Why the NIH Trial to Assess Chelation Should be Abandoned
Chelation therapy is the process of using chelating agents to remove heavy metals from the body. It has been widely used in complimentary medicine to treat heart conditions and autism.
Recently an article was published in the 2008 issue of Medscape outlining why the NIH Trial to Access Chelation Therapy (TACT) should be abandoned. They state that:
- There is no reliable preliminary evidence or logical reason to believe that the treatment will work.
- Chelation proponents used political connections to pressure the NIH to fund the study.
- The application for the trial misrepresented previous data and concealed evidence of risks.
- The study lacks precautions necessary to minimize risks.
- The consent form reflects these shortcomings and fails to disclose apparent proprietary interests.
- Many of the doctors administering the chelation therapy have been in regulatory trouble and are untrustworthy.
- The trial’s outcome will be unreliable and almost certainly equivocal, thus defeating the study’s stated purpose.
Authors have also challenged the mechanism of action of the Chelation therapy stating that it augmented atherosclerosis rather than reversed it:
- The dosing of Na2EDTA, although capable of toxicity in the short rn, is far too small to effect a significant, lasting reduction of metallic free radicals or calcium.
- EDTA is relatively ineffective in removing mercury, iron, and copper as contrasted with lead because the former metals are more tightly bound to tissues and proteins.
- The is evidence of EDTA’s paradoxical generalization of reactive oxygen species in the presence of iron and a possible augmentation of the effect by high ascorbate concentrations in the EDTA solutions that instead of protecting against and neutralizing metallic free radicals EDTA in the presence of iron and ascorbate produces free radicals and potentially induces the changes it intends to prevent.
The conclusion of this study is that the risks for Chelation therapy are far more than trivial. The evidence against Chelation is more than sufficient to disqualify it from future human trials. The current TACT study is scheduled to end July 1, 2009, but as this study suggests it should terminate early.
There is little reliable evidence that TACT will yield a reliable or definitive result and even less for predicting a favorable effect on clinical practice. The TACT is “pointless, dangerous unethical and a waste of public funds” quote the authors. It should be “stopped immediately and permanently and its origin and nature subjected to an independent comprehensive inquiry according to the study researchers.”
About the Author
Kathy Shattler received her Master of Science degree from Michigan State University in E. Lansing Michigan in Human Nutrition. Her twenty-two years of practice includes holding positions as a Lecturer, Chief Clinical Dietitian and Program Manager. Kathy is the Founder of Nutri-Care Consulting and is currently the Nutrition Director of www.CEU4U.COM, an online continuing education management company for Registered Dietitians and Dietetic Technicians.
