NIH Trial Gives Surprising Boost To Chelation Therapy
trial has turned up the first substantial evidence in support of chelation therapy for patients with coronary disease. Known as TACT (Trial to Assess Chelation Therapy), the highly controversial trial was presented November 4, 2012 at the American Heart Association by Gervasio Lamas. The trial was sponsored by two NIH institutes, the National Center for Complementary and Al- ternative Medicine and the National Heart Lung and Blood In- stitute.
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Chelation therapy with EDTA to remove heavy metals from the blood in order to treat coronary disease has been around– and provoked criticism– since the 1950s. Despite a lack of evidence and the skepticism of the medical community, passionate sup- porters have kept the therapy alive in alternative medicine circles. TACT was funded by the NIH more than a decade ago as
part of a much-publicized initiative to study the claims of alterna- tive medicine. Now the results of TACT will likely provide am- munition to chelation defenders, but the trial investigators and other experts have expressed considerable caution about the proper interpretation of the results. TACT was a double blind study testing active or placebo
infusions of disodium EDTA (ethylene–diamine-tetra-acetic acid) in stable patients with a history of MI. Due to slow enrollment the trial was downsized, ultimately enrolling 1,708 patients in- stead of the planned 2,372 patients. To maintain the trial’s power to achieve a meaningful result the follow-up time was increased to seven years. The primary endpoint of the trial– the composite of death, MI, stroke, coronary revascularization, or hospitalization for angina– was significantly lowered in the che- lation group:
26.5% in the chelation group versus 30% in the placebo group — 18 % lower.
In the one-third of patients in the trial who had diabetes: 102 events versus 67 events, 39% lower.
The authors said their findings were “unexpected and ad- ditional research will be needed to confirm or refute our results
ith a result that is likely to surprise and baffle much of the mainstream medical community, a large NIH-sponsored
and explore possible mechanisms of therapy.” TACT, they con- cluded, “does not constitute evidence to recommend the clinical application of chelation therapy.” At an AHA (American Heart Association) press conference,
Paul Armstrong said that TACT was a response to an unusual situation. On the one hand, most physicians and scientists have dismissed chelation therapy as lacking any evidence or rationale. On the other hand, chelation therapy is strongly supported by the alternative medicine community and more than 100,000 people receive chelation therapy each year. Armstrong said the results of the trial were “hypothesis generating, not practice changing.”
Here is the AHA press release:
Alternative therapy produces intriguing results in some heart patients but many questions remain. Study Highlights:
• Patients with prior heart attacks enrolled in a clinical trial of a weekly chelation infusion regiment that included disodium EDTA and vitamin C had 18% fewer cardiovascular disease complications than those who received placebo infusions.
• Chelation therapy removes heavy metals like lead and iron from the body. Disodium EDTA, the agent used in the study, does not have an FDA indication.
• Investigators caution that the results need to be reproduced and understood before consideration of clinical application.
Heart attack patients given weekly infusions of chemicals
used for chelation therapy had fewer cardiovascular events than those who received identical appearing placebo infusions, ac- cording to late-breaking clinical trial results presented at the American Heart Association’s Scientific Sessions 2012. In the multicenter, double-blind efficacy trial, Trial to Assess Chelation Therapy (TACT), 1,708 heart attack patients were ran-
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