Dronabinol and prochlorperazine alone and in combination as antiemetic agents for cancer chemotherapy.
Lane et al.·American Journal of Clinical OncologyImpact 1.3
GemischtGRADEModerat37 Zitate
Stichproben = 19 Pat.
Dauerunklar
KontrolleProchlorperazin 10 mg p.o. q.i.d. plus…
EndpunktDauer und Schwere der Nausea
Verblindungdoppelblind
DesignRCT (doppelblind, parallel)
Cannabinoidthc
Max. Dosis40.0 mg
Applikationoral
”Kernaussage
Dronabinol (allein oder kombiniert) zeigte signifikant bessere Wirksamkeit gegen Übelkeit und Erbrechen als Prochlorperazin allein, war aber mit mehr CNS-Nebenwirkungen assoziiert.
Zusammenfassung
n=19 (6+6+5 auswertbar), doppelblinde multizentrische RCT; Dronabinol 10 mg vs. Prochlorperazin 10 mg vs. Kombination bei chemoinduzierter Übelkeit/Erbrechen; mediane Dauer und Schwere der Übelkeits- und Erbrechensphasen signifikant geringer in Dronabinol-Gruppen vs. Prochlorperazin allein; nur 1/5 Patienten in der Kombinationsgruppe vs. je 3/6 in den Einzeltherapiegruppen litten unter Übelkeit; Nebenwirkungen (Sedierung, Schwindel) in Dronabinol-Gruppen häufiger, aber nicht signifikant unterschiedlich.
P
PopulationKrebspatienten unter Chemotherapie, n=19 (je 6 auswertbar in Mono-Gruppen, 5 in Kombinations-Gruppe)
I
InterventionDronabinol 10 mg p.o. q.i.d. (allein oder in Kombination mit Prochlorperazin 10 mg p.o. q.i.d.)
C
KontrolleProchlorperazin 10 mg p.o. q.i.d. plus Placebo
O
OutcomeSignifikant kürzere Dauer und geringere Schwere pro Nausea-Episode sowie kürzere Dauer pro Erbrechen-Episode in den Dronabinol-Gruppen vs. Prochlorperazin allein (p signifikant; p für Nausea-Prävalenz n.s.)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Moderat
Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.
Nineteen patients receiving cancer chemotherapy were randomized in a double-blind fashion to receive either (a) dronabinol, 10 mg plus placebo q.i.d.; (b) prochlorperazine, 10 mg plus placebo q.i.d.; or (c) dronabinol plus prochlorperazine, each 10 mg q.i.d. There were six evaluable patients in each of the two single-agent groups and five in the combination group. The median duration and severity per episode of nausea was significantly greater in the group receiving prochlorperazine alone versus the other two groups. The median duration per episode of vomiting was also significantly greater in the prochlorperazine group than in the other two groups. The proportion of patients vomiting was the same in all groups; however, only one patient in the combination group versus three each in the single-agent groups experienced nausea (p = NS). The majority of side effects were associated with the CNS, including somnolence, dizziness, and confusion. Side effects were somewhat more common in both groups receiving dronabinol, though they were not statistically different from the side effects in the group receiving prochlorperazine as a single agent. Efficacy, as measured by duration of nausea and vomiting and by severity of nausea, was significantly greater in both groups receiving dronabinol.