title: [Efficacy of compound digestive enzyme tablet for dyspeptic symptoms: a randomized double-blind parallel controlled multicenter clinical trial in China].
abstract: OBJECTIVE
  To explore the clinical efficacy and safety of compound digestive enzyme tablet in the treatment of dyspepsia.
  
  
  METHODS
  A randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter clinical trial was conducted for 203 dyspeptic patients from October 2011 to August 2012. And they were randomized into group A (experimental, n = 106) and group B (control, n = 97).Group A received 1 tablet of compound digestive enzyme tablet (Bearse) plus 2 analog capsules of compound digestive enzyme thrice daily. And group B had 2 capsules of compound digestive enzyme capsule (Dages) plus 1 analog tablet of compound digestive enzyme thrice daily. The total duration of drug treatment was 2 weeks. There were 3 follow-up visits (W0, W1, W2). The primary endpoint was the total effective rate of all dyspeptic symptoms.
  
  
  RESULTS
  The total efficacy rate of groups A and B were 80.2% (85/106) and 79.4% (77/97) (P > 0.05). The adverse effects were 1.9% (2/106) and 4.1% (4/97) in groups A and B (P > 0.05). The adverse effects were mild in both groups.
  
  
  CONCLUSIONS
  Compound digestive enzyme tablet and capsule are effective and safe for patients with dyspepsia. And compound digestive enzymes tablet is comparable to compound digestive enzyme capsule.
authors.affiliation: Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.
authors.forename: Yongdong
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Email: zhangst@ccmu.edu.cn.
authors.forename: Shutian
authors.initials: S
authors.lastname: Zhang
authors.forename: Zhonglin
authors.initials: Z
authors.lastname: Yu
authors.forename: Pengyan
authors.initials: P
authors.lastname: Xie
authors.forename: Jianyu
authors.initials: J
authors.lastname: Hao
authors.forename: Bangmao
authors.initials: B
authors.lastname: Wang
authors.forename: Lei
authors.initials: L
authors.lastname: Dong
authors.forename: Jiling
authors.initials: J
authors.lastname: Wang
authors.forename: Zitan
authors.initials: Z
authors.lastname: Feng
mesh_terms: D002214:Capsules; D002681:China; D004064:Digestive System; D004311:Double-Blind Method; D005765:Gastrointestinal Agents; D006801:Humans; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D002214:Capsules; D005765:Gastrointestinal Agents; D013607:Tablets