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Scientific Analysis
The following is a summary of the studies published on the
use of chelation therapy for the treatment of artherosclerotic heart disease and peripheral vascular disease.
Clarke, Clarke, and Mosher (1956) reported that symptoms of angina
pectoris improved in 19 of 20 patients with known CAD or PVD. The
patients were treated with a standard protocol of 5g of EDTA in 500 mL if normal
saline or 5% glucose over a four hour period. At total of 12 - 20
treatments were given in a two to three week timeframe. The importance of
this study is that it established that EDTA effectively chelates calcium at
physiologic pH and led the researchers to believe that EDTA could act on
the calcium in artherosclerotic plaques to effect their breakdown.
Kitchell (1963) conducted the first clinical trials on EDTA in the treatment
of heart disease. 28 patients with angina were given 20 EDTA
treatments. In addition, 9 patients were included in a double-blind,
cross-over study. After 18 months, out the 28 patients studied 46%
of patients reported subjective improvement, 22% reported no improvement, 7%
stated that they felt worse, and 25% were dead. In the double-blind study,
4 patients were treated with EDTA; 2 of the 4 stated that their condition
improved after three months. The conclusion by Kitchell was that EDTA was
not useful in treating heart disease.
Guldager conducted a randomized placebo-controlled, double-blind study
of the efficacy of EDTA in heart and peripheral vascular disease. 153
patients were randomized to receive 20 EDTA infusions over 5 to 9 weeks using
the protocol established by Clarke et al. The study used pain free walking
distance and maximum walking distance as markers of improvement. It was
determined there no difference between the placebo and treatment groups.
There are several case report series in the medical literature, the most
commonly referred to being the one conducted by Olszewer and Carter
(1988). They treated 1974 patients with EDTA who had known heart or
peripheral vascular disease. 94% of heart disease patients and 97% of
peripheral vascular disease patients reported "good" or
"marked" improvement. Proponents cite mainly the case
report studies as ample proof that chelation therapy works. Critics say
that these studies are "unscientific" and that there is a lack
double-blind clinical trials comparing chelation therapy to placebo.
Critics also cite that the sample sizes used in the above studies are too small
and that the efficacy of chelation therapy is judged based on qualitative
instead of quantitative data. New data and studies added at during
the most recent update of this site. The official position
statements of the American Heart Association, American College of Cardiology,
American Medical Association and the FDA, who have examined the available
scientific literature, on the use of chelation therapy for the treatment of
cardiovascular disease and peripheral vascular disease can be summarized as
follows: -American Heart Association-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.
-American College of Cardiology-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. -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. -FDA-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.
All of these organizations are open to and suggest that well designed
blinded and placebo controlled studies are needed to further evaluate the
clinical efficacy of chelation therapy for the treatment of cardiovascular
disease. There is currently a study by the National Center for
Complementary and alternative Medicine, which is a branch of the National
Institute of Health, that began in 2002 and has yet to publish data.
A randomized, placebo controlled study of chelation therapy for the treatment of
ischemic heart disease (Knudtson, 2002) concluded that when using the endpoints
of exercise time to ischemia, exercise capacity, and quality
of life measurements that "there is no evidence to support a beneficial effect
of chelation therapy inpatients with ischemic heart disease, stable angina, and
a positive treadmill test for ischemia".
The Cochrane Review on chelation
therapy for atheroscelrotic cardiovascular disease (Villarruz, 2006) examined 5
published studies (after collecting and eliminating studies that did not meet
the selection criteria) and came to the final conclusions that "there is
insufficient evidence to decide on the effectiveness or ineffectiveness of
chelation therapy in improving clinical outcomes of people with atherosclerotic
cardiovascular disease. This decision must be preceded by conducting randomized
controlled trials that would include endpoints that show the effects of
chelation therapy on longevity and quality of life among people with
atherosclerotic cardiovascular disease". More information:
American Heart Association-Chelation Therapy
American College of
Cardiology Position Statement on Chelation Therapy |
