Positive Health Online

The statistics regarding Cardiovascular Disease (CVD) and Coronary Heart Disease (CHD) make grim reading. In the UK, CHD affects 24% of all men and 25% of all women – with 150,000 deaths per annum, heart disease is the nation’s Number 1 killer. As of March 1992, there were over 11,000 patients awaiting some form of cardiology and cardiothoracic surgery; more than 14,500 Coronary Artery Bypass Grafts (CABG) were performed in 1990/91 and more than 8,000 amputations of limbs were performed in 1989-90.[1] These shocking figures are surpassed in America, where since 1968 over one million bypass operations have been performed and where in 1986 alone more than 250,0000 bypass operations were performed![2]

There are considerable morbidity and mortality figures regarding CABGs (1-4% fatality; 0-5% heart attacks precipitated by surgery; 20% serious after- effects), along with a poor success rate of bypass operations – 40% of grafted vessels close after 10 years, in the remaining 60%, half develop further narrowing. Thus, the target to reduce death rates by 40% in persons under 65 years and by 30% in 65-74 year olds by the year 2003 will only be achieved by researching and implementing a broad range of preventive and treatment options. As expressed in the government white paper, these include measures to reduce smoking, the consumption of saturated and total fat, alcohol and to increase physical activity.[3]

EDTA Chelation Not a Research Priority

NHS research programmes include a randomised intervention treatment study to compare the efficacy of angioplasties with that of CABG, funded by the Department of Health.1 Yet, EDTA intravenous chelation therapy, a long-standing and extensively tested preventive and clinical treatment for many forms of CVD (over 400,000 patients in the US as of 1990), is not even on the map in the UK for research or appraisal, let alone implementation as a treatment for CVD! According to Baroness Cumberlege,[1] "...EDTA chelation is not specifically cited as a national priority for research and development but may feature under regional programmes..." And according to Tom Sackville, Parliamentary Under Secretary of State for Health,[4] "...Professional advice is, that there is no evidence that chelation therapy is beneficial in the management of arterial disease...some patients have reported improvement in how they feel after chelation treatment, but there is no medical evidence to demonstrate physical benefits..."

The above statements regarding the apparent lack of medical evidence of EDTA chelation therapy’s efficacy in the management of CVD are incredulous in the light of the extensive body of research publications in this field dating from the 1950s to the present, contained in several recent reviews, citing hundreds of scientific publications relating to human clinical research as well as animal studies.[2,5,6,7] This body of literature reflects decades of refinement of EDTA chelation therapy protocol, clinical treatment of patients with numerous cardiovascular complaints by physicians internationally, and clinical trials and studies.

What is EDTA Chelation Therapy?

This therapy consists of repeated, slow (3-4 hours each) intravenous infusions of magnesium disodium ethylene diamine tetraacetate (Mg-EDTA), a proven and medically accepted chelating agent, in 500-1000 ml of an iso-osmolar carrier solution to which, in addition to sodium bicarbonate buffer, local anaesthetic and heparin, other ingredients such as vitamin C, B-complex vitamins and potassium are also sometimes added.[6] Chelation therapy improves metabolic and circulatory function by removing toxic metals – lead, cadmium – and free radical promoting metallic ions – copper, iron – from the body. Conditions which are treated by chelation therapy include atherosclerosis, angina, stroke and peripheral vascular disease. Following the removal of the enormous burden of free radical pathology via EDTA chelation therapy, a range of positive side-effects frequently occur, including improvements of symptoms of arthritis, multiple sclerosis, Parkinson’s disease, psoriasis, tinnitus, memory, concentration and general alertness.[2] EDTA chelation has the following effects upon free radical pathology which are the basis of its efficacy in treating atherosclerotic disease:[7]

• Controls free radical damage by removing abnormally located metal ions such as excess iron, which accumulate with age, and by stopping further lipid peroxidation, permitting healing of peroxidative damage;
• Enhances the integrity of cell membranes, stabilises mitochondrial membranes and enhances the efficiency of energy metabolism; Helps to restore prostaglandin balance, preventing arterial spasm, blood clot, plaque formation and arthritis;
• Protects the integrity of blood platelets, reducing their tendency toward over-coagulation; Attracts and chelates (binds) metallic ions which cause free radical activity – lead, cadmium, mercury, aluminium, iron – and removes them from the body;
• Normalises calcium metabolism and neutralises free radical activity which converts cholesterol into substances which cause plaque to accumulate calcium;
• Intermittently lowers serum calcium enabling gradual reversal of abnormal calcification by stimulating the uptake of calcium in bones;
• Uncouples tissue cross- linkages which cause rigidity and abnormal biochemical function and thus restores tissue flexibility and function.

