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Subsequent Cardiac and Stroke Events in Patients with Known Vascular Disease Treated with EDTA Chelation Therapy

Dr L. Terry Chappell, Rakesh Shukla, Jun Yang, René Blaha, Tammy Born, Claus Hancke, William Mitchell, Efrain Olszewer, Peter van der Schaar, James Ventresco;

Chappell23 Aug 2012

Context

Myocardial infarction (MI) and strokes are leading causes of death in the US. Surgical and medical treatments can be helpful, but carry risks of morbidity and mortality.

Objective

To evaluate whether cardiac events were reduced for patients with known vascular disease who were treated with intravenous ethylene diamine tetra-acetic acid (EDTA) chelation therapy.

Design

Retrospective study with a 3-year follow-up, compared with similar patient groups by use of meta-analysis.

Population and setting

A total of 220 consecutive patients with known vascular disease were treated with chelation therapy during 1992–2001. Eight outpatient centres were included: five from the US and one each from Denmark, the Netherlands and Brazil. Average patient age was 64 years, 72.3% were males and 18.2% were smokers. Average number of treatments was 58.

Main outcome measures

MI, stroke and death from any cause were primary outcome measures. Secondary measures were resolution of symptoms and need for coronary artery bypass surgery (CABG) and percutaneous transluminal coronary angioplasty.

Results

According to the meta-analysis, expected outcomes in a 3-year follow-up period for 220 patients with coronary artery disease treated only with conventional therapies would be 15 MIs and six deaths. There were no deaths and no MIs in this group of patients who received chelation therapy. Four patients had strokes but recovered well. There were two angioplasties and six CABG procedures. Compared with similar patient populations treated with conventional therapies, patients who also were chelated had a 93.6% lesser need for angioplasty and a 62.5% reduced need for CABG. Of the patients that initiated treatment with symptoms, 68.7% had complete resolution of symptoms.

Conclusions

This study indicates that the administration of intravenous EDTA chelation therapy for patients with vascular disease resulted in fewer subsequent cardiac events than primary treatment with CABG, angioplasty or conventional medical therapy. EDTA chelation therapy for vascular disease is a reasonable, off-label adjunct, especially for patients who refuse or are not eligible for surgery. Clinical trials such as the Trial to Assess Chelation Therapy (TACT) are needed for definitive proof.

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Managing Cardiovascular Diseases

Ramblings of a Maniacal Frenetic: Pragmatic Reflections on Helping Patients Understand Their Illnesses and Treatments

by John Parks Trowbridge, MD, FACAM

John 2My father told me, in early 1979, that he was going to see a doctor about doing chelation therapy. I went only slightly berserk, insisting that I would have heard about it in my training or residency if it had any value for cardiovascular diseases. He “wisely” stayed away from that charlatan. Then my mother needed drastic surgery for a bleeding ulcer in the fall of 1982. As I needed to fill my days while seeing her in San Francisco, I visited the office of Robert Haskell, MD. We discussed nutritional medicine and dietary programs … and then he asked, “Well, you do chelation therapy, of course?” I explained my reservation about doing any treatments that were exaggerated in their claims of helping … especially with a wide variety of illnesses. He said simply: “Come with me.” We climbed up one flight of stairs. “Here,” he said, “is my nurse. And my charts. And my patients. Have a good day.” And what a day it was! I could barely believe the documented results of patients who had barely been able to walk due to shortness of breath or chest pains or calf pains. And I got to hear their stunning stories, in person – and to lay my hands on their bodies. I was hooked. I spent the next five months studying everything that I could find on chelation, so that I would “ace” the written exam. At the training, I met Warren Levin, MD, of New York City, clearly the best lecturer at the meeting. I spent two glorious learning days in his office; the same for Milan Packovich, MD, of Pittsburgh; also for Charles Farr, PhD, MD, of Oklahoma City; and for another eight doctors who generously offered to share their best ideas with me, so that I could strive from the start “to be the best.” H. Ray Evers, MD, of Dothan, Alabama, graciously hosted me for three days to see the best of the past. And thus began my saga, to “learn more and do better than anyone else.” At the very least, each of my parents and I myself benefited greatly.

