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The effects of melatonin administration on disease severity and sleep quality in children with atopic dermatitis: A randomized, double-blinded, placebo-controlled trial.

Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology
December 1, 2018
Abbas Taghavi Ardakani et al. (10 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine the effects of melatonin on disease severity and sleep quality in children with atopic dermatitis (AD).

Results Summary

Melatonin supplementation significantly improved disease severity (SCORAD and objective SCORAD indices), serum total IgE levels, and sleep quality (CSHQ scores), but had no significant impact on pruritus, hs-CRP, sleep-onset latency, total sleep time, weight, or BMI.

Population

Children aged 6-12 years diagnosed with atopic dermatitis.

Effective Dosage

6 mg/d melatonin

Duration

6 weeks

Interactions

None mentioned

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin supplementation
decrease
SCORAD index
children diagnosed with atopic dermatitis (AD)
β -3.55; 95% CI, -6.11, -0.98; P = 0.007
significantly improved
#1
melatonin supplementation
decrease
objective SCORAD index
children diagnosed with atopic dermatitis (AD)
β -3.23; 95% CI, -5.08, -1.38; P = 0.001
significantly improved
#2
melatonin supplementation
decrease
serum total IgE levels
children diagnosed with atopic dermatitis (AD)
β -153.94 ku/L; 95% CI, -260.39, -47.49; P = 0.005
significantly improved
#3
melatonin supplementation
decrease
CSHQ scores
children diagnosed with atopic dermatitis (AD)
β -2.55; 95% CI, -4.34, -0.75; P = 0.006
significantly improved
#4
melatonin
no change
pruritus scores
children diagnosed with atopic dermatitis (AD)
no significant change
had no significant impact
#5
melatonin
no change
high-sensitivity C-reactive protein (hs-CRP)
children diagnosed with atopic dermatitis (AD)
no significant change
had no significant impact
#6
melatonin
no change
sleep-onset latency
children diagnosed with atopic dermatitis (AD)
no significant change
had no significant impact
#7
melatonin
no change
total sleep time
children diagnosed with atopic dermatitis (AD)
no significant change
had no significant impact
#8
melatonin
no change
weight
children diagnosed with atopic dermatitis (AD)
no significant change
had no significant impact
#9
melatonin
no change
BMI
children diagnosed with atopic dermatitis (AD)
no significant change
had no significant impact
#10
Abstract

BACKGROUND: The aim of this clinical trial was to determine the effects of melatonin administration on disease severity and sleep quality in children diagnosed with atopic dermatitis (AD). METHODS: This randomized, double-blinded, placebo-controlled trial was conducted by recruiting 70 patients, aged 6-12 years, who had been diagnosed with AD. Study participants were randomly allocated into two intervention groups to receive either 6 mg/d melatonin supplements or placebo (n = 35 each group) for 6 weeks. Severity of disease was assessed using the scoring atopic dermatitis (SCORAD) and objective SCORAD indices. Sleep quality was evaluated by completing the Children's Sleep Habits Questionnaire (CSHQ). RESULTS: Following 6 weeks of intervention, melatonin supplementation significantly improved SCORAD index (β -3.55; 95% CI, -6.11, -0.98; P = 0.007), objective SCORAD index (β -3.23; 95% CI, -5.08, -1.38; P = 0.001), serum total IgE levels (β -153.94 ku/L; 95% CI, -260.39, -47.49; P = 0.005), and CSHQ scores (β -2.55; 95% CI, -4.34, -0.75; P = 0.006). However, melatonin had no significant impact on pruritus scores, high-sensitivity C-reactive protein (hs-CRP), sleep-onset latency, total sleep time, weight, and BMI compared with placebo. CONCLUSIONS: Overall, melatonin supplementation had beneficial effects on disease severity, serum total IgE levels, and CSHQ among children diagnosed with AD.

Medical Subject Headings (MeSH)
ChildDermatitis, AtopicDouble-Blind MethodFemaleHumansImmunoglobulin EIranMaleMelatoninSeverity of Illness IndexSleepSurveys and QuestionnairesTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality90/10
Citation Metrics
Total Citations34
Citations/Year4.9
Relative Citation Ratio2.01
NIH Percentile74.7%
Research Impact Scores
APT Score0.75
Weight Score2.38
Normalized Score0.72
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