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"Chelation gathered momentum in the 1970s and 1980s as a treatment for cardiovascular disease," says Gervasio Lamas, ., director of cardiovascular research and academic affairs at Mount Sinai Medical Center-Miami Heart Institute, associate professor of medicine at University of Miami School of Medicine, and principal investigator of the TACT study. "After a couple of small studies that did not show particularly positive results, the therapy was discredited in conventional cardiology, and it then went into the realm of alternative medicine, where it continued to grow, based on several factors. For one, thousands of patients, as well as hundreds of case reports, describe a marked improvement in cardiovascular disease and better blood flow after chelation therapy. Because there are hundreds of thousands of infusions of chelation therapy each year in the United States, the NCCAM decided to target chelation therapy for a pivotal clinical trial."

Dr. Lamas' primary experience has been in treating heart patients with traditional treatments, but more frequently, patients are asking about complementary approaches, including chelation. Like many of his colleagues, Dr. Lamas, a conventionally trained cardiologist, was initially skeptical about chelation therapy's reputed benefits.

"My initial mindset was negative," reports Dr. Lamas. "I expected to find nothing new and physicians practicing chelation therapy who might view me as someone endangering a revenue source. I discovered the opposite. I found devoted clinicians who provided me with anecdotes of patients who had experienced marked benefits. Additionally, they were thrilled to have a conventional cardiologist conduct clinical trials on chelation therapy because they want the good they do generalized to society."

Many people seek out complementary therapies because they are confused and concerned over recent reports on potential cardiovascular side effects of some conventional medications.

"The consumer may confuse the volume of noise that the media make with the volume of data that is generated," cautions Dr. Lamas. "Many studies have been done on cholesterol-lowering statins, for example. If you take 1,000 patients with coronary disease and give them a statin, wait a few years, and then count how many people died from heart attacks, strokes, kidney failure, liver failure, or other events, you will always find fewer deaths in the statin group. That is solid data. While the consumer may think a drug kills, physicians like me are in their offices explaining to patients that you have to go with the statistics, showing that you're more likely to be alive if on this drug."

In the current trial that will run until 2008, patients will remain on conventional medications while undergoing adjunctive chelation therapy, potentially yielding another tool in the fight against heart disease.

"We have many medicines that show improvement, but if you have someone with established coronary disease, he or she will continue to have a 15 to 20 percent event rate over four years--death, nonfatal heart attacks, or strokes, for example," says Dr. Pamela Ouyang, associate professor of medicine at Johns Hopkins University School of Medicine and practicing cardiologist at Johns Hopkins Bayview Medical Center, one of the TACT trial test sites. "We have not managed to halt the process completely, so the TACT trial is not to look at chelation therapy as an alternative to conventional therapies, but as useful in addition to current medical therapy."

Physicians who use chelation therapy in clinical practice witness the benefits of the therapy in their patients, especially when they are treated with an integrated approach to achieve optimal wellness.

"In one sense, the benefits of chelation therapy are broad," says Dr. Dale Guyer, who administers chelation therapy in his Indianapolis-based practice--also a TACT site. "In my experience, almost everyone undergoing chelation therapy subjectively feels a lot better. They report improved energy, mood, sleep habits, and mental clarity. However, as it relates to CAD or any chronic diagnosis, I would also look at other risk factors, such as homocysteine, fibrinogen, C-reactive protein (CRP), lipid status, and hormone levels, among other factors. The important point is that chronic illnesses are multifactorial, and we must understand the whole picture and treat comprehensively to have the most significant impact."

At over 100 research and clinical centers across the country, scientists and physicians are busy recruiting 2,372 participants age 50 years and older who've had a heart attack to determine whether chelation therapy and/or high-dose vitamin therapy proves beneficial. One form of chelation therapy, EDTA (ethylenediamine tetra-acetic acid)--a synthetic, or man-made, amino acid--is delivered intravenously and, as practiced in the community, often includes administration of high doses of antioxidant vitamin and mineral supplements. In order to test whether some of the therapy's effect may be attributable to vitamin-mineral supplements, or to the EDTA solution itself, the investigators will first randomly assign participants to receive either EDTA chelation solution or placebo. Then the patients in these two groups will again be randomly selected to receive either high-dose vitamin-mineral supplements, or a placebo. All patients also receive a low-dose supplement."

The EDTA chelation therapy or placebo solution will be delivered through 40 intravenous infusions that are administered over a 28-month course of treatment. The first 30 infusions will be delivered on a weekly basis and the last 10 will be delivered bimonthly. Following the 30-week initial infusion phase, participants will have routine visits with study staff until the end of the trial.

Twenty times larger than any previous study of the treatment, TACT is designed to be large enough to detect mild or moderate benefits or risks associated with the treatment. Potential side effects to chelation therapy include a burning sensation at the IV site where the EDTA is delivered into the veins and, more rarely, fever, headache, nausea, or kidney damage.

The NIH study should add to a greater understanding about the treatment's effectiveness and safety in cardiovascular disease.

"I have had patients who have benefited from chelation therapy, but they usually get bored with taking the treatments. Once they stopped, the symptoms returned," heart surgeon Mehmet Oz, vice chair and professor of surgery at New York Presbyterian Hospital and Columbia University--another TACT trial site--told the Post. "The good thing about chelation is that with the newer, more mature chelation techniques, we can usually prevent major complications from the treatment itself.

"The interesting anecdotal data on this controversial approach hints that chelation might be effective in some patients and could act by inhibiting inflammation in the arteries or allowing the arteries to relax and open more. We don't know enough about chelation therapy, even though many Americans spend quite a bit of money on the treatment. We do have lots of data on other more invasive therapies and tend to trust these interventions more. So we think of chelation therapy as a complementary approach to use in conjunction with conventional therapies.

"If you don't have a life-threatening problem, you should look into this option. See if it works for you but be alert and cautious in using this still-unproven therapy. You must study yourself as you are being treated."

To learn more about the TACT study, locations of test sites, and enrollment, visit the National Center for Complementary and Alternative Medicine/NIH Web site at .nih. gov or call 888-644-6226.

To order a video on chelation therapy featuring Dr. Dale Guyer, please send $ (includes s&h) to Saturday Evening Post Video Library, . Box 567, Indianapolis, IN 46206 or by calling 800-558-2376.