Another spine surgical procedure called into question

| 4 Comments

New evidence is in on vertebroplasty and it isn't good.

The Pioneer Press reports:

A fast-growing medical procedure that injects medical cement into the spine to treat fractures apparently works no better than a placebo.That's the conclusion of a New England Journal of Medicine study released Wednesday.

In an accompanying editorial, Dartmouth's Dr. Jim Weinstein writes:

Americans prize advances in technology. However, if in major medical challenges, such as osteoporotic vertebral compression fractures, the alternative is to pay the cost of perpetual uncertainty, we need to support the research necessary to provide sufficient efficacy and safety information for patients to make a truly informed choice. Although the trials by Kallmes et al. and Buchbinder et al. provide the best available scientific evidence for an informed choice, it remains to be seen whether there will be a paradigm shift in the treatment of vertebral compression fractures with vertebroplasty or similar procedures.

Indeed, we've seen it before - when evidence overwhelmingly challenges a particular approach in medicine, it does not, necessarily, change the way doctors practice.

By the way, across town, the Star Tribune, with a bigger staff than the Pioneer Press, simply ran a 154-word brief taken from an Associated Press news wire story.

The Star Tribune did nothing more despite the fact that the story had at least three local angles that the Pioneer Press clearly saw:

• Mayo-led study
• local company involved in the product in question
• another local company involved in a competing approach

4 Comments

There are a variety of smaller studies that have been refuted in larger clinical trials. An entire past-proven pain treatment modality should not be discredited by two small trials. Instead, this should prompt further investigation into the discrepancies of these recently published trials with the mass amount of previous literature indicating substantial benefit of vertebroplasty.

Moreover, the studies did not use a true control group condition, where patients would receive no treatment. The 'control' patients actually received a different effective treatment and both groups demonstrated highly clinically significant reductions in pain. This demonstrates that vertebroplasty is an effective procedure, although facet injections are also effective.

To Mark Egge:

I posted your comment, but all I can say is, "Huh? Did you read the study? And did you read Jim Weinstein's accompanying editorial?"

Evidence speaks.

Data speaks.

Intuition and pure "believing that something works" just doesn't cut it.

To Mark's point. Page 571 clearly states "that a solution of lidocaine and bipuvicaine was used", far from placebo in my mind.

Everyone is acting like examining Vertebroplasty is a new idea. But there's over 100 articles from the past 20 years showing favorable outcomes and this is the first study bring up a discrepancy.

The bottom line is that more data and more research are needed. Both studies had trouble recruiting patients, so the resulting groups were very small.

My worry: now that mainstream media has grabbed a 2 second sound bite on the tails of the Obama agenda, have we blocked much needed treatment for vulnerable audiences (elderly osteo suffers) that don't have access to the research?

The highly-respected editor-in-chief of the journal, Spine, wrote an editorial calling the study "the best available scientific evidence for an informed choice." Neither of the previous pro-vertebroplasty commenters chose to comment on that editorial.

That editorial also predicted: "it remains to be seen whether there will be a paradigm shift in the treatment of vertebral compression fractures with vertebroplasty or similar procedures."

History has shown the resistance to evidence in the world of back surgery. We may be seeing it again.

About this Entry

This page contains a single entry by Gary Schwitzer published on August 6, 2009 7:09 AM.

CNN won't run ad critical of insurance industry exec's income was the previous entry in this blog.

More Minnesota med school questions arise - stem cell questions won't die is the next entry in this blog.

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