Commentary

Vertebroplasty, cognitive dissonance, and evidence-based medicine: What do we do when the ‘evidence’ says we are wrong?

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In both vertebroplasty studies, the activetreatment groups and the sham-treatment groups all showed significant and rapid improvement in pain and disability, and these results were maintained over the study period. Though most vertebral compression fractures do heal, the clinical improvement is usually gradual over a period of weeks. This raises the possibility that the sham treatment was actualy an active placebo.

There is some evidence to support this possibility. In a randomized trial of the efficacy of selective nerve root blocks for lumbar radiculopathy, Riew et al 27 showed that injection with a local anesthetic alone, although not as efficacious as a local anesthetic plus a corticosteroid at allowing patients to avoid surgery, showed an effect long after the expected duration of the anesthetic. The effect persisted even at 5 years of follow-up. 28

Is it possible that the local anesthetic in this trial and the vertebroplasty trials acted as some sort of “reset button” for pain sensation? This is an area that may bear further investigation.

WHERE DOES THIS LEAVE US?

So where does this leave us? On one hand, randomized controlled trials comparing vertebral augmentation with conventional medical therapy 24,25 showed augmentation to be beneficial. On the other hand, the studies by Kallmes et al 1 and Buchbinder et al 2 indicate vertebroplasty is no more effective than sham surgery.

It is very difficult for me to look at my own experience with vertebral augmentation and say that, on the basis of these trials, I am no longer going to offer it to my patients. I understand on an intellectual level that these trials call the efficacy of the procedure into question, but on a visceral level I cannot rationalize it. When faced with a patient who is barely ambulatory or in fact bed-bound due to pain, my experience tells me that vertebral augmentation has a very high chance of getting them ambulatory within hours. The trials of vertebroplasty would indicate this is a placebo effect or that local anesthetic alone is as effective, but I am not yet ready to make that leap.

Cognitive dissonance seems to rule.

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