Linpiyawan 2000.
Methods | Location of study: Thailand Loss to follow‐up: none Analysis: ITT |
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Participants | Inclusion criteria: oropharyngeal candidiasis, AIDS patients Exclusion criteria: treatment with any antifungal agent 2 weeks prior to study entry; pregnancy; breastfeeding; significant liver disease 29 enrolled Clotrimazole group = 15 Itraconazole group = 14 diagnosis confirmed using KOH and culture |
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Interventions | Clotrimazole troche 10mg five time daily Itraconazole oral soln 100mg/10ml twice daily Duration: 1 week |
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Outcomes | Clinical evaluation ‐ assessed by scoring method (0‐3, absent to severe) Mycological assessment ‐ KOH prep and fungal culture Global evaluation ‐ cure (all signs and symptoms resolved with no evidence of infection) ‐ improvement (decrease in clinical score without complete resolution) ‐ failure (lack of improvement or further deterioration) Adverse events: 2 patients had transient elevation of liver enzymes |
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Notes | Ethics: none mentioned No table with demographics. Mention in text that groups are comparable. Author contacted, no response to date 24/08/2004 Author contacted via email: 27/9/2004; 27/10/2004 ‐ no response by 08/11/2004 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Random allocation ‐ does not mention method used. |
Allocation concealment? | High risk | Not reported |
Blinding? All outcomes | Unclear risk | "...observer blinded..." |
Incomplete outcome data addressed? All outcomes | Low risk | No Loss to follow‐up |