Anello Clinic

Over the past decade there has been enormous interest and support for complementary medical therapies by the general public. Some of these therapies are relatively new on the scene, some have been around for decades, others for hundreds and even thousands of years. One such therapy which has survived a rather rocky road after first touted as exciting and highly promising by traditional medical circles, then demoted to the realm of 'quackery' is making a comeback in Canada. Chelation therapy has been around for 40 years and yet it is still considered controversial. What is it? What is it's history? What testing has been done on it's use? What is it's mode of action? These are the question which will be dealt with in this article.

The term 'chelation' comes from the Greek word 'to claw'. A chelating agent is simply a molecule which will bind a metal and mineral. (In scientific language chelation is defined as the incorporation of a metal ion into a heterocyclic ring structure.) In the human body the hemoglobin molecule contains heme a chelating molecule which binds iron. In fact the process of chelation is essential in many human enzymatic reactions. There are a number of medically useful chelators. The most widely used is a synthetic amino acid called ethylene diamine tetraacetic acid, more commonly called EDTA. (Other chelating agents include DMSA and DMPS used specifically as mercury chelators; D-penicillamine and desferoxamine are used for iron overload.) EDTA was first discovered by a German-Swiss biochemist in the 1930's and was used in industrial processes to remove calcium from textile dyes thus preventing the colours from running together. It was also used to remove mineral deposits from machinery. Today one may see EDTA on many foods labels; it binds minerals in foods, preventing spoilage and keeping frozen vegetables green. In medical laboratories EDTA is used as an anticlotting agent because it binds calcium which is required for the clotting reaction.

In the 1950's with the rise of the automobile industry, many workers were exposed to excessive levels of lead in the workplace. Noting it's use in industry to remove metals and minerals, physicians started experimenting with EDTA to remove excessive lead. It worked. Even today, the standard treatment for lead toxicity is intravenous EDTA chelation therapy. Some patients being treated with EDTA chelation therapy for lead toxicity in the 1950's noticed that symptoms of exertional chest pain improved; others noted that leg pains which occurred with walking also improved. Certain physicians listened to their patients' reports and concluded that the EDTA being administered to treat the lead toxicity might also be helping the patients circulation. One of the earliest studies of EDTA in the treatment of hardening of the arteries was published in 1956 by Dr. N.E. Clarke and colleagues in the American Journal of Medical Science (1956:654). It was a small study of twenty patients in which they reported that nineteen improved in clinical criteria of angina brought on by physical activity. In six of the patients the ECG (electrocardiogram) tracing of the hearts electrical activity also improved. Dr. Clarke published a number of studies, including an editorial in the American Journal of Cardiology. These studies included hundreds of patients over a number of years. They reported 'the overall relief from the manifestations of occlusive vascular disease has been superior to that obtained with other methods...' They reported impressive improvement in patients with decreased circulation to the legs due to diseased arteries (the medical term for this is intermittent claudication), in patients with dizziness due to decreased circulation through the carotid arteries to the brain and in patients with heart disease. Clarke et al reported that patients with heart disease had 'impressive symptomatic relief in 87 percent of a large series of patients with angina pectoris, few recurrences of symptoms and a significant lowering of previously reported mortality rates.' . In 1964 in the journal Angiology (1964:15:379), researcher C.P Lamar reported significant improvements on a small number of patients including improvments in diabetic retinopathy (disease of small arteries in the retina due to diabetes). In a 1961 study in the British medical journal the Lancet it was reported that over 2,000 chelation treatments were performed without any major side effects. It's obvious from the quotes from these articles published in major medical journals that EDTA chelation therapy was seen as a very promising, effective, safe treatment for cardiovascular disease in the 1950's and early 1960's. Other studies showed that EDTA chelation lowered blood cholesterol levels. It was reported to be helpful in the metabolic disorders called porphyria and scleroderma. A study of 32 patients with rheumatoid arthritis demonstrated excellent improvement in 25 percent with a further 40 percent showing good improvement in arthritis symptoms. In the late 1960's, the patent for EDTA expired. Without the financial backing of the pharmaceutical industry, funding for research studies dried up. EDTA which was at first reported to be highly promising became an orphan drug and was relegated to the medical backwaters.

