This is an older article (below) I wrote that didn't include the positive data found from a large, randomized TACT trial done with the National Institutes of Health (Lamas GA, et al. JAMA. 2013). The TACT Trial study showed a benefit from chelation therapy, especially in those with previous heart attack/MI and diabetes. Both positive and negative comments on the trial can be found with a search online. In my practice, I find that ozone therapy (major autohemotherapy) has had a larger effect on my patient's who have symptoms from poor circulation.
TACT Trial: The NIH trial on chelation therapy (Trial to Assess Chelation Therapy) of 50 years of age or older, post-MI (participants already had previous heart attack), received 40 IV EDTA chelation treatments and multivitamin/mineral supplement, and was placebo controlled. It showed good promise (chelation/vitamin/mineral treatment group had modestly reduced the risk of adverse cardiovascular outcomes, most commonly reduced coronary revascularization) especially for a subset of patients, those who had already had a heart attack as well as had been diagnosed with diabetes. Treatment effect continued over 5 year follow up period. 1708 patients were enrolled in this trial.
Chelation therapy may improve the circulation in smaller vessels, and improve nitric oxide function to improve blood flow. It removes lead, which is a poison for the enzyme (nitric oxide synthase). This enzyme creates your body's natural "nitroglycerin", to relax artery walls. A recent study of 14,000 patients showed that elevated blood lead, even at 1/20th the normal reference range, can be associated with a 2x increased risk of stroke Lanphear BP et al, 2018).
Question: My family doctor and cardiologist say it hasn’t been proven, or worse yet, that it’s been proven not to work. What’s the evidence that chelation therapy works (or doesn’t) in heart and artery disease?
When my patients ask their family doctor or cardiologist about chelation therapy, at least 90% of the time the response they get is that it doesn’t work, or it hasn’t been proven. The doctor, while meaning well and trying to give an informed opinion, is simply misinformed in my opinion.
Three publications in mainstream medical journals, which have summaries called abstracts available online, have negative conclusions. When a physician does a cursory search on a therapy using this database, they are only presented with the journal index and its summary, which does not include the raw data. All three of these trials have stated negative conclusions in their summaries, but their raw data indicates the opposite; that in fact, chelation therapy may be effective. The problem is that the doctor sees only a negative summary but not the positive data. Most physicians can not take the 2 hours required to go through the raw data, per study, and therefore take it for granted and simply go to the conclusion or summary of the study.
Furthermore, not all of the biomedical literature ends up indexed in the common medline or pubmed database. The database is definitely exhaustive and I research it every day in practice. However, every study that has drawn a positive, beneficial conclusion for chelation therapy has been refused indexing in this database. The studies are published, in peer-reviewed journals, but these journals are not indexed in the database and therefore physicians do not come across them.
Let’s examine the four “negative” trials on chelation therapy.
Kitchell and Melzer published in the American Journal of Cardiology a trial in which they treated in a double-blind fashion (neither doctor nor patient knew whether they were getting the EDTA or a non-active placebo). Their conclusion was that chelation therapy was not effective because…
Some of the patients who had improved significantly, got worse about a year after therapy was stopped. In other words, chelation benefits didn’t last forever.
There is no therapy in medicine, including bypass surgery, that in my opinion, you couldn’t make the same statement for! Furthermore, patients selected for the study were the worst of the worst in that they had severe angina (chest pain) that had previously been treated with conventional methods, which had wholly been unsuccessful. All patients were disabled at the time of therapy.
-71% of chelation patients had subjective improvement (they felt much better)
-64% had objective improvement (ECG test, exercise stress test)
-Improvement was maintained for 1.5 years after therapy was stopped
Their conclusion? Because after 1.5 to 2 years, the worst patients started to get worse again, chelation didn’t work at all (Kitchell, J.R., et al., 1969). (It also worth noting that nutritional changes, supplements, mineral replacements, smoking habits, were not attended to for these patients. Only chelation was used).
In the American Journal of Surgery (Sloth-Nielsen, J., et al., 1991) and the Journal of Internal Medicine (Guldager, B., et al, 1992) bypass surgeons published a study of EDTA chelation therapy. Being bypass surgeons, there probably was a bias to start with in this trial, and furthermore, these surgeons had no training in EDTA chelation. As such, the standard protocol developed by the American College for Advancement in Medicine, and used by most chelating physicians, was not used. The study was published as a double blind trial, but in fact, it was not double blind because the surgeons knew which patients got the treatment and which patients got the inactive fake medicine. The study in fact suffers from the same flaws that mainstream physicians use to criticize the positive studies of chelation therapy.
