Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.
Collin et al.·European journal of neurologyImpact 3.9
Clear benefitGRADEHigh381 citations
Samplen = 184 Pat.
Duration6 weeks
ControlPlacebo
EndpointNRS
Blindingdoppelblind
DesignRCT (doppelblind, multizentrisch)
Cannabinoidvollspektrum
Routeoromukosal
”Key finding
The cannabis-based medicine showed significant superiority over placebo in the primary endpoint measurement (Numeric Rating Scale for spasticity, P=0,048) and resulted in a 40% responder rate with >30% improvement (P=0,014).
Summary
n=184 MS patients with spasticity, oromucosal THC/CBD preparation vs. placebo (6 weeks, double-blind, multicentre); primary endpoint NRS spasticity favouring verum (P=0.048); responder analysis: 40% achieved >30% benefit (P=0.014).
P
PopulationAdults with confirmed multiple sclerosis and spasticity, n=189 (ITT n=184)
I
InterventionOromucosal cannabis-based medicine (THC + CBD, whole-plant extract), daily over 6 weeks
C
ControlPlacebo (oromucosal)
O
OutcomeSignificant superiority of the active preparation in the primary endpoint (NRS spasticity, p=0.048); 40% of patients achieved >30% improvement (p=0.014); secondary endpoints (Ashworth score, spasms) not significant, but favouring verum
Confidence in the evidence
Very lowLowModerateHigh
High
The highest of four GRADE levels, the effect estimate is very reliable.
Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be difficult to treat. We have investigated the efficacy, safety and tolerability of a standardized oromucosal whole plant cannabis-based medicine (CBM) containing delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. A total of 189 subjects with definite MS and spasticity were randomized to receive daily doses of active preparation (n = 124) or placebo (n = 65) in a double blind study over 6 weeks. The primary endpoint was the change in a daily subject-recorded Numerical Rating Scale of spasticity. Secondary endpoints included a measure of spasticity (Ashworth Score) and a subjective measure of spasm. The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). Secondary efficacy measures were all in favour of active preparation but did not achieve statistical significance. The responder analysis favoured active preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals were attributed to adverse events (AEs); six were on active preparation and two on placebo. We conclude that this CBM may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS.