Zou Kun, Wong Jean, Abdullah Natasya, Chen Xi, Smith Toby, Doherty Michael, Zhang Weiya
Division of Rheumatology, Orthopaedics and Dermatology, University of Nottingham, Nottingham, UK Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Affiliated Hospital of University of Electronic Science and Technology, Chengdu, China.
Pinfold Medical Practice, Loughborough, UK.
Ann Rheum Dis. 2016 Nov;75(11):1964-1970. doi: 10.1136/annrheumdis-2015-208387. Epub 2016 Feb 16.
To examine the overall treatment effect and the proportion attributable to contextual effect (PCE) in randomised controlled trials (RCTs) of diverse treatments for osteoarthritis (OA).
We searched Medline, Embase, Central, Science Citation Index, AMED and CINAHL through October 2014, supplemented with manual search of reference lists, published meta-analyses and systematic reviews. Included were RCTs in OA comparing placebo with representative complementary, pharmacological, non-pharmacological and surgical treatments. The primary outcome was pain. Secondary outcomes were function and stiffness. The effect size (ES) of overall treatment effect and the PCE were pooled using random-effects model. Subgroup analyses and meta-regression were conducted to examine determinants of the PCE.
In total, 215 trials (41 392 participants) were included. The overall treatment effect for pain ranged from the smallest with lavage (ES=0.46, 95% CI 0.24 to 0.68) to the largest with topical non-steroidal anti-inflammatory drugs (ES=1.37, 95% CI 1.19 to 1.55). On average, 75% (PCE=0.75, 95% CI 0.72 to 0.79) of pain reduction was attributable to contextual effect. It varied by treatment from 47% (PCE=0.47, 95% CI 0.32 to 0.70) for intra-articular corticosteroid to 91% (PCE=0.91, 95% CI 0.60 to 1.37) for joint lavage. Similar results were observed for function and stiffness. Treatment delivered by needle/injection and other means than oral medication, longer duration of treatment, large sample size (≥100 per arm) and public funding source were associated with increased PCE for pain reduction.
The majority (75%) of the overall treatment effect in OA RCTs is attributable to contextual effects rather than the specific effect of treatments. Reporting overall treatment effect and PCE, in addition to traditional ES, permits a more balanced, clinically meaningful interpretation of RCT results. This would help dispel the frequent discordance between conclusions from RCT evidence and clinical experience-the 'efficacy paradox'.
在骨关节炎（OA）多种治疗方法的随机对照试验（RCT）中，检验总体治疗效果以及情境效应（PCE）所占比例。
我们检索了截至2014年10月的Medline、Embase、CENTRAL、科学引文索引、AMED和CINAHL，并辅以手工检索参考文献列表、已发表的荟萃分析和系统评价。纳入的是OA的RCT，比较了安慰剂与代表性的补充治疗、药物治疗、非药物治疗和手术治疗。主要结局是疼痛。次要结局是功能和僵硬。使用随机效应模型汇总总体治疗效果的效应量（ES）和PCE。进行亚组分析和meta回归以检验PCE的决定因素。
总共纳入了215项试验（41392名参与者）。疼痛的总体治疗效果范围从灌洗最小（ES = 0.46，95%CI 0.24至0.68）到局部非甾体抗炎药最大（ES = 1.37，95%CI 1.19至1.55）。平均而言，75%（PCE = 0.75，95%CI 0.72至0.79）的疼痛减轻归因于情境效应。其因治疗而异，从关节内注射皮质类固醇的47%（PCE = 0.47，95%CI 0.32至0.70）到关节灌洗的91%（PCE = 0.91，95%CI 0.60至1.37）。在功能和僵硬方面观察到类似结果。通过针/注射和口服药物以外的其他方式进行的治疗、较长的治疗持续时间、大样本量（每组≥100）和公共资金来源与疼痛减轻的PCE增加相关。
OA RCT中的大多数（75%）总体治疗效果归因于情境效应而非治疗的特定效应。除了传统的ES之外，报告总体治疗效果和PCE能够对RCT结果进行更平衡、具有临床意义的解释。这将有助于消除RCT证据得出的结论与临床经验之间经常出现的不一致——“疗效悖论”。
Zotero 插件
