Saragiotto Bruno T, Machado Gustavo C, Ferreira Manuela L, Pinheiro Marina B, Abdel Shaheed Christina, Maher Christopher G
Musculoskeletal Division, The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia.
Cochrane Database Syst Rev. 2016 Jun 7;2016(6):CD012230. doi: 10.1002/14651858.CD012230.
Analgesic medication is the most frequently prescribed treatment for low back pain (LBP), of which paracetamol (acetaminophen) is recommended as the first choice medication. However, there is uncertainty about the efficacy of paracetamol for LBP.
To investigate the efficacy and safety of paracetamol for non-specific LBP.
We conducted searches on the Cochrane Central Register of Controlled Trials (CENTRAL, which includes the Back and Neck Review Group trials register), MEDLINE, EMBASE, CINAHL, AMED, Web of Science, LILACS, and IPA from their inception to 7 August 2015. We also searched the reference lists of eligible papers and trial registry websites (WHO ICTRP and ClinicalTrials.gov).
We only considered randomised trials comparing the efficacy of paracetamol with placebo for non-specific LBP. The primary outcomes were pain and disability. We also investigated quality of life, function, adverse effects, global impression of recovery, sleep quality, patient adherence, and use of rescue medication as secondary outcomes.
Two review authors independently performed the data extraction and assessed risk of bias in the included studies. We also evaluated the quality of evidence using the GRADE approach. We converted scales for pain intensity to a common 0 to 100 scale. We quantified treatment effects using mean difference for continuous outcomes and risk ratios for dichotomous outcomes. We used effect sizes and 95% confidence intervals as a measure of treatment effect for the primary outcomes. When the treatment effects were smaller than 9 points on a 0 to 100 scale, we considered the effect as small and not clinically important.
Our searches retrieved 4449 records, of which three trials were included in the review (n = 1825 participants), and two trials were included in the meta-analysis. For acute LBP, there is high-quality evidence for no difference between paracetamol (4 g per day) and placebo at 1 week (immediate term), 2 weeks, 4 weeks, and 12 weeks (short term) for the primary outcomes. There is high-quality evidence that paracetamol has no effect on quality of life, function, global impression of recovery, and sleep quality for all included time periods. There were also no significant differences between paracetamol and placebo for adverse events, patient adherence, or use of rescue medication. For chronic LBP, there is very low-quality evidence (based on a trial that has been retracted) for no effect of paracetamol (1 g single intravenous dose) on immediate pain reduction. Finally, no trials were identified evaluating patients with subacute LBP.
AUTHORS' CONCLUSIONS: We found that paracetamol does not produce better outcomes than placebo for people with acute LBP, and it is uncertain if it has any effect on chronic LBP.
镇痛药是治疗腰痛(LBP)最常用的处方药,其中对乙酰氨基酚(扑热息痛)被推荐为首选药物。然而,对乙酰氨基酚治疗LBP的疗效尚不确定。
研究对乙酰氨基酚治疗非特异性LBP的疗效和安全性。
我们对Cochrane对照试验中心注册库(CENTRAL,包括背部和颈部综述组试验注册库)、MEDLINE、EMBASE、CINAHL、AMED、Web of Science、LILACS和IPA进行了检索,检索时间从各数据库建库至2015年8月7日。我们还检索了符合条件论文的参考文献列表和试验注册网站(世界卫生组织国际临床试验注册平台和ClinicalTrials.gov)。
我们仅纳入了比较对乙酰氨基酚与安慰剂治疗非特异性LBP疗效的随机试验。主要结局为疼痛和功能障碍。我们还将生活质量、功能、不良反应、总体恢复印象、睡眠质量、患者依从性和急救药物使用情况作为次要结局进行研究。
两位综述作者独立进行数据提取,并评估纳入研究的偏倚风险。我们还使用GRADE方法评估证据质量。我们将疼痛强度量表转换为通用的0至100分制。我们使用连续结局的平均差和二分结局的风险比来量化治疗效果。我们将效应量和95%置信区间作为主要结局治疗效果的衡量指标。当治疗效果在0至100分制上小于9分时,我们认为该效果较小且无临床意义。
我们的检索共获得4449条记录,但仅3项试验(n = 1825名参与者)被纳入综述,2项试验被纳入荟萃分析。对于急性LBP,有高质量证据表明,在1周(近期)、2周、4周和12周(短期)时,对乙酰氨基酚(每日4克)与安慰剂在主要结局方面无差异。有高质量证据表明,在所有纳入的时间段内,对乙酰氨基酚对生活质量、功能、总体恢复印象和睡眠质量均无影响。在不良事件、患者依从性或急救药物使用方面,对乙酰氨基酚与安慰剂之间也无显著差异。对于慢性LBP,有非常低质量的证据(基于一项已撤回的试验)表明,对乙酰氨基酚(单次静脉注射1克)对即刻减轻疼痛无效。最后,未发现评估亚急性LBP患者的试验。
我们发现,对急性LBP患者而言,对乙酰氨基酚并不比安慰剂产生更好的疗效,其对慢性LBP是否有任何效果尚不确定。