Kim Yu-Kang, Yeom Mijung, Kang SeHyun, Park Hi-Joon, Kim Kyuseok, Lee Hyangsook
Department of Korean Medical Science, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 130-701, Republic of Korea.
Acupuncture & Meridian Science Research Centre, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 130-701, Republic of Korea.
Evid Based Complement Alternat Med. 2017;2017:1926806. doi: 10.1155/2017/1926806. Epub 2017 Nov 14.
This study aims to test the feasibility of a randomised clinical trial to evaluate how acupuncture affects atopic dermatitis (AD) symptoms and quality of life and to explore potential biomarkers that may be associated with AD. It is a sham-controlled trial in which 30 eligible patients will be randomly allocated in a 1 : 1 : 1 ratio to one of three groups: verum acupuncture (VA) group 1 (3 times weekly for 4 weeks); VA group 2 (twice weekly for 4 weeks); or sham acupuncture group (SA; twice weekly for 4 weeks). SA will consist of nonpenetrating acupuncture. Outcome measures will include the Visual Analogue Scale for itch, SCORing Atopic Dermatitis, and Eczema Area and Severity Index to evaluate AD symptoms improvement along with the Patient Oriented Eczema Measure and Dermatology Life Quality Index to assess quality of life. Measures will be collected at baseline, once weekly during the treatment period, and after a 4-week follow-up period. Blood collection will be at baseline and 4 and 8 weeks after treatment and compared with healthy controls. Illumina sequencing will be used to profile microRNA expression in each group to explore candidate microRNA biomarkers for specific effects of acupuncture in patients with AD. This trial is registered via US National Institutes of Health Clinical Trials registry (ClinicalTrials.gov) on 15 July 2016, identifier: NCT02844452.
本研究旨在测试一项随机临床试验的可行性，以评估针灸如何影响特应性皮炎（AD）症状和生活质量，并探索可能与AD相关的潜在生物标志物。这是一项假针刺对照试验，30名符合条件的患者将按1∶1∶1的比例随机分配到三组中的一组：真针灸（VA）组1（每周3次，共4周）；VA组2（每周2次，共4周）；或假针灸组（SA；每周2次，共4周）。SA将采用非穿透性针刺。结局指标将包括瘙痒视觉模拟量表、特应性皮炎评分、湿疹面积和严重程度指数，以评估AD症状的改善情况，同时采用患者导向性湿疹测量法和皮肤病生活质量指数来评估生活质量。测量将在基线时、治疗期间每周一次以及4周随访期后进行。血液采集将在基线时、治疗后4周和8周进行，并与健康对照进行比较。将使用Illumina测序对每组中的微小RNA表达进行分析，以探索针刺对AD患者特定作用的候选微小RNA生物标志物。本试验于2016年7月15日通过美国国立卫生研究院临床试验注册库（ClinicalTrials.gov）注册，标识符：NCT02844452。
