Background: Therapeutic guidelines in the management of circadian rhythm sleep disorders in the pediatric population are currently non-existent, which leads to adverse disease burden and encourages off-label prescribing. Objectives: To discuss the methodological issues experienced while we developed a Cochrane Review for the management of orphan disorder and to recommend a safe and effective dosing regimen and monitoring parameters of melatonin in a pediatric population. Methods: A mixed method study approach was followed. Ongoing phase 2 trial of melatonin evaluated the primary and secondary outcomes for improvement in sleep characteristics in children with neurodevelopmental disorders and visual impairment. Outcome from the trial was compared to the evidence (a systematic review and protocols developed by our team in collaboration with Cochrane Developmental, Psychosocial and Learning Problems Group and non-RCTs excluded from the Cochrane Review). Results: No studies met the inclusion criteria for our Cochrane Review. The quality of the excluded studies was acceptable but not on a par with methods determined by Cochrane. From our ongoing phase 2 trial of melatonin, an improvement in total sleep time, reduction in sleep onset latency, and fewer night-time waking was observed with low dose melatonin (0.5–2 mg; n = 11) compared with baseline/placebo. This is in contrast with the ongoing practice of high dose melatonin usage in pediatric sleep medicine in Australia and elsewhere. Conclusions: For highly-specialized therapeutic areas, a null-evidence report, based on strict inclusion criteria of Cochrane, runs the ethical risk of excluding potentially relevant practice-guiding evidence by determining that current practice lacks sufficient evidence (highly relevant for orphan disorders and drugs). Although melatonin is approved for its use in primary insomnia in adults (>55 years of age) in Australia and is used as hormonal supplement and/or complementary medicine elsewhere in the world, there is no clinical protocol or best practice tools for guiding GPs, pediatricians, and the family/carers on rational use in pediatric population.
|Number of pages||1|
|Journal||Cochrane database of systematic reviews (Online)|
|Issue number||9 Suppl|
|Publication status||E-pub ahead of print - 21 Sep 2014|
|Event||22nd Cochrane Colloquium - Hyderabad , India|
Duration: 21 Sep 2014 → 25 Sep 2014