Xu Hong Wei, Du Wei, He Lingling, Kuang Xiuying
Guangzhou University of Chinese Medicine.
The First Affiliated Hospital of Guangzhou University of Chinese, Medicine, Guangzhou, China.
Medicine (Baltimore). 2019 May;98(20):e15637. doi: 10.1097/MD.0000000000015637.
Warm needle acupuncture (WNA) is a traditional Chinese medicine (TCM) therapy which combines technical advantages of acupuncture and moxibustion. Climacteric insomnia is a common symptom in climacteric women, which can seriously affect the physical and mental health of patients. Relevant studies have been reported that WNA can improve insomnia in climacteric women. In this protocol, the effectiveness and safety of WNA on insomnia in climacteric women will be explored.
Seven electronic databases include 3 English databases [Excerpta Medica database (EMBASE), PubMed, the Cochrane Central Register of Controlled Trials (Cochrane Library)] and 4 Chinese databases [Chinese VIP Information, Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM) and Wanfang Database] for randomised controlled trials (RCT) of WNA on insomnia in climacteric women will be searched. The changes of the Pittsburgh sleep quality index was used as the main outcome, and the secondary outcome includes the changes of the Kupperman score, serum hormone level, and TCM syndrome score, as well as the adverse events caused by WNA. We will use RevMan software V5.3 to help us to analyze all data and use a Cochrane risk of bias tool to help us to assess the methodological quality for RCTs.
This study will provide reliable evidence for WNA on insomnia in climacteric women CONCLUSION:: The findings will be an available reference to evaluate the effectiveness and safety of WNA on insomnia in climacteric women.
PROS-PERO CRD42019125743.
温针疗法是一种结合了针灸和艾灸技术优势的中医疗法。更年期失眠是更年期女性的常见症状，会严重影响患者的身心健康。相关研究报道温针疗法可改善更年期女性的失眠症状。本方案将探讨温针疗法治疗更年期女性失眠的有效性和安全性。
检索七个电子数据库，包括3个英文数据库[医学文摘数据库（EMBASE）、PubMed、Cochrane系统评价数据库（Cochrane图书馆）]和4个中文数据库[中文科技期刊数据库、中国知网（CNKI）、中国生物医学文献数据库（CBM）和万方数据库]，以查找温针疗法治疗更年期女性失眠的随机对照试验（RCT）。以匹兹堡睡眠质量指数的变化作为主要结局指标，次要结局指标包括库珀曼评分、血清激素水平、中医证候评分的变化以及温针疗法引起的不良事件。我们将使用RevMan软件V5.3帮助分析所有数据，并使用Cochrane偏倚风险工具评估RCT的方法学质量。
本研究将为温针疗法治疗更年期女性失眠提供可靠证据。结论：本研究结果将为评估温针疗法治疗更年期女性失眠的有效性和安全性提供参考依据。
国际前瞻性注册库（PROSPERO）注册号：CRD42019125743
