Koes B W, Scholten R J, Mens J M, Bouter L M
Institute for Research in Extramural Medicine, Vrije Universiteit Amsterdam, The Netherlands.
Ann Rheum Dis. 1997 Apr;56(4):214-23. doi: 10.1136/ard.56.4.214.
To assess the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) for low back pain.
Computer aided search of published randomised clinical trials and assessment of the methods of the studies.
26 randomised clinical trials evaluating NSAIDs for low back pain were identified.
Score for quality (maximum = 100 points) of the methods based on four categories: study population; interventions; effect measurement; data presentation and analysis. Determination of success rate per study group and evaluation of different contrasts. Statistical pooling of placebo controlled trials in similar patient groups and using similar outcome measures.
The methods scores of the trials ranged from 27 to 83 points. NSAIDs were compared with placebo treatment in 10 studies. The pooled odds ratio in four trials comparing NSAIDs with placebo after one week was 0.53 (95% confidence intervals 0.32 to 0.89) using the fixed effect model, indicating a significant effect in favour of NSAIDs compared with placebo. In nine studies NSAIDs were compared with other (drug) therapies. Of these, only two studies reported better results of NSAIDs compared with paracetamol with and without dextropropoxyphene. In the other trials NSAIDs were not better than the reference treatment. In 11 studies different NSAIDs were compared, of which seven studies reported no differences in effect.
There are flaws in the design of most studies. The pooled odds ratio must be interpreted with caution because the trials at issue, including the high quality trials, did not use identical outcome measures. The results of the 26 randomised trials that have been carried out to date, suggest that NSAIDs might be effective for short-term symptomatic relief in patients with uncomplicated low back pain, but are less effective or ineffective in patients with low back pain with sciatica and patients with sciatica with nerve root symptoms.
评估非甾体抗炎药（NSAIDs）治疗腰痛的疗效。
通过计算机辅助检索已发表的随机临床试验并评估研究方法。
确定了26项评估NSAIDs治疗腰痛的随机临床试验。
根据四类对方法的质量评分（满分 = 100分）：研究人群；干预措施；效果测量；数据呈现与分析。确定每个研究组的成功率并评估不同的对比。对相似患者组中使用相似结局指标的安慰剂对照试验进行统计合并。
试验的方法评分范围为27至83分。10项研究将NSAIDs与安慰剂治疗进行了比较。使用固定效应模型，四项比较NSAIDs与安慰剂治疗一周后的合并比值比为0.53（95%置信区间0.32至0.89），表明与安慰剂相比，NSAIDs有显著疗效。9项研究将NSAIDs与其他（药物）疗法进行了比较。其中，只有两项研究报告NSAIDs与含或不含右丙氧芬的对乙酰氨基酚相比效果更好。在其他试验中，NSAIDs并不比对照治疗更好。11项研究对不同的NSAIDs进行了比较，其中7项研究报告效果无差异。
大多数研究设计存在缺陷。合并比值比必须谨慎解释，因为所讨论的试验，包括高质量试验，并未使用相同的结局指标。迄今为止进行的26项随机试验结果表明，NSAIDs可能对无并发症的腰痛患者短期症状缓解有效，但对伴有坐骨神经痛的腰痛患者和伴有神经根症状的坐骨神经痛患者效果较差或无效。
