Chelation Therapy Trial 2010 – 2013
The National Heart, Lung, and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM), are sponsoring a Trial To Assess Chelation Therapy (TACT). TACT is the first large-scale, multicenter study to determine the safety and efficacy of chelation therapy for individuals with coronary artery disease.
C. Hancke, MD and K. Flytlie, MD
Claus Hancke M.D. received his medical education at the University of Copenhagen. He is general practice and is president of the Danish Chelation Doctors. He is an ABCT diplomate. Knut Flytlie M.D. received his medical education at the University of Gutenberg, Germany. He is in general practice and operates a clinic for Preventive Medicine and Chelation. He is an ABCT diplomate.
ABSTRACT: In a retrospective study we report results of chelation in 470 patients, using a number of parameters, most of them objective. Although the patients acted as their own controls, we observed improvements of 80 to 90%, depending upon the measurement used. Of 92 patients referred for surgical intervention, only 10 required ultimate surgery after or during their chelation therapy, thus saving an estimated 3 million dollars of insurance money. Our experience covers a period of 6 years and we saw no severe side effects or casualties arising from the treatment. We conclude that chelation therapy is safe, effective and cost-saving.Journal of Advancement in Medicine Volume 6, Number 3, 1993
Efrain Olszewer, MD and James P. Carter, MD, DrPH
Dr. Olszewer is a cardiologist in Sao Paulo, Brazil, where this study was conducted.
Dr. Carter is Professor and Head, Nutrition Section, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.
ABSTRACT: Results are presented of a 28-month retrospective analysis of 2,870 patients with documented atherosclerosis and other degenerative, age associated diseases who were treated with intravenous disodium magnesium chelation therapy. Observed benefits strongly support the use of chelation therapy for those conditions. Marked improvement occurred in 76.9% and good improvement occurred in 17% of treated patients with ischemic heart disease. Marked improvement occurred in 91% and good improvement occurred in 8% of treated patients with peripheral vascular disease and intermittent claudication. In patients with cerebrovascular and other degenerative cerebral diseases, 24% had marked improvement, and 30% had good improvement. Of four patients with scleroderma, three had marked improvement and one had good improvement. Seventy-five percent of all patients had marked improvement in symptoms of vascular origin. Independent of pathology, 89% of all treated patients had marked or good improvement.
Journal of Advancement in Medicine, Volume 2, Numbers 1/2, Spring/Summer 1989
A Summary of Chelation Therapy Clinical Research by Elmer M. Cranton, M.D.
Arterial Stenosis Following Chelation
Fifty-seven patients were evaluated objectively for cerebral vascular arterial occlusion before and after an average of 28 intravenous infusions of disodium ethylene diamine tetraacetic acid. Measurements of arterial occlusion were made with the relatively simple, noninvasive oculocerebrovasculometric analysis. Cerebrovascular arterial occlusion diminished by an average of 18% (from a mean of 28% to a mean of 10%) following therapy (P<0.001). Eighty-eight percent of patients treated with chelation therapy showed objective improvements in measured cerebrovascular blood flow.E.W. McDonagh, DO, FACGP; C.J. Rudolph, DO, PhD; and E. Cheraskin, MD, DMD Dr. E.W. McDonagh, a member of the Board of Directors of the American Academy of Medical Preventics, founded the McDonagh Medical Center in Gladstone, Missouri, where he practices with Dr. C.J. Rudolph.Dr. E. Cheraskin is Professor Emeritus and former Chairman of the Department of Oral Medicine at the University of Alabama.
Benefits in Arteriosclerosis Study
In a retrospective study we report results of chelation in 470 patients, using a number of parameters, most of them objective. Although the patients acted as their own controls, we observed improvements of 80 to 90%, depending upon the measurement used. Of 92 patients referred for surgical intervention, only 10 required ultimate surgery after or during their chelation therapy, thus saving an estimated 3 million dollars of insurance money. Our experience covers a period of 6 years and we saw no severe side effects or casualties arising from the treatment. We conclude that chelation therapy is safe, effective and cost-saving.Claus Hancke M.D. received his medical education at the University of Copenhagen. He is general practice and is president of the Danish Chelation Doctors. He is an ABCT diplomate. Knut Flytlie M.D. received his medical education at the University of Gutenberg, Germany. He is in general practice and operates a clinic for Preventive Medicine and Chelation. He is an ABCT diplomate.
