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 |
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Interventions |
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Outcomes | Primary outcome:
Secondary outcomes:
Follow‐up up to 9 months |
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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 |