Relationship of negative affect and outcome of an opioid therapy trial among low back pain patients.

Relationship of negative affect and outcome of an opioid therapy trial among low back pain patients.
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DOI:
10.1111/j.1533-2500.2012.00575.x
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发表时间:
2013-03
期刊:
Pain practice : the official journal of World Institute of Pain
影响因子:
--
通讯作者:
Wasan AD
Wasan AD
中科院分区:
其他
文献类型:
--
作者:
Jamison RN;Edwards RR;Liu X;Ross EL;Michna E;Warnick M;Wasan AD

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患有慢性非癌性疼痛的患者经常报告抑郁和焦虑的症状(负面影响),这与更高的疼痛强度评分和更大的可能性有关。这项二级分析的目的是验证一项双盲、安慰剂对照研究中的假设,即在阿片类药物耐受的慢性腰痛患者中,初始负面情绪水平可以预测治疗相关的结果。459例(N = 459)患者参加了一项多中心研究的滴定/转换阶段,其中268例随机接受每日一次的氢吗啡酮或安慰剂。所有患者在基线时完成医院焦虑和抑郁量表(HADS),并根据得分平均分为低(N = 157)、中(N = 155)和高(N = 147)负性情绪组。在整个试验过程中,分析了家庭和诊所疼痛强度数值测量、Roland-Morris残疾评分和主观阿片戒断量表(SOWS)症状测量的组间差异。最初的459名受试者中有268人进入了2至4周的滴定/转换阶段(预处理),他们成功地随机分配到安慰剂组或ER氢吗啡酮组;共有110名患者完成了双盲阶段的研究。中度和高度负性情绪组在滴定/转换阶段因处方阿片类药物不良反应或疗效不足而退出的频率高于低负性情绪组(P < 0.05)。总体而言,中等和高组患者在家庭和临床疼痛强度评分上的疼痛强度评分显著高于低组(P < 0.05),在Roland-Morris量表上的残疾程度显著高于低组(P < 0.01),在SOWS上的戒断症状显著高于低组(P < 0.05)。较高的负面情绪评分也预示着在滴定阶段对研究药物的评分较低(P < 0.05)。有趣的是,高负情绪组在安慰剂条件下的疼痛改善最大(P < 0.05)。在阿片类药物治疗的试验中,负面影响与获益减少有关,并且在对照临床试验中预测退出。
Patients with chronic noncancer pain frequently report symptoms of depression and anxiety (negative affect), which are associated with higher ratings of pain intensity and a greater likelihood of being prescribed chronic opioid therapy. The purpose of this secondary analysis was to test the hypothesis that initial levels of negative affect can predict treatment-related outcomes in a double-blind, placebo-controlled study of extended-release (ER) hydromorphone among opioid-tolerant patients with chronic low back pain. Four hundred fifty-nine (N = 459) patients participated in the titration/conversion phase of a multicenter study, of which 268 were randomized to receive once-daily hydromorphone or placebo. All patients completed the Hospital Anxiety and Depression Scale (HADS) at baseline and were divided evenly into Low (N = 157), Moderate (N = 155), and High (N = 147) negative affect groups based on their scores. Group differences in numerical pain intensity measures at home and in the clinic, Roland–Morris Disability ratings, and measures of symptoms from the Subjective Opiate Withdrawal Scale (SOWS) throughout the trial were analyzed. Two hundred sixty-eight of the initial 459 subjects who entered the 2 to 4-week titration/conversion phase (pretreatment) were successfully randomized to either placebo or ER hydromorphone; a total of 110 patients then completed this double-blind phase of the study. Those in the Moderate and High negative affect groups tended to drop out more often during the titration/conversion phase because of the adverse effects or lack of efficacy of their prescribed opioid than those in the Low negative mood group (P < 0.05). Overall, those patients in the Moderate and High groups reported significantly higher pain intensity scores in at-home and in-clinic pain intensity ratings (P < 0.05), greater disability on the Roland–Morris Scale (P < 0.01), and more withdrawal symptoms on the SOWS (P < 0.05) than those in the Low group. Higher negative affect scores also predicted less favorable ratings of the study drug during the titration phase (P < 0.05). Interestingly, the High negative affect group showed the most improvement in pain in the placebo condition (P < 0.05). Negative affect is associated with diminished benefit during a trial of opioid therapy and is predictive of dropout in a controlled clinical trial.
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