Bells palsy - the effect of prednisolone and/or valaciclovir versus placebo in relation to baseline severity in a randomised controlled trial
Sara A et al. – Prednisolone treatment resulted in higher complete recovery rates, regardless of severity at baseline. Prednisolone treatment should be considered in all patients irrespective of degree of palsy.Methods
- Altogether 829 patients aged 18-75 years were treated within 72 hours of palsy onset.
- Patients were randomly assigned to treatment with prednisolone plus placebo (n=210), valaciclovir plus placebo (n=207), prednisolone plus valaciclovir (n=206), placebo plus placebo (n=206).
- Follow-up was 12 months.
- Facial function was assessed using the Sunnybrook grading scale at baseline and at 12 months.
- Complete recovery was defined as Sunnybrook score = 100.
- All patients, regardless of baseline severity, showed significantly higher complete recovery rates if treated with prednisolone compared with no prednisolone.
- In patients with severe palsy, recovery at 12 months was 51% with prednisolone treatment versus 31% without prednisolone (P=0.02).
- Corresponding results were 68% versus 51% (P=0.004) for moderate, and 83% versus 73% (P=0.02) for mild palsy.
- In patient groups with moderate and mild palsy at baseline, significantly fewer prednisolone-treated patients had synkinesis at 12 months (P=0.04 and P<0.0001, respectively).
- For patients with severe palsy at baseline, prednisolone versus no prednisolone made no significant difference regarding synkinesis at 12 months.
- Valaciclovir did not add any significant effect to prednisolone regarding recovery rate or synkinesis at 12 months.