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Normalization of the sleep-wake pattern and melatonin and 6-sulphatoxy-melatonin levels after a therapeutic trial with melatonin in children with severe epilepsy.

Journal of pineal research
March 1, 2011
J Uberos et al. (6 authors)
Clinical TrialJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effects of melatonin on sleep-wake patterns, plasma melatonin levels, and urinary excretion of its metabolite in children with severe epileptic disorders, as well as its impact on seizure control.

Results Summary

Melatonin significantly improved sleep efficiency, reduced night-time awakenings, restored periodic plasma melatonin levels, and decreased the number of seizures in pediatric patients with severe epilepsy.

Population

Pediatric patients with severe epileptic disorders (n=10).

Effective Dosage

3 mg nightly.

Duration

3 months.

Interactions

None mentioned.

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin
increase
Sleep efficiency
paediatric patients suffering from severe epileptic disorders
-
was significantly higher than among those given the placebo
#1
melatonin
decrease
night-time awakenings
paediatric patients suffering from severe epileptic disorders
-
fewer
#2
melatonin
increase
Periodic plasma melatonin levels
paediatric patients suffering from severe epileptic disorders
-
regained
#3
melatonin
decrease
convulsive episodes
paediatric patients suffering from severe epileptic disorders
-
a better control gained
#4
melatonin
decrease
the number of seizures
paediatric patients suffering from severe epileptic disorders
-
decreased
#5
Abstract

This study evaluated the sleep-wake pattern, plasma melatonin levels and the urinary excretion of its metabolite, 6-sulphatoxy-melatonin among children with severe epileptic disorders, before and after a therapeutic trial with melatonin. Ten paediatric patients, suffering from severe epileptic disorders, were selected and given a nightly dose of 3 mg of a placebo, for 1 wk; for the next 3 months, the placebo was replaced with a nightly dose of 3 mg of melatonin. At the end of each treatment period, the urinary excretion of 6-sulphatoxy-melatonin (for the intervals 09.00 - 21:00 hr or 21:00-09:00 hr) and plasma levels of melatonin (recorded at 01:00, 05:00, 09:00, 13:00, 17:00 and 21:00 hr) were recorded, over a period of 24 hr; an actigraph record was also kept. Sleep efficiency among patients who received melatonin was significantly higher than among those given the placebo, with fewer night-time awakenings. Periodic plasma melatonin levels were regained and a better control gained of convulsive episodes, in that the number of seizures decreased. We conclude that melatonin is a good regulator of the sleep-wake cycle for paediatric patients suffering from severe epilepsy, moreover, it to a better control of convulsive episodes.

Medical Subject Headings (MeSH)
ChildChild, PreschoolEpilepsyHumansMelatoninPlacebosSleep Wake DisordersTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality75/10
Citation Metrics
Total Citations35
Citations/Year2.5
Relative Citation Ratio1.34
NIH Percentile61.1%
Research Impact Scores
APT Score0.75
Weight Score1.34
Normalized Score0.69
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