As mentioned in my summary, I have had hundreds of EDTA treatments over the past 16+ years and feel it has been a major contributor to my continued health. There are many opponents to this therapy and challenge the studies on chelation therapy. Most of those that oppose EDTA treatment are strong advocates of only conventional treatment for heart disease and have had very little contact with this treatment procedure. I can only relate on how I feel it has been of a benefit to me and others that I have seen in over 16 years. I would also like to add that I have tried oral chelation and do not feel it was as beneficial as the 3 mg EDTA IV as been. This is just a short commentary on EDTA treatment and where you may obtain information on a current major study.
Chelation is a chemical process in which a substance is used to bind molecules, such as metals or minerals, and hold them tightly so that they can be removed from a system, such as the body. In medicine, chelation has been scientifically proven to rid the body of excess or toxic metals. For example, a person who has lead poisoning may be given chelation therapy in order to bind and remove excess lead from the body before it can cause damage.
In the case of EDTA chelation therapy, the substance that binds and removes metals and minerals is EDTA (ethylene diamine tetra-acetic acid), a synthetic, or man-made, amino acid that is delivered intravenously (through the veins). EDTA was first used in the 1940s for the treatment of heavy metal poisoning. EDTA chelation removes heavy metals and minerals, such as lead, iron, copper, and calcium, from the blood and is approved by the U.S. Food and Drug Administration (FDA) for use in treating lead poisoning and toxicity from other heavy metals. Although it is not approved by the FDA to treat CAD, some physicians and alternative medicine practitioners have recommended EDTA chelation as a way to treat this disorder.
When used as approved by the FDA (at the appropriate dose and infusion rate) for treatment of heavy metal poisoning, chelation with EDTA has a low occurrence of side effects. The most common side effect is a burning sensation experienced at the site where the EDTA is delivered into the veins. Rare side effects can include fever, hypotension (a sudden drop in blood pressure), hypocalcemia (abnormally low calcium levels in the blood), headache, nausea, vomiting, and bone marrow depression (meaning that blood cell counts fall). Injury to the kidneys has been reported with EDTA chelation therapy, but it is rare. Other serious side effects can occur if EDTA is not administered by a trained health professional.
How Does Chelation Work
Several theories have been suggested by those who recommend this form of treatment. One theory suggests that EDTA chelation might work by directly removing calcium found in fatty plaques that block the arteries, causing the plaques to break up. Another is that the process of chelation may stimulate the release of a hormone that in turn causes calcium to be removed from the plaques or causes a lowering of cholesterol levels. A third theory is that EDTA chelation therapy may work by reducing the damaging effects of oxygen ions (oxidative stress) on the walls of the blood vessels. Reducing oxidative stress could reduce inflammation in the arteries and improve blood vessel function. None of these theories has been well tested in scientific studies.
National Institute of Health Study
This placebo-controlled, double-blind study will recruit 2,372 participants aged 50 years and older with a prior myocardial infarction (heart attack) to test whether EDTA chelation therapy and/or high-dose vitamin therapy is effective for the treatment of CAD. This study, with a total cost of approximately $30 million, is over 20 times larger than any previous study of chelation therapy. It is designed to be large enough to detect if there are any mild or moderate benefits or risks associated with the therapy.
EDTA chelation therapy, as practiced in the community, often includes administration of high doses of antioxidant vitamin and mineral supplements. Thus, it is possible that effects of the therapy could be connected to these supplements. In order to test whether some of the therapy's effect may be attributable to vitamin/mineral supplements, or to the EDTA solution itself, the investigators will first randomly assign participants to receive either EDTA chelation solution or placebo. Then the patients in these two groups (about 1,186 in each) will again be randomly selected to receive either low-dose or high-dose vitamin/mineral supplements.
The EDTA chelation therapy or placebo solution will be delivered through 40 intravenous infusions that are administered over a 28-month course of treatment. The first 30 infusions will be delivered on a weekly basis and the last 10 will be delivered bimonthly. Following the infusion phase, participants will have contact with study staff at 3-month intervals until the study is complete.
The protocol for the trial was developed using a model protocol for EDTA chelation therapy endorsed by the American College for Advancement in Medicine (ACAM). The ACAM protocol is used worldwide by chelation practitioners. It is the intent of this study to ensure that the most widely practiced method of delivering EDTA chelation is rigorously tested.
Principle Investigator
The principal investigator for the trial is Gervasio A. Lamas, M.D., director of cardiovascular research and academic affairs at Mount Sinai Medical Center-Miami Heart Institute, Miami Beach, Florida. Dr. Lamas is a board-certified cardiologist and an associate professor of medicine at University of Miami School of Medicine. He has extensive experience in the design, conduct, and analysis of randomized, multi-center trials of the treatment and management of cardiac diseases, including CAD.
Information about the study, locations, and enrollment will be available from the NCCAM Clearinghouse at 1-888-644-6226, NCCAM's Web site, and from ClinicalTrials.gov, the NIH Web site for clinical trials information. From Canada, please call 305-674-2162 or e-mail tactnih@msmc.com
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