Smith 1991.

Methods	Patients were stratified at enrolment into one of three groups ‐ HIV constitutional disease (AIDS related complex), AIDS and AIDS plus esophageal candidiasis Study location: United Kingdom Dates for start and end of study not reported. Loss to follow‐up: Intraconazole ‐ 13/59 (22%) Ketoconazole ‐ 12/52 (23%) Analysis: no ITT. Patients placed on concomitant rifampicin, antacids, who were non‐compliant, or who died from other infections were excluded from the evaluation of efficacy.
Participants	Inclusion criteria: HIV positive; homosexual men; symptoms of oral disease or clinical appearance of candidiasis; mouth swab revealing numerous fungal hyphae on gram stain 111 participants enrolled 59 ‐ Intraconazole 52 ‐ Ketoconazole
Interventions	Intraconazole ‐ 200mg daily plus placebo ketoconazole Ketoconazole ‐ 200mg twice a day plus placebo itraconazole Duration treatment: 28 days
Outcomes	Clinical evaluation was based on the degree of aphthae, erythema, angular stomatitis, mucosal ulceration and dysphagia and graded as absent (0), mild disease (1), moderate disease (2), or severe disease (3). A clinical response was defined by an improvement of 2 grades or to grade 0 in all signs when compared with pretreatment values. Mouth washings and swabs were cultured and graded according to the number of CFUs: 0‐10 (grade 0), 10‐100 (grade 1), 100‐1000 (grade 2) and > 1000 (grade 3). Mycological response was defined by either improvement of 2 grades or no growth. Relapse was defined as clinical evidence of buccal and /or esophageal candidiasis with mycological confirmation noted between or at monthly follow‐up visits after active treatment. Adverse events: five patients had to stop ketoconazole due to serious toxic events ‐ 2 nausea, 2 hepatotoxicity and 1 generalized erythematous rash. One patient on itraconazole developed a maculopapular rash.
Notes	Ethics: no mention
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Method not reported
Allocation concealment?	Low risk	Sealed envelopes
Blinding? All outcomes	Low risk	Report "double‐blind", unclear who apart from patient blinded
Incomplete outcome data addressed? All outcomes	Low risk	No ITT. Those lost to follow‐up not included in evaluation of efficacy