What is chelation therapy?
Chelation (pronounced key-LAY-shun) therapy is an investigational therapy using a man-made
amino acid, called EDTA. It is added to the blood through a vein. An international research study is now
testing whether chelation therapy is safe and effective for treating heart disease.
Why is this study being conducted?
Many people are considering using chelation therapy because of the belief that it may treat heart
disease. However this has not been scientifically proven. Past studies did not show benefit, but may have
been too small to be conclusive. That is why the National Institutes of Health is conducting this large study to
find out whether chelation therapy is safe and effective in treating heart disease.
What will you be asked to do?
Before you join the study, you should discuss your participation with your doctor. Your participation in
the study will last up to 5 years. During that time, it will be important that you continue your standard heart
disease treatments.
You will be randomly assigned to receive one of several different treatment combinations. Randomly
assigning people to treatment groups helps ensure that the treatments can be compared objectively.
You will receive:
- Either chelation therapy or placebo solution (an inactive treatment)
- Either high-dose vitamins or placebo pills
- All participants will receive low-dose vitamins.
You will visit your study site for your treatments once a week for 30 weeks. Then, you will have 10 more visits,
between 2 weeks and 2 months apart. Each treatment will take about 3 hours. The study team will work with
you to schedule your visits at a time that works best for you.
Remember, participation in this study is your
choice. You can leave the study at any time.
Why participate?
• Help the medical community find new and effective treatments for heart disease.
• Join an international effort to learn whether chelation therapy works.
• Your health will be closely monitored while you are enrolled in the study.
Are there any risks or side effects?
Chelation with EDTA has been used to treat heavy metal poisoning such as lead. For this use, there is
a low occurrence of side effects. The safety of EDTA for treating heart disease has not been established.
The most common side effect is a burning sensation at the site where the EDTA is delivered into the
vein. Rare side effects can include fever, headache, nausea, and vomiting. Even more rare are serious side
effects that can include a sudden drop in blood pressure, abnormally low calcium levels in the blood,
permanent kidney damage, and bone marrow depression (meaning that blood cell counts fall). Reversible
injury to the kidneys, although infrequent, has been reported with EDTA chelation therapy. Other serious side
effects can occur if EDTA is not administered by a trained health professional you to take the vitamin
supplements supplied by the study. It is also important that you continue to take your standard heart
disease
treatments.
Is there any proof that chelation therapy works?
Supporters of chelation therapy rely on the testimonies of people who’ve had it done. Many people
claim that their lives were saved and their health improved because of chelation therapy.
But these aren’t the only claims. Supporters also claim that chelation therapy significantly improves
blood flow through previously narrowed blood vessels in some patients. Another claim is that chelation
therapy has restored lost bodily function and reduced pain in some cases.
The American Heart Association can’t say why some people feel better after having chelation therapy.
And we don’t deny that some people actually may feel better after treatment. So what’s the problem?
The problem is, we question whether these patients feel better because of chelation therapy. It’s possible
they feel better because of something else.
For example, chelation therapists usually require their patients to make lifestyle changes. This can
include quitting smoking, losing weight, eating more fruits and vegetables, avoiding foods high in saturated
fats and exercising regularly.These are healthy changes for anyone to make, and patients make them at the
same time that they’re undergoing chelation therapy. That’s what clouds the issue. Research has shown that
these lifestyle changes improve patients’ quality of life and sense of well-being. In fact, we have advocated
these lifestyle changes for many years.
The American Heart Association believes that these lifestyle changes are probably why the condition
of some patients improves. We believe they don’t feel better because of chelation therapy with EDTA, but
because of better, healthier habits that they adopt.
Patients also may feel better for psychological reasons. Sometimes a sick person’s symptoms
disappear for no apparent reason, due to a placebo effect. This could be why some patients report that they
feel better after they’ve spent $3,000 to $5,000 for chelation therapy.
Can chelation therapy be dangerous?
EDTA isn’t totally safe as a drug. There’s a real danger of kidney failure. (renal tubular necrosis).
EDTA can also cause bone marrow depression, shock, low blood pressure (hypotension), convulsions,
disturbances of regular heart rhythm (cardiac arrhythmias), allergic-type reactions and respiratory arrest.
In fact, a number of deaths in the United States have been linked with chelation therapy. Also, some
people are on dialysis because of kidney failure caused, at least in part, by chelation therapy.
The American Heart Association is concerned that some people who rely on this therapy may delay
undergoing proven therapies like drugs or surgery until it’s too late. This is the added danger of relying on an
unproven "miracle cure."
Clearly, people who choose chelation therapy are risking more than money.
