Chelation therapy, an alternative-medicine technique dismissed as fringe medicine by many conventional heart doctors, is getting a shot in the arm from federal officials who are providing a $37 million grant to study its benefits as a mainstream cardiovascular treatment.
The National Institutes of Health grant, announced this week, will allow the Mount Sinai Medical Center of Florida to conduct a follow-up study of promising preliminary research that suggests chelation therapy may be as beneficial as the use of conventional medication and treatments — or more so — in preventing heart attacks.
Lead researcher Dr. Gervasio Lamas — chief cardiologist with the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach — says the grant from the NIH’s National Center for Complementary and Integrative Health grant will help his team determine if chelation therapy can be a game changer for heart disease treatment.
He tells Newsmax Health the study — known the Trial to Assess Chelation Therapy (TACT2) — will involve 1,200 patients and is being conducted with the Duke Clinical Research Institute and other leading medical institutions.
“If TACT2 is positive, it will forever change the way we treat heart attack patients and view toxic metals in the environment,” says Lamas, noting chelation therapy cleanses the body of environmental pollutants that may be implicated in heart disease.
“Therefore, with NIH support and in collaboration with the Duke Clinical Research Institute, Columbia University, New York University, Mount Sinai (NYC), and hundreds of physicians and nurses throughout the U.S. and Canada, we are moving forward with TACT2.”
The new research aims to examine the use of intravenous chelation treatments in combination with oral vitamins in diabetic patients with a prior heart attack.
The goal is to determine if chelation can prevent recurrent heart episodes, such as heart attacks, stroke, death, and others, by removing toxins from the blood.
Chelation has long been approved by the U.S. Food and Drug Administration to rid the body of lead by using a synthetic amino acid (ethylene diamine tetraacetic acid), which binds to toxic metals and minerals in the bloodstream, allowing a patient to excrete them.
Some experts believe heavy metal contamination is linked to heart disease, Chelation rids the body of deposits that can lead to atherosclerosis, which causes coronary arteries to narrow, leading to heart attacks.
Lamas, who once dismissed chelation as “quackery,” began looking into its potential benefits 14 years ago. In 2002, he launched an NIH-sponsored study involving more than 1,700 heart attack survivors at 134 research sites across the U.S. and Canada, including such prestigious facilities as Johns Hopkins and the Mayo Clinic.
Over a seven-year period, the study participants were randomly assigned to receive 40 injections of a chelation solution (known as “infusions”) or an inactive placebo. Patients also received an oral vitamin and mineral regimen, or an oral placebo.
Lamas expected the study to show chelation provided no benefits to patients.
But, in fact, when the trial ended in 2012, the results showed those who received chelation plus vitamin supplements had a 26 percent lower risk of heart complications (such as a second heart attack, stroke, or bypass surgery), compared with those given placebos.
In diabetic patients, the findings were even more dramatic, with the combo therapy tied to a 49 percent lower risk of heart complications. Chelation (with or without vitamins) was also found to cut the risk of death among diabetics by half over the course of the study.
“There is nothing like this for diabetes care,” Lamas said, when the study findings were published in the Journal of the American Medical Assocation and the American Heart Journal. “There just isn’t.”
In follow-up meetings with the FDA, Lamas pressed for a follow-up study of chelation therapy as an approved treatment for heart patients.
Last October, the NIH’s National Center for Complementary and Integrative Health awarded Mount Sinai and Duke $800,000 to allow Lamas’ team to design a definitive follow-up study.
With that earlier grant, Lamas’ team met 20 specific milestones for conducting the new round of research.
The $37 million grant, announced Tuesday, will allow the next leg of Lamas’ research to move forward. The study will involve 100 medical facilities and enroll 1,200 patients in the U.S. and Canada, who will be treated and tracked for five years.
“If this study is positive, as the last one was, we will move to chelation of toxic metals as front-line therapy for heart disease,” Lamas tells Newsmax Health, noting he expects results by 2021.
Alternative practitioners have used chelation therapy for nearly 60 years in the absence of clinical trial data supporting its use. But because of the lack of such data, it has generally been believed by conventional medical practitioners and cardiologists to be without value.
“Unless we can show a consistent effect across the two TACT Trials, it will be difficult for chelation to enter the mainstream of other cardiovascular therapies,” Lamas observes.
But he hopes the new research will provide a definitive answer on chelation and lead to “the recognition that environmentally acquired toxic metals are a reversible risk factor for heart disease. This realization will have clinical and public health implications.”
TACT2 is recruiting patients for participation in the study. Details:
• Study participants must be at least 50 years of age.
• Candidates must have diabetes and experienced a prior heart attack.
• Those interested in participating can contact researchers through www.tact2.org, by calling 305-674-2260, or contacting Lamas directly at [email protected].