, et al
Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness
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Investigators from multiple institutions in the United Kingdom (UK) conducted a randomized controlled trial to assess the effectiveness of emollient bath additives as an adjunct treatment for children with eczema. Study participants were children 1–11 years old who fulfilled published UK diagnostic criteria for atopic dermatitis and were recruited at 96 UK practices. At enrollment, participants were randomized to use emollient bath additives or no bath additives for 52 weeks. All other eczema treatments were continued. Practices caring for children randomized to the active treatment group were recommended to prescribe Oilatum (63% light liquid paraffin), Balneum (85% soya oil), or Aveeno, but the specific product used was left to the clinician’s discretion. Parents of study participants completed the patient-oriented eczema measure (POEM) weekly for 16 weeks, and every 4 weeks subsequently. POEM is a validated measure to assess eczema severity, with possible scores ranging from 0 (clear) to 28 (severe). A minimally clinically relevant change in POEM score is considered to be 3 points. Data on age and ethnicity of study participants, use of soap substitutes, and number of baths per week were also collected. Information regarding office visits for eczema and other eczema treatments was abstracted from the study child’s medical record. The primary outcome was POEM score during the first 16 weeks of the trial. Secondary outcomes included POEM scores over 52 weeks and office visits for eczema. Regression analyses were used to compare primary outcomes between participants in the 2 groups. Regression models included baseline POEM scores, age, ethnicity, use of soap substitutes, and use of topical corticosteroids, and accounted for multiple measurements. Subgroup analyses, limited to children <5 years old and among those bathing >5 days per week, were also conducted.

A total of 483 children were enrolled in the study, including 265 in the intervention group (1 child withdrew) and 218 in the control group. Mean baseline POEM scores were 9.5 + 5.7 for those in the intervention group and 10.1 + 5.8 for controls. After adjusting for confounding variables and baseline POEM score, there was no significant difference in weekly POEM scores between children in the 2 treatment groups (difference = 0.41 points; 95% CI, −0.27, 1.10). There were also no differences between groups for secondary outcomes. POEM scores were significantly higher in controls than in those in the intervention group for the subgroup of children <5 years old (difference = 1.29 points; 95% CI, 0.33, 2.25), and in children who bathed >5 days per week (difference = 2.27 points; 95% CI, 0.63, 3.91), but the differences were less than the minimal clinically relevant change in POEM scores of 3 points.

The authors conclude that there was no clinical benefit to including bath emollients to standard...

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