Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial

RCT (n=3,797) found those given Tongxinluo (in addition to STEMI guideline-directed treatment) had a lower rate of major adverse cardiac and cerebrovascular events vs placebo at 30 days (3.4% vs 5.2%, RR 0.64, 95%CI 0.47-0.88) and 1 year (5.3% vs 8.3%, 0.64, 0.49-0.82).

SPS commentary:

The primary endpoint of major cardiac and cerebrovascular adverse effects was a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke.  Authors conclude research is needed to determine the mechanism of action of Tongxinluo in STEMI.

Two editorials discuss the research and implications.  They note that traditional Chinese medicine represents a radically different paradigm of medical practice, and given their wide application in China and many other countries, it remains the most commonly prescribed therapy worldwide.  Tongxinluo, is a mixture of ingredients extracted, concentrated, and freeze-dried from 7 plant and 5 animal products, including the dried bodies of cockroaches, centipedes, leeches, cicadas, and scorpions. Previous small-scale studies have suggested it may have pleiotropic cardioprotective effects, however many of the published clinical trials of Tongxinluo have been criticised for methodologic limitations.

Commentary notes this has been the first large multi-centre RCT investigating Tongxinluo. Limitations of the study are noted, e.g. the exclusively Chinese cohort where the generalisability of results to other populations with distinct genetic backgrounds, distinct lipid profiles, and distinct diets and social habits is uncertain. It adds that although the trial endorsed guideline-directed medical therapy, only 57% of patients were discharged with a β-blocker and only 49.6% with an ACEi or ARB.  It highlights that another important limitation to widespread adoption of Tongxinluo relates to the agent itself. Given that it is a mixture of multiple plant and animal products, the active ingredient(s) and mechanism(s) of action are unknown. It seems not unlikely that there are active components that may have variable actions, some of which may even be detrimental and therefore mitigate an even greater benefit of the putatively beneficial ingredient(s) or interact with co-administered Western medications.  It suggests that if further research could successfully isolate a specific component of Tongxinluo with beneficial cardiovascular activity in STEMI, this would also represent an important advance based on a traditional Chinese medicine. Until this is accomplished, skepticism will remain.

Source:

Journal of the American Medical Association

Resource links:

Editorial 1

Editorial 2