Questions and Answers About Chelation Therapy

Over the past 30 years people suffering from a type of hardening of the arteries called atherosclerosis have been hearing about a “miracle cure” called chelation (pronounced “ke-LA'shun”) therapy. But they may not know that the American Heart Association and other medical and scientific groups have spoken out against this form of treatment. This brochure contains answers to the most frequently asked questions about chelation therapy. It also outlines the American Heart Association’s position on this procedure, as well as those of other highly regarded scientific organizations.

What is atherosclerosis?
Atherosclerosis, or “hardening of the arteries,” occurs when the inner walls of the arteries become lined with atherosclerotic plaque, i.e., deposits of fat, cholesterol, fibrin (a clotting material found in the blood), cellular waste products and calcium. This process doesn’t occur overnight, but generally happens gradually over many years. That’s why middle-aged and older people are the most frequent sufferers from atherosclerosis. Atherosclerosis can begin early in life, too, however. As this buildup in the inner walls of the arteries increases, the arteries become hard and constricted. When this happens, the arteries lose their elasticity — their ability to expand and contract as the blood flows through them — and they become narrower. And as they narrow, it’s harder for blood to flow through them. The heart has to work harder to pump blood throughout the body. If the buildup continues, an artery can become completely blocked, resulting in a heart attack (in the case of a coronary artery), or a stroke (in the case of an artery leading to the brain). Another problem resulting from narrowed arteries is that it’s easier for a clot to form and plug them. If that happens, the flow of blood to the heart, brain or other organs is shut off. A heart attack, stroke or other serious medical problem can result this way, too.

What is chelation therapy?
Chelation therapy is the administration of a man-made amino acid called EDTA into the veins. (EDTA is an abbreviation for ethylenediamine tetraacetic acid. It’s marketed under several names, including Edetate, Disodium, Endrate, and Sodium Versenate.) EDTA is most often used in cases of heavy metal poisoning (lead or mercury), because it can latch onto or bind these metals, creating a compound that can be excreted in the urine. Besides binding heavy metals, EDTA also chelates (naturally seeks out and binds) calcium, one of the components of atherosclerotic plaque. In the early 1960s, this led to speculation that EDTA could be used to remove calcium deposits from atherosclerotic plaque. The idea was that once the calcium was removed by regular treatments of EDTA, the remaining elements in the atherosclerotic plaque would break up and the plaque would clear away. The narrowed arteries would be restored to their former state. Based upon this thinking, chelation therapy has been proposed both as a treatment for existing atherosclerosis and to prevent atherosclerosis from forming in the future.

These changes can include quitting smoking. In the first month. the American Heart Association has concluded that the benefits claimed for this form of therapy aren’t scientifically proven. because these lifestyle changes have been shown to improve patients’ quality of life and sense of wellbeing. because they underwent chelation therapy. Another claim is that chelation therapy has restored lost bodily function and reduced pain in some cases.After carefully reviewing all of the available scientific literature on this subject. healthier habits that they adopt. their lives were saved. So what’s the problem? The problem is that we question whether these patients feel better because of chelation therapy. the American Heart Association has advocated these lifestyle changes for many years. It’s possible that patients feel better. Often the patient is then advised to continue preventive (prophylactic) treatment once a month. but because of something else. These aren’t the only claims made on behalf of chelation therapy. Is there any proof that chelation therapy works? Supporters of chelation therapy rely on personal testimonies of people who have used the therapy. not because of chelation therapy. For example. The American Heart Association believes that these lifestyle changes (also called risk factor modifications) are probably why the condition of some patients improves. And there are many people who claim that. chelation therapists usually require their patients to make changes in their lifestyles. however. That’s what clouds the issue. patients usually receive from five to 30 treatments (with 30 being closer to the norm). insurance companies and Medicare won’t reimburse patients who undergo the treatments. Who pays for this treatment? The patient. . avoiding foods high in saturated fats and exercising regularly. Since EDTA isn’t a medically accepted procedure for atherosclerosis. That’s why we don’t recommend this type of treatment. but because of better. The American Heart Association can’t say why some people feel better after undergoing chelation therapy. We believe that patients don’t feel better because of chelation therapy with EDTA. These are healthy changes for anyone to make. losing weight. And we don’t deny that some people actually may feel better after treatment. In fact. depending on the clinic administering the treatment. Supporters of chelation therapy also claim that the blood flow through previously narrowed blood vessels has significantly improved in some patients after they’ve undergone treatment. and patients make them at the same time that they’re undergoing chelation therapy. How long does chelation therapy last and how much does it cost? A single chelation treatment usually lasts from two to four hours and costs between $50 and $100. their health was improved or their circulation was restored to their arms and legs. eating more fruits and vegetables.

