Public Release: 

Silk clothing did not improve eczema in children

PLOS

No significant differences were observed in eczema severity for children with moderate to severe eczema who wore silk garments compared with those who wore their usual clothing, according to a randomized controlled study published in PLOS Medicine by Kim Thomas from University of Nottingham, UK, and colleagues.

Clothing may play a role in either exacerbating or soothing eczema, and patients often avoid wool garments and turn to cotton and other fine weave fabrics, including silk. In the new study, 300 children age 1 to 15 years with moderate to severe eczema were recruited from five UK centers covering a range of rural and urban settings. The participants were randomly divided into two groups: half the children received the standard of care and the other half received the standard of care plus silk garments that are claimed to be beneficial for eczema.

After 6 months, there was no significant difference in eczema severity--based on the Eczema Area and Severity Index--and no difference in quality of life or medication use between the groups. The researchers report that the garments are unlikely to be cost-effective even if the small differences between groups were genuine, with a computed cost per quality adjusted life year of silk garments to be GBP 56,811.

A limitation of the study is that the use of an objective outcome measure (an eczema severity score assessed by research nurses) may underestimate changes in symptoms.

The authors say: "The results of this trial suggest that silk garments are unlikely to provide additional clinical or economic benefits over standard care for children with moderate to severe eczema."

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Research Article

Funding:

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number 11/65/01). Funder website: http://www.nets.nihr.ac.uk/programmes/hta. Espère Healthcare Ltd. (UK and Ireland distributor for DermaSilk™, AlPreTec SrL. Italy) and DreamSkin™ Health Ltd. donated the garments. Initial development of the CLOTHES trial was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0407-10177). SJB is supported by a Wellcome Trust Senior Research Fellowship in Clinical Science (106865/Z/15/Z). The trial was supported through the UK Dermatology Clinical Trials Network, who receive infrastructure funding from the British Association of Dermatologists. The NIHR had input into trial design through peer review of the funding proposal, and the companies supplying the garments provided advice in defining how the intervention should be used. Neither of the funders had a role in data collection, data analysis, data interpretation or writing of the report. Both had sight of the results prior to publication and provided comments to the team.

Competing Interests:

I have read the journal's policy and the authors of this manuscript have the following competing interests: KST, LEB, THS, JMB, SL, EFH, RHH, HCW, TD, NPB, IP, JL, CC, JDG, JG, EJM, FC and AAM received grants from NIHR Health Technology Assessment Programme (11/65/01), for the conduct of this study. KT reports silk garments for use in the trial were donated by Espère Healthcare Ltd. (UK and Ireland distributor for DermaSilk™, AlPreTec SrL. Italy) and DreamSkin Health Ltd. SL reports receiving an honorarium from Thornton & Ross and Bayer for educational activities outside the submitted work. HCW is Director of the NIHR Health Technology Assessment Programme. SJB reports grants from Wellcome Trust during the conduct of the study; personal fees from American Academy of Asthma Allergy and Immunology, outside the submitted work; In addition, SJB has a patent GB 1602011.7 pending (outside the submitted work). THS holds a Career Development Fellowship (NIHR-2014-07-006) supported by the National Institute for Health Research. AG reports salary support from Clinical Research Network and non-financial support from NCTU, outside the submitted work. Representatives of Espère Healthcare Ltd. and DreamSkin Health Ltd provided technical advice on how to use the garments. However, they played no role in the analysis or interpretation of the trial findings.

Citation:

Thomas KS, Bradshaw LE, Sach TH, Batchelor JM, Lawton S, Harrison EF, et al. (2017) Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial). PLoS Med 14(4): e1002280. doi:10.1371/journal.pmed.1002280

Author Affiliations:

Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom

Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, United Kingdom

Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom

Nottingham University Hospitals NHS Trust, Queens Medical Centre, Nottingham, United Kingdom

Patient and Public Involvement Representative, Nottingham, United Kingdom

Faculty of Science, University of Portsmouth, Portsmouth, United Kingdom

University of Brighton, Brighton, United Kingdom

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, United Kingdom

Royal Free London NHS Foundation Trust, Barnet Hospital, Barnet, United Kingdom

Isle of Wight NHS Trust, St. Mary's Hospital, Newport, United Kingdom

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital, Portsmouth, United Kingdom

Faculty of Health Education and Life Sciences, Birmingham City University, Birmingham, United Kingdom

Skin Research Group, University of Dundee, Dundee, United Kingdom

Department of Dermatology, Ninewells Hospital and Medical School, Dundee, United Kingdom

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