{"title":"度洛西汀治疗骨关节炎的疗效和安全性：一项随机对照试验的荟萃分析。","authors":"Baibhav Bhandari, Kanchan Bisht, Gaurav Purohit, Shiwam Gupta, Girish Kumar Singh, Sonal Goyal, Pradeep Atter, Ajit Kumar, Praveen Talawar","doi":"10.1007/s43465-025-01372-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy and safety of duloxetine in treatment of osteoarthritis compared with placebo.</p><p><strong>Method: </strong>We conducted a comprehensive search for pertinent randomized controlled trials (RCTs) across multiple databases, including PubMed, Embase, Scopus, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and Google scholar. These selected RCTs aimed to assess the effectiveness and safety of duloxetine versus a placebo in the management of osteoarthritis (OA). We computed the mean difference (MD) for continuous outcome measures and calculated the risk ratio (RR) for dichotomous outcome measures.</p><p><strong>Results: </strong>Data from 10 RCT including 2294 participants comparing duloxetine and placebo were pooled. Duloxetine showed improvement in BPI-S (Brief Pain Inventory-Severity)MD = - 0.66; 95% CI, [- 0.75, - 0.57], BPI-I (Brief Pain Inventory-Interference)MD = - 0.59; 95% CI [- 0.66, - 0.52], WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain sub scale scores SMD = - 2.56; 95% CI, [- 4.24, - 0.89] <i>P</i> = 0.003; physical function MD = - 4.59; 95% CI, [- 5.83, - 3.34] <i>P</i> < 0.00001; SF 36 (Short Form) Physical function MD = 1.56; 95% CI, [0.14, 2.97] <i>P</i> = 0.03 and patients global impressions scores SMD = - 0.47; 95% CI, [- 0.62, - 0.32]. Duloxetine resulted in higher number of treatment emergent adverse events RR = 1.34; 95% CI, [1.12,1.61] <i>P</i> = 0.002; and discontinuations RR = 2.54; 95%, CI, [1.89, 3.42] <i>P</i> < 0.00001. However duloxetine was no different from placebo in improving stiffness and in terms of incidence of serious adverse effects.</p><p><strong>Conclusion: </strong>Duloxetine demonstrates effectiveness in addressing chronic pain and mitigating the decline in physical function associated with knee osteoarthritis (OA), while maintaining a reasonable level of tolerable adverse events. However, it does not offer a distinct advantage in alleviating joint stiffness.</p><p><strong>Supplementary information: </strong>The online version contains supplementary material available at 10.1007/s43465-025-01372-y.</p>","PeriodicalId":13338,"journal":{"name":"Indian Journal of Orthopaedics","volume":"59 8","pages":"1123-1136"},"PeriodicalIF":1.1000,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12367579/pdf/","citationCount":"0","resultStr":"{\"title\":\"Navigating the Efficacy and Safety Landscape of Duloxetine in Osteoarthritis Management: A Meta-Analysis of Randomized Controlled Trials.\",\"authors\":\"Baibhav Bhandari, Kanchan Bisht, Gaurav Purohit, Shiwam Gupta, Girish Kumar Singh, Sonal Goyal, Pradeep Atter, Ajit Kumar, Praveen Talawar\",\"doi\":\"10.1007/s43465-025-01372-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the efficacy and safety of duloxetine in treatment of osteoarthritis compared with placebo.</p><p><strong>Method: </strong>We conducted a comprehensive search for pertinent randomized controlled trials (RCTs) across multiple databases, including PubMed, Embase, Scopus, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and Google scholar. These selected RCTs aimed to assess the effectiveness and safety of duloxetine versus a placebo in the management of osteoarthritis (OA). We computed the mean difference (MD) for continuous outcome measures and calculated the risk ratio (RR) for dichotomous outcome measures.</p><p><strong>Results: </strong>Data from 10 RCT including 2294 participants comparing duloxetine and placebo were pooled. Duloxetine showed improvement in BPI-S (Brief Pain Inventory-Severity)MD = - 0.66; 95% CI, [- 0.75, - 0.57], BPI-I (Brief Pain Inventory-Interference)MD = - 0.59; 95% CI [- 0.66, - 0.52], WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain sub scale scores SMD = - 2.56; 95% CI, [- 4.24, - 0.89] <i>P</i> = 0.003; physical function MD = - 4.59; 95% CI, [- 5.83, - 3.34] <i>P</i> < 0.00001; SF 36 (Short Form) Physical function MD = 1.56; 95% CI, [0.14, 2.97] <i>P</i> = 0.03 and patients global impressions scores SMD = - 0.47; 95% CI, [- 0.62, - 0.32]. Duloxetine resulted in higher number of treatment emergent adverse events RR = 1.34; 95% CI, [1.12,1.61] <i>P</i> = 0.002; and discontinuations RR = 2.54; 95%, CI, [1.89, 3.42] <i>P</i> < 0.00001. However duloxetine was no different from placebo in improving stiffness and in terms of incidence of serious adverse effects.</p><p><strong>Conclusion: </strong>Duloxetine demonstrates effectiveness in addressing chronic pain and mitigating the decline in physical function associated with knee osteoarthritis (OA), while maintaining a reasonable level of tolerable adverse events. 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引用次数: 0
