Outcome selection of randomized controlled trials in acute stroke: a comparative analysis between traditional Chinese...

Stroke is a serious worldwide health issue. In the management of stroke, traditional Chinese medicine (TCM) is frequently used as an alternative treatment. However, differences in outcome measures between Chinese herbal medicines (CHMs) and Western medicine (WM) trials have hindered progress in evidence-based acute stroke treatment. This study compares outcome measures between CHMs and WM, and aims to provide recommendations for improving TCM-based or integrative pharmaceutical trials in acute stroke.

This study focused on outcome measures in acute stroke randomized controlled trials (RCTs) published between 2020 and 2024. Seven databases were searched: PubMed, Embase, the Cochrane Library, CNKI, VIP, Wanfang, and Sinomed. We used multiple overlapping strategies to perform a comprehensive search.

Three hundred six RCTs were identified, comprising 171 WM trials and 135 CHMs trials. Ten CHMs trials (7.41%) defined a primary outcome measure, compared to 78 WM trials (45.61%). The most common primary outcome measure was the 90-day modified Rankin scale, used in 44 of 78 WM trials (56.41%) and all 7 of 7 CHMs trials that specified a primary outcome. While 143 WM trials (83.63%) utilized safety outcome measures, only 49.63% of CHMs trials specified safety outcomes.

Potential neglect of primary outcomes and inconsistencies in outcome measures may be expected due to the absence of guidance on core outcome sets (COS) for acute stroke in TCM trials. In order to generate high-quality evidence evaluating TCM as adjuvant therapies in acute stroke, future research should give methodologically rigorous COS development first priority.