Why is this study important?
Western caregivers depend on scientific methods to prove the value of treatments before they’re recommended to patients. Most herbal medicines (many from the east) cannot be recommended because objective evidence of value is lacking. This study put a traditional Chinese herbal medicine believed to have endothelium-enhancing properties, that has been used in China for atherosclerotic disease management since 1996, to the test in a multi-center, randomized, double-blinded clinical trial.
What question was this study supposed to answer?
CTS-AMI assessed whether oral tongxinluo, a powdered substance made from dried and compounded herbs and insects, given in capsule form at the time of treatment for STEMI and daily for 1 year, would reduce MACCE. Nearly 4,100 patients were enrolled and 3,777 randomized at 124 hospitals in China. Most patients were men, mean age 61 years, about half had anterior MI. There were no statistically important differences between treatment and control groups. 93% patients received primary PCI. The primary endpoint was MACCE at 30 days (cardiac death, repeat MI, stroke or urgent revascularization) and secondary endpoints included 30-day rates of MACCE components, STEMI complications, all-cause death, bleeding and 1-year MACCE.
What did the study show?
In a modified intention-to-treat analysis, tongxinluo treatment was associated with 1/3 fewer MACCE events at both 30 days (p=0.006) and 1 year (p<0.001), and favorable (though generally not statistically significant) findings for all other endpoints except heart failure at 30 days (RR 1.06, p=0.78). The composite primary endpoint was driven by statistically significant reductions in 30-day cardiac death (30% reduction, p=0.04) and recurrent MI (65% reduction, p=0.003). Additionally, tongxinluo-treated patients enjoyed nearly 75% reduction in repeat MI and >50% reduction in stroke over 1 year. No significant adverse events were reported. Although the mechanism of tongxinluo has not been fully elucidated, these findings are consistent with a substance that enhances endothelial function. If 1 or 2 additional trials in western patients have similar findings, this compound could find its way into US pharmacies.