Kim Jundong, Kwon Soon-Kyeong, Lee In-Seon, Yeom Mijung, Hahm Dae-Hyun, Park Hi-Joon, Kim Kyuseok
Department of Ophthalmology, Otorhinolaryngology and Dermatology of Korean Medicine, Graduate School of Korean Medicine, Kyung Hee University, Seoul 02447, Republic of Korea.
Division of Applied Life Science (Brain Korea 21 PLUS), Gyeongsang National University, Jinju 52828, Republic of Korea.
Evid Based Complement Alternat Med. 2021 Sep 4;2021:5584247. doi: 10.1155/2021/5584247. eCollection 2021.
Atopic dermatitis (AD) is a relapsing and remitting chronic inflammatory skin disease for which a variety of etiological factors are involved. Treatment strategies should be multifaceted and have few side effects. In this respect, acupuncture has become increasingly popular as a safe, consistently effective, and drug-free therapy that treats multiple AD symptoms. We aim to not only verify the effectiveness of acupuncture but also suggest patient-specific response determinants and a new underlying mechanism implicating the gut-brain axis. We have designed a randomized, participant-blinded, sham-controlled clinical trial for 60 mild to moderate AD patients. In a previous study, we observed that the clinical skin symptoms of AD were closely associated with gastrointestinal (GI) symptoms. From these findings, we developed an intervention with six acupuncture points: three for AD symptoms and three for GI symptoms. Also, since high responders and low responders to the acupuncture treatment could be identified in the previous study, we now aim to explore response-determining factors, with a particular focus on GI symptoms. Therefore, we will precisely evaluate not only AD symptoms using the SCORAD, EASI, and DLQI tools, but also GI symptoms using the GSRS, TDS, BSFS, and AR tools and abdominal examination. AD develops in association with complicated pathophysiological factors, such as skin barrier function, genetic susceptibility, and immunological factors. Moreover, the underlying mechanism by which acupuncture treatment works has not been clearly elucidated. We, therefore, will conduct a simultaneous cross-sectional study with a sample of 40 healthy individuals, wherein potential indicators, such as fMRI, gut microbiota, and serum TARC and ATX, will be investigated to determine the gut-brain axis-associated mechanism of acupuncture. We expect that the results of this study could provide important clinical evidence for the effects of acupuncture and help elucidate the therapeutic mechanisms that underlie acupuncture's efficacy in AD treatment. This trial is registered with https://clinicaltrials.gov/ct2/show/KCT0005422 (Trial registration: Korean Clinical Trial Registry (http://cris.nih.go.kr; registration number: KCT0005422); date of registration: September 23, 2020).
特应性皮炎（AD）是一种复发缓解型慢性炎症性皮肤病，涉及多种病因。治疗策略应是多方面的，且副作用少。在这方面，针灸作为一种安全、疗效持续且无药物的疗法，可治疗多种AD症状，越来越受欢迎。我们的目标不仅是验证针灸的有效性，还提出针对患者的反应决定因素以及一种涉及肠-脑轴的新潜在机制。我们为60例轻至中度AD患者设计了一项随机、参与者盲法、假针刺对照的临床试验。在先前的一项研究中，我们观察到AD的临床皮肤症状与胃肠道（GI）症状密切相关。基于这些发现，我们制定了一种针对六个穴位的干预措施：三个用于治疗AD症状，三个用于治疗GI症状。此外，由于在先前的研究中可以识别出对针灸治疗反应高和反应低的患者，我们现在旨在探索反应决定因素，特别关注GI症状。因此，我们不仅将使用SCORAD、EASI和DLQI工具精确评估AD症状，还将使用GSRS、TDS、BSFS和AR工具以及腹部检查来评估GI症状。AD的发生与复杂的病理生理因素有关，如皮肤屏障功能、遗传易感性和免疫因素。此外，针灸治疗起作用的潜在机制尚未完全阐明。因此，我们将对40名健康个体进行同步横断面研究，调查功能磁共振成像（fMRI）、肠道微生物群以及血清胸腺和活化调节趋化因子（TARC）和自分泌运动因子（ATX）等潜在指标，以确定针灸与肠-脑轴相关的机制。我们预计本研究结果可为针灸的疗效提供重要临床证据，并有助于阐明针灸在AD治疗中发挥疗效的治疗机制。本试验已在https://clinicaltrials.gov/ct2/show/KCT0005422注册（试验注册：韩国临床试验注册中心（http://cris.nih.go.kr；注册号：KCT0005422）；注册日期：2020年9月23日）。
