NIHR Signal Silk clothing for children does not reduce objective measures of eczema severity

Published on 22 August 2017

Six months of wearing special silk clothing had no effect on objective measures of child eczema severity, infection rates or medication use. Children and carers reported some small improvements in eczema severity on two scales but their awareness of the clothing worn by their child may have slightly influenced their judgment. Overall quality of life did not significantly improve.

Specialist silk clothing is currently available on NHS prescription, but prior to this trial there was limited evidence to guide its use.

The findings from this NIHR funded trial indicate that silk clothing is not very effective, and at almost £60,000 per year of quality-adjusted life gained, the clothing does not meet the cost effectiveness thresholds that are used as a guide to whether they are value for money if used in the NHS.

Most participants were happy to wear silk clothing and some parents felt that it had improved their child’s symptoms, so the garments are likely to be still available for purchase.

Silk clothing for children does not reduce objective measures of eczema severity

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Why was this study needed?

Eczema is an inflammatory skin condition that leads to dry, cracked, blistered and itchy skin. It is typically managed using moisturisers (emollients) and mild corticosteroids applied to the skin.

People with severe eczema or who have serious “flare ups” may require more intensive treatments such as oral corticosteroids and regular use of bandages to protect the skin. Severe eczema can be distressing and the broken skin can get infected.

Around 10% of children will experience eczema and parents or carers are often keen to manage symptoms to prevent the need for strong medications. One option is specialist silk clothing, which is designed not to irritate or damage the skin. Silk clothing is available on prescription via the NHS or to buy privately, however, there is limited evidence for its effectiveness.

What did this study do?

The CLOTHing for the relief of Eczema Symptoms (CLOTHES) trial randomised 300 children aged one to 15 years with moderate to severe eczema to either continue usual eczema care (moisturising creams, corticosteroid creams) or to wear specialist silk clothing in addition to usual care.

Participants were recruited via five centres around the UK, through secondary or primary care. Some self-referred after seeing adverts. Most participants were white (79%), over half were male (58%) and their average age was five years.

The 100% silk garments were made from antimicrobially protected material and supplied free to participants. Each received three sets of garments to be worn for up to six months (day and night). At six months the standard care group received the garments to use for the remaining two-month observational period.

Nurses assessing eczema severity were not aware of whether the child was using silk clothing or not, to reduce the chance that knowing this could bias their assessment. Participants and their families were aware of which group they had been allocated to and this may have influenced their assessments of the severity of their child’s eczema.

What did it find?

  • Eczema severity on the 72-point Eczema Area and Severity Index scale did not differ significantly between silk clothing and usual care groups at any time point. Baseline (9.2 vs 8.4), two months (6.4 vs 6.6), four months (5.8 vs 6.0) and six months (both 5.4) follow-up.
  • Participant-reported eczema severity on the 28-point Patient-Orientated Eczema Measure scale was lower in the silk group by six months (adjusted mean difference ‑2.8, 95% confidence interval [CI] ‑3.9 to ‑1.8).
  • Rates of skin infection were similar for usual care (28%) and silk clothing (25%). There were also no between-group differences in frequency or types of medication used, or health-related quality of life on any scale.
  • Participants generally wore the clothing as recommended. 82% wore the garments at least 50% of the time; compliance was higher at night-time (81% of nights) than daytime (34%). The clothing was considered acceptable to participants, 70% of whom were happy to wear them. There were some concerns raised about poor durability (45.5% of participants had at least one item replaced in six months) and fit, which could affect whether people wear them or not.
  • The silk clothing cost £318.52, which combined with other healthcare costs have an average (mean) cost of £364.94 (95% CI £217.47 to £512.42) per participant. The adjusted mean difference in QALY per participant was 0.0064 (95% CI –0.0004 to 0.0133). The modelling of costs and health benefits gave an extra cost of £56,811 per quality adjusted life year gained, which is higher than the £20,000 to £30,000 NICE uses as an indicative threshold for cost effectiveness.

What does current guidance say on this issue?

NICE guidance from 2007 on managing eczema in under 12s recommends that treatment is tailored according to the severity of eczema (“stepped care”). Mild eczema is managed using emollients (moisturising creams) and mild corticosteroids applied to the skin.

