This study placed 82 subjects on EDTA or placebo infusions over 6 months.  After that time, no significant differences between drug and placebo were shown in time to 1 mm ST elevation on a treadmill or in several quality of life surveys.  The “1 mm ST elevation” is an indication on an electrocardiogram (EKG) that heart trouble is starting to arise as the coronary arteries around the heart tighten up.

A critique has pointed out a number of flaws for this trial (Olmstead, 2007).  Most notable was the fact that 20 patients with a previous heart attack randomly ended up in the chelation group, while only 12 such patients wound up in the placebo group.  Furthermore, more patients in the placebo group happened to be taking antianginal medications which might affect their EKG results.  For instance, 19 placebo patients were taking nitrates before the trial and only 10 were doing so in the chelation group.  To me, these seem like deviations that come about when you randomize patients to different groups, but is it possible that the placebo patients were healthier and better-medicated?  A final fact worth mentioning is that 4 of the placebo patients underwent angioplasty in the year following the trial, compared to none of the chelation patients.  Did chelation prevent people from needing such procedures?

So here’s another trial with a small number of people, testing chelation for a short time, and finding only the faintest hint of benefits.

A Danish study reported in 1992 doesn’t find the happy results that the Tulane group found in 1990. This group looked at the ability of chelation to affect 153 patients suffering from IC.  Chelation or salt water was taken by IV for 5-9 weeks by two random subgroups. The authors say that significant markers, including as maximal walking distance, pain-free walking distance, and ankle/brachial pulse ratio, were similar in both groups after the trial (Guldager et al., 1992).

Now this study wasn’t without its flaws, and in my eyes it’s the most controversial of the five main EDTA trials. A guy named Elmer Cranton wrote a critique of the study and I want to point out a few of the things that he found. First, the study starts out with the placebo group able to walk 157 meters on average before their leg pain sets in, while the chelation group can only walk a mere 119 meters. Second, there’s a huge standard deviation of 266 meters for the placebo group, and only 38 meters for the chelation group. That means that there’s a wide spread of the amount that people can walk for the placebo group, which makes it difficult to interpret the data. Cranton interprets the 51% maximum walking distance improvement of the chelation group, compared to the 24% improvement of the placebo group, as a significant benefit from therapy. He also notes that the study focused on more than 80% smokers, which he claims hampers the effects of EDTA. Final criticisms are the high drop-out rate in this study, as 123 of 153 patients completed the 6-month follow-up (Cranton, 2005).

So, even though this is the largest study of chelation ever run, I don’t feel safe drawing too many conclusions from it. I definitely don’t see the amazing results that the Tulane group reported. But there are a few pretty valid weaknesses of the study that Cranton points out, which may have obscured some possible benefits.

After 10 IV treatments, all 5 guys taking EDTA showed amazing improvements in the distance they could walk, time they could bike, and steps they could climb.  On average, they could walk twice as far, bike twice as long, and climb twice as many steps.  They placebo people didn’t see any benefit.  Was EDTA clearing up atherosclerosis and helping with IC?

At this point, the doctors running the study did something very strange.  Knowing that half of the patients were doing incredibly well, they looked at who was getting what treatment, and of course saw that the people taking EDTA were the ones doing so well.  So they decided to give EDTA to everyone so that the people getting placebo might benefit now, too.  Now, they saw almost as much improvement in the 5 men getting chelation for the first time as with the first 5 men to get chelation.  And the men who had taken chelation for 10 weeks kept improving as they had more treatments.

So, this study shows some amazing effects.  This study stands alone among the five main chelation trials that I mentioned as it is the only one to show clear-cut benefits.  Exciting stuff.

The first such trial to suggest some improvement in cardiovascular performance after EDTA therapy was reported in 1963 (Kitchell et al., 1963). The study took 9 patients who were pretty sick with angina, or chest pain related to blockage of the coronary arteries that feed the heart. They assigned 4 of them to have IV chelation and 5 to have a placebo IV saline solution. Two of the members of the chelation group had “improved subjective markers” and electrocardiogram readings after 12 weeks, compared with none from the placebo group. 3 of the 5 people getting the placebo dropped out in frustration at this point, but the other 2 started taking the same type of chelation, and they saw no benefits.

