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The efficacy of Combizym in the treatment of Chinese patients with dyspepsia: a multicenter, randomized, placebo‐controlled and cross‐over study
Author(s) -
RAN Zhi Hua,
YUAN Yao Zong,
LI Zhao Shen,
WANG Ji Yao,
ZONG Chun Hua,
XIE Wei Fen,
ZHENG Ping,
CHEN Sheng Liang,
ZHAN Xian Bao,
CHEN Shi Yao,
XIAO Shu Dong
Publication year - 2009
Publication title -
journal of digestive diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 51
eISSN - 1751-2980
pISSN - 1751-2972
DOI - 10.1111/j.1751-2980.2008.00361.x
Subject(s) - medicine , placebo , gastroenterology , epigastric pain , abdominal distension , abdominal pain , diarrhea , adverse effect , meal , distension , randomized controlled trial , nausea , vomiting , alternative medicine , pathology
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.