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Clinical trial to examine treatment’s effectiveness

The National Institutes of Health needs to recruit 2,372 volunteers to participate in a clinical trial on the effectiveness of chelation therapy -- an intravenous drip mixture containing the man-made amino acid etholene diamine tetra-acetic acid and various vitamins -- to treat cardiovascular blockages.

The five-year study began in 2002 and will cost about $30 million to complete. In addition to learning whether chelation, which some doctors theorize breaks up the calcium that binds plaque to artery walls, is an effective treatment, researchers also want to determine whether the therapy’s effect is attributable to the EDTA solution, the vitamins and minerals added to the solution, or a combination of the two.

The double-blind clinical trial will involve a randomly selected chelation group and a placebo control group. To determine the role of vitamin and mineral supplementation, these two groups will then be subdivided to receive either low- or high-dose supplements. Participants will receive 40 chelation treatments over a 28-month period. The first 30 will be delivered weekly, and the final 10 will be delivered bimonthly.

To qualify for the study, participants must:

Be 50 or older

Have had a heart attack at least six weeks before evaluation

Have not had chelation therapy within the last five years.

For more information on the trial, visit http://nccam.nih.gov/chelation or call the Magaziner Center for Wellness and Anti-Aging Medicine at (856) 424-8222 or Integrative Family Medicine at (856) 869-3126. -- Shawn Rhea


Chelation and the heart

Patients undergo intravenous drip treatment to clear arteries

By SHAWN RHEA

Courier-Post Staff

Last December, 48-year-old Gary Bixby took a stress test as part of the requirements for his pilot’s license. The results were not good.

"I was told on Dec. 4 that I had a serious heart problem and that I need to be in bed resting or I’d be dead by Dec. 7,’ said Bixby.

Two cardiologists recommended he undergo angioplasty and heart stent implantation, but the Philadelphia resident decided to take a different path. He sought out a therapy called chelation in the hope of clearing the blockages in his arteries.

Bixby began chelation -- an intravenous drip mixture containing the man-made amino acid etholene diamine tetra-acetic acid and various vitamins, which some medical professionals say helps break up and remove artery-blocking plaque -- at the Magaziner Center for Wellness and Anti-Aging Medicine in Cherry Hill in February. He underwent 30 treatments over a 15-week period, followed by continued twice-monthly maintenance sessions. Each treatment takes roughly three hours.

Osteopathic physician Allan Magaziner said his center is treating 400 to 500 heart patients with chelation. He has been using the alternative technique for 18 years and is participating in a five-year National Institutes of Health trial on the effectiveness of chelation in treating blocked arteries.

"We don’t know the complete mechanism of chelation, that’s why this study is so important,’ he explained. Controversial treatment

Chelation was developed in the 1940s to remove dangerously high levels of metals such as lead and iron, as well as minerals such as calcium, from the body. The process works by binding onto these substances and pulling them from the blood. The deposits are then excreted as waste.

"What happened is that over the years, they found it helps improve vascular problems,’ said family practitioner Ronald Ciccone of Integrated Family Medicine in Collingswood.

He said one theory of how chelation may improve vascular function is by removing calcium deposits, it clears out the mortar that causes plaque to stick to arteries, thereby restoring blood flow to the heart and other vital organs.

Heart patients undergoing chelation typically receive 30 to 40 weekly treatments, then are scheduled for lifelong monthly sessions to keep the arteries free of plaque.

"Chelation is not a cure. It’s an ongoing thing,’ Ciccone said. "You have to keep coming for it or you risk blocking the arteries again.’

The therapy runs between $120 and $125 a session and averages roughly $5,000 for the initial weekly course of treatments. Because the Food and Drug Administration has approved the technique only for heavy metal treatment, chelation isn’t covered by insurance for treatment of heart disease. That means patients have to pick up the cost if they decide to undergo the treatment.

The use of chelation to clear artery blockages is also controversial. Only five clinical studies have looked at it as a treatment for heart disease, and the results have been inconclusive.

According to the National Centers for Complementary and Alternative Medicine, a division of NIH, three of the studies were too small to yield any discernible statistical differences in the outcome of heart patients receiving chelation compared to those receiving a placebo. The fourth study was never published in final form, and while the fifth study did show heart patients receiving chelation experienced an improved ability to exercise compared to those who received a placebo, only 10 patients participated in the study.

About 12 descriptive studies based on physician case reports have been published. They suggest chelation may provide some benefits to patients with blocked arteries, also called atherosclerosis. But these studies are only anecdotal, say many doctors.

