Department of Epidemiology and Health Economics, Institute of Social Medicine, corporate member of Freie Universität Berlin and Humboldt - Universität zu Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin, Berlin, Germany.
J Integr Complement Med. 2023 Feb;29(2):99-110. doi: 10.1089/jicm.2022.0699. Epub 2022 Nov 25.
Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0-100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP ( = 6), IFDP ( = 4), EP ( = 1), and control ( = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.
患有特应性皮炎（AD）的患者经常使用健康的生活方式行为，尽管其益处尚不清楚。本研究的目的是调查催眠疗法、调整饮食的禁食和运动在 AD 患者中的疗效。在一项四臂随机对照单中心开放性探索性临床试验中，轻度至中度严重 AD 成年患者接受了为期 16 周的五次催眠治疗组方案（HTP）、五次间歇性禁食和饮食调整组方案（IFDP）、五次运动组方案（EP）或不进行研究干预（如果需要，可添加局部皮质类固醇使用）。终点包括视觉模拟量表（VAS，0-100mm）上主观感知的瘙痒；SCORing 特应性皮炎（SCORAD）的疾病严重程度；以及不良事件（AE）。终点在全分析集（FAS）中进行描述性分析。由于 2019 年冠状病毒病（COVID-19）大流行，研究方案的相关更改包括在线以及“在场”组干预，在 120 名预期患者的随机分组前关闭 EP 研究臂并提前终止试验。在 COVID-19 大流行期间，研究招募情况不佳。FAS 包括 20 名患者（17 名女性），年龄为 35.0±12.1（平均值±标准差[SD]）。基线时，HTP（ = 6）、IFDP（ = 4）、EP（ = 1）和对照组（ = 9）的 VAS 瘙痒分别为 63.2±18.0、65.0±13.9、43.0mm 和 62.1±17.3；SCORAD 分别为 43.0±13.6、47.0±21.0、60.3 和 39.1±15.6。16 周后，终点为 VAS 瘙痒 26.0±16.4、31.7±9.9、23.0mm 和 39.3±27.0；SCORAD 分别为 24.1±12.2、29.1±19.1、49.1 和 25.5±14.4。未观察到与干预相关的严重 AE。尽管各组人数非常少，但研究结果表明 HTP 和 IFDP 对基线瘙痒强度、疾病严重程度和疾病特异性生活质量有潜在的有益变化。因此，应进行进一步的临床试验，以调查所有干预措施的有效性和安全性。2020 年 1 月 31 日，德国临床试验注册处（DRKS）：DRKS00020557，通用试验编号（UTN）：U1111-1247-1512。
