Krebs
Studienlage · Detail Randomized Controlled Trial (double-blind crossover) · Krebs · 1979

Superiority of nabilone over prochlorperazine as an antiemetic in patients receiving cancer chemotherapy.

Klarer Nutzen GRADE Hoch 216 Zitate
Stichproben = 113 Pat.
Dauerunklar
KontrolleProchlorperazin, oral, Crossover
EndpunktAntiemetische Ansprechrate
Verblindungdoppelblind
DesignRandomized Controlled Trial (double-blind crossover)
Cannabinoidthc
Applikationoral
Kernaussage

Nabilone zeigte signifikante Überlegenheit gegenüber Prochlorperazin: 80% vs. 32% Ansprechrate (P<0,001), signifikant weniger Übelkeit und Erbrechen, aber mit doppelt so häufigen und teilweise schwerwiegenden Nebenwirkungen.

Zusammenfassung

n=113 Krebspatienten unter Chemotherapie (Doppelblind-Crossover-RCT, NEJM 1979); Ansprechrate Nabilon 80% vs. Prochlorperazin 32% (p&lt;0,001); Übelkeit (p&lt;0,01) und Erbrechen (p&lt;0,001) jeweils signifikant seltener unter Nabilon; Patienten bevorzugten Nabilon zur Fortführung (p&lt;0,001).

P
PopulationKrebspatienten mit schwerer Übelkeit und Erbrechen unter Chemotherapie, n=113
I
InterventionNabilon (synthetisches Cannabinoid), oral, Crossover
C
KontrolleProchlorperazin (Standardantiemetikum), oral, Crossover
O
OutcomeAnsprechrate 80% (Nabilon) vs. 32% (Prochlorperazin), p<0,001; Übelkeit p<0,01, Erbrechen p<0,001 signifikant geringer unter Nabilon; Patientenpräferenz für Nabilon p<0,001
Vertrauen in die Evidenz
Hoch

Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.

Qualitätsprofil
Größe
Verblindung Doppelblind
Effektstärke Klarer Nutzen
Zitate / Jahr
Autoren
Herman TS, Einhorn LH, Jones SE, Nagy C, Chester AB, Dean JC, Furnas B, Williams SD, Leigh SA, Dorr RT, Moon TE
DOI 10.1056/nejm197906073002302
Design: Randomized Controlled Trial (double-blind crossover)
Teilen
Abstract
Two double-blind, crossover trials comparing the antiemetic effectiveness of nabilone, a new synthetic cannabinoid, with that of prochlorperazine were conducted in patients with severe nausea and vomiting associated with anticancer chemotherapy. Of 113 patients evaluated, 90 (80 per cent) responded to nabilone therapy, whereas only 36 (32 per cent) responded to prochlorperazine (P less than 0.001). Complete relief of symptoms was infrequent, occurring only in nine patients (8 per cent) given nabilone. When both drugs were compared, both nausea (P less than 0.01) and vomiting episodes (P less than 0.001) were significantly lower in patients given nabilone. Moreover, patients clearly favored nabilone for continued use (P less than 0.001). Predominant side effects noted by patients were similar for both agents and included somnolence, dry mouth and dizziness but were about twice as frequent and more often severe in patients receiving nabilone. In addition, four patients (3 per cent) taking nabilone had side effects (hallucinations in three, hypotension in one) that required medical attention. Euphoria associated with nabilone was infrequent (16 per cent) and mild.

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