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. 2020 Feb 28;2020(2):CD001168. doi: 10.1002/14651858.CD001168.pub3

Hegarty 2002.

Methods Study design: 2‐arm cross‐over RCT
Conducted in UK
Number of centres: 1
Recruitment period: unclear
Funding source: unspecified
Participants Inclusion criteria: symptomatic erosive or ulcerative OLP, had not previously used fluticasone or betamethasone, and were generally healthy
Exclusion criteria: unclear
Group A: randomised 22; analysed 19
Group B: randomised 22; analysed 20
Interventions Fluticasone 50 μg spray, 2 puffs applied to lesions 4 times daily, for 6 weeks and betamethasone sodium phosphate 500 μg (0.5 mg in 10 mL of water), 3 minutes mouthrinse 4 times daily for 6 weeks
Group A: sequence fluticasone and betamethasone
Group B: sequence betamethasone and fluticasone
Washout period: 2 weeks
Outcomes Pain (VAS), clinical score (modified from Thongprasom), size of affected mucosa, quality of life (OHIP, OHQoL), adverse effects
Notes All 5 people who left the study (3 in group A and 2 in group B) did so during fluticasone treatment because of adverse effects.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A table of random numbers was used."
Allocation concealment (selection bias) Low risk Quote: "The sequence was concealed until the effect of both intervention was analysed."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not feasible.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not feasible.
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.
Comment: data from this cross‐over study were not analysed as paired and, therefore, they could not be entered in a meta‐analysis.
Other bias Low risk No other sources of bias identified.