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. 2006 Apr 19;2006(2):CD004967. doi: 10.1002/14651858.CD004967.pub2

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