Thankfully a small group of physicians continued to treat patients and teach other physicians about chelation therapy. The initial protocol for using EDTA safely and effectively was further refined over the ensuing 30 years by the American College for the Advancement of Medicine. Today thousands of physicians in the United States and around the world are utilizing this protocol in treating heavy metal poisoning and as a complementary procedure for vascular diseases, rhumatoid arthritis, scleroderma and diabetes mellitus. Over two million people worldwide have undergone chelation therapy. In Holland Drs. Claus Hancke and Knut Flytlie studied 470 patients, of which 80 percent showed improvement; of the 92 patients that had been told they would require surgery for their condition, 82 ended up not requiring the surgery. Twenty four of these patients were told they would require their legs amputated because of severe arterial disease; their legs were saved with chelation. In Brazil similar studies on nearly 3000 patients showed that 90 percent of the them improved as measured by changes in their ability to walk, electrocardiograms and Doppler testing of blood flow to the legs. In a recent meta-analysis on over 24,000 patients treated with chelation therapy Chappell and Stahl found that 86 percent of these patients improved clinically and objectively (J. Advanc Med 1993:139). Not all studies on chelation therapy has been favourable. Two studies, one in Holland and the other in New Zeland came to the conclusion that chelation therapy was ineffective and these studies have been used by detractors as 'proof' that chelation therapy is useless. Yet when investigators have gone over these studies carefully, they point to serious problems in the design of these studies. In one study only smokers who continued to smoke were studied. Smokers are exposed to continued free radical activity and it is well known that they do not respond as well to treatment. Many chelation clinics will not accept smokers who persist to smoke. The Danish study was criticized by the Danish Committee on Scientific Dishonesty which pointed out that in spite of the obvious faults the study still showed that the treatment had some benefit. The New Zealand study compared one group given chelation therapy to a group not given chelation therapy but given oral vitamins. Both groups improved. Yet the study showed that the group receiving chelation therapy did much better than the 'control' group. The conclusion of the study that 'chelation therapy is of no benefit compared to placebo'. The New Zealand Medical Journal where the study was reported accepted a correction to the original study that showed the statistics were flawed and the control group was really a treatment group. Unfortunately both studies have damaged the reputation of chelation therapy in the minds of those already made up that this is a 'useless treatment'. Of note to those with a more open mind is that the medical textbook Cardiovascular Drug Therapy published in 1996 contains a chapter by Martin Rubin PhD on magnesium-EDTA chelation therapy which states in ' The complex pathophysiologic cascade of the development of atherosclerosis....EDTA chelation therapy has an implicit advantage in that it can favorably influence all facets of the disease development.' Chelation therapy, in spite of controversies has persisted and has been helpful as a complementary therapy, in my opinion, simply because it works and is safe.

Before a person is given chelation therapy a history, physical examination and laboratory analysis is undertaken. The persons overall health status and nutrient deficiencies needs to be assessed. Because the therapy will be promoting the removal of toxic metals that have been stored in tissues it is important that the body's metabolic machinery be as optimal as possible. Vitamin B12 levels can be less than optimal after the 5th decade of life and need to optimized. Magnesium and zinc levels are important in many detoxification reactions in the body and these need to be checked and optimized. Increased levels of homocystein and iron can contribute to dangerous free radical production in the body. Inflammatory rates can also be monitored. Laboratory analysis of kidney function before and during the course of treatment with chelation is imperative and determines the dose and frequency of the intravenous chelation treatments. Heavy metals which are removed by the chelation process must be excreted through the kidneys. Early on in the development of chelation therapy a number of patients died because the chelation solution was too concentrated or too frequent. Only health practitioners skilled in the administration of this therapy should be administering it in order to first do no harm. Typically an intravenous solution of EDTA, magnesium, calcium, thiamine, riboflavin, niacinamide, pantothenic acid, pyridoxine and vitamin C is prepared individually for the patient and administered over one and a half hours to four hours depending on the procedure and the patients biochemistry. Other nutrients may be administered intravenously including glutathione, DMPS, procaine and trace minerals. The person will also be required to take trace minerals, vitamins and certain nutrients in an oral supplementation program depending on their individual clinical situation. Chelation therapy is not covered by OHIP, nor by most insurance plans. It costs between $2,000 and $5,000 for the initial 20 to 30 treatment and then it is usually recommended that a maintenance program be followed. This out of pocket expense may become a thing of the past if chelation therapy becomes covered by Canadian health insurance as it is in England by the National Health Service.

