Skip to main content
. 2010 Nov 10;2010(11):CD003940. doi: 10.1002/14651858.CD003940.pub3

De Wit 1989.

Methods Location of study: Belgium
From November 1986 ‐ February 1988 patients presenting with severe oropharyngeal candidiasis were evaluated for the study.
Follow‐up: one month.
Loss to follow up: 
 During treatment ‐ Fluconazole 1/18 (6%) 
 Ketoconazole 3/19 (16%)
During follow‐up ‐ Fluconazole 3 
 Ketoconazole 3
Analysis: no ITT
Participants Eligibility criteria: AIDS/ARC patients, 18 years and older, severe oropharyngeal candidiasis confirmed by culture.
Exclusion criteria: esophageal Candidiasis, other systemic antifungal drugs, known sensitivity to imidazoles, previous abnormalities of blood or urine chemistry after ketoconazole, impaired renal function, moderate to severe liver disease, drugs capable of inducing more rapid clearance of ketoconazole or that reduce / neutralise gastric acid.
Diagnosis confirmed by culture
37 patients 
 fluconazole ‐ 18 
 ketoconazole ‐ 19
Interventions 50mg fluconazole once daily
200mg ketoconazole once daily
Treatment duration: 28 days
Outcomes Clinical cure ‐ complete disappearance of mucosal lesions and symptoms
Mycological cure ‐ culture assessments
Relapses ‐ weekly clinical and mycological assessments for 4 weeks after treatment completion
Adverse events: severe nausea in 1 fluconazole patient, transient rise ( < 3 times baseline) ALT or AST in 1 fluconazole and 4 ketoconazole patient
Notes Ethics: nil reported
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Method of allocation sequence generation not specified
Allocation concealment? Unclear risk Not reported
Blinding? 
 All outcomes Unclear risk Reported double blinding. Specified that participants were blinded. Unclear who else was blinded.
Incomplete outcome data addressed? 
 All outcomes Unclear risk Reasons given for those lost to follow‐up during treatment, not those lost during follow‐up period.