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Credit: Unsplash/CC0 Public domain
Credit: Unsplash/CC0 Public domain
A clinical trial led by Yuejin Yang of the Chinese Academy of Medical Sciences and Peking Union Medical College, China, concluded that a traditional Chinese medicine compound, Tongxinluo, reduced major adverse cardiac and cerebrovascular events and reduced deaths in cardiac origin.
In an article titled “Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction—The CTS-AMI Randomized Clinical Trial,” published in JAMAresearchers present the result of a clinical trial of an unclear combination of herbal and insect powder ingredients compared to placebo in combination with partially applied drug treatment for patients with acute myocardial infarction with ST segment elevation (STEMI).
The study included 3,797 patients with ST-segment elevation myocardial infarction (STEMI) from 124 hospitals in China. Patients were randomized into two groups, taking either Tongxinluo or a placebo of four capsules, three times a day for 12 months, or a matching placebo.
Patients in the test group received Tongxinluo, which the study describes as “…a traditional Chinese medicine compound, (sic) composed of powders and extracts of several plant and insect products.” Which plants, which insects and the active compounds they contain are not clear in the JAMA publication.
A previous publication from the group detailing the proposed study offers a list of ingredients such as Chinese scorpions, leeches, Chinese cockroaches, Chinese red-headed centipedes, the outer shell of a cicada, peony root red, sour jujube seed, agarwood, white sandalwood and synthetic borneol, a substance derived from camphor and known to be highly toxic.
Despite therapeutic advances, patients with STEMI still face high risks of in-hospital mortality and recurrent cardiovascular events. The study aimed to evaluate the potential benefits of Tongxinluo as a complementary therapy in addition to STEMI guideline-directed treatments.
According to the results, Tongxinluo significantly reduced major adverse cardiac and cerebrovascular events (MACCE) over 30 days compared to the placebo group (3.4% vs. 5.2%) and showed improvements in individual components of MACCE , including cardiac death and myocardial reinfarction. These beneficial effects persisted after one year of follow-up.
During hospitalization, approximately 64% of patients received beta-blockers and ACE inhibitors or ARBs were prescribed to approximately 52% of patients. These usage rates were lower at discharge, which may indicate that not all patients continued to take these medications after leaving the hospital. It is not clear from the study which patients continued or stopped these medications beyond the hospitalization period because no breakdown is provided.
The study clearly demonstrates the potential clinical benefits of certain components of the Tongxinluo complex compound as adjunctive therapy in a subpopulation of STEMI patients who may or may not have taken a primary treatment medication. Exactly what this potential is remains clear as mud due to some major limitations.
One of the main limitations of the study is the lack of a mechanism of action. Although the study illustrates a clinical benefit in terms of results, it should provide a better understanding of how Tongxinluo exerts its effects.
This limits the ability to understand the specific physiological and molecular processes involved, particularly with a compound from multiple sources, seriously compromising a more in-depth understanding of treatment effectiveness.
Suboptimal use of guideline-directed therapy
The study acknowledges that not all patients received guideline-recommended medical treatment, a crucial part of the study design. For example, rates of beta-blocker and ACE inhibitor/ARB use during hospitalization and at discharge were lower than expected.
This suboptimal adherence to guideline-prescribed treatment could potentially affect the interpretation of results, as these treatments are known to reduce mortality in STEMI patients.
Low-risk patient cohort
The study reports that more than 90% of enrolled patients had Killip class I, indicating a low risk of complications. This specific cohort of patients included in the study and the still confusing influence of the COVID-19 pandemic during the study period may not accurately represent the benefits of Tongxinluo in higher-risk patient populations , thus limiting the generalizability of the results.
Limitations regarding guideline-directed treatment adherence, patient risk profile, unclear ingredient quantities, and an unclear mechanism of action all highlight the need for additional research to confirm and expand on these findings.
Although more research is needed, it is difficult to imagine that a Western clinical trial would attempt to repeat a trial with supplements containing land scorpions, leeches, cockroaches and centipedes. The fact that somewhere in the ingredient list of insects, plants and camphor extract may be hiding a compound with clinical relevance suggests that all the work is still ahead of any research on this topic, starting with exactly what the ingredients contain, which ones are active, and how much was in the pill patients were taking.
The Chinese government has a stated goal of promoting patentable pharmaceutical applications for traditional Chinese medicinal ingredients in hopes of integrating them into the Western pharmaceutical industry, particularly as adjunct or complementary therapies.
This adds a level of research bias that cannot be avoided in any Chinese study on the subject. With continued efforts and ongoing funding, there will be many more studies like this, with intriguing results and no relevant applications.
Yuejin Yang et al, Traditional Chinese medicine compound (Tongxinluo) and clinical outcomes of patients with acute myocardial infarction, JAMA (2023). DOI: 10.1001/jama.2023.19524
Journal of the American Medical Association
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