Effectiveness and safety of Danshen injection on heart failure: Protocol for a systematic review and meta-analysis

BACKGROUND: Danshen injection (DSI) is a traditional Chinese medicine preparation extracted from Danshen (Salvia miltiorrhiza), which has the functions of promoting blood circulation and removing blood stasis. Heart failure (HF) is a complex cardiovascular disease, always leading to frequent onset and hospitalization, decreased quality of life, increased mortality, etc. Many clinical studies demonstrate that DSI has a good treatment on HF. We will provide a protocol to evaluate the effectiveness and safety of DSI for HF. METHODS: We will systematically search 3 English databases (PubMed, Excerpta Medica database [EMBASE], the Cochrane Central Register of Controlled Trials [Cochrane Library]) and 4 Chinese databases (Chinese National Knowledge Infrastructure [CNKI], Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database [CBM]) for randomised controlled trials (RCT) of DSI for HF. Left ventricular ejection fraction (LVEF), ejection fraction, left ventricular end diastolic dimension (LVEDD), and six-minute walk distance (SWD) will be set as the primary outcome measures. The secondary outcome measures will include NT-pro BNP, quality of life and adverse reaction. All data will be analysed by using Stata 14.0 software and TSA v0.9 software. We will use I(2) test statistics to assess the heterogeneity of included studies, and Begg's funnel plots and Egger's test to assess publication bias. Methodological quality will be assessed through a Cochrane risk of bias tool for randomized controlled trials (RCTs). RESULT: This study will provide a high quality evidence for DSI on HF. CONCLUSION: This protocol will provide a reliable evidence to evaluate the effectiveness and safety of DSI on HF. REGISTRATION: PROS-PERO CRD42019125274.