Lee 2013.

Methods	Randomised, controlled, double‐blind study, parallel‐group design
Participants	269 participants with severe Bell's palsy were recruited; 206 were included in the final analysis. 99 participants were assigned to the famciclovir and prednisolone group, 107 participants to the prednisolone group. The mean age was 46.7 (SD 16.2) years in the AS group and 48.6 (SD 15.1) in the OS group. Half of the AS group (50%) and 52% of the OS group were female. The authors state that there was no difference between both groups. All participants received treatment within 7 days of onset of palsy. Age range: 16‐77 years Inclusion criteria Acute unilateral peripheral facial paralysis without skin lesions or intraoral lesions occurring within 7 days of presentation Only patients with severe‐to‐complete Bell's palsy (House‐Brackmann scale Grade 5 or more) were enrolled Exclusion criteria Bell's palsy that occurred more than 7 days before presentation Suspected Ramsay‐Hunt syndrome Meningitis Myelitis Vasculopathy Patients who could not be observed for at least 6 months Initial use of several different types of treatments Pregnancy or breastfeeding Uncontrolled diabetes or hypertension Poor general medical conditions in which corticosteroid or antiviral therapy cannot be used Suspicion of Borrelia infection Tendency for neuropsychiatric disease Refusal to participate in the study
Interventions	AS group: prednisolone 64 mg for 4 days, 48 mg for 2 days, 32 mg for 2 days, and 16 mg for 2 days with famciclovir 750 mg/day for 7 days intravenously (N = 99) OS group: famciclovir 750 mg/day for 7 days intravenously (N = 107). Both drugs were given simultaneously
Outcomes	Primary outcome Full recovery, based on the House‐Brackmann scale (Grades 1 and 2) at 6 months (House 1983; House 1985) Evaluation of prognostic factors for incomplete recovery. Follow‐up at 2 weeks and 6 months after commencing treatment
Funding	Kyung Hee University Research Fund
Conflicts of interest	The authors state having no conflict of interest
Date conducted	September 2008 to August 2011
Notes	Single‐centre, Department of Otopharyngology at the Kyung Hee University in Korea
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random sequence generation using computer codes
Allocation concealment (selection bias)	Unclear risk	No information on concealment
Blinding of participants?	High risk	No placebo. No information on concealment of the intervention
Blinding of assessors?	High risk	Different treatment regimens in both groups. No information on concealment of the intervention
Incomplete outcome data?	High risk	Per protocol analysis only. Dropout rate reported: 13.1%. No intention‐to‐treat analysis
Selective outcome reporting?	Unclear risk	Adverse events were not reported
Other sources of bias?	Unclear risk	Two participants with adverse events in the corticosteroid group (not clearly specified) were excluded from the analysis