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Thursday, May 23, 2013

Chelation for your heart: Is it really that absurd?

Chelation therapy: An incredibly implausible therapy based on a hugely simplistic concept that because calcium accumulates in atherosclerotic lesions, then using chelation therapy, we could remove the calcium and reduce the lesions. Chelation therapy is a favorite treatment option recommended by naturopaths, and the claims made for it border on the absurd. It’s frequently referred to as “a “safe and effective” alternative to angioplasty or coronary artery bypass surgery.

Since it is being practiced by many  physicians and is a hotly debated topic in circles, a trial funded by The National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI) and National Center for Complementary and Alternative Medicine (NCCAM), was undertaken to provide some scientific evidence warranting the rise in the use of this therapy. 

Trial To Assess Chelation Therapy (TACT):

The purpose of this study was to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.


For the TACT study, the protocol specified 40 infusions. For the active chelation arm, a 10-component chelation solution was selected to match most closely the standard solution used by chelation practitioners. The solution contained disodium EDTA, ascorbic acid, magnesium chloride, procaine hydrochloride, unfractionated heparin, potassium chloride, sodium bicarbonate, pantothenic acid, thiamine, pyridoxine, procaine, and sterile water to make up 500 mL of solution. The placebo solution consisted of 500 mL of normal saline and 1.2 percent dextrose.

Over the four-year follow-up, the difference in the primary endpoint, (a composite of all-cause mortality, MI, stroke, revascularisation, and hospitalization for angina), between the two groups just reached statistical significance. 
In a subgroup analysis, the 31 percent of the study population with diabetes showed greater benefit for the primary endpoint compared with nondiabetic patients. 

Thus, this trial did show some promise but needed further evidence to back it. 

But TACT was panned by the critics who started questioning and rejecting the results because they were having trouble dealing with the results of a trial that seems to support a therapy that they find absurd. 

They echoed this sentiment. "Given the numerous concerns with this expensive, federally funded clinical trial, including missing data, potential investigator or patient unmasking, use of subjective end points, and intentional unblinding of the sponsor, the results cannot be accepted as reliable and do not demonstrate a benefit of chelation therapy. The findings of TACT should not be used as a justification for increased use of this controversial therapy."

An explanation was offered for the positive results. Heparin, it was said, was the reason for the benefits of chelation and not EDTA.

To add fuel to the fire, this trial very recently got its publication in JAMA which has further triggered a fascinating debate in the blogosphere.

The critics came alive yet again. "So messed up was this trial that it’s hard to fathom the decision of JAMA’s editors to publish it.  If published at all, TACT should have been published in some crappy, bottom-feeding journal, because that’s all that it deserves."

If we have little faith in chelation therapy, then it is hard to turn 180 degrees with a positive result and suddenly completely believe in it and recommend its use. Any trial can give an anomalous result and we need to be careful about jumping to a new position with each new piece of evidence. However, we cannot on one hand promote evidence-based medicine and on the other hand ignore what we do not like. 



7 comments:

  1. nice information.agree with u.
    Happy blogging :-)

    ReplyDelete
  2. Its a very helpful info thnx

    ReplyDelete
  3. But still not clear does this really work as a lay man's opinion ?

    ReplyDelete