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Health & Medicine for Senior Citizens

EDTA Chelation Therapy Reduces Cardiovascular Events in Heart Attack Victims Age 50 and Over

NIH says 18% reduction was ‘modest;’  Seniors with diabetes appeared to receive particular benefit from this chelation therapy that is supposed to clear plaques from the blood

March 27, 2013 - Chelation therapy, an unproven alternative medicine in the treatment for heart disease, “modestly” reduced cardiovascular events for seniors aged 50 and older who had suffered a prior heart attack, according a news release from the National Institutes of Health, which supported the research.

Although the reduction in cardiovascular events was called “modest” by NIH, the published results of the study show that infusions of a form of chelation therapy using disodium ethylene diamine tetra-acetic acid (EDTA) reduced cardiovascular events by 18 percent compared to a placebo treatment.

Results from the chelation arm of the Trial to Assess Chelation Therapy (TACT) were published in the March 27 issue of the Journal of the American Medical Association.

Investigators stated that more research is needed before considering routine use of chelation therapy for all heart attack patients. The EDTA-based chelation solution also contained high doses of vitamin C, B-vitamins, and other components.

Between 2002 and 2007, use of chelation therapy to treat heart disease and other diseases grew in the United States by nearly 68 percent to 111,000 people, according to the 2008 National Health Statistics Report. Chelation therapy removes heavy metals and minerals from the blood, such as lead, iron, copper, and calcium. Disodium EDTA is not approved by the FDA to treat heart disease, the leading cause of death for both men and women in the United States.

 

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“This study sheds light on a scientific controversy that has previously been untested,” said Gary H. Gibbons, M.D., director of the NIH's National Heart, Lung, and Blood Institute (NHLBI).

“We now know more about the safety and efficacy of this therapy than we did before the study. Further research is needed to fully understand these results before this treatment can be applied to the routine clinical care of heart attack patients. We do not yet know whether this therapy can be applied to most people with heart disease, which patients may potentially benefit from it, or how it may work.”

From 2003 to 2010, TACT investigators enrolled 1,708 adults aged 50 and older at 134 sites in the United States and Canada. Study participants had suffered a heart attack six weeks or more before enrollment (average was about 4.5 years). They were assigned randomly to receive 40 infusions of either the disodium EDTA chelation solution or a placebo solution. Patients also were randomly assigned to receive high doses of oral vitamins and minerals or an identical oral placebo.

Most participants also took standard medicines for heart attack survivors, such as aspirin, beta blockers, and statins. They were followed for a minimum of one year and up to five years, with follow-up ending in October 2011.

About Chelation Therapy
from Mayo Clinic

By Mayo Clinic Staff

Chelation therapy — long a treatment for mercury and lead poisoning — isn't a proven treatment for heart disease, and it can be dangerous when used as a heart disease treatment. Even so, some doctors and alternative medicine practitioners have used chelation therapy to treat heart disease and stroke.

The theory behind using chelation therapy for heart disease is that the medicine used in the treatment binds to the calcium that's in fatty deposits (plaques) in your arteries. Once the medicine binds to the calcium, the plaques are swept away as the medicine moves through your bloodstream.

The safety and effectiveness of chelation therapy for heart disease can't be determined, even after the results of the largest study conducted to date, the Trial to Assess Chelation Therapy (TACT), sponsored by the National Institutes of Health.

Neither the American Heart Association nor the American College of Cardiology recommends chelation therapy as a treatment for heart disease, and the Food and Drug Administration hasn't approved chelation therapy for use as a heart disease treatment.  Read more…

“The trial demonstrated that chelation therapy can be safely administered when rigid quality control parameters are in place, and that, under these conditions, therapy has modest benefits,” said Gervasio A. Lamas, M.D., the study’s principal investigator and chairman of Medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Fla. “Safety remained paramount throughout the course of the trial.”

The study assessed a composite primary endpoint that included death, recurrent heart attack, stroke, hospitalization for angina (chest pains sometimes indicating an impending heart attack), and coronary revascularization (coronary stenting or bypass surgery). The TACT investigators reported a clinically modest, but statistically significant, benefit of chelation therapy compared with placebo infusions.

Fewer participants in the chelation group (222, or 26 percent) experienced cardiovascular events than did participants in the placebo group (261, or 30 percent). There was no statistically significant effect on mortality. The study was not designed to have enough patients to detect a difference in mortality.

Some subgroups of study participants, who were predefined at the start of the study, appeared to receive particular benefit from chelation therapy, specifically adults with diabetes, who constituted almost a third of the study population. Lamas noted that subgroup analyses cannot be considered conclusive, but can guide future research.

TACT was not designed specifically to discover how or why chelation might benefit heart attack patients, which limits the potential application of these results.

TACT was supported by grants from the NHLBI (U01HL092607) and the NIH's National Center for Complementary and Alternative Medicine (U01AT001156).

Part of the National Institutes of Health, the mission of The National Center for Complementary and Alternative Medicine (NCCAM) is to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and their roles in improving health and health care. For additional information, call NCCAM’s Clearinghouse toll free at 1-888-644-6226, or visit the NCCAM website at http://nccam.nih.gov. Follow on Twitter, Facebook, and YouTube.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at http://www.nhlbi.nih.gov.

About the National Institutes of Health (NIH):

NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

Supplemental Information:

·         Clinicaltrials.gov page about TACT
http://clinicaltrials.gov/ct2/show/NCT00044213

·         NIH news release: NIH launches large clinical trial on EDTA chelation therapy for coronary artery disease
http://www.nhlbi.nih.gov/news/press-releases/2002/nih-launches-large-clinical-trial-on-edta-chelation-therapy-for-coronary-artery-disease.html

·         Statement from NHLBI Director Gary H. Gibbons, M.D., on the TACT preliminary results:
http://www.nhlbi.nih.gov/news/press-releases/2012/statement-from-nhlbi-director-gary-h-gibbons-md.html

·         Statement from NHLBI Director Gary H. Gibbons, M.D., on the TACT vitamin component:
http://www.nhlbi.nih.gov/news/press-releases/2013/nih-statement-on-the-vitamin-component-of-the-trial-to-assess-chelation-therapy.html

·         TACT Questions & Answers:
Bhttp://www.nhlbi.nih.gov/news/press-releases/supplement/questions-and-answers-the-nih-trial-of-edta-chelation-therapy-for-coronary-heart-disease.html

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