Wei Sha, Smits Marcel G, Tang Xiangdong, Kuang Li, Meng Huaqing, Ni Shifen, Xiao Mingzhao, Zhou Xinyu
Department of Psychiatry, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Department of Sleep-wake Disorders and Chronobiology, Gelderse Valley Hospital Ede, the Netherlands.
Sleep Med. 2020 Apr;68:1-8. doi: 10.1016/j.sleep.2019.02.017. Epub 2019 Mar 9.
To evaluate the efficacy and safety of melatonin in the treatment of sleep onset insomnia in children and adolescents.
Electronic databases and bibliographies of relevant reports were searched for randomized, placebo-controlled, clinical trials that used melatonin in children and adolescents with sleep onset insomnia. The quality of the included studies was assessed by the Cochrane Collaboration's risk-of-bias method. The mean differences (MD) and the odds ratios (OR) with 95% confidence interval (CI) were estimated by a random-effects model. Primary outcomes were sleep onset time (SOT), drop-out for all causes and drop-out for adverse events. Secondary outcomes included dim light melatonin onset (DLMO), sleep onset latency (SOL), total sleep time (TST), light-off time, and wake-up time.
Seven trials with 387 participants were finally included after a systematic search. The overall quality of the included studies was low to moderate. SOT in patients receiving melatonin advanced more than patients receiving placebo (MD = -0.62 h, 95% CI -0.80, -0.45), as well as DLMO (MD = -0.82 h, 95% CI -1.23, -0.41). No differences were found in the outcome of drop-out for all causes (OR = 1.51, 95% CI 0.57, 4.05) or drop-out for adverse events (OR = 3.35, 95% CI 0.13, 86.03). Severe adverse events, migraine, and mild generalized epilepsy were reported in two cases. SOL decreased and TST increased, MD = -0.36 h (95% CI -0.49, -0.24) and MD = 0.38 h (95% CI 0.09, 0.66), respectively. Light-off time and wake-up time did not differ significantly.
Melatonin was an effective and tolerable drug in the short-term treatment of sleep onset insomnia in children and adolescents. More studies, especially in adolescents, are needed to investigate the efficacy and safety of melatonin.
评估褪黑素治疗儿童和青少年入睡性失眠的疗效和安全性。
检索电子数据库及相关报告的参考文献，查找使用褪黑素治疗儿童和青少年入睡性失眠的随机、安慰剂对照临床试验。采用Cochrane协作网的偏倚风险评估方法评估纳入研究的质量。采用随机效应模型估计平均差（MD）和比值比（OR）及其95%置信区间（CI）。主要结局指标为入睡时间（SOT）、各种原因导致的退出研究情况及不良事件导致的退出研究情况。次要结局指标包括暗光褪黑素起始时间（DLMO）、入睡潜伏期（SOL）、总睡眠时间（TST）、熄灯时间和起床时间。
经过系统检索，最终纳入7项试验，共387名参与者。纳入研究的总体质量为低到中等。接受褪黑素治疗的患者的SOT比接受安慰剂治疗的患者提前更多（MD = -0.62小时，95% CI -0.80，-0.45），DLMO也是如此（MD = -0.82小时，95% CI -1.23，-0.41）。在各种原因导致的退出研究结局（OR = 1.51，95% CI 0.57，4.05）或不良事件导致的退出研究结局（OR = 3.35，95% CI 0.13，86.03）方面未发现差异。报告了2例严重不良事件、偏头痛和轻度全身性癫痫。SOL缩短，TST延长，MD分别为-0.36小时（95% CI -0.49，-0.24）和0.38小时（95% CI 0.09，0.66）。熄灯时间和起床时间无显著差异。
褪黑素是治疗儿童和青少年入睡性失眠的一种有效且耐受性良好的药物。需要更多研究，尤其是针对青少年的研究，来调查褪黑素的疗效和安全性。
