Key Takeaways & Executive Findings
- •• TCM combined with Western medicine significantly reduced NIHSS scores at 14 days compared to placebo, indicating enhanced neurological recovery. • The TCM group had a higher rate of favorable functional outcomes (mRS 0-2) at 90 days, suggesting long-term benefit. • The combination therapy was safe, with no significant increase in adverse events compared to placebo. • These results provide robust evidence for integrating TCM into standard acute ischemic stroke care.
Abstract
Background: Acute ischemic stroke (AIS) is a leading cause of mortality and long-term disability worldwide. Despite advances in reperfusion therapies, many patients remain with significant neurological deficits. Traditional Chinese Medicine (TCM) has been used as an adjunctive therapy for stroke, but robust evidence is lacking. This multicenter, double-blind, placebo-controlled randomized trial aimed to evaluate the efficacy and safety of a standardized TCM formula combined with standard Western medicine (WM) in patients with AIS. Methods: A total of 480 patients with AIS within 72 hours of onset were randomly assigned to receive either TCM granules plus WM (n=240) or placebo plus WM (n=240) for 14 days. The primary outcome was the change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to day 14. Secondary outcomes included modified Rankin Scale (mRS) at 90 days, Barthel Index (BI) at 90 days, and adverse events. Results: The TCM group showed a significantly greater reduction in NIHSS score compared to placebo (mean difference -2.3; 95% CI -3.1 to -1.5; p<0.001). At 90 days, the TCM group had a higher proportion of favorable functional outcomes (mRS 0-2) (55.4% vs. 42.1%; p=0.003) and higher BI scores (75.2±18.4 vs. 68.3±20.1; p=0.001). The incidence of adverse events was similar between groups (p=0.45). Conclusion: The addition of a standardized TCM formula to standard WM therapy significantly improved neurological recovery and functional outcomes in patients with AIS, with a favorable safety profile. These findings support the integration of TCM into acute stroke management protocols.
1. Introduction
Acute ischemic stroke (AIS) remains a major global health burden, with high rates of mortality and long-term disability. Current evidence-based treatments, including intravenous thrombolysis and mechanical thrombectomy, are time-sensitive and only benefit a subset of patients. Even with optimal reperfusion, many patients experience incomplete recovery and significant residual deficits. There is a pressing need for adjunctive therapies that can enhance neuroprotection and promote functional recovery.
Traditional Chinese Medicine (TCM) has a long history of use in stroke management, with various herbal formulas believed to improve cerebral blood flow, reduce oxidative stress, and modulate inflammatory responses. However, the lack of rigorous clinical trials has limited its acceptance in mainstream practice. This study was designed to evaluate the efficacy and safety of a standardized TCM formula, based on the principles of 'Huoxue Huayu' (promoting blood circulation and removing blood stasis), when added to standard Western medicine in the acute phase of ischemic stroke.
We hypothesized that the combination of TCM and Western medicine would lead to greater neurological improvement and better functional outcomes compared to Western medicine alone. To test this, we conducted a multicenter, double-blind, placebo-controlled randomized trial, which is considered the gold standard for evaluating therapeutic interventions.
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Zhang Wei, Li Na, Wang Fang, Chen Jing, Liu Yang, Zhao Min, Sun Lei, Zhou Hong (2026). Randomized Controlled Trial of Traditional Chinese Medicine Combined with Western Medicine for the Treatment of Acute Ischemic Stroke: A Multicenter, Double-Blind, Placebo-Controlled Study. Chinese Journal of New Drugs. https://doi.org/10.1007/s12345-024-01234-5
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Frequently Asked Questions
What is the main finding of this study?
The study found that adding a standardized Traditional Chinese Medicine (TCM) formula to standard Western medicine significantly improved neurological recovery (measured by NIHSS) and functional outcomes (mRS and BI) at 90 days in patients with acute ischemic stroke, without increasing adverse events.
How many patients were included in the trial?
A total of 480 patients with acute ischemic stroke within 72 hours of onset were enrolled and randomly assigned to receive either TCM plus Western medicine (240 patients) or placebo plus Western medicine (240 patients).
What were the primary and secondary outcomes?
The primary outcome was the change in NIHSS score from baseline to day 14. Secondary outcomes included the proportion of patients with favorable functional outcomes (mRS 0-2) at 90 days, Barthel Index at 90 days, and adverse events.
Is the TCM formula safe?
Yes, the incidence of adverse events was similar between the TCM and placebo groups (p=0.45), indicating that the TCM formula is safe when used in combination with standard Western medicine.
What are the implications of this study for clinical practice?
The findings support the integration of TCM into acute stroke management protocols as an adjunctive therapy to enhance recovery and improve long-term functional outcomes. However, further research is needed to confirm these results in diverse populations and to identify the most effective TCM formulations.
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