Modified Sini Powder in treating mild to moderate generalized anxiety disorder in patients with syndrome of liver depression transforming into fire: a single-center, randomized, double-blind, dose-controlled trial.
10.19540/j.cnki.cjcmm.20250414.501
- Author:
Jia-Xin XU
1
;
Hong-Jun YANG
2
;
Hong-Wei WU
2
;
Li-Jun MAO
3
;
Jian-Xin WANG
3
;
Zong-Liang YU
3
;
Yang ZHAO
3
;
Xiao-Nan HAO
4
;
Rui GAO
3
Author Information
1. Graduate School, Beijing University of Chinese Medicine Beijing 100029, China Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
2. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
3. Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
4. Peking University Sixth Hospital Beijing 100191, China.
- Publication Type:English Abstract
- Keywords:
evidence-based traditional Chinese medicine;
generalized anxiety disorder;
human use experience;
modified Sini Powder;
randomized controlled trial
- MeSH:
Humans;
Male;
Female;
Adult;
Middle Aged;
Double-Blind Method;
Drugs, Chinese Herbal/administration & dosage*;
Anxiety Disorders/drug therapy*;
Treatment Outcome;
Young Adult;
Powders;
Aged;
Liver/drug effects*;
Generalized Anxiety Disorder
- From:
China Journal of Chinese Materia Medica
2025;50(14):4063-4070
- CountryChina
- Language:Chinese
-
Abstract:
A single-center, randomized, double-blind, dose-controlled trial of modified Sini Powder in treating mild to moderate generalized anxiety disorder(GAD) in the patients with syndrome of liver depression transforming into fire was conducted at Xiyuan Hospital, China Academy of Chinese Medical Sciences. A total of 80 patients with mild to moderate GAD and the syndrome of liver depression transforming into fire were included. Patients were assigned by the central randomization system at a ratio of 3∶1 into an observation group(n=60, receiving a conventional-dose of granules of modified Sini Powder) and a control group(n=20, receiving low-dose granules with the active ingredients being 50% of that in observation group). Assessments were conducted before treatment(baseline), after 2 weeks of introduction, after 2/4/8 weeks of treatment, and after 4 weeks of follow-up. The results were summarized as follows. In terms of primary outcome indicators, the observation group(62.2%) showed higher total response rate than the control group(26.6%)(P<0.05), and greater Hamilton anxiety scale(HAMA) score reduction after 8 weeks of treatment(P<0.05). In terms of secondary outcome indicators, the HAMA score(somatic anxiety score), traditional Chinese medicine(TCM) syndrome scores, Pittsburgh sleep quality index(PSQI) scale, and clinical global impression(CGI) scale score in the observation group showed a significant compared to the control group at each visit points(P<0.05). Adverse events occurred in 10 cases, including 9(16.9%) cases in the observation group and 1(6.6%) case in the control group. No adverse reaction was observed. In conclusion, conventional-dose modified Sini Powder demonstrated superior efficacy and favorable safety for mild and moderate GAD in the patients with the syndrome of liver depression transforming into fire over low-dose treatment.