What kind of scientific experiment or study is needed to validate (or invalidate) chelation therapy? The best way to study chelation therapy would be to conduct an experiment or study in two parts: • The first step would be an experiment or study that proves that EDTA can remove calcium from atherosclerotic plaque (and that the plaque dissolves as a result).” Clearly. To be accepted as subjects for a study. disturbances of regular heart rhythm (cardiac arrhythmias). • . a number of deaths around the country have been linked with chelation therapy. convulsions. Can chelation therapy be dangerous? EDTA isn’t totally safe as a drug. based upon reliable information given to them by the scientists conducting the trial. This second step would only be performed if EDTA had been proven successful in reducing atherosclerotic plaque without dangerous side effects.” The treatments are free to the patients or subjects. allergic-type reactions and respiratory arrest. Also. too. EDTA is also known to cause bone marrow depression. participants must give their “informed consent. This could be another reason why some patients report that they feel better after they’ve spent $3. a number of people are now on dialysis because of kidney failure caused. In fact. Many physicians are familiar with cases in which a sick person’s symptoms disappear for no apparent reason. That reason is psychological. The second step would be to conduct properly controlled clinical trials in a large population. The experiment or study should also show that this occurs without dangerous side effects. • What is properly controlled clinical trial? A properly controlled clinical trial meets the following criteria: • The patients or subjects receiving the treatment formally agree to participate. at least in part. in choosing chelation therapy a person is risking more than money. by chelation therapy. This is the added danger of relying on an unproven “miracle cure. low blood pressure (hypotension). There is an undeniable medical risk. Another reason the American Heart Association is concerned by chelation therapy is that some people who begin by relying on chelation therapy may delay undergoing proven therapies like drugs or surgery until it’s too late. The information given to patients would include an explanation of the known risks involved and the possible (but unproven) benefits.There’s another reason why some patients may feel better after undergoing treatment.000 to $5. due to a placebo effect. The danger of kidney failure (renal tubular necrosis) is very real.000 for chelation therapy. shock.

• The trial is closely monitored and reviewed by 1) knowledgeable scientists who aren’t involved in the trial. What is the position of the American Heart Association? We have a task force that examines the medical support for new and unestablished therapies. Other precautions to ensure objectivity are 1) that the physician giving the treatment can’t be the person who records the results and 2) the person observing the results can’t know which substance a person under observation received. • Any type of study that doesn’t follow the methodology listed above will produce results open to question because of a lack of scientific safeguards. the study was discontinued. determined that EDTA chelation therapy was no more effective than a placebo (sugar pill) in treating men and women with peripheral vascular disease of the legs (intermittent claudication). the results wouldn’t be scientifically valid. Furthermore. Thus. no study of chelation therapy that rigorously follows accepted scientific methodology has ever been completed. Accordingly. 4) statisticians and 5) other interested persons. of which chelation is one. employment of this form of unproven treatment may deprive patients of the well-established benefits attendant to the many other valuable methods of treating these diseases. 2) representatives of the lay community. That’s why the American Heart Association has never funded such a study. a recent study of chelation therapy.” This means that neither the patient nor the physician giving the treatment knows whether the patient is getting EDTA or a neutral control substance (placebo). there still is no scientific evidence that demonstrates any benefit from this form of therapy. To the knowledge of the American Heart Association. and according to qualified scientists who are familiar with research in heart disease. Additionally. . using currently approved scientific methodology. there is only a very small chance that chelation therapy will work. after two of the patients died and the others showed no signs of improvement. Why hasn’t the American Heart Association ever funded a project to research this question? A scientifically valid trial would be very expensive. However. 3) representatives of the religious community. The report of the task force was adopted by the American Heart Association as our official policy statement on chelation therapy. The trial is “double blind. This report states: The American Heart Association’s Clinical Science Committee has reviewed the available literature on the use of chelation (EDTA) in the treatment of arteriosclerotic heart or blood vessel disease and finds no scientific evidence to demonstrate any benefit of this form of therapy. Have there ever been scientific studies done on chelation therapy? In the 1960s a small-scale study involving 30 patients was begun.

