Department of Rheumatology and Immunology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Osteoarthritis Cartilage. 2020 Jun;28(6):721-734. doi: 10.1016/j.joca.2020.03.001. Epub 2020 Mar 10.
To evaluate the efficacy and safety of duloxetine in the treatment of patients with osteoarthritis (OA) or chronic low back pain (CLBP).
Relevant randomized controlled trials (RCTs) were searched in PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov. Included RCTs compared the efficacy and safety of duloxetine vs placebo in the treatment of OA or CLBP. Weighted mean difference (WMD) were calculated for continuous outcomes while risk ratio (RR) were calculated for dichotomous outcomes.
Nine RCTs were included in our meta-analysis. Duloxetine had significant improvement over placebo in Brief Pain Inventory 24-h average pain [WMD: -0.67; 95% confidence interval (CI):-0.80, -0.53], weekly mean of the 24-h average pain (WMD: -0.65; 95% CI: -0.79, -0.52), Patient's Global Impression of Improvement (WMD: -0.41; 95% CI: -0.49, -0.32), Clinical Global Impression of Severity (WMD: -0.32; 95% CI: -0.38, -0.25), European Quality of Life Questionnaire-5 Dimension (WMD: 0.04; 95% CI: 0.02, 0.07). In addition, duloxetine is associated with more treatment-emergent adverse events (TEAEs) (RR: 1.25; 95% CI: 1.17, 1.33) and discontinuations for adverse events (AEs) (RR: 2.31; 95% CI: 1.81, 2.94). However, there was no statistically significant difference in serious AEs between duloxetine and placebo.
Duloxetine had modest to moderate effects on pain relief, function improvement, mood regulation and improvement in quality of life with mild AEs in the treatment of OA or CLBP. Future RCTs should focus on comparing duloxetine with other oral drugs and assessing the long-term safety of duloxetine.
评估度洛西汀治疗骨关节炎（OA）或慢性下腰痛（CLBP）患者的疗效和安全性。
在 PubMed、Embase、Web of Science、Cochrane 对照试验中心注册库和 ClinicalTrials.gov 中检索相关的随机对照试验（RCT）。纳入的 RCT 比较了度洛西汀与安慰剂治疗 OA 或 CLBP 的疗效和安全性。对于连续性结局，计算加权均数差（WMD）；对于二分类结局，计算风险比（RR）。
本荟萃分析纳入了 9 项 RCT。与安慰剂相比，度洛西汀在Brief Pain Inventory 24 小时平均疼痛[WMD：-0.67；95%置信区间（CI）：-0.80，-0.53]、每周 24 小时平均疼痛[WMD：-0.65；95% CI：-0.79，-0.52]、患者总体改善印象[WMD：-0.41；95% CI：-0.49，-0.32]、临床总体印象严重程度[WMD：-0.32；95% CI：-0.38，-0.25]和欧洲生活质量五维问卷（WMD：0.04；95% CI：0.02，0.07）方面有显著改善。此外，度洛西汀与更多的治疗中出现的不良事件（TEAEs）（RR：1.25；95% CI：1.17，1.33）和因不良事件（AE）而停药（RR：2.31；95% CI：1.81，2.94）相关。然而，度洛西汀与安慰剂之间在严重 AE 方面无统计学差异。
度洛西汀治疗 OA 或 CLBP 时，在缓解疼痛、改善功能、调节情绪和提高生活质量方面有适度至中度的效果，且不良事件较轻。未来的 RCT 应重点比较度洛西汀与其他口服药物的疗效，并评估度洛西汀的长期安全性。
