SPINE
Results of Vertebral Augmentation Treatment for Patients of Painful Osteoporotic Vertebral Compression Fractures: A Meta-Analysis of Eight Randomized Controlled Trials
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2015;3(24):31 PLoS One. 2015 Sep 17;10(9):e01381268 randomized controlled trials were included in this meta-analysis for the purpose of comparing pain relief, spinal function, and quality of life in percutaneous vertebral augmentation (PVA) in comparison to conventional treatment for painful osteoporotic vertebral compression fractures. Pain scores, spinal functional outcomes, and quality of life were all significantly in favor of the percutaneous vertebral augmentation groups up to 1 year post-operatively in comparison to conventional treatment. Subgroup analysis indicated that percutaneous vertebral augmentation in fractures less than 3 months old would cause greater pain relief.
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
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はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
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Introduction
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Accessing Data
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Analysing Data
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Results
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Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
The use and efficacy of percutaneous vertebral augmentation (PVA), such as vertebroplasty and balloon kyphoplasty, has been a topic of debate in the treatment of painful osteoporotic vertebral compression fractures. A number of reports have shown conflicting results ultimately altering the treatment recommendations for these fractures. Recent randomized controlled trials (RCTs) had been published comparing vertebroplasty and balloon kyphoplasty to conventional treatment in painful osteoporotic VCFs and thus the present study was prudent to provide an updated assessment of available high-quality literature.
主な研究課題は何ですか？
How do the clinical differences in pain relief, spinal functional outcomes, and overall quality of life compare between percutaneous vertebral augmentation and conventional treatment for the management of painful osteoporotic vertebral compression fractures?
重要な知見は？
- VAS pain in the early-term follow-up (1 week to 1 month), middle-term follow-up (2-3 months) and the late-term follow-up (1 year) all significantly favored the experimental group (Early: 7 studies; SMD 0.30 [95% CI 0.09, 0.51]; p=0.005; I2=77.9% | Middle: 7 studies; SMD 0.28 [95% CI 0.14, 0.42]; p=0.000; I2=51.3% | Late: 5 studies; SMD 0.26 [95% CI 0.12, 0.41]; p=0.000; I2=41.5%). Sensitivity analysis did not alter these results.
- Subgroup analysis of VAS scores indicated that the efficacy of vertebroplasty and balloon kyphoplasty on pain relief was greater than conventional treatment at all timepoints and that the difference was significant with the exception of vertebroplasty in the early follow-up (p=0.06)
- No difference in pain was noted between vertebroplasty and sham treatment in the early and middle term follow-up
- Subgroup analysis of VAS score suggested that patients with PVA performed with a fracture age of less than 3 months would get earlier pain relief than control group, and that MRI is beneficial as inclusion criteria at all time points (p<0.05)
- Spinal functional outcomes in the early-term, middle-term, and late-term follow up all significantly favored the experimental group (Early: 6 studies; SMD 0.32 [95% CI 0.10, 0.54]; p=0.004; I2=75.7% | Middle: 5 studies; SMD 0.24 [95% CI 0.05, 0.42]; p=0.011; I2=65.2% | Late: 3 studies; SMD 0.26 [0.14, 0.38]; p=0.000; I2=0%). Sensitivity analysis did not change the significance of these results (p<0.001).
- Quality of life outcomes in the early-term, middle-term, and late-term follow up all significantly favored the experimental group (Early: 6 studies; SMD 0.23 [95% CI 0.14, 0.33]; p=0.000; I2=0% | Middle: 4 studies; SMD 0.23 [95% CI 0.05, 0.41]; p=0.012; I2=60.3% | Late: 3 studies; SMD 0.23 [95% CI 0.11, 0.34]; p=0.000; I2=0.6%), sensitivity analysis did not alter these results.
- There was no significant difference in the risk of new VCFs (7 studies) or adjacent VCFs (5 studies) between 2 weeks and 2 years between the experimental and control groups (RR 1.09 [95% CI 0.61, 1.97]; p=0.77 and 1.80 [95% CI 0.61, 5.30]; p=0.28, respectively)
最も覚えておくべきことは？
Pain scores, spinal functional outcomes, and quality of life were significantly in favor of the percutaneous vertebral augmentation groups in the early, middle, and late term follow-up (up to 1 year) in comparison to control treatments. Subgroup analysis indicated that patients receiving percutaneous vertebral augmentation with a fracture age less than 3 months would get earlier pain relief than the control group.
それが私の患者ケアにどのように影響するか？
The results of this study indicate that percutaneous vertebral augmentation for the treatment of osteoporotic vertebral compression fractures may provide improvements in pain, spinal function, and quality of life in comparison to control treatments up to 1 year post-operatively. Further high quality RCTs are needed to add to the current body of literature and examine if differences clinically meaningful.
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