The use of chelation for the treatment of heart disease had been considered as bordering on quackery. Chelation started about a century ago, when it was used to treat metal poisoning, by administering a drug (“chelator”) which binds to the metal or minerals and this bound metal-EDTA complex is then expelled from the body by the kidney. Chelation has been scientifically proven to remove excess or toxic metals from the body.
Currently, the only “officially” approved used of chelation by the US Food and Drug Administration (FDA) is the administration of the chelator, calcium ethylenediaminetetraacetic acid (EDTA), for use in lead poisoning and other heavy metal poisoning, to remove the heavy metals before they damage the body .
For more than half a century, a similar agent, disodium EDTA, has been infused into patients by practitioners of alternative medicine to treat heart disease with reportedly good outcomes in case reports. However, in the early days when the dosage and administration of these agents were varied, complications including kidney problems arose resulting in the disparaging of chelation by mainstream medical organisations.
Despite this, large number of patients continued to undergo chelation eventually resulting in the eventual funding of a study in the USA by the National Center for Complementary and Alternative Medicine and the National Heart, Lung, and Blood Institute to investigate the medical effectiveness of chelation. This study, Trial to Assess Chelation Therapy (TACT), studied the safety and effectiveness of chelation for the treatment of patients aged 50 years and above who had a prior heart attack.
The placebo-controlled double blind study on more than 1700 patients showed that compared to those who were given placebo infusions, those who underwent chelation with disodium EDTA had an 18% decrease in “heart complications” (including death, recurrent heart attack, stroke, stenting or bypass, and hospitalization for heart disease), above and beyond the benefits of other proven treatments, including blood thinning and cholesterol lowering medication.
In the TACT study, some patients were also randomly assigned to take oral vitamins together with the EDTA infusions. This benefit was even more pronounced in this group who had EDTA infusions and oral vitamins, where the decrease in heart complications was 26% when compared with the placebo group.
Who can potentially benefit from chelation?
Subsequent subgroup analysis of the TACT study showed that the benefits of chelation were substantial in diabetics but those without diabetes did not show any significant benefit. In the study, diabetics made up about one third of study patients. For those with diabetes, the effects were very remarkable. There was a 41% decrease in the risk of any “heart complications”, including a 40% decrease in the risk of death from heart disease, reduced risk of nonfatal stroke, or nonfatal heart attack; a 52 percent reduction in recurrent heart attacks; and a 43 percent reduction in death from any cause over 5 years. Currently, there is no specific diabetic therapy which is able produce comparable benefits.
In the light of these outcomes, the US FDA reviewed the TACT in a positive light and have supported a TACT2 study to confirm these results. Recently, the American Heart Association had invited Dr Gervasio A. Lamas, the TACT study’s principal investigator and chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center to write in the highly regarded Circulation journal. Dr Lamas stated that “If patients with diabetes mellitus and a prior heart attack want chelation, I do not discourage them like I used to. And for high-risk patients in hospitals that offer chelation as a therapeutic choice like mine, I recommend it.”
Calcium and Diabetes
When computed tomography (CT) was used to scan heart arteries in the 1990s, it was viewed with scepticism. As more and more studies showed that calcium deposits in heart arteries was associated with increased severity of heart disease, CT scan was used with increasing frequency to measure the Coronary artery calcium or Calcium score. It has been observed that patients with diabetes mellitus have increased deposits of calcification in the walls of their arteries.
In the April 2012 Journal of the American College of Cardiology Cardiovascular Imaging, investigators of the MESA (Multi-Ethnic Study of Atherosclerosis) trial published data to demonstrate that those with diabetes mellitus have both a higher incidence and more progression of calcification of their heart arteries compared with non-diabetics.
The study also showed that those with progressive increase in calcification in heart arteries were more likely to develop future heart disease complications.
Statins and Calcium
Despite the known benefits of cholesterol lowering drugs, statins, in treatment of heart artery disease, the use of statins in diabetics have been ineffective in decreasing or slowing down the progressive calcification seen in heart arteries of diabetics. We do not fully understand the process of calcium deposits in the heart arteries and research studies have thrown up some surprises. Not only are statins ineffective in preventing calcification, but there is a possibility that the removal of cholesterol deposits from the arterial wall by statin use may trigger a reaction in the diverse cells present in the arterial wall resulting in production of additional “collagen-like” material which allows the calcium to deposit into.
Assessing the extent of calcification of the heart arteries by the use of CT scans of the heart arteries provides invaluable information on the risk of the individual and is highly recommended even in asymptomatic diabetic patients. It is proposed in the American College of Cardiology/American Heart Association guidelines that calcium score be used routinely in all asymptomatic diabetic patients >40 years of age.
CT scanning technology is advancing so rapidly that in the not too distant future, not only the CAC score but a 3 dimensional CT scan of the heart arteries can be performed with a radiation dose that is not much more than the radiation from a chest X-ray. This will be a boon for diabetics as it will be able to allow the detection of those who have progressive calcification and hence are at high risk of heart complications and will need more aggressive treatment.
Light at the end of the tunnel
The march of time has constantly reminded us that medicine is constantly evolving and the truths of today can become the fallacies of tomorrow and likewise the heresies of yesteryears can be the light of today. Ten years ago, it would have been considered heresy and one will be scorned by peers if one were to say that treatment to increase High Density Lipoprotein cholesterol (HDL-C) or “good” cholesterol was not beneficial, chelation can be very beneficial for diabetics with heart disease or CT scan of the heart arteries can provide a safer alternative to invasive tests of the heart.
Fast forward ten years to 2015 and there are at least 4 high profile major studies on treatment to increase HDL-C (AIM-HIGH, HPS-2 THRIVE, ILLUMINATE, Dal-OUTCOMES) which have shown no benefit in improving heart outcomes. A study that reported that some genetic mechanisms that raise HDL-C do not seem to decrease the risk of heart attacks was published in 2012 in the highly respected Lancet journal. Experts in cardiology now caution against the use of therapies that focus on increasing HDL-C. Likewise, chelation therapy which was considered quackery by many physicians a decade ago has now been shown by a double blind placebo controlled randomised trial to have significant benefits for diabetic patients with heart disease beyond current treatment. CT scan of heart arteries which was viewed with scepticism by many a decade ago is now considered an appropriate and useful diagnostic investigation by international cardiology organisations and is widely used in place of more expensive and invasive options.
Diabetics with heart disease who face the prospect of progressive calcification of their heart arteries which cannot be prevented by statins may perhaps finally be able to see light at the end of the tunnel through the most unexpected therapy – chelation. Chelation, which was previously considered as a “pariah” treatment, has produced the best outcomes for diabetics with heart disease and may be the answer to preventing progression of calcification in heart arteries.
Unlike most new drug treatments which are shown to have significant benefits, EDTA is not “owned” or supported by any major pharmaceutical company and its march into mainstream medicine will be purely on the basis of solid medical evidence. Hence, the success of chelation in medicine will be of major benefit to the man in the street with little benefit for the major pharmaceutical companies for this “no patent” treatment.