The George Institute for Global Health, Missenden Rd, PO Box M201, Sydney, NSW, 2050, Australia.
Eur Spine J. 2012 Mar;21(3):375-81. doi: 10.1007/s00586-011-2023-z. Epub 2011 Oct 27.
Previous reviews of randomised controlled trials (RCTs) for low-back pain (LBP) have failed to identify any positive trend in study quality with more recent years of publication. This study aimed to identify and describe trends over time in the study design characteristics and risk of bias in chronic LBP trials performed over the past 30 years.
One fifty-seven randomised trials of interventions for chronic LBP were extracted from recently published systematic reviews. The reviews included RCTs on physical and rehabilitation interventions, injection therapy and denervation procedures, complementary and alternative therapies and pharmacological interventions for chronic LBP. Study level data were extracted and analysed for trends associated with year of publication.
Overall, the mean sample size in the RCTs was 141 (median 70; range 17-3093). There was a slight increase in the median number of risk of bias criteria fulfilled from trials published prior to 1995 to those published after 1996. The analysis showed that in more recent years RCTs of medical interventions were more likely to be successfully blinded than RCTs of non-medical interventions.
The continuing uncertainty regarding the efficacy of many interventions for chronic LBP again stresses the need for large RCTs with low risk of bias. Further research is needed into specific risks of bias within the RCTs for chronic LBP and the effect they have on the plausibility of the results.
先前对腰痛（LBP）随机对照试验（RCT）的综述未能发现随着研究发表时间的推移，研究质量有任何积极的趋势。本研究旨在确定并描述过去 30 年来慢性 LBP 试验在研究设计特征和偏倚风险方面随时间的变化趋势。
从最近发表的系统综述中提取了 157 项慢性 LBP 干预措施的随机试验。综述包括物理和康复干预、注射治疗和去神经手术、补充和替代疗法以及慢性 LBP 的药物干预的 RCT。提取研究水平的数据并进行分析，以确定与发表年份相关的趋势。
总体而言，RCT 的平均样本量为 141 例（中位数 70 例；范围 17-3093 例）。在发表于 1995 年之前的试验和发表于 1996 年之后的试验中，满足偏倚风险标准的中位数数量略有增加。分析表明，在最近几年，医学干预 RCT 比非医学干预 RCT 更有可能成功进行盲法。
许多慢性 LBP 干预措施的疗效仍存在持续的不确定性，这再次强调了需要进行低偏倚风险的大型 RCT。需要进一步研究慢性 LBP RCT 中的具体偏倚风险及其对结果可信度的影响。
