Sullivan 2007.

Methods	Double‐blind, placebo‐controlled, randomised, 2 x 2 factorial trial
Participants	551 participants randomised; 496 included in final outcome assessment. Referred for assessment and treatment within 72 hours of paralysis onset. All participants aged 16 or older and no contraindications to corticosteroids or antivirals. The mean age was 44.0 ± 16.4. Patients were recruited in primary and secondary care setting and treated in 17 hospitals in Scotland, UK. Patients were recruited through their family doctors, emergency departments, the national 24‐hour medical telephone consultancy service, and dentists' offices. Inclusion criteria Unilateral facial nerve weakness of no identifiable cause who presented to primary care or the emergency department and could be referred to a collaborating otorhinolaryngologist within 72 hours after the onset of symptoms Exclusion criteria Pregnancy Breastfeeding Uncontrolled diabetes (glycated haemoglobin level, > 8%) Peptic ulcer disease Suppurative otitis media Herpes zoster Multiple sclerosis Systemic infection Sarcoidosis and other rare conditions An inability to provide informed consent
Interventions	Participants allocated to 1 of 4 treatment groups: either aciclovir, prednisolone, both agents, or 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 upon allocation
Outcomes	Primary outcome Recovery, rated on House‐Brackmann scale (House 1983; House 1985), where recovery was Grade 1 Secondary outcomes Health‐related quality of life Health Utilities Index Mark 3 Facial appearance (Derriford Appearance Scale; Harris 2001) Pain Adverse outcomes Frequency of incomplete recovery at end of study was recorded. Follow‐up at 3 months 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 School of Primary Care was funded by the Scottish Executive (Chief Scientist Office and National Health Service Education for Scot‐land) during the study. Practices were reimbursed for their contributions through national Support for Science mechanisms
Conflicts of interest	Drs. Sullivan and Donnan report receiving grant support from GlaxoSmithKline for projects unrelated to this trial. No other potential conflict of interest relevant to this article was 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?	Low risk	Participants not receiving active drug received placebo. All administered medication identical and in identical containers
Blinding of assessors?	Low risk	Assessors blinded to treatment group
Incomplete outcome data?	Low risk	All participants who were unable to complete were documented ‐ both frequency and reason. Intention‐to‐treat analysis performed
Selective outcome reporting?	Low risk	All planned outcome measures reported
Other sources of bias?	Low risk	No other potential sources of bias identified