In this study, the group that got the EDTA had significantly more severe disease than the placebo group (thus the group getting the treatment, and the group getting the fake placebo, were not equally matched). Some patients dropped out of the trial. The researchers refused access to the raw data, prompting some chelating doctors to wonder if the drop-outs stopped treatment because they were feeling all better.
The most important part of this study is though, that the final measure of improvement was walking distance possible before pain stopped the patient. Patients with poor blood flow can only walk short distances because of chest pain or leg pain. When walking distance was measured 3 months after the last treatment (when the maximum benefit is postulated to occur), patients who were able to walk the furthest, who had improved the most, were dropped from the data because they stopped for reasons other than pain.
The best improvers, in the chelation group, were excluded from their final analysis. Thus the negative conclusion.
Furthermore, all patients were given iron supplements, which is known to neutralize some of the effects of EDTA.
Despite these drawbacks, the EDTA chelation group had roughly twice the improvement compared to the placebo group.
The third negative chelation study was not published, but was presented at an atherosclerosis (fatty build up in the arteries) conference in Germany. The end result was that patients treated with EDTA had walking distance improve by 400%! The placebo group to which the EDTA was compared to was actually an approved drug called bencyclan, used in blockages of the arteries.
-the average improvement in the EDTA group was 400%, in that they were able to walk 4 blocks instead of the one block that the drug group was able
-some patients had no benefit, and some patients were cured in that they had no pain at all
-average was still 400% improvement
Here, the researchers threw out the data of patients who got completely well, calling it a “fluke” and therefore insignificant. Some doctors at this conference were upset with the researchers conclusions, and thus brought the data home to the chelation group the American College for the Advancement in Medicine, who reanalyzed the data. With the best improvers left in, improvement with EDTA was 400% better than the drug. Without the best improvers, EDTA was “only” 70% better than the drug.
Those are the three of the main studies that purported to have negative conclusions for chelation therapy. I’ve gone into detail about their shortcomings because it is important to know that well-meaning physicians might say “chelation has been proven to not work” or that “chelation has never been shown to work”, whereas, because they have only read the conclusions and not analyzed the raw data, they are misinformed.
Below is a much quicker summary of the positive studies in chelation, because the results speak for themselves.
Dr Olszewer in Brazil and Dr Carter (Olszewer & Carter, 1988) (former professor and chair in Tulane Medical School), observed 2,870 patients and found in heart disease patients 77% had marked improvement, 17% had good improvement. In peripheral artery disease of the legs, 90% had marked improvement. Alzeimer’s and stroke patients had only about a 25% to 30% improvement, because the nerve cells were most likely already damaged. Scleroderma patients (an autoimmune disease), had 75% patients get marked improvement, and all the remaining 25% patients had good improvement. I know of no better treatment for scleroderma.
Dr Casdorph, an assistant professor of medicine in California, used radioisotopes to measure blood flow to the brain. Consistently, after about 15 treatments, patients started to show improved blood flow. Improvement was much better after 20 treatments, and continued as treatments progressed.
Dr Mcdonagh and Cheraskin used a blood pressure device to measure blood flow in the ophthalmic artery, a branch of the carotid artery, which is normally affected by plaque build up. Patients were divided into three groups based on the severity of their disease. The most severe patients had improvements from 32% blockage to 17% blockage. The intermediate disease patients had 24% blockage to 9%. The least severe patients had 23% blockage go to 5% blockage (the best improvements, suggesting that chelation has the most benefit in PREVENTING blockages) (McDonagh et al, 1982). These measurements had no possibility of hypnosis, suggestion, or placebo, as they are actual blood flow measurements!
Dr Mcdonagh did blood pressure ratios in the arm and leg. The leg blood pressure is normally higher, but if there are blockages in the leg arteries, the pressure is lower. The critical point is 0.5, where gangrene (tissue death) of the toes starts. The average improvement went from a leg blood pressure of 77 percent (of the arm) all the way up to 90 % of the arm after chelation therapy. The worst patients who started out at 50%, still improved to 70%, not a cure, but improved! (McDonagh et al., 1985)
Dr Casdorph evaluated EDTA chelation in heart disease, where the heart muscle does not pump correctly. This is called ejection fraction, where the problematic heart does not eject as much blood per pump. He found improvements that were so significant, if due to random chance, it would be like flipping a coin 18 times in a row and getting 17 heads in a row. (Casdorph et al, 1981)
Dr Chappell of the International College of Integrated Medicine analyzed 22,700 patients. He found also that there was about an 87% chance that patients would objectively improve with chelation therapy (Chapell, LT, 1993). This was published data.
