title: The efficacy of Combizym in the treatment of Chinese patients with dyspepsia: a multicenter, randomized, placebo-controlled and cross-over study: Shanghai Combizym Clinical Cooperative Group.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of Combizym treatment in Chinese patients with dyspepsia.
  
  
  METHODS
  In this multicenter, randomized, placebo-controlled cross-over study, a total of 151 patients (76 men and 75 women, mean age: 44.67 +/- 6.46 years, range: 22-67 years) with dyspepsia whose symptoms were not relieved by placebos were recruited. They were randomly divided into group A (79 patients, 2 weeks of Combizym treatment, two tablets post-meal, t.i.d.; then 1 week of wash-out, followed by 2 weeks of placebo treatment, two tablets post-meal, t.i.d.) or group B (72 patients, 2 weeks of placebo treatment, two tablets post-meal, t.i.d. then one week of wash-out, followed by 2 weeks of Combizym treatment, 2 tablets post-meal, t.i.d.). The index of severity of the dyspepsia symptoms was evaluated before and after each treatment phase with Combizym or the placebo.
  
  
  RESULTS
  Compared with the placebo, 2 weeks of Combizym treatment decreased the severity index of dyspepsia symptoms significantly (27.64 +/- 1.77 to 9.72 +/- 1.33 vs 23.99 +/- 1.28 to 22.03 +/- 1.40, P < 0.01). The efficacy rates of Combizym and the placebo on dyspepsia were 89.63% and 21.68%, respectively (P < 0.01). According to the improvement of symptoms index, individual dyspepsia symptoms that could be attenuated by Combizym therapy were anepithymia, abdominal distension, belching, diarrhea, abdominal pain, epigastric burning. None of patients reported adverse events during the study.
  
  
  CONCLUSIONS
  Combizym treatment effectively ameliorates dyspepsia symptoms in Chinese patients, with satisfactory safety and compliance.
authors.affiliation: Department of Gastroenterology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Zhi Hua
authors.initials: ZH
authors.lastname: Ran
authors.forename: Yao Zong
authors.initials: YZ
authors.lastname: Yuan
authors.forename: Zhao Shen
authors.initials: ZS
authors.lastname: Li
authors.forename: Ji Yao
authors.initials: JY
authors.lastname: Wang
authors.forename: Chun Hua
authors.initials: CH
authors.lastname: Zong
authors.forename: Wei Fen
authors.initials: WF
authors.lastname: Xie
authors.forename: Ping
authors.initials: P
authors.lastname: Zheng
authors.forename: Sheng Liang
authors.initials: SL
authors.lastname: Chen
authors.forename: Xian Bao
authors.initials: XB
authors.lastname: Zhan
authors.forename: Shi Yao
authors.initials: SY
authors.lastname: Chen
authors.forename: Shu Dong
authors.initials: SD
authors.lastname: Xiao
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004338:Drug Combinations; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005656:Fungal Proteins / Q000627:therapeutic use*; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006026:Glycoside Hydrolases / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010194:Pancreatin / Q000627:therapeutic use*; D010447:Peptide Hydrolases / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D005656:Fungal Proteins; D005765:Gastrointestinal Agents; D010194:Pancreatin; C005335:Combizym; D006026:Glycoside Hydrolases; D010447:Peptide Hydrolases