Crossover comparison of the antiemetic efficacy of nabilone and alizapride in patients with nonseminomatous testicular cancer receiving cisplatin therapy.

Niederle et al. ·Journal of Molecular Medicine

Clear benefit GRADE Moderate 40 citations

Samplen = 20 Pat.

ControlAlizapride 3×150 mg/day orally

EndpointEmesis episodes

Blindingunklar

DesignRCT (Crossover)

Cannabinoidthc

Max. dose4.0 mg

Routeoral

Key finding

Nabilone reduced emesis episodes and nausea duration significantly better than alizapride during cisplatin chemotherapy.

Summary

n=20 testicular cancer patients (cisplatin, low-dose), nabilone 2×2 mg/day vs. alizapride 3×150 mg/day, crossover RCT; nabilone significantly superior: vomiting median 1,1 vs. 2,9 episodes (p<0,01), complete nausea control 65% vs. 30% (p<0,01), nausea duration 1,3 h vs. 5,1 h (p<0,01). More side effects with nabilone; dose reduction recommended.

PopulationPatients with non-seminomatous testicular carcinoma without prior treatment with emetogenic chemotherapy, n=20

InterventionNabilone 2×2 mg/day orally

ControlAlizapride 3×150 mg/day orally

OutcomeSignificantly fewer emesis episodes with nabilone vs. alizapride (median 1,1 vs. 2,9; p<0,01); complete nausea freedom more frequent (65% vs. 30%; p<0,01); shorter nausea duration (1,3 h vs. 5,1 h; p<0,01)

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 —

Effect size Clear benefit

Citations / year ★★★★★

Authors

Niederle N, Schütte J, Schmidt CG.

DOI 10.1007/bf01728184↗

Design: RCT (Crossover)

Abstract

Twenty nonseminomatous testicular cancer patients not pretreated with emetogenic chemotherapy were included in a crossover study of antiemetic therapy. Patients were randomly assigned to receive either nabilone (2 X 2 mg/day) or alizapride (3 X 150 mg/day) prior to beginning low-dose cisplatin chemotherapy. Patients on nabilone had significantly fewer episodes of emesis than those on alizapride (medians, 1.1 vs 2.9; p less than 0.01). Nabilone was superior to alizapride in giving complete relief from nausea (medians, 65% vs 30%; p less than 0.01), and was more effective in shortening the duration of nausea (medians, 1.3 h vs 5.1 h; p less than 0.01); however, it caused more adverse effects. It is concluded that nabilone has greater antiemetic activity than alizapride in young patients receiving low-dose cisplatin chemotherapy. Nabilone dosage should be reduced to decrease the incidence and degree of adverse reactions while leaving the definite antiemetic activity unchanged.

The impediment to action advances action. — Marcus Aurelius