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EDTA Chelation Study
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EDTA Chelation Study

I've heard of some doctors having success using EDTA chelation to treat heart disease. Also, is there a study of this treatment ongoing by the national institute of health? Any info on this treatment or results of the study?
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63984_tn?1385441539
I'm curious what doctors have had success using EDTA chelation to treat heart disease, and I'm curious what you are refering to as the national institute of health?  In the area where I live, there has been an interesting lawsuit where a naturopathic doctor has been involved in a lawsuit because of the death of two patients he was treating with this process.
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Avatar_m_tn
Info at the following link regarding the study:

http://nccam.nih.gov/news/2002/chelation/pressrelease.htm

The study is government funded. I assume drug companies won't fund as there's no financial incentive for them to do so.
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214864_tn?1229718839
Yes, there is a clinical trial ongoing to determine if IV chelation helps with coronary artery disease. I am really mad because I have emailed so many that are contacts for this trial and have to date received no information. The trial began in 2002 - 2003 and was supposed to end this year I think.

I also think that Ohio State university had the "lead" in this test and I know for a fact that the Cleveland Clinic, along with many other hospitals are participating.

It is almost like a conspiracy to withhold data or evidence. I have found no news whatsoever coming from the trial, as far as from medical advances type media/sources, which I am a member of more than a few.

There is an association of real MDs that are using intravenous chelation NOW. They report great success and train other physicians and sorry to say, but naturopathic doctors also how to safely perform this procedure. Vitamins and other minerals have to be given in conjunction the treatment, because iv chelation removes them.

I am not speaking of the "snake oil" pills that are on the internet now. They are not absorbed and are of no consequence, other than to remove money from your pocket.

While those of us die from CAD, these wienies lay around on their info. It is a disgrace. Someone should wake at dawn and ask a Cleveland Clinic doctor about this government trial and why all of the secrecy!!!

You can receive this treatment now, if you want to pay around $6k out of your pocket. The only qualified professionals even close to me are the naturopaths, and I don't trust them for this treatment.

I once considered that medical insurance companies were behind this secrecy, but why would they block a successful treatment that prevents heart attacks and strokes? Could it be that doctors, insurance companies, pharmaceutical companies and maybe hospital administrators have all come together to try to stop this? Way too sinister of thinking on my part, surely. You have to be paranoid to believe this could be true.....

The thing is that iv chelation (keelation) with EDTA has been approved for decades for heavy metal poisoning, such as lead and mercury. It is known to remove these metals from the blood.

Many, many cardiologist have sworn to the effectiveness of iv chelation for CAD, starting a long time ago.

Good luck,

Jack
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Avatar_m_tn
Hello Jack,
Just back from doing more stent work at CCF and tend to believe your stance on Chelation. I asked my cardio about it and was just briefly told that there were no positive results so far and he did not seem a bit interested. After 2 CABGs and several stent implants I too am interested in a genuine chelation treatment.
Hope alls well wiyh you
ChrisR
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214864_tn?1229718839
Hello Chris :)

Good to hear from you. So, you ask your doc specifically about this clinical trial? Thanks for this information. Yes, you are a/the poster boy for this treatment! There are many of us not as brave as you.....You my friend have walked through hell to survive.

Sometimes I do not know if it is worth fighting anymore. I live so far away from any hospital. It is such a hassle to just have a bad "spell" with angina where you go to the ER and have a cardiac cath only to be told your blockage is still to small to stent, which around here and across the nation is any blockage <70 %. I can witness to that; 6 stents and Rotational Arthectomy once, while I have had 11 cardiac caths. It gets old.

What I cannot understand is this belief in IV Chelation for CAD by many cardiologist and doubt by others.

I failed to mention above, I think, that insurance doesn't cover this already available treatment, because it has not been approved by the FDA. I also failed to mention that IV Chelation for heavy metal poisoning, has been approved by the FDA for decades. (I just said it was approved)

If this clinical trial results in IV Chelation helping some and not helping others; then I think it should be approved as long as it does no harm to those not benefited.

I plan to look up this association of medical doctors that are treating CAD patients with this procedure and will post the name of it here.

