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Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness

Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness
Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness
Objectives: to determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children.

Design: pragmatic randomised open label superiority trial with two parallel groups.

Setting:96 general practices in Wales and western and southern England.

Participants: 483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded.

Interventions: participants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants.

Main outcome measures: the primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed.

Results:483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean 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. 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 groups over 16 weeks. After controlling for baseline severity and confounders (ethnicity, topical corticosteroid use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additives group were 0.41 points higher than in the bath additives group (95% confidence interval −0.27 to 1.10), below the published minimal clinically important difference for POEM of 3 points. The groups did not differ in secondary outcomes, economic outcomes, or adverse effects.

Conclusions: this trial found no evidence of clinical benefit from including emollient bath additives in the standard management of eczema in children. Further research is needed into optimal regimens for leave-on emollient and soap substitutes.

Trial registration Current Controlled Trials ISRCTN84102309.
0959-8138
143-145
Santer, Miriam
3ce7e832-31eb-4d27-9876-3a1cd7f381dc
Ridd, Matthew
2f15120c-d5fa-4f5d-bb86-21356e034df7
Francis, Nick
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Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Rumsby, Kate
2002ee8a-32ac-4119-869d-ed35164c3b51
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Becque, Taeko
ecd1b4d5-4db8-4442-81c2-04aa291cf2fd
Roberts, Amanda
e6039287-3653-43e2-84ce-22b27db8640d
Liddiard, Lyn
c71daeff-4914-49bc-af95-b1823798c8f3
Nollett, Claire
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Hooper, Julie
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Prude, Martina
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Wood, Wendy
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Thomas, Kim
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Thomas-Jones, Emma
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Williams, Hywel
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Little, Paul
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Santer, Miriam
3ce7e832-31eb-4d27-9876-3a1cd7f381dc
Ridd, Matthew
2f15120c-d5fa-4f5d-bb86-21356e034df7
Francis, Nick
9b610883-605c-4fee-871d-defaa86ccf8e
Stuart, Beth
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Rumsby, Kate
2002ee8a-32ac-4119-869d-ed35164c3b51
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Becque, Taeko
ecd1b4d5-4db8-4442-81c2-04aa291cf2fd
Roberts, Amanda
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Liddiard, Lyn
c71daeff-4914-49bc-af95-b1823798c8f3
Nollett, Claire
488a5583-503e-4bb8-8a01-6a7cafd917c7
Hooper, Julie
45d8565c-aacc-433e-8bb4-1d06d3113ed4
Prude, Martina
ede98eab-1027-4a21-a38c-3bccb7c71e06
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Thomas, Kim
bc1408a5-4aaf-400d-ae9a-f5b72ecaf559
Thomas-Jones, Emma
bfbcac97-4d15-4c2c-8a4e-8b151805b318
Williams, Hywel
96eef11e-c789-4935-88c5-704bdab18cf3
Little, Paul
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Santer, Miriam, Ridd, Matthew, Francis, Nick, Stuart, Beth, Rumsby, Kate, Chorozoglou, Maria, Becque, Taeko, Roberts, Amanda, Liddiard, Lyn, Nollett, Claire, Hooper, Julie, Prude, Martina, Wood, Wendy, Thomas, Kim, Thomas-Jones, Emma, Williams, Hywel and Little, Paul (2018) Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness. BMJ, 361 (k1791), 143-145, [k1332]. (doi:10.1136/bmj.k1332).

Record type: Article

Abstract

Objectives: to determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children.

Design: pragmatic randomised open label superiority trial with two parallel groups.

Setting:96 general practices in Wales and western and southern England.

Participants: 483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded.

Interventions: participants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants.

Main outcome measures: the primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed.

Results:483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean 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. 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 groups over 16 weeks. After controlling for baseline severity and confounders (ethnicity, topical corticosteroid use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additives group were 0.41 points higher than in the bath additives group (95% confidence interval −0.27 to 1.10), below the published minimal clinically important difference for POEM of 3 points. The groups did not differ in secondary outcomes, economic outcomes, or adverse effects.

Conclusions: this trial found no evidence of clinical benefit from including emollient bath additives in the standard management of eczema in children. Further research is needed into optimal regimens for leave-on emollient and soap substitutes.

Trial registration Current Controlled Trials ISRCTN84102309.

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Accepted/In Press date: 14 March 2018
e-pub ahead of print date: 3 May 2018
Published date: 2018

Identifiers

Local EPrints ID: 420555
URI: http://eprints.soton.ac.uk/id/eprint/420555
ISSN: 0959-8138
PURE UUID: af956e6c-dd30-4a0f-879b-ddbcb4942027
ORCID for Miriam Santer: ORCID iD orcid.org/0000-0001-7264-5260
ORCID for Nick Francis: ORCID iD orcid.org/0000-0001-8939-7312
ORCID for Kate Rumsby: ORCID iD orcid.org/0000-0002-8573-3718

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Date deposited: 10 May 2018 16:30
Last modified: 27 Jan 2020 13:59

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Contributors

Author: Miriam Santer ORCID iD
Author: Matthew Ridd
Author: Nick Francis ORCID iD
Author: Beth Stuart
Author: Kate Rumsby ORCID iD
Author: Taeko Becque
Author: Amanda Roberts
Author: Lyn Liddiard
Author: Claire Nollett
Author: Julie Hooper
Author: Martina Prude
Author: Wendy Wood
Author: Kim Thomas
Author: Emma Thomas-Jones
Author: Hywel Williams
Author: Paul Little

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