Used as adjunctive therapy, a traditional Chinese medicine compound, Tongxinluo, improved 30-day and 1-year clinical outcomes among patients with acute ST-segment elevation myocardial infarction (STEMI), researchers report. “Further research is needed to determine the mechanism of action of Tongxinluo in STEMI,” the authors write. The product, a mixture of powders and extracts from multiple plant and insect products, contains several potentially active ingredients: peoniflorin, ginsenoside Rg1, and ginsenoside Rb1.
Conducted at 124 hospitals in China, the randomized, double-blind, placebo-controlled clinical trial included patients with STEMI within 24 hours of symptom onset from May 2019 to Dec. 2020. Participants were randomized to Tongxinluo or placebo orally for 12 months. The primary endpoint was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke.
Based on follow-up of MACCEs every 3 months for 1 year, the results showed the following: “Among 3,797 patients who were randomized, 3,777 (Tongxinluo: 1,889 and placebo: 1,888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo, group vs 99 patients (5.2%) in the control group (relative risk [RR], 0.64 [95% CI, 0.47 to 0.88]; risk difference [RD], −1.8% [95% CI, −3.2% to −0.6%]). Individual components of 30-day MACCEs, including cardiac death (56 [3.0%] vs 80 [4.2%]; RR, 0.70 [95% CI, 0.50 to 0.99]; RD, −1.2% [95% CI, −2.5% to −0.1%]), were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs (100 [5.3%] vs 157 [8.3%]; HR, 0.64 [95% CI, 0.49 to 0.82]; RD, −3.0% [95% CI, −4.6% to −1.4%]) and cardiac death (85 [4.5%] vs 116 [6.1%]; HR, 0.73 [95% CI, 0.55 to 0.97]; RD, −1.6% [95% CI, −3.1% to −0.2%]). There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis (<24 hours; 1-30 days; 1-12 months). More adverse drug reactions occurred in the Tongxinluo group than the placebo group (40 [2.1%] vs 21 [1.1%]; P = .02), mainly driven by gastrointestinal symptoms.”
Editorial: “An important limitation to widespread adoption of Tongxinluo relates to the agent itself,” an editorialist writes. “Given that Tongxinluo 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. Of related concern, there have been reports that independent analyses of some traditional Chinese medicines suggest they can contain undeclared material, heavy metals, and other adulterants associated with potentially toxic effects. In light of those issues, given the signal of benefit for Tongxinluo in CTS-AMI, efforts at identifying and purifying the active ingredient(s) of Tongxinluo for further clinical testing would seem a preferable pathway to therapeutic discovery. Like the historic identification and derivation of artemisinin as an effective treatment for malaria from the traditional Chinese medicine herb qinghao in the 1970s by the Chinese pharmacologist Youyou Tu, which earned the Nobel Prize in Physiology or Medicine in 2015, efforts at isolating and testing the specific active ingredient(s) of Tongxinluo might provide the world with the next advance in the treatment of acute STEMI.”