Additionally, selection bias could have also played a large part in the study's results. "Only 131 out of 431 (30.4 percent) eligible patients elected to participate, increasing the potential for selection bias," noted Dr. Syed.
A third issue was the crossover rate for patients who received the control or "placebo" procedure. Patients in the trial were able to "cross over" and get the other treatment after one month.
"Even though they had no confirmation of which treatment they received, nearly four times as many patients or 43 percent who had the control treatment crossed over to have vertebroplasty performed, compared to 12 percent of vertebroplasty patients who switched," said Dr. Syed.
The final issue to consider is that the control procedure included injecting 0.25 percent of bupivicaine into the periosteum of the pedicles. "The problem," explained Dr. Syed, "is that this resembles a medial branch block for the treatment of facet-related pain. The duration of relief following medial branch block is variable, but may last for several weeks."
He added that many patients with compression fractures have concurrent facet-related pain due to stress on the facet joint as a result of the fracture.
"I applaud Dr. Kallmes for his work. His study is very interesting, but I don't think it's conclusive. Additional research is needed to truly assess the efficacy of vertebroplasty," said Dr. Syed.
Dr. Syed is on staff at Good Samaritan Hospital and Dayton Heart Hospital in Dayton. He is also a founding partner of Dayton Interventional Radiology. In addition, Dr. Syed has participated in clinical trials and published several papers on vertebroplasty.
|SOURCE Dr. Mubin I. Syed|
Copyright©2009 PR Newswire.
All rights reserved