摘要
目的：比较度洛西汀与安慰剂治疗骨关节炎的疗效和安全性。方法：我们在PubMed、Embase、Scopus、Cochrane Central Register of controlled trials、ClinicalTrials.gov和谷歌scholar等多个数据库中进行了相关随机对照试验（RCTs）的综合检索。这些选择的随机对照试验旨在评估度洛西汀与安慰剂在治疗骨关节炎（OA）中的有效性和安全性。我们计算了连续结果测量的平均差（MD），并计算了二分类结果测量的风险比（RR）。结果：汇集了10项随机对照试验的数据，包括2294名受试者，比较了度洛西汀和安慰剂。度洛西汀改善BPI-S（短暂疼痛量表-严重程度）MD = - 0.66；95% CI, [- 0.75, - 0.57], BPI-I (Brief Pain Inventory-Interference)MD = - 0.59；95% CI [- 0.66, - 0.52]， WOMAC（西安大略省和麦克马斯特大学关节炎指数）疼痛分量表评分SMD = - 2.56；95% ci, [- 4.24, - 0.89] p = 0.003；身体机能MD = - 4.59；95% ci, [- 5.83, - 3.34] p < 0.00001；SF 36（简写）物理功能MD = 1.56；95% CI, [0.14, 2.97] P = 0.03，患者整体印象评分SMD = - 0.47；95% ci,[- 0.62, - 0.32]。度洛西汀导致更多的治疗紧急不良事件RR = 1.34；95% ci, [1.12,1.61] p = 0.002；停药RR = 2.54；95%, ci, [1.89, 3.42] p < 0.00001。然而，度洛西汀在改善僵硬和严重不良反应发生率方面与安慰剂没有什么不同。结论：度洛西汀在治疗慢性疼痛和缓解膝关节骨性关节炎（OA）相关的身体功能下降方面有效，同时保持合理的可耐受不良事件水平。然而，它在减轻关节僵硬方面没有明显的优势。补充资料：在线版本提供补充资料，网址为10.1007/s43465-025-01372-y。
Navigating the Efficacy and Safety Landscape of Duloxetine in Osteoarthritis Management: A Meta-Analysis of Randomized Controlled Trials.
Objective: To evaluate the efficacy and safety of duloxetine in treatment of osteoarthritis compared with placebo.
Method: We conducted a comprehensive search for pertinent randomized controlled trials (RCTs) across multiple databases, including PubMed, Embase, Scopus, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and Google scholar. These selected RCTs aimed to assess the effectiveness and safety of duloxetine versus a placebo in the management of osteoarthritis (OA). We computed the mean difference (MD) for continuous outcome measures and calculated the risk ratio (RR) for dichotomous outcome measures.
Results: Data from 10 RCT including 2294 participants comparing duloxetine and placebo were pooled. Duloxetine showed improvement in BPI-S (Brief Pain Inventory-Severity)MD = - 0.66; 95% CI, [- 0.75, - 0.57], BPI-I (Brief Pain Inventory-Interference)MD = - 0.59; 95% CI [- 0.66, - 0.52], WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain sub scale scores SMD = - 2.56; 95% CI, [- 4.24, - 0.89] P = 0.003; physical function MD = - 4.59; 95% CI, [- 5.83, - 3.34] P < 0.00001; SF 36 (Short Form) Physical function MD = 1.56; 95% CI, [0.14, 2.97] P = 0.03 and patients global impressions scores SMD = - 0.47; 95% CI, [- 0.62, - 0.32]. Duloxetine resulted in higher number of treatment emergent adverse events RR = 1.34; 95% CI, [1.12,1.61] P = 0.002; and discontinuations RR = 2.54; 95%, CI, [1.89, 3.42] P < 0.00001. However duloxetine was no different from placebo in improving stiffness and in terms of incidence of serious adverse effects.
Conclusion: Duloxetine demonstrates effectiveness in addressing chronic pain and mitigating the decline in physical function associated with knee osteoarthritis (OA), while maintaining a reasonable level of tolerable adverse events. However, it does not offer a distinct advantage in alleviating joint stiffness.
Supplementary information: The online version contains supplementary material available at 10.1007/s43465-025-01372-y.
期刊介绍：
IJO welcomes articles that contribute to Orthopaedic knowledge from India and overseas. We publish articles dealing with clinical orthopaedics and basic research in orthopaedic surgery. Articles are accepted only for exclusive publication in the Indian Journal of Orthopaedics. Previously published articles, articles which are in peer-reviewed electronic publications in other journals, are not accepted by the Journal. Published articles and illustrations become the property of the Journal. The copyright remains with the journal. Studies must be carried out in accordance with World Medical Association Declaration of Helsinki.
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