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Many independent groups, including heart specialists at Duke University, are monitoring the study, Lamas said. "The last time they looked at this was at the end of April and there were no safety concerns," he said.
As originally designed in 2002, the study was to enroll nearly 2,400 people, 50 or older, who had suffered a heart attack at least six weeks previously. Some would be randomly assigned to get either chelation or dummy infusions weekly for 30 weeks, then 10 more treatments bimonthly, over a 28-month period. The assumption was that chelation would cut heart-related problems and deaths by one-fourth.
Others in the study were randomly assigned to get high or low doses of antioxidant vitamin and mineral supplements. The study was to have been nearly completed by now, but enrollment lagged and researchers now aim to sign up fewer than 2,000.
Chelation has been highly controversial, and the American Heart Association and other groups have spoken out against it. The heart group's Web site says a single treatment costs $50 to $100. In the first month, patients usually are given daily treatments, which insurers do not cover since it is of unproven benefit.
The form of EDTA used in the trial is supplied by AkzoNobel, a Dutch company, Lamas said.
"EDTA isn't totally safe as a drug. There's a real danger of kidney failure," bone marrow problems, shock, low blood pressure, convulsions, heart rhythm problems, allergic reactions and breathing troubles, the heart association site says.
"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 site says. "Clearly, people who choose chelation therapy are risking more than money."
The FDA, the American College of Physicians, the American Medical Association and others have noted that chelation is experimental and of unknown value or risk for heart disease patients.
"What this controversy highlights is the need to do a trial of this treatment," Lamas said. "It goes on all the time in many physicians' offices in the U.S. and worldwide."
The American College of Cardiology is listed in study documents as one of the groups associated with the research. The group's president, Dr. W. Douglas Weaver, noted the treatment is "experimental, unproven." But he supports finding out if it might work, and the Henry Ford Health System in Detroit where he works is participating.
"It would be a real disservice to scare people" and cause any study participants to stop treatments, because then we'd never have answers, Weaver said Thursday. If there were a safety concern, the federal government would have stopped the trial, rather than study leaders just suspending enrollment in it, he said.
On the Net:
National Center for Complementary and Alternative Medicine:
Heart Association on chelation:
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