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Official Protocol For I/V Chelation

Official Protocol For Administering Intravenous Chelation Therapy

Before chelation infusion therapy is started a detailed study should be made of the patient to ensure that this is an appropriate approach to the problem(s) of the individual.

A full medical case history and examination is the first prerequisite, including a comprehensive personal and family history detailing all aspects of previous health problems and current status. Questions relating to diet, habits, emotional status, exercise, stress levels and a detailed listing of symptoms is part of this. A full physical examination is also required, most notably of all aspects of the circulatory and respiratory systems.

An electrocardiogram and chest X­ray might be required as well as a number of blood tests. Exercise tolerance tests may be used to see just how the functioning of the heart, lungs and circulation responds to activity. A commonly used procedure, before chelation therapy is started, and of major importance in establishing a 'before' picture of circulatory efficiency, is the use of what is known as bi­directional Doppler (sound wave) examination.

This is a painless, non­invasive use of sound waves (ultrasonic) which is used to investigate six major arterial sites which relate to circulation to the brain, as well as eight sites which relate to circulation to the legs. The Doppler equipment gives readings which tell the doctor running the tests three important pieces of information at each site:

1. It shows whether there is any turbulence which could relate to breakaway deposits of plaque, etc., which could be involved in production of a stroke.

2. It checks for any signs of capillary hardening in the brain, often associated with memory loss and age­related brain changes.

3. The major arteries are assessed for obstructions to normal flow of blood which could relate to over­burdened heart function or deficient circulation to the legs.

This sound­wave testing takes about an hour and all findings are recorded on charts so that later tests can be compared. This is also an excellent way for the patient to appreciate visually the degree of current circulatory difficulty.

Use of thermographically (heat) sensitive film allows areas of the body which are not receiving their full circulatory servicing to be photographed as a record which can be compared with the same region after treatment.

Among other tests, an initial one is performed (not for people with diabetes) after overnight fasting (14 hours without food). This test is usually done around mid­morning, the last food (or coffee or sugar) having been consumed around 9 pm the previous night. The fasting blood test gives an accurate idea of cholesterol levels as well as other key markers. Periodic monitoring of blood levels of cholesterol and other elements (giving evidence of levels of blood fats, carbohydrates, whether or not there is anaemia, infection, immune system problems, liver or kidney dysfunction, etc.) is made during the chelation treatment which can last for some months, with two or three infusions per week.

Depending upon the condition of the patient a blood sample may be required before each treatment, or periodically.

A 24­hour sample is required for assessment of normal urinary output of creatinine, a key guide as to kidney status. A periodic assessment is made of the creatinine levels of the urine as the series of chelation treatments progress, but this does not require collection of 24­hour samples. As with blood testing, the frequency of urine testing during a series of chelation infusions will vary, depending on the nature of the problem being treated and the health of the patient.

If there is any evidence that the kidneys could not be expected to deal efficiently with the elimination of EDTA during infusion, then the treatment series would be delayed or stopped until this factor had been dealt with appropriately. As we will see in a description of important research by Doctors McDonagh, Rudolph and Cheraskin later in this chapter, kidney dysfunction is often capable of being normalized by EDTA chelation therapy

A computerized dietary analysis (based on the filling in of lengthy questionnaires) of what the patient eats is often required so that comprehensive dietary and supplementation advice can be given to the person being chelated, to complement the treatment.

In addition, saliva, sweat and faeces may need to be tested for a variety of reasons, including assessment of what the patient's current metabolic and nutrient status is, how well foods are being digested and absorbed, etc. Whether such tests are needed will depend upon the individual problems being dealt with.

This non­invasive and inexpensive method is also sometimes used to provide an accurate indication of heavy metal toxicity as well as to give some idea of the current mineral status of the body. The findings from this and the other tests allow the doctor in charge to decide just what balance of minerals should be added to the basic EDTA infusion solution in order to obtain the best results.

Once it has been established that there is a problem which could benefit from EDTA infusion, a series of treatments are scheduled, either two or three times per week. Most chelation centres treat patients in a group setting.

A large room with appropriate seating (usually comfortable recliners) is all that is needed (not unlike a hairdressing or beauty salon). There are several advantages to this approach:

1. The mutual support of people having the same procedure is reassuring and encouraging. There will almost always be someone present who has had a number of infusions and who can give a personal account of what to expect.

