Spinal Fracture: Cement No Better Than Sham
Studies Raise Questions About Popular Treatment for Osteoporosis-Related Spinal Compression Fractures
Same Outcome, Different Interpretations continued...
The researchers measured pain, quality of life, and functional status one week after treatment and one, three, and six months later. They found that both groups had similar improvements in pain, function, and quality of life over time.
In the similarly designed Mayo Clinic trial, 131 patients from eight treatment centers in the U.S., U.K., and Australia were treated with either cement injection or sham.
One month later, both groups saw significant and similar improvements in pain, quality of life, and functional status.
Patients in the Mayo trial were able to “cross over” and get the other treatment after a month.
Even though they had no confirmation of which treatment that was, nearly four times as many patients who had the sham treatment switched, suggesting that more of them were less satisfied with their initial treatment.
“It is possible that there was a treatment effect (with the cement treatment) that we were just unable to measure,” Kallmes says. “I don’t think we should give up on this procedure. I think it needs to be studied in more detail.”
More Patients Needed for Trials
For this reason, Kallmes says he will not recommend the cement injections to patients in the future unless they agree to participate in clinical trials.
Interventional radiologist Avery Evans, MD, tells WebMD that there has been so much hype about the cement injections, patients have been reluctant to enroll in trials if it meant they might not get the treatment.
An associate professor of radiology and neurosurgery at the University of Virginia, Evans agrees that more research is needed to determine if vertebroplasty benefits specific subgroups of patients.
“Up until now no one was willing to randomize their patients because they were so convinced that vertebroplasty was the greatest thing in the world,” he says. “Now it’s time for us to admit that we aren’t as smart as we thought we were and ask the questions, ‘Are there patients who are helped by this treatment, and who are they?'"
In an editorial published with the studies, James N. Weinstein, DO, who directs the Dartmouth Institute for Health Policy and Clinical Practice, questioned whether the sham treatment really was a placebo treatment and whether either treatment was better than no treatment at all.