Pons 1997.

Methods	Multicentre study in the USA Loss to follow‐up: Fluconazole ‐ 13/83 (16%) Nystatin ‐ 14 /84 (17%) Analysis: no ITT
Participants	Inclusion criteria: oropharyngeal candidiasis;CDC criteria for HIV/ AIDS; diagnosis confirmed by mycologic culture Exclusion criteria: patients taking other forms of antifungal therapy at/ within 3 days of enrolment; known intolerance to imidazoles, triazoles or polyene components of nystatin, inability to tolerate oral medications, moderate to severe liver disease, life expectancy < 4 weeks, inability to be followed at one centre for study duration. Clinical diagnosis confirmed with KOH and culture 167 patients enrolled and randomised 83 fluconazole 84 nystatin
Interventions	Fluconazole ‐ 200mg (20ml) loading dose once off on day 1 then 100mg (10ml) once daily for 14 days Nystatin ‐ 5ml (500,000 U) four times daily for 14 days Duration of intervention ‐ 14 days Follow up period ‐ after 28 and 48 days
Outcomes	Clinical cure ‐ defined as complete resolution of signs and symptoms of oropharyngeal candidiasis Mycologic cure: absence of candidal spp in cultures on day 14 Adverse events: GIT most common
Notes	Ethics: informed consent obtained
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Random allocation, method not described
Allocation concealment?	Unclear risk	Not reported
Blinding? All outcomes	High risk	Single blind: clinical evaluator at each study point was unaware of treatment assignment.