A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia  

作　　者：Qing Su Sheng-Liang Chen Hua-Hong Wang Lie-Xin Liang Ning Dai Bin Lyu Jun Zhang Rong-Quan Wang Ya-Li Zhang Yue Yu Jin-Song Liu Xiao-Hua Hou 

机构地区：[1]Department of Gastroenterology, Wuhan Union Hospital of Huazhong University of Science and Technology, Wuhan, Hubei 430000, China [2]Department of Gastroenterology, Renji Hospital of Shanghai Jiaotong University School of Medicine, Shanghai 200127, China [3]Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China [4]Department of Gastroenterology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi 530021, China [5]Department of Gastroenterology, Sir Run Run Shaw Hospital, Zheliang University School of Medicine, Hangzhou, Zhejiang 310016, China [6]Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang 310006, China [7]Department of Gastroenterology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi 710004, China [8]Department of Gastroenterology, The Southwest Hospital of Third Military Medical University, Chongqing 400038, China [9]Department of Gastroenterology, The Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong 510515, China [10]Department of Gastroenterology, Anhui Provincial Hospital, Hefei, Anhui 230001, China

出　　处：《Chinese Medical Journal》2018年第13期1549-1556,共8页中华医学杂志（英文版）

摘　　要：Background： Functional dyspepsia （FD） is a common tipper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome （PDS）-predominant FD. Methods： The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by 〈50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared. Results： （1） The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group （38.82% vs. 8.75%, P 〈 0.001; 69.14% vs. 16.25%, P 〈 0.001＇ 77.65% vs. 21.25%, P 〈 0.001 ）. （2） The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. （3） The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. （4） The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. （5） Qi-Zhi-Wei-Tong granules did not have more adverse eflbcts than the placebo. Conclusion： Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo. Trial Registration： https：//clBackground： Functional dyspepsia （FD） is a common tipper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome （PDS）-predominant FD. Methods： The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by 〈50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared. Results： （1） The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group （38.82% vs. 8.75%, P 〈 0.001; 69.14% vs. 16.25%, P 〈 0.001＇ 77.65% vs. 21.25%, P 〈 0.001 ）. （2） The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. （3） The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. （4） The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. （5） Qi-Zhi-Wei-Tong granules did not have more adverse eflbcts than the placebo. Conclusion： Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo. Trial Registration： https：//cl

关 键 词：Clinical Trial Functional Dyspepsia Postprandial Distress Syndrome Qi-Zhi-Wei-Tong Granules 

分 类 号：R57[医药卫生—消化系统]