Vannabouathong Christopher, Bhandari Mohit, Bedi Asheesh, Khanna Vickas, Yung Patrick, Shetty Vijay, Khan Moin
OrthoEvidence, Inc., Burlington, Ontario, Canada.
Division of Orthopaedic Surgery, Center for Evidence-Based Orthopaedics (M.B.), and Department of Surgery, Faculty of Health Sciences (V.K.), McMaster University, Hamilton, Ontario, Canada.
JBJS Rev. 2018 Jul;6(7):e5. doi: 10.2106/JBJS.RVW.17.00167.
Guidelines recommending various nonoperative treatments for patients with knee osteoarthritis remain inconsistent. Much of this controversy relates to what constitutes a clinically important effect. The purposes of the present study were to compare treatment effect sizes from recent meta-analyses evaluating pharmacological or medical device interventions for the treatment of knee osteoarthritis and to further assess the clinical impact that the intra-articular placebo effect may have on intra-articular injection therapies.
A search of PubMed, MEDLINE, and Embase from the inception date of each database through May 30, 2017 was conducted for all articles involving meta-analyses of pharmacological or medical device knee osteoarthritis treatments compared with controls. Two reviewers independently screened articles for eligibility and extracted data for analysis. We present effect estimates on a standardized mean difference (SMD) scale and compare them all against a threshold for clinical importance of 0.50 standard deviation (SD) unit.
Ten meta-analyses (sample size range, 110 to 39,814) providing a total of 19 different effect sizes for pain were included in this review. SMD estimates ranged from 0.08 to 0.79 for various electrical modalities, orthotic devices, topical and oral nonsteroidal anti-inflammatory drugs (NSAIDs), dietary supplements, and intra-articular injection therapies. Seventeen treatments demonstrated significant improvements in terms of pain when patients who had received treatment were compared with controls. After accounting for the intra-articular placebo effect, the greatest effect estimates were those of intra-articular platelet-rich plasma and high molecular weight hyaluronic acid. When these were judged according to our threshold for clinical importance, high molecular weight intra-articular hyaluronic acid was found to have the most precise effect estimate that surpassed this threshold. Platelet-rich plasma was found to provide the greatest point estimate of the treatment effect, but the precision around this estimate had the largest amount of uncertainty across all treatments.
While many nonoperative treatments demonstrated significant improvements in pain, we found the greatest effect estimates for intra-articular treatments. While platelet-rich plasma provided the greatest point estimate of the treatment effect, variability among studies suggests that future research into optimal formulations is required. The strongest current evidence supports clinically important and significant treatment effects with intra-articular hyaluronic acid formulations between 1,500 and >6,000 kDa.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
推荐针对膝骨关节炎患者进行各种非手术治疗的指南仍不一致。这种争议很大程度上与什么构成临床重要疗效有关。本研究的目的是比较近期评估用于治疗膝骨关节炎的药物或医疗器械干预措施的荟萃分析中的治疗效应大小,并进一步评估关节内安慰剂效应可能对关节内注射疗法产生的临床影响。
对PubMed、MEDLINE和Embase数据库从各数据库创建日期至2017年5月30日进行检索,查找所有涉及将药物或医疗器械治疗膝骨关节炎与对照组进行荟萃分析的文章。两名审阅者独立筛选文章以确定其是否符合要求,并提取数据进行分析。我们以标准化均数差(SMD)量表呈现效应估计值,并将它们全部与临床重要性阈值0.50标准差(SD)单位进行比较。
本综述纳入了10项荟萃分析(样本量范围为110至39,814),共提供了19种不同的疼痛效应大小。各种电疗方式、矫形器械、局部和口服非甾体抗炎药(NSAIDs)、膳食补充剂以及关节内注射疗法的SMD估计值范围为0.08至0.79。与对照组相比,17种治疗方法在接受治疗的患者的疼痛方面显示出显著改善。在考虑关节内安慰剂效应后,最大的效应估计值是关节内富血小板血浆和高分子量透明质酸的效应估计值。根据我们的临床重要性阈值进行判断时,发现高分子量关节内透明质酸具有最精确的效应估计值且超过了该阈值。富血小板血浆被发现提供了最大的治疗效应点估计值,但在所有治疗方法中,围绕该估计值的精确性具有最大的不确定性。
虽然许多非手术治疗方法在疼痛方面显示出显著改善,但我们发现关节内治疗的效应估计值最大。虽然富血小板血浆提供了最大的治疗效应点估计值,但研究之间的差异表明需要对最佳配方进行进一步研究。目前最有力的证据支持1500至>6000 kDa之间的关节内透明质酸制剂具有临床重要且显著的治疗效果。
治疗性I级。有关证据水平的完整描述,请参阅作者须知。