Primary care

Randomised controlled trial of short bursts of a potent topical corticosteroid versus prolonged use of a mild preparation for children with mild or moderate atopic eczema

K S Thomas, trial coordinator, ^a S Armstrong, lecturer in medical statistics, ^c A Avery, professor of primary healthcare, ^b A Li Wan Po, professor of clinical pharmaceutics, ^d C O'Neill, reader in health economics and policy, ^e S Young, director, ^f H C Williams, professor of dermatoepidemiology. ^a

^a Centre of Evidence-Based Dermatology, Queen's Medial Centre, Nottingham NG7 2UH, ^b Division of General Practice, Queen's Medical Centre, ^c Trent Institute for Health Services Research, Queen's Medical Centre, Nottingham NG12 2HJ, ^d Centre for Evidence Based Pharmacotherapy, Aston University, Birmingham B4 ET, ^e School of Public Policy, Law and Economics, University of Ulster and Harkness, Newtonabbey, Northern Ireland, ^f Tissue Viability Unit, Nuffield House, Guy's Hospital, London SE1 1YR

Correspondence to: H C Williams hywel.williams{at}nottingham.ac.uk

Objective: To determine whether a three day burst of a potent corticosteroid is more effective than a mild preparation used for seven days in children with mild or moderate atopic eczema.
Design: Randomised, double blind, parallel group study of 18 weeks' duration.
Setting: 13 general practices and a teaching hospital in the Nottingham area.
Participants: 174 children with mild or moderate atopic eczema recruited from general practices and 33 from a hospital outpatient clinic.
Interventions: 0.1% betamethasone valerate applied for three days followed by the base ointment for four days versus 1% hydrocortisone applied for seven days.
Main outcome measures: Primary outcomes were total number of scratch-free days and number of relapses. Secondary outcomes were median duration of relapses, number of undisturbed nights, disease severity (six area, six sign atopic dermatitis severity scale), scores on two quality of life measures (children's life quality index and dermatitis family impact questionnaire), and number of patients in whom treatment failed in each arm.
Results: No differences were found between the two groups. This was consistent for all outcomes. The median number of scratch-free days was 118.0 for the mild group and 117.5 for the potent group (difference 0.5, 95% confidence interval 2.0 to 4.0, P=0.53). The median number of relapses for both groups was 1.0. Both groups showed clinically important improvements in disease severity and quality of life compared with baseline.
Conclusion: A short burst of a potent topical corticosteroid is just as effective as prolonged use of a milder preparation for controlling mild or moderate atopic eczema in children.