METABOLIC DISORDERS
Effects of protein-rich nutritional supplementation and bisphosphonates on body composition, handgrip strength and health-related quality of life after hip fracture: a 12-month randomized controlled study
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(4):22 BMC Geriatr. 2015 Nov 17;15(1):14979 elderly patients with femoral neck or trochanteric hip fractures were randomized to a group receiving protein-rich supplementation and weekly bisphosphonates, weekly bisphosphonates alone, or a control group; all three groups received calcium and vitamin D supplementation. The purpose of this randomized controlled trial was to compare these treatments in terms of their effect on body composition, hand-grip strength, and quality of life. The results displayed no significant differences between groups in body composition changes, hand-grip strength, or quality of life during the 1 year follow-up period. The quality of life decreased in all groups, most notably in the control and bisphosphonate groups.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
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。
3/4
Randomization
3/4
Outcome Measurements
3/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
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？
After a fracture of the hip, a significant proportion of patients are unable to return to their previous functional status. Muscle wasting and loss of strength (sarcopenia) often leads to a reduction in ambulatory capacity for the elderly, and may be due to protein malnutrition. The events surrounding fracture management are correlated with an increased loss of muscle mass from residual aging levels. Limited evidence was available indicating the benefits of protein and energy-rich nutritional supplements on body composition following hip fracture in the elderly, thus, the present study was conducted.
主な研究課題は何ですか？
How does the combination of protein-rich nutritional supplementation and bisphosphonates affect body composition, hand-grip strength, and quality of life following hip fracture in the elderly, assessed up to 1-year post-operatively?
重要な知見は？
- In the treatment group, 11 of 18 patients at final follow-up reported consuming only half of the prescribed intervention during the 6 months. No significant differences were noted between these patients and those who followed prescribed doses in total body mass, appendicular lean mass index, fat-free mass index, fat mass index, or hand grip strength at 6 and 12 months
- An overall loss of body mass, fat-free mass, and fat mass occurred in all groups from baseline to both 6 and 12 months. Between-group differences in these losses were not significant (all p>0.05)
- No significant differences were noted between groups in terms of fat-free mass index (FFMI), fat mass index (FMI), or appendicular lean mass index (alMl) at both 6 and 12 months (p>0.05), however a trend for an increased FMI and a greater drop in both FFMI and alMI was noted in the intervention group
- Intention-to-treat analysis confirmed this trend, with no drop in the FMI of the intervention group at 6 months (p=0.01) and a significantly greater drop of FFMI in this group compared to the other two groups at both 6 and 12 months (p<0.001 and p=0.0006, respectively)
- No significant differences were noted between groups in terms of hand grip strength (p>0.05), however, within the treatment group a significant increase in hand grip strength was noted during the first 6 months (p=0.04), but this result did not maintain significance at 12 months
- Health-related quality of life decreased from 0.85 +/- 0.21 at baseline to 0.77 +/- 0.23 at 6 months and 0.74 +/- 0.23 at 12 months in all groups; no significant differences were noted between groups at any time point (p>0.05)
- Significant decreases from baseline to 12 months were noted in the EQ-5D for the control and bisphosphonate groups (p=0.03 and p=0.01, respectively) but not for the intervention group (p=0.22)
- No significant differences were noted between all groups at baseline or at 6 or 12-month follow-ups in terms of biochemical markers (p>0.05)
最も覚えておくべきことは？
No significant differences were noted between hip fracture patients receiving protein-energy supplementation with bisphosphonates, bisphosphonates alone, or the control group in terms of the change in fat-free mass index, fat mass index, appendicular lean mass index, hand grip strength, or quality of life during the 1 year follow-up period. The quality of life decreased in all treatment groups, most notably in the control and bisphosphonate groups at 12 months.
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 displayed that protein-rich nutritional supplementation with bisphosphonates was unable to preserve lean mass more effectively than bisphosphonates or vitamin D and calcium alone in elderly patients with hip fracture. As well, no significant improvements in hand-grip strength or notable effects on quality of life were noted with supplementation. Further studies utilizing larger sample sizes are warranted to further determine if the within-group improvement in hand grip strength and quality of life with nutritional supplementation is noteworthy in clinical practice.
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