At 4:00 pm Eastern Standard Time on March 26th, 2013, the embargo was lifted on an article published in the Journal of the American Medical Association. It is titled:
We are sending out this alert because we wanted you to have access to this controversial data as soon as possible after release. It will doubtless create a lot of controversy and confusion around a highly controversial therapy. An accompanying editorial in JAMA by cardiologist Steve Nissen is highly critical of the research. As a result, many cardiologists will discount or disregard it and most physicians will likely ignore it. We think this research deserves your attention. After all, you paid for it! This 10-year study cost taxpayers $31 million.
In a nutshell: EDTA chelation therapy was shown to have “modest” cardiovascular benefit in high-risk heart patients. This was not what mainstream medicine expected. Read on to learn more about this contentious treatment.
We first learned about EDTA chelation therapy for treating lead toxicity in graduate school. EDTA stands for a tongue twister compound, Ethylene Diamine Tetraacetic Acid. When injected intravenously, this compound has the ability to circulate throughout the bloodstream and bind to or “chelate” metal ions from tissues, facilitating their removal from the body.
EDTA was first used medically in 1947 when a doctor at Georgetown University Medical Center used it to reduce toxic levels of nickel that a cancer patient had accumulated because of chemotherapy. During the 1950s doctors used EDTA to detoxify workers exposed to excessive levels of lead while working in battery factories or repainting old ships.
Some of the patients treated for metal or mineral toxicity (aluminum, arsenic, calcium, copper, iron, lead, mercury) noticed a wide array of improvements. Some reported less chest pain (angina), while others believed that their ability to concentrate improved, along with fewer aches and pains.
By the mid 1970s we were hearing from some physicians that EDTA chelation therapy was helpful for people with heart disease and poor circulation. Patients scheduled for bypass surgery were telling us that after a series of intravenous injections their chest pain disappeared, their ability to exercise improved and they postponed or completely reconsidered their plans for bypass surgery. EDTA was supposed to bind to calcium from the plaque that lines coronary arteries. Infusions of EDTA and vitamins also removed magnesium, lead, aluminum, cadmium, zinc and iron from the blood stream and from tissue.
By reducing calcium in plaque, the theory went, blood flow to the heart would improve and complications from atherosclerosis would be diminished. An antioxidant action was also believed to reduce inflammation both in arteries and in other soft tissue. By 2007 it was estimated that over 100,000 people were seeking out chelation doctors each year for this prolonged IV treatment.
Despite many glowing reports of success, we remained agnostic. In our minds there just wasn’t enough data to draw clear conclusions about the benefits or risks of EDTA chelation therapy.
Mainstream medicine seemed dead set against this approach. Many cardiologists and other physicians believed it was at best a placebo and at worst snake oil. After all, injecting a bag of liquid into veins is psychologically impressive. And patients paid a lot of money out of their own pockets for the many repeated IV infusions. Organizations like the AMA (American Medical Association), the AHA (American Heart Association) and the ACC (American College of Cardiology) came out strongly against using EDTA chelation for cardiovascular disease. It was perceived as ineffective and possibly dangerous even though there were no data on either count.
Because so many patients were undergoing this treatment anyway, the government decided to sponsor a long-term study called TACT (Trial to Assess Chelation Therapy). It was overseen by the National Heart, Lung, and Blood Institute and the National Center for Complementary and Alternative Medicine. Patients were recruited into the study if they had experienced a heart attack at least 6 weeks prior to the study. They were randomized to get either 40 infusions of EDTA plus vitamins and minerals or placebo infusions.
Between 2003 and 2011 over 1700 subjects were recruited and randomized almost equally to either EDTA or placebo. They were followed for roughly five years. This is undoubtedly the best study of EDTA chelation ever conducted.
The results, although not spectacular, were better than many physicians anticipated. Given that the expectation was that chelation therapy would be a waste of time and resources, it doubtless came as a great shock to many health professionals that there was any detectable benefit at all.
RESULTS OF CHELATION THERAPY
- 18% composite relative risk reduction in: death, second heart attack, stroke, repeat coronary artery procedure, or hospitalization for angina. The placebo group experienced 261 of these events (30%) compared to 222 events or 26% in the chelation group.
- 18% of the patients getting placebo had to have their coronary arteries reopened (“revascularization”) compared to 15% of those getting EDTA. That was a relative risk reduction of 19%.
- 2.1% of the placebo patients were hospitalized because of chest pain (angina) whereas 1.6% of those on EDTA were hospitalized for this problem. That was a relative risk reduction of 28%.
- Subgroup analysis: high-risk patients with diabetes or “anterior MI” (aka the widow maker) had a relative risk reduction of 39% and 37% of experiencing another cardiovascular event if they received EDTA.
SIDE EFFECTS OF CHELATION THERAPY:
Overall EDTA did not seem dangerous. There were a total of 4 “severe adverse events” during the trial–2 in the EDTA group with 1 death and 2 in the placebo group with 1 death. In other words, exactly the same. Heart failure was reported in 57 chelation patients (7%) compared to 71 placebo patients (8%). Again, no statistical difference. One patient getting EDTA developed hypocalcemia (low calcium levels) that led to muscle cramping and a trip to the emergency department.
We agree with the authors that EDTA chelation “modestly reduced the risk of a composite of adverse cardiovascular outcomes, many of which were revascularization procedures.” Many physicians will take that to mean that EDTA is virtually worthless. That was certainly the conclusion of cardiologist Steven Nissen in his JAMA editorial:
“…the results cannot be accepted as reliable and do not demonstrate a benefit of chelation therapy. The findings of TACT should not be used as a justification for increased use of this controversial therapy.”
What is missing from such conclusions is that drug therapy is often not that much better. The authors of this research point out that:
“…an 18% relative treatment effect is within the range of effects that have been considered clinically important in prior trials, such as the use of clopidogrel [Plavix] for patients with acute coronary syndromes.”
When drug companies detect a lowered risk of 18% to 30% they spend millions on marketing and TV ads to the public.
BOTTOM LINE ON EDTA CHELATION THERAPY:
Based on this new research, chelation is neither the great rip-off of all times nor the great savior for patients with heart disease. It is a hard treatment to complete because it involves at least 40 three-hour long infusions over many months. Such treatment is not inexpensive. Some practitioners charge over $100 per infusion and they are rarely, if ever, covered by insurance.
This study is likely to be the last of this magnitude. That’s because such research is expensive, takes years to complete and subjects tend to drop out because of the huge time commitment. We doubt that the government will spend tens of millions more on another study and no drug company is likely to invest in EDTA research since the compound is available generically.
What’s been your experience with EDTA? We’d like to hear your story positive or negative. Please comment below.