By Paul Savage, MD, FAARM, ABAARM
Coronary heart disease is THE leading cause of death among both men and women in the US. Lifestyle changes, medical and surgical procedures, medicine and cardiac rehab represent the mainstays of conventional CV care. However, ~111,000 per people per year (according to a 2007 survey) are turning to IV chelation therapy in addition to traditional treatments.
When used as a treatment for heart disease, providers administer a solution of EDTA in a series of infusions. The treatment course may require 30 or more infusions lasting several hours each, weekly, until the maintenance phase. Along with EDTA, patients are often given high-doses of supportive antioxidant vitamins and minerals, such as vitamin C and B-vitamins.
Although not yet approved by the FDA to treat arteriosclerosis, EDTA chelation can help improve circulation and treat the disorder by removing calcium deposits and plaques from the arteries. Formerly considered a controversial, non-standard treatment, the recent Trial to Assess Chelation Therapy (TACT) study showed that chelation therapy for heart disease is effective at preventing heart problems, especially for diabetic patients.
The TACT Study
The 1,708 TACT study patients had experienced heart attacks and were assigned to receive either a placebo or a series of intravenous chelation therapies. The results from this study—the first large, long-term trial of chelation for heart patients—showed that 40 infusions of chelation treatment reduced CV events by 18% compared to placebo.
Adults with diabetes, who comprised a third of study participants (633 individuals), experienced a particular benefit over participants without diabetes:
- 41% overall reduction in the risk of any CV event
- 40% reduction in the risk of death from heart disease, nonfatal stroke, or nonfatal heart attack
- 52% reduction in recurrent heart attacks
- 43% reduction in death from any cause
Researchers also found that the greatest reduction in risk of CV events came with chelation PLUS high-dose vitamins and minerals.
- Principle results of TACT can be found here.
- Results in patients with diabetes, who comprised 37% of the study participants (633 individuals), can be found here.
The second study, TACT2, is in progress to determine whether the findings can be duplicated in a group of patients with diabetes and prior heart attack.
Chelation Safety Concerns
Low Calcium Levels
Chelation therapy removes heavy metals and minerals, including calcium. If the IV therapy is given too quickly (it should be given over 3-4 hours), low calcium levels can cause weakness, drop in blood pressure and abnormal and potentially fatal heart rhythms.
Dangerously low calcium levels
According to the Mayo Clinic, some doctors think chelation helps heart patients because the medication that is being infused into patients binds to calcium in their clogged arteries, sweeping it away. However, “sweeping away” calcium is a double-edged sword. While it might help unclog coronary arteries, it might also lead to deadly low calcium levels in the blood, as happened to the three people whose deaths were described in the CDC report.
That’s one reason why the National Institutes of Health required that the infusions be done at a slow rate—over a period of three hours or more—so problems like low calcium levels could be caught easily.
In a series of letters to the study’s authors, the Department of Health and Human Service’s Office for Human Research Protection cited several concerns about the study, including that the researchers hadn’t followed the rules about doing the infusions at a slow rate.
In one letter, the government overseers expressed concern that infusions were performed in “shorter than recommended” times in 440 instances, involving 251 subjects. The study was stopped from September 2008 until June 2009 to respond to the government’s concerns.
Chelation Therapy is Still a Complimentary, Alternative Therapy
Many patients may wish to believe that Chelation therapy could/would replace traditional therapies such as angioplasty or by-pass surgery to treat established plaque formation. Chelation therapy should only be used in as an additive therapy to the established traditional therapy. As a physician, I worry that patients will hear only the positive results of the study and not the possible dangers, and would opt for it over proven treatments such as bypass surgery.
The Future of Chelation
We can hope that the TACT study results will help persuade insurance companies to start paying for chelation. But insurance companies usually only pay for treatments that are FDA approved — and there’s little chance the FDA would approve chelation for heart disease based on this study, experts say.