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Urdu“Many currently used drugs were first recognized by the study of natural or home remedies. While we do not know the exact active ingredient and mechanism of action in this traditional Chinese medicine that caused these benefits, it does point us toward exploring and refining this therapy,” said senior author Eric Peterson, M.D., M.P.H., Professor of Internal Medicine, Vice Provost, and Senior Associate Dean for Clinical Research at UT Southwestern. Dr. Peterson collaborated with Ying Xian, M.D., Ph.D., Associate Professor of Neurology and in the Peter O’Donnell Jr. School of Public Health at UTSW, and colleagues at several Chinese universities and hospitals to perform the study.
Tongxinluo – made of extracts derived from seven herbs and animals including cockroach, scorpion, cicada, centipede, and leech – has long been used as a traditional Chinese therapy to treat patients who have experienced heart attacks and/or strokes. Based on promising results in cellular and animal models, the State Food and Drug Administration of China in 1996 approved its use for angina pectoris and stroke. However, this medicine had never been evaluated in a randomized, double-blind, placebo-controlled clinical trial, a rigorous test required to approve most drug therapies in the U.S. and Europe.
For the study, the researchers worked with 3,777 patients at 124 clinical centers in China who had suffered the most severe form of heart attack – ST-segment elevation myocardial infarction, in which a blood clot completely blocks a major blood vessel supplying the heart – between May 23, 2019, and Dec. 8, 2020. These patients were treated within hours of onset by surgical or chemical removal of the clot. While they received standard treatments over the next year, such as taking a daily aspirin or medications including beta blockers, half of the patients were randomized to receive tongxinluo as well. The other half took a placebo designed to match the look, smell, and taste of the traditional Chinese medicine.
During the next year, medical providers followed these patients regularly to track the incidence of major adverse cardiac and cerebrovascular events (MACCEs), an umbrella term combining cardiac death, repeat heart attacks, stroke, and emergency procedures to restore blood flow to the heart. Results showed MACCEs were about 30% lower in the group that took tongxinluo compared with those taking the placebo at 30 days. These benefits persisted for one year after discharge. Patients receiving tongxinluo also had a lower risk of individual components of the MACCEs, including a 25% decreased risk of cardiac death. There were no major side effects from tongxinluo, suggesting its use was safe.
Dr. Xian noted that because tongxinluo is made of multiple components, further research should focus on determining which are responsible for these effects and how they reduce the risk of cardiovascular complications in the body. In addition, the benefits from this study will need to be duplicated in other populations in order for the treatment to gain approval from the U.S. Food and Drug Administration. A similar Chinese clinical trial is in the works to test tongxinluo’s safety and efficacy in patients with minor ischemic strokes.
“Many drugs have failed to achieve effects as impressive as this traditional Chinese medicine,” said Dr. Xian, who is an Investigator in the Peter O’Donnell Jr. Brain Institute. “Tongxinluo deserves further study.”
Dr. Peterson holds the Adelyn and Edmund M. Hoffman Distinguished Chair in Medical Science.
The study was funded by the National Key Research and Development Program of China (2017YFC1700503) and a research grant from Shijiazhuang Yiling Pharmacological Co. Ltd.
About UT Southwestern Medical Center
UT Southwestern, one of the nation’s premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty members have received six Nobel Prizes and include 26 members of the National Academy of Sciences, 20 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 3,100 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 120,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 5 million outpatient visits a year.
