Study register · detail
Clear benefit
GRADE
Very low
17 citations
Samplen = 50 Pat.
DurationApril 2008 to March 2012
EndpointTherapeutic response
Blindingn.a.
DesignKohortenstudie
Cannabinoidkombination
Routeinhalativ
Key finding
THC/CBD was effective in 80% of patients for improving spasticity in multiple sclerosis.
Summary
Retrospective observational study on THC/CBD oromucosal spray in MS spasticity (n=50); 80% of patients showed therapeutic response at a median dose of 5 (2-10) inhalations/day; 16 patients (32%) discontinued treatment (7 due to ineffectiveness, 5 due to side effects); most common side effects: dizziness (n=11), somnolence (n=6), muscle weakness (n=7).
P
PopulationAdults with multiple sclerosis and spasticity (primary progressive, secondary progressive, relapsing-remitting), n=50
I
InterventionInhaled THC/CBD (combination preparation), median dose 5 inhalations/day
O
OutcomeTHC/CBD was effective in 80% of patients; median exposure time with continued therapy 174 days vs. 30 days with discontinuation
Confidence in the evidence
Very low
The lowest GRADE level, the effect estimate remains uncertain.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
—
Effect size
Clear benefit
Citations / year
★★★★★
Authors
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Abstract
Introduction: Spasticity is a common symptom among patients with multiple sclerosis (MS). This study aims to assess the effectiveness and safety of the combination of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in clinical practice for the treatment of spasticity in
Ms. Methods: Retrospective observational study with patients treated with inhaled THC/CBD between April 2008 and March 2012. Descriptive patient and treatment variables were collected. Therapeutic response was evaluated based on the doctor's analysis and overall impression.
Results: Of the 56 patients who started treatment with THC/CBD, 6 were excluded because of missing data. We evaluated 50 patients (42% male) with a median age 47.8 years (25.6-76.8); 38% were diagnosed with primary progressive MS, 44% with secondary progressive MS, and 18% with relapsing-remitting MS. The reason for prescribing the drug was spasticity (44%), pain (10%), or both (46%). Treatment was discontinued in 16 patients because of ineffectiveness (7 patients), withdrawal (4), and adverse effects (5). The median exposure time in patients whose treatment was discontinued was 30 days vs 174 days in those whose treatment continued at the end of the study. THC/CBD was effective in 80% of patients at a median dose of 5 (2-10) inhalations/day. The adverse event profile consisted of dizziness (11 patients), somnolence (6), muscle weakness (7), oral discomfort (2), diarrhoea (3), dry mouth (2), blurred vision (2), agitation (1), nausea (1), and paranoid ideation (1).
Conclusions: THC/CBD appears to be a good alternative to standard treatment as it improves refractory spasticity in MS and has an acceptable toxicity profile.
The impediment to action advances action.