Chelation Therapy

Chelation therapy involves the intravenous infusion of EDTA (ethylene diamine tetraacetic acid) over a course of treatments in a doctor's office. EDTA is a synthetic amino acid, which has the ability to attach itself to metals and minerals, forming a particular kind of bond called a chelate.  Once the chelate is formed it is naturally excreted from the body.  Essentially, chelation therapy “washes out” heavy metals and minerals from the body.

Ethylenediaminetetraacetic acid ("EDTA") is a synthetic amino acid first used in the 1940's for treatment of heavy metal poisoning. It is widely recognized as effective for that use as well as certain others, including emergency treatment of hypercalcemia and the control of ventricular arrhythmias associated with digitalis toxicity. Studies by the National Academy of Sciences/National Research Council in the late 1960's indicated that EDTA was considered possibly effective in the treatment of occlusive vascular disorders caused by arteriosclerosis.

Clinical experience with EDTA chelation therapy has convinced substantial numbers of licensed physicians in North America that it is a safe and effective treatment for atherosclerotic vascular disease, as it consistently improves blood flow and relieves symptoms associated with the disease in greater than 80% of the patients treated. As members of the medical profession are generally aware, the pathogenesis of atherosclerotic disease is extraordinarily complex. The scientific principles underlying the efficacy of EDTA chelation therapy in impeding each step of the disease process are beyond the scope of this overview, but they are elaborated upon in the many published clinical studies and research papers available.

In its simplest terms, the rationale for its efficacy is that EDTA, in binding ionic metal catalysts and removing them from the body, reduces subsequent abnormal production of oxygen free radical reactive molecules and molecular fragments which react destructively with other molecules. See, E. M. Cranton, J. P. Frackelton, Free Radical Pathology in Age-Associated Diseases: Treatment with EDTA Chelation, Nutrition, and Antioxidants, Journal of Advancement in Medicine, Vol. 2, Nos. 1, 2, Spring/Summer, 1989.¹

There is now widespread agreement that EDTA removes metallic catalysts which cause excessive oxygen free radical proliferation, thereby reducing pathological lipid peroxidation of cell membranes, DNA, enzyme systems and lipoproteins and allowing the body's natural healing mechanisms to halt and often reverse the disease process.

Steinberg, et al., state in the April 6, 1989, New England Journal of Medicine, 1989; 320(14):915-924, concerning Modifications of Low-density Lipoprotein That Increase Its Atherogenicity through free radical peroxidation, "oxidative modification is absolutely dependent on low concentrations of copper or iron in the medium and is therefore completely inhibited by ethylenediaminetetraacetic acid (EDTA)."²

Chelation therapy is considered by the physicians who utilize it to be an effective first step alternative to surgical treatment for atherosclerotic vascular disease in most cases. In the instances where a physician believes that bypass surgery or the interventional cardiac catheterization techniques of thrombolysis and balloon angioplasty are more appropriate, he or she will refer those patients out. These alternatives to chelation therapy though are not without their respective detractors and attendant risks.

In September 1978 the Office of Technology Assessment ("OTA"), a branch of the United States Congress, aided by an advisory board composed of leading medical and university school faculty, published a report entitled Assessing the Efficacy and Safety of Medical Technologies. One portion of that report discussed the efficacy and safety of surgery for coronary artery disease, concluding as follows:

Coronary artery bypass surgery is based on a scientific rationale and may be of measurable benefit to some patients. It is usually performed for angina pectoris and appears to give substantial relief from symptoms, but the extent to which this relief is an effect of surgery is not known. Limited studies suggest that coronary bypass surgery improves life expectancy significantly for only a small number of patients, with a particular type of coronary artery disease. Controlled studies have shown no improvement in life expectancy for patients studied (emphasis added). Id. at page 44. ³

The importance of this analysis is its recognition, though over 70,000 operations were performed in 1977, that the benefits of such surgery have yet to be demonstrated.⁴

Another article in the New England Journal of Medicine (March 22, 1984) reported upon myocardial infarction and mortality in the coronary artery surgery study (CASS) randomized trial, and summarized as follows in the Abstract:

ABSTRACT: There were no statistically significant differences in the survival rate or in the myocardial infarction rate between subgroups of patients randomly assigned to medical and to surgical therapy when they were analyzed according to initial group assignment, number of diseased vessels, or ejection fraction. Therefore, as compared with medical therapy, coronary bypass surgery appears neither to prolong life nor to prevent myocardial infarction in patients who have mild angina or who are asymptomatic after infarction in the five-year period after coronary angiography. ⁵

The necessity of heart surgery and the scheduling of such surgery have undergone substantial criticism of late by many in the medical community. Despite this criticism, in 1981 an estimated 110,000 patients underwent bypass surgery. By 1983 the annual number of operations had increased to 191,000, and by 1989 the number had soared to over 368,000.⁶

As stated by Dr. Thomas A. Preston, professor of cardiology at the University of Washington School of Medicine and chief of cardiology at Pacific Medical Center:

[Coronary-bypass surgery] is heralded by the popular press, aggrandized by our profession, and actively sought by the consuming public. It is the epitome of modern medical technology. Yet, as it is now practiced, its net effect on the nation's health is probably negative. The operation does not cure patients, it is scandalously overused, and its high cost drains resources from other important areas of need.