Calcium; big problem in the arteries for many. Yet if it forms a layer over unstable plaque, the plaque becomes stable, which can help prevent a certain type of mi. What does EDTA do to calcium after receiving all of the treatments standard for $6k. Also the ingredients of soft plaque are known from thousands of autopsies. What does EDTA do to this soft plaque? Why does it take so long to come up with results? I was under the impression that this trial was fully funded by the NIH, but maybe not?

Maybe the different types of blockages are responding differently to the treatment.

Those of us whose lives are being threatened and made miserable and painful by CAD, are very desperate. Many of us have had more than one mi. I think "awareness" of IV Chelation and it's potential by those with CAD, will help all of us. I thank Al321 for this post and thread, which I hope I have not hijacked......

I hope that you are as well as can be Chris :)

Jack
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Avatar_m_tn
I don't know the full merits of EDTA Chelation and the treatment of heart disease. However, I gotta believe there's some benefit to the treatment based on the number of Docs' promoting it. That being said, the medical community needs to do a legitimate study of the procedure and not just write it off. Hopefully, the NIH study will be legit and shed some light on the treatment.

alan      
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214864_tn?1229718839
Alan the link you provided I used and found a lot of disturbing news. I googled Mount Sinai Medical Center of Miami, where the doctor in charge, Dr. Lamas was doing his research.

This is only one small part of the article written on August 8th this year:


COVER STORY

Turmoil at Mount Sinai Medical Center


'GREAT LOSS'

The three acknowledged that while Sonenreich has made some good additions to the medical staff, there have also been some major defections, the biggest of which was Tony Lamas, a cardiologist who was director of academic affairs and cardiovascular research, who left several months ago for the University of Miami.

The three called Lamas' leaving a ''great loss.'' Lamas did not return a phone call seeking comment.e three acknowledged that while Sonenreich has made some good additions to the medical staff, there have also been some major defections, the biggest of which was Tony Lamas, a cardiologist who was director of academic affairs and cardiovascular research, who left several months ago for the University of Miami.

The three called Lamas' leaving a ''great loss.'' Lamas did not return a phone call seeking comment.

http://www.miamiherald.com/business/story/655487.html

--------------------------------------------------------------------------------------------

The hospital was also accused of using grant money to pay ordinary debt. The hospital spokesman more or less said that this was legal.

This may be one of the reasons for the delay in medical information from the clinical trial.
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214864_tn?1229718839
Enrollment Stopped in NIH-Funded Trial Studying Chelation Therapy for Treatment of CAD

September 25, 2008 (updated September 26, 2008) (Miami, FL) — Enrollment into the Trial to Assess Chelation Therapy (TACT), a five-year, $30-million National Institutes of Health (NIH)--funded clinical study, has been stopped.

"The investigators and institutions performing the trial, in conjunction with their institutional review boards [IRBs], have temporarily and voluntarily suspended enrollment of new participants in the study," Susan Dambrauskas, a media officer at the National Heart, Lung, and Blood Institute (NHLBI), a cosponsor of the study, wrote in an email to heartwire.

The American College for Advancement in Medicine (ACAM), an organization that promotes findings and emerging procedures in complementary, alternative, and integrative medicine, issued a statement about the stoppage, but with it raised the possibility of wrongful conduct [1].

According to the statement, ACAM supports the NIH's decision to suspend patient accrual of TACT "until allegations of impropriety can be proven false." It goes on to state the allegations are "of a political nature" before calling for a swift end to the moratorium and resumption of the trial.

Speaking with heartwire, lead TACT investigator Dr Gervasio Lamas (University of Miami Miller School of Medicine, FL) said the Office for Human Research Protections (OHRP) received a complaint from an outside party about the consent process for patient enrollment in the trial. There were concerns raised that the consent form was incomplete, as well as safety concerns raised about the therapy, Asked for specifics, Lamas would not disclose the exact nature of the complaint, saying the issue is currently under review with the IRBs as requested by the OHRP.

"If the OHRP has these questions, we need to really look at everything in the most serious way possible," said Lamas. "While we do that and while we consult with our own IRB regarding the consent form, it would be best to temporarily stop enrolling new patients. The deliberation is ongoing. We're working with the University of Miami IRB, which is the parent IRB for the study, and we expect an answer about the study as it's designed."

