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Comment & Response |

Vertebral Augmentation for Symptomatic Compression Fractures Is Supported by Randomized Clinical Trials—Reply

Douglas C. Bauer, MD1,2
[+] Author Affiliations
1Department of Medicine, University of California, San Francisco
2Department of Epidemiology and Biostatistics, University of California, San Francisco
JAMA Intern Med. 2014;174(2):307-308. doi:10.1001/jamainternmed.2013.13024.
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In Reply Drs Levy and Beall, both of whom perform vertebral augmentation procedures and serve as consultants for 1 or more companies that manufacture vertebral augmentation equipment, believe that my Invited Commentary lacks scientific support. They offer an industry-funded study by Papanastassiou et al,1 pooling 27 randomized and nonrandomized studies as evidence that vertebral augmentation is associated with improved subjective outcomes such as pain and quality of life. Unfortunately, unblinded studies with subjective outcomes are particularly prone to bias, and some or all of the apparent superiority of vertebral augmentation in that meta-analysis might be attributed to the fact that all but 2 of the 27 studies were unblinded. They further claim that the 2 blinded randomized trials, which showed no pain or quality-of-life advantage with augmentation,2 had been “downgraded” to “Oxford level 2” in a meta-analysis of randomized trials by Anderson et al,3 but that publication does not provide a detailed description of the process or who made such a decision. The study by Anderson et al3 follows the approach of the industry-sponsored meta-analysis and pools the 2 blinded and 4 unblinded randomized trials with predictable results: pain and quality of life appear to be improved among those who receive vertebral augmentation compared with nonsurgical treatment. Had Anderson et al3 performed a sensitivity analysis limited to the 2 blinded study, as others have done, they would have found that that vertebral augmentation had no meaningful effect on pain or quality of life.

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February 1, 2014
Jason R. Levy, MD; Douglas P. Beall, MD
1Department of Interventional Radiology, Northside Hospital, Atlanta, Georgia
2Clinical Radiology of Oklahoma, Edmond
JAMA Intern Med. 2014;174(2):307. doi:10.1001/jamainternmed.2013.13035.
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