Adjuvant treatment with the bacterial lysate (OM-85) improves management of atopic dermatitis: A randomized study
| العنوان: | Adjuvant treatment with the bacterial lysate (OM-85) improves management of atopic dermatitis: A randomized study |
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| المؤلفون: | Jean-François Bach, Franck Boralevi, Christine Bodemer, Christian Milliet, Stefania Ballarini, Frédéric Cambazard, Paola Bertuccio, Yves de Prost, Carlo La Vecchia, Gérard Guillet |
| المصدر: | PLoS ONE PLoS ONE, Vol 12, Iss 3, p e0161555 (2017) |
| بيانات النشر: | Public Library of Science, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | 0301 basic medicine, Cell Extracts, Male, Eczema, lcsh:Medicine, Administration, Oral, Atopic Dermatitis, Pathology and Laboratory Medicine, law.invention, 030207 dermatology & venereal diseases, Immunologic Adjuvants, 0302 clinical medicine, Randomized controlled trial, law, Adrenal Cortex Hormones, Allergies, Medicine and Health Sciences, Prevalence, Public and Occupational Health, lcsh:Science, Child, Multidisciplinary, Allergic Diseases, Pharmaceutics, Incidence (epidemiology), Hazard ratio, Hygiene, Atopic dermatitis, Vaccination and Immunization, 3. Good health, Treatment Outcome, Tolerability, Child, Preschool, Female, Research Article, medicine.medical_specialty, Drug Research and Development, Immunology, Dermatology, Placebo, Research and Analysis Methods, Microbiology, Dermatitis, Atopic, 03 medical and health sciences, Signs and Symptoms, Drug Therapy, Double-Blind Method, Diagnostic Medicine, Internal medicine, medicine, Adjuvant therapy, Humans, Clinical Trials, Adjuvants, Pharmaceutic, Pharmacology, business.industry, Probiotics, Therapeutic effect, lcsh:R, Biology and Life Sciences, Infant, medicine.disease, 030104 developmental biology, Erythema, lcsh:Q, Clinical Immunology, Preventive Medicine, Dermatologic Agents, Clinical Medicine, business |
| الوصف: | Background Environmental factors play a major role on atopic dermatitis (AD) which shows a constant rise in prevalence in western countries over the last decades. The Hygiene Hypothesis suggesting an inverse relationship between incidence of infections and the increase in atopic diseases in these countries, is one of the working hypothesis proposed to explain this trend. Objective This study tested the efficacy and safety of oral administration of the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®), in the treatment of established AD in children. Methods Children aged 6 months to 7 years, with confirmed AD diagnosis, were randomized in a double-blind, placebo-controlled trial to receive, in addition to conventional treatment with emollients and topical corticosteroids, 3.5mg of the bacterial extract OM-85 or placebo daily for 9 months. The primary end-point was the difference between groups in the occurrence of new flares (NF) during the study period, evaluated by Hazard Ratio (HR) derived from conditional Cox proportional hazard regression models accounting for repeated events. Results Among the 179 randomized children, 170 were analysed, 88 in the OM-85 and 82 in the placebo group. As expected most children in both treatment groups experienced at least 1 NF during the study period (75 (85%) patients in the OM-85 group and 72 (88%) in the placebo group). Patients treated with OM-85 as adjuvant therapy had significantly fewer and delayed NFs (HR of repeated flares = 0.80; 95% confidence interval (CI): 0.67-0.96), also when potential confounding factors, as family history of atopy and corticosteroids use, were taken into account (HR = 0.82; 95% CI: 0.69-0.98). No major side effect was reported, with comparable and good tolerability for OM-85 and placebo. Conclusions Results show an adjuvant therapeutic effect of a well standardized bacterial lysate OM-85 on established AD. |
| اللغة: | English |
| تدمد: | 1932-6203 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::efe224310480110bfee751a077c7c12dTest http://europepmc.org/articles/PMC5363804Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....efe224310480110bfee751a077c7c12d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19326203 |
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