Study register · detailRCT · Multiple Sclerosis · 2012
Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebo-controlled trial
Corey-Bloom et al.·Canadian Medical Association JournalImpact 1.4
Clear benefitGRADEModerate229 citations
Samplen = 30 Pat.
Duration3 days treatment + 11 days…
ControlIdentical placebo cigarettes, once daily…
EndpointModified Ashworth scale
Blindingdoppelblind
DesignRCT
Cannabinoidvollspektrum
Routeinhalativ
”Key finding
Smoked cannabis reduced spasticity (Ashworth scale by 2,74 points more than placebo, p<0,0001) and pain significantly, but impaired cognition (PASAT score worsened by 8,67 points more, p=0,003).
Summary
n=30 MS patients with treatment-refractory spasticity, randomised crossover study of smoked cannabis (1x daily for 3 days) vs. placebo. Primary endpoint: Cannabis reduced spasticity (modified Ashworth Scale) by an average of 2,74 points more than placebo (p<0,0001). Secondary: pain reduction (VAS) by 5,28 points more than placebo (p=0,008). Timed Walk with no significant difference (p=0,2). Cognitive function (PASAT) worsened under cannabis by 8,67 points more than under placebo (p=0,003). No serious adverse events.
P
PopulationAdults with multiple sclerosis and spasticity (treatment-resistant), n=30 completers (37 randomised)
I
InterventionSmoked cannabis (cannabis cigarette), once daily over 3 days
C
ControlIdentical placebo cigarettes, once daily over 3 days
O
OutcomeReduction of spasticity on the modified Ashworth scale by an average of 2,74 points more than placebo (p<0,0001); pain reduction (VAS) by 5,28 points more than placebo (p=0,008); cognitive function (PASAT) worse by 8,67 points than placebo (p=0,003)
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Background: Spasticity is a common and poorly controlled symptom of multiple sclerosis. Our objective was to determine the short-term effect of smoked cannabis on this symptom.
Methods: We conducted a placebo-controlled, crossover trial involving adult patients with multiple sclerosis and spasticity. We recruited participants from a regional clinic or by referral from specialists. We randomly assigned participants to either the intervention (smoked cannabis, once daily for three days) or control (identical placebo cigarettes, once daily for three days). Each participant was assessed daily before and after treatment. After a washout interval of 11 days, participants crossed over to the opposite group. Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale. Our secondary outcomes included patients' perception of pain (as measured using a visual analogue scale), a timed walk and changes in cognitive function (as measured by patient performance on the Paced Auditory Serial Addition Test), in addition to ratings of fatigue.
Results: Thirty-seven participants were randomized at the start of the study, 30 of whom completed the trial. Treatment with smoked cannabis resulted in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo (p < 0.0001). In addition, treatment reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo (p = 0.008). Scores for the timed walk did not differ significantly between treatment and placebo (p = 0.2). Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo (p = 0.003). No serious adverse events occurred during the trial.
Interpretation: Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity. Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact.