Neuroprotective effects of Tongxinluo capsule in acute ischemic stroke: A systematic review and meta-analysis

Clinical Snapshot

Key Findings

• P Value: Not reported

• Effect Size: 21% relative increase in functional independence

• Primary Outcome: Functional independence (mRS <2): RR 1.21 (95% CI 1.02-1.44)

• Nnt Or Sensitivity: NNT approximately 20 patients (estimated from 21% relative risk reduction)

• Confidence Interval: 95% CI 1.02 to 1.44

Clinical Application

Limited by availability of Tongxinluo capsule outside China and lack of TGA approval Not applicable to Australian practice - Tongxinluo capsule not TGA-approved, not listed on PBS, and traditional Chinese medicines require careful evaluation under Australian regulatory framework Patients with acute ischemic stroke, particularly in settings where traditional Chinese medicine is accepted

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE: Tongxinluo capsule is widely used in patients with acute ischemic stroke (AIS), although the literature does not consistently agree on its efficacy and safety. AIM OF THE STUDY: We aimed to assess the efficacy and safety of Tongxinluo capsule for patients with AIS. MATERIALS AND METHODS: A systematic search of the databases PubMed, Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang data, VIP Chinese Journal Service Platform, and SinoMed was conducted from their inception dates to January 2025. Randomized controlled trials (RCTs) that enrolled patients with AIS who receive Tongxinluo capsule and compared effects with placebo or as an add-on therapy to usual care were included. Literature screening, risk of bias assessment, and data extraction were independently conducted in duplicate. Fixed-effects or random-effects models were used to perform meta-analysis for pooling data from eligible studies. The primary outcome was long-term functional independence (defined as modified Rankin Scale [mRS] grade less than 2). Secondary outcomes included all-cause mortality, improvements in activities of daily living (measured with the Barthel Index [BI]), and neurological impairment (measured with the National Institutes of Health Stroke Scale [NIHSS]). Incidence of adverse events were identified as safety outcomes. RESULTS: We included 4842 patients with AIS from 12 RCTs (2422 [50.02 %] treated with Tongxinluo capsule) in the final analysis. Tongxinluo capsule treatment in AIS significantly improved the proportion of patients with mRS less than 2 (RR, 1.21; 95 % CI, 1.02 to 1.44), improved the change in BI score (MD, 11.47; 95 % CI, 10.34 to 12.60) and NIHSS score (MD, 3.48; 95 % CI, 2.87 to 4.09). No significant differences were detected in all-cause mortality (RR, 0.57; 95 % CI, 0.17 to 1.95), or the incidence of overall adverse events (RR, 1.01; 95 % CI, 0.91 to 1.12). CONCLUSION: Administration of Tongxinluo capsule for AIS demonstrated potential benefits in improving the long-term functional outcomes and activities of daily living, and relieving neurological impairment, without observing major safety concerns.

References

1. 1.Liu, Y., Ai, J., Feng, L., Wang, Y., Liu, Z., Liang, N., & Wang, G. (2026). Neuroprotective effects of Tongxinluo capsule in acute ischemic stroke: A systematic review and meta-analysis. Journal of Ethnopharmacology, 121191. https://doi.org/10.1016/j.jep.2026.121191