Renshen (Panax ginseng) and Huanglian (Rhizoma Coptidis) For T2DM: A protocol of systematic review and meta-analysis of randomized clinical trials

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a metabolic disease characterized by high blood sugar caused by impaired insulin action. With an increasing incidence year by year, it has become a worldwide epidemic. Because of its serious, long-term condition, T2DM has a bad impact on the life and well-being of individuals, families and society. Renshen and Huanglian or compound prescription contain Renshen and Huanglian for treatment of T2DM has already been confirmed. However, due to the lack of evidence, there is no specific method or suggestion, so it is necessary to carry out systematic evaluation on Renshen and Huanglian and provide effective evidence for further research. METHODS AND ANALYSIS: We will search English databases (PubMed, Embase, Web of Science, Nature, Science on line, the Cochrane Library) and Chinese databases (CNKI, Wan Fang, VIP, Chinese biomedical database), from the establishment of database to October 2020, for randomized controlled trials (RCTs) of ginseng and coptis and the compound containing ginseng and coptis in the treatment of T2DM. Primary outcomes: fasting blood-glucose (FBG), 2 Hours Postprandial Blood Glucose (2hPBG), Glycosylated hemoglobin A1c (HbA1c). Additional outcomes: Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), triglycerides (TG), total serum cholesterol (TC). Two researchers independently extracted the data and evaluated the quality of the included research, and meta-analysis was conducted on the included data using the software of RevMan5.3 and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the effectiveness and safety of Renshen and Huanglian intervention for people with T2DM. CONCLUSION: The systematic review of this study will summarize the current published evidence of Renshen and Huanglian or compound prescription contain Renshen and Huanglian for the treatment of T2DM, which can further guide the promotion and application of it. ETHICS AND DISSEMINATION: This study is a systematic review; the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRAMEWORK (OSF) REGISTRATION NUMBER: October 18, 2020. osf.io/8gz7c (https://osf.io/8gz7c).