Complementary Alternative Cardiovascular Medicine

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190 Alternative Cardiovascular Medicine extremely few, small in size, and poorly designed, offering few conclusions concerning its effectiveness. If chelation therapy is proved safe and effective in treating ischemic heart disease or peripheral vascular disease, it would represent a new therapeutic modality and would gain widespread application. However, if chelation therapy is ineffective for coronary artery disease (CAD), these data will provide important information to the public and allow for informed decision making. This chapter attempts to put chelation therapy in perspective for the clinician. It is important for physicians to ask patients who are using or intending to use chelation therapy to determine their concerns, expectations, misconceptions, and to discuss treatment options before patients undergo chelation therapy. Topics addressed in this chapter include: 1. EDTA pharmacology 2. An evidence-based review of EDTA as a therapy for atherosclerotic disease 3. Mechanisms of action 4. Clinical applications EDTA PHARMACOLOGY EDTA is an amino acid that was first synthesized in 1930. It is currently approved by the FDA for removal of toxic metal cations, such as lead. The term chelation derives from the Greek chele, which refers to the claws of a crab or a lobster. Chelation is the chemical reaction in which a molecule surrounds and bonds with a metal cation to form a heterocyclic structure. The compound resulting from a chelating agent and a metal is described as a metal chelate. Metal chelates are widely represented in biologic systems. For example, hemoglobin, chlorophyll, and vitamin B 12 are metal chelates of iron, magnesium, and cobalt, respectively. EDTA is a tetrabasic acid with four replaceable hydrogen ions. It is poorly soluble in water, but it is soluble in alkaline hydroxides. In the United States, the commercially available salts are the disodium and the calcium disodium salts of EDTA. In these formulations, EDTA is widely used as an in vitro anticoagulant for blood collection and as an antioxidant synergist, stabilizer, and preservative for pharmaceutical preparations. Calcium EDTA is used for lead toxicity, whereas disodium EDTA is used to treat atherosclerosis. EDTA binds with divalent and trivalent metal cations, such as iron, copper, calcium, magnesium, zinc, mercury, aluminum, and lead, with differing affinities. EDTA is poorly absorbed from the gastrointestinal (GI) tract. After iv administration, EDTA is found primarily in plasma.
Chapter 12 / Chelation Therapy and CVD 191 It is distributed in the extracellular fluid, and it does not penetrate cells. Only approx 5% of the plasma concentration is found in spinal fluid. The half-life is 20–60 min. It is excreted mainly by the kidney, with approx 50% excretion in 1 h and more than 95% within 24 h. Almost none of the compound is metabolized. CLINICAL STUDIES Initial Reports In 1955, Norman Clarke suggested that atherosclerosis could be treated with EDTA. He observed that patients who were treated for lead toxicity and had concomitant atherosclerosis experienced improvements in their vascular disease (3). Clarke later reported on the successful use of EDTA in the management of angina pectoris and occlusive vascular disease (4,5). Meltzer and Kitchell initially confirmed Clarke’s work, and then in 1963, after further investigation, concluded that chelation therapy was no more beneficial than existing therapies for coronary artery disease (CAD) (6–8). This placebo-controlled, double-blind, crossover study of nine patients with coronary heart disease (CHD) assessed treadmill performance as a primary end point. In the group treated with EDTA, two of four patients showed benefit at 12 wk. However, only two patients enrolled in the second phase, and neither showed improvement. No statistical analysis was reported. Until this year, this report was the only controlled trial assessing chelation therapy for ischemic heart disease. Observational Studies and Small Clinical Studies The majority of the clinical literature describing the benefits of chelation therapy in patients with CAD or peripheral arterial, noncarotid disease is in case reports and case series. Cranton reported that by 1993, there were more than 4600 published case reports and case series supporting the potential benefits of chelation therapy (9). A large, retrospective analysis of 2870 patients with vascular and other degenerative diseases was reported by Olszewer, which suggested a beneficial effect of chelation therapy (10). Chappell and Stahl conducted a meta-analysis covering 19 studies and a total of 22,765 patients with vascular disease treated with EDTA chelation. This analysis revealed a measurable improvement in approx 87% of patients (11). However, two large uncontrolled retrospective studies dwarfed the other 17 studies in the analysis. It also involved a mixture of patients with CAD, peripheral vascular disease, and cerebrovascular disease, which make the results difficult to interpret for any one condition.
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Complementary and Alternative Cardi
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CONTEMPORARY CARDIOLOGY CHRISTOPHER
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© 2004 Humana Press Inc. 999 River
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vi Preface physician or other healt
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viii Contents 10 Massage Therapy an
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x Contributors ERIN L. OLIVO, PhD
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Chapter 1 / CAM and CVD 1 1 Complem
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Chapter 1 / CAM and CVD 3 patients
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Chapter 1 / CAM and CVD 5 The crite
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Chapter 1 / CAM and CVD 7 disease c
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Chapter 1 / CAM and CVD 9 analyses,
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12 Alternative Cardiovascular Medic
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Chapter 3 / Botanical Medicine and
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Table 2 Type and Quantity of Dietar
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Table 2 (Continued) Type and Quanti
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Index 279 INDEX A N-Acetylcysteine
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Index 281 taurine studies, 106 Conj
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Index 283 Homeopathic medicine, see
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Index 285 funding of studies, 148 g
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Contemporary Cardiology COMPLEMENTA
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