A clinical trial in China has found that a traditional Chinese medicine compound significantly reduced cardiac death among people with a serious type of heart attack.
Acute ST-elevation myocardial infarction (STEMI) is a life-threatening condition that carries high risks of in-hospital mortality and recurrent cardiovascular events, but there have been no major advances in therapeutics in more than a decade.
Now a team of scientists in China and the United States have carried out the first large clinical trial to evaluate the efficacy and safety of a potentially cardioprotective Chinese medicine compound as an adjunctive treatment for patients with acute STEMI.
“Oral administration of Tongxinluo for 12 months, compared with placebo, significantly reduced … major adverse cardiac and cerebrovascular events, with a significant reduction in cardiac death [within 30 days]. These benefits persisted within one year,” the team said.
The researchers, from the state key laboratories of cardiovascular disease and component-based Chinese medicine, hospitals in Beijing, Guangdong, Henan, Jiangsu, Liaoning, Shandong and Xinjiang, as well as the University of Texas Southwestern Medical Centre, published the clinical trial results in the peer-reviewed Journal of the American Medical Association (JAMA).
Tongxinluo, a compound of powders and extracts from several plant and insect products, means “opening the network of the heart” in Chinese. The patent medicine is developed and produced by Shijiazhuang Yiling Pharmaceutical.
In 1996, China approved it for angina pectoris – chest pain due to coronary heart disease – and ischemic stroke, which happens when a vessel supplying blood to the brain is obstructed. The product can be bought online as a dietary supplement.
But while it has shown promise in in-vitro, animal and human studies, it “has not been rigorously evaluated in large randomised clinical trials”, according to the study.
In the trial, nearly 3,800 patients with STEMI were recruited across 124 Chinese hospitals in 2019 and 2020 to receive either the Chinese medicine capsule or a placebo for 12 months, in addition to standard treatments.
In the first 30 days, events including cardiac death, recurrent heart attack, emergent coronary revascularisation (treatments to restore blood flow to parts of the heart) and stroke were experienced by 5.2 per cent of the placebo group, compared with 3.4 per cent of the Tongxinluo group.
The cardiac death rate was 4.2 per cent in the placebo group and 3 per cent in the Tongxinluo group.
And after one year, the results were 8.3 per cent versus 5.3 per cent for cardiac events and 6.1 per cent versus 4.5 per cent for cardiac deaths.
The team said further research was needed to determine which of Tongxinluo’s active ingredients were contributing to the positive results, as well as their exact mechanisms of action.
In an accompanying editorial also published by JAMA, Richard Bach, a professor of medicine at Washington University in St Louis, agreed that isolating and testing the specific active ingredients of Tongxinluo could help contribute to the next advance in the treatment of acute STEMI.
“Given that Tongxinluo is a mixture of multiple plant and animal products, the active ingredients and mechanisms of action are unknown,” said Bach, who also serves as the medical director of the cardiac intensive care unit at Barnes-Jewish Hospital in St Louis.
He added that one or more clinical trials would be needed to understand how Tongxinluo might affect outcomes in a Western population.
via scmp