First large-scale clinical trial of chelation therapy, a controversial treatment for heart disease

NYU Medical Center has begun enrolling patients in the first large-scale clinical trial of chelation therapy, a controversial treatment for heart disease widely practiced by complementary and alternative medicine physicians. The new, government-funded nationwide study will determine whether the therapy benefits people with coronary artery disease, the leading cause of death for both men and women in the United States.

"Chelation is widely practiced in the alternative medicine community with little evidence to show that is effective or ineffective, safe or harmful," says Harmony Reynolds, M.D., a cardiologist in the Leon H. Charney Division of Cardiology in the Department of Medicine at NYU School of Medicine. "A large-scale trial using rigorous scientific methods is the only way to validate or debunk the use of chelation for coronary heart disease," says Dr. Reynolds, who is leading the chelation trial at NYU.

Chelation involves the use of a synthetic amino acid that is administered intravenously through the veins. The treatment acts as a kind of sponge, drawing heavy metals and minerals such as lead, iron, copper, and calcium from the blood, and it is used to treat lead poisoning and toxicity from other heavy metals. Although the FDA has not approved chelation to treat coronary artery disease, some doctors and alternative medicine practitioners have recommended it as a way to lower the risk of heart attacks, strokes and other maladies.

"Many patients use nontraditional treatment such as chelation as an alternative to established treatments for coronary artery disease," says Dr. Reynolds. "This is unfortunate because several medications are available that have been tested extensively and have been shown to reduce the risk of death or heart attack in patients with this disease."

NYU is one of more than 100 research sites nationwide participating in the chelation trial, which will involve more than 2,300 patients and take five years to complete. All patients will receive standard medical therapy for treating coronary artery disease, according to the latest guidelines, regardless of the treatment they receive as part of the trial. Coronary artery disease occurs when the arteries carrying oxygen to the heart become blocked by plaque. As the plaque builds, the arteries narrow and less oxygen and nutrients are brought to the heart, causing serious health problems such as chest pain and heart attacks.

"If chelation therapy has something to add to conventional treatment, this trial has the power to show it," says Dr. Reynolds. "Many physicians find it difficult to keep an open mind about complementary and alternative therapies when there is such a large scientific literature to support the use of standard therapy," she notes. "Regrettably, this can create a barrier to effective communication with patients, some of whom believe strongly in alternative medicine. By funding this trial, the NIH is sending a message to patients: the scientific community is listening and giving these treatments a chance."

Patients interested in being evaluated for the study should be at least 50 years of age and have had a heart attack. Dr. Reynolds can be reached at 212-263-6958. Additional information can also be found at the NCCAM website http://nccam.nih.gov/news/2002/chelation/q-and-a.htm