事实上，疼痛性骨质疏松压缩骨折椎体成形术的治疗饱受争议。特别是Kallmes等人[1]和Buchbinder等人[2]在2009年6月刊新英格兰医学杂志（New England Journal of Medicine）发表随机试验研究，试图戳穿疼痛性骨质疏松压缩骨折椎体成形术治疗的假面具。使已经和即将投入这项技术研究的人倍感误导、挫折和意外。Kallmes等人多中心随机双盲实验显示，实验组（骨水泥注射组）和对照组（非骨水泥注射组）术后随访期间，在关于疼痛和疼痛相关受限运动的改善上相似。Buchbinder等人实验组和对照组（假操作，sham procedure）比较，实验组治疗后6各月随访不获益。虽然两位作者的文章为前瞻性随机实验研究，但其设计也不是没有瑕疵。但却引发了广泛的争论。而且成为当时纽约时报的头版新闻。
本站连续两篇《PVP想说爱你不容易》阐述这一争论的来龙去脉。
这一报告也遭遇其它报告的挑战。同意参加研究病人是迄今为止最大的挑战，因为病人之间参与随机意愿演变成系统差异（systematic differences）。愿意治疗病人与拒绝参与治疗病人在风险承担，期望值，毅力方面有显著性差异。这一志愿者偏差与观察研究中的选择性偏差密切相关[8]。
1. David F. Kallmes, M.D., Bryan A. Comstock, M.S., Patrick J. Heagerty, Ph.D., Judith A. Turner, Ph.D., David J. Wilson, F.R.C.R., Terry H. Diamond, F.R.A.C.P., Richard Edwards, F.R.C.R., Leigh A. Gray, M.S., Lydia Stout, B.S., Sara Owen, M.Sc., William Hollingworth, Ph.D., Basavaraj Ghdoke, M.D., Deborah J. Annesley-Williams, F.R.C.R., Stuart H. Ralston, F.R.C.P., and Jeffrey G. Jarvik, M.D., M.P.H. A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures. NEJM Volume 361:557-568 August 6, 2009 Number 6
2. Rachelle Buchbinder, Ph.D., Richard H. Osborne, Ph.D., Peter R. Ebeling, M.D., John D. Wark, Ph.D., Peter Mitchell, M.Med., Chris Wriedt, M.B., B.S., Stephen Graves, D. Phil., Margaret P. Staples, Ph.D., and Bridie Murphy, B.Sc. A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures. NEJM Volume 361:557-568 August 6, 2009 Number 6
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