Effectiveness of alpine climate treatment for children with difficult to treat atopic dermatitis: results of a pragmatic randomized controlled trial (DAVOS trial)

Abstract

Background

Alpine climate treatment has historically been used in Europe to treat atopic dermatitis (AD), but no randomized trials have been conducted to provide evidence for its effectiveness.

Objective

To investigate the long-term effectiveness of alpine climate treatment for children with difficult to treat AD.

Materials & Methods

A pragmatic, open, randomized controlled trial was conducted. Children diagnosed with AD that was considered difficult to treat, aged between 8 and 18 years and willing to be treated in Switzerland were randomized to a six week personalized integrative multidisciplinary treatment period in a clinical setting in the alpine climate (Switzerland) or an outpatient setting in moderate maritime climate (Netherlands). Study assessments were conducted at the Wilhelmina Children's Hospital; an electronic portal was used for the collection of questionnaire data.

Primary outcomes were disease activity (SAEASI), quality of life (CDLQI), and catastrophizing thoughts (JUCKKI/JU) six months after intervention. Other assessments were immediately and six weeks after intervention. Subgroup analyses concerned asthma-related outcomes. Children were randomly assigned to either the intervention or control group using a covariate adaptive randomization method, taking age and asthma diagnosis into account. Children, parents, and health care professionals involved in treatment were not blinded to group assignment. Data were analyzed according to intention-to-treat with linear mixed effects models for continuous outcomes. The trial is registered at Current Controlled Trials ISCRTN88136485.

Results

Between September 14^th 2010 and September 30^th 2014, 88 children were enrolled in the trial, 84 children were randomized (41 assigned to intervention, 43 to control) of whom 77 completed the intervention (38/41 (93%) intervention, 39/43 (91%) control) and 74 completed follow-up (38/41 (93%) intervention, 36/43 (84%) control). Six months after intervention there were no significant differences between the groups on disease activity (SAEASI mean difference -3.4 (95%CI -8.5 to 1.7)), quality of life (CDLQI mean difference -0.3 (95%CI -2.0 to 1.4)), and catastrophizing thoughts (JUCCKI/JU subscale mean difference -0.7 (95%CI -1.4 to -0.0)). Immediately and six weeks after intervention, disease activity and quality of life were significantly different in favor of alpine climate treatment. Mean differences on SAEASI were -10.1 (95%CI -14.5 to -5.8) and -8.4 (95%CI -12.2 to -4.6) and on CDLQI -1.9 (95%CI -3.3 to -0.5) and -1.5 (95%CI -2.8 to -0.3) immediately and six weeks after the intervention, respectively. There were no long-term differences on asthma related outcomes. Five serious adverse events occurred during the study period, which were not thought to be related to the treatment.

Conclusions & Clinical relevance

For children with difficult to treat AD, there was no additional long-term benefit of alpine climate treatment, in contrast to the short-term, compared to an outpatient treatment program in moderate maritime climate, using a personalized integrative multidisciplinary treatment approach.

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