Chinese Medicine, 2010, 1, 49-54
doi:10.4236/cm.2010.12010 Published Online September 2010 (http://www.SciRP.org/journal/cm)
The Effect of EDTA Chelation Therapy in Symptomatic
Coronary Heart Disease: An Observational Study
Chulananda D. A. Goonasekera1, Rohini Tennakoon2, Premil N. Rajakrishna3, Gammadegedara A.
Gunasena3, Chandima R. Wanniarachchi3, Asanka B. Yatawatta3, Udawatta A. D. D. Munidasa3
1 Department of Anesthesiology, Faculty of Medicine, Peradeniya
2Consulta nt Cardi ologist, Gene ral Hospital, Kandy, Per adeniya
3Temporary Lecturer, Department of Anesthesiology, Faculty of Medicine, Peradeniya
Received May 7, 2010; revised July 8, 2010; accepted July 26, 2010
Abstract
Ethylene Diamine Tetra Acetic Acid (EDTA) chelation therapy has been considered a definitive alternative
therapy for by-pass surgery in atherosclerotic cardiovascular disease for more than four decades. It is a rela-
tively inexpensive method believed to restore blood flow in atherosclerotic vessels. However, the benefits of
chelation therapy yet remain controversial in the treatment of ischemic heart disease. We observed the effect
of EDTA chelation therapy on exercise tolerance in 13 volunteering patients receiving conventional treat-
ment for established symptomatic coronary heart disease. Each patient received 30 weekly infusions of
EDTA followed by monthly 12 boosters according to the ACAM protocol (American College for Advance-
ment in Medicine). This was in addition to the conventional therapies they received from their respective
physician in hospital. Stress ECG, echocardiography and coronary angiogram findings were obtained at the
beginning of treatment. The distance that a patient could walk on level ground at moderate speed and the
number of steps he/she can climb up on a staircase until he/she begins to feel either chest pain or breathless-
ness were the two clinical parameters of exercise tolerance recorded to grade angina. Liver and renal func-
tions were tested at 1st, 5th, 10th, 15th and 30th infusions. Of the 13 patients, 11 showed improvement in angina
grading whilst 2 experienced no effect. One patient improved from angina grade IV to I, 6 from grade III to I,
1 from grade III to II and 3 from grade II to I. A statistically significant reduction in the mean score (p =
0.002) was noticed at 6th month of treatment when compared to that of the first month. A significant 1.7 fold
increase (p = 0.009) in the mean SGPT level was observed at the 30th infusion when compared to the
pre-treatment values. The SGOT level showed no significant change (p = 0.664). None of the patients
showed clinical features of hepato-cellular damage. The mean serum creatinine level showed a trend for re-
duction (p = 0.083) with treatment. The recognized side effects of intravenous EDTA chelation therapy such
as liver damage, renal damage, hypersensitivity, symptomatic hypocalcaemia, and thrombophlebitis were not
encountered. Thus, EDTA chelation therapy as prescribed by the ACAM protocol seems safe and effective in
improving exercise tolerance in ischemic heart disease when administered concurrently with conventional
therapy.
Keywords: EDTA Chelation Therapy, Coronary Heart Disease, E xercise Tolerance
1. Introduction
Ischaemic heart disease (IHD) resulting from the nar-
rowing of coronary arteries due to atheromatous plaques,
is the commonest cause of deaths in Sri Lanka [1]. Its
definitive treatment comprise of revascularization sur-
gery [i.e. Percutaneous Transluminal Coronary Angio-
plasty (PTCA), or Coronary Artery Bypass Grafting
(CABG)]. Its symptomatic management includes drug
therapy (aspirin, beta blockers, nitrates, etc.) and lifestyle
modifications. Surgical revascularization procedures are
costly and not widely available. Often, most needy pa-
tients are unsuitable for surgery due to their poor physi-
cal condition or age. In this context, the search for an

C. D. GOONASEKERA ET AL. 50
alternative, definitive and cost effective treatment is im-
portant. One such treatment is “chelation therapy” i.e. a
therapy of intravenous Ethylene Diamine Tetra Acetic
Acid (EDTA), a synthetic amino acid.
The benefits of EDTA Chelation therapy practiced
worldwide since 1950s are still unclear. This is because
of scarcity of well-controlled clinical trials. The exact
mechanism of action of EDTA is not yet fully under-
stood. One theory suggests that EDTA might work by
removing calcium from atheromatous plaques clearing
the blocked coronary arteries. Others believe that EDTA
reduces oxidative stress related damage on coronary
vessels [2]. Some evidence suggests that EDTA reduces
platelet aggregation [3].