It’s really hard to draw many conclusions from this study. First of all, the doctors write that they looked at improvement in ability to walk on a treadmill and based on the electrocardiogram information that they see during this exercise, but they don’t publish this data in the report. That makes it hard for readers to judge for themselves whether there was an improvement in those two patients. Second, the authors aren’t so sure about the reliability of their analysis of the electrocardiogram, as they saw “good” electrocardiograms in patients that dropped dead the next day. A lot of doctors don’t put a lot of stock in the clinical trial design and statistical analysis methods of trials that were conducted so long ago, and the tiny number of patients looked at here makes it even harder to draw any conclusions.

Oral therapy has gained traction in recent years. Cardio Chelate, picture above, is available at AllChelation.com. It contains 400 mg Calcium EDTA, 40 mg ascorbic acid, 40 mg methylsulfomethane, and 50 mg N-acetyl cysteine as ingredients. 6 pills (2400 mg) are recommended daily, for instance 3 pills twice daily on an empty stomach. The container claims that 5% of orally administered EDTA is absorbed in the gut, which would result in a two- to three-fold lower effective intake of the oral formulation compared to a once-weekly 3 g intravenous formulation.

For the “direct evidence” that Lamas and Hussein are talking about, you have to look at randomized, double blind, placebo controlled trials. These are the gold standard in modern medicine for testing new drugs and therapies. When conducted properly they can filter out bias on the part of the researcher, improvement based solely on the “placebo effect,” and differences in patients’ socioeconomic status, race, and other factors that might confound the results. The authors of this article tell us about three such trials, one published by a Danish group in 1992, another by a New Zealand group in 1993, and the most recent from a Canadian group in 2002. Here’s what the reviewers conclude: “there are ample reports in the form of case tudies and case series to support the benefits of EDTA chelation therapy. On the other hand, a small number of randomized trials enrolling an aggregate of fewer than 300 patients have had generally null results” (Lamas and Hussein, 2006). Without a slam-dunk trial in hand, is it possible that doctors want to stick with tried-and-true methods like coronary bypass surgery to treat cardiovascular woes?

“Chelation” is a word that you’ll find in every chemistry textbook. It refers to the binding of metals by organic compounds, for instance drugs or proteins. There are many drugs that work as chelators, and a lot of them are used in hospitals every day to help people with Wilson’s disease or lead poisoning. It’s thought that these tiny molecules enter your bloodstream and grab all of the nasty metals that are giving you problems, and then filter through the kidneys and exit in urine- with the metal. The chelator I’m interested in is a man-made substance called EDTA (ethylenediaminetetraacetic acid).

The use of the EDTA as a therapeutic began with its success in treating lead and other heavy metal poisonings, and that’s what it’s FDA-approved for today. Today, dimercaprol is the often the chelation agent of choice in this scenario, with intravenous or oral EDTA indicated as an add-on therapy (Habal et al., 2006). What I want to talk about is the use of EDTA to improve cardiovascular and overall health, which dates back more than 50 years.

Dr. Garry Gordon, a cofounder of the American College for Advancement in Medicine (ACAM), writer of “The Chelation Answer,” and a major innovator of modern chelation therapy, says that lead, mercury, and cadmium are present in high levels in the body as a result of life in industrial society. He holds that taking EDTA either in pill or IV form can lead to overall well-being by eliminating these metals, leading to “fewer infections in childhood” and “less death and longer lifespans.” Dr. Gordon goes on to state that “many [EDTA-treated] people still find that their memory improves, their sex life gets better, their feet get warmer, their blood pressure grows more normal, and they can suddenly run upstairs” (Brown, 2007). You may have happened upon his website. Sounds pretty amazing, doesn’t it?