Effectiveness of Xuanshen Yishen Decoction on Intensive Blood Pressure Control: Emulation of a Randomized Target Trial Using Real-World Data.
10.1007/s11655-025-4007-6
- Author:
Xiao-Jie WANG
1
;
Yuan-Long HU
2
;
Jia-Ming HUAN
2
;
Shi-Bing LIANG
3
;
Lai-Yun XIN
4
;
Feng JIANG
4
;
Zhen HUA
4
;
Zhen-Yuan WANG
4
;
Ling-Hui KONG
2
;
Qi-Biao WU
5
;
Yun-Lun LI
6
,
7
Author Information
1. Faculty of Chinese Medicine, Macau University of Science and Technology, Macau, 999078, China.
2. First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.
3. Clinical Study Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.
4. Department of Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.
5. Faculty of Chinese Medicine, Macau University of Science and Technology, Macau, 999078, China. qbwu@must.edu.mo.
6. Faculty of Chinese Medicine, Macau University of Science and Technology, Macau, 999078, China. li.yunlun@
7. com.
- Publication Type:Pragmatic Clinical Trial
- Keywords:
6-month all-cause readmission rate;
Xuanshen Yishen Decoction;
hypertension;
intensive blood pressure control;
real-world data;
target trial emulation
- MeSH:
Adult;
Aged;
Female;
Humans;
Male;
Middle Aged;
Antihypertensive Agents/pharmacology*;
Blood Pressure/drug effects*;
Drugs, Chinese Herbal/pharmacology*;
Hypertension/physiopathology*;
Patient Readmission;
Treatment Outcome
- From:
Chinese journal of integrative medicine
2025;31(8):677-684
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To investigate the effectiveness of Xuanshen Yishen Decoction (XYD) in the treatment of hypertension.
METHODS:Hospital electronic medical records from 2019-2023 were utilized to emulate a randomized pragmatic clinical trial. Hypertensive participants were eligible if they were aged ⩾40 years with baseline systolic blood pressure (BP) ⩾140 mm Hg. Patients treated with XYD plus antihypertensive regimen were assigned to the treatment group, whereas those who followed only antihypertensive regimen were assigned to the control group. The primary outcome assessed was the attainment rate of intensive BP control at discharge, with the secondary outcome focusing on the 6-month all-cause readmission rate.
RESULTS:The study included 3,302 patients, comprising 2,943 individuals in the control group and 359 in the treatment group. Compared with the control group, a higher proportion in the treatment group achieved the target BP for intensive BP control [8.09% vs. 17.5%; odds ratio (OR)=2.29, 95% confidence interval (CI)=1.68 to 3.13; P<0.001], particularly in individuals with high homocysteine levels (OR=3.13; 95% CI=1.72 to 5.71; P<0.001; P for interaction=0.041). Furthermore, the 6-month all-cause readmission rate in the treatment group was lower than in the control group (hazard ratio=0.58; 95% CI=0.36 to 0.91; P=0.019), and the robustness of the results was confirmed by sensitivity analyse.
CONCLUSIONS:XYD could be a complementary therapy for intensive BP control. Our study offers real-world evidence and guides the choice of complementary and alternative therapies. (Registration No. ChiCTR2400086589).