In 2001, a metanalysis of 19 studies with data on
22765 patients revealed a statistical correlation coeffi-
cient of 0.88, which was indicative of a positive rela-
tionship between EDTA therapy and improved cardio-
vascular function [4]. There were also a few studies such
as the Calgary PATCH EDTA chelation therapy study
2002, which stated that there was no evidence to support
chelation therapy in patien ts with ischaemic heart disease,
stable angina, and positive treadmill test for ischemia [5].
This study has been criticized as non scientific [6].
In spite of above controversies, “Chelation Therapy”
for ischaemic heart disease is practiced in many coun-
tries including USA, UK, Australia and New Zealand
using accepted protocols (ACAM, Rozema TC). An
overview of all clinical investigations of chelation ther-
apy conducted in the year 2000 states that out of 22
uncontrolled studies, 20 reported subjective sympto-
matic improvement [7]. A study of 18 patients using
Technetium 99m echocardiography has shown a statis-
tically significant improvement in left ventricular ejec-
tion fraction with chelation therapy [8]. Several recent
reviews conducted on the subject, whilst acknowledg-
ing the fact that there is a scarcity of solid data to ap-
prove its use [9], conclude that EDTA therapy may be
used in the context of a research trial [10] or as a ‘last
resort’ cardiovascular revitalization strategy extending
beyond revascularization [11] especially in patients
considered unsuitable for r evascularization [12]. On the
other hand EDTA therapy as prescribed is not consid-
ered a highly invasive or harmful therapy [13]. As a
result groups of physicians in Sri Lanka conduct chela-
tion therapy as an ‘alternative medicine’ for CABG in
ischaemic heart disease, on a non-profit basis, for vol-
unteering patients.
This paper presents an observational study of out-
comes, adverse effects, exercise tolerance and hepato
renal function in 13 such patients who have completed a
standard course of EDTA chelation therapy over the past
three years at a non-profit clinic condu cted in the Cen tral
Province of Sri Lanka.
2. Methods
Volunteering patients, self referring themselves for che-
lation therapy whilst receiving conventional drug treat-
ment for established ischaemic heart disease qualified for
recruitment for this study. Subjects with co-morbid con-
ditions such as a) psychiatric illness affecting under-
standing b) severe renal impairment (s. creatinine >
2.5mg/dl) c) significant liver disease (liver enzymes>
twice the upper limit) d) severe cardiac failure e) allergy
to EDTA f) suspected lead encephalopathy or else if
pregnant were excluded.
Informed written consent was obtained after explain-
ing the background, the ambiguous nature of treatment,
and side effects. Their pre-treatment assessment included
a history, physical examination and baseline investiga-
tions: i.e. urine for sugar and protein, serum creatinine,
full blood count, SGOT, SGPT, lipid profile, fasting
blood sugar, ECG, 2D Echocardiography, and treadmill
exercise test (modified Bruce Protocol). All angina pa-
tients were graded according to the Canadian Cardio-
vascular Society Classification System before the treat-
ment, namely, Class I—No limitation of physical activity
(Ordinary physical activity does not cause symptoms.),
Class II—Slight limitation of physical activity (Ordinary
physical activity does cause symptoms.), Class III—
Moderate limitation of activity (Patient is comfortable at
rest, but less than ordinary activities cause symptoms.),
and Class IV—Unable to perform any physical activity
without discomfort, therefore severe limitation (Patient
may be symptomatic even at rest) [14].
ACAM Protocol for the safe and effective administra-
tion of EDTA Chelation therapy was followed [8]. Each
patient was given weekly 30 infusions followed by
monthly 12 boosters. The duration of therapy was ap-
proximately 1½ years. The therapeutic infusions were
given over a period of 3 hours accord ing to the following
formula.
The EDTA dose, rate of infusion and the frequency of
administration were re-adjusted according to the crea-
tinine clearance. If the creatinine clearance was 100 ml/
min/1.73m2, full dose of EDTA was given. If it was be-
low 100 ml/min, for example 70 ml/min/1.73m2, then
70% of the EDTA dose was given. The total fluid load
was reduced to 400 ml or 300 ml in patients presenting
with clinical features of heart failure (lung basal crepita-
tions, ankle oedema, etc.) [8].
