Wednesday, March 27, 2013

Is Chelation the New H pylori? Part 2

The proof is in the pudding.  Three weeks ago, results of the Trial to Assess Chelation Therapy (TACT) study were announced at the annual meeting of the American College of Cardiology to much press & noise.  While some of the details of the study were discussed, we usually wait to comment until the study has been published in a peer reviewed journal.  And thus, I would direct your attention to today's issue of JAMA which includes not only the TACT study, but also to an editorial concerned about the deficiencies of the study, and a second editorial focused on what TACT brings to the table.  I think it's important that you make the time to read both editorials to gain better insight into TACT and help you formulate your own understanding of this controversial study.

And more thought, if the proof is in the pudding, then the devil is in the details.  Just as when a randomized controlled study demonstrates the benefit of some particular drug, we cannot automatically generalize those same results to another drug in the same family.  So whether you believe in the benefits of chelation with regards to cardiovascular events, remember that this study was one of 30 weekly infusions plus an additional 10 infusions 2-8 weeks apart of a 500mL solution comprised of 3g of disodium EDTA, 7g ascorbate, B vitamins, electrolytes, procaine & heparin vs placebo.  Another part of the arm randomized patients to either an oral mineral-vitamin vs an oral placebo.  Thus was the 2x2 factorial study developed.  My point is that we need to acknowledge that chelation therapy has many variations on a theme and this study was specifically on this regimen, not to be generalized to all chelation solutions.

Just like a recent study of niacin + laropripant vs placebo can only tell you about the combination drug, yet the lay press and our health care pundits are impugning the repetition of niacin by generalizing.  But what if the negative outcomes were due to laropripant?  We've conveniently forgotten how to interpret studies, just like a decade ago when we studied Premarin or PremPro in women >10yrs post-menopause.  In our haste to place the blame on someone/something, we sacrificed (conjugated equine) Estrogen when a decade's time in front of the retrospectograph suggests that Women's Health Initiative only applies to asymptomatic post-menopausal women 10 years after menopause.

Let's not forget history and end up repeating it again.



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