Feds to Study Chelation Therapy

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Feds to Study Chelation Therapy

Wed Aug 7, 5:53 PM ET

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON (AP) - The government is beginning a $30 million study to

determine once and for all whether chelation therapy offers any benefit for

sufferers of heart disease.

Chelation therapy is the main treatment for lead poisoning. A manmade amino

acid called EDTA is seeped into patients' blood, through a vein, to sop up

the toxic metal so it can be excreted in urine.

Some doctors have argued for decades that chelation therapy also could clear

blocked heart arteries, perhaps by sopping up inflammation-causing molecules

or calcium in buildups that clog blood vessels.

No one has ever proved chelation truly helps the heart. The first rigorously

controlled clinical trial found last year that chelation failed to relieve

heart disease.

Federal regulators have cracked down on proponents for falsely promoting

chelation as a proven heart remedy ‹ several years ago the Federal Trade

Commission forced a doctor's group to quit such advertising ‹ and warned

that the therapy can cause kidney damage or other side effects, especially

if not administered by a properly trained professional.

Last year's clinical trial was small, however, and proponents counter with

numerous reports of patients who say chelation relieved their chest pain.

Americans spend millions of dollars each year on chelation, either in

addition to standard treatments like cholesterol-lowering drugs or as an

alternative.

So the National Institutes of Health ( news - web sites)'s alternative

medicine center decided to fund a big enough experiment ‹ involving 2,372

heart-attack survivors ‹ to possibly settle the debate. Led by Dr. Gervasio

Lamas of the Mount Sinai Medical Center-Miami Heart Institute, the five-year

study will begin enrolling participants at about 100 different spots around

the country in March.

Participants will receive 40 intravenous infusions, each lasting three to

four hours, under methods endorsed by the American College for Advancement

in Medicine, a doctors group that promotes the treatment.

Half the participants will have chelation drugs dripped into their veins;

the other half will get a dummy intravenous solution. Scientists will track

whether chelation recipients live longer, suffer fewer heart attacks or

strokes, need less hospitalization for chest pain and need fewer

angioplasties or bypass surgeries.

Study participants will get standard heart treatments, so the question is

whether chelation will provide any added benefit.

Lamas said he decided to design the study when one of his own patients asked

about chelation.

" While my answer, as a very conventional cardiologist, was initially, 'No,

that's silly,' as I looked into it I realized I didn't really have the

evidence base to say that, " Lamas said. " Now we'll see what the real truth

is. "

Indeed, Lamas said, the need for a rigorous chelation study was reinforced

last month when the NIH abruptly stopped a study of hormone replacement

therapy that found ‹ to many doctors' shock ‹ that long-term use harmed

instead of helped women's health.

The chelation study is " really important, " agreed Dr. Rose Marie on,

former president of the American Heart Association ( news - web sites). " If

it's a positive study, that will be wonderful, and if it's not then we can

in a definitive way tell people not to use this. "

The heart association has long cautioned patients not to try chelation in

place of proven heart treatments. Patients now considering chelation should

" wait for the results of this trial, " on advised ‹ or enter the study

instead of seeking chelation elsewhere.

To enroll in the NIH-funded study, patients must be heart-attack survivors

age 50 or older who have never undergone chelation therapy, don't smoke and

haven't undergone an angioplasty or bypass surgery or have one planned

within the next six months. Study sites aren't final yet, but people

interested in participating may get more information by calling (888)

644-6226 or checking the National Center for Complementary and Alternative

Medicine's Web site.