Lodi 2007.

Methods	Study design: RCT Conducted in Italy Number of centres: 1 Recruitment period: May 2002 to January 2003                  Funding source: University of Milan
Participants	Inclusion criteria: clinical and histological diagnosis of OLP; symptomatic form of the disease; aged > 18 years Exclusion criteria: previous treatment for OLP; systemic or local treatment with antifungal or corticosteroids in the 6 months prior to study; hypersensitivity to clobetasol propionate or miconazole; or uncontrolled diabetes or hypertension, systemic conditions that could hamper participation and compliance with the study Group A: randomised 18; analysed 15 Group B: randomised 17; analysed 15
Interventions	Group A: clobetasol propionate gel 0.05% (twice daily) and miconazole 2% gel (once daily) for 6 weeks Group B: clobetasol propionate gel 0.05% (twice daily) and placebo gel (once daily) for 6 weeks
Outcomes	Pain (VAS), percentage of mucosa affected, adverse effects
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "allocation sequence was generated using software available online."
Allocation concealment (selection bias)	Low risk	Quote: "sequence was hidden from the researchers determining patient eligibility."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Neither the patient nor the clinician was aware of the content of the syringes."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Neither the patient nor the clinician was aware of the content of the syringes."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: missing data balanced in numbers across intervention groups (3 and 2) and not likely to have a clinically relevant impact on the intervention effect estimate. Unlikely to have introduced bias.
Selective reporting (reporting bias)	Low risk	Planned outcomes reported.
Other bias	Low risk	No other sources of bias identified.