2. The costs can be reduced, since fewer supervisory staff are required if patients are grouped together in this way.

3. During the 3 1/2 hours of the infusion the patient can read, doze, chat, watch TV, listen to a pep talk on diet or exercise from a clinician (this is a truly 'captive audience').

The infusion itself involves the insertion into a vein (usually in the hand or forearm, but sometimes the lower leg) of a needle which is attached to the container (hung on an adjustable stand), from which is drip­fed around half a litre of fluid over the 3 1/2 hours' duration of each treatment. This liquid usually contains 2 to 3 grams of EDTA and whatever additional minerals the doctor has decided will best help achieve a balanced blood content.

EDTA mixture

Among the other substances often placed in solution with the EDTA are a complex of B vitamins, vitamin C, magnesium (extremely useful for cardiovascular health) and heparin (an anti­coagulant, enough of which is sometimes used just to prevent any clotting at the injection site). Cranton suggests (Cranton and Frackelton, 1982) that since magnesium is a natural calcium antagonist and also the ion least likely to be removed by EDTA (see Chapter 4), and that it is relatively deficient in many people with cardiovascular and circulatory problems, it should be supplied with the chelation process. He suggests that the best way to do this is to use magnesium­EDTA, which would provide an efficient delivery system and thereby increase magnesium stores in the body.

When the infusion is being performed, the arm is kept stable as a rule by being taped to a padded board which rests on a cushion for comfort. It is usually quite possible (although it is not encouraged) for the patient to move around freely during treatment (to visit the toilet, for example) as long as the mobile infusion is wheeled alongside.

The rate at which the EDTA solution is dripped into the bloodstream can be varied but usually it is at a rate of one drop per second.

As a general rule, two, but sometimes three, treatments are given each week, and a total of anything from 20 (for relatively mild problems) to 30 infusions in all comprise one complete series.

On a number of occasions (sometimes at each visit) blood and urine testing (as well as other tests) may be carried out to ensure that kidney and other functions are operating sufficiently well to cope with the EDTA detoxification. This is obviously more important in elderly patients or anyone with compromised kidney function. In some instances where a great deal of circulatory pathology exists, follow­up series of chelation infusions might be encouraged, with many people showing benefits after up to 100 infusions.

The EDTA is eliminated from the body, 95 per cent via the kidneys and 5 per cent via the bile, along with the toxic metals and free ionic calcium which it has locked on to in its transit through the circulatory system.

In hospital settings, EDTA infusions have in the past been given daily for up to five days, followed by a two­day rest period for the kidneys. This protocol is now discouraged by the American medical group with the most experience of chelation, the American Academy of Medical Preventics.

General toxicity

Walker and Gordon (1982) inform us that EDTA is far safer than aspirin, digoxin, tetracyclin, ethyl alcohol or the nicotine from two cigarettes, in equivalent therapeutic doses. EDTA is used in thousands of food products (it is in most canned foods) and its toxicity is known to be extremely low.

In assessing the relative toxicity of a substance a therapeutic index is established. Firstly, the amount of the substance which would prove lethal to half the animals in an experimental setting is discovered by the gruesome process of increasing their intake until half of them die. This is the LD­50 measurement (LD for lethal dose). When this amount is divided by the amount required for a therapeutic effect we end with a number which is the therapeutic index.

The LD­50 of EDTA is 2000 milligrams per kilo of body weight, whether taken orally or intravenously. In comparison aspirin has a toxicity equal to 558 milligrams per kilo of body weight. So in general there is no need for concern as to general toxicity with EDTA usage, whether by mouth (see Chapter 9) or directly into the blood.

Kidney toxicity

In the early 1950s several deaths occurred from nephrotoxicity after EDTA treatment. At that time the dosage used was around 10 grams per infusion, whereas the recommended dose now adays is 3 grams.

Halstead (1979) states:

The problem in EDTA nephrotoxicity is based upon two fundamental principles of toxicology: dosage and route of administration. Dosage is concerned with both the amount administered and the rate of administration, or the time period in which the EDTA is given.

It appears that toxicity for the kidneys may relate directly to too large a dose infused at too fast a rate. In general, if no more than 3 grams is infused in any 24­hour period (diluted with 500 ml sterile Lactated Ringer's solution or-except in the case of diabetes-5 per cent dextrose solution), with a 24­hour rest period between chelation infusions (2­3 per week) and if the infusion of these 3 grams (less than 50 milligrams per kilo of body weight) is timed to take around three hours, little if any danger exists of producing toxicity for the kidneys.

