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 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.