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Stichproben = 50 Pat.
DauerApril 2008 bis März 2012
EndpunktTherapeutisches Ansprechen
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DesignKohortenstudie
Cannabinoidkombination
Applikationinhalativ
Kernaussage
THC/CBD war bei 80% der Patienten wirksam zur Verbesserung der Spastizität bei Multipler Sklerose.
Zusammenfassung
Retrospektive Beobachtungsstudie zu THC/CBD-Oromukosalspray bei MS-Spastik (n=50); 80% der Patienten zeigten therapeutisches Ansprechen bei medianer Dosis von 5 (2-10) Inhalationen/Tag; 16 Patienten (32%) brachen die Behandlung ab (7 wegen Ineffektivität, 5 wegen Nebenwirkungen); häufigste Nebenwirkungen: Schwindel (n=11), Somnolenz (n=6), Muskelschwäche (n=7).
P
PopulationErwachsene mit Multipler Sklerose und Spastik (primär progredient, sekundär progredient, schubförmig-remittierend), n=50
I
InterventionInhaliertes THC/CBD (Kombinationspräparat), mediane Dosis 5 Inhalationen/Tag
O
OutcomeTHC/CBD war bei 80% der Patienten wirksam; mediane Expositionszeit bei Therapiefortführung 174 Tage vs. 30 Tage bei Abbruch
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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.
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