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.
“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
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.
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.
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.
“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
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
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).
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mission of The National Center for Complementary and Alternative
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investigation, the usefulness and safety of complementary and
alternative medicine interventions and their roles in improving health
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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
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