Objective:To evaluate the clinical efficacy and safety of traditional Chinese patentmedicine(TCM)in treating Qi stagnation and blood stasis of hyperlipidemia,and to provide evidence based medicine basis for the clinical application of traditional Chinese patent medicine in the treatment of Qi stagnation and blood stasis of hyperlipidemia hyperlipidemia.Methods:Through a comprehensive search China hownet,a database of ten thousand,VIP,Chinese biomedical literature database,PubMeb,EMbase controlled clinical trial registry,find since establishing database library to February 2019 proprietary Chinese medicine in the treatment of qi and blood stasis type hyperlipidemia randomized controlled trials(randomized clinical trials,RCTs),and the treatment group of proprietary Chinese medicine or proprietary Chinese medicine with other methods of intervention measures.The control group received either a placebo or an FDA or cfda-approved drug.According to the relevant standards,the extraction table of literature materials was designed,and the two persons conducted literature screening and data extraction independently,and then compared with each other.The inconsistencies were determined by the intervention of a third party.According to the Cochrane Review Handbook5.0 quality assessment criteria and methods recommended by the international federation of evidence-based medicine,the Cochrane risk bias assessment tool was used to comprehensively evaluate the risk of bias in randomized controlled trials.Adopt international evidence-based medicine RevMan 5.3 software developed by Cochrane collaboration,Meta analysis was carried out on the part of the ending index,test results and make the Forest figure(Forest plots)and Funnel graph(good plots).The continuous variables in outcome indexes were weighted mean difference(WMD),and the binary variables were relative risk(RR)and 95%confidence interval(CI),respectively.In homogeneous studies,fixed effect model was used for Meta analysis.When the studies were of clinical homogeneity but with statistical heterogeneity,the random effect model was used for Meta analysis.Results:A total of 27,936 literatures were retrieved,including 9 qualified literatures,including 8 types of proprietary Chinese medicines.The overall literature quality was low,and only 5 literatures mentioned random methods.Statistical outcome indicators:TC,TG,HDL-C,LDL-C,TCM syndrome integral were used for meta analysis of continuous variables,and the results were TC(WMD:-0.05,95%CI:[-0.10,0.00],I2=97%,P<0.00001)?TG((WMD:-0.25,95%CI:[-0.30,-0.21],I2=97%,P<0.00001)?HDL-C((WMD:-0.01,95%CI:[-0.03,-0.01],I2=83%,P<0.00001)?LDL-C(WMD:-0.04,95%CI:[-0.08,-0.00],I2=97%,P<0.00001)?TCM syndrome integral(WMD:-0.65,95%CI:[-1.10,-0.20],I2=50%,P=0.06);A meta-analysis was performed on the blood lipid response rates of traditional Chinese medicine and western medicine,and the results were as follows:western medicine response rate(RR:1.20,95%ci:[1.13,1.28],I2=83%,P<0.00001),traditional Chinese medicine response rate(OR:5.31,95%ci:[2.17,13.04],I2=0%,P=0.55).Other TCM symptoms such as chest distension and tightness,walking pain,precordial tingling,upset and other adverse reactions were recorded too little,and only descriptive analysis was conducted.There are five research interventions for simvastatin tablets subgroup analysis,the results are:TC(WMD:0.17,95%CI:[0.10,0.23],I 2=91%,P<0.00001)?TG(WMD:0.16,95%CI:[0.08,0.24],I2=91%,P<0.00001)?HDL-C(WMD:-0.05,95%CI:[-0.07,-0.02],I2=85%,P<0.00001)?LDL-C(WMD:0.13,95%CI:[0.08,0.18],I2=95%,P<0.00001),Results still prompt heterogeneity;When subgroup analysis was performed on 3 papers with a course of 4 weeks,the heterogeneity of ldl-c and ldl-c was small.The results indicated that there was no significant difference in the treatment between the experimental group and the control group:TC(WMD=-0.06,95%CI:[-0.19,0.08],I2=70%,P=0.005)?TG(WMD=0.05,95%CI:[-0.15,0.26],I2=80%,P=0.0001)?HLD-C(WMD=0.02,95%CI:[-0.03,0.07],I2=10%,P=0.35)?LDL-C(WMD=-0.16,95%CI:[-0.36,0.04],I2=0%,P=0.97)?Conclusion:All of the 9 included clinical studies showed that Chinese patent medicine was effective in treating dyslipidemia of qi stagnation and blood stasis,which was comparable to western medicine in improving dyslipidemia.It had advantages in improving TCM syndromes of patients,with fewer side effects and higher safety.However,due to the small sample size,large heterogeneity and low methodological quality,the effectiveness of Chinese patent medicine in the treatment of hyperlipidemia with qi stagnation and blood stasis needs to be confirmed by more high-quality randomized controlled literatures in the future and by providing a larger sample size. |