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. 2016 Jul 18;2016(7):CD001942. doi: 10.1002/14651858.CD001942.pub5

Austin 1993.

Methods Double‐blind, randomised, controlled study
Participants 107 people were initially randomised; 76 completed follow‐up until acute recovery and were included in the study analyses
Participants were treated within 5 days of onset
Sex: male 39 (51%), female 37 (49%)
Age: mean 36.8 years, range 18 to 70 years
37 cases (49%) right side palsy and 39 cases (51%) left side palsy
Interventions
  • Prednisone (n = 35): in a scheduled dosage (30 mg twice daily for 5 days reducing to 20 mg twice daily on day 6, 15 mg twice daily on day 7, 10 mg twice daily on day 8, 5 mg twice daily on day 9, and 5 mg once daily on day 10)

  • Equivalent placebo (n = 31)

Outcomes Primary outcome:
  • time to resolution in days of facial function as defined by the House‐Brackmann scale


Secondary outcomes:
  • distribution of facial nerve grade at 6 months after recovery, in addition to

  • crocodile tears and

  • anxiety during follow‐up


Follow‐up up to 9 months
Funding Not stated
Conflicts of interest Not stated
Date conducted 1 October 1989 to 31 December 1990
Notes Good recovery defined as grade I or II of the House‐Brackmann scale
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated to be randomised at the pharmacy but details not given
Allocation concealment (selection bias) Unclear risk Allocation of participants not described
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "The study was blinded to both the patient and the clinical investigators". Further details of blinding not given
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "The study was blinded to both the patient and the clinical investigators". Further details of blinding not given
Incomplete outcome data (attrition bias) 
 All outcomes High risk 107 participants randomised, 31 did not attend for follow‐up assessment. 76 allocated to prednisone or placebo
Analysis 6 months after resolution of Bell's palsy included 53 participants (23 prednisolone and 30 placebo), representing over 50% loss to follow‐up at this point. Reasons for additional drop‐outs at 6 months not described
Selective reporting (reporting bias) Low risk All primary outcomes reported
Other bias Low risk Single‐centre study