Objective:

2

To investigate the effectiveness of Xuanshen Yishen Decoction (XYD) in the treatment of hypertension.

Methods:

2

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:

2

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% confide

nce 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:

2

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)