Treatment of moderate eczema includes moderate topical corticosteroids and the potential addition of calcineurin inhibitors (anti-inflammatory creams) and bandages. Severe eczema is managed in the same way, but using stronger topical corticosteroids, and potentially phototherapy (using UV light) or systemic therapy using oral corticosteroids or ciclosporin (which suppresses the immune system).

There are no recommendations regarding specialist silk clothing.

What are the implications?

Prescribing specialist silk clothing does not improve eczema severity or quality of life for those that suffer sufficiently to justify its cost to the NHS.

Silk clothing is available via prescription currently, but this study suggests that the commissioning or funding priorities could be reviewed because of the overall cost of the garments and lack of evidence on clinical effectiveness.

Citation and Funding

Thomas KS, Bradshaw LE, Sach TH, et al. Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial. HealthTechnol Assess. 2017;21(16):1-260.

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 11/65/01).

Bibliography

British Skin Foundation. Eczema (atopic eczema). London: British Skin Foundation.

DermNet NZ. EASI score. Hamilton (NZ): DermNet NZ; 2015.

NHS Choices. Atopic eczema. London: Department of Health; 2016.

NICE. Atopic eczema in under 12s: diagnosis and management. CG57. London: National Institute for Health and Care Excellence; 2007.

The University of Nottingham. How to use EASI. Nottingham: The University of Nottingham; 2014.

The University of Nottingham. POEM: patient-oriented eczema measure. Nottingham: The University of Nottingham; 2015.

Why was this study needed?

Eczema is an inflammatory skin condition that leads to dry, cracked, blistered and itchy skin. It is typically managed using moisturisers (emollients) and mild corticosteroids applied to the skin.

People with severe eczema or who have serious “flare ups” may require more intensive treatments such as oral corticosteroids and regular use of bandages to protect the skin. Severe eczema can be distressing and the broken skin can get infected.

Around 10% of children will experience eczema and parents or carers are often keen to manage symptoms to prevent the need for strong medications. One option is specialist silk clothing, which is designed not to irritate or damage the skin. Silk clothing is available on prescription via the NHS or to buy privately, however, there is limited evidence for its effectiveness.

What did this study do?

The CLOTHing for the relief of Eczema Symptoms (CLOTHES) trial randomised 300 children aged one to 15 years with moderate to severe eczema to either continue usual eczema care (moisturising creams, corticosteroid creams) or to wear specialist silk clothing in addition to usual care.

Participants were recruited via five centres around the UK, through secondary or primary care. Some self-referred after seeing adverts. Most participants were white (79%), over half were male (58%) and their average age was five years.

The 100% silk garments were made from antimicrobially protected material and supplied free to participants. Each received three sets of garments to be worn for up to six months (day and night). At six months the standard care group received the garments to use for the remaining two-month observational period.

Nurses assessing eczema severity were not aware of whether the child was using silk clothing or not, to reduce the chance that knowing this could bias their assessment. Participants and their families were aware of which group they had been allocated to and this may have influenced their assessments of the severity of their child’s eczema.

What did it find?

  • Eczema severity on the 72-point Eczema Area and Severity Index scale did not differ significantly between silk clothing and usual care groups at any time point. Baseline (9.2 vs 8.4), two months (6.4 vs 6.6), four months (5.8 vs 6.0) and six months (both 5.4) follow-up.
  • Participant-reported eczema severity on the 28-point Patient-Orientated Eczema Measure scale was lower in the silk group by six months (adjusted mean difference ‑2.8, 95% confidence interval [CI] ‑3.9 to ‑1.8).
  • Rates of skin infection were similar for usual care (28%) and silk clothing (25%). There were also no between-group differences in frequency or types of medication used, or health-related quality of life on any scale.
  • Participants generally wore the clothing as recommended. 82% wore the garments at least 50% of the time; compliance was higher at night-time (81% of nights) than daytime (34%). The clothing was considered acceptable to participants, 70% of whom were happy to wear them. There were some concerns raised about poor durability (45.5% of participants had at least one item replaced in six months) and fit, which could affect whether people wear them or not.
  • The silk clothing cost £318.52, which combined with other healthcare costs have an average (mean) cost of £364.94 (95% CI £217.47 to £512.42) per participant. The adjusted mean difference in QALY per participant was 0.0064 (95% CI –0.0004 to 0.0133). The modelling of costs and health benefits gave an extra cost of £56,811 per quality adjusted life year gained, which is higher than the £20,000 to £30,000 NICE uses as an indicative threshold for cost effectiveness.