Cancer Patients Ninety Percent Reduction in Cancer Mortality After Chelation Therapy
Mortality from cancer was reduced 90% during an 18-year follow-up of 59 patients treated with chelation therapy. Only one of 59 treated patients (1.7%) died of cancer while 30 of 172 nontreated control subjects (17.6%) died of cancer (P = 0.002). Death from atherosclerosis was also reduced. Treated patients had no evidence of cancer at the time of entry into this study. Observations relate only to long term prevention of death from malignant disease, if chelation therapy is begun before clinical evidence of cancer occurs. Controls and treated patients lived in the same neighborhood, adjacent to a heavily traveled highway in a small Swiss city. Both groups were exposed to the same amount of lead from automobile exhaust, industrial pollution and other carcinogens. Exposure to carcinogens was no greater for the studied population than exists in most other metropolitan areas throughout the world. Statistical analysis showed chelation therapy to be the only significant difference between controls and treated patients to explain the marked reduction in cancer mortality. Faculty of the University of Z urich Medical School reviewed this data
NOTE: The above study shows benefit only as a preventative, before any evidence of cancer was detected. Chelation was administered in relatively young patients who had no evidence
of cancer at the time of treatment. They were subsequently followed for another 18 years. The results therefore cannot be applied to patients with an established diagnosis of cancer.
Study Averts Amputation
Four patients are presented, each of whom represents end stage occlusive peripheral arterial disease with gangrene of the involved extremity. These patients had exhausted all traditional forms of therapy and they had all been referred for surgical amputation. Instead of surgery, intravenous chelation therapy was instituted with complete success in each case. These gangrenous extremities all healed and were saved from amputation. Long-term follow-up, extending for more than a year, indicates that all four patients are continuing to do well, with their previously gangrenous extremities intact and pain free. Adjunctive therapies included vitamin and mineral supplementation and, in two cases, hyperbaric oxygen therapy (HBO).Richard Casdorph, MD, Ph.D. and Charles H. Farr, MD, Ph.D.
Clinical Studies and Documentation
The Food and Drug Administration has approved the synthetic amino acid, ethylene diamine tetra acetic acid, as a pharmaceutical agent for the treatment of lead and other heavy metal poisoning or exposure. In older literature, the FDA also approved intravenous treatment as possibly effective in occlusive vascular disorders; arrhythmias and atrioventricular induction defects…and in the treatment of pathologic conditions to which calcium tissue deposits or hypercalcemia may contribute other than those listed above. These possibly effective indications were removed from FDA-approved literature in the late 1970’s for reasons known only to the FDA. Fortunately, physicians are not limited solely to FDA-approved indications and may prescribe approved drugs for whatever conditions they find them to be effective. Consequently, since Chelation is approved for the treatment of heavy metal poisoning (especially lead), many physicians continue to use Chelation Therapy with great benefit in many diseases and conditions other than their officially approved uses. There are two medical associations whose physician members are trained in the administration of the treatment and prevention of atherosclerosis and other chronic degenerative diseases.
These organizations are the American College for Advancement in Medicine (800-532-3688) and the Great Lakes Association of Clinical Medicine (800-286-6013). Members of these organizations and their patients find that chelation therapy is highly effective as an alternative or addition to more traditional / widely accepted approaches such as angioplasty or bypass surgery.
Beneficial Uses of Oral Chelation Therapy in Cardiovascular Disease
In addition to the controversial but widespread recognition of intravenous benefits, is its less well-known clinical uses when administered orally. Early clinical studies reported loss of fat in rats, reduction of cholesterol in rabbits, and reduced blood pressure in humans. Consequently, a study of the effects of oral Chelation on patients with atherosclerosis and/or hypertension was conducted on 10 patients. Four of these patients had hypertension, four had angina pectoris, one had peripheral vascular disease (intermittent claudication), and one was recovering from a heart attack. All were treated with 1gm of oral chelation daily for 3 months. Seven of the ten patients experienced significant reductions in their cholesterol levels, and blood pressure was reduced in all ten. The most marked change occurred in the patient with intermittent claudication, whose cholesterol dropped from 278mg per 100ml to 128. This patient also reported improved exercise tolerance, and the researchers found improved pulsations in the extremities. The four patients with angina pectoris also all reported improvement.
In another series of 20 patients who suffered from hypercholesterolemia, hypertension, angina or peripheral vascular disease, one gram was administered orally every day for 3 months. During that short time, elevated cholesterol levels in nine of the patients dropped to within the normal range. No adverse results were experienced by any of the patients. Angina attacks were reduced in frequency and severity in five individuals. One person who previously had suffered a heart attack and experienced several angina attacks daily thereafter, obtained complete relief.
In another study, two patients with extremely elevated cholesterol were treated with oral Chelation. One patient took it in progressively increasing doses ranging from 500mg to 4gm daily for one year, and the other took 1,000mg daily for three years (Fig 1). Although the first patient suffered a heart attack after three years of therapy, she recovered uneventfully, and had reduced angina pains and improved sense of well-being with continued use of chelation. The second patient – in addition to hypercholesterolemia – had a condition known as xanthomatosis (yellowish papules in the skin, related to elevated blood lipids). She not only experienced dramatic reductions in her cholesterol levels with oral treatment, but her skin lesions completely resolved. Other laboratory studies (including kidney and liver function) remained normal throughout the study for both patients. This is further confirmation of the safety of oral chelation, considering that doses as high as 4gm daily were consumed.
