Shugan Jianpi Granules （疏肝健脾颗粒） Combined with Chushi Zhiyang Oinement （除湿止痒软膏） for Atopic Dermatitis with Sleep Disturbance of Liver Constraint and Spleen Deficiency Syndrome： A Randomized Controlled Trial
10.13288/j.11-2166/r.2025.11.009
- VernacularTitle:疏肝健脾颗粒联合除湿止痒软膏治疗特应性皮炎合并睡眠障碍肝郁脾虚证的随机对照试验
- Author:
Danyang LI
1
;
Qiang YIN
2
;
Zebing ZHU
3
;
Xingwu DUAN
2
;
Jiuli ZHAO
2
Author Information
1. Wangjing Hospital，China Academy of Chinese Medical Sciences，Beijing，100102
2. Dongzhimen Hospital，Beijing University of Chinese Medicine
3. Hubei Provincial Hospital of Traditional Chinese Medicine
- Publication Type:Journal Article
- Keywords:
atopic dermatitis;
sleep disturbance;
Shugan Jianpi Granules （疏肝健脾颗粒）;
liver constraint and spleen deficiency syndrome;
inflammatory factors;
melatonin
- From:
Journal of Traditional Chinese Medicine
2025;66(11):1133-1139
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo explore the effectiveness and potential mechanism of Shugan Jianpi Granules （疏肝健脾颗粒） combined with Chushi Zhiyang Ointment （除湿止痒软膏） in the treatment of atopic dermatitis with sleep disturbance of liver constraint and spleen deficiency syndrome. MethodsSixty-six patients with atopic dermatitis combined with sleep disturbance of liver constraint and spleen deficiency syndrome were randomly divided into 33 cases each in the treatment group and the control group. Both groups were treated with Chushi Zhiyang Ointment for external use. The treatment group additionally received Shugan Jianpi Granules orally， one dose per day； and the control group received cetirizine hydrochloride tablets orally， 10mg per day， taken before bedtime. Both groups were under the treatment for 4 weeks. Clinical effectiveness was evaluated after treatment， and the SCORing Atopic Dermatitis （SCORAD） index， pruritus visual analog scale （VAS） score， Insomnia Severity Index （ISI） score， and Pittsburgh Sleep Quality Index （PSQI） score were recorded before and after treatment， and serum levels of melatonin （MLT）， interleukin-4 （IL-4）， interleukin-6 （IL-6）， interleukin-13 （IL-13）， and tumor necrosis factor-α （TNF-α） were measured. The patients were also tested for blood routine， liver function and kidney function before and after treatment， and the occurrence of adverse events was also observed. ResultsThe total effective rate in the treatment group （90.63%， 29/32） was significantly higher than that in the control group （66.67%， 20/30， P＜0.05）. After the interventions， the scores for SCORAD， VAS， ISI， and PSQI， as well as the levels of IL-4， IL-6， IL-13， and TNF-α， were significantly reduced in both groups. In contrast， the MLT levels in treatment group significantly elevated compared to that before treatment （P＜0.05）. Comparing between the two groups after treatment， the scores of SCORAD， ISI， PSQI， and VAS， as well as the levels of serum IL-4 and IL-13 in the treatment group were significantly lower than those in the control group， while the MLT levels were markedly higher than that in the control group （P＜0.05 or P＜0.01）. There was no obvious abnormality in blood routine， liver function and kidney function in both groups when compared before and after treatment. The incidence rate of adverse reactions was 9.38% （3/32） in the treatment group and 13.33% （4/30） in the control group， and the difference between groups showed no statistical difference （P＞0.05）. ConclusionOn the basis of topical application of Chushi Zhiyang Ointment， the combined application of Shugan Jianpi Granules can significantly alleviate the degree of skin lesions and itching， and improve the quality of sleep in atopic dermatitis patients with sleep disturbance of liver constraint and spleen deficiency syndrome， and its mechanism may be related to regulating the immune balance， reducing the secretion of inflammatory factors， and elevating the level of MLT.
