SIR member and vertebroplasty expert J. Kevin McGraw, M.D., FSIR, agrees. "While we welcome the two studies by researchers David F. Kallmes, M.D., and Rachelle Buchbinder, Ph.D., to the body of literature on this technique, the results of these trials are discordant with personal experience and more than 15 years of accumulated medical literature espousing the benefits of vertebroplasty," said McGraw, section head, interventional radiology, at Riverside Radiology and Interventional Associates in Columbus, Ohio. "SIR recognizes the value of randomized controlled trials and evidence-based medicine; however, the weakness in the studies and the degree of discordance between the outcomes of these studies, prior studies and experience, suggest that it is prematureand possibly incorrectto conclude that vertebroplasty is no better than a control sham procedure," he noted.
Criticisms of both studies include the small numbers of patients treated; the small percentage of eligible patients who were actually enrolled in the trial; inclusion of patients with milder degrees of pain and disability than are usually treated in a typical practice; the small amount of cement injected; treatment of patients with chronic compression fractures; the incomplete use of MRI or CT to confirm that the fracture was the likely source of pain; and the high rate of crossover from placebo to vertebroplasty in one of the studies, explained McGraw.
Criticism has also come from one of the studies' investigators. William Clark, M.D., St. George Private Hospital, Sydney, Australia, an investigator with the Kallmes study, said he regarded that study as "meaningless." In addition, he called the Buchbinder study "a rush to judgment on 'science-based medicine' without applying scientific technique in appraising the studies" in comments posted to the Arthritis Today Web site. Clark noted numerous flaws in the
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Society of Interventional Radiology