One caveat needs to be mentioned here. Chelation therapy is not a 'magic bullet' which will undo decades of damage in the body. Unhealthy lifestyle choices must also be changed. Dietary changes, physical exercise and mind-body influences, are an important part of any program to prevent and reverse cardiovascular disease..

There are a number of oral chelation programs which have been around for a number of years. Many people have found them very helpful. These supplement programs include high doses of antioxidants, herbs such as hawthorn which influence the heart and EDTA. The typical dosage of EDTA in these programs are about 250mg. It is well known that 10 to 15% of this oral EDTA will be absorbed from the gastrointestinal tract. Compare this to the 1500 to 3000 mg which is infused directly intravenously in an intravenous EDTA chelation program and one can understand the difference between the two. Oral EDTA is most helpful as an addition to the more effective intravenous program.

There is some talk of a new type of EDTA which will be better absorbed from the GI tract. Once this is availble studies will likely be undertaken to asses its effectiveness as an oral chelator. Another new development is a rectal suppository which contains similar amounts of EDTA as an intravenous solution. The mucus lining of the rectum has long been known to absorb medication administered either as a suppository or in solution format. The advantage of this method is that you do not have to go to a physician to have it administered and it is about half the price of an intravenous solution. The disadvantage is the route of administration. I am not aware of any studies completed as yet on its effectiveness. A note of caution would be wisely heeded here. A person pursuing this option should do so with medical supervision because of the possibility of kidney damage if the dose or frequency is too much for their kidneys to handle. Also remember that chelation therapy has been safe because it is well supervised by a health practitioner skillfull in its administration.

Another caveat. For people with severe blockages of coronary arteries, coronary artery bypass surgery or angioplasty can be a life saver. In this situation, after surgery, patients may find that chelation therapy helps to maintain the bypass, as well as improve circulation to other parts of the body.

As I mentioned at the beginning of the article a grassroots movement has allowed complementary medicine to become more open and accepted. The Ontario legislature passed a private member's bill put forth by Liberal MPP Monte Kwinter in 2000 . Bill 2 amends the Medicine Act and states that doctors shall not be found guilty of professional misconduct or incompetence 'solely' for practicing an alternative therapy unless there is evidence to prove it is more risky than the conventional practice. The College of Physicians and Surgeons of Ontario which had previously banned chelation therapy for angina now classifies it as a form of alternative medicine.

Those of us in the 'boomer' generation are looking for ways to maintain health and prevent disease. Dr. Linus Pauling said 'Chelation therapy is far safer and much less expensive than surgical treatment of atherosclerosis. Chelation therapy might eliminate the need for bypass surgery and is equally valid when used as a preventive treatment.' Prevention of heart disease and atherosclerosis through healthy lifestyle choices and when appropriate with modalities like chelation therapy is helping to stem the tide of premature cardiovascular death.

Some Commonly Asked Questions

How often is Chelation therapy given?
Chelation therapy is a course of treatments consisting of 20 to 30 treatments and then scheduled maintenance treatments. It usually takes 20 to 30 treatments for there to be a demonstrable clinical benefit for people with arterial blockages. the first 6 treatments are usually twice weekly or weekly, after which the frequency of treatments decreases. Maintenance is usually one treatment every 3 to 4 months. For preventive purposes the treatments are given less frequently, monthly being the average frequency. The numbers of treatments and frequency depends upon the persons individual circumstance.

What are the risks or side effects of Chelation Therapy?
There may be minor discomfort at the site where the needle enters the vein. There may be a drop in blood pressure or blood sugar causing dizziness, muscle cramps or sweating. It is advisable to eat before a chelation session. If you are prone to blood sugar problems please bring a snack with you. Juice and water is encouraged during the chelation session to avoid these side effects.

