Department of Korean Medicine Ophthalmology and Otolaryngology and Dermatology, Wonkwang University Korean Medicine Hospital, Iksan, Jeollabuk-do, Republic of Korea.
Department of Acupuncture and Moxibustion, Wonkwang University Korean Medicine Hospital and Research Center of Traditional Korean Medicine, Wonkwang University, Deokjingu, Jeonju, Jeollabuk-do, Republic of Korea.
J Ethnopharmacol. 2021 Jun 28;274:114006. doi: 10.1016/j.jep.2021.114006. Epub 2021 Mar 23.
Because of the growing incidence of AD, psychosocial and economic burden of AD patients are often considerable. Steroid treatments are widely used, but long term use of this treatment can cause side effects. To reduce the burden of AD patients and find new efficient treatment, this study chose Soshiho-tang, a traditional medicine used in eastern Asia.
Soshiho-tang (SSHT) is a traditional herbal medicine that has anti-inflammatory effects and improves immune function. This clinical trial evaluated the efficacy and safety of SSHT in atopic dermatitis (AD) patients with gastrointestinal disorders in comparison with placebo.
This study was a single-center, randomized, double-blinded, placebo-controlled, and investigator-initiated clinical trial. A total of 60 patients aged 3-18 years with gastrointestinal disorders and diagnosed with AD by Hanifin & Rajka criteria with a Scoring Atopic Dermatitis (SCORAD) index between 15 and 49 were enrolled. Participants were randomly assigned to the SSHT or placebo groups in a ratio of 1:1 and efficacy evaluation was conducted at week 4 and 8. The participants orally administered SSHT or placebo three times a day for 4 weeks. The primary outcome was measured based on a change of SCORAD index. The secondary outcome measurements included the following: survey questionnaires of gastrointestinal disorder, amount and frequency of ointment application for AD, dermatology quality of life index, and safety evaluation (diagnostic test, adverse reaction, and vital sign monitoring).
During efficacy evaluation, the SCORAD score and digestive symptoms in the experimental and placebo groups were not statistically significant. However, the amount and frequency of ointment application in the experimental group were reduced compared to those in the placebo group at week 8. Also, In the Children's Dermatology Life Quality Index (CDLQI), statistically significant Quality of Life (QOL) improvement was observed in the SSHT experimental group compared to the placebo group. In safety evaluation, all participants were within the normal range during the study period. Blood sample testing indicated that the lymphocytes ratio decreased, and neutrophils ratio increased in the experimental group, whereas the placebo group showed the opposite immune response pattern.
We concluded that SSHT administration can reduce steroid ointment dependence and improve the QOL in AD patients by regulating neutrophil-lymphocyte ratio.
由于 AD 的发病率不断上升，AD 患者的心理社会和经济负担往往相当大。类固醇治疗被广泛应用，但这种治疗方法的长期使用会引起副作用。为了减轻 AD 患者的负担并找到新的有效治疗方法，本研究选择了一种在东亚使用的传统药物——知伯芍药汤（Soshiho-tang，SSHT）。
知伯芍药汤（SSHT）是一种具有抗炎作用和改善免疫功能的传统草药。本临床试验评估了 SSHT 对伴有胃肠道疾病的特应性皮炎（AD）患者的疗效和安全性，并与安慰剂进行了比较。
本研究为单中心、随机、双盲、安慰剂对照、研究者发起的临床试验。共纳入 60 名年龄在 3-18 岁之间、有胃肠道疾病且 Hanifin & Rajka 标准诊断为 AD 的患者，其 SCORAD 指数在 15-49 之间。参与者按照 1:1 的比例随机分配到 SSHT 组或安慰剂组，并在第 4 周和第 8 周进行疗效评估。参与者每天口服 SSHT 或安慰剂 3 次，连续 4 周。主要疗效评估指标基于 SCORAD 指数的变化。次要疗效评估指标包括胃肠道疾病调查问卷、AD 软膏用量和频率、皮肤病生活质量指数（Dermatology Life Quality Index，DLQI）和安全性评估（诊断检测、不良反应和生命体征监测）。
在疗效评估期间，实验组和安慰剂组的 SCORAD 评分和消化症状无统计学差异。然而，实验组在第 8 周时的软膏用量和频率均低于安慰剂组。此外，在儿童皮肤病生活质量指数（Children's Dermatology Life Quality Index，CDLQI）中，SSHT 实验组的生活质量（Quality of Life，QOL）改善情况明显优于安慰剂组。在安全性评估中，所有参与者在研究期间均处于正常范围内。血液样本检测表明，实验组的淋巴细胞比例下降，中性粒细胞比例升高，而安慰剂组则表现出相反的免疫反应模式。
我们得出结论，SSHT 给药可以通过调节中性粒细胞-淋巴细胞比例减少 AD 患者对类固醇软膏的依赖，并改善 QOL。
