Hegarty 2002.
Methods | Study design: 2‐arm cross‐over RCT Conducted in UK Number of centres: 1 Recruitment period: unclear Funding source: unspecified |
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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 |
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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 |
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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. |