Yarlas Aaron, Miller Kate, Wen Warren, Lynch Shau Yu, Munera Catherine, Dain Bradley, Pergolizzi Joseph V, Raffa Robert, Ripa Steven R
Optum, Lincoln, Rhode Island, U.S.A.
Purdue Pharma LP, Stamford, Connecticut, U.S.A.
Pain Pract. 2016 Apr;16(4):473-85. doi: 10.1111/papr.12298. Epub 2015 Apr 11.
Chronic pain (CP) patients with depression typically exhibit worse post-treatment outcomes than nondepressed CP patients. The cause is often assumed to reflect a differential response to treatment, neglecting other potential explanations, such as the continuation of differences in pretreatment outcomes. This post hoc analysis examines whether worse post-treatment outcomes for depressed patients with chronic low back pain (CLBP) are driven by reduced treatment efficacy.
Data were from opioid-naïve adult patients with moderate-to-severe CLBP who participated in a randomized, placebo-controlled, double-blind clinical trial of Butrans(®) (buprenorphine) Transdermal System (BTDS) for pain relief. Depression screening was based on baseline SF-36v2 Mental Health subscale scores. Patient-reported measures of pain severity, pain interference, quality of life, sleep problems, and functional disability were administered at screening and during the study. Differential treatment efficacy for each outcome was examined using analysis of covariance models that included interaction terms between treatment arm and depression status.
At baseline, patients classified as depressed showed greater pain interference, lower quality of life, more sleep problems, and greater functional disability than nondepressed patients; the two groups did not differ in pain severity. No statistically significant interactions between treatment arm and depression status were observed. The direction of improvement post-treatment favored the depressed group on nine of seventeen outcomes.
Results do not support a differential response to BTDS treatment between depressed and nondepressed CLBP patients across a variety of patient-reported outcomes. These findings raise the question of whether depressed mood actually moderates the effectiveness of treatment in CP patients.
与无抑郁的慢性疼痛（CP）患者相比，伴有抑郁的CP患者通常治疗后结局更差。原因通常被认为反映了对治疗的不同反应，而忽略了其他潜在解释，例如治疗前结局差异的持续存在。这项事后分析检验了伴有慢性下腰痛（CLBP）的抑郁患者治疗后结局更差是否是由治疗效果降低所致。
数据来自未使用过阿片类药物的中重度CLBP成年患者，他们参与了一项关于Butrans（®）（丁丙诺啡）透皮系统（BTDS）缓解疼痛的随机、安慰剂对照、双盲临床试验。抑郁筛查基于基线SF - 36v2心理健康子量表评分。在筛查时和研究期间对患者报告的疼痛严重程度、疼痛干扰、生活质量、睡眠问题和功能障碍进行测量。使用协方差分析模型检验每个结局的差异治疗效果，该模型包括治疗组与抑郁状态之间的交互项。
在基线时，被分类为抑郁的患者比无抑郁的患者表现出更大的疼痛干扰、更低的生活质量、更多的睡眠问题和更大的功能障碍；两组在疼痛严重程度上无差异。未观察到治疗组与抑郁状态之间有统计学意义的交互作用。治疗后改善的方向在17个结局中的9个上有利于抑郁组。
结果不支持在各种患者报告的结局方面，抑郁和无抑郁的CLBP患者对BTDS治疗有不同反应。这些发现提出了抑郁情绪是否真的会调节CP患者治疗效果的问题。
