LAUSR

Abstract Background: Diabetes mellitus (DM) is one of the main health problems that perplex people all over the world. The prevalence of DM is still increasing in spite of the great efforts have been made to control DM in recent years. Type 2 diabetes mellitus (T2DM) is the most common type of diabetes, accounting for about 90% of all DM cases. Traditional Chinese medicine has been used on treatment of DM and diabetic complications in China for many years. Baihu Jia Renshen Decoction (BJRD) is one of the oldest classic prescriptions of traditional Chinese medicine that applied in the field of diabetes’ treatment. BJRD is proved to be effective after years of clinical practice and basic research. The application of BJRD improves the overall clinical efficacy of T2DM. Therefore, a systematic review is necessary to provide available evidence for BJRD in therapy of T2DM. Methods: Different studies from various databases will be involved in this study. Only randomized controlled trials of T2DM patients diagnosed with World Health Organization 1999 diagnostic criteria will be included. We will search the literature in the databases from China Conference Paper Database, manual searching. Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, CNKI (China National Knowledge Internet), WanFang, VIP (Chongqing VIP), and CBM (China Biomedical Literature CDROM Database). The primary outcomes include 2 hour plasma glucose, fasting plasma glucose, hemoglobin A1c, homeostasis model assessment of insulin resistance, and fasting plasma insulin. The secondary outcomes include clinical efficacy and adverse events. 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: This study will synthesize and provide high-quality evidence based on the data of the currently published BJRD for the treatment of T2DM, in terms of 2 hour plasma glucose, fasting plasma glucose, hemoglobin A1c, homeostasis model assessment of insulin resistance and fasting plasma insulin, clinical efficacy, and safety. Conclusion: This systematic review aims to evaluate the benefits and harms of BJRD for the treatment of T2DM reported in randomized controlled trials, and provide more options for clinicians and patients to treat T2DM. Registration number: INPLASY202040006.