Patients were advised to take an adequate meal prior to
the infusion. The infusion was given in a comfortable
sitting position and patients were served with refresh-
ments and drinking water if required.

C. D. GOONASEKERA ET AL. 51
Investigations were repeated soon after the 5th, 10th,
15th and 30th weekly infusions to assess their renal and
liver functions. Their lipid profiles were checked at 10th
and 30th infusions. The distance that a patient could walk
on level ground at moderate speed and the number of
steps he/she can climb up on a staircase until he/she be-
gins to feel either chest pain or breathlessness were re-
corded prior to, and at the end of the first course (30 in-
fusions) of EDTA therapy.
The importance of life style adjustment measures was
emphasized. Regular aerobic exercise, quitting smoking
and alcohol, stress free life, and dietary control measures
such as limitation of salt, sugar, and fat intake and in-
crease in fiber content were the key advices conveyed to
the patients via leaflets and interv iews.
Angina grading was reassessed at the end of 30
weekly infusions using two subjective parameters;
namely a) the distance that a patient could walk on level
ground at moderate speed and b) the number of steps he
could climb up on a staircase until he begins to feel ei-
ther chest pain or breathlessness. The patient’s opinion
on the effectiveness of the treatment was also sought.
The biochemical parameters; Urine sugar and protein,
Serum creatinine, Full blood count, and SGOT, SGPT,
and Lipid profile were repeated.
All causes of death, myocardial infarction, stroke,
hospitalization for angina, and coronary revasculariza-
tion surgery were taken as study end points.
3. Results
All 13 patients (10 male, age median 57yrs, range 45-71)
completed 30 infusions. Of the 13, 10 patients had had
coronary angiograms and 9 had been recommended to
have CABG. Their angina grading before and after
treatment is shown in Table 1.
Of those 9 patients, 7 improved in angina grading. One
patient recommended for medical management also im-
proved.
Of 11 patients with stress ECGs, 7 were positive at
stage I, 2 at stage II, and 2 at stage III. All patients im-
proved in angina grading except for the 2 patients who
were positive at stage I.
The mean blood pressures of our study group during
treatment are shown in Figures 1 & 2. The reduction in
the mean systolic blood pressure at 3rd, 4th, 5th and 6th
months were statistically significant when compared to
that of the first month.
The patient’s opinion on the effectiveness of treatment
obtained after completion of the 30 infusions is shown in
Table 2. The number of steps they could walk on flat
ground and climb significantly improved as shown in
Figure 3 and Figure 4 respectively.
Table 1. Angina grading before and after EDTA therapy
course i.e. 30 infusions.
Angina Grading
Before infusions After 30 infusions N=
IV I 1
III I 6
III II 1
III III 1
II I 3
II II 1
Table 2. Patients’ perception on the effectives of the treat-
ment.
Patients’ opinion Number of pa tients
Symptoms totally improved 2
Symptoms improved to a greater exten t 7
Symptoms improved to a lesser extent 2
No change 2
Symptoms worsened 0
Month
7654321
95% CI Systolic Blood Pressure (mmHg)
150
145
140
135
130
125
120
115
110
Figure 1. Monthly systolic blood pressure during chelation
therapy.
The mean SGPT levels before and after treatment were
29.19 U/L and 41.58 U/L and showed a significant 1.42
fold rise (p = 0.009). The mean SGOT was 27.64 U/L
and 32.64U/L show ed no significant change (p = 0.664).
The mean serum creatinine level was 1.10mg/dl before
and 1.02 mg/dl after treatment and showed a declining
trend (p = 0.083).
Major complications of EDTA i.e. liver damage, renal
damage, hypersensitivity, symptomatic hypocalcaemia
and thrombophlebitis were not seen in our patients. One
patient developed faintishness after her 2nd infusion. An-
other patient quit the treatment at the 5th infusion, com-
plaining that a rash in the leg exacerbated with the infusion.

C. D. GOONASEKERA ET AL. 52
Month
7654321
95% CI Diastolic Blood Pressure
90
85
80
75
70
65
60
Figure 2. Monthly diastolic blood pressure during chelation
therapy.
Figure 3. The number of steps subjects could walk on flat
ground before and after the completion of full course of
EDTA.
4. Discussion
We studied the effect of EDTA therapy in 13 patients
with established symptomatic ischaemic heart disease
who were on conventional drug treatment with life style
modifications. They were also either considered not suit-
able for cardiac revascularization or were not willing to
undergo the procedure. Of the 13 patients, 11 showed an
improvement in angina grading at least by one class.
