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About Chelation Therapy
   Chelation therapy is a series of intravenous infusions containing a synthetic amino acid (EDTA) and various other substances. Proponents claim it is effective against atherosclerosis and many other serious health problems. Its use is widespread because patients have been led to believe that it is a valid alternative to established medical interventions such as coronary bypass surgery. However, there is no scientific evidence that this is so.
   The proponents' viewpoints have been summarized in four books: The Chelation Answer: How to Prevent Hardening of the Arteries and Rejuvenate Your Cardiovascular System (1982), by Morton Walker, D.P.M., and Garry Gordon, M.D.; Chelation Therapy: The Key to Unclogging Your Arteries (1985), by John Parks Trowbridge, M.D., and Morton Walker D.P.M.; A Textbook on EDTA Chelation Therapy (1989), by Elmer M. Cranton, M.D.; and Bypassing Bypass: The New Technique of Chelation Therapy (2nd edition, 1990), by Elmer Cranton, M.D., and Arline Brecher.
   The scientific jargon in these books may create the false impression that chelation therapy for atherosclerosis, and a host of other conditions, is scientifically sound. The authors allege that between 300,000 and 500,000 patients have safely benefited. However, their evidence consists of anecdotes, testimonials, and poorly designed experiments.
   This article identifies the major claims made for chelation and examines each in light of established scientific fact. The sources used for this review included position papers of professional societies, technical textbooks, research and review articles, newspaper articles, patient testimonials, medical records, legal depositions, transcripts of court testimony, privately published books, clinic brochures, and personal correspondence.

Early History
   The term chelate, from the Greek chele for claw, refers to the "claw-like" structure of the organic chemical ethylenediaminetetraacetic acid (EDTA), first synthesized in Germany in the 1930s. With this claw, EDTA binds di- and trivalent metallic ions to form a stable ring structure. EDTA is water- soluble and chelates only metallic ions that are dissolved in water. At pH 7.4 (the normal pH of blood) the strength with which EDTA binds dissolved metals, in decreasing order, is: iron+++ (ferric ion), mercury++, copper++, aluminum+++, nickel++, lead++, cobalt++, zinc++, iron++ (ferrous ion), cadmium++, manganese++, magnesium++, and calcium++.
   Mercury, lead, and cadmium cannot be metabolized by the body and, if accumulated, can cause toxic effects by interfering with various physiological functions. These substances are called "heavy metals," a term applied to metallic elements whose specific gravity is about 5.0 or greater, especially those that are poisonous. Except for aluminum, the other elements in the above list are essential nutrients that are needed for normal metabolic activity.
   After EDTA was found effective in chelating and removing toxic metals from the blood, some scientists postulated that hardened arteries could be softened if the calcium in their walls was removed. The first indication that EDTA treatment might benefit patients with atherosclerosis came from Clarke, Clarke, and Mosher, who, in 1956, reported that patients with occlusive peripheral vascular disease said they felt better after treatment with EDTA [American Journal of Medical Science 230:654-666, 1956].
   In 1960, Meltzer et al., who had studied ten patients with angina pectoris, reported that there was no objective evidence of improvement in any of them that could be ascribed to the course of EDTA chelation treatment. However, during the next two months, most of the patients began reporting unusual improvement in their symptoms. Prompted by these results, Kitchell et al. studied the effects of chelation on 28 additional patients and reappraised the course of the ten patients used in the original trial [American Journal of Cardiology 11:501-506, 1963].
   They found that although 25 of the 38 patients had exhibited improved anginal patterns and half had shown improvement in electrocardiographic patterns several months after the treatment had begun, these effects were not lasting. At the time of the report, 12 of the 38 had died and only 15 reported feeling better. (This "improvement" was not significant, however, because it was no better than would be expected with proven methods and because there was no control group for comparison.) Kitchell et al. concluded that EDTA chelation, as used in this study, was "not a useful clinical tool in the treatment of coronary disease."

The "Approved" Protocol
   The primary organization promoting chelation therapy is the American College of Advancement in Medicine (ACAM), which was founded in 1973 as the American Academy for Medical Preventics. Since its inception, ACAM's focus has been the promotion of chelation therapy. The group conducts courses, sponsors the American Journal of Advancement of Medicine, and administers a "certification" program that is not recognized by the scientific community. The 1992-93 edition of Encyclopedia of Medical Organizations and Agencies states that ACAM has 450 members.
   ACAM's protocol for "the safe and effective administration of EDTA chelation therapy" is included in Cranton's "textbook," a 420-page special issue of the journal that contains 28 articles and a foreword by Linus Pauling. The protocol calls for intravenous infusion of 500 to 1,000 ml of a solution containing 50 mg EDTA per kilogram of body weight, plus heparin, magnesium chloride, a local anesthetic (to prevent pain at the infusion site), several B-vitamins, and 4 to 20 grams of vitamin C. This solution is infused slowly over 3.5 to 4 hours, one to three times a week.
   The initial recommendation is about 30 such treatments, with the possibility of additional ones later. Additional vitamins, minerals, and other substances—prescribed orally—"vary according to preferences of both patients and physicians." Lifestyle modification, which includes stress reduction, caffeine avoidance, alcohol limitation, smoking cessation, exercise, and nutritional counseling, is encouraged as part of the complete therapeutic program.
   The number of treatments to achieve "optimal therapeutic benefit" for patients with symptomatic disease is said to range from 20 ("minimum"), 30 (usually needed), or 40 ("not uncommon" before benefit is reported") to as many as 100 or more over a period of several years. "Full benefit does not normally occur for up to 3 months after a series is completed," the protocol states, and "follow-up treatments may be given once or twice monthly for long-term maintenance, to sustain improvement and to prevent recurrence of symptoms."
   The cost, typically $75 to $100 per treatment, is not covered by most insurance companies. Some chelationists, in an attempt to secure coverage for their patients, misstate on their insurance claims that they are treating heavy-metal poisoning.

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