The efficacy and safety of traditional Chinese medicine's tonifying-kidney, strengthening-spleen, and invigorating-blood circulation (Bushen-Jianpi-Huoxue) principle for type 2 diabetes mellitus with osteoporosis: A protocol for systematic review and meta-analysis

BACKGROUND: Type 2 diabetes mellitus (T2D) and osteoporosis (OP) often coexist, and both are systemic metabolic diseases and seriously increase the risk of fragility fracture. However, there is no specific Western medicine for the treatment of T2D with OP (T2DOP). As reported in clinical and experimental studies, traditional Chinese medicine (TCM) based on principle of tonifying-kidney, strengthening-spleen, and invigorating blood circulation (Bushen-Jianpi-Huoxue) (BSJPHX) has significant efficacy against T2DOP. This protocol will be designed for a systematic review and meta-analysis to assess the efficacy and safety of TCM BSJPHX principle in the treatment of T2DOP. METHODS: All relevant randomized controlled trials (RCTs) related to TCM therapies conducted in BSJPHX principle for T2DOP will be searched in the 8 electronic databases: PubMed, Cochrane Library, Wed of Science, EMBASE, Chinese National Knowledge Infrastructure Database (CNKI), Chinese Biomedical Literatures Database (CBM), Chinese Scientific Journal Database (VIP), Wanfang Database, from inception to October 2020. The main outcomes will contain: fasting blood glucose (FPG), 2 hours postprandial blood glucose (2hPG), glycosylated hemoglobin (HbA1c), serum calcium, bone mineral density (BMD), TCM syndrome integral, and the additional outcomes will consist of visual analog scale (VAS), and adverse events. Two reviewers will independently carry out literature search, data selection and synthesis, and literature quality assessment. In case of any dispute, it will be settled by group discussion. Assessment of risk of bias, reporting bias, and data synthesis would be performed with Review Manager software (Rev-Man 5.3). RESULT: This study will collate and summarize the various current evidences of TCM BSJPHX principle for T2DOP. CONCLUSION: This study will offer convincing evidence for judging the efficacy and safety of TCM BSJPHX principle for T2DOP. PROSPERO REGISTRATION NUMBER: CRD42020218877.