Their exercise tolerance as indicated by walking dis-
tance and climbing ab ility substantially improved. Seven
Figure 4. The number of steps subjects could climb before
and after the completion of full course of EDTA
patients who had been recommended for early CABG
were within the improved group.
Objective parameters to assess the effect of EDTA,
such as stress ECG for exercise tolerance, echocardi-
ography for cardiac function were not used in this study
as patients could not afford the expenses.
The mean blood pressure of our study group was
within the normal range. Interestingly we found a sig-
nificant reduction in systolic blood pressure between 8th
and 24th week of EDTA infusion therapy. Most of these
patients were on antihypertensive medication and regular
physical exercise, which are known to control blood
pressure. It has also been previously reported that chela-
tion therapy lowered the systolic blood pressure at all
stages of the sub maximal treadmill stress test in both
exercising and non exercising groups [15]. Therefore, it
is worth considering further research to elucidate
whether chelation therapy has a permissive action on
controlling hypertension.
Critics of chelation therapy have frequently suggested
that reported improvements are a placebo effect. A pla-
cebo effect begins shortly after its first administration
and rarely, persists for more than three months. Benefits
shown in our study are 30 weeks apart. Chelation therapy,
by contrast, shows its full range of b enefits quite slowly.
Usually it required not only several months of therapy
but also an additional several months after the course of
therapy for the full benefit of treatment to occur. The
benefits accrued generally persist for years thereafter
[16].
The results we obtained might have been affected by
other confounding factors such as vitamin B supplemen-

C. D. GOONASEKERA ET AL. 53
tation, life style modifications and conventional drug
therapy. Several studies have shown that favorable life
style modifications like quitting smoking, regular exer-
cise and dietary adjustments have a significant effect on
attenuating abnormal cardiovascular risk factors [17].
Some authors continue to refuse EDTA Chelation
therapy claiming that it has serious side effects including
renal and hepatic toxicity. EDTA does have them when
given at higher doses for heavy metal poisoning. So
would it be for any other medication if toxic doses are
used [2]. However, with the use of accepted protocols
(e.g. ACAM) for EDTA therapy in heart disease none of
the major side effects have been reported in previous
studies. Out observations are similar.
SGPT levels were within the normal range before
treatment and only two patients had values slightly above
the upper normal at the end of treatment (46.4 U/L and
57 U/L; normal range 0-40 U/L). One patient who had
elevated SGOT level at the end of treatment (99 U/L)
also had an abnormal level (47 U/L) pre-EDTA treat-
ment. However these post treatment liver enzyme eleva-
tions are relatively low when compared to that of known
liver pathologies [18]. Since the study group was on
statins (a group of cholesterol lowering drugs known to
raise liver enzymes) as a component of their conven-
tional therapy, a reliable causal relationship between
EDTA and raised liver enzymes could not be made.
However, none of our patients showed any clinical fea-
tures of hepa to-cellular damage during the s tudy perio d.
We observed a decreasing trend in the mean serum
creatinine level during treatment. EDTA induced renal
damage is a very rare adverse effect and it is usually as-
sociated with higher doses [19]. There is even a sugges-
tion that this treatment procedure may improve renal
function. A study carried out on 383 subjects with
chronic degenerative disorders who were treated with
EDTA for 50 days showed an overall decline in fasting
serum creatinine levels [20].
Other known side effects of intravenous EDTA chela-
tion therapy (hypersensitivity, symptomatic hypocalcae-
mia and thrombophlebitis) were not encountered during
our study period. Intravenous access related complica-
tions were minor and rarely observed. Pain at the injec-
tion site and allergy to plastic tourniquet (mild erythema)
troubled a rare pat i ent .
5. Conclusions
We observe that EDTA chelation therapy is effective in
improving the clinical outcome in a majority of IHD pa-
tients with negligible side effects when given according
to approved protocols. Further research is needed to con-
firm this causal relationship. The variability of the effect
of EDTA on different patients creates the need for fur-
ther research to recognize the clinical subset of IHD pa-
tients for whom it is most suitable.
6. Acknowledgements
We thank all staff members of EDTA chelation therapy
clinic, Kandy, and all patients who participated. We ap-
preciate the support received from the Torance Company
Pharmaceuticals to import the relevant drugs under a
special license.
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