Pump, Pipes, and Performance
Cardiovascular diseases (CVD), in order to be adequately evaluated and treated, need to be classified according to the likely etiology or explanation. Simply stated, CVD are associated with the pump (the heart), the pipes (arteries of whatever size and location), and performance (impaired function despite adequate anatomy). One last classification – pediatric – will be ignored for this article, since congenital heart diseases, as genetic or developmental irregularities, have their own unique considerations. When the “pipes” involve the venous system, such as with thrombophlebitis, this is treated as a special case of inflammation.

Hey, Buddy, Can You Really Treat That?
If we have incomplete or missing diagnoses, should you proceed with treatment? In fact, that complaint has been leveled at chelation therapists for years, that we fail to do “enough” diagnostic workup. If you want the details of your problem delineated down to the molecular level, go to your local university cardiologist. But if you want to feel better now and get on with your life, why not consider a treatment that works for most heart and blood vessel problems (and those of many other systems) that plague most people? Problems that don’t improve can continue to be evaluated. The only heart problems that don’t reliably show desired improvement are pediatric, because of their distorted anatomic features. The only peripheral (or central) blood vessel problems that don’t show expected improvement are ….. sorry, can’t recall any.

What Do People Really Need to Know?
For the most part, medical explanations use technical terms that confuse or oversimplifications that mislead. Using the framework presented here, concepts can easily be offered that lead patients into a fair understanding of the treatments proposed and what to expect. (Much of “doctoring” is teaching, which improves compliance dramatically.)

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Prevention of Lower-Extremity Amputation with EDTA Chelation Therapy

By H. Joseph Holliday, MD, FACAM, RVT; 2000

ABSTRACT:

This patient review was designed to compare the lower-extremity amputation rate of patients treated with traditional surgery interventions with those who received EDTA chelation for treatment of peripheral vascular insufficiency. The patient populations were similar and the follow-up period was compatible between chelation patients and those progressing to amputation after surgery. All amputations occurred within 1 year after surgery. The chelation-treated group was observed for 36 months. 89 patients were treated surgically with 8 failures leading to amputation (9% amputation rate). Rest pain was relieved in 9 of 14 patients after surgery. Therefore, 64% of the patients who presented with rest pain experienced improvement in quality of life with no rest pain after surgery. Five patients with continued rest pain after surgery required amputation. Seventy-six patients (87%) were able to walk without claudication after surgery. Twenty-two chelation patients received a combined total of 750 treatments. Four patients presented with rest pain and all but 1 patient received total relief after an average of 12 treatments; consequently, 75% of patients with rest pain were improved. The patient who experienced no improvement in rest pain stopped chelation after 12 treatments. Twenty-one patients completed 30 or more EDTA treatments; of those patients, 20 experienced an increase in walking distance without pain. The patient who did not experience an increase in walking distance without pain received complete relief from rest pain. None of the patients receiving chelation therapy progressed to amputation. Chelation treated patients were found to have a lower amputation rate than surgically treated patients with comparable lower-extremity arterial disease. Symptom relief with chelation is excellent. Therefore, EDTA chelation can be considered an option to surgical intervention for the initial and complete treatment of patients with lower-extremity arterial occlusive disease.

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Holliday, MD: Carotid Restenosis: A Case for EDTA Chelation

By H. Joseph Holliday, MD, FACA, RVT

hollidayABSTRACT

Carotid restenosis has been found in up to 25% of patients after carotid endarterectomy. The most common cause of restenosis is continuation of the atherosclerotic process. Surgery can be beneficial in stroke prevention and should be considered in those patients at high risk for stroke. However, surgery does not arrest the disease of atherosclerosis. This report demonstrates a 10% reduction in the degree of stenosis in a patient treated with EDTA chelation for restenosis of a carotid artery after endarterectoy. EDTA chelation does arrest and reverse atherosclerosis and should be used in conjuction with surgery or as a primary treatment for carotid restenosis as well as for vascular occlusive disease in any artery whether initial or recurrent.