The maximum effect of any given number of chelation treatments, be it after 10 or 30 or 50 treatments, is usually 3 months after the last chelation. This is heavy evidence against a placebo or suggestive effect of chelation in my opinion, because placebo acts right away, and wears off after 3 months. The most likely mechanism of chelation therapy, in my opinion, is in redistribution of diseased accumulations of metals (nutritional metals like zinc, chromium, and iron) in diseased tissue. Removal of toxic heavy metals most likely contributes to the effect. This is the reason why chelation therapy appears to last longer than other therapies, and if patients start to go downhill again, a touch up treatment can be done once a month or similar. The goal is to bathe the cells in EDTA for a period of 2 to 2.5 hours, in order to maximally rearrange the diseased accumulations of metals. Simple heavy metal detoxification, appropriate in other diseases, and in patients whom lead exposure might be more important, a different form of chelation can be given much more rapidly. However, this method, if done alone, is not as effective in heart disease as the slow chelation, and heart disease patients may need to be switched over to the slow 2-2.5 hour chelation.
IV Chelation involves:
-testing of kidney function
-a challenge of EDTA given by injection & urine test for heavy metals and/or blood lead (Lanphear BP et al, 2018)
-individualization of therapy based on case history, test results
-treatment is usually once to twice a week, 10-30 treatments
Potential side effects IV chelation: Occasionally headache, low blood sugar, sweating, dizziness, lightheadedness, mild discomfort / vein irritation may occur. Side effects (generally rare in our experience): changes in kidney function (kidney function checked routinely, before and periodically during treatment regime). Irregular heartbeats, high blood pressure, thrombophlebitis have been reported. Allergy reaction or rash is possible with any medicine. It is generally recommended to eat prior to receiving IV chelation to prevent feeling like you have low blood sugar. Vitamin/mineral supplements are often recommended between chelation treatments to help prevent mineral deficiencies that could occur.
A course of chelation generally involves 30 treatments for heart disease, and typically anywhere from 10-20 for heavy metal detoxification.
Evidence: IV chelation, vitamins/minerals & cardiovascular disease
Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL. 2013. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50.
Issa OM, Roberts R, Mark DB, Boineau R, Goertz C, Rosenberg Y, Lewis EF, Guarneri E, Drisko J, Magaziner A, Lee KL, Lamas GA. 2018. Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT). Am Heart J. 2018 Jan;195:70-77.
Diaz D, Fonseca V, Aude YW, Lamas GA. 2018. Chelation therapy to prevent diabetes-associated cardiovascular events. Curr Opin Endocrinol Diabetes Obes. 2018 Aug;25(4):258-266.
Fulgenzi, A.; De Giuseppe, R.; Bamonti, F.; Ferrero, M.E. Improvement of oxidative and metabolic parameters by cellfood administration in patients affected by neurodegenerative diseases on chelation treatment. Biomed. Res. Int. 2014, 2014.
References: Earlier Articles IV EDTA & Cardiovascular Disease
Chappell LT, Stahl JP. The correlation between EDTA chelation therapy and improvement in cardiovascular function: a meta-analysis. J Adv Med 1993;6:139-163.
Olmstead SF. A Critical Review of EDTA Chelation Therapy in the Treatment of Occlusive Vascular Disease. Klamath Falls, OR: Merle West Medical Center Foundaton; 1998.
Olszewer E, Carter JP. 1988. Med Hypotheses. 1988 Sep;27(1):41-9. EDTA chelation therapy in chronic degenerative disease.
Casdorph, H.R. 1981. EDTA Chelation Therapy II, Efficicay in Brain Disorders. Journal of Holistic Medicine 1981; 3: 101-117.
McDonagh, E.W., Rudolph, C.J., Cheraskin, E. 1982. An Oculocerevraovasculometric Analysis of Improvement in Arterial Stenosis Following EDTA Chelation Therapy. Journal of Holistic Medicine 1982;4: 2 1-23.
McDonagh, E.W., Rudolph, R.J., Cheraskin, E. 1985. Effect of EDTA Chelation Therapy Plus Multi-vitamin Trace Mineral Supplementation Upon Vascular Dynamics; Ankle/Brachial Doppler Blood Pressure Ratio. Journal of Holistic Medicine 1985; 7: 16-22.
