Bensadoun 2008.

Methods	Randomised, parallel group multicentre single blind study conducted in France, Tunsia and Morocco. Patients and carers not blinded. Primary outcome assessment made by blinded assessor. No evidence of funding apart from one collaborator is a consultant for pharmaceutical company who produced the tablets. Patients were recruited from May 2002 until June 2004.
Participants	Adults with head and neck cancer. 306 patients randomised, 154 to miconazole tablet and 152 to miconazole gel. 6 patients in each group had no treatment, analysis conducted on 141 patient in each group. OP confirmed by direct mycological examination (culture).
Interventions	2 groups: miconazole tablet Lauriad 50 mg MBT (kept in mouth as long as possible) or 500 mg miconazole gel MOG (applied to gums) once daily for 14 days.
Outcomes	Primary outcome success at day 14 (clinical eradication) and partial response was defined as improvement by 2 points on Murray Scoring Scale compared with score at baseline. Assessment made at 2, 6, 20 days, unclear which presented. Secondary endpoint was success at day 7. Improvement in clinical symptoms, mycological cure (culture), recurrence rate and safety also reported.
Notes	Modified intention‐to‐treat analysis ‐ all randomised patients who received at least 1 treatment dose and had efficacy evaluation after randomisation. Non‐inferiority statistical approach used. Authors contacted about assessor blinding.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Quote: "patients were randomised".
Allocation concealment?	Unclear risk	Not reported.
Blinding of participants and carers?	High risk	Comment: Tablet versus gel.
Blinding of outcome assessors?	Unclear risk	Quote: "An amendment introduced a blind assessment of the primary criterion performed in each investigational centre by an independent healthcare member who was unaware of the study drug allocated to each patient. It was implemented after the inclusion of 59 patients". Comment: lack of clarity about how this affected the results.
Incomplete outcome data addressed?	Unclear risk	Comment: Figure 1 provides clear description of patients for data analysis. Two patients were given the wrong intervention, 6 in each group did not receive treatment and 6 did not have an outcome assessment. Numbers do not add up and true intention to treat analysis was not undertaken.
Free of selective reporting?	Low risk	Comment: Both clinical and mycological assessment reported and other secondary outcomes.
Free of other biases?	Unclear risk	One author is consultant for pharmaceutical company who produced tablets for study.