Session Information
Session Title: AA 2021 Virtual Posters - General Rehabilitation
Session Time: None. Available on demand.
Disclosures: Mary A. Willis, MD: Alexion (Products/Services: No) (Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Biogen (Products/Services: No) (Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Genentech (Products/Services: No) (Consultant/Advisory Board)Greenwich Biosciences (Products/Services: Yes) (Consultant/Advisory Board)
Objective: Review and report changes in spasticity-related pain or sleep impairment among PwMS using nabiximols.
Design: A systematic literature review of observational studies of nabiximols for treatment of MS spasticity, reporting concurrent pain or sleep impairment outcomes.Setting : Observational studies and treatment registries.Participants : Adults with MS-related spasticity.
Interventions: Nabiximols oromucosal spray (delta-9-tetrahydrocannibinol [THC], cannabidiol [CBD], and other plant-derived cannabinoids and non-cannabinoid constituents).
Main Outcome Measures: Study design, patient characteristics, and spasticity, sleep, and pain outcomes.
Results: Of 95 records identified, 7 met inclusion criteria. All 7 studies assessed pain; 5 assessed sleep. Improvements in spasticity were reported across all studies, typically measured by spasticity numerical rating scale (NRS, 0–10) score after 1 month of treatment (mean reductions ranged from 0.9 to 2.8 points). All 7 studies reported some degree of improvement in pain at follow-up times ranging from 1 to 6 months. In the 4 studies that included the pain NRS (0–10), mean reductions from baseline were statistically significant in each study, with point estimates for mean (percentage) change ranging between 1.2 (24%) and 3.1 (51%). Across all 5 studies reporting on sleep, nabiximols decreased sleep disruptions and/or improved sleep quality at follow-up times ranging from 1 to 12 months. In the 4 studies in PwMS that assessed sleep impairment with the sleep NRS score (0–10), mean reductions from baseline were statistically significant in each study, with point estimates for mean (percentage) change ranging between 0.9 (23%) and 1.9 (37%). Nabiximols treatment was generally well tolerated, with adverse events occurring in 10% to 81% of participants; dizziness and fatigue were most common.Conclusions: Results from 7 real-world studies assessing nabiximols for the treatment of MS spasticity showed improvements in spasticity and concurrent pain and sleep disturbances. Additional research is needed to better understand the relationship between improvements in spasticity and concurrent MS symptoms.
Level of Evidence: Level II
To cite this abstract in AMA style:
Willis MA, Nichol KE, Hollenack KA. Systematic Review of Real-World Evidence on the Effect of Nabiximols on Pain and Sleep Impairment in Persons with MS (PwMS) Experiencing Spasticity [abstract]. PM R. 2021; 13(S1)(suppl 1). https://pmrjabstracts.org/abstract/systematic-review-of-real-world-evidence-on-the-effect-of-nabiximols-on-pain-and-sleep-impairment-in-persons-with-ms-pwms-experiencing-spasticity/. Accessed May 24, 2025.« Back to AAPM&R Annual Assembly 2021
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/systematic-review-of-real-world-evidence-on-the-effect-of-nabiximols-on-pain-and-sleep-impairment-in-persons-with-ms-pwms-experiencing-spasticity/