TACT: A Controversial Study Called Wasteful, Pointless, and Dangerous
TACT is a randomized, double-blind, placebo-controlled study evaluating the efficacy of ethylene-diamine-tetra-acetic acid (EDTA) chelation therapy in the treatment of coronary artery disease. Patients 50 years of age and older who have had a prior MI have been randomly assigned to receive 40 infusions of the standard chelation solution or placebo.

The primary end point of the trial is a composite of all-cause mortality, MI, stroke, hospitalization for angina, and hospitalization for congestive heart failure. Enrollment was estimated at around 2000 patients, and the trial was to be completed in July 2009. So far, 1500 patients have been enrolled and 22 000 injections of EDTA been given.

There is skepticism, however, in the medical community about the safety and efficacy of chelation therapy. While TACT was designed to definitively answer the question about the potential benefit of using chelation to treat coronary artery disease, the trial itself has become a lightning rod for criticism.

In a peer-reviewed article appearing May 13, 2008 in the Medscape Journal of Medicine [2], Dr Kimball Atwood (Newton-Wellesley Hospital, MA) and colleagues wrote: "The TACT is pointless, dangerous, unethical, and a waste of public funds. It should be stopped immediately and permanently, and its origin and nature subjected to an independent, comprehensive inquiry."

In the article, Atwood, who is an associate editor of the Scientific Review of Alternative Medicine, writes that chelation poses risks for patients and that the evidence against its use should disqualify it from further clinical trials. Atwood said the trial exists only because political pressure willed it into existence.

The review goes on to state that the application for the trial misrepresented previous data and concealed evidence of risks, as well as lacked precautions to minimize that risk. The consent form, according to Atwood et al, reflects these shortcomings. Moreover, they say, the trial is flawed because the consent form fails to disclose financial information--particularly, that some investigators profit from chelation therapy.

"There is little basis for predicting that the TACT will yield a reliable or definitive result and even less for predicting a favorable effect on clinical practice," according to Atwood and colleagues. "Numerous coinvestigators are unfit to care for subjects in a human trial or to submit trustworthy information to the NIH."

Lamas said the investigators are sensitive to the criticisms and take the issues raised by the Medscape Journal of Medicine article seriously. When the review was published, the TACT investigators convened several conference calls to discuss the issues raised but felt there was no need to make any changes to the study or the consent form and continued with the trial. After the issue went to the OHRP, they decided to voluntarily suspend enrollment to address these concerns for a second time.