Clinical Research Validating EDTA Chelation

Chappell and Stahl conducted a meta-analysis of currently available scientific literature to test the hypothesis that intravenous EDTA chelation therapy is effective in treating cardiovascular disease.[8] They performed a very thorough literature search which had to extend to databases beyond Medline, including Exerpta Medica, Current Contents and the French PASCAL databases, Science Citation Index search, Health Periodicals Database, Toxline and the American College of Advancement in Medicine (ACAM). This search of the literature identified 40 articles, of which 18 publications met the criteria for inclusion, with data from 22,502 patients. The criteria for inclusion in the meta-analysis were the following:

1. Limited to human studies;
2. Included only the data that specified whether or not the subjects improved;
3. Included only the data that referred to objective measurement of improvement in cardiovascular disease.

Chappell and Stahl explain at great length which studies were not included in the meta-analysis and why; this section contains some extremely invaluable information regarding methodologies, analyses and results of many published studies. There is a most informative historical overview of the decades of research of EDTA chelation therapy.

They also refer to several double-blind studies which are nearing completion or have been completed but have not yet been published, including one conducted at Baylor University School of Medicine, an FDA approved double-blind study cosponsored by the American Institute of Medical Preventics, and a study by Van Rij in New Zealand, which is due to be published in Circulation in August/September 1994.

Included in the meta-analysis was the pre-publication draft of a large retrospective study of 19,147 patients, conducted by Hoekstra, Gedye, Scarchilli, Parente et al,[9] which evidence has been accepted in several legal proceedings and has been instrumental in New Zealand government acceptance of EDTA chelation therapy. All patients initially had at least moderate stenosis; 86% improved measurably following EDTA treatment.

The control group did not improve. Other studies included were ones conducted by Olszewer and Carter from Brazil with 2,482 patients,[10]

Hancke and Flytlie of Denmark, in which 39 out of 45 patients on waiting lists for bypass or amputation were able to cancel their surgery,[11] and studies by McDonagh, Rudolph and Cheraskin which used oculocerebrovascular analysis, the A/B index and Doppler ultrasound to document improvement to carotid and peripheral circulation following treatment with EDTA chelation.[12-14]

The meta-analysis sought to determine the extent of the relationship between EDTA chelation therapy and cardiovascular improvement, with a correlation coefficient of 0 indicating no relationship and a value of 1.0 indicating a perfect relationship between EDTA therapy and cardiovascular improvement. The results of the meta-analysis revealed a correlation coefficient of 0.88, a highly positive relationship between EDTA therapy and improved cardiovascular function. The correlation coefficient was changed very little whether the analysis was limited to large studies or small studies. In the meta-analysis of treatment results of 22,502 patients, 87% of them had favourable outcomes. Of the more than 40 published reports and one major work submitted for publication, only one multi-patient study contained data showing negative results[15] and this study has been harshly criticised by scientific peers.[16,17]

Acceptance of EDTA Chelation by the Wider Medical Community

The authors of the meta-analysis acknowledge that the majority of EDTA chelation research is of the pretest-posttest, no control group design, where each patient’s cardiovascular capability is measured prior to treatment, and again following treatment. In their opinion, the acceptance of the efficacy of EDTA chelation therapy has not been widespread among the medical community to its merited extent because of the lack of control in these studies. However, "...even though control has, for the most part, been absent in existing EDTA studies, this does not mean that the data collected is not valid or useful. When an effect is present, then the data will show the presence of the effect whether the study is a well designed and well executed double-blind study or a pretest-posttest no control group study. This assumes, of course, that good measuring techniques are used and that the variables are not confounded..."

