Nyst 1992.

Methods	Single centre, single country study conducted in the medical wards of Mama Yemo Hospital, Kinshasa, Zaire. Patients enrolled into study from 9 May 1989 to 31 May 1990. Loss to follow‐up: Gentian violet ‐ 23/49 (47%) Ketoconazole ‐ 22/45 (49%) Nystatin ‐ 24/47 (51%) Analysis: no ITT
Participants	Inclusion criteria: adult patients; no anti mycotic treatment in previous 2 weeks; clinical diagnosis of oropharyngeal candidiasis; confirmed by microscopy. Exclusion criteria: none mentioned. 150 patients enrolled 9 excluded from analysis (3 HIV negative; 6 missing HIV status) 49 ‐ Gentian violet 45 ‐ Ketoconazole 47 ‐ Nystatin
Interventions	Gentian violet ‐ mouth washes with 0.5% aqueous solution 1.5ml bid; wash for 2 minutes then swallow Ketoconazole ‐ 200mg/day Nystatin ‐ mouth washes with oral suspension 200.000 U qid; wash for 2 minutes then swallow Duration: 10 days or longer until complete clearance of symptoms.
Outcomes	Primary: Clinical and mycological cure judged on clinical and microscopy assessment. Adverse events: 2 patients receiving gentian violet developed irritation and small superficial ulcers of the oral mucosa 24 hours of start of therapy.
Notes	Ethics: signed informed consent
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Patients were stratified into patients with oropharyngeal candida only and patients with both oropharyngeal and esophageal candida. Within these strata consecutive patients received an incremental study number which has been randomised beforehand. Method of sequence generation not reported.
Allocation concealment?	Low risk	Listing of study numbers and treatments was kept by one of the authors who ws not involved in the initial assessment to the patients. Treatment to be given only disclosed after patient was enrolled in the study.
Blinding? All outcomes	High risk	No blinding due to characteristics of drugs ‐ one is a dye
Incomplete outcome data addressed? All outcomes	Unclear risk	No ITT analysis done