Clinical efficacy and safety of Chinese herbal medicine for the treatment of patients with early diabetic nephropathy: A protocol for systematic review and meta-analysis

BACKGROUND: Diabetic nephropathy (DN) is among the common and serious complications of diabetes and is also a major cause of end-stage kidney disease. Early DN is also called diabetic microalbumin period, the main treatment is in the control of blood sugar on the basis of kidney protection and urine lowering protein. There are few effective methods of western medicine treatment, and most of them are accompanied by adverse reactions. But some studies have shown that traditional Chinese medicine has achieved the curative effect and has certain superiority. However, there are few systematic reviews on the treatment of traditional Chinese herbal medicine for early DN currently. Therefore, this study conducted a systematic review of clinical efficacy and safety of Chinese herbal medicine for the treatment of patients with early DN, aim to comprehensively analyze the role of traditional Chinese herbal medicine in the treatment of early DN. METHODS AND ANALYSIS: The protocol of this systematic review and meta-analysis was registered on the INPLASY website (https://inplasy.com/inplasy-2020-4-0139/) and INPLASY registration number is INPLASY202040139. A systematic literature search will be conducted in 3 English database and 4 Chinese databases with a language limitation of English and Chinese. Search for clinical research literature on Chinese herbal medicine treatment of DN published in domestic and foreign biomedical journals. The time is limited from January 2010 to February 2020. We will investigate heterogeneity across studies and publication bias. To assess the risk of bias and quality of the included studies, we will use the Cochrane Collaboration's ROB tool. According to the relevant standards in the Cochrane Intervention System Evaluation Manual, it will be divided into low risk, high risk, and unclear. We will also use the RevMan 5.3 software and Stata 13.0 software for meta-analysis of the effectiveness and symptom scores of DN proteinuria. ETHICS AND DISSEMINATION: The ethical considerations are not required because the systematic review is based on published studies. The systematic review and meta-analysis will be published in a peer-reviewed Journal.