A correlation coefficient of 0.88 using data from over 22,000 patients is a stunning result. Other studies show that following EDTA chelation there is a statistically significant decrease in obstructive blockage of carotid arteries[18] and in a retrospective study of 470 patients, improvements of 80-91% resulted; only 10 of an original 92 patients referred for surgery actually required surgery following chelation therapy.[19] The imminent publication of results from the FDA and Van Rij studies, if also positive, will further strengthen the clinical research basis for the efficacy of EDTA chelation therapy. With 150,000 deaths in the UK per annum from cardiovascular disease and evidence that all adults are afflicted to some degree, it would be an act of flagrant neglect for the NHS to ignore EDTA chelation therapy and block its introduction into the armamentarium of preventive and treatment measures for cardiovascular disease, the UK’s number one killer.

References

1. Answers to questions in the House of Lords posed by Lord Colwyn and answered by Baroness Cumberlege.
2. Cranton E and Brecher A. Bypassing Bypass – The New Technique of Chelation Therapy. Medex Publishers. 1990.
3. The Health of the Nation. Government White Paper. HMSO. 1992.
4. Letter from Tom Sackville, Parliamentary Under Secretary of State for Health (Lords) to Winston Churchill, MP. 15 June 1992.
5. Value of EDTA in atherosclerosis. The Royal College of General Practitioners Official Reference Book. pg 213-4. 1989.
6. Perry W. Protocol of the American College of Advancement in Medicine for the Safe and Effective Administration of EDTA Chelation Therapy. 1989.
7. Chappell, LT. Bibliography on Mechanisms of Action of EDTA. Townsend Letter for Doctors. 130:475. May 1994.
8. Chappell LT and Stahl JP. The Correlation between EDTA Chelation Therapy and Improvement in Cardiovascular Function: A Meta-Analysis. Journal of Advancement in Medicine 6:2. 1993.
9. Hoekstra PP III, Gedye JL, Hoekstra P, Lewis HT, Scarchilli AJ, Parente PA. Serial infusions of magnesium disodium ethylene diamine tetraacetic acid enhance perfusion in human extremities. Pre-publication draft, Therma-Scan, Inc, 26711 Woodward Ave, Huntington Woods, MI 48070. 1993.
10. Olszewer E and Carter JP. EDTA chelation therapy in chronic degenerative disease. Med Hyp. 27(1): 41-9. 1988.
11. Hancke C and Flytlie K. Manipulation with EDTA. Ugeskar Laeger. 154(32): 2213-5. 1992.
12. Rudolph CJ, McDonagh EW. Effect of EDTA chelation and supportive multivitamin/trace mineral supplementation on carotid circulation: case report. J Advancement in Med. 3(1): 5-12. 1990.
13. McDonagh EW, Rudolph CJ and Cheraskin E. An oculocerebrovasculometric analysis of the improvement in arterial stenosis following EDTA chelation therapy. J Hol Med. 4(1): 21-3. 1982.
14. McDonagh EW, Rudolph CJ, Cheraskin E. The effect of EDTA chelation therapy plus multivitamin/trace mineral supplementation upon vascular dynamics (ankle/brachial systolic blood pressure). J Hol Med. 7(1): 16-22. 1985.
15. Guldager B, et al. EDTA treatment of intermittent claudication – a double-blind, placebo controlled study. J Int Med. 231(3): 261-7. 1992.
16. EDTA chelation: a rebuttal. J Advancement in Med. 5(1): 3-5. 1992.
17. Cranton EM and Frackelton JP. Negative Danish study of EDTA chelation biased. Townsend Letter for Doctors. 604-5. July 1992.
18. Rudolph CJ, McDonagh EW and Barber RK. A Nonsurgical Approach to Obstructive Carotid Stenosis Using EDTA Chelation. Journal of Advancement in Medicine. 4(3): 157-67. 1991.
19. Hancke C and Flytlie K. Benefits of EDTA Chelation Therapy in Arteriosclerosis: A Retrospective Study of 470 Patients. Journal of Advancement in Medicine. 6(3): 161-71.1993.

Research by Richard Brown.