A Cochrane review [Abstract] 1 included 5 studies. Mortality, non-fatal events, and cerebrovascular events were not reported in any of the studies. Four of the studies, with a total recruitment rate of 250 participants, showed no significant difference in the following outcomes: direct or indirect measurement of disease severity and subjective measures of improvement. One of the studies, which included only 10 patients, was interrupted prematurely, because of an apparent treatment effect. However, relevant data were not available in the report.
A systematic review 2 including 5 studies with a total of 288 subjects was abstracted in DARE. Since the above-mentioned Cochrane review there has been one RCT (n=84) on the effect of EDTA on cardiovascular disease (ischaemic heart disease). When compared to placebo, a total of 33 rounds of EDTA treatment per patient were found to have no effect in any of the outcomes measured (exercise time to ischemia, exercise capacity, and quality of life measurements). Both groups exhibited improvements from baseline but this was independent of EDTA use. One chelation patient had therapy discontinued for a transient rise in serum creatinine.
Comment: The quality of evidence is downgraded by study quality, by inconsistency (variability in results across studies) and by imprecise results (limited study size for each comparison).
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