Effect of large dosage of Fuling on urinary protein of diabetic nephropathy: A protocol of systematic review and meta-analysis of randomized clinical trials

INTRODUCTION: Diabetic nephropathy (DN) is one of the most common and serious microvascular complications in patients with diabetes, which seriously affects their life quality and survival time. large dose herb Fuling or compound prescription contain large dose Fuling for treatment of DN 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 Fuling 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 WangFang, VIP medicine information, and China National Knowledge Infrastructure (CNKI). Primary outcomes:24-hurinary-albumin, Urinary albumin-to-creatinine ratio. Additional outcomes: Serum creatinine, Blood urea nitrogen, Glomerular filtration rate, Endogenous creatinine clearance rate. 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 Fuling intervention for people with DN. CONCLUSION: The systematic review of this study will summarize the current published evidence of large dose Fuling for the treatment of DN, 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: August 24, 2020. osf.io/ym2c6. (https://osf.io/ym2c6).