Large dosage Huangqin (Scutellaria) 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 with widespread concern in the world. It has the characteristics of high incidence rate and high disability rate, which seriously affects economic and social development. large dose herb Rhizoma Coptidis (Huanglian) and Scutellaria (Huangqin) or compound prescription contain large dose Huanglian 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 Coptidis and Scutellaria and provide effective evidence for further research. METHODS AND ANALYSIS: The following databases will be searched from their inception to June 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WanFang, VIP medicine information, and China National Knowledge Infrastructure. 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). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the effectiveness and safety of large dose Huanglian and Huangqin intervention for people with T2DM. CONCLUSION: The systematic review of this study will summarize the current published evidence of large dose Huanglian and Huangqin 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: July 21, 2020. osf.io/b6r3z. (https://osf.io/b6r3z)