002681:China; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013035:Spasm / Q000188:drug therapy; D013607:Tablets; D013997:Time Factors; D055815:Young Adult
chemical_list: D002214:Capsules; D018727:Muscarinic Antagonists; D013607:Tablets; D002086:Butylscopolammonium Bromide