Trial reportBMJ open2024
Effectiveness of potent topical corticosteroids versus mild ones in primary care for children with moderate flare-ups of atopic dermatitis; results of a randomised controlled trial.
Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the effectiveness of a potent topical corticosteroid (TCS) as an initial treatment in primary care for children with moderate flare-ups of atopic dermatitis (AD), compared to starting on a mild TCS.
designAn observational prospective cohort study with an embedded pragmatic multicentre open-label randomised controlled trial.
settingA total of 53 general practices in the southwest of the Netherlands took part in the study.
participants209 children aged 3 months to 17 years diagnosed with AD (International Classification of Primary Care codes S87 or S88) who visited their general practitioner (GP) for AD or received repeat prescriptions for AD in the previous 12 months were included in the cohort study through the general practices. Finally, 32 patients (15%) were randomised and assigned to the trial (13 girls; 19 boys; median age 4.0 years).
interventionsIf cohort participants experienced a moderate flare-up (ie, need to intensify topical treatment from the child's and/or parents' point of view of AD and a three-item severity score from three to<6 scored by their GP) during cohort follow-up, they were randomised to either the intervention group, a strong TCS (class III, fluticasone propionate 0.05%), or the control group, a mild TCS (class I, hydrocortisone acetate 1%). PRIMARY AND SECONDARY OUTCOME MEASURES: We measured outcomes at baseline and at 1, 4 and 24 weeks. The primary outcome was AD-related symptoms (Patient-Oriented Eczema Measure (POEM) score) measured over 24 weeks of follow-up. Secondary outcomes included the Eczema Area and Severity Index, the Investigators Global Assessment, quality of life (QoL), Patient Global Assessment, Numeric Itch Intensity Score and TCS use.
resultsThe primary outcome showed a significant difference in the POEM scores over 24 weeks of follow-up between the intervention group (n=17) and the control group (n=15) (3.3 vs 9.4, p=0.023). The potent TCS also significantly improved the POEM at 1 week (5.5 vs 12.0, p=0.042) and 4 weeks (4.3 vs 12.7, p=0.030). Improvement in the QoL was significant at 4 weeks (1.0 vs 4.5, p=0.014) and 24 weeks (0.0 vs 2.0, p=<0.000).
conclusionDespite the small sample size, the data suggests a clinical benefit from starting with a potent TCS rather than a mild TCS when a flare-up of AD is moderate.
trial registrationThe Netherlands National Trial Register: NTR6679.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.