Efficacy and safety of berberine in the treatment of type 2 diabetes with insulin resistance Protocol for a systematic review

Background: The incidence of diabetes mellitus (DM) is increasing year by year, and various complications can endanger the lives of patients. Type 2 diabetes mellitus (T2DM) accounts for more than 90% of DM, most of which is associated with insulin resistance (IR), and IR has been shown to be closely related to the onset of T2DM and the presence of DM complications. Berberine (BBR) has been shown to improve T2DM with IR in a number of ways. In this study, we aim to evaluate the efficacy and safety of BBR in the treatment of T2DM with IR to provide the newest evidence for clinical use. Methods and analysis: Literature research will be divided into 2 parts: electronic search and manual search. We will search PubMed, EMBASE, The Cochrane Library, the China National Knowledge Infrastructure, China Biology Medicine disc, the China Science and Technology Journal database, and the Wanfang database online. We will select the eligible studies published up to June 30, 2019. Dissertations, conference papers, ongoing trials, internal reports, etc., are searched by manual search methods. We use Homeostatic Model Assessment for IR (HOMA-IR) as the primary outcome of T2DM with IR, and we will also focus on the patient's blood glucose levels and all adverse reactions that occur during medication. Two reviewers will read the articles, extract the data information, and assess the risk of bias independently. Data analysis will use the software such as RevMan 5.3.5, ENDNOTE X7, and STATA 13.0. Results: This study will provide a high-quality synthesis of current evidence of BBR for T2DM with IR from several aspects including HOMA-IR, blood glucose levels, and adverse events. Conclusion: This systematic review will provide evidence to assess the efficacy and safety of BBR in the treatment of T2DM with IR. Ethics and dissemination: Because all of the data used in this systematic review has been published, ethical approval is not required. Trial registration number: PROSPERO CRD42019123225.