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.

CONCLUSION:

Combizym treatment effectively ameliorates dyspepsia symptoms in Chinese patients, with satisfactory safety and compliance.

• Authors: Zhi Hua Ran, Yao Zong Yuan, Zhao Shen Li, Ji Yao Wang, Chun Hua Zong, Wei Fen Xie, Ping Zheng, Sheng Liang Chen, Xian Bao Zhan, Shi Yao Chen, Shu Dong Xiao
• Journal: Journal of digestive diseases (J Dig Dis) Vol. 10 Issue 1 Pg. 41-8 (Feb 2009) ISSN: 1751-2980 [Electronic] Australia
• PMID: 19236546 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Drug Combinations
• Fungal Proteins
• Gastrointestinal Agents
• Pancreatin
• Combizym
• Glycoside Hydrolases
• Peptide Hydrolases

Topics

• Adult
• Aged
• Cross-Over Studies
• Drug Combinations
• Dyspepsia (drug therapy)
• Female
• Fungal Proteins (therapeutic use)
• Gastrointestinal Agents (therapeutic use)
• Glycoside Hydrolases (therapeutic use)
• Humans
• Male
• Middle Aged
• Pancreatin (therapeutic use)
• Peptide Hydrolases (therapeutic use)
• Young Adult