This is an older article I wrote that didn't include the positive data found from a large, randomized trial done with the National Institutes of Health. This study showed a benefit from chelation therapy. Both positive and negative comments on the trial can be found with a search online. In my practice, I find that ozone therapy has had a much larger effect on my patient's who have symptoms from poor circulation.
My family doctor and cardiologist say it hasn’t been proven, or worse yet, that it’s been proven not to work. What’s the real evidence that chelation therapy works (or doesn’t) in heart and artery disease?
When my patients ask their family doctor or cardiologist about chelation therapy, at least 90% of the time the response they get is that it doesn’t work, or it hasn’t been proven. The doctor, while meaning well and trying to give an informed opinion, is simply misinformed.
Four publications in mainstream medical journals, which have summaries called abstracts available online, have negative conclusions. When a physician does a cursory search on a therapy using this database, they are only presented with the journal index and its summary, which does not include the raw data. All four of these trials have stated negative conclusions in their summaries, but their raw data indicates the opposite; that in fact, chelation therapy is effective. The problem is that the misinformed doctor sees only a negative summary but not the positive data. Most physicians can not take the 2 hours required to go through the raw data, per study, and therefore take it for granted and simply go to the conclusion or summary of the study.
Furthermore, only about 10% of biomedical literature ends up indexed in the common medline or pubmed database. The database is definitely exhaustive and I research it every day in practice. However, every study that has drawn a positive, beneficial conclusion for chelation therapy has been refused indexing in this database. The studies are published, in peer-reviewed journals, but these journals are not indexed in the database and therefore physicians do not come across them.
Let’s examine the four “negative” trials on chelation therapy.
Kitchell and Melzer published in the American Journal of Cardiology a trial in which they treated in a double-blind fashion (neither doctor nor patient knew whether they were getting the EDTA or a non-active placebo). Their conclusion was that chelation therapy was not effective because…
Some of the patients who had improved significantly, got worse about a year after therapy was stopped. In other words, chelation benefits didn’t last forever.
There is no therapy in medicine, including bypass surgery, that you couldn’t make the same statement for! Furthermore, patients selected for the study were the worst of the worst in that they had severe angina (chest pain) that had previously been treated with conventional methods, which had wholly been unsuccessful. All patients were disabled at the time of therapy.
-71% of chelation patients had subjective improvement (they felt much better)
-64% had objective improvement (ECG test, exercise stress test)
-Improvement was maintained for 1.5 years after therapy was stopped
Their conclusion? Because after 1.5 to 2 years, the worst patients started to get worse again, chelation didn’t work at all. (It also worth noting that nutritional changes, supplements, mineral replacements, smoking habits, were not attended to for these patients. Only chelation was used).
In the American Journal of Surgery, and the Journal of Internal Medicine, bypass surgeons published a study of EDTA chelation therapy. Being bypass surgeons, there probably was a bias to start with in this trial, and furthermore, these surgeons had no training in EDTA chelation. As such, the standard protocol developed by the American College for Advancement in Medicine, and used by most chelating physicians, was not used. The study was published as a double blind trial, but in fact, it was not double blind because the surgeons knew which patients got the treatment and which patients got the inactive fake medicine. The study in fact suffers from the same flaws that mainstream physicians use to criticize the positive studies of chelation therapy.
In this study, the group that got the EDTA had significantly more severe disease than the placebo group (thus the group getting the treatment, and the group getting the fake placebo, were not equally matched). Some patients dropped out of the trial. The researchers refused access to the raw data, prompting some chelating doctors to wonder if the drop-outs stopped treatment because they were feeling all better.
The most important part of this study is though, that the final measure of improvement was walking distance possible before pain stopped the patient. Patients with poor blood flow can only walk short distances because of chest pain or leg pain. When walking distance was measured 3 months after the last treatment (when the maximum benefit is postulated to occur), patients who were able to walk the furthest, who had improved the most, were dropped from the data because they stoppedfor reasons other than pain.
The best improvers, in the chelation group, were excluded from their final analysis. Thus the negative conclusion.
Furthermore, all patients were given iron supplements, which is known to neutralize some of the effects of EDTA.
Despite these drawbacks, the EDTA chelation group had roughly twice the improvement compared to the placebo group.
There is also a study out of New Zealand that concluded EDTA was not effective. Raw data from this study was crystal clear (in terms of benefit!):
-ankle:arm Doppler BP index measured the blood flow to the legs
-pulsatility index measured the blood flow in the worst leg
-data showed that EDTA group had more improvement than the placebo group
The chances of this happening by random was less than 1 in 100, and yet it was published with a negative conclusion.
The fourth negative chelation study was not published, but was presented at an atherosclerosis (fatty build up in the arteries) conference in Germany. The end result was that patients treated with EDTA had walking distance improve by 400%! The placebo group to which the EDTA was compared to was actually an approved drug called bencyclan, used in blockages of the arteries.
