The Study In Clinical Trial Design Of Traditional Chinese Medicine To Treat Chronic Heart Failure

Objective1.The study was aimed to definite defections in randomized controlled clinical trial design of traditional Chinese medicine to treat the chronic heart failure(CHF)based on system evaluation.And it provide reference for the design of Xinbaowan to treat the chronic heart failure.2.The study analyze the defections in clinical trial design of Xinbaowan to treat the chronic heart failure and evaluate it ’ s effectiveness and safety in the system evaluation.And it provide more targeted reference for the design of Xinbaowan to treat the chronic heart failure.3.A multicenter,randomized,placebo-controlled clinical trial of Xinbaowan in the treatment of chronic heart failure was designed on the basis of sufficient literature.In order to provide high quality clinical research evi dence for the treatment of chronic chronic heart failure Xinbaowanl through the scientific design and standardized implementation.Methods1.The study analyze some key links in the design of randomized controlled cl inical study on the treatment of CHF with the traditional Chinese medicine.It includes the selection of object in study,the specific intervention and course,the selection of the control drug,the outcome and the result evaluation and so on.Then we present suggestions and strategies for the design of the clinical study on the treatment of CHF with traditional Chinese medicine.2.The randomized control led trial s(RCT)about Xinbaowan in chronic CHF treatment published before Feb.28,2018 were retrieved,and qual i fi ed RCT were chosen according to inclusion and exclusion criteria.All included RCT documents were given risk reviewing by using Cochrane bias risk tool,and review index and sample volume were extracted from texts and tables by 2 independent reviewers in trial group and control group before and after treatment.The weighting average difference and 95%CI were analyzed by using RevMan 5.3 software.Result1.There 509 randomized controlled clinical trails of traditional Chinese medicine to treat CHF were collected and analyzed.Improper choice of control,improper blinding,non-scientific diagnostic criteria and improper efficacy and safety standards were existed in the RCT of TCM to treat CHF.Combined with the design of Xinbao pills to treat CHF,we make some discussions and present suggestions.2.There were totally 5 RCT included involved 591 cases.The result of Meta-analysis showed that Xinbaowan combining routine therapies could improve NYHA function class(OR:3.65,95%CI:2.16～6.16,P<0.00001),increase left ventricular ejection fraction(WMD=6.64,95%CI:2.32～10.96,P<0.01),improve exercise capacity(WMD=28.87,95%CI:13.01～44.73,P=0.0004),decrease LVEDd(WMD=-1.99,95%CI:-3.42～-0.56,P=0.006),decrease LVESd(WMD=-2.1 1,95%CI:-3.39～-0.83,P=0.001),increase SV(WMD=3.54,95%CI:1.86～5.23,P<0.0001).There was no significant difference between 2 groups of plasma brain natriuretic lecels and cardiac output.And there were no severe adverse events reported with all included RCT documents.3.The study is aimed to complete the design of a multicenter,randomized,placebo-controlled clinical study of Xinbaowan in the treatment of chronic heart failure.Conclusion1.The key links in the design of randomized controlled clinical study on the treatment of CHF with the traditional Chinese medicine are the selection of object in study,the specific intervention and course,the selection of the control drug,the outcome and the result evaluation.2.Because of the deficiencies in the design of the clinical study,the evidence for the effect and safety in the treatment of CHF with Xinbaowan need more high-quality multicenter,randomized,controlled clinical studies to be proved.3.On the basis of the comprehensive literature research,it is helpful to design and develop the clinical study more targeted and scientific,which definite the defections in the design of clinical study of TCM in the treatment of CHF.