Pons 1993.
| Methods | Multicentre study conducted in the USA Loss to follow‐up: Fluconazole ‐ 10/176 (6%) Clotrimazole ‐ 17/158 (11%) Analysis: ITT |
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| Participants | Inclusion criteria:> 17 years, with CDC criteria for AIDS, or serologic/virologic evidence of HIV infection, signs and symptoms of oropharyngeal candidiasis confirmed by KOH prep Exclusion criteria: patients with signs and symptoms of oesophagitis, pregnancy, using any antifungal treatment within 3 days preceding study entry, taking barbiturates, phenytoin, coumarin‐type anticoagulants, rifampicin, oral hypoglycaemics, cyclosporin, known history of intolerance or allergy to imidazoles or triazoles and patients unable to tolerate oral medication, moderate to severe liver disease, breast feeding, life expectancy < 4 weeks and patients unable or unwilling to be followed at the same centre for duration of study. Diagnosis confirmed using KOH and culture 334 enrolled and randomised Fluconazole ‐ 176 Clotrimazole ‐ 158 |
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| Interventions | Fluconazole ‐ 100 mg once daily for 14 days Clotrimazole ‐ 10 mg five times daily for 14 days |
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| Outcomes | Clinical cure ‐ resolution of signs and symptoms of oropharyngeal candidiasis Mycologic cure based on culture results Recurrence during follow‐up of cured patients Adverse events: GIT most common, less common included headache, dizziness, pruritus, rash, sweating and dry mouth as well as liver function abnormalities |
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| Notes | Ethics: written informed consent obtained | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Computer generated random number codes provided for each study centre. Patients assigned numbers in sequence. |
| Allocation concealment? | Low risk | Randomisation code held by the pharmacy |
| Blinding? All outcomes | High risk | Single‐blind, clinician assessing clinical response and who obtained culture specimens unaware of treatment regimen. Patients not blinded due to nature of treatment |
| Incomplete outcome data addressed? All outcomes | Unclear risk | Analysis: ITT No reasons given for loss to follow‐up |