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What is chelation?

The Greek word “chele” means claw. Chelation is the binding of metals (like lead) or minerals (like calcium) to a protein “chelator” in a pincer-like fashion, forming a ring-like structure. Chelation is an important treatment protocol for the removal of toxic metals such as lead and mercury from the body’s bloodstream and tissues. Natural chelation, although weak, regularly occurs from eating certain foods such as onions and garlic. A stronger chelation effect can be induced when certain supplements, such as some amino acids, are taken orally. The strongest chelation effect is achieved with intravenous chelation. 

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For someone who has diabetes, and has also already suffered a heart problem, the chances for another heart attack, stroke or sudden death are very high.

The government has now funded a new clinical trial.

It could lead to a new way to treat heart disease, or it could prove skeptics right.

Fifty-eight-year-old Lorrie Entwistle is hoping an infusion, given as part of a clinical trial, will help protect her heart.

"I have 17 grandchildren and I want to be around here for them," said Entwistle of Riverside, New Jersey.

Heart disease runs in her family. Both her grandfathers died of a heart attack. Her parents also have heart disease.

She suffered her first heart attack at age 47. She also has diabetes, which puts her at an even greater risk for more problems.

Dr. Allan Magaziner in Cherry Hill, New Jersey, is now one of several doctors nationwide involved in a trial to see if chelation can help.

Chelation means to "bind to". The treatment uses an intravenous solution that binds to heavy metals in the blood, such as from industrial pollution. The body then flushes them out.

It's only FDA approved to treat lead poisoning.

But it's been given for years as an alternative therapy for many other uses, including heart disease.

"The theory is by ridding the body of these heavy metals, the body will then function much better," said Dr. Allan Magaziner, Magaziner Center for Wellness.

The theory is not proven, but it's getting another look after results of the first TACT trial to assess chelation therapy were published a few years ago.

"It was very surprising to everyone once we teased out the data," said Dr. Magaziner.

The biggest benefit was in heart patients who were also diabetic.

• A 50 percent reduction in recurrent heart attacks.
• A 43 percent reduction in deaths.

The NIH has now funded TACT 2, a $37 million double-blind trial to see if TACT 1 results can be replicated.

There are still plenty of skeptics, including Dr. Douglas Jacoby, a preventative cardiologist at Penn Medicine.

Like many, he doesn't buy into the theory, and as for the first trial, he says, "the issue is most of us still don't believe the results." He says there were technical issues and it's just one trial. He doesn't object to patients enrolling in TACT 2, but he emphasizes sticking to things that are proven to reduce risk.

"A heart healthy lifestyle is important. Exercise can lower risk as much as chelation therapy did. Healthy diet is important and medicines are important," said Dr. Douglas Jacoby, Penn Medicine.

Like all patients in the trial, Entwistle doesn't know if she's getting chelation or placebo. Patients get one three-hour-long infusion each week for 40 weeks, along with vitamins.

"If I am getting chelation, I believe that it will help me," said Entwistle.

"If the results are as effective in the TACT 2 trial as compared to TACT 1, it could change the scope of how we treat heart disease," said Dr. Magaziner. "This may be a preventable way to reduce risk of heart disease, stroke, sudden death in millions and millions of Americans."

Most experts agree chelation is relatively safe if done as part of a clinical trial.

They are still looking for volunteers. You must be at least 50 years old, have diabetes and experienced a prior heart attack.

For more details, contact the Magaziner Center for Wellness at 856-424-8222.

The new heart patient asked Dr. Gervasio Lamas if he thought chelation therapy was worth a try. “Of course not!” the cardiologist replied emphatically. His Harvard training had taught him that alternative therapies were a waste of time and money, and potentially risky to boot. “I told him it was quackery.”

But Lamas went home that night unsure if he had given his patient the best medical advice. He looked up research on chelation therapy, which removes heavy metals from the body, and found very little data either supporting or contradicting the procedure.

Lamas was troubled by the idea that he had offered this man a medical opinion that wasn’t supported by science. And he decided to conduct a study himself. He had no idea what he was getting into.

Seventeen years later, his research into a therapy many of his colleagues consider bunk has earned him scorn and sideways glances at medical meetings. Some accuse him of wasting taxpayer money. But Lamas persevered — even briefly taking out a second mortgage on his house to help pay for a clinical trial.

Three years ago, he announced results of that $30 million study: Chelation was safe and potentially helpful. The conclusion shocked the mainstream medical world, including Lamas. After all, the procedure had been so discredited that doctors previously could lose their medical licenses for using it.

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About Mount Sinai Medical Center 
Founded in 1949, Mount Sinai Medical Center is the largest independent, private, not-for-profit teaching hospital in South Florida. Mount Sinai’s mission is to provide quality healthcare to a diverse community enhanced through teaching, research, charity care and financial responsibility. Mount Sinai’s Centers of Excellence combine technology, research and academics to provide innovative and comprehensive care in cardiology, neuroscience, oncology, urology and orthopaedics. One of the original statutory teaching hospitals in the state of Florida, Mount Sinai is the hospital of choice for those who seek the level of expertise and care that only a teaching hospital can offer. Mount Sinai currently offers six convenient locations in Miami-Dade County. For more information on Mount Sinai Medical Center, visit 
www.msmc.com or call 305-674-CARE (2273). 

