Objectives: We aim to evaluate the benefits and harms of intervertebral disc therapies (IDTs) in people with non-specific chronic low back pain (NScLBP). Methods: We conducted a systematic review and meta-analysis of randomized trials of IDTs versus placebo interventions, active comparators or usual care. EMBASE, MEDLINE, CENTRAL and CINHAL databases and conference abstracts were searched from inception to June 2020. Two independent investigators extracted data. The primary outcome was LBP intensity at short term (1 week–3 months), intermediate term (3–6 months) and long term (after 6 months). Results: Of 18 eligible trials (among 1396 citations), five assessed glucocorticoids (GCs) IDTs and were included in a quantitative synthesis; 13 assessed other products including etanercept ( n = 2), tocilizumab ( n = 1), methylene blue ( n = 2), ozone ( n = 2), chymopapaine ( n = 1), glycerol ( n = 1), stem cells ( n = 1), platelet-rich plasma ( n = 1) and recombinant human growth and differentiation factor-5 ( n = 2), and were included in a narrative synthesis. Standardized mean differences (95% CI) for GC IDTs for LBP intensity and activity limitations were −1.33 (−2.34; −0.32) and −0.76 (−1.85; 0.34) at short term, −2.22 (−5.34; 0.90) and −1.60 (−3.51; 0.32) at intermediate term and −1.11 (−2.91; 0.70) and −0.63 (−1.68; 0.42) at long term, respectively. Odds ratios (95% CI) for serious and minor adverse events with GC IDTs were 1.09 (0.25; 4.65) and 0.97 (0.49; 1.91). Conclusion: GC IDTs are associated with a reduction in LBP intensity at short term in people with NScLBP. Positive effects are not sustained. IDTs have no effect on activity limitations. Our conclusions are limited by high heterogeneity and a limited methodological quality across studies. Registration PROSPERO: CRD42019106336.
BackgroundIntervertebral disc therapies (IDT) for the management of non-specific chronic low back (NScLBP) pain are raising interest (1).ObjectivesTo review evidence on the benefits and harms of IDT in people with NScLBP.MethodsWe searched 4 databases and conference abstracts, from inception to July 2018, for randomized trials of IDT versus placebo interventions, active comparators or usual care. Two independent investigators extracted data and assessed the risk of bias. The primary outcome was LBP intensity at short, intermediate and long terms (2). Secondary outcomes were LBP-specific activity limitation and safety (3). Our review was registered with the International Prospective Register of Systematic Reviews (CRD42019106336).ResultsOf 17 eligible trials, 5 trials (436 patients) assessed glucocorticoid (GC) IDT and were included in a quantitative synthesis. Twelve trials assessed IDT of other products including ozone (n=2, 140 patients), methylene blue (n=1, 72 patients), stems cells (n=1, 24 patients), glycerol (n=1, 11 patients), etanercept (n=2, 96 patients), tocilizumab (n=1, 60 patients), platelet-rich plasma (n=1, 47 patients), chymopapaine (n=1, 39 patients) and rhGDF-5 (n=2, 55 patients) and were included in a narrative synthesis. Standardized mean differences (SMD) of GC IDT for LBP intensity and activity limitations were -1.33 (-2.34;-0.32) and -0.76 (-1.85;0.34) at short-term, -2.22 (-5.34;0.90) and -1.60 (-3.51;0.32) at intermediate-term and -1.11 (-2.91;0.70) and -0.63 (-1.68;0.42) at long-term, respectively. OR of GC IDT for serious and minor adverse events were 1.13 (0.20; 4.59) and 0.97 (0.49;1.91).ConclusionGC IDT are associated with a reduction in LBP intensity at short-term in people with NScLBP. Positive effects are not sustained. There is no effect on activity limitations.References[1] Knezevic NN, Mandalia S, Raasch J, Knezevic I, Candido KD. Treatment of chronic low back pain - new approaches on the horizon. J Pain Res. 2017;10:1111-23.[2] Chiarotto A, Boers M, Deyo RA, Buchbinder R, Corbin TP, Costa LOP, et al. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018;159(3):481-95.[3] Team QAaSM. Safety of medicines : a guide to detecting and reporting adverse drug reactions : why health professionals need to take action. In: Organization WH, ed. Geneva; 2002.Disclosure of InterestsNone declared
BackgroundDisability, alteration in quality of life and fatigue are frequently reported in spondyloarthritis (SpA). Anti-TNF demonstrated clinical efficacy in SpA. However efficacy on patient-reported outcomes (PROs) may differ from medical assessment.ObjectivesTo assess the impact of anti-TNF on quality of life, disability and fatigue reported by SpA patients.Methods Design: systematic review and meta-analysis of the literature. Data sources: two authors (SL and YD) independently screened PubMed-Medline, Cochrane library and EMBASE databases until November 2016. Key words: (“Patient reported” OR “quality of life” OR fatigue OR FACIT) AND (spondyloarthritis OR “psoriatic arthritis” OR “ankylosing spondylitis”) AND (anti-TNF OR certolizumab OR etanercept OR adalimumab OR infliximab OR golimumab). Articles selection: randomized controlled trials (RCTs), published in English, assessing efficacy of anti-TNF on PROs, in ankylosing spondylitis (AS), psoriatic arthritis (PsA) or SpA according to the ASAS criteria. Data collected: fatigue assessed by FACIT score, quality of life assessed by Short Form 36 (SF36) mental and physical component or by Health AssessementQuestionnary Disability Index (HAQ). Data analysis: Article quality was evaluated by the JADAD scale. For SF36 and HAQ outcomes, pooled variations at 12 and 24 weeks were computed by meta-analysis. Heterogeneity was measured by I2 index.ResultsOf the 604 articles identified, 37 references were eligible for systematic review and 13 for meta-analysis. Our systematic review identified 10 RCTs concerning AS, 20 concerning PsA and 7 concerning axial SpA. However due to the heterogeneity in available statistical data, references eligible for meta-analysis were mainly related to PsA.HAQ assessment was available for a meta-analysis in 8 studies. HAQ was significantly improved at 12 and 24 weeks with anti-TNF. The impact on HAQ variation at week 24 was -0.29 points [95% CI: -0.37, -0.22]. Heterogeneity was important (I2 =57%; see figure).Ten studieswere eligible for a meta-analysis of anti-TNF effect on SF36 mental form. An improvement was observed at 12 and 24 weeks, although superior at 24 weeks. The effect at week 24 was 2.78 [95% CI: 1.87 - 3.68], without heterogeneity (I2 =0%; see figure).Twelve studies were eligible for a meta-analysis of anti-TNF effect on SF36 physical form. We observed a similar and significant improvement at 12 and 24 weeks. The effect at week 24 was 6.74 [95% CI: 5.34 – 8.13], with an important heterogeneity (I2 =84%; see figure)Fatigue was evaluated in 3 studies. Adalimumab induced a significant improvement in FACIT score at 12 and 24 weeks in one study. Two studies using different scores (Fatigue Assessment Scale, BASDAI fatigue item) to assess certolizumab effect highlighted similar findings: an early improvement in fatigue at week 12, remaining significant and stable at week 24.ConclusionsAnti-TNFs agents significantly improve disability, quality of life and fatigue in patients with PsA.AcknowledgementsAbbvie France pharmaceutical company ...
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