←Nausea

Study register · detail RCT (randomisiert, doppelblind, placebo-kontrolliert, crossover) · Nausea · 1979

Delata-9-tetrahydrocannabinol as an antiemetic in cancer patients receiving high-dose methotrexate. A prospective, randomized evaluation.

Chang et al. ·Annals of Internal Medicine Impact 4.3

Clear benefit GRADE Moderate 258 citations

Samplen = 15 Pat.

Durationunclear

ControlPlacebo

EndpointNumber of vomiting/retching…

Blindingdoppelblind

DesignRCT (randomisiert, doppelblind, placebo-kontrolliert, crossover)

Cannabinoidthc

Key finding

THC significantly reduces nausea and vomiting under high-dose methotrexate compared to placebo (p<0,001).

Summary

RCT n=15 osteosarcoma patients under high-dose methotrexate chemotherapy; oral/inhaled THC vs. placebo. 14/15 patients showed reduction of nausea and vomiting under THC vs. placebo (p<0,001). Plasma THC >10 ng/mL: only 6% nausea/vomiting incidence vs. 72% under placebo.

PopulationPatients with osteogenic sarcoma under high-dose methotrexate chemotherapy, n=15

InterventionOral and smoked delta-9-tetrahydrocannabinol (THC), different dose levels (plasma THC <5, 5–10, >10 ng/mL)

ControlPlacebo (oral/smoked)

OutcomeTHC significantly more effective than placebo in reducing vomiting/retching, nausea severity, duration, and vomiting volume (p<0,001); nausea/vomiting incidence 72% under placebo vs. 6% with THC >10 ng/mL

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

Chang AE, Shiling DJ, Stillman RC, Goldberg NH, Seipp CA, Barofsky I, Simon RM, Rosenberg SA.

DOI 10.7326/0003-4819-91-6-819↗

Design: RCT (randomisiert, doppelblind, placebo-kontrolliert, crossover)

Abstract

Fifteen patients with osteogenic sarcoma receiving high-dose methotrexate chemotherapy were studied in a randomized, double-blind, placebo-controlled trial of oral and smoked delta-9-tetrahydrocannabinol (THC) as an antiemetic. Each patient served as his or her own control. Fourteen of 15 patients had a reduction in nausea and vomiting on THC as compared to placebo. Delta-9-tetrahydrocannabinol was significantly more effective than placebo in reducing the number of vomiting and retching episodes, degree of nausea, duration of nausea, and volume of emesis (P less than 0.001). There was a 72% incidence of nausea and vomiting on placebo. When plasma THC concentrations measured less than 5.0 ng/mL, 5.0 to 10.0 ng/mL, and greater than 10.0 ng/mL, the incidences of nausea and vomiting were 44%, 21%, and 6%, respectively. Delta-9-tetrahydrocannabinol appears to have significant antiemetic properties when compared with placebo in patients receiving high-dose methotrexate.

The impediment to action advances action. — Marcus Aurelius