Meta-AnalysisDevelopmental medicine and child neurology2019

Oral melatonin for non-respiratory sleep disturbance in children with neurodisabilities: systematic review and meta-analyses.

Adwoa Parker, Bryony Beresford, Vicki Dawson and 8 others

PMID 30710339

WHAT IT FOUND

In children with neurodisabilities, melatonin compared with placebo increased total sleep time and shortened time to fall asleep, but did not clearly improve night wakings or sleep efficiency.

Benefit appeared greatest in children with ASD, though the studies were small and inconsistent.

Key findings

01Melatonin compared with placebo increased total sleep time and shortened sleep onset latency.

02Melatonin did not significantly improve sleep efficiency or number of night wakings.

03Subgroup analyses suggested larger effects for children with ASD, but these subgroup results should be interpreted with caution.

STILL TO COME

How it was doneWhat they found

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What it does not show

Only one of the 13 included RCTs was assessed as having low risk of bias across all domains. Many trials did not adequately report randomisation, allocation concealment, blinding, missing data, or prospective registration. The pooled effects varied widely across trials, so the average results are unlikely to be generalizable. Subgroup analyses were based on few studies and are observational rather than randomised comparisons. Follow-up was only immediately after treatment, so longer-term effects and effects after stopping melatonin are unknown. Crossover trials without a washout period and count outcomes with likely skew make some analyses questionable.

Declared interests

This review was funded by the Health Technology Assessment programme of the UK National Institute for Health Research. The supplied text does not state authors' competing interests.

The easy way to misread this

Do not conclude melatonin is proven effective for all children with neurodisabilities. The sleep-time and sleep-onset results varied widely across trials, most trials had unclear or high risk of bias, and for parent-reported total sleep time the paper notes that neither the unadjusted nor adjusted pooled estimate included the 60-minute minimum clinically important difference specified in the low-risk trial.

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The study

Participants
13 RCTs; 589 randomized participants in the 11 melatonin versus placebo trials; individual trial sample sizes ranged from 6 to 160
Certainty of evidence
Moderate

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    Adwoa Parker, Bryony Beresford, Vicki Dawson, et al. Oral melatonin for non-respiratory sleep disturbance in children with neurodisabilities: systematic review and meta-analyses. Developmental medicine and child neurology. 2019.

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