Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial.
Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial.
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DOI：
10.1001/jamanetworkopen.2022.42533
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发表时间：
2022-11-01
影响因子：
13.8
通讯作者：
Bair, Matthew J.
中科院分区：
文献类型：
--
作者：
Bushey, Michael A.;Slaven, James E.;Outcalt, Samantha D.;Kroenke, Kurt;Kempf, Carol;Froman, Amanda;Sargent, Christy;Baecher, Brad;Zillich, Alan J.;Damush, Teresa M.;Saha, Chandan;French, Dustin D.;Bair, Matthew J.
阿片类药物处方患者最有效的疼痛治疗方法是什么？在这项随机临床试验中，261名患有慢性腰痛的退伍军人处方阿片类药物，12个月内，药物优化（降低1.10分）的简明疼痛量表的疼痛改善程度大于认知行为治疗（降低0.68分），这是一个显着但临床上适度的差异。药理学和行为学方法都是治疗阿片类药物患者慢性腰痛的合理选择。这项随机临床试验在接受长期阿片类药物治疗的慢性腰痛美国退伍军人中比较了护理经理提供的疼痛药物优化干预与心理学家提供的认知行为治疗12个月。药物管理和认知行为疗法（CBT）是慢性腰痛（CLBP）的常用治疗方法。然而，几乎没有证据可以比较这些方法的有效性。比较协作护理药物优化与CBT对疼痛强度、干扰和其他疼痛相关结局的影响。有效使用阿片类药物的护理管理（CAMEO）试验是一项为期12个月的比较有效性随机临床试验，具有盲态结局评估。从2011年9月1日至2014年12月31日，7家退伍军人事务部初级保健诊所招募了CLBP长期阿片类药物的退伍军人，并于2015年12月31日完成了随访。分析基于所有随机化受试者的意向治疗，并于2015年3月22日至2021年11月1日进行。患者随机接受护理经理提供的药物优化（MED组）（n = 131）或心理医生提供的CBT（CBT组）（n = 130）的合作护理6个月，9个月时进行登记访视，12个月时进行最终结局评估。主要结局是6个月（治疗完成）和12个月（随访完成）时简明疼痛量表（BPI）总评分的变化，这是疼痛强度和干扰分量表的复合评分。BPI评分范围为0 - 10，评分越高表示疼痛影响越大，30%的改善被认为是有临床意义的治疗反应。次要结局包括疼痛相关残疾、疼痛灾难化、自我报告的物质滥用、健康相关生活质量、抑郁和焦虑。共有261例患者（241例[92.3%]男性;平均[SD]年龄，57.9 [9.5]岁）被随机化并纳入分析。MED组和CBT组的基线平均（SD）BPI评分分别为6.45（1.79）和6.49（1.67）。MED组在12个月时BPI评分的改善显著更大（组间差异，-0.54 [95%CI，-1.18至0.31]; P = 0.04），但在6个月时没有（组间差异，-0.46 [95%CI，-0.94至0.11]; P = 0.07）。治疗组间次要结局无显著差异。在这项随机临床试验中，在接受长期阿片类药物治疗的CLBP美国退伍军人中，在12个月的研究期间，协作护理药物优化在减少疼痛影响方面比CBT更有效。然而，这种差异可能没有临床意义或推广到非退伍军人群体。ClinicalTrials.gov标识符：NCT 01236521
What are the most effective pain treatments for patients prescribed opioids? In this randomized clinical trial of 261 veterans with chronic low back pain prescribed opioids, pain improvement on the Brief Pain Inventory was greater with medication optimization (decrease of 1.10 points) than cognitive behavioral therapy (decrease of 0.68 points) for 12 months, a significant but clinically modest difference. Both pharmacological and behavioral approaches are reasonable options for treating chronic low back pain in patients prescribed opioids. This randomized clinical trial compares a care manager–delivered, pain medication optimization intervention with psychologist-delivered cognitive behavioral therapy for 12 months among US veterans with chronic low back pain who are receiving long-term opioid therapy. Medication management and cognitive behavioral therapy (CBT) are commonly used treatments for chronic low back pain (CLBP). However, little evidence is available comparing the effectiveness of these approaches. To compare collaborative care medication optimization vs CBT on pain intensity, interference, and other pain-related outcomes. The Care Management for the Effective Use of Opioids (CAMEO) trial was a 12-month, comparative effectiveness randomized clinical trial with blinded outcome assessment. Recruitment of veterans with CLBP prescribed long-term opioids occurred at 7 Veterans Affairs primary care clinics from September 1, 2011, to December 31, 2014, and follow-up was completed December 31, 2015. Analyses were based on intention to treat in all randomized participants and were performed from March 22, 2015, to November 1, 2021. Patients were randomized to receive either collaborative care with nurse care manager–delivered medication optimization (MED group) (n = 131) or psychologist-delivered CBT (CBT group) (n = 130) for 6 months, with check-in visits at 9 months and final outcome assessment at 12 months. The primary outcome was change in Brief Pain Inventory (BPI) total score, a composite of the pain intensity and interference subscales at 6 (treatment completion) and 12 (follow-up completion) months. Scores on the BPI range from 0 to 10, with higher scores representing greater pain impact and a 30% improvement considered a clinically meaningful treatment response. Secondary outcomes included pain-related disability, pain catastrophizing, self-reported substance misuse, health-related quality of life, depression, and anxiety. A total of 261 patients (241 [92.3%] men; mean [SD] age, 57.9 [9.5] years) were randomized and included in the analysis. Baseline mean (SD) BPI scores in the MED and CBT groups were 6.45 (1.79) and 6.49 (1.67), respectively. Improvements in BPI scores were significantly greater in the MED group at 12 months (between-group difference, −0.54 [95% CI, −1.18 to −0.31]; P = .04) but not at 6 months (between-group difference, −0.46 [95% CI, −0.94 to 0.11]; P = .07). Secondary outcomes did not differ significantly between treatment groups. In this randomized clinical trial among US veterans with CLBP who were prescribed long-term opioid therapy, collaborative care medication optimization was modestly more effective than CBT in reducing pain impact during the 12-month study. However, this difference may not be clinically meaningful or generalize to nonveteran populations. ClinicalTrials.gov Identifier: NCT01236521
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影响因子：
7.4
作者：
Butler, Stephen F.;Budman, Simon H.;Jamison, Robert N.
通讯作者：
Jamison, Robert N.
影响因子：
3
作者：
HART, LG;DEYO, RA;CHERKIN, DC
通讯作者：
CHERKIN, DC
CDC规定慢性疼痛的阿片类药物的指南 - 美国，2016年。
DOI：
10.1001/jama.2016.1464
发表时间：
2016-04-19
期刊：
JAMA
影响因子：
--
作者：
Dowell D;Haegerich TM;Chou R
通讯作者：
Chou R
影响因子：
39.2
作者：
DeBar L;Mayhew M;Benes L;Bonifay A;Deyo RA;Elder CR;Keefe FJ;Leo MC;McMullen C;Owen-Smith A;Smith DH;Trinacty CM;Vollmer WM
通讯作者：
Vollmer WM
影响因子：
120.7
作者：
Dobscha, Steven K.;Corson, Kathryn;Gerrity, Martha S.
通讯作者：
Gerrity, Martha S.