F M Sullivan

Dr F M Sullivan, University of Dundee, Dundee, UK; f.m.sullivan@chs.dundee.ac.uk

STUDY DESIGN

Design:

2 × 2 factorial, randomised, placebo-controlled trial.

Allocation:

concealed.*

Blinding:

blinded (clinicians, patients, data collectors, and outcome assessors).*

STUDY QUESTION

Setting:

17 hospitals in Scotland, UK.

Patients:

551 patients ⩾16 years of age (mean age 44 y, 51% men) with unilateral facial nerve weakness of no identifiable cause who were referred by their primary care physician or the emergency department within 72 hours of onset of symptoms. Exclusion criteria included pregnancy, uncontrolled diabetes, peptic ulcer disease, herpes zoster, and multiple sclerosis. 54% of patients started treatment within 24 hours of onset of symptoms. Mean score on the 6-grade House–Brackmann scale was 3.6 (higher grade indicates worse facial paralysis).

Intervention:

prednisolone, 25 mg twice daily, plus placebo for acyclovir (n = 138); acyclovir, 400 mg 5 …