Fuling Sini decoction for patients with chronic heart failure: A protocol for a systematic review and meta-analysis.

Background: Chronic heart failure (CHF) is one of the most important cardiovascular diseases worldly, with high morbidity and mortality. Fuling Sini decoction (FSD) has been used in the management of CHF widely in China, while its effective evidence is not clear. A systematic review and meta-analysis to evaluate FSD for CHF is lacking. Hence, we propose a protocol for systematic evaluation of its efficacy and safety for CHF.

Methods: We will search the following electronic databases from inception to October 2018, including EMBASE, Cochrane Center Registration Controlled trials (Cochrane Library), PubMed, Medline, WHO International Clinical Trials Registry Platform, China Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wan-fang database. Only randomized controlled trials (RCTs) of FSD alone or combined with other management for CHF will be included. Two independent reviewers will screen the literature and extract data according to the Cochrane Handbook method. The assessment of bias risk, data synthesis, subgroup analysis, and meta-analyses and finally meta-analysis will be performed by using RevMan V.5.3.5 software.

Results: This systematic review will provide high-quality evidence and may be the first to evaluate efficacy and safety of FSD in the treatment of CHF.

Conclusion: This systematic review will provide evidence for judging whether FSD is an effective management for CHF or not.

Prospero Registration Number: CRD 42018110210.