| Objective: Diabetes Mellitus(DM)is a group of metabolic disease characterized by chronic hyperglycemia,which results from multiple causes.It is caused by the deficiency of insulin secretion and(or)action.At present,with the lack of exercise,unhealthy eating habits,changes in lifestyle,increased obese population and survival time of people with diabetes and other reasons,an increasing trend in prevalence of diabetes was observed.International Diabetes Association(IDF)released the latest Diabetes Atlas in December 2015.It showed that about 415 million adults have diabetes worldwide,and diabetic population in China reached 111 million.Currently,modern medical treatment of diabetes is not ideal,it can only delay the development of DM and its complications through various means.The traditional Chinese medicine has a mild and lasting effect.It also has fewer toxicity and adverse effects.Syndrome differentiation and treatment should be carried out under the guidance of holistic concept,and diabetes mellitus could be treated by multi-target and multi-channel.This article aims to assess the clinical effect and safety of Baihu Jia Renshen Decoction combined hypoglycemic western drug for the treatment of type 2 diabetes(T2DM),and provides an evidence-based basis for clinical trials.Methods : Medical literature retrieval was systematically performed in seven databases from their inception to January 1,2016 without limiting language published in the literature.The seven electronic databases were as followed: CNKI,VIP,CBM,Wanfang database,Pub Med,EMBASE and The Cochrane Library.All randomized or quasi-randomized controlled trials were about Baihu Jia Rensheng Decoction combined hypoglycemic western drug for the treatment of type 2 diabetes.Two reviewers independently collected data and assessed the quality of included studies based on the quality evaluation standard in the Cochrane Handbook 5.1.0(updated March 2011).Finally,cross-checking was performed.Review Manager 5.3 software was used to complete quantitative synthesis analysis,heterogeneity analysis,sensitivity analysis,publication bias test and other statistical analyses.Results: In this article,the intervention measures of experimental groups were Baihu Jia Renshen Decoction combined with hypoglycemic western medicine,and the intervention measures of control groups were hypoglycemic western medicine.The latter included metformin,glipizide,gliclazide,glyburide,rosiglitazone,and gliquidone.We conducted a meta analysis of seven outcomes,which included 2h postprandial glucose(2hPG),fasting blood glucose(FBG),hemoglobin A1c(HbA1c),homeostasis model assessment of insulin resistance(HOMA-IR),fasting insulin(FINS),the total clinical efficiency,and adverse reaction.Among them,the former 5 were the main outcome measures,and the latter 2 were secondary outcome measures.This study included twelve randomized or quasi-randomized controlled trials,involving 881 patients with T2 DM.Meta analysis results showed that:1.Compared with hypoglycemic western medicine alone,Baihu Jia Renshen Decoction combined with hypoglycemic western medicine could reduce FBG,2hPG,HbA1 c of T2 DM patients more effectively(P?0.05);2.Compared with hypoglycemic western medicine alone,Baihu Jia Renshen Decoction combined with hypoglycemic western medicine could improve the total clinical efficiency of T2 DM patients more effectively(P?0.05);3.In terms of improving patient's FINS and HOMA-IR,Baihu Jia Renshen Decoction combined with hypoglycemic western medicine has therapeutic equivalence to hypoglycemic western medicine alone(P>0.05);4.Only two trials reported adverse events,whereas the other ten trials didn't provide information about adverse reactions.Conclusion: Baihu Jia Renshen Decoction is effective in improving the clinical symptoms and blood glucose of T2 DM patients,but the evidence is weak.Because of the low quality,small sample size,unclear randomization,no mention of blinding and allocation concealment,and the possibility of publication bias in the twelve studies,the reliability and authenticity of the systematic review results were decreased.Based on the available evidence,we cannot recommend Baihu Jia Renshen Decoction as the clinical routine drug to treat T2 DM.Therefore,in future clinical studies,we should carry out multi-center,randomized,double-blind and controlled trials about Baihu Jia Renshen Decoction to provide more basis for the treatment of T2DM. |
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