| Methods |
Randomised, parallel group study conducted in USA. Patient, carer and assessor blind. Unclear information on withdrawals given. Pharmaceutical company provided the tablets but no other information about funding. No dates for recruitment period. |
| Participants |
Children and adults with mixed cancer. 64 enrolled, 56 completed. |
| Interventions |
2 groups, placebo versus ketoconazole. 200 mg twice/day. 2 weeks duration. |
| Outcomes |
Clinical and mycological eradication (culture). Assessment made at day 14. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Quote: "Randomised in a double blind placebo controlled study". |
| Allocation concealment? |
Unclear risk |
Comment: Drug supplied by pharmaceutical company but concealment still unclear. |
| Blinding of participants and carers? |
Low risk |
Quote: "Randomised in a double blind placebo controlled study". |
| Blinding of outcome assessors? |
Low risk |
Quote: "Randomised in a double blind placebo controlled study". |
| Incomplete outcome data addressed? |
Unclear risk |
8 patients (12%) withdrawn 5 for noncompliance and 3 by request, but unclear which group. |
| Free of selective reporting? |
Low risk |
Comment: Clinical and mycological eradication (culture). |
| Free of other biases? |
Unclear risk |
No information on funding except being given drug by pharmaceutical company. |
