Efficacy of Sativex® on pain, spasticity, and disability in patients with multiple sclerosis: A systematic review and meta-analysis

: Multiple Sclerosis (MS) is a neurological disorder that commonly begins in young adulthood and impacts central nervous system (CNS) through an autoimmune process. Pain is a frequent and heterogeneous symptom of this disease, but it is often overlooked and inadequately treated. Furthermore, among the most significant clinical manifestations, spasticity, present in 60-84% of MS patients, is not only a major disability factor but also contributes significantly to pain perception and worsening motor function.This systematic review and meta-analysis were conducted to evaluate the available evidence on the efficacy of Sativex® (Nabiximols), not only in pain control but also in the management of spasticity and disability caused by MS.A literature search was conducted on three main databases (PubMed, Scopus, and Web of Science), following the PRISMA guidelines, retrieving 1203 articles, of which 20 met the inclusion criteria and were selected for the systematic review and meta-analysis.Results showed a significant reduction in pain intensity, measured using the Numeric Rating Scale (NRS), after treatment with Sativex® (Standardized Mean Change [SMC]: -0.88, 95% CI -1.20 to -0.57, p < 0.0001). A significant reduction in spasticity severity was also observed (SMC: -1.29, 95% CI -1.63 to -0.94, p < 0.0001). In addition, a modest but statistically significant improvement in disability, assessed by Expanded Disability Status Scale (EDSS), was detected (SMC: -0.17, 95% CI -0.28 to -0.07, p = 0.0015). Overall, evidence suggests that Sativex may represent an effective therapeutic option for the management of pain and spasticity in patients with MS, with potential benefits for functional disability.