A randomized trial on efficacy of purified cannabidiol on spasticity in multiple sclerosis patients with gait problems: first report in Iran

Abstract

This study aims to assess the effectiveness of pure cannabidiol (CBD) in reducing spasticity in multiple sclerosis (MS) patients with spasticity-related walking difficulties. 49Forty-nine MS patients were randomly assigned to receive either CBD C2 oral drops (n = 24, initially 5 mg/day, increasing to 70 mg/day over 2 weeks, and 80 mg/day from the third week to the fourth week) or a placebo (n = 25) at Ghaem Hospital, Mashhad, Iran. After one 1 month of treatment, the timed 25-foot walk (T25-FW) test was conducted, and patients completed several questionnaires, including the Modified Fatigue Impact Scale (MFIS), Multiple Sclerosis Walking Scale (MSWS-12), Urinary Frequency, Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI-II), and EuroQoL (EQ-5D).The duration of the T25-FW test decreased in both groups, but the reduction was significantly greater in the intervention group (IG) compared to the placebo group (PG) (p = 0.031). Both groups experienced a reduction in maximum pain after 1 month, with the IG showing a significantly higher decrease (p = 0.033). There was no significant difference in plasticity levels between the groups at baseline, 4, and 8 weeks. Results indicate that CBD does not significantly reduce spasticity severity in MS patients. However, the T25-FW test results showed a notable reduction in test duration.