Study finds heart chelation therapy effective but raises questions
By Elizabeth Cohen and John Bonifield, CNN
November 6, 2012
STORY HIGHLIGHTS
- Chelation therapy for heart patients involves a series of IV drug infusions
- A new study shows the therapy was effective at preventing heart problems
- But some experts are challenging the validity of the study and its results
- The study "raises more questions that must be answered," says one expert
(CNN) -- In results that are stunning cardiologists, a new study
shows a "fringe" alternative treatment for heart disease was found to be
very effective at preventing heart problems -- but the report is so
controversial even its lead author is questioning the results.
The patients in the study had had heart attacks, and were assigned to
receive either a placebo or a series of intravenous drug infusions
called chelation therapy, an unorthodox treatment that has long been
looked down upon by cardiologists.
In the report -- the first large, long-term trial of chelation for
heart patients -- the therapy reduced the risk of heart attacks, deaths,
strokes and other cardiovascular problems by 18%.
"If this were true, it would be significant. It would put this
therapy in the same ballpark as high blood pressure drugs, or drugs used
to lower cholesterol," said Dr. Steven Nissen, chair of the department
of cardiovascular medicine at the Cleveland Clinic, who doubts the
results of the study.
A doctor with the American Heart Association warned that the results
"should not be interpreted as an indication to adopt chelation therapy
into clinical practice."
"(The study) raises more questions that must be answered before we're
ready to act on the observations reported today," said Dr. Elliott
Antman, professor of medicine at Harvard Medical School.
Even the lead author of the study tempered his enthusiasm about the results by warning that they might not be valid.
"The most exciting part of this study is that there may be an
unexpected signal of benefit," Dr. Gervasio Lamas, chief of Columbia
University Division of Cardiology at Mount Sinai Medical Center in Miami
Beach, Florida, said in a press release put out by the American Heart
Association. "We need to understand whether the signal is true, or
whether it occurred by chance."
Safety concerns
Doctors who practice chelation welcomed the new study results, which
were announced at the American Heart Association's annual meeting in Los
Angeles.
These doctors believe chelation can help remove heavy metals from the
body. Chelation is approved by the Food and Drug Administration for the
treatment of lead poisoning, but doctors are free to use it for other
purposes.
"I'll be pushing this data to my patients, and I'll be reaching out
to local cardiologists, because chelation should be a part of the
regular regimen for heart patients, like taking an aspirin or a statin,"
said Dr. Kirti Kalidas, who charges his heart patients in Orlando,
Florida, around $3,000 for a full round of chelation treatments.
This enthusiasm is exactly what frightens many doctors. Chelation is
already popular -- more than 100,000 people said they'd used it in the
past 12 months, according to a 2007 report from the Centers for Disease
Control and Prevention -- and they fear the new study results will
encourage more people to use it.
In 2006, the CDC reported that two children and one adult had died
after receiving chelation. They all developed dangerously low calcium
levels, which can cause the heart to stop beating.
In this new study, one patient receiving the therapy died and another
had a "severe adverse event." Both events were "possibly or definitely
related to study therapy," according to the study author's slide
presentation. A patient who received a placebo solution also died, and
another had an adverse event.
It wasn't clear from the presentation exactly how the patients were
harmed, and Lamas, the lead study author, declined to answer questions
about the study until the research is published in a medical journal.
Some doctors worry patients will hear only the positive results of
the study and not the possible dangers, and would opt for it over proven
treatments such as bypass surgery.
"I'm fearful that patients will hear the sales pitch for this
treatment and, not being well-versed in medicine, will succumb to the
seduction of this therapy," said Nissen, adding that chelation might
sound more appealing than an invasive procedure like bypass surgery.
Dr. Kimball Atwood agrees. In an article about the chelation trial,
Atwood and his colleagues labeled the $30 million study funded at
taxpayer expense by the federal National Institutes of Health
"unethical, dangerous, pointless, and wasteful" and called for it to be
abandoned.
"These new study results will encourage chelationists, and state
medical boards will be loath to step in because the chelationists have
this study on their side," said Atwood, a clinical assistant professor
of anesthesiology at Tufts Medical Center.
"Every now and then somebody will get killed," he added.
Kalidas, the doctor who practices chelation, disagreed, saying this study would help -- not hurt -- patients.
"Chelation has been lifesaving for hundreds of my patients," he said.