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Melatonin treatment in children with therapy-resistant monosymptomatic nocturnal enuresis.

Journal of pediatric urology
August 1, 2012
B T Merks et al. (5 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effects of exogenous melatonin on wet night frequency, sleep-wake cycle, and melatonin profiles in children with therapy-resistant MNE.

Results Summary

The study found that exogenous melatonin altered melatonin profiles but did not affect enuresis frequency or sleep-wake cycles in the studied patients. No significant differences were observed between the melatonin and placebo groups.

Population

Children with therapy-resistant monosymptomatic nocturnal enuresis (MNE).

Effective Dosage

Not specified

Duration

6 months

Interactions

None mentioned

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
exogenous melatonin
change
melatonin profile
children with therapy-resistant MNE
-
observed a change in profile
#1
exogenous melatonin
no change
sleep-wake cycle
children with therapy-resistant MNE
-
did not observe a difference
#2
exogenous melatonin
no change
frequency of wet nights
children with therapy-resistant MNE
-
did not observe a difference
#3
exogenous melatonin
no change
enuresis frequency
this select group of patients
-
did not observe a change
#4
exogenous melatonin
no change
sleep-wake cycle
this select group of patients
-
did not observe a change
#5
Abstract

OBJECTIVE: To evaluate the effects of exogenous melatonin on the frequency of wet nights, on the sleep-wake cycle, and on the melatonin profile in children with therapy-resistant MNE. PATIENTS AND METHODS: 24 patients were included. Patients had to maintain a diary including time of sleep and arousal, and whether they had a dry or a wet bed in the morning. We measured baseline melatonin profiles in saliva. Hereafter, patients were randomized to synthetic melatonin or placebo. After 3 and 6 months we evaluated the frequency of enuresis and the melatonin profiles. RESULTS: 11 patients were randomized to melatonin, 13 to placebo. We evaluated melatonin profiles of 7 patients in the melatonin group and of 8 in the placebo group. We observed a change in profile in the melatonin group, but we did not observe a difference in the sleep-wake cycle or the frequency of wet nights in either group. CONCLUSION: This is the first time exogenous melatonin has been evaluated in the treatment of MNE. Although we observed a change in melatonin profile after the use of exogenous melatonin, we did not observe a change in enuresis frequency or in the sleep-wake cycle of this select group of patients.

Medical Subject Headings (MeSH)
AdolescentChildCircadian RhythmDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug ResistanceFemaleFollow-Up StudiesHumansMaleMedical RecordsMelatoninNocturnal EnuresisProspective StudiesReference ValuesRenal AgentsSeverity of Illness IndexTime FactorsTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy30/10
Quality75/10
Citation Metrics
Total Citations15
Citations/Year1.2
Relative Citation Ratio0.84
NIH Percentile43.7%
Research Impact Scores
APT Score0.50
Weight Score1.34
Normalized Score0.47
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Melatonin treatment in children with therapy-resistant monos... | Panacea Index