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Original Investigation |

Melatonin Supplementation for Children With Atopic Dermatitis and Sleep Disturbance A Randomized Clinical Trial

Yung-Sen Chang, MD, MPH1,2,3; Ming-Hung Lin, MD, MS4; Jyh-Hong Lee, MD, PhD5; Pei-Lin Lee, MD, PhD6; Yang-Shia Dai, MD, MS7; Kuan-Hua Chu, PhD5; Chi Sun, MD5; Yu-Tsan Lin, MD, PhD5; Li-Chieh Wang, MD, PhD5; Hsin-Hui Yu, MD5; Yao-Hsu Yang, MD, PhD5; Chun-An Chen, MD, PhD5; Kong-Sang Wan, MD, PhD1; Bor-Luen Chiang, MD, PhD5,8,9
[+] Author Affiliations
1Department of Pediatrics, Taipei City Hospital Renai Branch, Taipei, Taiwan
2Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan
3School of Medicine, National Yang-Ming University, Taipei, Taiwan
4Department of Pediatrics, Yonghe Cardinal Tien Hospital, New Taipei City, Taiwan
5Department of Pediatrics, National Taiwan University Children’s Hospital, Taipei, Taiwan
6Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
7Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan
8Graduate Institute of Immunology, College of Medicine, National Taiwan University, Taipei, Taiwan
9Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan
JAMA Pediatr. 2016;170(1):35-42. doi:10.1001/jamapediatrics.2015.3092.
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Importance  Sleep disturbance is common in children with atopic dermatitis (AD), but effective clinical management for this problem is lacking. Reduced levels of nocturnal melatonin were found to be associated with sleep disturbance and increased disease severity in children with AD. Melatonin also has sleep-inducing and anti-inflammatory properties and therefore might be useful for the management of AD.

Objective  To evaluate the effectiveness of melatonin supplementation for improving the sleep disturbance and severity of disease in children with AD.

Design, Setting, and Participants  This randomized clinical trial used a double-blind, placebo-controlled crossover design to study 73 children and adolescents aged 1 to 18 years with physician-diagnosed AD involving at least 5% of the total body surface area. The study was conducted at the pediatric department of a large tertiary care hospital in Taiwan from August 1, 2012, through January 31, 2013. Forty-eight children were randomized 1:1 to melatonin or placebo treatment, and 38 of these (79%) completed the cross-over period of the trial. Final follow-up occurred on April 13, 2013, and data were analyzed from January 27 to April 25, 2014. Analyses were based on intention to treat.

Interventions  Melatonin, 3 mg/d, or placebo for 4 weeks followed by a 2-week washout period and then crossover to the alternate treatment for 4 weeks.

Main Outcomes and Measures  The primary outcome was AD severity evaluated using the Scoring Atopic Dermatitis (SCORAD) index, with scores ranging from 0 to 103 and greater scores indicating worse symptoms. Secondary outcomes included sleep variables measured by actigraphy, subjective change in sleep and dermatitis, sleep variables measured by polysomnography, nocturnal urinary levels of 6-sulfatoxymelatonin, and serum IgE levels.

Results  After melatonin treatment among the 48 children included in the study, the SCORAD index decreased by 9.1 compared with after placebo (95% CI, −13.7 to −4.6; P < .001), from a mean (SD) of 49.1 (24.3) to 40.2 (20.9). Moreover, the sleep-onset latency shortened by 21.4 minutes after melatonin treatment compared with after placebo (95% CI, −38.6 to −4.2; P = .02). The improvement in the SCORAD index did not correlate significantly with the change in sleep-onset latency (r = −0.04; P = .85). No patient withdrew owing to adverse events, and no adverse event was reported throughout the study.

Conclusions and Relevance  Melatonin supplementation is a safe and effective way to improve the sleep-onset latency and disease severity in children with AD.

Trial Registration  clinicaltrials.gov Identifier: NCT01638234

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Figure 1.
CONSORT Diagram of the Randomization and Follow-up of the Study Participants
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Figure 2.
Severity of Atopic Dermatitis and Sleep-Onset Latency Before and After Melatonin Treatment

Data are expressed as both patient groups combined. A, The mean Scoring Atopic Dermatitis (SCORAD) index decreased significantly after melatonin treatment compared with placebo. B, The treatment sequence (melatonin first vs placebo first) did not result in a significant difference in the treatment effect. C, The mean objective SCORAD index decreased significantly after melatonin treatment compared with placebo. D, The mean sleep-onset latency decreased significantly after melatonin treatment compared with placebo. Error bars indicate standard errors. The SCORAD index ranges from 0 to 103, and the objective SCORAD index ranges from 0 to 83, with greater scores indicating worse symptoms.

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