By Dave Anderson:
A common surgery used to relieve back pain and improve mobility is no more effective at those tasks than a placebo treatment. Here is some info from the Wall Street Journal on the testing:
But in the first two studies to rigorously examine the effect of the procedure, known as vertebroplasty, researchers found no detectable benefit when compared with a placebo group of patients who received a sham procedure that only mimicked the real thing.
Vertebroplasty is usually performed by radiologists, who inject bone cement directly into a fractured vertebra to shore it up. The procedure, which is covered by Medicare, ranges in cost from $2,000 to $5,000.
After a month, both groups saw a substantial reduction in various measures of disability and pain, assessed by a questionnaire. But the reductions were a statistical tie�the actual procedure yielded no gain beyond the placebo effect of the sham surgery.
A separate study, including 78 patients and conducted similarly, was funded by the Australian government and Cook Medical Inc., a U.S. manufacturer of bone cement. It reached a similar conclusion: Vertebroplasty didn�t relieve pain any more than the sham surgery, measured three months later.
This is a good argument for comparative effectiveness research in determining what gets paid for by Medicare or a public option. We as a society want to pay for things that work and not pay for things that offer solely a placebo effect as a few white lies and Lidocaine are way cheaper as a placebo than actually sticking bone cement in someone's back. Defenders of the procedure argue that accepted, ancetodal wisdom should trump a double blind statistical study or more convincincly argue that perhaps the study group was composed of individuals with less severe pain and mobility issues than the general popualtion of recipients. If that is the case, then more research should be conducted, while reserving the invasive and called into doubt procedure as a special approval application after cheaper and similiarily effective regimes are tried.
Comparative effectiveness research should be used to encourage best practices by linking payment to those best practices and not paying for treatments that are no more effective but much more expensive than placebo treatments. This should be common sense and not a source of great controversey or political costs.
"This is a good argument for comparative effectiveness research in determining what gets paid for by Medicare or a public option. We as a society want to pay for things that work and not pay for things that offer solely a placebo effect as a few white lies and Lidocaine are way cheaper as a placebo than actually sticking bone cement in someone's back."
ReplyDeleteI essentially agree with the sentiment expressed here, but there seems to remain a bit of a dilemma. The study cited in the WSJ compared bone cement injection versus sham procedure (placebo) and found no difference. But would there be a difference between placebo and doing nothing (or just giving lidocaine)? If there were, what would be the 'white lie'? Because the fact that any ostensible 'vertebroplasty' procedure is just a sham procedure wouldn't remain hidden from patients for very long. Yet the way I understand the apparent efficacy of a placebo or a placebo treatment, the patient needs to believe that the placebo drug or the placebo treatment is the real thing.
Just to be clear, it is not my intention to argue for the continuation of the vertebroplasty procedure after the results of the cited study. But there is a dilemma, isn't there?
What was labeled a placebo in this study is actually known as a Facet Joint Injection-a legit treament for back pain in some insctances. (Page 571 of the study states: "that a solution of lidocaine and bipuvicaine was used")
ReplyDeleteWhat is interesting is that the patients were only followed for 1 month post-procedure...which often times is the duration of success for a Facet Joint Injection.
I believe if they had followed participants (and more of them) for a longer period of time, the benefits of Vertebroplasty would have been clear.
It is apparent that more research need to be done.
Read more on Vertebroplasty and decide for yourself: http://www.jvir.org/article/PIIS1051044307003120/fulltext