A J Láinez Ramos-Bossini1,2,3, D López Zúñiga4, F Ruiz Santiago4,5. 1. Department of Radiology, Virgen de las Nieves University Hospital, Fuerzas Armadas Av. 2, 18014, Granada, Spain. ajbossini@ugr.es. 2. Department of Radiology, Faculty of Medicine, University of Granada, Granada, Spain. ajbossini@ugr.es. 3. Programme in Clinical Medicine and Public Health, University of Granada, Granada, Spain. ajbossini@ugr.es. 4. Department of Radiology, Virgen de las Nieves University Hospital, Fuerzas Armadas Av. 2, 18014, Granada, Spain. 5. Department of Radiology, Faculty of Medicine, University of Granada, Granada, Spain.
Abstract
OBJECTIVES: 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). MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. KEY POINTS: • 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.
OBJECTIVES: 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). MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. KEY POINTS: • 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.
Authors: Jonathan A C Sterne; Jelena Savović; Matthew J Page; Roy G Elbers; Natalie S Blencowe; Isabelle Boutron; Christopher J Cates; Hung-Yuan Cheng; Mark S Corbett; Sandra M Eldridge; Jonathan R Emberson; Miguel A Hernán; Sally Hopewell; Asbjørn Hróbjartsson; Daniela R Junqueira; Peter Jüni; Jamie J Kirkham; Toby Lasserson; Tianjing Li; Alexandra McAleenan; Barnaby C Reeves; Sasha Shepperd; Ian Shrier; Lesley A Stewart; Kate Tilling; Ian R White; Penny F Whiting; Julian P T Higgins Journal: BMJ Date: 2019-08-28
Authors: P Lips; C Cooper; D Agnusdei; F Caulin; P Egger; O Johnell; J A Kanis; U Liberman; H Minne; J Reeve; J Y Reginster; M C de Vernejoul; I Wiklund Journal: Osteoporos Int Date: 1997 Impact factor: 4.507
Authors: Shanil Ebrahim; Bradley C Johnston; Elie A Akl; Reem A Mustafa; Xin Sun; Stephen D Walter; Diane Heels-Ansdell; Pablo Alonso-Coello; Gordon H Guyatt Journal: J Clin Epidemiol Date: 2014-03-05 Impact factor: 6.437
Authors: Caroline A H Klazen; Paul N M Lohle; Jolanda de Vries; Frits H Jansen; Alexander V Tielbeek; Marion C Blonk; Alexander Venmans; Willem Jan J van Rooij; Marinus C Schoemaker; Job R Juttmann; Tjoen H Lo; Harald J J Verhaar; Yolanda van der Graaf; Kaspar J van Everdingen; Alex F Muller; Otto E H Elgersma; Dirk R Halkema; Hendrik Fransen; Xavier Janssens; Erik Buskens; Willem P Th M Mali Journal: Lancet Date: 2010-08-09 Impact factor: 79.321
Authors: M H J Voormolen; W P T M Mali; P N M Lohle; H Fransen; L E H Lampmann; Y van der Graaf; J R Juttmann; X Jansssens; H J J Verhaar Journal: AJNR Am J Neuroradiol Date: 2007-03 Impact factor: 3.825
Authors: David F Kallmes; Bryan A Comstock; Patrick J Heagerty; Judith A Turner; David J Wilson; Terry H Diamond; Richard Edwards; Leigh A Gray; Lydia Stout; Sara Owen; William Hollingworth; Basavaraj Ghdoke; Deborah J Annesley-Williams; Stuart H Ralston; Jeffrey G Jarvik Journal: N Engl J Med Date: 2009-08-06 Impact factor: 91.245
Authors: Rachelle Buchbinder; Richard H Osborne; Peter R Ebeling; John D Wark; Peter Mitchell; Chris Wriedt; Stephen Graves; Margaret P Staples; Bridie Murphy Journal: N Engl J Med Date: 2009-08-06 Impact factor: 91.245