Sullivan 2007.

Methods	Double‐blind, placebo‐controlled, randomised, factorial trial
Participants	552 participants randomised and 496 included in final outcome assessment Referred for assessment and treatment within 72 hours of paralysis onset. All participants aged ≥ 16 years and no contraindications to corticosteroids or antiviral therapy Sex: male 253 (51%), female 243 (49%) Age: mean (± SD) 44 (± 16.4) years
Interventions	Participants allocated to 1 of 4 treatment groups to receive: aciclovir prednisolone aciclovir with prednisolone placebo Participants received prednisolone 25 mg twice daily for 10 days or aciclovir 400 mg 5 times daily for 10 days, both treatments or neither treatment, depending on allocation
Outcomes	Primary outcome: recovery rated on House‐Brackmann scale, where recovery was grade I Secondary outcomes: health‐related quality of life Health Utilities Index Mark 3 facial appearance (Derriford Appearance Scale) pain adverse effects frequency of incomplete recovery at end of study Follow‐up at 3 and 9 months Final outcomes reported at 9 months
Funding	Supported by a grant (02/09/04) from the Health Technology Assessment Programme of the National Institute for Health Research (Department of Health, England). The Scottish Executive (Chief Scientist Office and National Health Service Education for Scotland) funded the Scottish School of Primary Care during the study. Practices were reimbursed for their contributions through national Support for Science mechanisms
Conflicts of interest	Drs Sullivan and Donnan reported receiving grant support from GlaxoSmithKline for projects unrelated to the trial. No other potential conflict of interest relevant to this article reported
Date conducted	June 2004 to June 2006
Notes	Multicentre: 17 hospitals
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "... patient was randomly assigned to a study group by an independent, secure, automated telephone randomisation service"
Allocation concealment (selection bias)	Low risk	All parties blinded to allocation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants not receiving active drug received placebo. All administered medication was identical and in identical containers
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors blinded to treatment group
Incomplete outcome data (attrition bias) All outcomes	Low risk	Frequency and reason for drop‐outs documented: 138 assigned to prednisolone, of whom 127 completed the trial: 3 received an incorrect drug and 11 were lost to follow‐up (4 withdrew consent, 2 sought active treatment, 1 did not provide primary outcome data, 4 could not be contacted after the 1st visit) 141 assigned to placebo of whom 122 completed the trial: 19 were lost to follow‐up (6 withdrew consent, 3 could not be contacted, 3 sought active treatment, 1 did not provide primary outcome data, 3 could not be contacted after the 1st visit, 2 died, 1 withdrawn by investigator)
Selective reporting (reporting bias)	Low risk	All planned outcome measures reported
Other bias	Low risk	No other potential sources of bias identified