Study register · detailRCT · Multiple Sclerosis · 2025
A randomized trial on efficacy of purified cannabidiol on spasticity in multiple sclerosis patients with gait problems: first report in Iran.
Mousavi et al.·Naunyn-Schmiedeberg's archives of pharmacologyImpact 3.0
MixedGRADEModerate0 citations
Samplen = 49 Pat.
Duration1 month
ControlPlacebo
EndpointT25-FW
Blindingdoppelblind
DesignRCT
Cannabinoidcbd
Max. dose80.0 mg
Routeoral
”Key finding
CBD did not significantly reduce spasticity, but significantly improved walking speed (T25-FW) and reduced pain more than placebo.
Summary
n=49 MS patients with spasticity-related walking problems, randomized to purified CBD (5–80 mg/day over 4 weeks, n=24) vs. placebo (n=25). Timed 25-Foot Walk (T25-FW): significantly greater reduction in the intervention group (p=0.031); maximum pain significantly more reduced (p=0.033). No significant difference in spasticity severity (Modified Ashworth Scale) between groups at baseline, 4 and 8 weeks.
P
PopulationMS patients with spasticity-related walking problems, n=49
I
InterventionPure CBD (C2 oral drops), up-titration from 5 mg/day to 70 mg/day over 2 weeks, then 80 mg/day until week 4, oral
C
ControlPlacebo (oral drops)
O
OutcomeT25-FW test duration significantly more reduced in the CBD group vs. placebo (p=0,031); pain reduction also significantly greater (p=0,033); no significant difference in spasticity severity
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeMixed
Citations / year★★★★★
Authors
Mousavi P, Emadzadeh M, Karimikhoshnoudian B, Sahraian MA, Ghaffari M, Shaygannejad V, Payere M, Baghaei A, Zabeti A, Nahayati M
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.