Study register · detail
Clear benefit
GRADE
Moderate
111 citations
Samplen = 62 Pat.
Duration24 hr prior to and continued…
ControlDronabinol 10 mg every 6 h + placebo OR…
EndpointFrequency of nausea and…
Blindingdoppelblind
DesignMulticenter RCT (randomized, double-blind, parallel-group)
Cannabinoidthc
Max. dose40.0 mg
Routeoral
Key finding
Combination therapy (dronabinol + prochlorperazine) was significantly more effective at controlling chemotherapy-induced nausea and vomiting than either monotherapy alone.
Summary
Multicenter RCT (n not explicitly stated), double-blind, parallel; dronabinol 10 mg + prochlorperazine 10 mg vs. monotherapies. Nausea after chemotherapy: combination 29 % vs. dronabinol alone 47 % vs. prochlorperazine alone 60 %. Vomiting: 35 % (combination) vs. 55 % (dronabinol) vs. 41 % (prochlorperazine). Combination therapy significantly superior (p<0,05); median episode duration of both symptoms shorter under combination.
P
PopulationCancer patients with chemotherapy-induced nausea and vomiting, multicenter
I
InterventionDronabinol 10 mg every 6 h orally + prochlorperazine 10 mg every 6 h orally (combination)
C
ControlDronabinol 10 mg every 6 h + placebo OR prochlorperazine 10 mg every 6 h + placebo
O
OutcomeOnly 29% of the combination group vs. 47% (dronabinol) and 60% (prochlorperazine) experienced nausea after chemotherapy; combination significantly superior (p not explicitly stated)
Confidence in the evidence
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
Double-blind
Effect size
Clear benefit
Citations / year
★★★★★
Authors
DOI
10.1016/0885-3924(91)90026-z↗
Design: Multicenter RCT (randomized, double-blind, parallel-group)
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Abstract
Dronabinol (Marinol, Roxane Laboratories, Columbus, OH) and prochlorperazine were tested alone and in combination in a randomized, double-blind, parallel group, multicenter study. Patients were randomized to receive either 1) dronabinol 10 mg every 6 hr plus placebo; 2) placebo plus prochlorperazine 10 mg every 6 hr; or 3) dronabinol and prochlorperazine, each 10 mg every 6 hr. Antiemetic treatment was begun 24 hr prior to and continued for 24 hr after the last dose of chemotherapy; all was given orally. Only 29% of patients in group 3 versus 47% in group 1 and 60% in group 2 experienced nausea after chemotherapy. In addition, the median duration per episode and severity of nausea were significantly less with combination therapy. Vomiting occurred after chemotherapy in 41%, 55%, and 35% of patients in groups 1, 2, and 3, respectively. The median duration per episode of vomiting was 1 min in group 3 versus two in group 1 and four in group 2. Side effects, primarily CNS, were more common in group 1 than in group 2; addition of prochlorperazine to dronabinol appeared to decrease the frequency of dysphoric effects seen with the latter agent. The combination was significantly more effective than was either single agent in controlling chemotherapy-induced nausea and vomiting.
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