The Journal of the American Medical Association has published the details on a controversial $31 million study to compare chelation--a favorite among the alternative medicine crowd involving the removal of heavy metals from the blood of heart patients--with a placebo and found that the federal government managed to buy a fresh, very expensive debate over just what investigators found.
Here are the facts: In a lengthy, four-and-a-half year study, investigators found no significant difference between the chelation arm and the placebo arm in the number of people suffering a heart attack or stroke. But if you add up all the incidents--strokes, heart attacks, hospitalizations, surgeries and deaths--the chelation arm did just a bit better. The score was 26% suffering setbacks in the chelation arm vs. 30% in the placebo arm. Put another way, there was an 18% reduction in risk. And while questions about the data will linger, the bottom line will likely encourage advocates even as physicians go on a rant against what many view as mere "quackery."
"The trial demonstrated that chelation therapy can be safely administered when rigid quality control parameters are in place, and that, under these conditions, therapy has modest benefits," said Gervasio Lamas, chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, in a statement. "Safety remained paramount throughout the course of the trial."
|Dr. Steve Nissen|
More than 100,000 people undergo the procedure every year, despite the widespread condemnation. Detractors have already shouted out their problems with the study, which took years longer than planned, including a halt to consider a claim that the study was unethical, despite enrolling fewer patients than the trial design called for as well as a decision to lower the threshold required to achieve statistical significance. Also a large number of patients dropped out.
"The biggest danger here is that people get diverted from established therapies that we know work, to this sort of therapy that doesn't work," the Cleveland Clinic's Foundation Dr. Steve Nissen tells Reuters Health. Nissen, a longtime critic of chelation, is in the big camp of physicians who call chelation a form of "quackery."
Experts rip chelation heart study despite a hint of efficacy