Einhorn 1981.
Study characteristics | ||
Methods | Randomised, prospective, double‐blind, 2‐period cross‐over study | |
Participants | 100 people aged 15‐74 years, mean = 28 years Tumour type; sarcoma (1 person), Hodgkin's disease (2 people), lymphoma (4 people), bladder carcinoma (3 people), testicular carcinoma (70 people) Chemotherapy regimens: doxorubicin hydrochloride and cyclophosphamide (1 person), nitrogen mustard, vincristine, prednisone and procarbazine (2 people), cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone (4 people), cisplatin, doxorubicin hydrochloride and 5‐fluorouracil (3 people), cisplatin, vinblastine and bleomycin (45 people), cisplatin, vinblastine, bleomycin and doxorubicin hydrochloride (25 people). No information on doses reported Chemotherapy emetogenicity: high |
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Interventions | Nabilone 2 mg, orally every 6 hours, n = 100 Prochlorperazine 10 mg, orally every 6 hours, n = 100 |
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Outcomes | Episodes of nausea and vomiting during 24 hours of therapy; frequency of vomiting; withdrawal due to adverse effects; withdrawal due to early death and change of chemotherapy; episodes of 'feeling high', depression, hallucination, paranoia, hypotension | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Low risk | "Identical capsules used" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 80/100 (80%) participants received nabilone, 80/100 (80%) participants received prochlorperazine |
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", identical capsules used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind", identical capsules used |