Stevens 1991.
Methods | Prevention study in USA Loss to follow‐up: Fluconazole ‐ 3/12 (25%) Placebo ‐ 5/13 (38%) Analysis: ITT |
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Participants | Inclusion criteria: at least 18 years of age; previous history of at least one episode of thrush; AIDS or ARC Exclusion criteria: less than 18 years of age; pregnant or lactating; women not observing accepted birth control measures; history of allergy to azoles; inability to take oral drugs; serum creatinine > 221 micromol/L; receiving barbiturates, anticoagulants, hypoglycaemic drugs, immunotherapy, rifampicin or its derivatives, concurrent antifungal agents. Diagnosis confirmed: yes ‐ KOH preparation and culture 25 patients enrolled 12 ‐ fluconazole therapy 13 ‐ placebo |
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Interventions | Fluconazole 100mg tablets once per day
Placebo once daily Duration: 12 weeks |
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Outcomes | Relapse of thrush defined as the presence of white or rarely red oropharyngeal patches that when smears are examined produced the characteristic microscopic appearance of C Albicans or that on culture yielded C albicans or were positive in both assays. Adverse events: increased liver function tests, GIT symptoms. |
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Notes | Ethics: ethics approval obtained from IRb committee for protection of human subjects, Santa Clara Valley Medical Centre and California Institute for medical research, San Jose; informed consent obtained | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Method of sequence generation not reported |
Allocation concealment? | Unclear risk | Not reported |
Blinding? All outcomes | Low risk | Double‐blind: patients, investigators and caregivers. |
Incomplete outcome data addressed? All outcomes | Low risk | ITT |