A placebo-controlled randomized clinical trial of nortriptyline for chronic low back pain
A placebo-controlled randomized clinical trial of nortriptyline for chronic low back pain
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DOI：
10.1016/s0304-3959(98)00064-5
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发表时间：
1998-06-01
期刊：
影响因子：
7.4
通讯作者：
Garfin, SR
中科院分区：
文献类型：
--
作者：
Atkinson, JH;Slater, MA;Garfin, SR
为了评估去甲替林（一种三环抗抑郁药）作为无抑郁慢性背痛镇痛药的疗效，我们进行了一项随机、双盲、安慰剂对照的8周试验，招募了78名来自初级保健和普通骨科的男性，他们患有慢性腰痛（每天疼痛在T-6或以下，持续6个月或更长时间）。其中57人完成了试验；在21名未完成治疗的患者中，有4人因不良反应而退出治疗。干预包括惰性安慰剂或去甲替林滴定到治疗重度抑郁症的治疗范围内（50-150 ng/ml）。主要结局终点是疼痛（描述差异量表）、残疾（疾病影响概况）、健康相关生活质量（幸福质量量表）、情绪（贝克抑郁量表、斯皮尔伯格状态焦虑量表、汉密尔顿焦虑/抑郁评定量表）和医生评定结果（临床总体印象）。随机分配到去甲替林组的参与者疼痛强度评分的降低明显更大（平均变化差异为1.68,95% -0.001,CI -3.36, P = 0.050），疼痛减轻22%，而安慰剂组为9%。去甲替林在减少残疾方面有微弱优势（P = 0.055），但与健康相关的生活质量、情绪和医生对总体结果的评价在两种治疗之间没有显著差异。研究完成者的亚组分析支持意向治疗分析。此外，与安慰剂组（n = 6）相比，去甲替林组（n = 5）有明显（P < 0.05）更好的镇痛效果和总体结果。结果提示去甲肾上腺素能机制与背痛镇痛有关。这种疼痛强度的适度降低表明，医生应该仔细权衡去甲替林治疗无抑郁症的慢性背痛的风险和益处。(C) 1998国际疼痛研究协会。Elsevier Science B.V.出版
To assess the efficacy of nortriptyline, a tricyclic antidepressant, as an analgesic in chronic back pain without depression, we conducted a randomized, double-blind, placebo-controlled, 8-week trial in 78 men recruited from primary care and general orthopedic settings, who had chronic low back pain (pain at T-6 or below on a daily basis for 6 months or longer). Of these 57 completed the trial; of the 21 who did nor complete, four were withdrawn because of adverse effects. The intervention consisted of inert placebo or nortriptyline titrated to within the therapeutic range for treating major depression (50-150 ng/ml). The main outcome endpoints were pain (Descriptor Differential Scale), disability (Sickness Impact Profile), health-related quality of life (Quality of Well-Being Scale), mood (Beck Depression Inventory, Spielberger State Anxiety Inventory, Hamilton Anxiety/Depression Rating Scales), and physician rated outcome (Clinical Global Impression). Reduction in pain intensity scores was significantly greater for participants randomized to nortriptyline (difference in mean change 1.68, 95% -0.001, CI -3.36, P = 0.050), with a reduction of pain by 22% compared to 9% on placebo. Reduction in disability marginally favored nortriptyline (P = 0.055), but health-related quality of life, mood, and physician ratings of overall outcome did not differ significantly between treatments. Subgroup analyses of study completers supported the intent-to-treat analysis. Also, completers with radicular pain on nortriptyline (n = 5) had significantly (P < 0.05) better analgesia and overall outcome than did those on placebo (n = 6). The results suggest noradrenergic mechanisms are relevant to analgesia in back pain. This modest reduction in pain intensity suggests that physicians should carefully weigh the risks and benefits of nortriptyline in chronic back pain without depression. (C) 1998 International Association for the Study of Pain. Published by Elsevier Science B.V.