Vaporized cannabis versus placebo for acute migraine: A randomized, double-blind, placebo-controlled crossover trial.
Schuster et al.·HeadacheImpact 3.0
Klarer NutzenGRADEModerat2 Zitate
Stichproben = 92 Pat.
DauerNachbeobachtung bis 48 h
KontrollePlacebo-Cannabis-Blüte
EndpunktSchmerzlinderung
Verblindungdoppelblind
DesignRCT
Cannabinoidkombination
THC:CBD6:11
Applikationinhalativ
”Kernaussage
Die Kombination 6% THC + 11% CBD zeigte Überlegenheit gegenüber Placebo beim primären Endpunkt Schmerzlinderung nach 2 h (67,2% vs. 46,6%) mit anhaltenden Vorteilen bis 48 h.
Zusammenfassung
RCT (cross-over) mit n=92 Migräne-Patienten, 247 behandelte Attacken; vaporisiertes Cannabis 6% THC + 11% CBD vs. Placebo. Primärer Endpunkt Schmerzlinderung nach 2h: THC+CBD 67,2% vs. Placebo 46,6% (OR 2,85 [95%-KI 1,22–6,65], p=0,016). Schmerzfreiheit nach 2h: THC+CBD 34,5% vs. Placebo 15,5% (OR 3,30 [1,24–8,80], p=0,017). Most bothersome symptom freedom nach 2h: THC+CBD 60,3% vs. Placebo 34,5% (OR 3,32 [1,45–7,64], p=0,005). Anhaltende Schmerzfreiheit nach 24h und anhaltende Symptomfreiheit nach 24h und 48h signifikant überlegen. THC-dominant (6% THC) überlegen bei Schmerzlinderung (68,9% vs. 46,6%, OR 3,14 [1,35–7,30], p=0,008), aber nicht bei Schmerzfreiheit. CBD-dominant (11% CBD) nicht überlegen vs. Placebo. Keine schwerwiegenden Nebenwirkungen.
P
PopulationErwachsene mit Migräne (bis zu vier separate Migräneanfälle behandelt), n=92 randomisiert, 247 Migräneanfälle ausgewertet
OutcomeTHC+CBD vs. Placebo: Schmerzlinderung 67,2% vs. 46,6% (OR 2,85 [1,22–6,65], p=0,016); Schmerzfreiheit 34,5% vs. 15,5% (OR 3,30 [1,24–8,80], p=0,017); Freiheit vom störendsten Symptom 60,3% vs. 34,5% (OR 3,32 [1,45–7,64], p=0,005), je 2 h nach Vaporisation
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Moderat
Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.
Herabgestuft wegen
Ungenauigkeit
Qualitätsprofil
Größe★★★★★
VerblindungDoppelblind
EffektstärkeKlarer Nutzen
Zitate / Jahr★★★★★
Autoren
Schuster NM, Wallace MS, Marcotte TD, Buse DC, Lee E, Liu L, Sexton M
Objective: To assess the efficacy of cannabis for the treatment of acute migraine.
Background: Preclinical and retrospective studies suggest cannabinoids may be effective in migraine treatment. However, there have been no randomized clinical trials examining the efficacy of cannabinoids for acute migraine.
Methods: In this randomized, double-blind, placebo-controlled, crossover trial, adults with migraine treated up to four separate migraine attacks, one each with vaporized (1) 6% Delta9-tetrahydrocannabinol (THC) (THC-dominant), (2) 11% cannabidiol (CBD) (CBD-dominant), (3) 6% THC + 11% CBD, and (4) placebo cannabis flower in a randomized order. Washout period between treated migraine attacks was >/=1 week. The primary endpoint was pain relief, and secondary endpoints were pain freedom and most bothersome symptom freedom, all assessed at 2-h post-vaporization.
Results: Ninety-two participants were enrolled and randomized, and 247 migraine attacks were treated. THC + CBD was superior to placebo at achieving pain relief (67.2% vs. 46.6%, odds ratio [95% confidence interval] 2.85 [1.22, 6.65], p = 0.016), pain freedom (34.5% vs. 15.5%, 3.30 [1.24, 8.80], p = 0.017), and most bothersome symptom freedom (60.3% vs. 34.5%, 3.32 [1.45, 7.64], p = 0.005) at 2 h, as well as sustained pain freedom at 24 h and sustained most bothersome symptom freedom at 24 and 48 h. THC-dominant was superior to placebo for pain relief (68.9% vs. 46.6%, 3.14 [1.35, 7.30], p = 0.008) but not pain freedom or most bothersome symptom freedom at 2 h. CBD-dominant was not superior to placebo for pain relief, pain freedom, or most bothersome symptom freedom at 2 h. There were no serious adverse events.
Conclusion: Acute migraine treatment with 6% THC + 11% CBD was superior to placebo at 2-h post-treatment with sustained benefits at 24 and 48 h.