Efficacy of Vertebroplasty for Osteoporotic Fractures Tested Randomized trials show it doesn't reduce pain or pain-related disability compared to placebo
07 aug 2009-- In patients with painful, osteoporotic vertebral compression fractures, vertebroplasty appears to be no more beneficial than placebo, according to two studies published in the Aug. 6 issue of the New England Journal of Medicine.
In one study, David F. Kallmes, M.D., of the Mayo Clinic in Rochester, Minn., and colleagues randomly assigned 131 patients to receive either vertebroplasty or a simulated procedure without cement. They found no significant group differences in the primary outcomes -- scores on the modified Roland-Morris Disability Questionnaire and patient ratings of average pain intensity on a scale of zero to 10 -- after one month.
In a second study, Rachelle Buchbinder, Ph.D., of Monash University in Malvern, Australia, and colleagues randomly assigned 78 patients to receive either vertebroplasty or a sham procedure. They found no significant group differences in the primary outcome -- overall pain on a scale of zero to 10 -- after three months.
"Given the increasing use, limited benefit, and potential risk, how often should vertebroplasty be performed?" asks the author of an accompanying editorial. "When best evidence suggests a toss-up between treatment options and no benefit, informed patient choice is essential. When faced with several choices for which the evidence is less than clear, patients and doctors must thoroughly review the options together."
Authors of both studies reported financial relationships with pharmaceutical and medical companies.