Smits Marcel G, van Stel Henk F, van der Heijden Kristiaan, Meijer Anne Marie, Coenen Anton M L, Kerkhof Gerard A
Sleep Centre, Hospital Gelderse Vallei, Willy Brandtlaan 10, Box 9025, 6710 HN Ede, the Netherlands.
J Am Acad Child Adolesc Psychiatry. 2003 Nov;42(11):1286-93. doi: 10.1097/01.chi.0000085756.71002.86.
To investigate the effect of melatonin treatment on health status and sleep in children with idiopathic sleep-onset insomnia.
A randomized, double-blind, placebo-controlled trial was conducted in a Dutch sleep center, involving 62 children, 6 to 12 years of age, who suffered more than 1 year from idiopathic chronic sleep-onset insomnia. Patients received either 5 mg melatonin or placebo at 7 pm. The study consisted of a 1-week baseline period, followed by a 4-week treatment. Health status was measured with the RAND General Health Rating Index (RAND-GHRI) and Functional Status II (FS-II) questionnaires. Lights-off time, sleep onset, and wake-up time were recorded in a diary, and endogenous dim light melatonin onset was measured in saliva.
The total scores of the RAND-GHRI and FS-II improved significantly more during melatonin treatment compared to placebo. The magnitude of change was much higher in the melatonin group than in the placebo group, with standardized response means for the RAND-GHRI of 0.69 versus 0.07 and for the FS-II of 1.61 versus 0.64. Melatonin treatment also significantly advanced sleep onset by 57 minutes, sleep offset by 9 minutes, and melatonin onset by 82 minutes, and decreased sleep latency by 17 minutes. Lights-off time and total sleep time did not change.
Melatonin improves health status and advances the sleep-wake rhythm in children with idiopathic chronic sleep-onset insomnia.
探讨褪黑素治疗对特发性入睡性失眠儿童健康状况和睡眠的影响。
在一家荷兰睡眠中心进行了一项随机、双盲、安慰剂对照试验，纳入62名6至12岁、患有特发性慢性入睡性失眠超过1年的儿童。患者于晚上7点服用5毫克褪黑素或安慰剂。该研究包括1周的基线期，随后是4周的治疗期。使用兰德综合健康评定指数（RAND-GHRI）和功能状态II（FS-II）问卷来测量健康状况。通过日记记录熄灯时间、入睡时间和起床时间，并测量唾液中的内源性暗光褪黑素起始时间。
与安慰剂相比，褪黑素治疗期间RAND-GHRI和FS-II的总分改善更为显著。褪黑素组的变化幅度远高于安慰剂组，RAND-GHRI的标准化反应均值为0.69对0.07，FS-II为1.61对0.64。褪黑素治疗还使入睡时间显著提前57分钟，起床时间提前9分钟，褪黑素起始时间提前82分钟，并使睡眠潜伏期缩短17分钟。熄灯时间和总睡眠时间没有变化。
褪黑素可改善特发性慢性入睡性失眠儿童的健康状况并提前睡眠-觉醒节律。
