Childhood eczema is a common condition that can have a substantial impact on quality of life for children and their families. Clinical guidelines recommend that total emollient therapy forms the main treatment with emollients applied by three ways, leave on creams, soap substitutes and bath emollients. There is evidence for the effectiveness of leave on emollients and clinical consensus on the use of soap substitutes, but uncertainty exists about the effectiveness of bath emollients with a lack of reliable evidence. Despite this lack of evidence, bath additives are widely prescribed at a cost of £23m per annum in the NHS in England.
The present trial was a pragmatic, multicentre, open-label parallel group design comparing emollient bath additives in addition to standard eczema care with standard care alone on childhood eczema. Participants were recruited from 96 general practices in Wales and England and eligible children were aged 1-11 years and excluded children with inactive or very mild eczema and who bathed less than once per week. Participants in the intervention group were prescribed bath additives and asked to use them regularly for 12 months. The control group were asked not to use bath additives for 12 months. The primary outcome was eczema severity measured by the patient oriented eczema measure (POEM) reported by parents or carers weekly over 16 weeks.
A total of 12,504 letters of invitation were sent to parents or carers and 1,451 responses were received. Overall, 662 met the eligibility criteria and were approached to participate and a total of 483 entered the trial. One participant subsequently withdrew giving a total randomised of 482 participants, comprising 264 participants in the intervention arm and 218 in the control arm. The groups were well balanced on a range of baseline characteristics. By contrast, the groups were clearly different according to bath additive use with 93% of participants in the intervention arm using bath additives all of the time or more than half of the time and in the control arm 92% of participants never used bath additives or used them less than half of the time.
The baseline POEM score was 9.5 (SD 5.7) in the bath additives group and 10.1 (SD 5.8) in the no bath additives group (POEM score range 0-28, the higher the score the more severe the eczema). The mean POEM score over the 16 week period was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group. No statistically significant difference was found in weekly POEM scores between the two groups over the 16 week period. In addition, no significant differences were seen between the groups for a range of secondary outcomes, including number of eczema exacerbations, or prescribing of flare up medication.
The authors conclude that the trial provides strong evidence that emollient bath additives provide minimal or no additional benefit beyond standard eczema care in the management of eczema in children.
You can read the full report here.