Department of Neuropsychiatry of Korean Medicine, Pohang Korean Medicine Hospital, Daegu Haany University, 411 Saecheonnyeon-daero, Nam-gu, Pohang-si, Gyeongsangbuk-do.
Department of Neuropsychiatry, School of Korean Medicine, Pusan National University, 49 Busandaehak-ro, Mulgeum-eup, Yangsan, Republic of Korea.
Medicine (Baltimore). 2021 Jun 4;100(22):e26223. doi: 10.1097/MD.0000000000026223.
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.
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.
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.
This study will provide evidence regarding the efficacy and safety of HM for the treatment of PSI.
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.
10.17605/OSF.IO/PEHQZ.
中风后失眠（PSI）是中风患者的一种高发并发症。然而，目前还没有全面的系统评价评估草药（HM）治疗 PSI 的疗效和安全性。本方案旨在进行系统评价和荟萃分析，以评估与 HM 治疗 PSI 的疗效和安全性相关的证据。
我们将全面检索电子数据库，包括 Medline、EMBASE、CENTRAL、AMED、CINAHL、PsycARTICLES 以及中、韩、日数据库，检索时间从建库至 2020 年 11 月。本系统评价仅纳入 HM 治疗 PSI 的随机对照临床试验。主要结局是匹兹堡睡眠质量指数评分。两名研究人员将独立筛选引文和摘要，确定纳入的全文文章，提取数据，并评估纳入研究的质量和偏倚风险。使用 Review Manager 5.4 进行荟萃分析。根据推荐、评估、发展和评估（Grades of Recommendation, Assessment, Development, and Evaluation，GRADE）标准评估每个结局的证据质量。
本方案遵循系统评价和荟萃分析的首选报告项目（Preferred Reporting Items for Systematic Reviews and Meta-Analyses-P，PRISMA-P）指南，以确保系统评价各阶段报告的清晰性和完整性。
本研究将为 HM 治疗 PSI 的疗效和安全性提供证据。
由于将检索和分析先前发表的研究数据，这些研究均已获得主要研究者的知情同意，因此不需要伦理批准。我们将在同行评议的期刊上发表本系统评价。
OSF 注册号：10.17605/OSF.IO/PEHQZ。
