Study register · detail
No benefit demonstrated
GRADE
High
42 citations
Samplek = 16 Studien
n = 2.597 Pat.
n = 2.597 Pat.
Duration19 weeks
ControlPlacebo or standard therapy
EndpointSpasticity
Blindingdoppelblind
DesignMeta-Analyse
Key finding
Cannabinoids showed no statistically significant benefit for spasticity or spasm frequency, but markedly increased side effects such as dizziness, somnolence and nausea.
Summary
SR+MA of k=16 RCTs (n=2.597) on cannabinoids for MS spasticity or paraplegia spasticity. Moderate evidence for NON-significant spasticity reduction (SMD 0.36, 95% CI -0.17 to 0.88, p=0.18, I²=88%); increased adverse effects: dizziness (RR 3.45, 95% CI 2.71–4.4), somnolence (RR 2.9, 95% CI 1.98–4.23), nausea (RR 2.25, 95% CI 1.62–3.13).
P
PopulationAdults with spasticity due to multiple sclerosis or paraplegia, pooled n=2597
I
InterventionCannabinoids (various substances/administrations)
C
ControlPlacebo or standard therapy
O
OutcomeNo statistically significant reduction in spasticity (SMD 0,36 [95%-CI −0,17 to 0,88; p=0,18]) or spasm frequency (SMD 0,04 [95%-CI −0,15 to 0,22]); significantly increased rate of dizziness (RR 3,45), somnolence (RR 2,9) and nausea (RR 2,25)
Confidence in the evidence
High
The highest of four GRADE levels, the effect estimate is very reliable.
Quality profile
Sample size
★★★★★
Blinding
Double-blind
Effect size
No benefit
Citations / year
★★★★★
Authors
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Abstract
Objectives: Spasticity remains highly prevalent in patients with spinal cord injury and multiple sclerosis. To summarize the effects of cannabinoids compared with usual care, placebo for spasticity due to multiple sclerosis (MS) or paraplegia.
Methods: Searches of MEDLINE, EMBASE, CENTRAL and LILACS to March 2017 were performed to identify randomized controlled trials. The primary outcomes were spasticity and spasm frequency. The criteria were any patient with MS and spasticity affecting upper or lower limbs or both, and that had a confirmed diagnosis of MS based on validated criteria, or however defined by the authors of the included studies.
Results: 16 trials including 2597 patients were eligible. Moderate-certainty evidence suggested a non-statistically significant decrease in spasticity (standardized mean difference (SMD) 0.36 [confidential interval (CI) 95% -0.17 to 0.88; p=0.18; I2=88%]), and spasm frequency (SMD 0.04 [CI 95% -0.15 to 0.22]). There was an increase in adverse events such as dizziness (risk ratio (RR) 3.45 [CI 95% 2.71-4.4; p=0.20; I2=23%]), somnolence (RR 2.9 [CI 95% 1.98-4.23; p=0.77; I2=0%]), and nausea (RR 2.25 [CI 95% 1.62-3.13; p=0.83; I2=0%]).
Conclusions: There is moderate certainty evidence regarding the impact of cannabinoids in spasticity (average 0.36 more spasticity; 0.17 fewer to 0.88 more) due to multiple sclerosis or paraplegia, and in adverse events such as dizziness (419 more dizziness/1000 over 19 weeks), somnolence (127 more somnolence/1000 over 19 weeks), and nausea (125 more somnolence/1000 over 19 weeks).
The impediment to action advances action.