Department of Interventional Radiology, St George Private Hospital, Sydney, New South Wales, Australia.
Department of Medicine, St George and Sutherland Clinical school, Univsersity of New South Wales, Kogarah, New South Wales, Australia.
BMJ Evid Based Med. 2020 Jun;25(3):85-89. doi: 10.1136/bmjebm-2019-111171. Epub 2019 Mar 9.
The Cochrane vertebroplasty review of April 2018 was replaced with an updated version in November 2018 to address complaints of errors in analysis. The updated version continues to misrepresent the evidence supporting early intervention with vertebroplasty for patients with uncontrolled, severe pain and fracture duration <6 weeks. The VAPOUR trial is the only blinded trial of vertebroplasty restricted to this patient group. It showed the benefit of vertebroplasty over placebo, particularly when the intervention occurred within 3 weeks of fracture. The Cochrane vertebroplasty review has ignored the positive outcomes in the VAPOUR trial. Open randomised trials of fractures <6-week duration support the positive findings of the VAPOUR trial. This is not described in the Cochrane review. The VAPOUR trial is clinically heterogeneous from other blinded trials. Cochrane protocol stipulates that clinically heterogeneous trials be described separately, as independent evidence, and not combined in analysis with dissimilar trials. Failure to observe this represents a serious protocol breach in the Cochrane review.
2018 年 4 月的 Cochrane 椎体成形术综述被更新版本所取代，以解决分析错误的投诉。更新版本继续错误地描述了支持早期干预椎体成形术治疗疼痛失控和骨折持续时间<6 周的患者的证据。VAPOUR 试验是唯一一项针对该患者群体的椎体成形术盲法试验。它表明椎体成形术优于安慰剂的益处，特别是在骨折后 3 周内进行干预时。Cochrane 椎体成形术综述忽略了 VAPOUR 试验中的阳性结果。<6 周持续时间的开放性随机试验支持了 VAPOUR 试验的阳性发现。这在 Cochrane 综述中并未描述。VAPOUR 试验与其他盲法试验在临床方面存在异质性。Cochrane 方案规定，临床异质性试验应分别作为独立证据进行描述，而不应与不同的试验进行合并分析。Cochrane 综述中没有遵守这一点，这代表了严重的方案违反。
