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- W2990366068 abstract "We thank Ning and colleagues for their question on the relationship of pain duration to the effects of vertebroplasty, in relationship to our article.1 In response, we refer the authors to the updated Cochrane review,2 an individual patient data meta-analysis including two placebo-controlled trials,3 and our response to a previous letter,4 which provides comprehensive answers to their queries. The Cochrane review includes a detailed description and potential risk of bias of each of the trials included in the evidence synthesis that formed the basis of our conclusions about the value of vertebroplasty for treatment of painful osteoporotic vertebral fractures.2 Three of the five placebo-controlled trials included in the review only included acute fractures, which was defined variously as pain duration of <6 weeks in the VAPOUR trial, ≤8 weeks,5 and <9 weeks.6 Although the other two trials included some participants with longer symptom duration (mean duration 9 to 9.5 weeks in Buchbinder and colleagues,7 and 16 to 20 weeks in Kallmes and colleagues8), the individual patient data meta-analysis clearly reports that 40% and 20% of participants in the Australian and US trials, respectively, had symptoms for ≤6 weeks.3 The Cochrane review found that overall, based upon high-quality to moderate-quality evidence from five placebo-controlled trials (541 randomized participants), vertebroplasty has no important benefit over placebo in terms of pain, disability, quality of life, or treatment success in the treatment of acute or subacute osteoporotic vertebral fractures.2 A subgroup analysis found that these results were consistent irrespective of average duration of pain, indicating that symptom duration is not a treatment-effect modifier. For example, based upon five trials with 378 participants with acute symptoms (including data from all three trials with only participants with acute fractures, and participants with symptoms for 6 weeks or less from the other two trials), the mean difference in pain at 1 month was –0.25 (95% CI, –0.47 to –0.04) on a 0 to 10 scale, a difference that is clinically unimportant. The corresponding mean difference in pain at 1 month in the participants with fractures for >6 weeks from the Australian and US trials (142 participants) was similarly clinically unimportant (–0.14; 95% CI, –0.47 to 0.19). The test for subgroup differences indicated these results were not different (χ2 = 0.33; degree of freedom [df] = 1; p = 0.57; I2 = 0%). Including only participants with pain defined as having been present for ≤6 weeks (thereby excluding data from both Hansen5 and Firanescu and colleagues6), did not alter these findings. These data are also consistent with the adequately powered subgroup analysis of the individual patient data meta-analysis of the Australian and US trials, which also failed to find a benefit of vertebroplasty over placebo for participants with recent onset fractures.3 Between-group differences in mean change scores at 1 month for pain on a 0 to 10 pain scale was 0.1 (95% CI, –1.4 to 1.6), and for disability, measured on a 0 to 23 modified Roland Morris disability questionnaire, was 0.2 (95% CI, –3.0 to 3.4). We therefore continue to stand by our conclusions that vertebroplasty provides no benefit over placebo for osteoporotic vertebral fractures irrespective of symptom duration." @default.
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- W2990366068 date "2019-11-19" @default.
- W2990366068 modified "2023-09-27" @default.
- W2990366068 title "Response to: Some Questions About the Article “The Efficacy and Safety of Vertebral Augmentation: A Second ASBMR Task Force Report”" @default.
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- W2990366068 doi "https://doi.org/10.1002/jbmr.3906" @default.
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