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Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain
JAMA ( IF 120.7 ) Pub Date : 2018-03-06 , DOI: 10.1001/jama.2018.0899
Erin E Krebs 1, 2 , Amy Gravely 1 , Sean Nugent 1 , Agnes C Jensen 1 , Beth DeRonne 1 , Elizabeth S Goldsmith 1, 3 , Kurt Kroenke 4, 5, 6 , Matthew J Bair 4, 5, 6 , Siamak Noorbaloochi 1, 2
Affiliation  

Importance Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain. Objective To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects. Design, Setting, and Participants Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized. Interventions Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response. Main Outcomes and Measures The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores = worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19). Results Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P = .58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, −0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P = .03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]). Conclusions and Relevance Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain. Trial Registration clinicaltrials.gov Identifier: NCT01583985

中文翻译:

阿片类药物与非阿片类药物对慢性背痛或髋关节或膝关节骨关节炎疼痛患者疼痛相关功能的影响

重要性 关于阿片类药物与非阿片类药物治疗慢性疼痛的长期结果的证据有限。目的 比较 12 个月内阿片类药物与非阿片类药物对疼痛相关功能、疼痛强度和不良反应的影响。设计、设置和参与者 实用的、为期 12 个月的随机试验,具有隐蔽结果评估。患者是从 2013 年 6 月至 2015 年 12 月从退伍军人事务部初级保健诊所招募的;随访于 2016 年 12 月完成。符合条件的患者尽管使用镇痛剂,但仍有中度至重度的慢性背痛或髋关节或膝关节骨关节炎疼痛。在入组的 265 名患者中,25 名在随机化前退出,240 名被随机化。干预 两种干预(阿片类药物和非阿片类药物治疗)都遵循针对目标的治疗策略,旨在改善疼痛和功能。每个干预措施都有自己的处方策略,包括分 3 个步骤的多种药物选择。在阿片类药物组中,第一步是立即释放吗啡、羟考酮或氢可酮/对乙酰氨基酚。对于非阿片类药物组,第一步是使用对乙酰氨基酚(扑热息痛)或非甾体抗炎药。根据个体患者的反应,在分配的治疗组内改变、添加或调整药物。主要结果和措施 主要结果是 12 个月内的疼痛相关功能(Brief Pain Inventory [BPI] 干扰量表),主要次要结果是疼痛强度(BPI 严重程度量表)。对于两个 BPI 量表(范围,0-10;较高的分数 = 较差的功能或疼痛强度),1 分的改善在临床上很重要。主要不良结果是与药物相关的症状(患者报告的清单;范围,0-19)。结果 在随机分组的 240 名患者(平均年龄 58.3 岁;女性,32 名 [13.0%])中,234 名(97.5%)完成了试验。12 个月内,各组在疼痛相关功能方面没有显着差异(总体 P = .58);阿片类药物组的平均 12 个月 BPI 干扰为 3.4,非阿片类药物组为 3.3(差异,0.1 [95% CI,-0.5 至 0.7])。12 个月内,非阿片类药物组的疼痛强度明显更好(总体 P = .03);阿片类药物组的平均 12 个月 BPI 严重程度为 4.0,非阿片类药物组为 3.5(差异,0.5 [95% CI,0.0 至 1.0])。12 个月内,阿片类药物组的不良药物相关症状明显更常见(总体 P = .03);阿片类药物组 12 个月时的平均药物相关症状为 1.8,非阿片类药物组为 0.9(差异,0.9 [95% CI,0.3 至 1.5])。结论和相关性 在 12 个月内,阿片类药物治疗在改善疼痛相关功能方面并不优于非阿片类药物治疗。结果不支持对中度至重度慢性背痛或髋关节或膝关节骨关节炎疼痛开始阿片类药物治疗。试验注册clinicaltrials.gov 标识符:NCT01583985 结论和相关性 在 12 个月内,阿片类药物治疗在改善疼痛相关功能方面并不优于非阿片类药物治疗。结果不支持对中度至重度慢性背痛或髋关节或膝关节骨关节炎疼痛开始阿片类药物治疗。试验注册clinicaltrials.gov 标识符:NCT01583985 结论和相关性 在 12 个月内,阿片类药物治疗在改善疼痛相关功能方面并不优于非阿片类药物治疗。结果不支持对中度至重度慢性背痛或髋关节或膝关节骨关节炎疼痛开始阿片类药物治疗。试验注册clinicaltrials.gov 标识符:NCT01583985
更新日期:2018-03-06
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