Itâ€™s one in the eye for cardiologists all over the medical establishment in America. It was a bit of a surprise for many of them when a much disputed alternate therapy turned out to be efficacious for some people with heart disease. Results from a clinical trial showed it cut the mortality rate and cardiovascular problems.
The controversial treatment, that is called chelation therapy, it has to be said only just proved statistically significant. There were also question marks over the repeatability of the study. Even the researchers admit that the results were not enough to generally recommend the treatment.
The study cost $30 million and was funded by the National Institute of Health and has had a long and tortuous time in being completed. The ultimate judgment on chelation treatment was given by the lead author of the study, and he said to a conference of the American Heart Association,
â€œThere may be a biological effect and that biological effect should be taken seriously and pursued with additional research.”
Chelation therapy is an alternative treatment that aims to prevent arterial plaque buildup by removing calcium from the patientâ€™s bloodstream. The active ingredients in chelation therapy remove metals as well as calcium and thereby reduces the risk of heart attack and heart disease. Over 100, thousand Americans pay for chelation therapy each year with every course of treatment costing $5000.
There is a consensus among the medical establishment that points to the lack of evidence supporting chelation therapy and claim it does not even justify a small clinical trial. Supporters of the therapy point out that so many people are already using the therapy that this in itself should justify testing the treatment as they would be any other therapy.
Some top cardiologists say that this study was â€˜fatally flawedâ€™ as well as mostly inconclusive. The American Heart Association says, â€œIntriguing as these results are, they are unexpected and should not be interpreted as an indication to adopt chelation therapy into clinical practice.” They feel that if people start taking seriously the idea that chelation therapy can be efficacious, â€œit would be a public health catastrophe.”
The Chelation trial began enlisting patients in â€˜03, but has had a patchy progress since then. It never reached its target of 2,400 patients, and the trials were also suspended in â€˜08 to allow FDA investigations of their conduct at a few sites, and some patients were not well enough informed of the danger of chelation. The study resumed in â€˜09, after some modifications.
The study ended with 1,708 patients at 134 sites in America and Canada. All of the subjects had previous heart attacks. Half of them got the chelation therapy, doses of synthetic amino acid and other substances. These were taken by infusion weekly for 30 sessions, followed by 10 additional doses at intervals of 2 to eight weeks. The other 50% were given a placebo.
Revisiting the patients after more than four years 26% of the chelation receivers had either died or had serious heart problems. The figure for the placebo population was under 30%. So no statistical significance.