Casdorph, H.R., 1981. EDTA Chealtion Therapy, Efficacy in Arteriosclerotic Heart Disease. Journal of Holistic Medicine 1981; 3: 53-59.
Chappell, L.T., Stahl, J.P. 1993. The Correlation between EDTA Chelation Therapy and Improvement in Cardiovascular Function Meta-Analysis. Journal of Advancement in Medicine 1993; 6; 3: 139-160.
Knudtson ML, Wyse DG, Galbraith PD, et al. Chelation therapy for ischemic heart disease: a randomized controlled trial. JAMA 2002;287:481486.
J.Roderick Kitchell, M.D., F.A.C.C., Florentino Palmon Jr., M.D.∗, Neset Aytan, M.D.∗, Lawrence E. Meltzer, M.D. 1963. The treatment of coronary artery disease with disodium EDTA A reappraisal. April 1963Volume 11, Issue 4, Pages 501–506
Sloth-Nielsen J, Guldager B, Mouritzen C, Lund EB, Egeblad M, Nørregaard O, Jørgensen SJ, Jelnes R. 1991. Arteriographic findings in EDTA chelation therapy on peripheral arteriosclerosis. Am J Surg. 1991 Aug;162(2):122-5.
Guldager B, Jelnes R, Jørgensen SJ, Nielsen JS, Klaerke A, Mogensen K, Larsen KE, Reimer E, Holm J, Ottesen S. 1992. EDTA treatment of intermittent claudication--a double-blind, placebo-controlled study. J Intern Med. 1992 Mar;231(3):261-7.
References: Chelation therapy, heavy metals
Lanphear BP, Rauch S, Auinger P, Allen RW, Hornung RW. 2018. Low-level lead exposure and mortality in US adults: a population-based cohort study. Lancet Public Health. 2018 Apr;3(4):e177-e184.
Menke A, Muntner P, Batuman VV, Silbergeld EK, Guallar E. 2006. Blood lead below 0.48 micromol/L (10 microg/dL) and mortality among US adults. Circulation. 2006; 114(13):1388–1394.
Weisskopf MG, Jain N, Nie H, et al. 2009. A prospective study of bone lead concentration and death from all causes, cardiovascular diseases, and cancer in the department of veterans affairs normative aging study. Circulation. 2009; 120(12):1056–1064.
Agarwal S, Zaman T, Tuzcu EM, Kapadia SR. 2011. Heavy metals and cardiovascular disease: Results from the national health and nutrition examination survey (NHANES) 1999–2006. Angiology. 2011; 62(5):422–429.
Alessandro Fulgenzi and Maria Elena Ferrero 2019. EDTA Chelation Therapy for the Treatment of Neurotoxicity Int. J. Mol. Sci. 20(5), 1019.
Bamonti, F.; Fulgenzi, A.; Novembrino, C.; Ferrero, M.E. 2011. Metal chelation therapy in rheumathoid arthritis: A case report: Successful management of rheumathoid arthritis by metal chelation therapy. Biometals 2011.
Fulgenzi, A.; Zanella, S.G.; Mariani, M.M.; Vietti, D.; Ferrero, M.E. 2012. A case of multiple sclerosis improvement following removal of heavy metal intoxication: Lessons learnt from Matteo’s case. Biometals 2012, 25, 569–576.
Fulgenzi, A.; Vietti, D.; Ferrero, M.E. 2014. Aluminium involvement in neurotoxicity. Biomed. Res. Int. 2014, 2014,758323.
Fulgenzi, A.; De Giuseppe, R.; Bamonti, F.; Vietti, D.; Ferrero, M.E .2015. Efficacy of chelation therapy to remove aluminium intoxication. J. Inorg. Biochem. 2015, 152, 214–218.
Fulgenzi, A.; De Giuseppe, R.; Bamonti, F.; Ferrero, M.E. 2014. Improvement of oxidative and metabolic parameters by cellfood administration in patients affected by neurodegenerative diseases on chelation treatment. Biomed. Res. Int. 2014, 2014.
Roussel, A.M.; Hininger-Favier, I.;Waters, R.S.; Osman, M.; Fernholz, K.; Anderson, R.A.2009. EDTA Chelation therapy, without added vitamin C, decreases oxidative DNA damage and lipid peroxidation. Altern. Med. Rev. 2009, 14, 56–62.