A government study raises more questions than answers about the validity of cleansing the body of heavy metals in order to prevent heart disease.
Chelation therapy involves infusing the bloodstream with agents designed to remove heavy metals such as lead or iron from the bloodstream, and is approved by the U.S. Food and Drug Administration (FDA) for treating lead poisoning. Its other uses, however, including as a treatment for autism, Alzheimer’s and heart disease, remain unapproved, although its popularity in such off-label uses in growing.
In order to find out whether chelation has any role in preventing these diseases, the National Institutes of Health (NIH) funded the first scientific trial to investigation any potential correlation, and presented its findings at the American Heart Association’s Scientific Sessions 2012 in Los Angeles. Researchers say that patients receiving weekly infusions of the treatment were slightly less likely to have adverse heart events. Heart experts, including the study author, however, remain unconvinced.
The study was designed to address the long-simmering controversy over how valid chelation might be for heart disease, and took over a decade to complete due to challenges in recruiting participants. While heavy metals are not a known cause of heart problems, reports of chelation aiding patients with chest pains prompted some, particularly those in the alternative medicine field, to advocate studying the therapy for heart patients. In the end, 1,708 volunteers who suffered previous heart attacks at 134 centers in the United States and Canada were included. One group received a combination chelation solution that included a different version of the agent used to treat lead poisoning along with vitamins, blood thinner and an anesthetic, while the other group received a placebo solution. After nearly a year of 40 infusions each lasting about 3 hours, the participants agreed to report on their heart health a year later. At that time, 27% of the patients who received the chelation therapy had an adverse cardiovascular event like a death, stroke, heart attack, stent procedure to open a heart artery or a hospitalization for chest pain. This was slightly less than the 30% of patients receiving placebo.
The findings are statistically significant, meaning they represent a true link between chelation and heart disease outcomes, but just by a hair, leading experts to be cautious about recommending the treatment. Dr. Steven Nissen, chair of the department of cardiovascular medicine at the Cleveland Clinic, called the study “fatally flawed,” telling Forbes “It would be tragic if the result of this was a widespread use of chelation.”
Even the study’s primary author, Dr. Gervasio A. Lamas, chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Florida said in an AHA statement that the medical community needs to “look carefully at these unexpected results.” He said a definitive answer will require further research, and the study authors need to understand whether “the signal is true, or whether it occurred by chance.”
Among the reasons for being skeptical about the findings are the fact that many of the participants did not complete the full round of chelation infusions; by the study’s end, 600 had failed to finish. In addition, the benefit only seemed to appear after two years, an odd trend since the idea of removing metals that might trigger heart problems would suggest immediate benefits on heart health. Another unexplained pattern: almost all the differences in results between treatment and placebo groups occurred in diabetic patients, suggesting there was something unique about these patients’ response to chelation that researchers cannot explain.
Still, some doctors are encouraged by the results and vow to continue offering the therapy to their heart patients, galvanized by the findings. “I’ll be pushing this data to my patients, and I’ll be reaching out to local cardiologists, because chelation should be a part of the regular regimen for heart patients, like taking an aspirin or a statin,” Dr. Kirti Kalidas, told CNN. Kalidas charges about $3,000 for a full round of chelation treatments for his patients in Orlando, Florida.
According to the New York Times, more than 100,000 Americans with heart disease use chelation therapy each year and treatments can cost about $5,000.
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So is it worth trying? “I don’t think any of us are saying that this therapy should be recommended. Now, that’s not a negative against this study,” says Dr. Clyde Yancy, AHA spokesperson and former president and chief of Cardiology at Northwestern University. “What it means is that we are intrigued with the results, but we need to pause and think very carefully about what may have driven the results, understand that the results, although they are positive, are minimally positive. We are still trying to be certain that this isn’t a statistical play of chance.”
Lamas agrees, and wrote in a statement: “Unless we can show a consistent effect across studies, understand why this treatment might work and establish a similar mechanism to deliver the treatment safely, it will be difficult for chelation to enter the mainstream of other cardiovascular therapies.”
And regardless of the fact that the study results are still open to interpretation, Yancy applauds the NHLBI for studying chelation in a rigorous, scientific way. “We are intrigued the NHLBI has taken the initiative to support research in these provacative and controversial areas,” says Yancy. “If we are to be an evidence-based healthcare system, then we should seek evidence for all the different therapies being utilized, particularly those for which there are major unanswered questions, and chelation therapy was one of those.” Only by studying such controversial therapies can they be either validated or discredited and thus help patients to receive the latest and highest quality care.