MONDAY, Nov. 5 (HealthDay News) -- A controversial alternative
treatment known as chelation therapy, in which a special infusion
seeks to remove heavy metals from the body, did show modest
benefits for heart patients, researchers report.
The trial -- the first large, long-term study of its kind on the
issue -- was funded by the U.S. National Center for Complementary
and Alternative Medicine and the U.S. National Heart, Lung and
Blood Institute. However, its findings are not likely to settle the
decades-old debate on chelation therapy, which has never gained
U.S. Food and Drug Administration approval for use in heart
The trial results were presented Sunday at the American Heart
Association (AHA) annual meeting in Los Angeles. Speaking at an AHA
press briefing, commentator Dr. Paul Armstrong said chelation
therapy has had staunch supporters and equally adamant
"On one hand, it's been suggested that chelation therapy is valuable, effective and safe, while the other pole of opinion suggests that it's likely unsafe, certainly ineffective and should be abandoned," said Armstrong, chair of the department of medicine at the University of Alberta in Edmonton, Canada.
The treatment is arduous, expensive (about $5,000 on average,
according to experts) and involves dozens of infusions of a complex
mixture aimed at leaching metals from the body. The new study
involved more than 1,700 heart attack patients from 134 sites
across North America, most of whom had already undergone major
interventions such as bypass surgery or angioplasty.
The patients received 40 infusions of chelation solution, at 500
milliliters per infusion. Some of the patients were randomly
assigned to receive the chelating solution, which contained
disodium EDTA (an amino acid), vitamin C, B-vitamins, electrolytes,
a local anesthetic and the blood thinner heparin. The other
patients were randomly assigned to receive either vitamin and
mineral supplements or an inactive placebo pill.
Patient outcomes were tracked for more than four-and-a-half
According to lead researcher Dr. Gervasio Lamas, chief of the
division of cardiology at Columbia University, there was a slight
benefit noted among those receiving the therapy. Twenty-six percent
of the people taking the treatment suffered a serious
cardiovascular event (such as death, heart attack or stroke) versus
30 percent of those who took the placebo. The highest benefit
occurred among diabetic patients, but this subset of patients was
relatively small, "so we must look at this in a very cautious way,"
A second study presented at the meeting looked at patients'
quality of life after chelation therapy, but unlike the Lamas
study, it found no benefit. Researchers led by Dr. Daniel Mark,
professor of medicine at Duke University Medical Center, randomized
more than 900 heart attack survivors to either chelation therapy or
The study found no difference in patients' ability to perform
the tasks of daily living or their overall emotional well-being.
"Patients weren't any worse, but they weren't any better," Mark
said in an AHA news release.
So, where does all this leave patients and their doctors?
For his part, Lamas said that the findings, while "unexpected,"
are not the green light for this controversial treatment.
"Additional research will be needed to confirm or refute our
results and explore possible mechanisms of therapy," he said at the
news briefing. According to Lamas, the study "does not at this time
constitute sufficient evidence to recommend the clinical
application of chelation therapy."
He also warned that chelation therapy does carry dangers,
especially if patients receive the infusions too quickly. "Very
rapid infusions can cause hypercalcemia [calcium overload], and if
they are administered to patients that have kidney failure it can
increase the risk of kidney failure," Lamas noted. "So, there is
the potential for danger which has been reported and deaths have
been reported with chelation therapy over time."
Armstrong agreed that the trial would not change his advice to
patients who might ask about chelation therapy.
"When I am asked that question, I say that there is significant potential hazard and I am unaware of any benefit, and I would advise against it," he said. "And my advice to that patient today would be the same as it was before."
Findings presented at medical meetings are typically considered
preliminary until published in a peer-reviewed journal.
Find out more about chelation therapy at the
National Center for Complementary and A...rnative Medicine.
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