Buchbinder Rachelle, Osborne Richard H, Ebeling Peter R, Wark John D, Mitchell Peter, Wriedt Chris, Graves Stephen, Staples Margaret P, Murphy Bridie
Monash Department of Clinical Epidemiology, Cabrini Hospital, and Monash University, Malvern, VIC, Australia.
N Engl J Med. 2009 Aug 6;361(6):557-68. doi: 10.1056/NEJMoa0900429.
Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.
We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (< 6 weeks or > or = 6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.
A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (+/-SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6+/-2.9 and 1.9+/-3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, -0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.
We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.)
椎体成形术已成为治疗疼痛性骨质疏松性椎体骨折的常用方法，但支持其应用的证据有限。
我们进行了一项多中心、随机、双盲、安慰剂对照试验，将磁共振成像证实有一或两个持续时间少于12个月且未愈合的疼痛性骨质疏松性椎体骨折的参与者随机分配接受椎体成形术或假手术。参与者根据治疗中心、性别和症状持续时间（<6周或≥6周）进行分层。在1周以及1、3和6个月时评估结果。主要结局是3个月时的总体疼痛（采用0至10分制，10分为可想象的最大疼痛）。
共纳入78名参与者，71名（椎体成形术组38名中的35名，安慰剂组40名中的36名）完成了6个月的随访（91%）。椎体成形术在任何时间点的任何测量结局中均未显示出显著优势。在每次随访评估时，两个研究组的总体疼痛均有显著减轻。3个月时，椎体成形术组和对照组疼痛评分的平均（±标准差）降低分别为2.6±2.9和1.9±3.3（调整后的组间差异为0.6；95%置信区间为-0.7至1.8）。两组在夜间和休息时的疼痛、身体功能、生活质量以及自我感觉的改善方面均有类似改善。在6个月的随访期内发生了7例新发椎体骨折（椎体成形术组3例，安慰剂组4例）。
我们发现，对于疼痛性骨质疏松性椎体骨折患者，与假手术相比，椎体成形术在治疗后1周或1、3或6个月时均无有益效果。（澳大利亚新西兰临床试验注册编号，ACTRN012605000079640。）
