Lee Boram, Ko Mi Mi, Ahn You Mee, Park Hyo-Ju, Jung So Young, Jung Hyun-A, Lee Hesol, Kim Pyung-Wha, Choi Yujin, Han Kyungsun, Shin Sarah, Jung Jeeyoun
KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Front Pharmacol. 2025 Jun 3;16:1593477. doi: 10.3389/fphar.2025.1593477. eCollection 2025.
Atopic dermatitis (AD) is often associated with gastrointestinal symptoms, including anorexia and alterations in the gut microbiome. A traditional East Asian herbal medicine (BJT; in Chinese, in Japanese) has been commonly used to manage AD and anorexia. This study aimed to evaluate the effects and safety of BJT in anorexic patients with AD and to investigate its therapeutic mechanism through gut microbiome analysis.
The trial included 26 adults with AD and anorexia, randomized (1:1) into BJT or waiting list groups for 12 weeks, including 8 weeks of treatment and 4 weeks of follow-up. The severity of anorexia and AD was assessed using the Visual Analog Scale (VAS), SCORing of Atopic Dermatitis (SCORAD), and Dermatology Life Quality Index (DLQI). Serum cytokine concentrations were measured before and after treatment using a multiplex immunoassay. Fecal samples were collected before and after treatment, and 16S rRNA sequencing was performed to analyze the gut microbiota.
The BJT group showed a significant decrease in anorexia VAS scores compared to the waiting list group at 8 weeks. Only the BJT group showed significant improvements in SCORAD and DLQI scores compared to baseline, with effects maintained through follow-up. No serious adverse events related to BJT were reported. Among the serum cytokines, IL-1β significantly decreased only in the BJT group, while IL-4 and IL-17 significantly decreased in both groups, with a more pronounced reduction observed in the BJT group. After 8 weeks of BJT treatment, significant changes were observed in the gut microbiome, including alterations in the genus, , and species.
BJT may improve symptoms of anorexia and AD without serious adverse events, potentially through modifications in the gut microbiota.
The study protocol was registered at the Clinical Research Information Service (KCT0006784, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=21298&search_page=L).
特应性皮炎(AD)常与胃肠道症状相关,包括厌食和肠道微生物群改变。一种传统的东亚草药(中文名为白及汤,日文中也有相关名称)常用于治疗AD和厌食症。本研究旨在评估白及汤对AD厌食症患者的疗效和安全性,并通过肠道微生物群分析探讨其治疗机制。
该试验纳入了26名患有AD和厌食症的成年人,随机(1:1)分为白及汤组或等待名单组,为期12周,包括8周的治疗期和4周的随访期。使用视觉模拟量表(VAS)、特应性皮炎评分(SCORAD)和皮肤病生活质量指数(DLQI)评估厌食症和AD的严重程度。治疗前后使用多重免疫测定法测量血清细胞因子浓度。治疗前后收集粪便样本,并进行16S rRNA测序以分析肠道微生物群。
与等待名单组相比,白及汤组在8周时厌食症VAS评分显著降低。与基线相比,只有白及汤组的SCORAD和DLQI评分有显著改善,且疗效在随访期间得以维持。未报告与白及汤相关的严重不良事件。在血清细胞因子中,只有白及汤组的IL-1β显著降低,而IL-4和IL-17在两组中均显著降低,白及汤组的降低更为明显。白及汤治疗8周后,肠道微生物群出现显著变化,包括属、种的改变。
白及汤可能改善厌食症和AD的症状,且无严重不良事件,可能是通过改变肠道微生物群实现的。
该研究方案已在临床研究信息服务中心注册(KCT0006784,https://cris.nih.go.kr/cris/search/detailSearch.do?seq=21298&search_page=L)。