and Blood Institute. we have been handed unorganized data without any attempt to describe a formal study. National Heart.What do other authorities say about this treatment? Food and Drug Administration: In the absence of evidence of safety and effectiveness. At the present time. Under the circumstances. American Medical Association: The AMA believes that chelation therapy for atherosclerosis is an experimental process without proven efficacy. therefore. or digitalis toxicity. such therapy should be regarded as investigational and (should be) conducted under carefully controlled conditions in an academic institution by experienced investigators. no physician or sponsor has filed a plan or protocol to study its (EDTA’s) use in such treatment. and cancer. More importantly. instead. American College of Physicians: Chelation therapy with EDTA has been used in the treatment and prevention of atherosclerosis. we have had no choice but to attempt to prevent improper promotion of the drug and to point out its unproven status. Because of the risk of severe renal (kidney) toxicity and lack of objective evidence suggesting therapeutic benefit from EDTA therapy…. (b) adhere to Food and Drug Administration (FDA) guidelines for the investigation of drugs. Lung. hypercalcemia. and (c) disseminate results of scientific studies in the usually accepted channels. it is the responsibility of its proponents to (a) conduct properly controlled scientific studies. To date. “…if chelation therapy is to be considered a useful medical treatment for anything other than heavy metal poisoning. American College of Cardiology: There is insufficient scientific evidence to justify the application of chelation therapy for atherosclerosis on a clinical basis. National Institutes of Health: There is no reason to expect benefit from chelation in the management of arteriosclerosis. No party has ever provided us with an organized submission attempting to show that it is an effective therapy in atherosclerosis. . They have also reaffirmed their 1984 House of Delegates Resolution stating: “…there is no scientific documentation that the use of chelation therapy is effective in the treatment of cardiovascular disease. the use of this treatment for atherosclerosis is investigational. there has been no scientific evidence of such benefit — and there is scientific evidence of no benefit. chelation therapy should be applied only under an investigational protocol. rheumatoid arthritis. atherosclerosis.

but only a relatively small percentage develop problems severe enough to require surgery. with chelation. particularly surgeons? No. Surgery. Organized medicine opposes chelation therapy because it’s an unproven procedure and it involves extreme risks to patients who receive it. can be performed on only one patient at a time. EDTA could be administered to all patients who had atherosclerosis. The reason is that many people have atherosclerosis. the number of patients who can be treated is limited only by the amount of room in the practitioner’s office. however. . after all.Isn’t it true that practicing physicians and medical organizations oppose chelation therapy because widespread use of the procedure would mean a loss of income to cardiovascular specialists. The truth is that physicians who treat cardiovascular diseases could significantly increase their income if chelation therapy was a scientifically proven treatment procedure. If chelation was scientifically proven.

org For information on life after stroke. Texas 75231-4596 1-800-AHA-USA1 www. You can also visit us online at www. Your contributions will support research and educational programs that help reduce disability and death from America’s No. handles these calls.americanheart. The American Stroke Association.americanheart.For more ©2000. [Click here to return to Heart and Stroke A-Z Guide] . please call our Stroke Family "Warmline" at 1-800-5536321. American Heart Association National Center 7272 Greenville Avenue Dallas. a division of the American Heart Association. call 1-800-AHA-USA1 (1-800-242-8721) or contact your nearest office. American Heart Association. 1 killer.

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