EXPRESSION OF CONCERN: The effects of melatonin administration on disease severity and sleep quality in children with atopic dermatitis: A randomized, double‐blinded, placebo‐controlled trial
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 70 participants or records.
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