THURSDAY, Oct. 26, 2023 (HealthDay News) — For patients with ST-segment elevation myocardial infarction (STEMI), the traditional Chinese medicine Tongxinluo can significantly improve clinical outcomes as an adjunct to guideline-directed treatment.According to a study published in the October 24, 2031 issue of Journal of the American Medical Association.
Dr. Yang Yuejin of Peking Union Medical College and colleagues investigated whether adjunctive Tongxinluo therapy could improve clinical outcomes in patients with STEMI. The analysis included 3,797 patients who were randomized (1:1) to receive oral Tongxinluo or placebo for 12 months (post-randomization loading dose of 2.08 g, followed by a maintenance dose of 1.04 g three times daily) . In the preliminary analysis, 3,777 patients were included.
Researchers found that 3.4% of patients in the Tongxinluo group experienced a 30-day major adverse cardiac and cerebrovascular event (MACCE) compared with 5.2% in the control group (relative risk (RR), 0.64). The risk of each component of the 30-day MACCE, including cardiac death, was also lower in the Tongxinluo group compared with the placebo group (3.0% vs 4.2%; RR, 0.70). The incidence of MACCE (5.3% vs 8.3%; hazard ratio (HR), 0.64) and cardiac mortality (4.5% vs 6.1%; HR, 0.73) at one year remained lower in the Tongxinluo group. There were no significant differences for secondary endpoints including 30-day stroke, 30-day and one-year major bleeding, one-year all-cause mortality, and stent thrombosis (<24 hours; 1 to 30 days; and 1 to 12 months) . The Tongxinluo group experienced more adverse drug reactions than the placebo group (2.1% vs. 1.1%), which were mainly caused by gastrointestinal symptoms.
“Unlike most traditional Chinese medicine studies where the level of evidence is relatively low, the current study design incorporates all key elements of a randomized clinical trial,” the authors wrote. “Therefore, the current study can serve as a model for future clinical trials assessing the safety and effectiveness of traditional Chinese medicines.”
Several authors disclosed links to industry.
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