Department of Radiology, Virgen de las Nieves University Hospital, Fuerzas Armadas Av. 2, 18014, Granada, Spain.
Department of Radiology, Faculty of Medicine, University of Granada, Granada, Spain.
Eur Radiol. 2021 Nov;31(11):8542-8553. doi: 10.1007/s00330-021-08018-1. Epub 2021 May 7.
To assess the current evidence regarding the efficacy of percutaneous vertebroplasty (PVP) over conservative treatment (CT) and placebo in osteoporotic vertebral fractures (OVFs) by performing a meta-analysis of randomized controlled trials (RCTs).
A systematic search was conducted on PubMed, EMBASE, and Cochrane databases. The main outcomes were pain relief, improvement of functional disability, and quality of life at different time points: short-term (1-2 weeks), medium-term (1-3 months), and long-term (≥ 6 months). Subgroup analyses based on time from fracture onset and sham procedure were also performed.
A total of 14 RCTs were included in the meta-analysis. PVP showed significant benefits over CT in all outcomes, but slight-to-none clear differences over placebo. Subgroup analyses revealed that PVP performed in fractures < 6 weeks provided superior short-term pain relief than the control group (p = .02), and better quality of life in the medium-term (p = .03) and long-term (p = .006). Placebo based on infiltrating the skin alone was significantly inferior to PVP at most time points in all outcomes, but no significant differences between PVP and placebo were found when the sham procedure consisted of infiltrating both the skin and periosteum.
PVP showed significant advantages over CT in terms of efficacy, but benefits were more limited when compared to placebo. In addition, benefits of PVP are more prominent in recent OVFs. Differences in the sham procedure or criteria regarding patient's selection/allocation seem to be the main causes of disparity in previous RCTs.
• Previous RCTs showed significant advantages of PVP over CT in terms of efficacy, but benefits were more limited when compared to placebo. • Differences in patient allocation or in the sham procedure might explain the lack of benefits of PVP versus placebo found in previous RCTs. • Despite controversial opinions, PVP should be offered to patients with OVFs as an alternative option to conservative treatment.
通过对随机对照试验(RCT)进行荟萃分析,评估经皮椎体成形术(PVP)相对于保守治疗(CT)和安慰剂治疗骨质疏松性椎体骨折(OVFs)的疗效。
系统检索 PubMed、EMBASE 和 Cochrane 数据库。主要结局指标为不同时间点(1-2 周、1-3 个月和≥6 个月)的疼痛缓解、功能障碍改善和生活质量。还进行了基于骨折发病时间和假手术的亚组分析。
共有 14 项 RCT 纳入荟萃分析。PVP 在所有结局指标上均优于 CT,但与安慰剂相比差异较小。亚组分析显示,在骨折<6 周时,PVP 治疗可提供短期(p=0.02)更好的疼痛缓解,中、长期(p=0.03 和 p=0.006)更好的生活质量。单纯皮肤浸润的安慰剂在大多数时间点在所有结局指标上均明显劣于 PVP,但当假手术包括皮肤和骨膜浸润时,PVP 与安慰剂之间无显著差异。
PVP 在疗效方面优于 CT,但与安慰剂相比优势更为有限。此外,PVP 在近期 OVFs 中的优势更为明显。假手术或患者选择/分配标准的差异似乎是先前 RCT 差异的主要原因。
先前的 RCT 表明,PVP 在疗效方面优于 CT,但与安慰剂相比优势更为有限。
患者分配或假手术的差异可能解释了先前 RCT 中 PVP 与安慰剂相比无获益的原因。
尽管存在争议,PVP 仍应作为保守治疗的替代方案,提供给 OVFs 患者。