About the Duke Clinical Research Institute (DCRI) 
The DCRI is the largest academic research organization in the world, with a mission to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding. 

For Media Inquiries: Joanna Palmer | Public Relations Director | 305-674-2589 | Joanna.Palmer@msmc.com

Often dismissed as quackery, chelation therapy was the subject of a recently completed NIH study (Trial to Assess Chelation Therapy [TACT]) that showed the practice to be of moderate benefit to heart-attack survivors. Yet the controversy continues unabated, with some calling the study misguided or flawed and few in the conventional medical community willing to embrace chelation therapy as a legitimate option for heart patients.

How Chelation Therapy Works
Chelation therapy consists of a series of IV administrations of disodium or calcium ethylenediaminetetraacetic acid (EDTA) mixed with minerals and vitamins.

Typically, patients recline in a chair in the clinician’s office for one to four hours once to three times weekly for a series of 20 to 80 chelations. “Booster” chelations may be administered on a monthly basis or intermittently for years.

The purported benefits of chelation therapy vary but typically include the following:

• Improves such circulatory disorders as coronary artery disease (CAD), cerebrovascular disease, or peripheral vascular disease;
• Detoxifies the body of such heavy metals as lead, cadmium, and mercury; and
• Combats degenerative diseases and slows the aging process.

The procedure is usually not covered by Medicare or private insurance. The out-of-pocket costs are borne by patients and may total thousands of dollars for a single course of treatment.

History
The term chelation (derived from the Greek chelos or claw) refers to the mineral- or metal-binding properties of certain compounds that can hold a central cation in a pincerlike grip. Developed in Germany in 1935, EDTA was originally used as a means of binding and extracting calcium in the dye industry.

In the 1940s, Martin Rubin, Professor Emeritus of Biochemistry at Georgetown University Medical Center in Washington, D.C., discovered EDTA’s effects on calcium in biological systems. This discovery led to the product’s use as an anticoagulant and is still used in “purple top” blood-collection tubes. Professor Rubin’s research led him to advance the use of EDTA for treatment of hypercalcemia and, eventually, lead poisoning.

In the 1950s and 1960s, several clinicians began to observe that patients treated for lead poisoning with IV EDTA experienced improvements in their cardiovascular conditions. This observation led to the widespread, but mostly empirical, use of EDTA therapy for heart patients within a growing community of alternative medicine practitioners.

Studies were undertaken, but these were mostly observational or uncontrolled and involved only small numbers of patients. Chelation therapy for other than the approved indications of refractory hypercalcemia or severe lead toxicity remained highly touted but poorly substantiated.

Clinicians practicing chelation therapy were sometimes targeted by medical boards for disciplinary action, irrespective of whether specific patient harm had occurred. Some states adopted regulations prohibiting the practice of chelation therapy. To this day, disodium EDTA is not approved by the FDA to treat any diseases. However, disodium EDTA is produced by compounding pharmacies for individual patients, so the treatment can still be obtained.

In 1998, the U.S. Federal Trade Commission (FTC) targeted the American College for Advancement of Medicine (ACAM), an organization that has trained and certified physicians in methods of safe administration of chelation therapy since the 1970s, for allegedly outsized advertising claims made regarding the treatment of atherosclerosis.

The FTC concluded that there was a lack of scientific studies to support these claims and that pro-chelation statements made by ACAM were false. As an alternative to litigation, ACAM stipulated that it would curtail public pronouncements presenting chelation therapy as an effective treatment for heart disease.

The public’s enthusiasm for chelation therapy remained undiminished, however. Between 2002 and 2007, use of chelation therapy to treat heart disease and other conditions grew in the United States by nearly 68% to 111,000 people.¹ As of the start of the TACT Study in 2001, it was estimated that patients received 800,000 individual EDTA infusions per year.²

Until the TACT study, mainstream clinicians widely believed that EDTA chelation therapy for conditions other than acute lead intoxication was an unwarranted and dangerous modality. This is true to the extent that excessive doses of EDTA can be nephrotoxic; cases of renal failure resulting in dialysis or death have been recorded. Additionally, transient hypocalcemia provoked by EDTA calcium sequestration can trigger cardiac arrhythmias or sudden death.

But these outcomes have generally occurred only in rare instances where EDTA is administered in too high a dose and/or too rapidly or without regard to a patient’s glomerular flow rate. In 1989, a “Protocol for the Safe and Effective Administration of EDTA” was developed and subsequently updated.³

The detailed protocol provides strict criteria for patient selection and cautions clinicians to perform an initial evaluation of renal function using the Cockcroft-Gault equation and to frequently monitor renal function throughout a series of chelation treatments. Emergency procedures are outlined should adverse reactions occur.

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http://www.empr.com/chelation-therapy-clinically-relevant-or-just-quackery/article/333324/