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.
RCT Entities:
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.