Indeed, research has shown that in general chelation therapy improves kidney function, particularly if any impairment to these vital organs relates to circulatory problems.

Improved kidney function after EDTA

McDonagh, Rudolph and Cheraskin (1982d) have investigated the alleged toxicity of EDTA in relation to kidney function and their results are worth some consideration.

They examined the results of treating 383 people with a variety of chronic degenerative disorders (primarily occlusive arterial disease) with EDTA chelation therapy (plus supportive multivitamin/mineral supplementation) for 50 days.

The measurement of the levels of creatinine in the blood is commonly used in medicine as a guide to kidney efficiency.

Creatinine is the end breakdown product of muscle activity which is cleared from the body by filtration through the normal kidney. The levels found in the bloodstream are known to correlate well with the rate and efficiency of clearance, giving a simple way of judging kidney function. The researchers made specific measurements of the levels of creatinine in the blood of these patients at the first visit (fasting levels) and then gave 10 infusions of 3 grams of EDTA in a solution of 1000 cc normal saline with an interval of five days between each infusion (supplementation was also given). After this the serum creatinine was again assessed.

They found that a very interesting balancing effect could be seen when the overall picture was revealed, very similar to that noted when cholesterol ratios were examined (see Chapter 4). Those people who initially had low levels of serum creatinine showed a very slight increase; those in the mid­range (normal?) showed no change and those above the mid­range of normal and actually with a creatinine excess (therefore indicating poor clearance by the kidneys) showed a drop towards normal.

Overall the total measurement showed an average decline in serum levels (indicating improved kidney function), but far more significant, according to the judgement of the researchers, is the homoeostatic effect in which ­ whether high or low to start with ­ a tendency towards the mid­range (between 0.5 and 1.7 milligrams/decilitre) is observed.

It seems that EDTA therapy may actually improve kidney function if it is applied slowly with normal dosages.

One exception
These researchers make note of one exceptional case amongst nearly 400 patients tested in this way, and the progression of events is worth noting as an example which highlights both the initial concerns which some patients might produce and the long­term benefits of chelation therapy.

This was an 86­year­old female in whom the initial measurement of creatinine was 1.9 mg/dl, which is regarded as abnormally high and therefore indicative of poor kidney function. After starting chelation every five days, a rise was seen in the creatinine levels by day 25 (fifth infusion) to a very unhealthy 3.5 mg/dl. As treatment progressed, it dropped to 2.8 mg/dl by day 60 and had dropped to 1.8 mg/dl by day 100, some time after the course of chelation therapy had finished.

As the researchers point out: 'this emphasizes the need to follow renal function during EDTA therapy, and, one might add, for a while after, as the benefits frequently are not fully manifest before about three months after treatment is over.

Special considerations: age, heavy metals or parathyroid deficiency

If the patient is very elderly, or has low parathyroid activity or is suffering from heavy metal toxicity which is damaging kidney tubules, treatment should be modified to use less EDTA less frequently (once weekly perhaps). Heavy metals damage the kidneys and too rapid infusion can overload them. Heavy metals most likely to produce kidney damage during infusion therapy (if this is done too rapidly, that is) are lead, aluminium, cadmium, mercury, nickel, copper and arsenic.

Renal function tests should always be performed before chelation therapy is started in which serum nitrogen (BUN) and serum creatinine is examined. In any case of significant renal impairment, lower dosage EDTA infusions should be used with extreme caution with suitable periods of rest between.

Too much calcium removed

If, through inexperience or error, there is too rapid an infusion (or too much EDTA used), levels of calcium in the blood can drop rapidly, resulting in cramps, tetany, convulsions, etc. An injection of calcium gluconate will swiftly control such abnormal reactions. This hypocalcaemia reaction is almost unheard of where the guidelines given above are followed as to dosage, speed of infusion and spread of treatments.

Inflammation of a vein

If an infusion into a vein is performed too rapidly, inflammation may occur (thrombophlebitis). This is unlikely in the extreme if guidelines as described above are followed concerning dilution of EDTA with Ringers solution or dextrose solution and slow infusion.

Should the needle carrying the infusion slip, a local soft tissue irritation may develop. This may best be treated with use of alternate hot and cold packs. Supplementation with antioxidant nutrients such as vitamins C and E (make sure of a good source) and the mineral selenium should protect against such an incident.

