Redding 1992.
Methods | Study conducted in USA, no dates provided. Loss to follow‐up: none during treatment Analysis: ITT |
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Participants | Eligibility criteria: HIV positive adults with thrush; subjective complaints of oral discomfort Exclusion criteria: Other anti‐fungals within 3 days before enrolment; pregnancy; breastfeeding; life expectancy < 4 weeks Diagnosis confirmed: yes ‐ KOH preparation/gram stain; positive culture 24 patients Fluconazole‐13 Clotrimazole‐11 |
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Interventions | Fluconazole 100mg tablets once per day
Clotrimazole 10mg troches five times per day Duration: 14 days Clinically cured patients followed‐up for relapse at d28 and d42 |
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Outcomes | Clinical cure: defined as absence of lesions
Colonisation: Positive culture of clinically cured
Relapse Adverse events: nausea; flatulence |
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Notes | Ethics: no mention No demographics reported Author contacted, no response to date 24/08/2004 Author contacted via email: 08/11/2004 (age groups) Location of study: USA |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Computer generated |
Allocation concealment? | Unclear risk | Not reported |
Blinding? All outcomes | Low risk | Single‐blind: clinician blinded |
Incomplete outcome data addressed? All outcomes | Unclear risk | ITT analysis. |