A Melbourne professor has today called on the federal government to review Medicare’s routine funding of a controversial procedure called vertebroplasty, where bone cement is injected into a person’s vertebrae to try and fix painful spinal fractures.
Monash University’s Dr Rachelle Buchbinder and colleagues have just published the results of a small randomized controlled trial in one of the world’s big journals — the New England Journal of Medicine.
Their trial and a similar one conducted at the Mayo clinic in the United States — published today as well — found the procedure works no better than a sham procedure at improving pain. People given a fake procedure did just as well as people who had the injection of bone cement.
An accompanying editorial in the NEJM said the results “may change vertebroplasty from a procedure that is virtually always considered to be successful to one that is considered no better than placebo”.
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Despite the fact there have been no rigorous randomised controlled trials until now, this spinal procedure has been performed thousands of times in Australia — often at Medicare’s expense — and is done more than 20,000 times a year in the US.
“This is another of numerous examples of promoting and using promising new treatment — before there is evidence of benefit from rigorous trials,” says Buchbinder, an arthritis specialist who also has a position at Melbourne’s Cabrini Institute.
Buchbinder says the government should urgently review the Medicare item number for this unproven procedure, and Australia needs to find a better way of assessing new procedures, so that patients aren’t exposed to potentially ineffective or harmful treatments.
However, Dr Bill Clark, an interventional radiologist from St. George Private Hospital in Sydney argues the studies are statistically meaningless, in part because they had very poor levels of enrollment, which make results less relevant.
Bill Clark has performed more than 2000 of these spinal procedures and is a strong promoter. While he acknowledges there’s been a lack of randomized trials he says that in the rapidly changing world of medical technology, “sometimes we need to work without them”.
Clark claims Buchbinder’s paper has underestimated the numbers of people who declined to participate in the study, he’s asked the authors if he can see their raw data and says he’ll write to the NEJM.
He says the problems with the latest studies, including the difficulties enrolling patients, show how hard it is to run a rigorous trial, but that he is currently planning one of his own.
Buchbinder rejects Clark’s criticisms as “simply untrue” saying the article went through rigorous peer-review, the trial is still underway and sharing data would not be appropriate.
Disclosure: The debate between Clark and Buchbinder over this spinal procedure is an example featured in Ten Questions You Must Ask Your Doctor, (Allen & Unwin, 2008) co-written with Melissa Sweet, which carries an endorsement on the back cover from Buchbinder.