By Margaret Ann Miille
For years, using chelation to treat heart disease has been pretty much an act of faith. The intravenous process, which removes heavy metals and minerals from the blood, has long had a following among practitioners of alternative medicine who say its cleansing abilities work on arteries, too. But mainstream doctors have rarely put stock in the treatment because there's only sparse scientific evidence that it helps treat heart disease, the leading cause of death for American men and women.
"Chelation, so far, has been a little like religion: either you believe in it or you don't," said Randy Hartman, a cardiologist at the Heart & Vascular Center of Sarasota [Florida]. Now the largest study of its kind — the "Trial to Assess Chelation Therapy," or TACT — is being launched to end the debate. The Heart & Vascular Center and Bradenton's [Florida] Integrated Healing Arts recently joined the five-year, $30 million project, which is being funded by the National Institutes of Health. The clinical trial will involve nearly 2,400 patients at more than 100 research sites nationwide. The federal Food and Drug Administration has approved chelation as a treatment for lead poisoning and toxicity from other heavy metals, but the federal agency hasn't approved it for coronary artery disease.
Hartman, the principal TACT investigator at the Sarasota research site, says he doesn't have a pat answer for patients asking if chelation would help them. Like most board-certified cardiologists, he prescribes traditional treatments: controlling high blood pressure and cholesterol with medication and lifestyle changes such as eating well, exercising and quitting smoking. More severe cases are treated with angioplasty or bypass surgery. "This is something that needs to be studied so we can finally get some definitive answers," Hartman said. "Does it help, who does it help and in what way does it help?"
Many have tried it More than 800,000 Americans have undergone chelation therapy in the last 40 years, most of them for cardiovascular disease, says the American College of Advancement in Medicine. The therapy involves an intravenous treatment using ethylene diamine tetra-acetic acid, a synthetic amino acid. TACT patients sit, generally in a recliner, for three hours at a stretch while receiving the infusion. Evidence on how well chelation works remains largely anecdotal because of the size and scope of chelation studies to date. The next-largest one conducted in Denmark a few years ago had only 153 patients, said Gervasio A. Lamas, director of cardiovascular research and academic affairs at Mount Sinai Medical Center-Miami Heart Institute in Miami Beach. Lamas wrote the NIH proposal for TACT, which was approved in 2002, and he's the study's chairman.
Earlier clinical trials gave doctors little reason to support chelation because they failed to show significant differences between those heart disease patients who tried the therapy compared with those who didn't, he said. Even alternative medicine practitioners, who are generally much more enthusiastic about chelation, found the same studies inconclusive because the numbers of patients involved were so small. "I don't think there is significant evidence for or against chelation," said Lamas, a cardiologist who doesn't use the therapy at his practice. "I think there is a swirling controversy about something on which there is little data. There is not enough data for a clinician to make a decision."
TACT will enroll 2,372 patients who are 50 or older, have had a heart attack, but no chelation, within the last five years. They cannot have smoked within the last three months or have had heart surgery within the last six months. Half will be randomly selected to receive a standardized chelation solution; the rest will get a placebo. It's a double-blind study in which neither the patients nor the doctors will know who is getting the placebo and who is getting the treatment. Patients will undergo a series of 40 infusions — the first 30 are weekly — and take vitamin supplements. They will be monitored until the end of the study to gauge chelation's clinical benefits or side effects. The study will end in the spring of 2008, five years after the first patient was enrolled. "Whatever the results, you can't deny them," Lamas said. "The study is well-designed and it has enough patients in it so that whatever we get will have to be taken into account by all cardiology and alternative medicine, whether it is positive or negative." Cooperation from the alternative medical community was essential to the project because its members are the most familiar with chelation, Lamas said. "They feel that they have been practicing a treatment that has benefited thousands of patients, that conventional medicine refuses to recognize what is obvious to them."
Some are convinced Jeff Morrison, one of four chiropractors at Bradenton's Integrated Healing Arts, fits that bill. As site coordinator for TACT, he's sure the study will prove what he says he's known all along. "I think it's going to show that chelation therapy is very efficient for cardiovascular disease. I don't think it's going to replace any current treatments out there, but it will add a very important tool for cardiovascular diseases," he said. "It will open a whole new treatment. … It will save a lot of lives." Chelation has been used since 1998 at Morrison's practice, a multidisciplinary operation that also has massage therapists, physical therapists, an acupuncturist and a hypnotherapist. There, chelation is used mostly to treat patients with cardiovascular disease. To a lesser extent, it's given to people with heavy metal toxicity, which manifests itself in such symptoms as fibromyalgia and chronic fatigue syndrome. Reluctance by doctors to use chelation may be partly fueled by their desire to perform more profitable operations, Morrison said.
Insurance usually only pays for chelation for lead poisoning or toxicity. It typically costs others from $80 to $120 for a single infusion. Chelation is free to patients in the study. Eighty-two TACT sites nationwide are considered "activated," including 15 in Florida. About 170 patients have enrolled across the country. Integrated Healing Arts has one signed up and the Heart & Vascular Center has six. That includes Sarasota's Frank Laudano, an active 70-year-old retiree who's had two heart attacks and one angioplasty. Other treatments, such as strapping inflatable cuffs to his body to increase blood flow, helped him feel stronger for a while. Laudano got his first infusion nearly two weeks ago. "My heart is such that I'm not a good candidate for open heart surgery," he said. "I'm a strong believer that it will work. If it doesn't work, I have the satisfaction of contributing to medical science, and other people may benefit. "It may be my children." Source: heraldtribune.com (Southwest Florida)