Anne Rowling Regenerative Neurology Clinic, Chancellor's Building, University of Edinburgh, 49 Little France Crescent, Edinburgh EH16 4SB, United Kingdom.
Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.
Mult Scler Relat Disord. 2022 Jul;63:103925. doi: 10.1016/j.msard.2022.103925. Epub 2022 May 28.
Evidence-based treatment of pain in people with MS presents a major unmet need.
We aimed to establish if use of Fluoxetine, Riluzole or Amiloride improved neuropathic pain outcomes in comparison to placebo, in adults with secondary progressive MS participating in a trial of these putative neuroprotectants.
In pre-specified secondary analyses of the MS SMART phase-2b double-blind randomised controlled trial (NCT01910259), we analyzed reports of neuropathic pain, overall pain, and pain interference. Multivariate analyses included adjustment for baseline pain severity. Additionally, we explored associations of pain severity with clinical and MRI brain imaging variables.
445 Participants were recruited from 13 UK neuroscience centres. We found no statistically significant benefit of active intervention on any rating of neuropathic pain, or pain overall. Compared to placebo, adjusted mean difference in pain intensity was 0.38 (positive values favouring placebo, 95%CI -0.30 to 1.07, p = 0.27) for Amiloride; 0.52 (-0.17 to 1.22, p = 0.14) for Fluoxetine; and 0.40 (-0.30 to 1.10, p = 0.26) for Riluzole. Pain severity was positively correlated with depressive symptoms (Spearman correlation 0.19, 95%CI 0.10-0.28) and fatigue (Rho 0.30, 95%CI 0.20-0.39).
Use of Fluoxetine, Riluzole or Amiloride was not associated with improvement in neuropathic pain symptoms, in comparison to placebo.
在多发性硬化症患者中，基于证据的疼痛治疗存在重大未满足的需求。
我们旨在确定与安慰剂相比，氟西汀、利鲁唑或阿米洛利在参与这些潜在神经保护剂试验的继发性进展性多发性硬化症成人中是否改善了神经性疼痛结局。
在 MS SMART 二期双盲随机对照试验（NCT01910259）的预先指定的二次分析中，我们分析了神经性疼痛、总体疼痛和疼痛干扰的报告。多变量分析包括对基线疼痛严重程度的调整。此外，我们还探讨了疼痛严重程度与临床和 MRI 脑成像变量的关联。
从 13 个英国神经科学中心招募了 445 名参与者。我们没有发现活性干预对任何神经性疼痛或总体疼痛评分有统计学上的显著益处。与安慰剂相比，阿米洛利的疼痛强度调整平均差异为 0.38（正值有利于安慰剂，95%CI-0.30 至 1.07，p=0.27）；氟西汀为 0.52（-0.17 至 1.22，p=0.14）；利鲁唑为 0.40（-0.30 至 1.10，p=0.26）。疼痛严重程度与抑郁症状（Spearman 相关系数 0.19，95%CI 0.10-0.28）和疲劳（Rho 0.30，95%CI 0.20-0.39）呈正相关。
与安慰剂相比，使用氟西汀、利鲁唑或阿米洛利与神经性疼痛症状的改善无关。