What other factors are considered in your programme?
Diet, lifestyle and mind-body influences are also important. You are encouraged to attend the 'Journey towards Wellness' series which deals with changes in diet and nutritional supplements to encourage healing. Physical exercise is important. Starting with 20 minutes of walking daily (or using a stationary bike or treadmill) and increasing to 45 minutes at least three times a week helps improve circulation in the body. Of great importance is to eliminate the use of tobacco in all forms. If you would like help with this please ask and we will assist you in whatever way we can.

Plaque reduction versus contents of plaque and the functioning of arterial wall.
Do not get fixated on the size of the plaque and the percentage of blockage to the arterial wall. The contents of the plaque and the functioning of the arterial wall are very important. Studies in the recent past have called to question the Regression paradox. These studies show that large reductions in heart attacks and anginal pain, 30% to 80% were seen with small reductions of 1% to 2% of the amount of blockage in the arterial wall. Contrary to popular belief, most heart attacks are not caused by blockages of more that 75%, but by blockages of less than 60%. Treatments that modify the nature of the plaque and improve the functioning of the arterial wall are of great importance. Thus diet, nutritional therapy, lifestyle changes and chelation therapy help in removing toxic elements in the arterial wall and thus improve functioning. This is why many patients get significant improvement without major reductions in the percentage of arterial blockage. Improvement in your quality of life is our primary goal.

New discoveries in the causes of atherosclerosis.
Recent studies are showing that there are other causative agents which need to be dealt with in specific persons. These may necessitate changes in the intravenous and oral programmes which are instituted.

These are:
1. certain infectious agents such as chlamydia, H. pylori, Herpes, dental bacteria.
2. elevated levels of the amino acid Homocysteine.

Is Chelation Therapy for you?
Only you can make this determination. Please consider the information in this packet carefully. Talk with others who share this dilemma. Feel free to contact others who have undergone chelation therapy. You may come in during the chelation hours and talk with people undergoing the programme. Most people come to chelation after being recommended by a person who has successfully received results in a chelation programme.

What do I do next if I decide to start chelation?
Fill out the patient questionairre.

Call the office and set up an appointment for a chelation assessment. This will include a medical history and physical examination. A requisition for laboratory testing will be given to you at this appointment. Please bring the completed questionairre, the consent form and a list your current drugs and nutritional supplements with you to your chelation assessment appointment. At that time an appointment for your first chelation treatment will be made.

Thank you.

Dr. Francesco Anello
401 Laurel Street., Cambridge 519 653 3731

I, ___________________________________ understand that Chelation Therapy is considered a Complementary Medical Treatment and is thus not covered by the OHIP plan. I understand that Chelation therapy with EDTA is an 'off label' use of EDTA.

I agree to follow all medical therapies as prescribed by my own physician or cardiologist and to discuss any changes with my physicians. As with other medical and surgical therapies, I understand there is no guarantee as to the success of chelation therapy.

I have done one or more of the following to educate myself as to chelation therapy:

_____ I have attended the Chelation information session.

_____ I have read over the information provided.

_____ I have attended a previous physician for chelation therapy and would like to attend Dr. Anello for continuation.

_____other information

sources____________________________________

_____________________________________________________________.

Name_______________________________________

Date________________

Sign_____________________________________________

CHELATION THERAPY

DO'S

1. Do drink plenty of water.

Drink 2 big glasses an hour before your chelation treatment.

Drink 6 to 8 glasses of water daily.

2. Do Eat a well balanced meal befor coming in for your treatment.

Please bring a snack (fruit or sandwich) if you experience blood sugar problems (eg.diabetes).

3. Do wear loose fitting sleeves.

No restrictive sleeves. This makes it easier to administer the iv.

4. Plan to be at the clinic 2 to 3 hours.

5. Let the nurse know if you are experiening any discomfort at the iv site.

DON'TS

1. Don't drink any caffeinated beverages especially coffee and tea. Caffeine makes it more difficult to start your i.v.

2. Don't drink milk or take vitamin supplements with calcium on the day of your treatment.

3. Don't exercise before your treatment because you dehydrate while exercising, making it more difficult to start your i.v.

Don't exercise for at least 2 hours after the chelation because your blood sugar may drop rapidly.

4. Don't cross your legs during your treatment because it cuts off circulation to your feet and toes.

IF YOU EXPERIENCE ANY PROBLEMS OR HAVE ANY QUESTIONS PLEASE LET US KNOW.