On September 26, a groundbreaking clinical study titled “Efficacy of Tongxinluo Capsule in Treating Acute Ischemic Stroke: A Randomized Controlled Clinical Trial” was published in JAMA Network Open, a prestigious journal associated with the American Medical Association that holds an impact factor of 10.5. This significant research was led by Professor Dong Qiang from Huashan Hospital at Fudan University.
This trial marks the first investigation into the use of an innovative oral traditional Chinese medicine for treating acute ischemic stroke, also known as acute cerebral infarction, within 72 hours of onset. The study involved 2,007 acute stroke patients from 50 hospitals across China, who were randomly assigned in a 1:1 ratio to either the Tongxinluo group or a placebo group. Patients received either “standard treatment + Tongxinluo” or “standard treatment + placebo” over a 90-day period. Ultimately, 1,946 patients were analyzed, focusing on the rate of participants achieving a modified Rankin Scale (mRS) score of 0-1 after 90 days. The results demonstrated that when combined with standard treatment, Tongxinluo significantly enhanced neurological function, increasing the likelihood of patients living independently by 33% compared to those receiving the placebo. Remarkably, the benefits were even more pronounced when treatment began within 48 hours of the stroke’s onset.
Developed by Yiling Pharmaceutical and introduced to the market in 1996, Tongxinluo capsules are primarily used for treating coronary heart disease and cerebral infarction. They are included in the first category of China’s National Health Insurance and are listed in the nation’s essential drug catalog. Previous research on Tongxinluo for coronary heart disease was awarded the National Science and Technology Progress Award in 2000, while its manufacturing technology received the National Technology Innovation Award in 2007. Subsequent studies have confirmed Tongxinluo’s benefits in regulating lipids, preventing coagulation, reducing inflammation, protecting endothelial cells, stabilizing plaques, safeguarding small vessels, and alleviating vascular spasms.
According to Professor Dong Yi from Huashan Hospital, this randomized, double-blind, placebo-controlled, multicenter study provides a solid scientific foundation for the clinical use of Tongxinluo in treating ischemic stroke. He noted that the research delivers clearer criteria for selecting treatment options for acute ischemic stroke and demonstrates the efficacy of Tongxinluo across various stroke patient populations.
The publication of this study in JAMA Network Open follows the earlier inclusion of research on “Tongxinluo Capsule for Myocardial Protection in Acute Myocardial Infarction” in the Journal of the American Medical Association. This trend underscores the increasing international acknowledgment of Tongxinluo’s safety and effectiveness in treating cardiovascular and cerebrovascular diseases, significantly fostering the globalization of traditional Chinese medicine. The investigation into Tongxinluo’s role in addressing cerebrovascular diseases will persist, with a new randomized, double-blind, placebo-controlled, multicenter clinical study targeting small vessel disease already underway in China. We eagerly anticipate the emergence of more robust evidence to support treatment options for patients in the future.
