Efficacy and safety of TCM Yangxin Anshen Therapy for insomnia

Abstract

Background:Traditional Chinese Medicine (TCM) has gradually drawn the attention of clinicians as an alternative choice for insomniacs and TCM Yangxin Anshen Therapy (TYAT) is a crucial therapy of treating insomniacs. The purpose of this study was to evaluate the efficacy and safety of TYAT for insomnia.Methods:Seven electronic databases were searched from inception to July 2019. Two authors independently identified Randomized Controlled Trials (RCTs), extracted data and assessed risk of bias by Cochrane risk bias assessment tool. Comprehensive meta-analysis was conducted with the Review Manager for eligible and appropriate studies.Results:Fourteen trials (1549 participants) were finally included in this study. The included studies were of moderate-to-high quality. Twelve trials reported the specific methods of random sequence generation, and 4 of them used the allocation concealment. Blinding of participants and personnel were used in 7 studies, and blinding of outcome assessment was performed in 3 studies. The main meta-analysis showed:1.TYAT was superior to placebo from the point view of PSG parameters, Pittsburgh Sleep Quality Index (PSQI) scale, TCM curative efficacy, and PSQI curative efficacy.2.TYAT was not inferior to benzodiazepines from the point view of PSG parameters, PSQI scale, TCM curative efficacy, and PSQI curative efficacy.3.In terms of PSQI scale and PSQI curative efficacy, there were no significant differences between TYAT and nonbenzodiazepine hypnotics in the treatment of insomnia.4.The clinical application of TYAT was relatively safe.Conclusion:TYAT is an effective alternative therapy for insomnia, and its clinical application appears safe. The conclusions of this paper have a certain reference value for further research and clinical practice.Trial registration number:PROSPERO CRD 42019135115.