Adour 1996.

Methods	Randomised, placebo‐controlled double‐blind trial, two parallel groups
Participants	The trial was conducted in primary care clinics and emergency departments in North America in 119 participants with confirmed facial paralysis. Data of 99 participants were published. Age range: > 18 years The mean age was 41.9 (SD 14.1) years in the aciclovir plus prednisolone group (N = 53) and 44.6 (SD 15.1) years in the prednisolone plus placebo group (N = 46). In the combination treatment group 45% were women, whereas the prednisolone group had 57% women. Inclusion criteria Paralysis commenced ≤ 3 days before treatment All participants over 18 years of age Good physical health determined by history and physical exam No contraindication for corticosteroid or aciclovir treatment All women of childbearing age had a negative pregnancy test result lack of clear definition of diagnostic criteria (possibly affects generalisability/validity) Exclusion criteria Any other medication for idiopathic facial paralysis Urea nitrogen or creatinine > 2x upper limit of normal Liver transaminase > 3x upper limit of normal Haemoglobin level < 100 g/L Platelet count < 75,000/mm3 or neutrophil count < 1 x 10 to the 6/L Loss to follow‐up: 20 patients (group allocation unknown)
Interventions	Aciclovir (2000 mg per day for 10 days) and prednisone (1 mg/kg for 5 days tapered to 10 mg/day for remaining 5 days) or placebo and prednisone (1 mg/kg for 5 days tapered to 10 mg/day for remaining 5 days)
Outcomes	Primary outcome Recovery on facial paralysis recovery index, where incomplete recovery is a Facial Paralysis Recovery Profile ≤ 7 (Adour 1974), at 4 months Maximal stimulation test with or without electroneurography at follow‐up at 2 weeks, 2, 3, and 4 months (if incomplete recovery) after paralysis onset Final outcomes reported at 3 months or when recovered or palsy stabilised (not more clearly defined) Seconday outcomes Motor synkinesis Adverse events
Funding	Grants from Burroughs Welcome Company and the Community Service Program of Kaiser Foundation Hospitals Inc. Elmore C. Wallace contributed additional funding
Conflicts of interest	Information not given
Date conducted	Information not given, presumably 1995
Notes	Single‐centre The authors stated a dropout rate of 16.8%. The reason for dropout was documented for each participant, such as inability to keep appointments, low adherence to the treatment regimen, adverse events, and moving from the area.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "the bottles [of aciclovir and placebo], provided by Burroughs Wellcome, were randomised in groups of 10"
Allocation concealment (selection bias)	Low risk	Quote: "Each bottle...had a sealed identification label which was removed intact and kept with the patient's record"
Blinding of participants?	Low risk	Quote: "eligible patients were given identical, unlabeled bottles of 100 capsules that contained either placebo or aciclovir (Zovirax), 200 mg" Comment: participants in each group received identical follow‐up
Blinding of assessors?	Low risk	The study was reported as double‐blind; the method reported was consistent with being able to achieve this
Incomplete outcome data?	High risk	The numbers of participants unable to complete the study was given. High dropout rate reported: 16.8%. Not an intention‐to‐treat analysis
Selective outcome reporting?	High risk	Primary outcomes of facial paralysis recovery profile and bilateral facial nerve electrical testing reported, but no data given on audiometry with stapedial reflex testing; adverse events were not specified
Other sources of bias?	Low risk	No other risks of bias reported