Data_Sheet_1_Melatonin Treatment for Sleep Disorders in Parkinson's Disease: A Meta-Analysis and Systematic Review.docx

ObjectiveThe efficacy of melatonin on sleep disorders in Parkinson's disease (PD) is still unclear. The purpose of this study was to investigate the efficacy of melatonin on sleep disorders in PD by summarizing evidence from randomized clinical trials (RCTs).
MethodsPubMed, Cochrane Library, EMBASE, and Web of Science databases were searched for studies published before 20 August 2021. Results were analyzed using Review Manager 5.2 software. We used Trial Sequential Analysis (TSA) software to avoid false-positive results caused by random errors.
ResultsWe included 7 studies in this systematic review and meta-analysis. The results of the meta-analysis showed that compared with placebo, the subjective sleep quality of patients with PD significantly improved after melatonin treatment (MD = −2.19, 95% CI: −3.53 to −0.86, P = 0.001). In the systematic review, we qualitatively analyzed the efficacy of melatonin on the objective sleep quality of patients with PD, and the results showed that melatonin exerted a positive effect with good safety and tolerability. However, there was no significant improvement in excessive daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS).
ConclusionWe found that melatonin can significantly improve the subjective and objective sleep quality of patients with PD with good safety and tolerability. Melatonin could be considered an effective treatment for insomnia in patients with PD.

研究目的：目前褪黑素对帕金森病（Parkinson's disease, PD）患者睡眠障碍的疗效尚不明确。本研究旨在通过汇总随机对照试验（randomized clinical trials, RCTs）的相关证据，探讨褪黑素对帕金森病患者睡眠障碍的治疗效果。
研究方法：检索PubMed、Cochrane图书馆、EMBASE及Web of Science数据库中2021年8月20日前发表的相关研究。采用Review Manager 5.2软件对研究结果进行数据分析，并使用试验序贯分析（Trial Sequential Analysis, TSA）软件以规避随机误差引发的假阳性结果。
研究结果：本系统评价与荟萃分析共纳入7项研究。荟萃分析结果显示，与安慰剂组相比，褪黑素治疗后帕金森病患者的主观睡眠质量显著改善（均差MD=-2.19，95%置信区间CI：-3.53~-0.86，P=0.001）。本系统评价同时对褪黑素改善帕金森病患者客观睡眠质量的疗效开展定性分析，结果表明褪黑素可发挥积极治疗作用，且安全性与耐受性良好。但采用爱丁堡嗜睡量表（Epworth Sleepiness Scale, ESS）评估的日间过度嗜睡症状未出现显著改善。
研究结论：本研究证实，褪黑素可显著改善帕金森病患者的主观与客观睡眠质量，且安全性与耐受性良好，因此褪黑素可作为帕金森病患者失眠症状的有效治疗方案。