摘要Background:Functional dyspepsia (FD) is a common upper 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 effects than the placebo.Conclusion:Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo.