“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.
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 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.
“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.