A Systematic Review Of Chinese Patent Medicine In The Treatment Of Hyperlipidemia With Phlegm And Blood Stasis Repression

Objective:To evaluate the clinical efficacy and safety of traditional Chinese patent medicine(TCM)in treating phlegm and blood stasis repressor hyperlipidemia,and to provide evidence based medicine basis for the clinical application of traditional Chinese patent medicine in the treatment of phlegm and stasis repressor hyperlipidemia.Methods:The clinical controlled trial registries were searched in China,Wanfang database,Weipu Web,Chinese biomedical literature database and so on.From December 2017 to December 2017,a randomized controlled trial was conducted to treat hyperlipidemia of phlegm and stasis repressor type with Chinese patent medicine.The treatment group was treated with hyperlipidemia of phlegm and stasis repressor syndrome,and the intervention measures of traditional Chinese patent medicine and other methods were used to treat hyperlipidemia of phlegm and stasis repressor syndrome.The control group was given placebo or drugs approved by FDA or CFDA.Design according to relevant standards The documents were selected and extracted independently,and then compared with each other.The inconsistency was decided by the third party.According to the Cochrane Review Handbook5.0 quality evaluation standard and method recommended by the International Alliance of Evidence-based Medicine(IEBM),a comprehensive evaluation of bias risk in randomized controlled trials was carried out using the Cochrane risk bias assessment tool for literature quality evaluation.By using the RevMan 5.3 software published by the International Evidence-Based Medicine(Cochrane)Cooperative Network,the Meta analysis of some outcome indicators was carried out to verify the results obtained.The forest map forest plotsand funnel plots were obtained.The continuous variables of the outcome index were divided into two groups:weighted mean difference(WMD)and relative relative risk(RRR)and 95%confidence confidence intervalency(CI)were used to indicate the therapeutic effect.Meta Analysis based on fixed effect Model and fixed effect Model When each study has clinical homogeneity but statistical heterogeneity,random effect model is used for Meta analysis.Results:1178 articles were retrieved,14 articles were included,9 kinds of related Chinese patent medicines were involved,and the quality of literature was relatively low.Only 2 of them mentioned random methods.Statistical outcome indicators:Statistical outcome indicators:Meta Analysis of continuous variables in TCM symptom integral、TC、TG、HDL-C、LDL-C,The results are TC(WMD:-0.27,95%CI:[-0.45,-0.08],I2=81%,P<0.00001)、TG(WMD:-0.33,95%CI:[-0.56,-0.09],I2=90%,P<0.00001)、HDL-C(WMD:0.11,95%CI:[0.02,0.21],I2=81%,P<0.00001)、LDL-C(WMD:-0.24,95%CI:[-0.55,0.08],I2=96%,P<0.00001)、TCM symptom integral((WMD:-2.77,95%CI:[-4.60,-0.94],I2=70%,P=0.02);The efficiency of TCM and Western medicine was analyzed by meta analysis of two-class variables,the results are:Efficiency of Western Medicine(RR:1.26,95%CI:[1.01,1.56],I2=90%,P=0.04)、effective rate of traditional Chinese medicine(RR:1.34,95%CI:[1.04,1.72],I2=70%,P=0.0002);Other specific TCM symptoms such as body obesity,head dizziness,chest tightness,prickly pain in the precordial area,numbness of limbs and too few adverse reactions were recorded only by descriptive analysis,not by meta analysis.The results of 4 Hedan tablets subgroup analysis were as follows:TC(WMD:-0.04,95%CI:[-0.23,0.16],I2=74%,P=0.009)、TG(WMD:-0.27,95%CI:[-0.43,0.11],I2=70%,P=0.02)、HDL-C(WMD:0.14,95%CI:[0.04,0.32],I2=83%,P=0.0004)、LDL-C(WMD:-0.07,95%CI:[-0.23,0.08],I2=90%,P<0.00001),the results showed that the heterogeneity was higher.The results showed that there was no significant difference between Hedan tablet and control group in the treatment of Hedan tablets.Theresults are:TC(WMD=0.15,95%CI:[-0.08,0.37],I2=0%,P=0.61)、TG(WMD=0.05,95%CI:[-0.16,0.25],I2=36%,P=0.21)、HLD-C(WMD=0.04,95%CI:[-0.04,-0.12],I2=0%,P=0.84)、LDL-C(WMD=0.14,95%CI:[-0.04,0.32],I2=33%,P=0.22).Conclusion:the treatment of phlegm and stasis repressor hyperlipidemia with traditional Chinese patent medicine may be effective in regulating blood lipids and improving TCM symptoms,but the quality of methodology is low because of the small sample size and low quality of methodology.This study maintains a conservative attitude towards this conclusion,and more high-quality large samples of RCTs are needed to confirm it in the future.