Care regarding insulin shock and hypoglycaemia

During EDTA infusion it is possible for blood glucose to drop, leading to insulin shock. This is more likely amongst diabetics in whom no dextrose solution should be used. Patients having EDTA infusions are advised to have a snack before or during the three hours plus treatment period. Walker and Gordon (1982) recommend the following strategy:

You should eat something before the three to four hour infusions, but not high­calcium­containing foods such as dairy products. Rather, eat adequate unrefined complex carbohydrates and avoid most sugars, including overripe bananas.

During an infusion they recommend eating fruit.

In diabetic individuals, using zinc­bound insulin involves a risk of too rapid a release of insulin, leading to hypoglycaemia and shock. A rapid introduction of sugar is needed in such an instance and a change in the form of insulin used before further EDTA infusions are tried. Most people with known diabetes find that with chelation therapy their requirement for insulin declines.

Congestive heart failure

If the heart is already unable to cope adequately with movement of fluids, and there is evidence of congestive heart failure (extreme shortness of breath, swollen ankles) and/or if digitalis­like medication is being taken, extreme care is needed over chelation infusions, since EDTA prevents digitalis working adequately. Sodium EDTA would appear to be undesirable in such people as it could increase the fluid retention tendency. However, Halstead is adamant that:

Na2 EDTA does not appear to have any significant deleterious effects in congestive heart patients since the sodium (Na2) is apparently excreted intact with the metal chelate. However, the use of 5 per cent dextrose and water is recommended in such cases.

Short­term side­effects

A number of variable side­effects have been observed with use of intravenous EDTA infusion, including the following:

• Headaches ­ which often relate to the same phenomenon discussed above, of low blood sugar. Eating before treatment, or during it, will usually prevent this possibility. It is reported that a common recommendation which prevents 'EDTA­headaches' is that a banana, not overripe, be eaten during the first hour of infusion.
• Diarrhoca ­ this unusual side­effect should be treated with rest and a bland diet with plenty of liquids for a day or so. Urinary frequency is common as kidney efficiency improves and a weight loss (from fluid excretion) of 3­5 pounds (1.3­2.2 kg) is common after an infusion if fluid retention was previously evident.
• Local skin irritation may result and is usually associated with a reduction in zinc and vitamin B6 (pyridoxine). For this reason supplementation of these nutrients is usually suggested during chelation therapy.
• Nausea or stomach upset may also be related to vitamin B6 deficiency in the less than one patient in 100 receiving chelation therapy who feels this side­effect. It is best treated by B6 supplementation, although short­term relief (up to eight hours) from nausea can be achieved by applying thumb pressure to a point two thumb­widths above the wrist crease on either forearm (acupuncture point P6) for a minute or so whenever the symptom is felt.
• Feeling faint may relate to a drop in blood pressure. It is common for those who start treatment with high blood pressure to see a return to more normal levels. If it were normal to start with, it could drop slightly as well as leading to feelings of faintness on standing after sitting or lying. Treatment is to rest for an hour or so when this happens, ideally with the feet slightly higher than the head. The amino acid tyrosine can safely be supplemented to help restore normal pressure levels if this symptom persists.
• Fever may develop in a very few people during the day after chelation therapy sessions (approximately one in 5000). Whoever is in charge of the treatment should be told, although the condition normally resolves on its own.
• Extreme fatigue may be felt in some people and this is usually the result of a general nutrient deficiency in minerals such as magnesium, zinc or potassium. Taking a potassium­rich supplement and/or the regular eating of potassium­rich foods is suggested before and during chelation (grapes, bananas, peaches, potato skins), as this mineral may be removed by the process itself.
• Pains in the joints are more likely where infusions are frequent (three weekly). An immediate reduction to once weekly is suggested, and also possibly a reduction in dosage of EDTA being used, if strong flu­like aches develop. The symptoms should pass fairly soon if these strategies are adopted.
• Cramps in the legs are not uncommon (one patient in 20), usually at night. The supplementation of magnesium (either by mouth or in the El)TA infusions) will usually prevent this happening. If it is added to the infusion this could be in the form of magnesium chloride or magnesium sulphate. Such additions also reduce the chance of local skin irritation at the site of the infusion.

Other minor side­effects have been reported in the many millions of chelation infusions already given, but all seem to vanish when the therapy is reduced or stopped. As Bruce Halstead states: 'The number of significant untoward reactions is probably less than in any other major therapeutic modality'

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