Licciardone John C, Aryal Subhash
The Osteopathic Research Center, University of North Texas Health Science Center, United States; Department of Medical Education, Texas College of Osteopathic Medicine, University of North Texas Health Science Center, United States.
The Osteopathic Research Center, University of North Texas Health Science Center, United States; Department of Biostatistics, School of Public Health, University of North Texas Health Science Center, United States.
Man Ther. 2014 Dec;19(6):541-8. doi: 10.1016/j.math.2014.05.012. Epub 2014 Jun 5.
Clinical response and relapse following a regimen of osteopathic manual treatment (OMT) were assessed in patients with chronic low back pain (LBP) within the OSTEOPATHIC Trial, a randomized, double-blind, sham-controlled study. Initial clinical response and subsequent stability of response, including final response and relapse status at week 12, were determined in 186 patients with high baseline pain severity (≥50 mm on a 100-mm visual analogue scale). Substantial improvement in LBP, defined as 50% or greater pain reduction relative to baseline, was used to assess clinical response at weeks 1, 2, 4, 6, 8, and 12. Sixty-two (65%) patients in the OMT group attained an initial clinical response vs. 41 (45%) patients in the sham OMT group (risk ratio [RR], 1.45; 95% confidence interval [CI], 1.11-1.90). The median time to initial clinical response to OMT in these patients was 4 weeks. Among patients with an initial clinical response prior to week 12, 13 (24%) patients in the OMT group vs. 18 (51%) patients in the sham OMT group relapsed (RR, 0.47; 95% CI, 0.26-0.83). Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.
在整骨疗法试验中，对慢性腰痛（LBP）患者采用整骨手法治疗（OMT）方案后的临床反应和复发情况进行了评估。该试验是一项随机、双盲、假对照研究。在186例基线疼痛严重程度较高（100毫米视觉模拟量表上≥50毫米）的患者中，确定了初始临床反应以及随后的反应稳定性，包括第12周时的最终反应和复发状态。LBP的显著改善定义为相对于基线疼痛减轻50%或更多，用于评估第1、2、4、6、8和12周时的临床反应。OMT组中有62例（65%）患者获得了初始临床反应，而假OMT组中有41例（45%）患者获得了初始临床反应（风险比[RR]，1.45；95%置信区间[CI]，1.11 - 1.90）。这些患者对OMT产生初始临床反应的中位时间为4周。在第12周之前有初始临床反应的患者中，OMT组中有13例（24%）患者复发，而假OMT组中有18例（51%）患者复发（RR，0.47；95% CI，0.26 - 0.83）。总体而言，OMT组中有49例（52%）患者在第12周时达到或维持了临床反应，而假OMT组中有23例（25%）患者达到或维持了临床反应（RR，2.04；95% CI，1.36 - 3.05）。OMT短期疗效的大效应量是由未复发的稳定反应者驱动的。
