Effects of Modified Guomin Decoction （加味过敏煎） on Traditional Chinese Medicine Syndromes and Quality of Life in Patients with Mild to Moderate Atopic Dermatitis of Heart Fire and Spleen Deficiency Pattern：A Randomized，Double-Blind，Placebo-Controlled Trial
10.13288/j.11-2166/r.2025.10.010
- VernacularTitle:加味过敏煎对轻中度特应性皮炎心火脾虚证患者中医证候和生活质量的影响——一项随机、双盲、安慰剂对照试验
- Author:
Jing NIE
1
;
Rui PANG
2
;
Lingjiao QIAN
2
;
Hua SU
2
;
Yuanwen LI
3
;
Xinyuan WANG
1
;
Jingxiao WANG
2
;
Yi YANG
1
;
Yunong WANG
1
;
Yue LI
1
;
Panpan ZHANG
1
Author Information
1. Beijing University of Chinese Medicine Third Affiliated Hospital，Beijing，100029
2. Beijing University of Chinese Medicine
3. Dongfang Hospital，Beijing University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
atopic dermatitis;
heart fire and spleen deficiency;
Guomin Decoction （过敏煎）;
quality of life;
immune function
- From:
Journal of Traditional Chinese Medicine
2025;66(10):1031-1037
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical efficacy and safety of Modified Guomin Decoction （加味过敏煎， MGD） in patients with mild to moderate atopic dermatitis （AD） of the traditional Chinese medicine （TCM） pattern of heart fire and spleen deficiency， and to explore its possible mechanisms. MethodsIn this randomized， double-blind， placebo-controlled study， 72 patients with mild to moderate AD and the TCM pattern of heart fire and spleen deficiency were randomly divided into a treatment group and a control group， with 36 cases in each group. The treatment group received oral MGD granules combined with topical vitamin E emulsion， while the control group received oral placebo granules combined with topical vitamin E treatment. Both groups were treated twice daily for 4 weeks. Clinical efficacy， TCM syndrome scores， Visual Analogue Scale （VAS） for pruritus， Dermatology Life Quality Index （DLQI） scores， Scoring Atopic Dermatitis （SCORAD） and serum biomarkers， including interleukin-33 （IL-33）， interleukin-1β （IL-1β）， immunoglobulin E （IgE）， and tumor necrosis factor-α （TNF-α） were compared before and after treatment. Safety indexes was also assessed. ResultsThe total clinical effective rates were 77.78% （28/36） in the treatment group and 38.89% （14/36） in the control group， with cure rates of 19.44% （7/36） and 2.78% （1/36）， respectively. The treatment group showed significantly better clinical outcomes compared to the control group （P＜0.05）. The treatment group exhibited significant reductions in total TCM syndrome scores， including erythema， edema， papules， scaling， lichenification， pruritus， irritability， insomnia， abdominal distension， and fatigue scores， as well as reductions in VAS， DLQI， SCORAD， and serum IgE and IL-33 levels （P＜0.05 or P＜0.01）. Compared to the control group， the treatment group had significantly better improvements in all indicators except for insomnia （P＜0.05）. No adverse events occurred in either group. ConclusionMGD is effective and safe in treating mild to moderate AD patients with heart fire and spleen deficiency pattern. It significantly alleviates pruritus， improves TCM syndromes and quality of life， and enhances clinical efficacy， possibly through modulation of immune responses.
