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Thursday, May 19, 2005 11:33:01 AM
AHA Recommendation
The American Heart Association has reviewed the available literature on using chelation (ke-LA'shun) (E.D.T.A., ethylenediamine tetraacetic acid) to treat arteriosclerotic (ar-te"re-o-skleh-ROT'ik) heart disease. We found no scientific evidence to demonstrate any benefit from this form of therapy.
Chelation therapy is a recognized treatment for heavy metal (such as lead) poisoning. EDTA, injected into the blood, will bind the metals and allow them to be removed from the body in the urine. Chelation therapy is not approved by the FDA to treat coronary artery disease, but some physicians and alternative medicine practitioners use it for this purpose.
Up to now, there have been no adequate, controlled, published scientific studies using currently approved scientific methodology to support this therapy for cardiovascular disease. The United States Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the American College of Cardiology all agree with the American Heart Association on this point.
In August 2002, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Heart, Lung, and Blood Institute (NHLBI), which are both components of the National Institutes of Health (NIH), announced that they have launched the Trial to Assess Chelation Therapy (TACT). This will be the first large-scale, multicenter study to find out if EDTA chelation therapy is safe and effective for people with coronary heart disease. This placebo-controlled, double-blind study will involve 2,372 participants age 50 years and older who’ve had a heart attack. They will be representative of the U.S. population. TACT will be more than 20 times larger than any prior study of chelation therapy — large enough to show if chelation therapy has mild or moderate benefits.
This study is being done because there is a public health need to conduct a large, well-designed clinical trial to find out if chelation therapy is safe and effective for treating people with coronary heart disease. If people use chelation therapy and it doesn’t work, they may be deprived of the well-established benefits from the many other valuable methods of treating these diseases, such as lifestyle modifications, medications and surgical procedures.
The trial will take place at about 100 research sites across the United States and will test EDTA chelation therapy by using the most widely practiced means of administering it. Participants will begin being recruited in March 2003; patients will receive 30 weekly intravenous treatments, then 10 more treatments given bimonthly, over a 28-month period. They will also receive high doses of vitamins, which are also often given with chelation therapy. (The effect of such vitamin doses will also be examined in the trial.) Once recruitment begins, the study will take about five years to complete. To learn more about this study, visit nccam...nih...gov and ClinicalTrials...gov.
For more information about chelation therapy, see the American Heart Association online pamphlet, Questions and Answers About Chelation Therapy.
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