Why the study?
Tongxinluo was approved in China for angina pectoris and ischemic stroke, but evidence regarding its cardiovascular benefits as an adjunct to guideline-directed therapies remained sparse and not well-defined.
Does Tongxinluo improve clinical outcomes in patients with acute STEMI or acute ischemic stroke?
Does Tongxinluo improve clinical outcomes in patients with acute STEMI or acute ischemic stroke?
Recent trials suggest Tongxinluo provides cardiovascular and cerebrovascular benefits in acute STEMI and ischemic stroke, though its integration into standard guidelines remains uncertain.
Promising RCT signals in STEMI and stroke warrant caution; leaves open guideline integration pending independent confirmation.
In recent years, there has been active research investigating whether traditional Chinese medicines, such as Tongxinluo, generate any cardiovascular benefits. Tongxinluo, composed of powders and extracts from multiple plant, insect, and animal products, was approved in 1996 in China for the treatment of angina pectoris and ischemic stroke, but the evidence regarding its benefits remained sparse. Recently, a large randomized controlled trial investigated the use of Tongxinluo in acute ST-segment elevation myocardial infarction and found a significant difference in the 30-day major adverse cardiac and cerebrovascular events (MACCEs) in the Tongxinluo group compared with the control group. The individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group. After 1 year, the Tongxinluo group still had a significantly lower rate of MACCEs. In search of further benefits, another recent large randomized controlled trial investigated the use of Tongxinluo in acute ischemic stroke, and the results showed a significantly higher proportion of favorable functional outcomes at day 90 in the Tongxinluo group compared with the control group. The Tongxinluo group also had a significantly higher proportion of patients with a National Institutes of Health Stroke Scale score reaching 0 or 1 or with a reduction of more than 4 points. Despite these studies demonstrating Tongxinluo's cardiovascular benefits, its role in the treatment of these diseases as an adjunct to guideline-directed therapies is still not well-defined, and it remains to be seen whether these trials will result in significant changes in Tongxinluo's clinical utility.
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Kallash et al. (2025) studied this question.
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