Killed Mycobacterium vaccae suspension in children with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled trial
Randomized controlled trial published in Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology (2006)
Abstract
BACKGROUND: The hygiene hypothesis is often proposed to explain the high prevalence of atopy in the western world. Dysregulation of the immune system may result from inadequate exposure to micro-organisms such as mycobacteria. A small trial suggested that a killed extract of Mycobacterium vaccae ameliorates atopic dermatitis (AD). OBJECTIVES: To confirm in a large clinical trial whether killed M. vaccae ameliorates AD in 5-16-year-old children. METHODS: This was a randomized, placebo-controlled, double-blind, multi-centre study of the effect of intradermal injection of killed M. vaccae (0.1 or 1 mg) on patients, aged 5-16, with moderate-to-severe AD. Patients were followed up for 24 weeks. The primary end point was the change in severity of AD at 12 weeks, assessed using the six area, six-sign, atopic dermatitis (SASSAD) score. Secondary end points included changes in disease extent, patient's global assessment and children's dermatology life quality index. RESULTS: There were 166 patients randomized. The mean SASSAD score fell to a similar degree at week 12 in all treatment arms: from 33 to 24, (26%) in the high-dose group, from 30 to 23 (25%) in the low-dose group and from 36 to 27 (24%) in the placebo group (P>0.05). Secondary end points followed the same trend. Adverse events were generally those expected to occur in this population. Injection site reactions occurred in 32 patients at week 4. CONCLUSIONS: M. vaccae was no more effective than the placebo in ameliorating the severity of AD.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Резюме
The hygiene hypothesis is often proposed to explain the high prevalence of atopy in the western world.
Почему это важно для гирудотерапии
В данном рандомизированном двойном слепом плацебо-контролируемом многоцентровом исследовании оценивалось, может ли суспензия убитых Mycobacterium vaccae, вводимая внутрикожно, улучшить течение атопического дерматита средней и тяжёлой степени у детей в возрасте 5–16 лет; первичной конечной точкой служило изменение показателя тяжести SASSAD через 12 недель. Во всех лечебных группах было отмечено сопоставимое улучшение (~24–26% снижение), без статистически значимой разницы между M. vaccae (в высокой или низкой дозе) и плацебо. Данная статья не имеет отношения к пиявкам, гирудотерапии, гирудину или секретому пиявок. Какой-либо обоснованной релевантности для предметной области ASH не имеется; исследование представляет собой клиническое испытание иммунотерапии атопического дерматита у детей без какого-либо содержания, связанного с антикоагулянтами или пиявками.
Цитирование
Killed Mycobacterium vaccae suspension in children with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled trial
Berth-Jones J et al. · Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 2006
Связанный клинический контекст
Узнайте, как это исследование связано с клинической практикой
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