Liu Cuiling, Chen Zhiqiang, Li Ting, Yang Zhihua, Zhang Qingsong, Yin Jianping, Zhou Peng, Fu Wei, Chen BaiShu
Baoan Hospital of Traditional Chinese Medicine in Shenzhen, Shenzhen.
Guangzhou University of Chinese Medicine, Guangzhou, China.
Medicine (Baltimore). 2019 Feb;98(7):e14509. doi: 10.1097/MD.0000000000014509.
Fire-needle moxibustion (FNM) is an ancient method of external therapy that combines acupuncture with moxibustion, and has the property of high temperature resistance. Insomnia is a major public health problem and strongly associated with a high prevalence, impact on daily life, comorbidity with other disorders, and societal costs. The clinical practice demonstrates that FNM has a therapeutic effect on insomnia. Here we will provide a protocol to evaluate the effectiveness and safety of FNM for insomnia.
We will search the randomized controlled trial literatures of FNM for insomnia in 7 electronic databases, including 3 English databases (PubMed, EMBASE, the Cochrane Central Register of Controlled Trials [Cochrane Library]) and 4 Chinese databases (Chinese National Knowledge Infrastructure, Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database). Pittsburgh Sleep Quality Index will be considered as the primary outcome, and the secondary outcome will include biochemical, indicators total scores on the insomnia severity index, quality of life, adverse events caused by FNM, and changes of TCM syndromes scores. Review Manager 5.2 software will be use for assessment of risk of bias, data synthesis. Begg and Egger tests will be use for assessing symmetries of funnel plot by software Stata 12.0. Methodological quality will be assessed with the risk of bias according to Cochrane Handbook.
This study will provide a rational synthesis of current evidences for Fire-needle moxibustion on insomnia.
The conclusion of this study will provide evidence to judge the effectiveness and safety of Fire-needle moxibustion on insomnia.
PROS-PERO CRD42019120875.
火针艾灸是一种将针刺与艾灸相结合的古老外治疗法，具有耐高温特性。失眠是一个重大的公共卫生问题，与高患病率、对日常生活的影响、与其他疾病的共病以及社会成本密切相关。临床实践表明，火针艾灸对失眠有治疗作用。在此，我们将提供一项评估火针艾灸治疗失眠有效性和安全性的方案。
我们将检索7个电子数据库中关于火针艾灸治疗失眠的随机对照试验文献，包括3个英文数据库（PubMed、EMBASE、Cochrane对照试验中心注册库[Cochrane图书馆]）和4个中文数据库（中国知网、维普资讯、万方数据库和中国生物医学文献数据库）。匹兹堡睡眠质量指数将被视为主要结局，次要结局将包括生化指标、失眠严重程度指数总分、生活质量、火针艾灸引起的不良事件以及中医证候评分变化。将使用Review Manager 5.2软件评估偏倚风险、进行数据合成。将使用Begg和Egger检验通过Stata 12.0软件评估漏斗图的对称性。将根据Cochrane手册，依据偏倚风险评估方法学质量。
本研究将对目前火针艾灸治疗失眠的证据进行合理综合。
本研究的结论将为判断火针艾灸治疗失眠的有效性和安全性提供证据。
PROSPERO CRD42019120875