What does current guidance say on this issue?

NICE guidance from 2007 on managing eczema in under 12s recommends that treatment is tailored according to the severity of eczema (“stepped care”). Mild eczema is managed using emollients (moisturising creams) and mild corticosteroids applied to the skin.

Treatment of moderate eczema includes moderate topical corticosteroids and the potential addition of calcineurin inhibitors (anti-inflammatory creams) and bandages. Severe eczema is managed in the same way, but using stronger topical corticosteroids, and potentially phototherapy (using UV light) or systemic therapy using oral corticosteroids or ciclosporin (which suppresses the immune system).

There are no recommendations regarding specialist silk clothing.

What are the implications?

Prescribing specialist silk clothing does not improve eczema severity or quality of life for those that suffer sufficiently to justify its cost to the NHS.

Silk clothing is available via prescription currently, but this study suggests that the commissioning or funding priorities could be reviewed because of the overall cost of the garments and lack of evidence on clinical effectiveness.

Citation and Funding

Thomas KS, Bradshaw LE, Sach TH, et al. Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial. HealthTechnol Assess. 2017;21(16):1-260.

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 11/65/01).

Bibliography

British Skin Foundation. Eczema (atopic eczema). London: British Skin Foundation.

DermNet NZ. EASI score. Hamilton (NZ): DermNet NZ; 2015.

NHS Choices. Atopic eczema. London: Department of Health; 2016.

NICE. Atopic eczema in under 12s: diagnosis and management. CG57. London: National Institute for Health and Care Excellence; 2007.

The University of Nottingham. How to use EASI. Nottingham: The University of Nottingham; 2014.

The University of Nottingham. POEM: patient-oriented eczema measure. Nottingham: The University of Nottingham; 2015.

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Published on 11 April 2017

Thomas K S, Bradshaw L E, Sach T H, Cowdell F, Batchelor J M, Lawton S, Harrison E F, Haines R H, Ahmed A, Dean T, Burrows N P, Pollock I, Buckley H K, Williams H C, Llewellyn J, Crang C, Grundy J D, Guiness J, Gribbin A, Wake E V, Mitchell E J, Brown S J & Montgomery A A.

Health Technology Assessment Volume 21 Issue 16 , 2017

Background Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood. Objectives To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease. Design Parallel-group, observer-blind, randomised controlled trial of 6 months’ duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE. Setting Secondary care and the community in five UK centres. Participants Children aged 1–15 years with moderate or severe AE. Interventions Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilkTM (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkinTM (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period. Main outcome measures Primary outcome – AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes – patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility – 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes – number of skin infections and hospitalisations for AE. Results A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of –1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds. Limitations Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes. Conclusions The addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making. Future work Non-pharmacological interventions for the management of AE remain a research priority among patients. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.

Expert commentary

The CLOTHES study was a well-designed randomised controlled trial which provided the clear conclusion that silk garments provide little benefit for the treatment of atopic eczema in children. Additionally, there was no evidence that silk garments reduced the risk of infection in atopic eczema.

These findings are important because silk garments are expensive and the money could be more effectively used to enhance alternative evidence based aspects of eczema care. Additionally, for parents and children alike, the notion of wearing garments to treat their atopic eczema may detract from the focus on practising important topical treatments where we know the intervention is beneficial.

Whilst the silk clothing did not lead to a clinical improvement in atopic eczema, it is worth noting that 70% of families felt that they were satisfied or very satisfied with the garments, suggesting that they may offer some utility as comfortable clothing for those with sensitive skin as found in those with atopic eczema.

Dr Michael Ardern-Jones, Associate Professor, Consultant Dermatologist, University of Southampton

Expert commentary

Overheating at night is a trigger factor in most children’s eczema, and sleep loss in children and parents is a major contributor to quality of life impairment in eczema. Given that sleep deprivation is linked to loss of productivity at work, these garments whilst expensive had the possibility of being cost effective in health economic terms.

Given these costs, it is important that this large well designed pragmatic study has failed to show evidence of benefit in children with moderate to severe eczema in terms of severity, quality of life and topical steroid use demonstrating that routine use of silk garments for management of eczema is not justified.

Dr Paula Beattie, Consultant Dermatologist, Royal Hospital for Children, Glasgow

Categories

  •   Child Health, Haematological and immunological disorders, Skin conditions, Acute and general medicine