Van Roey 2004.

Methods	Treatment study. Patients recruited by 6 investigators at 4 hospitals in Kampala, Uganda Loss to follow‐up: Ketoconazole ‐ 25/179 (14%) Miconazole ‐ 24/178 (13%) Analysis: no ITT
Participants	Inclusion criteria: at least 18 years of age; presumed HIV positive; Life expectancy > 6 months; living within 10 km from study site; presenting with clinical signs of oropharyngeal candidiasis Exclusion criteria: patients who received antifungal therapy within 2 weeks of entry (except local treatment for vaginal candidiasis), pregnant, known history of allergy or intolerance to trial drugs; concomitant use of rifampicin, rifabutin, isoniazid, phenobarbital, phenytoin, carbamazepine, methylprednisolone, terfenadine, astemizole or cisapride; significant hepatic abnormalities. Diagnosis was by clinical examination. Presence of mycelia as observed by microscopic evaluation was documented. 357 patients enrolled 179 ‐ ketoconazole therapy 178 ‐ miconazole nitrate
Interventions	Ketoconazole 400mg daily Miconazole nitrate 10mg daily Duration: 7 ‐ 14 days
Outcomes	Primary outcome was clinical response after 1 week of treatment. Clinical cure was defined as an absence of signs and symptoms (score of 0) as confirmed by the investigator. Signs and symptoms were scored by the same physician at each visit. Symptoms defined as presence (2) or absence (0) of dysphagia, oral pain and loss of taste provided a maximum score of 6. Signs (extent of oral lesions [erythema or removable white plaques]) were scored as 0 = no lesions, 1 = covering < 1 cm2, 3 = moderate covering > 1 cm2 and involving both buccal mucosa and palatal or peritonsillar regions and 4 = severe lesions with extensive involvement of buccal mucosa and palatal peritonsillar regions and pharyngeal mucosa. A subgroup analysis on clinical response was performed based on baseline CD4 count, absence/presence of dysphagia at baseline and concurrent use of broad spectrum antibiotics during the treatment phase. Relapse, amongst those clinically cured, was defined as the recurrence of at least 1 sign or symptom 14 days after treatment stopped. Adverse events: fewer drug related adverse events in miconazole group.
Notes	Ethics: ethics approval obtained from AIDS research committee; informed consent obtained
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Random allocation, method of sequence generation not reported
Allocation concealment?	Unclear risk	Not reported
Blinding? All outcomes	High risk
Incomplete outcome data addressed? All outcomes	Unclear risk	No ITT