USA Today (3/26, Szabo, 1.71M) reports, "Ten years ago, the National Institutes of Health launched a study to see if patients with heart disease could be helped by chelation therapy, a controversial procedure that has been used by 110,000 Americans annually, but which many doctors regard as quackery." The study, called TACT (Trial to Assess Chelation Therapy), is now published in the Journal of the American Medical Association. Researchers found that "chelation seemed to slightly reduce the risk of heart problems, mainly in people with diabetes." However, "that small benefit was so statistically wobbly that it could have been due to chance." In a statement, National Heart, Lung, and Blood Institute Director Gary H. Gibbons said, "This study sheds light on a scientific controversy that has previously been untested."
On its "Booster Shots" blog, the Los Angeles Times (3/26, Healy, 692K) reports that the "findings were immediately discounted by the editors of" JAMA. Additionally, "the findings were...set upon by a leading cardiologist, who charged that the study was poorly designed and executed and should not be seen as justification for a practice that diverts heart patients from therapies with clearer evidence of benefit."
Reuters (3/27, Pittman) reports that just three years ago, the FDA said companies should cease marketing of chelation products to treat autism and heart disease, among other things. Following the release of the new study, an agency spokesperson said, in an email to Reuters Health, "There are no chelation therapy products approved to treat heart disease. Additionally, all FDA-approved chelation therapy products require a prescription because they can only be used safely under the supervision of a healthcare practitioner."
In Forbes (3/26, 928K), Larry Husten writes that in an editorial, "the JAMA editors, in a highly unusual situation, discuss their detailed review of TACT and explain their decision to publish the trial. Although they acknowledge multiple limitations of the trial, they defend its value: 'reports of rigorous investigations should not be censored because of preexisting ideological positions' they write." Meanwhile, in a separate "editorial, Steve Nissen agrees with the JAMA editors decision to publish the trial but issues a fierce indictment of the trial and its conduct."
Heartwire (3/27, O'Riordan) reports that Nissen "pointed to some of the trial's flaws, noting that the sponsors of the study, including the National Heart, Lung, and Blood Institute (NHLBI) and National Center for Complementary and Alternative Medicine (NCCAM), were unblinded throughout the trial." Nissen wrote, "The unblinding of the study sponsor represents a serious deviation from acceptable standards of conduct for supervision of clinical trials." He also "said that the occurrence of the primary end point in just a few more patients in the placebo arm would have turned the trial into a negative study."
HealthDay (3/27, Mundell) points out that "the results of this latest study are published in the March 27 issue of the Journal of the American Medical Association. Findings from the same study were also presented earlier this month at the annual meeting of the American College of Cardiology (ACC) in San Francisco, and at last fall's annual meeting of the American Heart Association." When "speaking at the ACC meeting on March 10, the study's lead researcher said that the modest benefit noted in the study had not made him any more ready to recommend chelation therapy."
MedPage Today (3/27, Kaiser) points out that the study "was supposed to put an end to the controversy that surrounds chelation, but instead it seems to have raised the level of dispute even more."
POSTED BY: Steven Almany M.D.