Efficacy and safety of traditional Chinese medicine yangxin anshen therapy for insomnia: A protocol of systematic review and meta-analysis

BACKGROUND: Traditional Chinese medicine (TCM) has gradually drawn the attention of clinicians as an alternative choice for insomniacs and TCM yangxin anshen therapy (TYAT), as a crucial therapy of treating insomniacs, is based on the theory of syndrome differentiation. However, owing to the lack of evidence-based medical evidence, the authors intend to carry out this study to evaluate TYAT's effectiveness and safety. METHODS: Seven electronic databases will be searched from inception to July 2019. Two authors will independently identify randomized controlled trials, fetch data and assess the risk of bias with tools provided by Cochrane. A comprehensive meta-analysis will be conducted with the Cochrane Collaboration software (Review Manager 5.3) for eligible and appropriate studies. Further, the evidence will be assessed with the grading of recommendations assessment, development, and evaluation approach. RESULTS: This article will be dedicated to assessing TYAT's efficacy and safety for insomniacs. CONCLUSION: This systematic review and meta-analysis may provide persuasive evidence for the clinical application of TYAT in treating insomnia. TRIAL REGISTRATION NUMBER: PROSPERO CRD 42019135115.