Chelation therapy for ischemic heart disease - A randomized controlled trial
Chelation therapy for ischemic heart disease - A randomized controlled trial
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DOI：
10.1001/jama.287.4.481
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发表时间：
2002-01-23
影响因子：
120.7
通讯作者：
Burgess, E
中科院分区：
文献类型：
--
作者：
Knudtson, ML;Wyse, DG;Burgess, E
Context Chelation therapy using EDTA is an unproven but widely used alternative therapy for ischemic heart disease.Objective To determine if current EDTA protocols have a favorable impact on exercise ischemia threshold and quality of life measures in patients with stable ischemic heart disease.Design Double-blind, randomized, placebo-controlled trial conducted between January 1996 and January 2000.Setting Participants were recruited from a cohort of cardiac catheterization patients and practices of cardiologists in Calgary, Alberta.Participants We screened 3140 patients, performed a qualifying treadmill test in 171, and enrolled 84. Entry criteria included age at least 21 years with coronary artery disease proven by angiography or a documented myocardial infarction and stable angina while receiving optimal medical therapy. The required treadmill test used a gradual ramping protocol and patients had to demonstrate at least 1-mm ST depression.Interventions Patients were randomly assigned to receive infusion with either weight-adjusted (40 mg/kg) EDTA chelation therapy (n=41) or placebo (n=43) for 3 hours per treatment, twice weekly for 15 weeks and once per month for an additional 3 months. Patients in both groups took oral multivitamin therapy as welt.Main Outcome Measure Change from baseline to 27-week follow-up in time to ischemia (1-mm ST depression).Results Thirty-nine patients in each group completed the 27-week protocol. One chelation patient had therapy discontinued for a transient rise in serum, creatinine. The mean (SD) baseline exercise time to ischemia was 572 (172) and 589 (176) seconds in the placebo and chelation groups, respectively. The corresponding mean changes in time to ischemia at 27 weeks were 54 seconds (95% confidence interval [CI], 23-84 seconds; P
