Cancer
Study register · detail Randomized Controlled Trial (double-blind crossover) · Cancer · 1979

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

Clear benefit GRADE High 216 citations
Samplen = 113 Pat.
Durationunclear
ControlProchlorperazine, oral, crossover
EndpointAntiemetic response rate
Blindingdoppelblind
DesignRandomized Controlled Trial (double-blind crossover)
Cannabinoidthc
Routeoral
Key finding

Nabilone showed significant superiority over prochlorperazine: 80% vs. 32% response rate (P<0,001), significantly less nausea and vomiting, but with twice as frequent and in part serious side effects.

Summary

n=113 cancer patients under chemotherapy (double-blind crossover RCT, NEJM 1979); response rate nabilone 80% vs. prochlorperazine 32% (p<0,001); nausea (p<0,01) and vomiting (p<0,001) each significantly less frequent under nabilone; patients preferred nabilone for continuation (p<0,001).

P
PopulationCancer patients with severe nausea and vomiting under chemotherapy, n=113
I
InterventionNabilone (synthetic cannabinoid), oral, crossover
C
ControlProchlorperazine (standard antiemetic), oral, crossover
O
OutcomeResponse rate 80% (nabilone) vs. 32% (prochlorperazine), p<0,001; nausea p<0,01, vomiting p<0,001 significantly lower under nabilone; patient preference for nabilone p<0,001
Confidence in the evidence
High

The highest of four GRADE levels, the effect estimate is very reliable.

Quality profile
Sample size
Blinding Double-blind
Effect size Clear benefit
Citations / year
Authors
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)
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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.

The impediment to action advances action. — Marcus Aurelius