A propensity score matched comparison of blood pressure lowering in essential hypertension patients treated with antihypertensive Chinese herbal Medicine: comparing the real-world registry data vs. randomized controlled trial

ABSTRACT

Background

Randomized controlled trials have demonstrated that Songling Xuemaikang capsule (SXC) is effective in blood pressure (BP) lowering for essential hypertension. However, the effectiveness of SXC in real-world clinical practice remains unknown. We aimed to investigate whether the BP-lowering effectiveness of SXC in the real-world practice setting is comparable to the efficacy of the intervention in a randomized controlled trial.

Methods

We included 1325 patients treated with SXC monotherapy from a real-world registry and 300 from the SXC-BP trial. A propensity score matching (PSM) approach was used to select participants from the two cohorts. The primary outcome was a change in the office of BP from baseline to 8 weeks.

Results

After PSM, there were 552 patients for the comparative analysis. Clinically meaningful BP reductions were observed both in the real world and in the RCT cohorts after 8-week SXC treatment. The 8-week systolic/diastolic BP was 129.50/81.33 mm Hg vs. 134.97/84.14 mm Hg in the real-world population and the RCT population, respectively. The changes in systolic BP (15.82 ± 10.71 vs. 10.48 ± 10.24; P < .001), and diastolic BP (10.01 ± 7.73 vs. 7.75 ± 8.14; P = .001) from baseline to 8 weeks were significantly greater in the real-world population.

Conclusion

The current comparison demonstrated that SXC monotherapy is at least as effective in real-world settings as within the randomized controlled trial for BP lowering in patients with grade 1 hypertension.

KEYWORDS:

• Hypertension
• mild hypertension
• real-world
• randomized controlled trial
• propensity score
• Chinese herbal medicine

Acknowledgments

We thank all patients and their families for participating in the registry or the SXC-BP trial and all the centers and investigators who devoted their effort and time to the two studies.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Abbreviations

BMI	=	body mass index
BP	=	blood pressure
PSM	=	propensity score matching
RCT	=	randomized controlled trial
SXC	=	Songling Xuemaikang capsule.

Additional information

Funding

This work was supported by the Beijing Nova Program of Science and Technology (Z211100002121061) and the Young Elite Scientist Sponsorship Program by the China Association for Science and Technology (2021-QNRC1-04).