Scandinavian Bell's Palsy Study
Summary
The main objective of this study is to study the effects of prednisolone and valaciclovir, with equal importance, compared to placebo for the treatment of Bell´s palsy. The combination of prednisolone and valaciclovir will also be studied.
Timeline
- Start
- 2001-05
- Primary completion
- 2007-09
- Completion
- 2007-09
Outcome
Mixed primary results
paper The primary outcome event was time to complete recovery of facial function, as assessed with a regional Sunnybrook scale score of 100 points. PMID 18849193 ↗
paper Time to recovery was significantly shorter in the 416 patients who received prednisolone compared with the 413 patients who did not PMID 18849193 ↗
paper hazard ratio 1.40, 95% CI 1.18 to 1.64; p<0.0001. PMID 18849193 ↗
paper There was no difference in time to recovery between the 413 patients treated with valaciclovir and the 416 patients who did not receive valaciclovir PMID 18849193 ↗
paper (1.01, 0.85 to 1.19; p=0.90). PMID 18849193 ↗
Publications
- Berg T, Bylund N, Marsk E, Jonsson L, Kanerva M, Hultcrantz M, Engstrom M. The effect of prednisolone on sequelae in Bell's palsy. Arch Otolaryngol Head Neck Surg. 2012 May;138(5):445-9. doi: 10.1001/archoto.2012.513.
- Engstrom M, Berg T, Stjernquist-Desatnik A, Axelsson S, Pitkaranta A, Hultcrantz M, Kanerva M, Hanner P, Jonsson L. Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Neurol. 2008 Nov;7(11):993-1000. doi: 10.1016/S1474-4422(08)70221-7. Epub 2008 Oct 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisolone | Other / unclassified | 60 mg | Oral |
| Subject | Valaciclovir | Unknown | 1000 mg | Oral |