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Meta-Analysis
. 2019 Oct 29;2019(10):CD003871.
doi: 10.1002/14651858.CD003871.pub3.

Interventions to reduce Staphylococcus aureus in the management of eczema

Susannah Mc George  1 , Sanja Karanovic  2 , David A Harrison  3 , Anjna Rani  4 , Andrew J Birnie  5 , Fiona J Bath-Hextall  6 , Jane C Ravenscroft  7 , Hywel C Williams  8
Affiliations
Meta-Analysis

Interventions to reduce Staphylococcus aureus in the management of eczema

Susannah Mc George et al. Cochrane Database Syst Rev. .

Abstract

Background: Staphylococcus aureus (S. aureus) can cause secondary infection in eczema, and may promote inflammation in eczema that does not look infected. There is no standard intervention to reduce S. aureus burden in eczema. It is unclear whether antimicrobial treatments help eczema or promote bacterial resistance. This is an update of a 2008 Cochrane Review.

Objectives: To assess the effects of interventions to reduce S. aureus for treating eczema.

Search methods: We updated our searches of the following databases to October 2018: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We searched five trials registers and three sets of conference proceedings. We checked references of trials and reviews for further relevant studies. We contacted pharmaceutical companies regarding ongoing and unpublished trials.

Selection criteria: Randomised controlled trials of products intended to reduce S. aureus on the skin in people diagnosed with atopic eczema by a medical practitioner. Eligible comparators were a similar treatment regimen without the anti-staphylococcal agent.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Our key outcomes were participant- or assessor-rated global improvement in symptoms/signs, quality of life (QOL), severe adverse events requiring withdrawal, minor adverse events, and emergence of antibiotic-resistant micro-organisms.

Main results: We included 41 studies (1753 analysed participants) covering 10 treatment categories. Studies were conducted mainly in secondary care in Western Europe; North America; the Far East; and elsewhere. Twelve studies recruited children; four, adults; 19, both; and six, unclear. Fifty-nine per cent of the studies reported the mean age of participants (range: 1.1 to 34.6 years). Eczema severity ranged from mild to severe. Many studies did not report our primary outcomes. Treatment durations ranged from 10 minutes to 3 months; total study durations ranged from 15 weeks to 27 months. We considered 33 studies at high risk of bias in at least one domain. We present results for three key comparisons. All time point measurements were taken from baseline. We classed outcomes as short-term when treatment duration was less than four weeks, and long-term when treatment was given for more than four weeks. Fourteen studies evaluated topical steroid/antibiotic combinations compared to topical steroids alone (infective status: infected (two studies), not infected (four studies), unspecified (eight studies)). Topical steroid/antibiotic combinations may lead to slightly greater global improvement in good or excellent signs/symptoms than topical steroid alone at 6 to 28 days follow-up (risk ratio (RR) 1.10, 95% confidence interval (CI) 1.00 to 1.21; 224 participants; 3 studies, low-quality evidence). There is probably little or no difference between groups for QOL in children, at 14 days follow-up (mean difference (MD) -0.18, 95% CI -0.40 to 0.04; 42 participants; 1 study, moderate-quality evidence). The subsequent results for this comparison were based on very low-quality evidence, meaning we are uncertain of their validity: severe adverse events were rare (follow-up: between 6 to 28 days): both groups reported flare of dermatitis, worsening of the condition, and folliculitis (325 participants; 4 studies). There were fewer minor adverse events (e.g. flare, stinging, itch, folliculitis) in the combination group at 14 days follow-up (218 participants; 2 studies). One study reported antibiotic resistance in children at three months follow-up, with similar results between the groups (65 participants; 1 study). Four studies evaluated oral antibiotics compared to placebo (infective status: infected eczema (two studies), uninfected (one study), one study's participants had colonisation but no clinical infection). Oral antibiotics may make no difference in terms of good or excellent global improvement in infants and children at 14 to 28 days follow-up compared to placebo (RR 0.80; 95% CI 0.18 to 3.50; 75 participants; 2 studies, low-quality evidence). There is probably little or no difference between groups for QOL (in infants and children) at 14 days follow-up (MD 0.11, 95% CI -0.10 to 0.32, 45 participants, 1 study, moderate-quality evidence). The subsequent results for this comparison were based on very low-quality evidence, meaning we are uncertain of their validity: adverse events requiring treatment withdrawal between 14 to 28 days follow-up were very rare, but included eczema worsening (both groups), loose stools (antibiotic group), and Henoch-Schönlein purpura (placebo group) (4 studies, 199 participants). Minor adverse events, including nausea, vomiting, diarrhoea, and stomach and joint pains, at 28 days follow-up were also rare and generally low in both groups (1 study, 68 infants and children). Antibiotic resistance at 14 days was reported as similar in both groups (2 studies, 98 infants and children). Of five studies evaluating bleach baths compared to placebo (water) or bath emollient (infective status: uninfected (two studies), unspecified (three studies)), one reported global improvement and showed that bleach baths may make no difference when compared with placebo at one month follow-up (RR 0.78, 95% CI 0.37 to 1.63; 36 participants; low-quality evidence). One study showed there is probably little or no difference in QOL at 28 days follow-up when comparing bleach baths to placebo (MD 0.90, 95% CI -1.32 to 3.12) (80 infants and children; moderate-quality evidence). We are uncertain if the groups differ in the likelihood of treatment withdrawals due to adverse events at two months follow-up (only one dropout reported due to worsening itch (placebo group)) as the quality of evidence was very low (1 study, 42 participants). One study reported that five participants in each group experienced burning/stinging or dry skin at two months follow-up, so there may be no difference in minor adverse events between groups (RR 1.00, 95% CI 0.35 to 2.87, 36 participants, low-quality evidence). Very low-quality evidence means we are also uncertain if antibiotic resistance at four weeks follow-up is different between groups (1 study, 80 participants ≤ 18 years).

