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

Abbas Taghavi Ardakani, Maryam Farrehi, Mohammad Reza Sharif, Vahidreza Ostadmohammadi, Naghmeh Mirhosseini, Davood Kheirkhah, Seyed Gholam Abbas Moosavi, Milad Behnejad, Russel J. Reiter, Zatollah Asemi

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). This randomized, double-blinded, placebo-controlled trial was conducted by recruiting 70 patients, 6-12 years of age, who had been diagnosed with AD. Study participants were randomly allocated into two intervention groups to receive either 6 mg/day 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). 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). Though, 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. Overall, melatonin supplementation had beneficial effects on disease severity, serum total IgE levels and CSHQ among children diagnosed with AD. This article is protected by copyright. All rights reserved.