Findings from the Best Emollients for Eczema randomised trial comparing four types of emollients in children with eczema

Conference: 
SAPC ASM 2021 - virtual
Talk Code: 
4A.2
Presenter: 
Matthew Ridd
Twitter: 
@riddmj
Co-authors: 
Miriam Santer,2 Stephanie MacNeill,3 Emily Sanderson, 3 Sian Wells, 1Jonathan Banks,4 Alison R G Shaw, 1Eileen Sutton, 1Amanda Roberts,5 Julie Clayton,1 Kirsty Garfield,3 Lyn Liddiard, 1 Tiffany J Barrett,6 J Athene Lane, 3 Helen Baxter,1 Laura Howells,7 Jodi Taylor,3 Alastair D Hay, 1 Hywel C Willi
Author institutions: 
1 Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK 2 Primary Care and Population Sciences, University of Southampton, Southampton, UK 3 Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK 4 National Institute for Health Research Applied Research Collaborative West (NIHR ARC West), University Hospitals Bristo

Problem

Eczema affects ~20% of children and emollients are the mainstay of treatment. However, there are many products and weak evidence that any one is better than another. Consequently, a “trial and error” approach to prescribing is commonplace, causing frustration and waste. In the 2013 James Lind Alliance eczema research prioritisation exercise, “Which emollients are the most effective and safe in treating eczema?” was one of the highest ranked uncertainties. We have completed a randomised trial comparing the effectiveness and acceptability of the four most commonly prescribed types of lotion, cream, gel and ointment.

Approach

The BEE study is a pragmatic, multicentre, individually randomised, parallel group superiority trial. To be eligible, children had to be >6 months and <12 years of age, with eczema of at least mild severity, and no known sensitivity to the study emollients. Invitation was via GP surgeries in West of England, Wessex, and East Midlands Clinical Research Networks. Participants were randomised to one of the four types of study-approved emollient to use as their only “leave-on” moisturiser for 16 weeks (the primary outcome period). However, if the family had problems with or disliked their allocated emollient, they could stop it and seek an alternative from their GP. Participants were followed-up for 52-weeks. Data were collected on eczema symptoms (POEM – Patient Orientated Eczema Measure, primary outcome), signs (Eczema Area Severity Index, by masked researcher), adverse events, and quality of life. We estimated that 416 participants (520 allowing for 20% loss to follow-up) were required to detect a clinically important difference of 3.0 in POEM scores between any two groups with 90% power and a significance level of 0.05 (after adjustment for multiple pairwise comparisons). Analysis is by intention-to-treat, using linear mixed models for repeated measures. Ethical approval: NHS REC (South West - Central Bristol Research Ethics Committee 17/SW/0089. Trial registration: ISRCTN84540529.

Findings

We exceeded our recruitment target, and 550 children were recruited via 77 GP surgeries. At baseline, 46.4% (255) were female, with a mean age of (SD) 4.9 (3.2) years and POEM score of 9.3 (5.5) – indicating moderately severe disease. Follow-up was 76.7% at 16 weeks and 66.0% at 52 weeks. Electronic medical record data was obtained on 95.3% of participants. Analyses are underway and the findings will be presented at the July meeting.

Consequences

This is the first head-to-head pragmatic trial comparing commonly prescribed emollients for children with eczema. The findings will inform shared decision-making about which emollient to try first, whilst supporting patient choice and access to effective treatments.

Submitted by: 
Matthew Ridd
Funding acknowledgement: 
Funded by the NIHR Health Technology Assessment (15/130/07). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.