Authors' conclusions: We found insufficient evidence on the effects of anti-staphylococcal treatments for treating people with infected or uninfected eczema. Low-quality evidence, due to risk of bias, imprecise effect estimates and heterogeneity, made pooling of results difficult. Topical steroid/antibiotic combinations may be associated with possible small improvements in good or excellent signs/symptoms compared with topical steroid alone. High-quality trials evaluating efficacy, QOL, and antibiotic resistance are required.

PubMed Disclaimer

Conflict of interest statement

Susannah MC George: none known. Sanja Karanovic: none known. David A Harrison: none known. Anjna Rani: none known. Andrew J Birnie has received payment from Leo Pharma and Almirall for delivering lectures on skin cancer and sun damage. Almirall has covered meeting registration fee, plus travel and accommodation, for the American Academy of Dermatology meeting in March 2017. Fiona J Bath‐Hextall: none known. Jane C Ravenscroft: none known. Hywel C Williams: I am director of the NIHR HTA Programme. HTA is part of the NIHR which also supports the NIHR systematic reviews programme from which this work is funded. I was also a co‐applicant on a relevant clinical trial (SCIN trial) that is not yet published that sought to prevent hand eczema in nurses, funded by the National Institute of Health Research Health Technology Assessment Programme

Figures

1
1
Eczema. Copyright © 2009 Centre of Evidence Based Dermatology: reproduced with permission.
2
2
Study flow diagram.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

References

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References to studies awaiting assessment

ACTRN12610000438055 {published data only}
    1. ACTRN12610000438055. A randomised, double‐blind, placebo‐controlled phase I study to determine the safety and efficacy of recombinant human ß defensin 2 (rHuB[beta]D2 cream) in the treatment of staphylococcus aureus and other infections in the skin of patients with atopic dermatitis. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335452 (first received 6 May 2010).
EudraCT 2006‐004233‐15 {published data only}
    1. 2006‐004233‐15. Multicentric, randomized, double‐blinded, vehicle‐controlled, phase III‐bilateral comparative study for treatment of staphylococcus superinfection in atopic dermatitis with hydrophobic Triclosan‐cream 2% (InfectoDermaSept). www.clinicaltrialsregister.eu/ctr‐search/search?query=2006‐004233‐15 (first received 16 April 2009).
EudraCT 2008‐005890‐37 {published data only}
    1. 2008‐005890‐37. Assessment of the effects on barrier impairment, clinical features and bacterial colonization of topical formulations in patients with atopic eczema; a phase IIa, single‐center, randomized, observer‐blinded study. www.clinicaltrialsregister.eu/ctr‐search/search?query=2008‐005890‐37 (first received 20 October 2008).
NCT03009734 {published data only}
    1. NCT03009734. Evaluation of ATx201 as a topical antibiotic agent. clinicaltrials.gov/ct2/show/NCT03009734 (first received 20 March 2018).
NCT03047954 {published data only}
    1. NCT03047954. Broncho‐Vaxom (OM 85 BV) in children suffering from atopic dermatitis. clinicaltrials.gov/ct2/show/NCT03047954 (first received 9 February 2017).
Totté 2017 {published data only}
    1. NCT02840955. The effect of gladskin on disease severity and the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis. clinicaltrials.gov/ct2/show/NCT02840955 (first received 11 July 2016).
    1. Totté J, Wit J, Pardo L, Schuren F, Doorn M, Pasmans S. Targeted anti‐staphylococcal therapy with endolysins in atopic dermatitis and the effect on steroid use, disease severity and the microbiome: study protocol for a randomized controlled trial (MAAS trial). Trials 2017;18(1):404. [PUBMED: 28859690] - PMC - PubMed

References to ongoing studies

NCT03052348 {published data only}
    1. NCT03052348. Efficacy of combining topical antibiotic/steroid/moisturizer therapy compared to active comparator in atopic dermatitis. clinicaltrials.gov/ct2/show/NCT03052348 (first received 10 February 2017).

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