Davies Reece A, Maher Christopher G, Hancock Mark J
Back Pain Research Group, University of Sydney, Sydney, Australia.
Eur Spine J. 2008 Nov;17(11):1423-30. doi: 10.1007/s00586-008-0783-x. Epub 2008 Sep 17.
The objective of this study was to assess the efficacy of paracetamol (acetaminophen) in the treatment of pain and disability in patients with non-specific low back pain. We conducted a systematic review of randomized controlled trials to assess the efficacy of paracetamol in the treatment of pain and disability in patients with non-specific low back pain. A search for randomized controlled trials was conducted using the Medline, Embase and CINAHL databases. Trials were eligible if they were randomized controlled trials comparing paracetamol to no treatment, placebo or another treatment in patients with non-specific low back pain. Two of the authors independently assessed trials for methodological quality on the PEDro Scale and extracted data. Continuous pain and disability data were converted to a common 0-10 scale; ordinal data were dichotomized (e.g., no pain, pain). The data was analyzed using the MIX version 1.61 meta-analysis software. Out of 205 unique articles found in the searches, 7 eligible trials were identified. The trials enrolled a total of 676 participants with 5 investigating acute low back pain, 1 investigating chronic low back pain and 1 investigating both. No trial provided data comparing paracetamol to placebo and only one trial compared paracetamol to no treatment. In general the trials were small (only 1 trial had >25 subjects per group) and of low methodological quality (only 2 had a score above 6 on the quality scale). All but one of the trials provided imprecise estimates of the effects of treatment with confidence intervals spanning clinically important beneficial and also harmful effects of paracetamol. No trial reported a statistically significant difference in favor of paracetamol. There is insufficient evidence to assess the efficacy of paracetamol in patients with low back pain. There is a clear need for large, high quality randomized controlled trials evaluating paracetamol, to provide reliable evidence of paracetamol's effectiveness in patients with low back pain and to establish the validity of the recommendations in clinical guidelines.
本研究的目的是评估对乙酰氨基酚（扑热息痛）治疗非特异性下腰痛患者疼痛和功能障碍的疗效。我们对随机对照试验进行了系统评价，以评估对乙酰氨基酚治疗非特异性下腰痛患者疼痛和功能障碍的疗效。使用Medline、Embase和CINAHL数据库检索随机对照试验。纳入标准为：将对乙酰氨基酚与未治疗、安慰剂或其他治疗方法进行比较的非特异性下腰痛患者的随机对照试验。两位作者独立根据PEDro量表评估试验的方法学质量并提取数据。持续性疼痛和功能障碍数据转换为通用的0至10分制；有序数据进行二分法处理（如无疼痛、疼痛）。使用MIX 1.61版荟萃分析软件进行数据分析。在检索到的205篇独特文章中，确定了7项符合条件的试验。这些试验共纳入676名参与者，其中5项研究急性下腰痛，1项研究慢性下腰痛，1项研究两者。没有试验提供对乙酰氨基酚与安慰剂比较的数据，只有1项试验将对乙酰氨基酚与未治疗进行了比较。总体而言，试验规模较小（每组只有1项试验的受试者超过25人）且方法学质量较低（质量量表上只有2项得分高于6分）。除1项试验外，所有试验对治疗效果的估计均不精确，置信区间涵盖了对乙酰氨基酚临床上重要的有益和有害效应。没有试验报告对乙酰氨基酚有统计学上的显著优势。没有足够的证据评估对乙酰氨基酚对下腰痛患者的疗效。显然需要进行大规模、高质量的评估对乙酰氨基酚的随机对照试验，以提供对乙酰氨基酚对下腰痛患者有效性的可靠证据，并确立临床指南中建议的有效性。
