A pair of randomized controlled trials published in the current issue of the New England Journal of Medicine suggests the use of background vertebroplasty, an increasingly common treatment for osteoporotic vertebral fractures, provides no added benefit to patients with that condition.
David F. Kallmes, MD, of the Mayo Clinic in Rochester, Minn., and his colleagues performed a multicenter, randomized, double-blind, placebo-controlled trial with 131 patients at medical centers in the U.S., Britain and Australia. The patients, mostly women with fractures from osteoporosis, were randomly assigned to receive vertebroplasty (68 patients) or a simulated procedure (63 patients). Neither the patient nor the person who evaluated them knew which treatment was received.
Rachelle Buchbinder, PhD, of Monash University in Melborne, Australia, and her colleagues also performed a multicenter, randomized, double-blind, placebo-controlled trial with 78 participants that had one or two painful unhealed osteoporotic vertical fractures of less than 12 months duration.
Approximately half the group (35 patients) was assigned to undergo vertebroplasty, the other half (36 patients) underwent a simulated procedure.
Although scores on measures of pain improved “modestly” in both groups over time, the authors say, they found that vertebroplasty was no more effective at relieving pain than the sham procedure—whether it was after one week, or one, three or six months.
"Vertebroplastydid not result in a significant advantage in any measured outcome at any time point," wrote Buchbinder's group.
These results are at odds with 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 natural 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.”
According to Kallmes, there are approximately 80,000 Medicare-reimbursed vertebroplasties performed in the U.S. on an annual basis. Medicare pays between $1,500 to $2,100 per procedure.
The Buchbinder and Kallmes findings mean that patients and doctors need to review the options for spinal compression fractures together, wrote James N. Weinstein, MD, in an accompanying editiorial.
"When best evidence suggests a tossup between treatment options and no benefit, informed patient choice is essential," he wrote.