Efficacy and safety of Linggui Zhugan decoction in the treatment of chronic heart failure with Yang deficiency: A protocol for systematic review and meta-analysis

Abstract

Background: Chronic heart failure (CHF) is an advanced stage of various heart diseases and has become a major global health problem. In 2018, the Chinese guideline for the diagnosis and treatment of HF suggested adding traditional Chinese medicine (TCM) as an adjunct to the treatment of CHF, but also pointed out the need for more convincing clinical evidences. Linggui Zhugan decoction (LGZGD) is one of the widely used TCM for CHF treatment, especially for patients with Yang deficiency. Given that treatment based on syndrome differentiation is an important principle in TCM, we provide a protocol to systematically evaluate efficacy and safety of LGZGD for CHF with Yang deficiency.

Methods: We will search the following electronic databases from inception to April 30, 2021, including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Chinese National Knowledge Infrastructure, VIP Information Database, Chinese Biomedical Literature Database (CBM), and Wanfang Database. Randomized controlled trials (RCT) examining the LGZGD on CHF patients with Yang deficiency will be included. Study selection, data extraction and quality assessment will be conducted by 2 researchers, respectively. The primary outcome measures will be n-terminal brain natriuretic peptide and left ventricular ejection fraction. The risk of bias will be evaluated by the Cochrane Collaboration tool. We will use the fixed-effects model or random-effects model of RevMan V.5.3 based on the results of heterogeneity assessment. The evidence quality of results will be assessed by Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.

Results: It will provide the results about efficacy and safety of LGZGD in the treatment of CHF with Yang deficiency by various comprehensive assessments.

Conclusions: This study will provide reliable evidences about the efficacy and safety of LGZGD in the treatment of CHF with Yang deficiency.

Ethics and dissemination: Ethical approval is not necessary for this study because the data extracted does not involve any individual privacy. We plan to presented the results of this review in a peer-reviewed journal.

Prospero registration number: CRD 42019140797.