Inspite of the witch hunts and dirty tactics of
*organized medicine*
Facts are, people are using it will success. They know all
about the efforts to stop it, they are aware of the group of
debunkers who eagerly claim, it doesn't work, rather than it
remains unproven. They are only concerned with RESULTS. It
is a real pity that this dirty tactic group could care less
if it saves from sawing open the chest and having bypasses.
They are the group who want no further studies.
nccam.nih.govpressrelease.htmOpen ↗
The National Center for Complementary and Alternative
Medicine (NCCAM) and the National Heart, Lung, and Blood
Institute (NHLBI), components of the National Institutes of
Health (NIH), have launched the first large-scale clinical
trial to determine the safety and efficacy of EDTA
chelation therapy in individuals with coronary artery
disease, the leading cause of death for both men and women
in the United States.
The 5-year Trial To Assess Chelation Therapy (TACT) will
involve over 2,300 patients at more than 100 research sites
across the country.
"The public health imperative to undertake a definitive
study of chelation therapy is clear. The widespread use
of chelation therapy in lieu of established therapies,
the lack of adequate prior research to verify its safety
and effectiveness, and the overall impact of coronary
artery disease convinced NIH that the time is right to
launch this rigorous study," said Stephen E. Straus,
M.D., NCCAM Director.
Over 800,000 patient visits were made for chelation therapy
in the United States in 1997. Chelation therapy involves the
use of EDTA (ethylene diamine tetra-acetic acid), a
synthetic amino acid that is administered intravenously
(through the veins). EDTA, which effectively speeds removal
of heavy metals and minerals such as lead, iron, copper, and
calcium from the blood, 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 coronary artery disease, some
physicians and alternative medicine practitioners have
recommended EDTA chelation as a way to treat this disorder.
Coronary artery disease (CAD) is a type of heart disease in
which the coronary arteries (vessels that supply oxygen-
carrying blood to the heart) become blocked by deposits of a
fatty substance called plaque. As plaque builds, the
arteries become narrower and less oxygen and nutrients are
transported to the heart for proper function. CAD can lead
to serious health problems such as angina (pain caused by
insufficient oxygen-carrying blood reaching the heart) and
heart attack.
There are standard and well-proven ways to reduce the risks
or complications of CAD. These include stopping smoking and
controlling high blood pressure and high blood cholesterol
through lifestyle changes and medication. More invasive
procedures are used to treat symptomatic CAD including
balloon angioplasty (dilation of a blocked artery to open it
up) or coronary artery bypass surgery (using arteries or
veins from other areas of the body to create detours for
blood flow around areas of blockage in the heart artery).
"NCCAM's leadership in initiating and supporting this study
is to be commended," said NHLBI Director Claude Lenfant,
M.D. "It is important for heart disease patients to know
whether we should add chelation therapy to the list of
proven treatments for coronary artery disease. Scientific
evidence is needed to resolve this issue. And only a large
clinical trial can definitively answer the question of
whether chelation treatment is truly safe and effective,"
added Lenfant.
The randomized, double-blind study will enroll 2,372
patients aged 50 or older who have had a heart attack. The
$30 million study, led by Gervasio A. Lamas,
M.D., director of cardiovascular research and academic
affairs at Mount Sinai Medical Center-Miami Heart
Institute in Miami Beach, Florida, will test whether
EDTA chelation therapy and/or high-dose vitamin therapy
is effective for the treatment of CAD. Vitamin and
mineral supplements, consistent with the regimen used by
practitioners who deliver EDTA chelation therapy, will
be used in the study.
Following baseline assessments, about 1,186 patients will be
randomly assigned to receive a standardized chelation
solution, and about 1,186 patients will receive a placebo
(dummy) solution. Each of these two groups will additionally
be randomized to receive high-dose vitamin/mineral
supplements versus low-dose vitamin/mineral supplements.
Study participants will receive 30 weekly infusions of EDTA
chelation therapy followed by 10 bimonthly infusions. All
patients enrolled will be followed until the end of the
study to observe any significant clinical benefits or side
effects. The primary study endpoint (a marker of
improvement) of this trial will be a composite of heart
attack, stroke, hospitalization for angina (pain associated
with CAD), coronary revascularization, and death. The study
will also evaluate cardiac deaths, nonfatal heart attacks,
health-related quality of life, and cost effectiveness,
among other factors.
TACT includes a Data Coordinating Center led by Kerry Lee,
Ph.D., and a Quality of Life Coordinating Center led by
Daniel Mark, M.D., M.P.H., both at the Duke Clinical
Research Institute in Durham, North Carolina. In addition,
an independent Data Safety Monitoring Board will oversee
the study.
Patient recruitment for the study is expected to begin in
March 2003, after preparations are completed to enroll
participants at the many study sites.
Questions and answers about this study are located at
www.nccam.nih.gov/news/2002/chelation/q-and-a.htm.
Information about the study, locations, and enrollment will
be available from the NCCAM Web site and from
ClinicalTrials.gov, the NIH Web site for clinical trial
information.
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The National Center for Complementary and Alternative
Medicine (NCCAM) is dedicated to exploring complementary and
alternative medical (CAM) practices in the context of
rigorous science, training CAM researchers, and
disseminating authoritative information to the public and
professionals. For additional information, call NCCAM's
Clearinghouse toll free at 1-888-644-6226, or visit the
NCCAM Web site at nccam.nih.gov.
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. For
additional information, contact the NHLBI Health Information
Center at 301-592-8573, or visit the NHLBI Web site at
www.nhlbi.nih.gov.
Jan