"There’s no scientific evidence that it works on cardiovascular disease,’ said Bob Singer, a cardiologist at Virtua-West Jersey Hospitals in Marlton and Voorhees.

"It’s not a totally benign treatment,’ Singer added, noting kidney failure, bone marrow depression (a decrease in the production of blood platelets and cells), low blood pressure, cardiac arrhythmia and allergic reaction are possible side effects of chelation. Weighing risks

The biggest risk chelation presents to heart patients is some don’t use it as a complementary treatment, but as a replacement for conventional treatment, Singer said.

"I think it’s dangerous for patients to put all their hope into it,’ he explained. "But as long as they’re doing it with other things like diet change, exercise and the use of statins, then go for it.’

Magaziner takes a slightly different view, saying chelation may enable some patients to get off statins because it can keep the arteries free of the blockages that these drugs seek to control. But, he also said he never recommends patients discontinue conventional treatments without the approval of their cardiologists. Still, he acknowledged some patients who experience success with the treatment think of it as a magic bullet and don’t follow through with other key lifestyle changes. That behavior can be risky and impede the success of chelation.

"If (the patient) leaves here and eats McDonald’s each day, I can’t help them as much,’ he said.

Bixby admitted he is struggling to make the lifestyle changes Magaziner and his family physician have said are necessary to control his cardiovascular disease.

"I still have the pizza. I still have the quick, processed foods. (My doctors) were pretty clear (treatment) was a total health package,’ said Bixby, who admits he should also lose weight.

But Bixby said he feels a declining sense of urgency to change those habits, due in large part to what he believes has been successful treatment of his condition using chelation. A test revealed his cholesterol has dropped significantly since beginning chelation.

"The results were so low they couldn’t believe it,’ he said. "It dropped a huge amount, even considering the Lipitor (I’m taking).’

Bixby also feels less winded when climbing stairs.

Bixby’s primary care physician isn’t as convinced chelation is improving his health and would like him to undergo another stress test.

"I’m not against it, but even if it shows no change, I’m not going to do (angioplasty and stenting), because I know something is working with chelation,’ Bixby said.

Other patients, like Gibbsboro resident Mike Dempsey, are combining chelation with more conventional treatment and lifestyle changes.

Dempsey, who undergoes chelation at Integrative Family Medicine, learned about the therapy last November. Chest pains sent him to Our Lady of Lourdes Hospital in Camden, where doctors discovered three blockages in a ventricle leading directly to his heart. Hospital cardiologists recommended he undergo angioplasty and stenting to clear the artery and maintain blood flow. But after reading a brochure about Integrative Family Medicine -- a Lourdes practice -- and chelation, he decided to consult with Ciccone before making his decision.

"I learned that chelation took time, and I didn’t feel that I had that time,’ said Dempsey, who decided to undergo the surgery and use chelation as follow-up treatment.

The surgery didn’t have the outcome Dempsey and his doctors had hoped for. The artery blocked again, and Dempsey had a heart attack the day he was released from the hospital. He underwent a second procedure, but a 2002 study published in Circulation, an American Heart Association journal, found re-stenting offers only short-term benefits for cardiovascular patients.

Dempsey decided to increase his odds for success by undergoing chelation, changing his diet and exercising more frequently. He plans to check his progress with chelation by undergoing a follow-up ultrasound of his arteries, as well as other tests, after he completes his regimen of weekly treatments in January.

"What I’m hoping is there will be a significant change, like from a 60 to 70 percent blockage to 40 percent,’ he said. Study at risk

Dempsey and Bixby are convinced chelation is helping to improve their coronary health, and according to the American College for Advancement in Medicine, a professional organization that supports the use of chelation therapy, in 1997 more than 800,000 chelation sessions took place in the United States.

Despite the therapy’s popularity, Magaziner and Ciccone, who is also participating in the NIH study, admitted they have been challenged to recruit heart patients for the clinical trial.

"We need 2,372 patients nationwide, and we only have about 400,’ Magaziner said. "A lot of people don’t want to do the trial because they fear receiving the placebo.’

As a result, the majority of patients are willing to pay the out-of-pocket costs despite having only anecdotal proof the therapy may be effective.

Magaziner worries the study could be pulled if the 100 physicians involved aren’t able to recruit more patients.

"We’re trying to avoid that, because heart disease is a number one killer in our country, so this is a crucial study,’ he said.

Reach Shawn Rhea at (856) 486-2475 or srhea@courierpostonline.com.