Ungerleider 1982.
Study characteristics | ||
Methods | Randomised, double‐blind, 2‐period cross‐over study | |
Participants | 214 people (107 men/107 women) aged 18‐82 years (median = 47 years) Tumour types: "wide variety of neoplasms" Chemotherapy regimens: antibiotics (70 people), nitrosoureas (21 people), alkylating agents (119 people), antimetabolites (82 people), vinca‐alkaloids (60 people), hormones (13 people), miscellaneous (33 people) and combinations. Rated as high for 66% of people, moderate for 27% of people or low for 7% of people emetic potential Chemotherapy emetogenicity: unable to classify ‐ unknown combinations |
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Interventions | Dronabinol 7.5 mg for < 1.4/m2, 10 mg for 1.4‐1.8 m2 or 12.5 mg for > 1.8 m2 orally, n = 214 Prochlorperazine 10 mg 1 hour prior to chemotherapy, then every 4 hours x 4 doses per day x all chemotherapy days orally, n = 214 |
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Outcomes | Episodes of nausea and vomiting during 24 hours; withdrawal due to adverse effects; episodes of sedation, depression, feeling high | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 172/214 (80%) participants received THC, 181/214 (85%) received prochlorperazine |
Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
Other bias | Low risk | Washout period 1‐3 weeks. Paired analysis was performed. Groups were balanced at baseline |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Reported as "double‐blind" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind" |