Memorial Sloan Kettering Cancer Center, New York, NY, USA.
China Academy of Chinese Medical Sciences, Beijing, China.
Integr Cancer Ther. 2023 Jan-Dec;22:15347354231162080. doi: 10.1177/15347354231162080.
Sleep disturbances are common and bothersome among cancer and noncancer populations. () is commonly used to improve sleep, yet its efficacy and safety are unclear.
We systematically searched PubMed, Cochrane Library, and EMBASE from inception through October 5, 2021, to identify randomized trials of . We included randomized trials comparing to placebo, medications, cognitive behavioral therapy (CBT), or usual care for improving sleep outcomes in cancer and noncancer patients with insomnia or sleep disturbance. We performed a risk of bias analysis following Cochrane guidelines. Depending on heterogeneity, we pooled studies with similar comparators using fixed- and random-effects models.
We included participants with insomnia disorder (N = 785) or sleep disturbance (N = 120) from 9 trials. Compared with placebo, led to significant subjective sleep quality improvements in participants with insomnia and patients with sleep disturbance combined (standard mean difference -0.58, 95% CI -1.04, -0.11; < .01); Compared with benzodiazepines or CBT, was associated with a significant decrease in insomnia severity (mean difference -2.68 points, 95% CI -5.50, -0.22; = .03) at 4 weeks in the general population and cancer patients. The long-term effects of were mixed among trials. did not increase the incidence of major adverse events. The placebo-controlled studies had a low risk of bias.
is associated with short-term patient-reported sleep quality improvements among individuals with insomnia or sleep disturbance. Due to the small sample size and variable study quality, the clinical benefits and harms of , particularly in the long term, should be further assessed in a sufficiently powered randomized trial.
PROSPERO CRD42021281943.
睡眠障碍在癌症患者和非癌症患者中很常见且令人困扰。褪黑素通常被用于改善睡眠，但它的疗效和安全性尚不清楚。
我们系统地检索了 PubMed、Cochrane 图书馆和 EMBASE，从建库到 2021 年 10 月 5 日，以确定褪黑素的随机试验。我们纳入了比较褪黑素与安慰剂、药物、认知行为疗法（CBT）或常规护理治疗失眠或睡眠障碍的癌症患者和非癌症患者的睡眠结果的随机试验。我们按照 Cochrane 指南进行了偏倚风险分析。根据异质性，我们使用固定效应和随机效应模型对具有相似对照的研究进行了汇总。
我们纳入了 9 项试验中失眠障碍（N=785）或睡眠障碍（N=120）的参与者。与安慰剂相比，褪黑素可显著改善失眠患者和睡眠障碍合并患者的主观睡眠质量（标准均数差-0.58，95%置信区间-1.04，-0.11； < .01）；与苯二氮䓬类药物或 CBT 相比，褪黑素在 4 周时与失眠严重程度的显著降低相关（平均差值-2.68 分，95%置信区间-5.50，-0.22； = .03）在一般人群和癌症患者中。褪黑素的长期效果在试验中存在差异。褪黑素并未增加主要不良事件的发生率。安慰剂对照研究的偏倚风险较低。
褪黑素与失眠或睡眠障碍患者的短期患者报告睡眠质量改善相关。由于样本量小和研究质量的差异，褪黑素的临床获益和危害，特别是在长期，应在一项足够大的随机试验中进一步评估。
PROSPERO CRD42021281943。
