Doctors Studying Chelation to Remove Heavy Metals: Fibromyalgia & Chronic Fatigue Syndrome News

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Doctors Studying Chelation to Remove Heavy Metals: Fibromyalgia &

Chronic Fatigue Syndrome News

05-26-2004

By Margaret Ann Miille

For years, using chelation to treat heart disease has been pretty

much an act of faith. The intravenous process, which removes heavy

metals and minerals from the blood, has long had a following among

practitioners of alternative medicine who say its cleansing abilities

work on arteries, too.

But mainstream doctors have rarely put stock in the treatment because

there's only sparse scientific evidence that it helps treat heart

disease, the leading cause of death for American men and women.

" Chelation, so far, has been a little like religion: either you

believe in it or you don't, " said Randy Hartman, a cardiologist at

the Heart & Vascular Center of Sarasota [Florida].

Now the largest study of its kind -- the " Trial to Assess Chelation

Therapy, " or TACT -- is being launched to end the debate. The Heart &

Vascular Center and Bradenton's [Florida] Integrated Healing Arts

recently joined the five-year, $30 million project, which is being

funded by the National Institutes of Health.

The clinical trial will involve nearly 2,400 patients at more than

100 research sites nationwide. The federal Food and Drug

Administration has approved chelation as a treatment for lead

poisoning and toxicity from other heavy metals, but the federal

agency hasn't approved it for coronary artery disease.

Hartman, the principal TACT investigator at the Sarasota research

site, says he doesn't have a pat answer for patients asking if

chelation would help them. Like most board-certified cardiologists,

he prescribes traditional treatments: controlling high blood pressure

and cholesterol with medication and lifestyle changes such as eating

well, exercising and quitting smoking. More severe cases are treated

with angioplasty or bypass surgery.

" This is something that needs to be studied so we can finally get

some definitive answers, " Hartman said. " Does it help, who does it

help and in what way does it help? "

Many have tried it

More than 800,000 Americans have undergone chelation therapy in the

last 40 years, most of them for cardiovascular disease, says the

American College of Advancement in Medicine.

The therapy involves an intravenous treatment using ethylene diamine

tetra-acetic acid, a synthetic amino acid. TACT patients sit,

generally in a recliner, for three hours at a stretch while receiving

the infusion.

Evidence on how well chelation works remains largely anecdotal

because of the size and scope of chelation studies to date.

The next-largest one conducted in Denmark a few years ago had only

153 patients, said Gervasio A. Lamas, director of cardiovascular

research and academic affairs at Mount Sinai Medical Center-Miami

Heart Institute in Miami Beach. Lamas wrote the NIH proposal for

TACT, which was approved in 2002, and he's the study's chairman.

Earlier clinical trials gave doctors little reason to support

chelation because they failed to show significant differences between

those heart disease patients who tried the therapy compared with

those who didn't, he said.

Even alternative medicine practitioners, who are generally much more

enthusiastic about chelation, found the same studies inconclusive

because the numbers of patients involved were so small.

" I don't think there is significant evidence for or against

chelation, " said Lamas, a cardiologist who doesn't use the therapy at

his practice. " I think there is a swirling controversy about

something on which there is little data. There is not enough data for

a clinician to make a decision. "

TACT will enroll 2,372 patients who are 50 or older, have had a heart

attack, but no chelation, within the last five years.

They cannot have smoked within the last three months or have had

heart surgery within the last six months.

Half will be randomly selected to receive a standardized chelation

solution; the rest will get a placebo. It's a double-blind study in

which neither the patients nor the doctors will know who is getting

the placebo and who is getting the treatment.

Patients will undergo a series of 40 infusions -- the first 30 are

weekly -- and take vitamin supplements. They will be monitored until

the end of the study to gauge chelation's clinical benefits or side

effects.

The study will end in the spring of 2008, five years after the first

patient was enrolled.

" Whatever the results, you can't deny them, " Lamas said. " The study

is well-designed and it has enough patients in it so that whatever we

get will have to be taken into account by all cardiology and

alternative medicine, whether it is positive or negative. "

ation from the alternative medical community was essential to

the project because its members are the most familiar with chelation,

Lamas said.

" They feel that they have been practicing a treatment that has

benefited thousands of patients, that conventional medicine refuses

to recognize what is obvious to them. "

Some are convinced

Jeff on, one of four chiropractors at Bradenton's Integrated

Healing Arts, fits that bill. As site coordinator for TACT, he's sure

the study will prove what he says he's known all along.

" I think it's going to show that chelation therapy is very efficient

for cardiovascular disease. I don't think it's going to replace any

current treatments out there, but it will add a very important tool

for cardiovascular diseases, " he said. " It will open a whole new

treatment. … It will save a lot of lives. "

Chelation has been used since 1998 at on's practice, a

multidisciplinary operation that also has massage therapists,

physical therapists, an acupuncturist and a hypnotherapist. There,

chelation is used mostly to treat patients with cardiovascular disease.

To a lesser extent, it's given to people with heavy metal toxicity,

which manifests itself in such symptoms as fibromyalgia and chronic

fatigue syndrome.

Reluctance by doctors to use chelation may be partly fueled by their

desire to perform more profitable operations, on said.

Insurance usually only pays for chelation for lead poisoning or

toxicity. It typically costs others from $80 to $120 for a single

infusion.

Chelation is free to patients in the study.

Eighty-two TACT sites nationwide are considered " activated, "

including 15 in Florida. About 170 patients have enrolled across the

country. Integrated Healing Arts has one signed up and the Heart &

Vascular Center has six. That includes Sarasota's Laudano, an

active 70-year-old retiree who's had two heart attacks and one

angioplasty. Other treatments, such as strapping inflatable cuffs to

his body to increase blood flow, helped him feel stronger for a while.

Laudano got his first infusion nearly two weeks ago.

" My heart is such that I'm not a good candidate for open heart

surgery, " he said. " I'm a strong believer that it will work. If it

doesn't work, I have the satisfaction of contributing to medical

science, and other people may benefit. " It may be my children. "

Source: heraldtribune.com (Southwest Florida)