"All of us take it very seriously and if our IRB says the consent form has to change, it will change," said Lamas. The data safety and monitoring board, he added, last met in April 2008, a point when approximately 20 000 active-therapy infusions had been given, and no safety concerns were raised.
"When you get a respected federal agency involved, you really need to step back and say, 'Am I really providing the best patient protection and patient information that I can?' " said Lamas. "And I'm happy to do that. The purpose of this is never to carry out research in a way where research is not valid or people are unhappy. The primary purpose in any of these research studies has to be to maintain patient safety."
Chelation therapy has been used since 1955 for the treatment of coronary artery disease. Agents such as EDTA, which bind metals and are approved by the FDA to treat heavy-metal poisoning, are given intravenously to decalcify atherosclerotic plaque. Proponents of the therapy, led by ACAM, which has issued a protocol for chelation therapy, reason that this therapy may alter plaque morphology and volume or improve endothelial function.
The National Center for Complementary and Alternative Medicine (NCCAM) is also a study sponsor.
The Medscape Journal of Medicine is an open-access peer-reviewed general medical journal available on Medscape. Medscape is owned by WebMD, which also owns theheart.org.
American College for Advancement in Medicine. ACAM supports NIH decision to suspend TACT trial [press release]. September 3, 2008. Available at: www.acamnet.org
Atwood KC, Woeckner E, Baratz RS, Sampson WI. Why the NIH Trial to Assess Chelation Therapy (TACT) should be abandoned. Medscape J Med 2008; 10:115. Abstract
The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals
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Avatar_m_tn
i would like to add to the info about chelation therapy. a number of years ago i went to mexico to receive iv treatment of chelation therapy for multiple sclorosis...VERY SUCCESSFUL..found more flexability, strengh, etc. now i have a heart condition and living in Panama where the chelation therapy is by suppositorys..i have been on that for a few weeks and have found GREAT imrovment in the chest pain, etc. i strongly advise whoever is interested in chelation therapy to take advantage of this successful protocal...al
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Avatar_f_tn
I take chelation capsules everyday. Learned about them through the Amish. My mom had high blood pressure and after one month on chelation is is back to normal. My father also has had great results. I got mine be googling oral chelation and found the health resourses group to be very helpful. 3 weeks on it myself now and the blood pressure has improved.
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Avatar_m_tn
I'd be interested in knowing the name of the assn. of drs. who use chelation.
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976897_tn?1379171202
It is also clear how a patient can believe in a cure so much that he/she will actually believe an improvement has taken place. I have seen so many studies where placebo
replacements have produced dramatic results. When a patient beleives a drug is working
for them, of course their blood pressure will improve with the sheer relief. I have seen
a small study where people were given sugar balls claimed to be sleep disorder cures.
Within two weeks, every single person seemed to sleep much better.
Good hard physical evidence is required with regards to chelation. How about a before/after set of coronary artery images for patients as proof. To rely on someone
simply saying they feel better is not scientific enough.
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Avatar_m_tn
Mexico! i'm all for it. I live in Guatemala. Please say what your heart condition is. Mine is 'suspected' triple block of as yet unknown degree. There's no way I can pay a bypass.Meantime un millón por la buena noticia
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Avatar_m_tn
Here's link for what is posted on am. heart assn. website (dated Sept. 20th of this year) about trials they say are still ongoing on Chelation - to be completed in 2010 - www.americanheart.org/presenter.jhtml?identifier=4493
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Avatar_m_tn
HAI FRIENDS
ME A CARDIOLOGIST IN INDIA AND INVOLVED WITH A CENTRE WITH CARTIGRAM AND CHELATION THERAPHY

HERE EVERYTHING UNDER ACAM PROTOCOL AND ALL OUR PATIENTS WERE CONSULTED BY ME BEFORE STARTING TREATMENT AND IF NAY PROBLEM LIKE RENAL OR LIVER WE CANCEL THE THERAPHY AND ADVISE NEPHRO OR GASTROENTEROLOGIST OPININON

HERE MOST OF MY PATIENTS ARE DOING WELL AND ONE OF MY PATIENT HIS LV FUNCTION BECAME NORMAL WITH INTENSE MEDICAL MANAGEMENT WITH ADJUVANT CHELATION THERAPHY

ANOTHER FROM MUMBAI CLEARED OFF FROM HIS VARIXOSE ULCER AND CELLULITIS ; ME ALSO AMZED BY OUR CHELATION CONSULATANT

SO WITH GOOD CENTRE WITH CARDIOLOGIST BACKUP AND REGULAR MONITORING PATIENTS ARE DOING WELL

AND WE DO POST CHELATION CARTOGRAM FOR EVALUATION

MAY BE STUDIES TO COME FOR APPROVAL LATER


DR.MOHAN- MBBS DIP CARD
CARDIOLOGIST
INDIA
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976897_tn?1379171202
Perhaps you may be able to explain how you see the dangers associated with chelation which most cardiologists show concern about. It is generally felt that hardened plaque forms a protective cap over the softer plaque, preventing it from travelling into smaller vessels and blocking them. If you remove the calcium during chelation therapy it is believed that the hard plaque will break down, exposing this soft plaque, possibly causing eruption. Doctors who believe in chelation state that this gives the body time to remove the soft plaque in a safe way, mostly using HDL lipids. However it is felt by most Doctors that this is too much of a risk and offers a way for more soft plaque to accumulate. Obviously chelation will not remove fat, so can you give us information regarding what you have observed in patients with atherosclerosis, pre treatment, during and post. Mainly what happens to the plaque, both hard and soft.
Many thanks
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159619_tn?1318997813
From the AHA;

EDTA isn’t totally safe as a drug. There’s a real danger of kidney failure. (renal tubular necrosis). EDTA can also cause bone marrow depression, shock, low blood pressure (hypotension), convulsions, disturbances of regular heart rhythm (cardiac arrhythmias), allergic-type reactions and respiratory arrest.    
In fact, a number of deaths in the United States have been linked with chelation therapy. Also, some people are on dialysis because of kidney failure caused, at least in part, by chelation therapy.

