A cross-over comparison of nabilone and prochlorperazine for emesis induced by cancer chemotherapy.

Niiranen et al. ·American Journal of Clinical Oncology Impact 1.3

Mixed GRADE Moderate 52 citations

Samplen = 24 Pat.

Durationtwo consecutive identical…

ControlProchlorperazine 15 mg orally every 12 hours

EndpointNumber of vomiting episodes

Blindingdoppelblind

DesignRCT (Cross-over)

Cannabinoidthc

Max. dose4.0 mg

Routeoral

Key finding

Nabilone was significantly more effective antiemetically than prochlorperazine, but was associated with considerably more side effects.

Summary

Crossover RCT (n=24 lung cancer patients undergoing chemotherapy); nabilone 2 mg vs. prochlorperazine 15 mg orally; nabilone significantly superior in reducing episodes of vomiting (p<0.05); two thirds of patients preferred nabilone. Side effects (dizziness/coordination disturbances) in approx. 50% of patients on nabilone; 3 discontinuations due to CNS side effects.

PopulationLung cancer patients undergoing chemotherapy, n=24

InterventionNabilone 2 mg orally every 12 hours (starting the evening before chemotherapy)

ControlProchlorperazine 15 mg orally every 12 hours

OutcomeNabilone significantly superior to prochlorperazine in reducing episodes of vomiting (p not explicitly stated); 2/3 of patients preferred nabilone

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 Mixed

Citations / year ★★★★★

Authors

Niiranen A, Mattson K.

DOI 10.1097/00000421-198508000-00013↗

Design: RCT (Cross-over)

Abstract

An anti-emetic drug, nabilone, a synthetic cannabinoid, has been compared with prochlorperazine in 24 lung cancer patients receiving cancer chemotherapy. Each of the drugs studied was given orally every 12 hours, starting the night before chemotherapy, during one of two consecutive identical chemotherapy cycles in accordance with a double-blind cross-over random order assignment. Single doses were 2 mg of nabilone, or 15 mg of prochlorperazine. The chemotherapeutic regimens given included the following drugs in various combinations: cis-platinum, vincristine, cyclophosphamide, adriamycin, vindesine, and etoposide (VP16). Nabilone was significantly superior to prochlorperazine in the reduction of vomiting episodes. Side effects, mainly vertigo, were evident in nearly half of the patients after nabilone, and three patients were withdrawn from the study due to decreased coordination and hallucinations after nabilone. Side effects from prochlorperazine were limited to mild drowsiness in one patient. Two-thirds of the patients preferred nabilone to prochlorperazine. We conclude that nabilone is a moderately effective anti-emetic drug, but that the unpredictability of its side effects call for careful patient information, especially with elderly outpatients. We recommend that at least after the first dose of nabilone, the patient should be kept under close observation during 4 hours.

The impediment to action advances action. — Marcus Aurelius