When evaluating the effectiveness of a drug, a Randomized Controlled Trial (RCT) is often considered the gold standard due to its perfect randomization. While RCT assures strong internal validity, its restricted external validity poses challenges in extending treatment effects to the broader real-world population due to possible heterogeneity in covariates. In this study, we employed the augmented inverse probability of sampling weighted (AIPSW) estimator to generalize findings from an RCT comparing the efficacy of Songling Xuemaikang Capsule (SXC) -- a traditional Chinese medicine (TCM) and Losartan on hypertension reduction to a real-world trial-eligible population. Additionally, we conducted sensitivity analyses to assess the robustness of the AIPSW estimation against unmeasured confounders. The generalization results indicated that although SXC is less effective in lowering blood pressure than Losartan on week 2, week 4, and week 6, there is no statistically significant difference among the trial-eligible population at week 8, and the generalization is robust against potential unmeasured confounders.

The authors have declared no competing interest.

The study protocol was approved by the Institutional Review Board of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (approval number: ECSL-BDY-2011-19) and was registered on the Chinese Clinical Trial Registry Platform (www.chictr.org.cn; Unique identifier: ChiCTRONC-11001612)

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).

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Institutional Review Board of Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine (approval number: ECSL-BDY-2011-19)

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