A Randomized Double-Blind Study to Investigate the Clinical Efficacy of Adding a Non-Migrating Antimicrobial to a Special Silk Fabric in the Treatment of Atopic Dermatitis

Stinco, Giuseppe; Piccirillo, Fabio; Valent, Francesca

doi:10.1159/000141648

Cited by 44 publications

(30 citation statements)

References 26 publications

(13 reference statements)

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“…In the study by Stinco and colleagues, 339 both the severity of eczema under the area covered by the fabrics and participant-assessed itching were significantly better with DermaSilk fabric than with the same fabric without the impregnated antimicrobial. The difference in the pruritus score was 1.88 SD ± 1.7 (p < 0.0001) on a 10-point VAS and the difference in severity measured by the SCORAD index was a reduction of 10.98 SD ± 11.9 (p < 0.0001) more in the DermaSilk group than in the DermaSilk without antimicrobial group.…”

Section: Benefitsmentioning

confidence: 92%

“…The two studies on DermaSilk by Koller and colleagues 338 and Stinco and colleagues 339 reported that there were no adverse events during the study periods. The trial by Fontanini and colleagues 340 did not report information about adverse events.…”

Section: Harmsmentioning

confidence: 95%

“…[338][339][340] In 2007, Koller and colleagues 338 published a trial comparing DermaSilk arm tubes against ordinary silk arm tubes. Twenty-two children with mild to moderate eczema were included in the trial.…”

Section: Silkmentioning

confidence: 99%

“…A double-blind, within-person randomised trial by Stinco and colleagues 339 published in 2008 compared DermaSilk sleeves against the same fabric without the impregnated antimicrobial for 28 days in 30 children and adults with eczema. The ages of the participants ranged from 3 to 31 years.…”

Section: Silkmentioning

confidence: 99%

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Scoping systematic review of treatments for eczema

Nankervis

Kim

Delamere

et al. 2016

Programme Grants Appl Res

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BackgroundEczema is a very common chronic inflammatory skin condition.ObjectivesTo update the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) systematic review of treatments for atopic eczema, published in 2000, and to inform health-care professionals, commissioners and patients about key treatment developments and research gaps.Data sourcesElectronic databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Skin Group Specialised Register, Latin American and Caribbean Health Sciences Literature (LILACS), Allied and Complementary Medicine Database (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL) were searched from the end of 2000 to 31 August 2013. Retrieved articles were used to identify further randomised controlled trials (RCTs).Review methodsStudies were filtered according to inclusion criteria and agreed by consensus in cases of uncertainty. Abstracts were excluded and non-English-language papers were screened by international colleagues and data were extracted. Only RCTs of treatments for eczema were included, as other forms of evidence are associated with higher risks of bias. Inclusion criteria for studies included availability of data relevant to the therapeutic management of eczema; mention of randomisation; comparison of two or more treatments; and prospective data collection. Participants of all ages were included. Eczema diagnosis was determined by a clinician or according to published diagnostic criteria. The risk of bias was assessed using the Cochrane Collaboration risk-of-bias tool. We used a standardised approach to summarising the data and the assessment of risk of bias and we made a clear distinction between what the studies found and our own interpretation of study findings.ResultsOf 7198 references screened, 287 new trials were identified spanning 92 treatments. Trial reporting was generally poor (randomisation method: 2% high, 36% low, 62% unclear risk of bias; allocation concealment: 3% high, 15% low, 82% unclear risk of bias; blinding of the intervention: 15% high, 28% low, 57% unclear risk of bias). Only 22 (8%) trials were considered to be at low risk of bias for all three criteria. There was reasonable evidence of benefit for the topical medications tacrolimus, pimecrolimus and various corticosteroids (with tacrolimus superior to pimecrolimus and corticosteroids) for both treatment and flare prevention; oral ciclosporin; oral azathioprine; narrow band ultraviolet B (UVB) light; Atopiclair™ and education. There was reasonable evidence to suggest no clinically useful benefit for twice-daily compared with once-daily topical corticosteroids; corticosteroids containing antibiotics for non-infected eczema; probiotics; evening primrose and borage oil; ion-exchange water softeners; protease inhibitor SRD441 (Serentis Ltd); furfuryl palmitate in emollient; cipamfylline cream; andMycobacterium vaccaevaccine. Additional research evidence is needed for emollients, bath additives, antibacterials, specialist clothing and complementary and alternative therapies. There was no RCT evidence for topical corticosteroid dilution, impregnated bandages, soap avoidance, bathing frequency or allergy testing.LimitationsThe large scope of the review coupled with the heterogeneity of outcomes precluded formal meta-analyses. Our conclusions are still limited by a profusion of small, poorly reported studies.ConclusionsAlthough the evidence base of RCTs has increased considerably since the last NIHR HTA systematic review, the field is still severely hampered by poor design and reporting problems including failure to register trials and declare primary outcomes, small sample size, short follow-up duration and poor reporting of risk of bias. Key areas for further research identified by the review include the optimum use of emollients, bathing frequency, wash products, allergy testing and antiseptic treatments. Perhaps the greatest benefit identified is the use of twice weekly anti-inflammatory treatment to maintain disease remission. More studies need to be conducted in a primary care setting where most people with eczema are seen in the UK. Future studies need to use the same core set of outcomes that capture patient symptoms, clinical signs, quality of life and the chronic nature of the disease.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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Section: Benefitsmentioning

confidence: 92%

Section: Harmsmentioning

confidence: 95%

Section: Silkmentioning

confidence: 99%

Section: Silkmentioning

confidence: 99%

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Scoping systematic review of treatments for eczema

Nankervis

Kim

Delamere

et al. 2016

Programme Grants Appl Res

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“…The review found two small RCTs of silk clothing, 353,354 but these were too small (22 and 30 participants, respectively) and of too limited a duration (12 and 4 weeks, respectively) to be able to inform clinical practice. The NIHR HTA systematic review of treatments for eczema 224 has now been updated as described in the first section of this report (see Chapter 1), but no additional RCTs on the use of silk clothing have been identified.…”

Section: What Did This Study Add?mentioning

confidence: 99%

A programme of research to set priorities and reduce uncertainties for the prevention and treatment of skin disease

Kim

Batchelor

Bath‐Hextall

et al. 2016

Programme Grants Appl Res

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Programme Grants for Applied ResearchISSN 2050-4322 (Print) ISSN 2050-4330 (Online) This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: nihredit@southampton.ac.ukThe full PGfAR archive is freely available to view online at www.journalslibrary.nihr.ac.uk/pgfar. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Programme Grants for Applied Research journalReports are published in Programme Grants for Applied Research (PGfAR) if (1) they have resulted from work for the PGfAR programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. Programme Grants for Applied Research programmeThe Programme Grants for Applied Research (PGfAR) programme, part of the National Institute for Health Research (NIHR), was set up in 2006 to produce independent research findings that will have practical application for the benefit of patients and the NHS in the relatively near future. The Programme is managed by the NIHR Central Commissioning Facility (CCF) with strategic input from the Programme Director.The programme is a national response mode funding scheme that aims to provide evidence to improve health outcomes in England through promotion of health, prevention of ill health, and optimal disease management (including safety and quality), with particular emphasis on conditions causing significant disease burden.For more information about the PGfAR programme please visit the website: http://www.nihr.ac.uk/funding/programme-grants-forapplied-research.htm This reportThe research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0407-10177. The contractual start date was in September 2008. The final report began editorial review in April 2014 and was accepted for publication in April 2016. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, NETSCC, PGfAR or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, ...

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