The American Heart Association is concerned that some people who rely on this therapy may delay undergoing proven therapies like drugs or surgery until it’s too late. This is the added danger of relying on an unproven "miracle cure."

Clearly, people who choose chelation therapy are risking more than money.

Also, a recent study of chelation therapy, using currently approved scientific methodology, was done on people with intermittent claudication. (This is peripheral artery disease [fatty buildups] in leg arteries.) This study found that EDTA chelation therapy was no more effective than a placebo (sugar pill).

Finally, a recent study entitled "Chelation therapy for ischemic heart disease” was published in the Journal of the American Medical Association (JAMA 2002;287:481-486). The authors followed 84 patients for 27 weeks. All of the patients had coronary artery disease. One-half of the patients received intravenous chelation therapy during the study period and the other one-half received intravenous placebo (fluid with no drug). Neither the physicians nor the patients knew whether they were receiving chelation or placebo. Patients were given exercise tests to see how long they could exercise before their electrocardiogram (ECG) showed changes indicating ischemia. They also answered quality-of-life questionnaires. At the end of the 27 weeks, the patients who received chelation were no better than the patients who received placebo. The authors concluded that "Based on exercise time to ischemia, exercise capacity and quality-of-life measurements, there is no evidence to support a beneficial effect of chelation therapy in patients with ischemic heart disease, stable angina, and a positive treadmill test for ischemia."

Thus, there’s still no scientific evidence that demonstrates any benefit from chelation therapy.

The American Heart Association’s Clinical Science Committee has reviewed the available literature on the use of chelation (EDTA) in the treatment of arteriosclerotic heart or blood vessel disease and finds no scientific evidence to demonstrate any benefit of this form of therapy. Furthermore, employment of this form of unproven treatment may deprive patients of the well-established benefits attendant to the many other valuable methods of treating these diseases.

What others say;

Food and Drug Administration:
In the absence of evidence of safety and effectiveness, the use of this treatment for atherosclerosis is investigational. To date, no physician or sponsor has filed a plan or protocol to study its (EDTA’s) use in such treatment.

No party has ever provided us with an organized submission attempting to show that it is an effective therapy in atherosclerosis; instead, we have been handed unorganized data without any attempt to describe a formal study.

Under the circumstances, we have had no choice but to attempt to prevent improper promotion of the drug and to point out its unproven status.

American College of Physicians:
Chelation therapy with EDTA has been used in the treatment and prevention of atherosclerosis. Because of the risk of severe renal (kidney) toxicity and lack of objective evidence suggesting therapeutic benefit from EDTA therapy … such therapy should be regarded as investigational and (should be) conducted under carefully controlled conditions in an academic institution by experienced investigators.

National Heart, Lung, and Blood Institute, National Institutes of Health:
There is no reason to expect benefit from chelation in the management of arteriosclerosis. More importantly, there has been no scientific evidence of such benefit — and there is scientific evidence of no benefit.

American Medical Association:
The AMA believes that chelation therapy for atherosclerosis is an experimental process without proven efficacy. They have also reaffirmed their 1984 House of Delegates Resolution stating:

"…there is no scientific documentation that the use of chelation therapy is effective in the treatment of cardiovascular disease, atherosclerosis, rheumatoid arthritis, and cancer;

"…if chelation therapy is to be considered a useful medical treatment for anything other than heavy metal poisoning, hypercalcemia, or digitalis toxicity, it is the responsibility of its proponents to (a) conduct properly controlled scientific studies, (b) adhere to Food and Drug Administration (FDA) guidelines for the investigation of drugs, and (c) disseminate results of scientific studies in the usually accepted channels."

American College of Cardiology:
There is insufficient scientific evidence to justify the application of chelation therapy for atherosclerosis on a clinical basis. At the present time, therefore, chelation therapy should be applied only under an investigational protocol.

Good enough for me,

Jon
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Avatar_m_tn
I have seen good clinical improvement in patients with CAD in terms ofreduction of symptoms like exercise tolerance. Dr. M.M. Neema
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976897_tn?1379171202
can you give a link to where you got this statement please
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