Tongxinluo and Functional Outcomes Among Patients With Acute Ischemic Stroke: A Randomized Clinical Trial

Area of Science:

• Neurology
• Pharmacology
• Traditional Chinese Medicine

Background:

• Limited effectiveness of current neuroprotective agents for acute ischemic stroke (AIS).
• Tongxinluo, a traditional Chinese medicine, shows potential neuroprotective and anti-inflammatory properties.
• Previous studies indicated Tongxinluo's efficacy in stabilizing plaques in animal models and myocardial infarction patients.

Purpose of the Study:

• To evaluate the efficacy and safety of Tongxinluo as an adjunct treatment for patients with acute ischemic stroke (AIS).

Main Methods:

• A multicenter, randomized, double-blind, placebo-controlled trial involving 2007 AIS patients.
• Patients received either Tongxinluo or placebo orally, three times daily for 90 days, alongside standard care.
• Functional outcome was assessed using the modified Rankin Scale (mRS) at 90 days.

Main Results:

• Tongxinluo significantly increased favorable functional outcomes (mRS 0-1) at 90 days compared to placebo (65.8% vs 59.1%, OR 1.33, P=.002).
• The treatment effect was consistent across prespecified subgroups.
• No significant adverse events related to Tongxinluo were highlighted, suggesting a favorable safety profile.

Conclusions:

• Adjunctive Tongxinluo treatment improves functional outcomes in patients with acute ischemic stroke within 72 hours of symptom onset.
• Tongxinluo represents a viable neuroprotective option for AIS management.
• Further research is recommended to explore its effects in patients receiving thrombolysis and endovascular treatments.