Gould Hilary M, Atkinson Joseph Hampton, Chircop-Rollick Tatiana, D'Andrea John, Garfin Steven, Patel Shetal M, Funk Stephen D, Capparelli Edmund V, Penzien Donald B, Wallace Mark, Weickgenanta Anne L, Slater Mark, Rutledge Thomas
VA San Diego Healthcare System, San Diego, CA, United States.
University of California, San Diego, CA, United States.
Pain. 2020 Jun;161(6):1341-1349. doi: 10.1097/j.pain.0000000000001834.
This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipramine and CBT; and (4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland Morris Disability Questionnaires before and after treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre-treatment to post-treatment in pain intensity (mean changes ranged from = -2.58 to 3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04 to 4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from 0.06 to 0.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain.
这项临床试验评估了三环类抗抑郁药（地昔帕明）和认知行为疗法（CBT）相对于活性安慰剂治疗对慢性背痛的独立作用和联合作用。参与者（n = 142）为每日经历强度≥4/10的慢性背痛的患者，他们被随机分配到一项单中心、双盲、为期12周、四组平行对照的临床试验中，试验分组如下：（1）低浓度地昔帕明，滴定至血清浓度水平达到15至65 ng/mL；（2）CBT和活性安慰剂药物（甲磺酸苯扎托品，0.125 mg）；（3）低浓度地昔帕明和CBT；（4）活性苯扎托品安慰剂药物。参与者在治疗前后分别完成差异描述量表和罗兰·莫里斯残疾问卷，作为背痛强度和残疾结果的有效测量指标。每种治疗条件下的参与者从治疗前到治疗后在疼痛强度方面均有显著降低（平均变化范围为=-2.58至3.87，科恩d值=0.46 - 0.84），在疼痛残疾方面有所改善（平均变化=-3.04至4.29，科恩d值=0.54 - 0.88）。然而，治疗后的意向性分析显示，任何治疗条件之间均无显著差异，效应量较小，范围为0.06至0.27。这项临床试验的结果不支持以下假设：即地昔帕明、CBT或它们二者联用在减轻慢性背痛强度或残疾方面在统计学上优于活性药物安慰剂。主要局限性包括招募的样本量为计划样本量的71%，以及使用了多个纳入/排除标准，这可能会限制研究结果推广至更广泛的慢性背痛患者群体。
