Shikanai‐Yasuda 2002.
Methods | Randomized controlled trial Generation of allocation sequence: randomization table Allocation concealment: not described Blinding: not described Inclusion of all randomized participants in the final analysis: 100% for cure |
|
Participants | ||
Interventions | 1. Itraconazole: 50 to 100 mg/d for 4 to 6 months; mean duration 169.8 days 2. Ketoconazole: 200 to 400 mg/day for 4 to 6 months; mean duration 154.1 day 3. Sulfadiazine: 100 to 150 mg/kg/day for 4 to 6 months; mean duration 163.7 days | |
Outcomes | 1. Cure, defined as total disappearance of clinico‐radiological lesion and of complaints due to their inflammatory activity 2. Marked clinical improvement, defined as reduction in lesion size and number of > 90% or persistence of residual fibrotic scars and disappearance of clinical complaints 3. Partial clinical improvement, defined as reduction in lesion size and number of < 90% and/or resolution of some lesion but persistence of others 4. Mycologic examination 5. Antibody level 6. Adverse events: increase of serum level of uric acid, cholesterol, triglycerides, alkaline phosphatase, and oliguria and haematuria | |
Notes | Location: Brazil Date: 1988 to 1993 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | randomization table |
Allocation concealment (selection bias) | Unclear risk | no detail given |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | no information given |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | no information given |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | no information given |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | all patients reported on |