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Effect of chelation therapy on progressive diabetic nephropathy in patients with type 2 diabetes and high-normal body lead burdens.

Chen KH1, Lin JL, Lin-Tan DT, Hsu HH, Hsu CW, Hsu KH, Yen TH., 2012

diabetes-1327517-640x480BACKGROUND:

A previous study in type 2 diabetic patients with high-normal body lead burdens showed that EDTA chelation therapy for 3 months slows progressive diabetic nephropathy during a 12-month follow-up. The effect of a longer course of therapy on kidney function decrease over a longer follow-up is not known.

STUDY DESIGN:

A 12-month run-in phase, then a randomized single-blind study with a 27-month intervention.

SETTING & PARTICIPANTS:

University medical center; 50 patients (serum creatinine, 1.5-3.9 mg/dL) with high-normal body lead burden (≥80-<600 μg) were randomly assigned to the treatment and control groups.

INTERVENTION:

The treatment group received weekly chelation therapy for 3 months to reduce their body lead burden to <60 μg and then as needed for 24 months to maintain this level. The control group received placebo for 3 months and then weekly for 5 weeks at 6-month intervals for 24 months.

OUTCOMES:

The primary end point was change in estimated glomerular filtration rate (eGFR) over time. A secondary end point was a 2-fold increase in baseline serum creatinine level or the requirement for renal replacement therapy.

MEASUREMENTS:

Body lead burdens were assessed by EDTA mobilization tests and eGFR was calculated using the equation for Chinese patients with type 2 diabetes.

RESULTS:

Mean baseline eGFRs in the treatment and control groups were similar. After 3 months of chelation therapy, the change in eGFR in the treatment group (+1.0 ± 4.8 mL/min/1.73 m(2)) differed significantly from that in the control group (-1.5 ± 4.8 mL/min/1.73 m(2); P = 0.04). In the subsequent 24-month intervention, the yearly rate of decrease in eGFR (5.6 ± 5.0 mL/min/1.73 m(2) per year) in the treatment group was slower than that (9.2 ± 3.6 mL/min/1.73 m(2) per year; P = 0.04) in the control group. 17 (68%) control-group patients and 9 (36%) treatment-group patients achieved the secondary end point.

LIMITATIONS:

Small sample size, not double blind.

CONCLUSIONS:

A 27-month course of EDTA chelation therapy retards the progression of diabetic nephropathy in type 2 diabetic patients with high-normal body lead burdens.

http://www.ncbi.nlm.nih.gov/pubmed/22721929

Clinical Benefit of EDTA-based Chelation Therapy and High-dose Oral Multivitamins and Multiminerals in TACT- An Expanded Comparison of 2 Factorial Groups

Lamas, et al. (See below for other contributors)

Background: Chelation therapy, in combination with high dose oral multivitamins and multiminerals (MV), has been used to treat atherosclerotic disease. This analysis of the NIH-funded Trial to Assess Chelation Therapy (TACT) focuses on the comparison of 2 treatment groups chelation + MV versus placebo infusions + placebo MV, evaluating a treatment strategy reflecting clinical practice, and not previously presented in detail.

Methods: TACT, a multi-center, double-blind, placebo-controlled, 2 X 2 factorial trial of EDTA chelation and MV enrolled 1708 patients age ≥ 50 years, MI ≥ 6 weeks prior, creatinine ≤ 2.0, assigned to 40 IV chelation or placebo infusions and a 28-component oral MV or placebo. Primary endpoint was death, MI, stroke, coronary revascularization, or hospitalization for angina. Secondary endpoint was cardiovascular mortality, MI, or stroke. We describe the intent-to-treat comparison of 2 factorial groups: chelation + MV (n=421) vs placebo chelation + placebo MV (n=437). Treatment comparisons were by log rank test.

