复方刺五加颗粒治疗失眠(心脾两虚证)有效性和安全性的多中心、随机、双盲双模拟、阳性药平行对照临床试验OA

To evaluate the safety and efficacy of Compound Ciwujia Granules in the treatment of insomnia(heart-spleen deficiency syndrome),a multicenter,randomized,double-blind,double-dummy,positive drug-controlled,parallel-group clinical trial was conducted.A total of 423 eligible patients were enrolled and randomly assigned in 1∶1 ratio to experimental group or control group using block randomization.The experimental group(n=212)received Compound Ciwujia Granules+placebo for Guipi Granules,while the control group(n=211)received Guipi Granules+placebo for Compound Ciwujia Granules.The treatment lasted for 4 weeks,with visits conducted at baseline and at weeks 2 and 4 of treatment.The primary efficacy outcomes were the change in PSQI scale scores after 4 weeks of treatment(reduction from baseline)and improvement rate of PSQI scale scores.The secondary efficacy outcomes were PSQI single factor scores,changes in sleep diary records,ISI scale scores,use of sedatives and hypnotics,and TCM syndrome scores.Regarding primary efficacy outcomes,after 4 weeks of treatment,the reduction in PSQI scale scores in the experimental group was greater than that in the control group(P<0.000 1),and the PSQI improvement rate was also superior to that of the control group(P<0.000 1).The least-squares mean difference in PSQI scale scores changes between the two groups(experimental group minus control group)and the corresponding 95%CI were-1.13[-1.63,-0.64]in FAS and-1.16[-1.65,-0.67]in PPS.As the upper limits of the confidence intervals were below 0,the efficacy of the experimental group was considered superior to that of the control group,and the superiority test was confirmed.Regarding secondary efficacy outcomes,after 4 weeks of treatment,PSQI single factor scores in the experimental group were significantly improved,and both the ISI scale scores and TCM syndrome scores were significantly reduced compared with those in the control group(P<0.05).No statistically significant differences were observed between the two groups in changes in sleep diary records the use of sedative-hypnotic drugs.In terms of safety,61 patients(83 events,28.77%)in the experimental group and 44 patients(82 events,21.05%)in the control group experienced adverse events.Adverse drug reactions occurred in 7 patients(8 events)in the experimental group and in 8 patients(12 events)in the control group.No serious adverse reactions were reported,and laboratory examinations revealed no abnormalities requiring special attention.These results indicate that Compound Ciwujia Granules administered for 4 weeks are effective and safe for the treatment of insomnia(heart-spleen deficiency syndrome).