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This risk-benefit analysis is part of Forever Healthy's "Rejuvenation Now" initiative that seeks to continuously identify potential rejuvenation therapies and systematically evaluate their risks, benefits, and associated therapeutic protocols to create transparency.

Ethylenediaminetetraacetic acid (EDTA) is a synthetic amino acid that can chelate metals (lead, iron, copper, calcium, mercury, arsenic, aluminum, chromium, cobalt, manganese, nickel, selenium, zinc, tin, and thallium) and metal ions.  Chelation is a process in which the reversible binding of a chelator to a metal ion forms a metal complex (in a redox inactive state), that can then be excreted by the kidney or liver.

EDTA is an approved medication for lead poisoning, hypercalcemia, and digitalis toxicity. The "off label" use of EDTA to prevent and/or reverse cardiovascular and other chronic diseases is widespread but still the subject of much debate.

It is hypothesized that EDTA chelation therapy acts to stabilize or reduce atherosclerotic plaques through the removal of metastatic calcium. Other proposed mechanisms of its beneficial effects include stimulation of parathyroid hormone (PTH), free radical scavenging, reduction of total body iron, membrane stabilization, prevention of epigenetic changes, decreasing platelet aggregation, and arterial dilatation due to calcium channel blocking effects. 

This analysis seeks to answer the following questions:

• Which benefits result from EDTA chelation therapy? 

• Which risks are involved in EDTA chelation therapy (general and method-specific)?

• What are the potential risk mitigation strategies?

• Which method or combination of methods is the most effective for EDTA chelation therapy?

• Which of the available methods are safe for use? 

• What is the best therapeutic protocol available at the moment?

Impatient readers may choose to skip directly to Vascular Rejuvenation using EDTA#Section 6 for the conclusion and tips on practical application. 

This RBA has been prepared based on the principles outlined in A Comprehensive Approach to Benefit-Risk Assessment in Drug Development ( Sarac et al., 2012 ). 

A literature search was conducted on Pubmed, Google Scholar, and the Cochrane Library using the search terms shown in Vascular Rejuvenation using EDTA#Table 1 . Titles and abstracts of the resulting studies were screened and relevant articles downloaded in full text. The references of the full-text articles were manually searched in order to identify additional trials that may have been missed by the search terms.

Inclusion criteria: All studies performed in humans that used EDTA as a therapy to prevent or reverse cardiovascular or other chronic diseases were included. 

Exclusion criteria: We excluded preclinical studies from our analysis because of the large amount of human data available.