Fully half of the bypass operations performed in the United States are unnecessary. A decade of scientific study has shown that except in certain well-defined situations, bypass surgery does not save lives or even prevent heart attacks: Among patients who suffer from coronary-artery disease, those who are treated without surgery enjoy the same survival rates as those who undergo open-heart surgery (emphasis added). MD Magazine, Feb. 1995.

In an article entitled The Appropriateness of Performing Coronary Artery By-Pass Surgery published by the American Medical Association in JAMA 1988, 260:      505- 509, the authors report the results of a randomized study conducted to determine the level of judiciousness currently being applied by physicians in performing coronary artery bypass surgery. The authors report that only fifty-six percent (56%) of the surgeries were performed for appropriate reasons. As stated in the abstract to this article, "eliminating the performance of [such] inappropriate procedures may lead to reductions in health care expenditures or to improved patient outcomes."

Balloon angioplasty is an alternative to venous grafting which is enjoying increased popularity among vascular surgeons. Experience with this technique, though, has shown that serious complications, including permanent renal failure, occur in up to 8% of cases and that technical failure rates for iliac and femoral angioplasties occur in up to 50% of cases.⁷ Moreover, it must be remembered that both this technique and venous grafting are very point specific, in distinct contrast to chelation therapy, which benefits the entire vascular system. Furthermore, the costs associated with the various treatment modalities are widely disparate. A typical bypass surgery costs the patient in excess of $30,000.00, the usual balloon angioplasty over $12,000.00, and an average course of chelation treatments $3,000.00 to $5,000.00, including ancillary costs.

The scientific rationale of chelation therapy is demonstrated in the before noted article of E. M. Cranton, M.D. and J. P. Frackelton, M.D. As stated in the Abstract:

"Recent discoveries in the field of free radical pathology provide a coherent, unifying scientific basis to explain the many and diverse benefits reported from treatment with EDTA chelation therapy. The free radical concept provides a scientific basis for treatment and prevention of the major causes of disability and death, including arteriosclerosis, dementia, cancer, arthritis and numerous other diseases. EDTA chelation therapy, nutritional supplementation, physical exercise and moderation of health destroying habits all have common therapeutic mechanisms which reduce free radical causes of age-related diseases."

Chelation therapy, like bypass surgery and angioplasty, is based upon a scientific rationale and is of measurable benefit to patients. There is no reason why surgery should be condoned, while chelation therapy is often condemned simply because it has not heretofore undergone large-scale, double-blind, placebo-controlled trials.

As elaborated upon in the OTA report, only 10 to 20 percent of all procedures currently used in medical practices have been shown to be efficacious by controlled trial.⁸

The efficacy of chelation therapy has been clinically demonstrated to thousands of doctors through positive results in hundreds of thousands of cases where this treatment was utilized. One pilot double blind study has already been completed with strongly favorable results.⁹

The safety of this therapy, when properly administered, is not an issue. It is estimated that physicians utilizing the protocol developed by the American College for Advancement in Medicine nationally have safely treated over 500,000 patients with this therapy.¹⁰ No reported fatalities have occurred in the United States when the ACAM protocol has been followed. Whenever chelation is used in its widely-accepted role to combat lead poisoning, the dosages given even to children are administered much more rapidly than those administered to adults under this protocol. The risks associated with surgical procedures are far greater by comparison.

The Food and Drug Administration determined that EDTA chelation therapy was safe prior to approving the Investigational New Drug protocol for the ongoing double-blind placebo-controlled studies.

It is the treating, clinical physician who is best acquainted with the patient's medical history, examination results, condition and needs. It is the attending physician who is in the best position to assess the condition (medical, socioeconomic, and psychological) of the patient as well as what constitutes the best treatment for the patient. Despite criticism in the form of opinions from physicians who characteristically have never utilized the treatment modality, not a single valid study has ever been shown to support or warrant such distraction.

Under current treatment protocols, EDTA chelation therapy is safe and relatively free of side effects which may include, but are not limited to, discomfort at the injection site, thrombophebitis, fatigue, hypocalcemia, muscle cramps, nausea, vomiting, allergic reaction (although rare),  nephrotoxicity (although rare), congestive heart failure, liver disease, anticoagulation, lowering of blood sugar levels, mineral loss, shock (although rare), infection, and generalized complaints.  Chelation therapy patients are advised to take a comprehensive approach to their treatment and health, including diet, exercise, stress management programs and dietary supplements. As with any other medical treatment, patients should insure that their treating physicians have appropriate training and credentials for administration of EDTA chelation therapy. ¹¹

Despite the lack of controlled scientific studies as proof of its effectiveness, physicians have used EDTA chelation therapy for over fifty years to treat such related diseases as cardiovascular disease, diabetic arterial disease, decreased mental function from vascular disease and intermittent claudication (leg pain with exercise). Many of these doctors also use EDTA in preventive medicine.

There an in-depth wealth of information from reliable sources available on the web about chelation; some useful web sites include:

¹¹http://www.acam.org/ The American College for Advancement in Medicine (ACAM) provides a position paper and further information on chelation. 

http://nccam.nih.gov/news/2002/chelation/pressrelease.htm/   “NIH Launches Large Clinical Trial on EDTA Chelation Therapy for Coronary Artery Disease”  

http://216.185.112.5/presenter.jhtml?identifier=3000843  American Heart Association. Questions and answers about chelation therapy.