Chelation Therapy: Hype or Hope?

THE ISSUE:

October 2010: The FDA today warned eight companies that their over-the-counter chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products.

The companies claim their products treat a range of diseases; including autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions; by removing toxic metals from the body.  

THE BACKGROUND:

The National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM), both components of the National Institutes of Health (NIH), are sponsoring the Trial To Assess Chelation Therapy (TACT). TACT is the first large-scale, multicenter study to determine the safety and efficacy of EDTA chelation therapy for individuals with coronary artery disease.

What is chelation therapy?

Chelation is a  process in which a substance is used to bind molecules, so that they can be removed from the body. For example, a person who has lead poisoning may be given chelation therapy in order to bind and remove excess lead, or in other cases, iron, copper, and calcium, from the body before it can cause damage. EDTA chelation therapy, (ethylene diamine tetra-acetic acid), is administered through the veins.   Some physicians and alternative medicine practitioners have recommended disodium EDTA chelation as a way to treat coronary artery plaque (hardening of the arteries). The TACT study uses  disodium EDTA,  as an investigational new drug (IND). Disodium EDTA it is not yet approved by the FDA to treat CAD,

The possible side effects:

A common side effect is a burning sensation at the vein insertion site. Rare side effects can include fever, headache, nausea, vomiting, permanent kidney damage,  bone marrow supression, heart failure,  blood pressure dropping acutely, and dangerously low  levels of calcium in the blood.

How might chelation work?

No one knows how or if chelation works. Some theories are that it removes the calcium that is part of the plaque in the walls of the coronary arteries. Other thoughts are that it reduces inflammation of the artery wall. A less plausible theory is that it causes the lowering of cholesterol or induces hormones that remove the calcium from the plaque.

What is the scientific evidence that chelation works?

No significant scientific studies have been done to verify EDTA chelation therapy's safety and effectiveness for coronary disease, most are just anecdotal reports that a scattered patient or so had a reduction in chest pain episodes.  There are only  5 randomized controlled clinical trials regarding the use of EDTA chelation for coronary disease, three trials involved very few people, that only a dramatic improvement could have been detected.  The fourth study reported that EDTA chelation was associated with an improvement in ability to exercise in only 10 patients. and the fifth study was never published in completed format.  Twelve uncontrolled published descriptive studies reported a reduction in angina. These types of studies are the least scientific type of studies and use clinical observations or review past data.


The Bottom Line:
There is no evidence that chelation works, none at all to date. I believe it should be avoided at this point until the evidence from the TACT study is complete. It is foolish to forgo proven treatments for coronary artery disease. If there is significant chest pain of cardiac origin (angina) there are many options available. Save your money for now and avoid chelation therapy unless there are no other options available:


The Hope:
I hope chelation is proven to work. What doctor would not want to administer it in his/her office? It requires no doctor time, it can be administered by a nurse and it is quite lucrative, certainly more lucrative than the administration of the standard treatments such as cholesterol medications and stents.


As a side:
Thirty years ago when I first started private practice in Orange County, California, I went on a local cable TV show to debate/discuss chelation therapy with a doctor using it to treat heart disease. How some 3 decades later we still do not have a definitive answer and it is not supported by the FDA or any medical society. In fact, The FDA has recently sued manufactures for selling it. I do hope it is proven to work!