Vazquez 2002.

Methods	Treatment study. A single‐centre study conducted from July 1997 to December 1998 in the USA Loss to follow‐up: 5 of the 27 enrolled participants did not complete treatment. Does not give breakdown per study arm. Analysis: Modified intention to treat analysis done where all randomised participants who received at least one dose of study medication were included
Participants	Inclusion criteria: between 18 and 65 years of age; HIV positive; presenting with clinical signs of oropharyngeal candidiasis confirmed on KOH and subsequent culture; failed to respond to 14 days or more of 400mg fluconazole daily 27 patients enrolled 13 ‐ alcohol based melaleuca oral solution 14 ‐ alcohol‐free melaleuca oral solution
Interventions	alcohol based melaleuca oral solution ‐ 15 ml 4 times daily alcohol‐free melaleuca oral solution ‐ 5 ml 4 times daily Swish for 30‐60 seconds then expel; no rinsing afterwards for at least 30 minutes Duration: 2 weeks Add 2 weeks therapy if clinical improvement but nor complete clinical response at end of 2 weeks
Outcomes	Clinical and mycological response. Clinical assessments were graded as cured (clearance of all symptoms and signs), improved (minimal signs or symptoms remaining), unchanged or deteriorated. An assessment at the end of therapy of cured or improved was considered clinical response. Mycological cure was defined as <20 CFU/ml. Mycological response was defined as a significant decrease in CFU/ml from the baseline yeast count. Overall response was then defined as a clinical plus a mycological response. Adverse events: oral burning experience in 8 receiving alcohol based solution and 2 receiving the alcohol free solution.
Notes	Ethics: ethics approval obtained; informed consent obtained
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Method of sequence generation not reported
Allocation concealment?	Unclear risk	Not reported
Blinding? All outcomes	High risk	Reported as "open‐label"
Incomplete outcome data addressed? All outcomes	High risk