Results: The median age was 65 years, 83% had prior coronary revascularization, and 73% were on statins. Key baseline characteristics were similar between groups. Primary endpoint occurred in 108 (26%) patients in the chelation + MV, and 139 (32%) in the placebo + placebo group (p=0.016). The 5-year Kaplan Meier estimates for the primary endpoint in the chelation + high-dose vitamin group was 31.9%, and in the placebo infusions + placebo vitamin group 40.2%. The secondary endpoint occurred in 39 (9%) of chelation + MV and in 58 (13%) of placebo + placebo (p=0.045). The point estimates for each component of the combined endpoints were all <1.0 and consistent with the overall effect (Table).

Conclusions: In stable patients with a history of MI on appropriate evidence based medical therapy, the beneficial effect of the combination of high-dose vitamins and chelation therapy was statistically significant and of potential clinical relevance.

chelation graph

http://circ.ahajournals.org/cgi/content/meeting_abstract/128/22_MeetingAbstracts/A11054

Gervasio A Lamas1; Richard L Nahin2; Lauren Lindblad3; Christine Goertz4; Robin Boineau5; Terry Chappell6; Greg Flaker7; Theodore Rozema8; Tammy Born9; Mario Stylianou10; Eldrin F Lewis11; Daniel B Mark12; Kerry L Lee3

1 Div of Cardiology, Mount Sinai Med Cntr, Miami Beach, FL
2 31 Cntr Dr, MS 2182, National Cntr for Complementary and Alternative Medicine, Bethesda, MD
3 Biostatistics & Bioinformatics, Duke Clinical Rsch Institute, Durham, NC
4 Chiropractic Rsch, Palmer College of Chiropractic, Davenport, IA
5 HEART FAILURE & ARRHYTHMIAS BRANCH, National Heart, Lung and Blood Institute, Bethesda, MD
6 N/A, Celebration of Heath Association, Bluffton, OH
7 Cardiovascular Medicine, Univ of Missouri Health Care, Columbia, MO
8 N/A, Biogenesis Med Cntr, Landrum, SC
9 N/A, Born Preventive Health Care Clinic, Grand Rapids, MI
10 Biostatistics, National Heart, Lung and Blood Institute, Bethesda, MD
11 Cardiovascular Div, Brigham & Women’s Hosp, Boston, MA
12 Medicine – Cardiology, Duke Clinical Rsch Institute, Durham, NC

EDTA Chelation Therapy: Efficacy in Arteriosclerotic Coronary Heart Disease

H. Richard Casdorph, MD, PhD

Dr. Casdorph is Assistant Clinical Professor of Medicine at the University of California Medical School, Irvine California

ABSTRACT: EightCasdorph_hearteen patients with documented arteriosclerotic heart disease were studied utilizing the radioactive isotope technetium 99m to measure left ventricular ejection fraction before and after the administration of EDTA chelation therapy. A statistically significant improvement in left ventricular ejection fraction occurred in this group of patients. The patients were tested at rest, but conditions under which tests were performed were controlled to be identical before and after chelation.

http://drcranton.com/chelation/casdor1.htm

 

Chelation therapy for patients with elevated body lead burden and progressive renal insufficiency. A randomized, controlled trial.

Chelation therapy for patients with elevated body lead burden and progressive renal insufficiency. A randomized, controlled trial.

Lin JL1, Ho HH, Yu CC, 1999

lab-work-1575843-640x960Abstract

BACKGROUND:

Nephropathy is known to occur in persons exposed to high levels of lead, but the question of whether long-term exposure to low levels of environmental lead is associated with impaired renal function remains controversial.

