Effectiveness and safety of fire-needle moxibustion on insomnia Protocol for a systematic review and meta-analysis

Background: 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. Methods: 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. Result: This study will provide a rational synthesis of current evidences for Fire-needle moxibustion on insomnia. Conclusion: The conclusion of this study will provide evidence to judge the effectiveness and safety of Fire-needle moxibustion on insomnia. Registration: PROS-PERO CRD42019120875.