Effect of Qirui Weishu Capsules on Chronic Superficial Gastritis with Erosion and Dampness-heat Stasis Syndrome:A Randomized,Double-blinded,Placebo-controlled Parallel Multi-center Trial
To evaluate the efficacy and safety of Qirui Weishu Capsules in the treatment of chronic superficial gastritis with erosion and dampness-heat stasis syndrome.Methods:A total of 231 patients with chronic superficial gastritis with erosion and dampness-heat stasis syndrome treated in the Jiangsu Province Hospital of Chinese Medicine,Gansu Provincial Hospital of Traditional Chinese Medicine,Hebei Provincial Hospital of Traditional Chinese Medicine,Affiliated Hospital of Changchun University of Chinese Medicine,and Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from October 2012 to March 2015 were enrolled and randomly divided into an observation group(Qirui Weishu Capsules),a control group(Sanjiu Weitai Capsules),and a placebo group(placebo).All patients were treated correspondingly 30 min before meals,4 capsules each time,two times a day for 28 days.The changes in symptoms and adverse reactions after treatment were observed.Results:The disappearance rate of epigastric pain in the observation group was higher than those in the control group and the placebo group(P<0.05).The recovery rate of gastric mucosal erosion in the observation group was higher than those in the control group and the placebo group(P<0.05).The cure rate and total effective rate in the experimental group were higher than those in the control group and the placebo group(P<0.05).The eradication rate of Helicobacter pylori in the observation group was higher than those in the control group and the placebo group,and the difference in the eradication rate between the observation group and the placebo group was statistically significant(P<0.01),but there was no statistical difference between the observation group and the control group(P>0.05).The incidence of adverse reactions in the observation group was 2.6%,while no adverse reactions were recorded in the control group,and the incidence of adverse reactions in the placebo group was 1.8%,with no significant difference between the three groups(P>0.05).Conclusion:Qirui Weishu Capsules show significant clinical efficacy and good safety in the treatment of chronic superficial gastritis with erosion and dampness-heat stasis syndrome.