Rheumatology Section, VA Boston Healthcare System, Boston, Massachusetts; VA Cooperative Studies Program, VA Boston Healthcare System, Boston, Massachusetts.
VA Cooperative Studies Program, VA Boston Healthcare System, Boston, Massachusetts.
Clin Ther. 2023 May;45(5):468-477. doi: 10.1016/j.clinthera.2023.03.013. Epub 2023 Apr 10.
Low-dose naltrexone (LDN) is commonly used to control pain and other symptoms, especially in patients with autoimmune diseases, but with limited evidence. This study tests the efficacy of LDN in reducing chronic pain in patients with osteoarthritis (OA) and inflammatory arthritis (IA), where existing approaches often fail to adequately control pain.
In this randomized, double-blind, placebo-controlled, crossover clinical trial, each patient received 4.5 mg LDN for 8 weeks and placebo for 8 weeks. Outcome measures were patient reported, using validated questionnaires. The primary outcome was differences in pain interference during the LDN and placebo periods, using the Brief Pain Inventory (scale, 0-70). Secondary outcomes included changes in mean pain severity, fatigue, depression, and multiple domains of health-related quality of life. The painDETECT questionnaire classified pain as nociceptive, neuropathic, or mixed. Data were analyzed using mixed-effects models.
Seventeen patients with OA and 6 with IA completed the pilot study. Most patients described their pain as nociceptive (n = 9) or mixed (n = 8) rather than neuropathic (n = 3). There was no difference in change in pain interference after treatment with LDN (mean [SD], -23 [19.4]) versus placebo (mean [SD], -22 [19.2]; P = 0.90). No significant differences were seen in pain severity, fatigue, depression, or health-related quality of life.
In this small pilot study, findings do not support LDN being efficacious in reducing nociceptive pain due to arthritis. Too few patients were enrolled to rule out modest benefit or to assess inflammatory or neuropathic pain.
gov identifier: NCT03008590.
低剂量纳曲酮（LDN）常用于控制疼痛和其他症状，尤其在自身免疫性疾病患者中，但证据有限。本研究旨在测试 LDN 降低骨关节炎（OA）和炎症性关节炎（IA）患者慢性疼痛的疗效，这些患者的疼痛通常无法通过现有方法充分控制。
这是一项随机、双盲、安慰剂对照、交叉临床试验，每位患者分别接受 LDN（4.5mg）治疗 8 周和安慰剂治疗 8 周。使用经过验证的问卷评估患者报告的结果。主要结局为 LDN 和安慰剂期间疼痛干扰的差异，采用 Brief Pain Inventory（量表，0-70）评估。次要结局包括平均疼痛严重程度、疲劳、抑郁和多个健康相关生活质量领域的变化。疼痛 DETECT 问卷将疼痛分类为伤害感受性、神经病理性或混合性。使用混合效应模型分析数据。
17 例 OA 患者和 6 例 IA 患者完成了这项初步研究。大多数患者（9 例描述为伤害感受性，8 例描述为混合性）而非神经病理性疼痛（3 例）。LDN 治疗后疼痛干扰的变化与安慰剂治疗无差异（LDN：平均[标准差]，-23[19.4]；安慰剂：平均[标准差]，-22[19.2]；P=0.90）。疼痛严重程度、疲劳、抑郁或健康相关生活质量均未见显著差异。
在这项小型初步研究中，LDN 对关节炎引起的伤害感受性疼痛无效，结果不支持 LDN 有效。纳入的患者太少，无法排除适度获益或评估炎症性或神经病理性疼痛。
gov 标识符：NCT03008590。
