According to a pair of randomized, control trials, vertebroplasty may not effectively treat osteoporotic vertebral fractures.
David F. Kallmes, MD, of the Mayo Clinic in Rochester, Minn., and team conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 131 patients at medical centers in the US, Britain and Australia. Of all, 68 women patients with osteoporosis fractures were randomly assigned to receive vertebroplasty and 63 women were assigned to simulated procedure. Neither the patient nor the evaluated person knew which treatment was received.
Rachelle Buchbinder, PhD, of Monash University in Melborne, Australia and team also performed a multicenter, randomized, double-blind, placebo-controlled trial for less than 12 months duration involving 78 participants who had one or two painful unhealed osteoporotic vertical fractures.
Almost half the group (35 patients) was assigned to undergo vertebroplasty, the other half (36 patients) underwent a simulated procedure.
While the authors reported that scores on measures of pain improved modestly in both groups over time, they found that vertebroplasty was not as effective as sham procedure at relieving pain whether it was after one week, or one, three or six months.
Vertebroplasty did not result in a significant advantage in any measured outcome at any time point, wrote Buchbinder’s group.
These results were contradictory to previous studies that suggested there was a benefit to the use of vertebroplasty.
“Our results show not for the first time—the hazards of relying on the results of uncontrolled or poorly controlled studies to assess treatment efficacy,” wrote Buchbinder and her colleagues. “These studies tend to overestimate the treatment benefit by failing to take into account the favorable nature history of the condition, the tendency for a regression to the mean, and the placebo response to treatment, which may be amplified when the treatment is invasive.”
James N. Weinstein, MD reported that the findings mean that patients and doctors need to review the options for spinal compression fractures together.
When best evidence suggests a tossup between treatment options and no benefit, informed patient choice is essential, he wrote.