作者
Kim S Thomas, Lucy E Bradshaw, Tracey H Sach, Jonathan M Batchelor, Sandra Lawton, Eleanor F Harrison, Rachel H Haines, Amina Ahmed, Hywel C Williams, Taraneh Dean, Nigel P Burrows, Ian Pollock, Joanne Llewellyn, Clare Crang, Jane D Grundy, Juliet Guiness, Andrew Gribbin, Eleanor J Mitchell, Fiona Cowdell, Sara J Brown, Alan A Montgomery, UK Dermatology Clinical Trials Network’s, CLOTHES Trial Team
发表日期
2017/4
期刊
PLoS medicine
卷号
14
期号
4
出版商
Public Library of Science
简介
Background
The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease.
Methods and findings
This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections.
Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits …
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