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

• Published in: Clinical and experimental allergy 2018-02, Vol.48 (2), p.186-195
• Main Authors: Fieten, K. B., Schappin, R., Zijlstra, W. T., Figee, L., Beutler, J., Raymakers, F., Os‐Medendorp, H., Stellato, R., Vandewall, M., Winkelhof, J., Uniken Venema, M., Bruijnzeel‐Koomen, C. A. F. M., Rijssenbeek‐Nouwens, L., Ent, C. K., Hoffen, E., Meijer, Y., Pasmans, S. G. M. A.
• Format: Article
• Language: English
• Subjects: Adolescent; Alpine environments; Altitude; Anti-Asthmatic Agents - pharmacology; Anti-Asthmatic Agents - therapeutic use; Asthma; Atopic dermatitis; Child; Children; Climate; Climate effects; Climatotherapy; Clinical trials; Data processing; Dermatitis; Dermatitis, Atopic - diagnosis; Dermatitis, Atopic - epidemiology; Dermatitis, Atopic - therapy; Drug Resistance; Eczema; environment and hygiene hypothesis; Environmental assessment; Historical account; Humans; Medical personnel; Motivation; multidisciplinary; pediatrics; Quality of Life; Randomization; rct; rhinitis; Surveys and Questionnaires; Switzerland; Treatment Outcome
• ISSN: 0954-7894; 1365-2222
• DOI: 10.1111/cea.13058

Summary 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) 6 months after intervention. Other assessments were immediately and 6 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 healthcare professionals involved in treatment were not blinded to group assignment. Data were analysed according to intention‐to‐treat with linear mixed‐effects models for continuous outcomes. The trial is registered at Current Controlled Trials ISCRTN88136485. Results Between 14 September 2010 and 30 September 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 of 41 (93%) intervention, 39 of 43 (91%) control) and 74 completed follow‐up (38 of 41 (93%) intervention, 36 of 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 6 weeks after intervention, disease activity and quality of life were significantly different in favour of alpine climate treatment. Mean differences on SAEASI were −10.1 (95%CI −14.5 to −5.8) and −8.4