-the average improvement in the EDTA group was 400%, in that they were able to walk 4 blocks instead of the one block that the drug group was able
-some patients had no benefit, and some patients were cured in that they had no pain at all
-average was still 400% improvement
Here, the researchers threw out the data of patients who got completely well, calling it a “fluke” and therefore insignificant. Some doctors at this conference were upset with the researchers conclusions, and thus brought the data home to the chelation group the American College for the Advancement in Medicine, who reanalyzed the data. With the best improvers left in, improvement with EDTA was 400% better than the drug. Without the best improvers, EDTA was “only” 70% better than the drug.
Those are the four main studies that purported to have negative conclusions for chelation therapy. I’ve gone into detail about their shortcomings because it is important to know that well-meaning physicians might say “chelation has been proven to not work” or that “chelation has never been shown to work”, whereas, because they have only read the conclusions and not analyzed the raw data, they are misinformed. Below is a much quicker summary of the positive studies in chelation, because the results speak for themselves.
Dr Olszewer in Brazil and Dr Carter (former professor and chair in Tulane Medical School), observed 2,870 patients and found in heart disease patients 77% had marked improvement, 17% had good improvement. In peripheral artery disease of the legs, 90% had marked improvement. Alzeimer’s and stroke patients had only about a 25% to 30% improvement, because the nerve cells were most likely already damaged. Scleroderma patients (an autoimmune disease), had 75% patients get marked improvement, and all the remaining 25% patients had good improvement. I know of no better treatment for scleroderma.
Dr Casdorph, an assistant professor of medicine in California, used radioisotopes to measure blood flow to the brain. Consistently, after about 15 treatments, patients started to show improved blood flow. Improvement was much better after 20 treatments, and continued as treatments progressed.
Dr Macdonaugh and Cheraskin used a blood pressure device to measure blood flow in the ophthalmic artery, a branch of the carotid artery, which is normally affected by plaque build up. Patients were divided into three groups based on the severity of their disease. The most severe patients had improvements from 32% blockage to 17% blockage. The intermediate disease patients had 24% blockage to 9%. The least severe patients had 23% blockage go to 5% blockage (the best improvements, suggesting that chelation has the most benefit in PREVENTING blockages). These measurements had no possibility of hypnosis, suggestion, or placebo, as they are actual blood flow measurements!
Dr Macdonaugh did blood pressure ratios in the arm and leg. The leg blood pressure is normally higher, but if there are blockages in the leg arteries, the pressure is lower. The critical point is 0.5, where gangrene (tissue death) of the toes starts. The average improvement went from a leg blood pressure of 77 percent (of the arm) all the way up to 90 % of the arm after chelation therapy. The worst patients who started out at 50%, still improved to 70%, not a cure, but improved!
Dr Casdorph evaluated EDTA chelation in heart disease, where the heart muscle does not pump correctly. This is called ejection fraction, where the problematic heart does not eject as much blood per pump. He found improvements that were so significant, if due to random chance, it would be like flipping a coin 18 times in a row and getting 17 heads in a row.
A Denmark physician studied EDTA chelation in 92 patients scheduled for bypass surgery. After chelation, only 10 out of 92 went on to bypass surgery. The other 82 patients deferred bypass after chelation therapy was completed; these patients were followed for 6 years.This mirrors my experience in that about 80% of patients improve, and about 5-10% of patients see no benefit.
Dr Chappel of the International College of Integrated Medicine analyzed 22,700 patients. He found also that there was about an 87% chance that patients would objectively improve with chelation therapy. This was published data.
The maximum effect of any given number of chelation treatments, be it after 10 or 30 or 50 treatments, is usually 3 months after the last chelation. This is heavy evidence against a placebo or suggestive effect of chelation, because placebo acts right away, and wears off after 3 months. The most likely mechanism of chelation therapy is in redistribution of diseased accumulations of metals (nutritional metals like zinc, chromium, and iron) in diseased tissue. Removal of toxic heavy metals almost definitely contributes to the effect. This is the reason why chelation therapy lasts longer than other therapies, and if patients start to go downhill again, a touch up treatment can be done once a month or similar. The goal is to bathe the cells in EDTA for a period of 2 to 2.5 hours, in order to maximally rearrange the diseased accumulations of metals. Simple heavy metal detoxification, appropriate in other diseases, and in patients whom lead exposure might be more important, a different form of chelation can be given much more rapidly. However, this method, if done alone, is not as effective in heart disease as the slow chelation, and heart disease patients may need to be switched over to the slow 2-2.5 hour chelation.
Overall, the mechanism of chelation doesn’t really matter. The important thing is that we can expect about 80% of patients with heart or artery disease to improve with good or hopefully marked improvements. This improvement tends to start to be noticed after 15 treatments, and the number of treatments depends on the severity of disease. Patients over 40 interested in prevention of heart attacks would probably only need 20 treatments. Symptomatic patients might benefit from 20-40 treatments. The scheduling of the treatments does not matter, in that it is the total amount of treatments that matters. It can be done as much as daily for patients with severe disease (a few extra blood tests are needed during treatment), or as infrequently as monthly in patients interested in prevention. The average though, is usually once or twice a week. If you are interested in, or have any questions, please email or call the office.