Journal
MULTIPLE SCLEROSIS AND RELATED DISORDERS
Volume 63, Issue -, Pages -Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.msard.2022.103925
Keywords
Pain; Neuropathic pain; Multiple sclerosis; Secondary progressive multiple sclerosis; Analgesia; Randomized controlled trial; Serotonin uptake inhibitor
Categories
Funding
- University College London (UCL)
- ClinicalTrials.gov. [NCT01910259]
- Efficacy and Mechanism Evaluation (EME) Programme [11/30/11]
- Medical Research (MRC)
- National Institute for Health Research (NIHR)
- UK Multiple Sclerosis (MS) Society
- US National MS Society
- University of Edinburgh
- NIHR-UCL Hospitals Biomedical Research Centre and UCL
- NIHR Leeds Clinical Research Facility (Dental Translation and Clinical Research Unit)
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The use of Fluoxetine, Riluzole, or Amiloride did not result in significant improvement of neuropathic pain symptoms in adults with secondary progressive MS, compared to a placebo.
Background: Evidence-based treatment of pain in people with MS presents a major unmet need. Objective: 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. Methods: 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. Results: 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). Conclusion: Use of Fluoxetine, Riluzole or Amiloride was not associated with improvement in neuropathic pain symptoms, in comparison to placebo.
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