Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials.
Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials.
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DOI：
10.1136/bmj.h1225
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发表时间：
2015-03-31
期刊：
影响因子：
--
通讯作者：
Ferreira ML
中科院分区：
文献类型：
--
作者：
Machado GC;Maher CG;Ferreira PH;Pinheiro MB;Lin CW;Day RO;McLachlan AJ;Ferreira ML
目的观察扑热息痛治疗脊柱疼痛和髋、膝关节骨性关节炎的疗效和安全性。设计系统综述和荟萃分析。数据来源Medline、Embase、AMED、CINAHL、Web of Science、LILACS、International Pharmaceutical Abstracts和科克伦对照试验中心注册中心（从成立到2014年12月）。选择研究的合格标准比较对乙酰氨基酚与安慰剂治疗脊柱疼痛（颈部或腰痛）和髋关节或膝关节骨关节炎的疗效和安全性的随机对照试验。数据提取两名独立的评审员提取了有关疼痛、残疾和生活质量的数据。次要结局是不良反应、患者依从性和急救药物的使用。将疼痛和残疾评分转换为0（无疼痛或残疾）至100（最严重的疼痛或残疾）的量表。我们使用随机效应模型计算加权平均差或风险比和95%置信区间。使用科克伦协作网的工具评估偏倚风险，使用GRADE方法评价证据质量并总结结论。结果共纳入12篇文献（13个随机对照试验）。有“高质量”证据表明，对乙酰氨基酚在短期内对降低腰痛患者的疼痛强度（加权平均差-0.5，95%置信区间-2.9至1.9）和残疾（0.4，-1.7至2.5）或改善生活质量（0.4，-0.9至1.7）无效。对于髋关节或膝关节骨关节炎，有“高质量”的证据表明，扑热息痛在短期内对疼痛（−3.7，−5.5至−1.9）和残疾（−2.9，−4.9至−0.9）有显著的影响，尽管在临床上不重要。对乙酰氨基酚组和安慰剂组报告任何不良事件（风险比1.0，95%置信区间0.9 - 1.1）、任何严重不良事件（1.2，0.7 - 2.1）或因不良事件退出研究（1.2，0.9 - 1.5）的患者数量相似。两组之间的患者治疗依从性（1.0，0.9 - 1.1）和急救药物使用（0.7，0.4 - 1.3）也相似。“高质量”证据显示，服用扑热息痛的患者肝功能检查结果异常的可能性几乎是其他患者的四倍（3.8，1.9至7.4），但这种影响的临床重要性尚不确定。结论扑热息痛治疗下腰痛无效，对骨关节炎患者的短期获益极小。这些结果支持重新考虑临床实践指南中对腰痛和髋关节或膝关节骨关节炎患者使用对乙酰氨基酚的建议。系统综述注册PROSPERO注册号CRD 42013006367。
Objective To investigate the efficacy and safety of paracetamol (acetaminophen) in the management of spinal pain and osteoarthritis of the hip or knee. Design Systematic review and meta-analysis. Data sources Medline, Embase, AMED, CINAHL, Web of Science, LILACS, International Pharmaceutical Abstracts, and Cochrane Central Register of Controlled Trials from inception to December 2014. Eligibility criteria for selecting studies Randomised controlled trials comparing the efficacy and safety of paracetamol with placebo for spinal pain (neck or low back pain) and osteoarthritis of the hip or knee. Data extraction Two independent reviewers extracted data on pain, disability, and quality of life. Secondary outcomes were adverse effects, patient adherence, and use of rescue medication. Pain and disability scores were converted to a scale of 0 (no pain or disability) to 100 (worst possible pain or disability). We calculated weighted mean differences or risk ratios and 95% confidence intervals using a random effects model. The Cochrane Collaboration’s tool was used for assessing risk of bias, and the GRADE approach was used to evaluate the quality of evidence and summarise conclusions. Results 12 reports (13 randomised trials) were included. There was “high quality” evidence that paracetamol is ineffective for reducing pain intensity (weighted mean difference −0.5, 95% confidence interval −2.9 to 1.9) and disability (0.4, −1.7 to 2.5) or improving quality of life (0.4, −0.9 to 1.7) in the short term in people with low back pain. For hip or knee osteoarthritis there was “high quality” evidence that paracetamol provides a significant, although not clinically important, effect on pain (−3.7, −5.5 to −1.9) and disability (−2.9, −4.9 to −0.9) in the short term. The number of patients reporting any adverse event (risk ratio 1.0, 95% confidence interval 0.9 to 1.1), any serious adverse event (1.2, 0.7 to 2.1), or withdrawn from the study because of adverse events (1.2, 0.9 to 1.5) was similar in the paracetamol and placebo groups. Patient adherence to treatment (1.0, 0.9 to 1.1) and use of rescue medication (0.7, 0.4 to 1.3) was also similar between groups. “High quality” evidence showed that patients taking paracetamol are nearly four times more likely to have abnormal results on liver function tests (3.8, 1.9 to 7.4), but the clinical importance of this effect is uncertain. Conclusions Paracetamol is ineffective in the treatment of low back pain and provides minimal short term benefit for people with osteoarthritis. These results support the reconsideration of recommendations to use paracetamol for patients with low back pain and osteoarthritis of the hip or knee in clinical practice guidelines. Systematic review registration PROSPERO registration number CRD42013006367.
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7.2
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