Gralla 1984.
Study characteristics | ||
Methods | Randomised, double‐blinded parallel group trial | |
Participants | 31 people (23 men/ 5 women). THC n = 15 (13 men/2 women), aged 39‐72 years (median = 58 years); metoclopramide n = 16 (11 men/5 women), aged 45‐70 years (median = 58 years) Tumour types: bronchogenic carcinoma (12 people), oesophageal carcinoma (2 people), head and neck carcinoma head and neck carcinoma (1 person) Chemotherapy regimens: all receiving first course of cisplatin 120 mg/m2 IV Chemotherapy emetogenicity: high |
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Interventions | Dronabinol 10 mg/m2 1.5 hours prior to chemotherapy, then at 1.5, 4.5, 7.5 and 10.5 hours after chemotherapy orally, n = 15 Metoclopramide, 2 mg/kg 30 minutes prior to chemotherapy, then 1.5, 3.5, 5.5 and 8.5 hours after chemotherapy IV, n = 16 |
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Outcomes | Episodes of nausea and vomiting during 24 hours, sedation, dizziness, orthostatic hypotension, feeling high | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Paired design in which one patient in every pair was randomly assigned to each treatment" |
Allocation concealment (selection bias) | Low risk | "Identical vials and capsules used" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 15/15 (100%) participants received THC, 15/16 (94%) participants received metoclopramide |
Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
Other bias | Unclear risk | Unclear if groups were balanced at baseline |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Identical vials and capsules used" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind" |