Randomized controlled trial of melatonin for children with autistic spectrum disorders and sleep problems
Randomized controlled trial of melatonin for children with autistic spectrum disorders and sleep problems
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DOI：
10.1111/j.1365-2214.2006.00616.x
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发表时间：
2006-09-01
影响因子：
1.9
通讯作者：
Wallis, M.
中科院分区：
文献类型：
--
作者：
Garstang, J.;Wallis, M.
背景资料：褪黑激素是经常用于自闭症儿童睡眠障碍，尽管缺乏公开发表的证据，在此population.Methods：褪黑激素的随机，安慰剂对照的双盲交叉试验进行了11名儿童与自闭症谱系障碍（ASD）。基线睡眠潜伏期为2.6 h [95%置信区间（CI）2.28-2.93]，安慰剂组为1.91 h（95% CI 1.78-2.03），褪黑素组为1.06 h（95% CI 0.98-1.13）。每晚觉醒次数基线为0.35（95% CI 0.18-0.53），安慰剂组为0.26（95% CI 0.20-0.34），褪黑素组为0.08（95% CI 0.04-0.12）。总睡眠时间为8.05 h（95% CI 7.65-8.44）基线，8.75 h（95% CI 8.56-8.98），安慰剂组和9.84 h（95% CI 9.68-9.99）。虽然由于招募困难，这项研究规模很小，但它仍然提供了褪黑激素对睡眠困难和ASD儿童有效的证据，我们预计一项更大规模的研究会证实这一点。
Background: Melatonin is often used for autistic children with sleep disorders, despite a lack of published evidence in this population.Methods: A randomized, placebo-controlled double-blind crossover trial of melatonin was undertaken in 11 children with autistic spectrum disorder (ASD).Results: Seven children completed the trial. Sleep latency was 2.6 h [95% confidence intervals (CI) 2.28-2.93] baseline, 1.91 h (95% CI 1.78-2.03) with placebo and 1.06 h (95% CI 0.98-1.13) with melatonin. Wakings per night were 0.35 (95% CI 0.18-0.53) baseline, 0.26 (95% CI 0.20-0.34) with placebo and 0.08 (95% CI 0.04-0.12) with melatonin. Total sleep duration was 8.05 h (95% CI 7.65-8.44) baseline, 8.75 h (95% CI 8.56-8.98) with placebo and 9.84 h (95% CI 9.68-9.99) with melatonin.Conclusions: Although the study was small owing to recruitment difficulties, it still provides evidence of effectiveness of melatonin in children with sleep difficulties and ASD, which we predict a larger study would confirm.