Could the next major heart attack treatment come from a traditional Chinese medicine? A new JAMA study suggests that might be more realistic than many of us think, after showing that the Chinese medicine Tongxinluo significantly improves outcomes among patients with acute ST-segment elevation myocardial infarction (STEMI).
- Tongxinluo has been cleared in China to treat angina and stroke since 1996, and has shown to have cardioprotective effects in over a dozen previous clinical studies
- It also has a list of ingredients that’s sure to raise Western eyebrows (plants, cockroach, scorpion, cicada, centipede, leech)
CTS-AMI trial researchers randomized 3,777 patients from 124 hospitals in China to take either Tongxinluo or a placebo within 24 hours of STEMI, and then receive guideline-directed treatments (antiplatelet therapy and coronary reperfusion) for one year.
As you might have guessed, the results were far stronger in the Tongxinluo group.
- MACCE at 30 days (3.4% vs. 5.2%)
- Cardiac death at 30 days (3.0% vs 4.2%)
- Myocardial reinfarction at 30 days (0% vs 0.5%)
- MACCE at 1 year (5.3% vs 8.3%)
- Cardiac death 1 year (4.5% vs. 6.1%)
- All cause death at 1 year (5.1% vs. 6.6%)
The Tongxinluo group did have more adverse drug reactions than placebo-takers (2.1% vs 1.1%), largely due to GI issues like stomach discomfort and nausea.
The Tongxinluo group’s 36% lower MACCE rate is quite remarkable, avoiding one major adverse event for every 55 patients who took it, which is even below alirocumab’s “number needed to treat” of 62.
However, the CTS-AMI study generated far more pushback than we typically see when a drug shows these types of improvements in a double-blind RCT.
- An accompanying JAMA editorial expressed doubts about whether these results could be repeated outside of China given genetic, diet, and health differences, while emphasizing that Tongxinluo’s mechanisms are unknown.
- An Editor’s Note discussed the challenges JAMA faced when deciding whether to even publish this study, given that none of Tongxinluo’s ingredients are known to benefit STEMI patients.
- Other online comments suggested that the Chinese government pressures researchers to show positive results in traditional Chinese medicine studies.
The loudest proponent of the CTS-AMI trial ended up being John Mandrola, MD, who suggested that this might be “selective skepticism” given the trial’s solid design and outcomes, and considering that we don’t understand the mechanisms behind a number of major Western cardiovascular pharmaceuticals without similar concerns.
The Takeaway
Tongxinluo has been approved to treat angina and stroke patients in China for over 26 years, and based on the results of the CTS-AMI trial it might also reduce post-STEMI events by a very significant 36%.
However, responses to this study suggest that Western clinicians and scientists will need a lot more evidence that Tongxinluo (and its individual ingredients) actually improve MI outcomes before they’re ready to accept it. It is made out of centipedes after all…