Further support of the anti-atherosclerotic effects of oral Chelation are provided by Italian researchers who found that two grams daily were effective in reducing blood cholesterol. Scientists at Wayne State University quantified reversal in atherosclerotic plaque in rabbits that were treated with daily subcutaneous injections.
Multiple uses as a food additive
In addition to its remarkable pharmaceutical uses, Ethylene-diaminetetraacetic-acid is also approved as a food additive that is generally recognized as safe (GRAS). It’s array of biochemical properties make it extremely valuable as a food additive. It has the ability to: (1) bind with many metals; (2) act synergistically with other antioxidants to stabilize fats and oils; (3) prevent discoloration of potato products; (4) stabilize vitamins; (5) prevent discoloration of fish and shellfish; (6) prevent flavor changes in milk; (7) inhibit the thickening of stored condensed milk; (8) enhance the foaming properties of reconstituted skim milk; (9) prevent color changes of scrambled eggs prepared from egg powder; (10) preserve canned legumes; (11) prevent gushing in beer; (12) promote flavor retention and delay loss of carbonation in soft drinks; (13) prevent oxidation of meat products; and (14) prevent discoloration of canned fruits and vegetables. In fact, it’s use in foods is so widespread that its presence in bloody evidence even created questions during the O.J. Simpson trial as to its source-i.e., from food or from blood previously drawn as evidence – since Ethylene-diaminetetraacetic-acid is also used as an anticoagulant in blood used for laboratory studies.
Absorption of Oral Chelation
In 1954, Dr. Harry Foreman and his colleagues performed a landmark study to determine how much orally administered Chelation the body absorbs. The scientists found that the body absorbs a maximum of 5% of orally consumed Chelation (Fig. 2) and that it can take up to three days to be totally excreted. If someone consumed nutritional supplements that contained 800mg of Ethylene-diamine-tetraacetic acid (used as a stabilizer of the ingredients in the supplement), then we can assume from Dr. Foreman’s research that about 40mg will be absorbed each day and that 1,200mg will be absorbed each month. That equates to almost the same amount administered in one intravenous chelation treatment using the low-dose optimum protocol of Drs. Born and Geurkink that was described in last month’s Nutritional News.
Consequently, those unable to obtain intravenous chelation therapy due to financial, occupational, geographical or other restraints, or who wish to undergo a less-intensive preventive approach may be able to obtain many of the same benefits of intravenous chelation therapy by consuming food-additive Ethylene-diamine-tetraacetic acid that is used as a stabilizer in food supplements. Because of concern that long-term use might result in depletion of certain elements, Drs. Ira Manville and Robin Moser recommended that a potent vitamin and mineral formula be administered during treatment. (This should be taken with meals and not with the formula.) Dr. Garry Gordon agrees and also recommends that because the formula binds to nutritional as well as to unwanted metallic elements, it is most effective when taken on an empty stomach. (1 hr before or 2-3 hours after a meal.)
Calcium disodium edetate and disodium edetate. Federal Register, Volume 35, No. 8, Tuesday, January 13, 1970, 585-587
Perry, H. Mitchell, Schroeder, Henry A. Depression of cholesterol levels in human plasma following ethylenediamine tetracetate and hydralazine. J Chronic Diseases, 1955, 2: 5, 520-532
Schroeder, Henry A. A practical method for the reduction of plasma cholesterol in man. J Chronic Diseases, 1956, 4: 461-468
Perry, Jr., and Camel, G., Some effects of CaNa2edta on plasma cholesterol and urinary zinc in man, in: Metal Binding in Medicine, by Marvin J. Seven and L. Audrey Johnson (eds), 1960, J.B. Lippincott Company, Philadelphia, 209-215
Mariani, B., Bisetti, A., and Romeo, V. Blood-cholesterol-lowering action of the sodium salt of calciumethylenediaminotetraacetic acid. Gazz Intern Med e Chir, 1957. 62: 1812-1823
Wartman, A., Lampe, T.L., McCann, D.S., and Boyle, A.J. Plaque reversal with Mgedta in experimental atherosclerosis: Elastin and collagen metabolism. J Atherosclerosis Res, 1967, 7: 331-341
Aamoth, H.L., and Butt, F.J. Maintaining food quality with chelating agents. Annals New York Academy of Sciences, 1960, 526-531
Furia, T. EDTA in Foods-A Technical Review. Food Technology, 1964, 18: 12, 1874-1882
Foreman, H., Trujillo, T. The metabolism of C14 labeled ethylenediaminetetra-acetic acid in human beings. J Lab Clin Med, 1954, 43: 566-571
Born, G.R., and Geurkink, T.L. Improved peripheral vascular function with low dose intravenous ethylene diamine tetraacetic acid. Townsend Letter for Doctors. July, 1994, # 132, 722-726
Manville, I., and Moser, R. Recent developments in the care of workers exposed to lead. AMA Arch Indust Health, 1955, 12: 528-538
Gordon, G. Oral Chelation Therapy. J Holistic Medicine, 1986, 8: 1 & 2, 79-80