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.
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.
Ran
Zhi Hua
ZH
Department of Gastroenterology, Shanghai Institute of Digestive Disease, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Yuan
Yao Zong
YZ
Li
Zhao Shen
ZS
Wang
Ji Yao
JY
Zong
Chun Hua
CH
Xie
Wei Fen
WF
Zheng
Ping
P
Chen
Sheng Liang
SL
Zhan
Xian Bao
XB
Chen
Shi Yao
SY
Xiao
Shu Dong
SD
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
D004338:Drug Combinations; D005656:Fungal Proteins; D005765:Gastrointestinal Agents; D010194:Pancreatin; C005335:Combizym; D006026:Glycoside Hydrolases; D010447:Peptide Hydrolases