Kleinman 1983.
Study characteristics | ||
Methods | Randomised, double‐blind, 4‐period cross‐over study | |
Participants | 16 people (9 men/7 women) aged 18‐53 years (median = 38 years) Tumour types: not reported Chemotherapy regimens: "Cancer chemotherapy known to cause acute gastrointestinal toxicity" Chemotherapy emetogenicity: unable to classify |
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Interventions | Prochlorperazine 10 mg + dronabinol 15 mg x 2 courses orally, n = 16 Prochlorperazine + placebo orally, n = 16 |
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Outcomes | Episodes of nausea and vomiting 24 hours after chemotherapy, euphoria, sedation | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 28/32 (87.5%) participants received prochlorperazine + THC, 24/32 (75%) participants received prochlorperazine + placebo (overall 52/64 (81%) participants received either of the 2 courses) |
Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
Other bias | Unclear risk | Assumed washout period sufficient. Unclear if paired analysis was performed. Unclear if groups were balanced at baseline |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Reported as "double‐blind" and "identical capsules used" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind and identical capsules used" |