Studienlage · Detail
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GRADE
Hoch
42 Zitate
Stichprobek = 16 Studien
n = 2.597 Pat.
n = 2.597 Pat.
Dauer19 Wochen
KontrollePlacebo oder Standardtherapie
EndpunktSpastik
Verblindungdoppelblind
DesignMeta-Analyse
Kernaussage
Cannabinoide zeigten keinen statistisch signifikanten Nutzen für Spastizität oder Spasm-Häufigkeit, erhöhten aber deutlich Nebenwirkungen wie Schwindel, Somnolenz und Übelkeit.
Zusammenfassung
SR+MA über k=16 RCTs (n=2.597) zu Cannabinoiden bei MS-Spastik oder Paraplegie-Spastik. Moderate Evidenz für NICHT-signifikante Spastik-Reduktion (SMD 0.36, 95% CI -0.17 bis 0.88, p=0.18, I²=88%); erhöhte Nebenwirkungen: Schwindel (RR 3.45, 95% CI 2.71–4.4), Somnolenz (RR 2.9, 95% CI 1.98–4.23), Übelkeit (RR 2.25, 95% CI 1.62–3.13).
P
PopulationErwachsene mit Spastik infolge Multipler Sklerose oder Paraplegie, gepoolt n=2597
I
InterventionCannabinoide (verschiedene Substanzen/Applikationen)
C
KontrollePlacebo oder Standardtherapie
O
OutcomeKeine statistisch signifikante Reduktion der Spastik (SMD 0,36 [95%-KI −0,17 bis 0,88; p=0,18]) oder Spasmusfrequenz (SMD 0,04 [95%-KI −0,15 bis 0,22]); signifikant erhöhte Rate an Schwindel (RR 3,45), Somnolenz (RR 2,9) und Übelkeit (RR 2,25)
Vertrauen in die Evidenz
Hoch
Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.
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★★★★★
Verblindung
Doppelblind
Effektstärke
Kein Nutzen
Zitate / Jahr
★★★★★
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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).
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