Abstract
BACKGROUND: Post-stroke insomnia (PSI) is a highly prevalent complication in patients with stroke. However, there has been no comprehensive systematic review assessing the efficacy and safety of herbal medicine (HM) on PSI. This protocol was developed to conduct a systematic review and meta-analysis to evaluate the evidence related to the efficacy and safety of HM on PSI. METHODS: We will perform a comprehensive electronic search, including Medline, EMBASE, CENTRAL, AMED, CINAHL, PsycARTICLES, and Chinese, Korean, and Japanese databases from their inception to November 2020. This systemic review will include only randomized controlled clinical trials of HM on PSI. The main outcome is the Pittsburgh Sleep Quality Index score. Two researchers will independently screen citations and abstracts, identify full-text articles for inclusion, extract data, and appraise the quality and risk of bias of included studies. A meta-analysis will be conducted using Review Manager 5.4. The evidence quality of each outcome will be appraised according to Grades of Recommendation, Assessment, Development, and Evaluation. RESULTS: This protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-P (PRISMA-P) guidelines to ensure clarity and completeness of reporting in all phases of the systematic review. CONCLUSION: This study will provide evidence regarding the efficacy and safety of HM for the treatment of PSI. ETHICS AND DISSEMINATION: No ethical approval will be needed because data from previously published studies in which informed consent was obtained by primary investigators will be retrieved and analyzed. We will publish this systematic review in a peer-reviewed journal. OSF REGISTRATION DOI: 10.17605/OSF.IO/PEHQZ.