OBJECTIVE:

To examine whether chelation therapy slows the progression of renal insufficiency in patients with mildly elevated body lead burden.

DESIGN:

Randomized, controlled trial.

SETTING:

Academic medical center in Taiwan.

PATIENTS:

32 patients with chronic renal insufficiency (serum creatinine level > 132.6 micromol/L [1.5 mg/dL] and < 353.8 micromol/L [4.0 mg/dL]), mildly elevated body lead burden (> 0.72 micromol [150 microg] of lead per 72-hour urine collection and < 2.90 micromol [600 microg] of lead per 72-hour urine collection [EDTA mobilization tests]), and no history of heavy lead exposure.

INTERVENTION:

The treatment group received 2 months of chelation therapy; the control group received no therapy.

MEASUREMENTS:

The reciprocal of serum creatinine (1/Cr) was used as an index of progressive renal insufficiency.

RESULTS:

Rates of progression of renal insufficiency were similar in the treatment group and the control group during a 12-month baseline observation period (1/Cr, 0.000054 L/micromol per month compared with 0.000046 L/micromol per month; P > 0.2). After the 2-month treatment period, improvement in renal function was greater in the treatment group than in the control group. In the 12 months after the treatment period, renal insufficiency progressed more slowly in the treatment group than in the control group (1/Cr, 0.000033 +/- 0.00038 L/micromol per month compared with 0.000045 +/- 0.000038 L/micromol per month; P = 0.0030).

CONCLUSION:

Chelation therapy seems to slow the progression of renal insufficiency in patients with mildly elevated body lead burden. This implies that long-term exposure to low levels of environmental lead may be associated with impaired renal function in patients with chronic renal disease.

The role of mercury and cadmium heavy metals in vascular disease, hypertension, coronary heart disease, and myocardial infarction.

by Houston MC

medical-doctor-1236728-639x717Abstract

Mercury, cadmium, and other heavy metals have a high affinity for sulfhydryl (-SH) groups, inactivating numerous enzymatic reactions, amino acids, and sulfur-containing antioxidants (NAC, ALA, GSH), with subsequent decreased oxidant defense and increased oxidative stress. Both bind to metallothionein and substitute for zinc, copper, and other trace metals reducing the effectiveness of metalloenzymes. Mercury induces mitochondrial dysfunction with reduction in ATP, depletion of glutathione, and increased lipid peroxidation; increased oxidative stress is common. Selenium antagonizes mercury toxicity. The overall vascular effects of mercury include oxidative stress, inflammation, thrombosis, vascular smooth muscle dysfunction, endothelial dysfunction, dyslipidemia, immune dysfunction, and mitochondrial dysfunction. The clinical consequences of mercury toxicity include hypertension, CHD, MI, increased carotid IMT and obstruction, CVA, generalized atherosclerosis, and renal dysfunction with proteinuria. Pathological, biochemical, and functional medicine correlations are significant and logical. Mercury diminishes the protective effect of fish and omega-3 fatty acids. Mercury, cadmium, and other heavy metals inactivate COMT, which increases serum and urinary epinephrine, norepinephrine, and dopamine. This effect will increase blood pressure and may be a clinical clue to heavy metal toxicity. Cadmium concentrates in the kidney, particularly inducing proteinuria and renal dysfunction; it is associated with hypertension, but less so with CHD. Renal cadmium reduces CYP4A11 and PPARs, which may be related to hypertension, sodium retention, glucose intolerance, dyslipidemia, and zinc deficiency. Dietary calcium may mitigate some of the toxicity of cadmium. Heavy metal toxicity, especially mercury and cadmium, should be evaluated in any patient with hypertension, CHD, or other vascular disease. Specific testing for acute and chronic toxicity and total body burden using hair, toenail, urine, serum, etc. with baseline and provoked evaluation should be done.

http://www.ncbi.nlm.nih.gov/pubmed/17405690