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Bell's palsy - the effect of prednisolone and/or valaciclovir versus placebo in relation to baseline severity in a randomised controlled trial.

Axelsson, Sara LU ; Thomas, Berg; Lars, Jonsson; Mats, Engström; Mervi, Kanerva and Stjernquist-Desatnik, Anna LU (2012) In Clinical Otolaryngology 37(4). p.283-290
Abstract
Objectives:

To evaluate the treatment effect of prednisolone and/or valaciclovir in Bell's palsy patients with different baseline severity of palsy.



Design:

Patient data were collected from the Scandinavian Bell's Palsy Study, a prospective, randomized, double-blind, placebo-controlled, multi-centre trial. Setting: Sixteen otorhinolaryngological centres in Sweden and one in Finland.



Participants:

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).... (More)
Objectives:

To evaluate the treatment effect of prednisolone and/or valaciclovir in Bell's palsy patients with different baseline severity of palsy.



Design:

Patient data were collected from the Scandinavian Bell's Palsy Study, a prospective, randomized, double-blind, placebo-controlled, multi-centre trial. Setting: Sixteen otorhinolaryngological centres in Sweden and one in Finland.



Participants:

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.



Main outcome measures:

Facial function was assessed using the Sunnybrook grading scale at baseline and at 12 months. Complete recovery was defined as Sunnybrook score = 100.



Results: 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.



Conclusion:

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. © 2012 Blackwell Publishing Ltd. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Clinical Otolaryngology
volume
37
issue
4
pages
283 - 290
publisher
Wiley-Blackwell
external identifiers
  • wos:000308040800004
  • pmid:22776019
  • scopus:84865570175
ISSN
1749-4486
DOI
10.1111/j.1749-4486.2012.02526.x
language
English
LU publication?
yes
id
2a597d8e-4386-47b0-bee7-8399d3bbab97 (old id 2967337)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/22776019?dopt=Abstract
date added to LUP
2012-08-09 18:10:09
date last changed
2017-10-22 04:54:45
@article{2a597d8e-4386-47b0-bee7-8399d3bbab97,
  abstract     = {Objectives: <br/><br>
To evaluate the treatment effect of prednisolone and/or valaciclovir in Bell's palsy patients with different baseline severity of palsy. <br/><br>
<br/><br>
Design: <br/><br>
Patient data were collected from the Scandinavian Bell's Palsy Study, a prospective, randomized, double-blind, placebo-controlled, multi-centre trial. Setting: Sixteen otorhinolaryngological centres in Sweden and one in Finland. <br/><br>
<br/><br>
Participants: <br/><br>
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. <br/><br>
<br/><br>
Main outcome measures: <br/><br>
Facial function was assessed using the Sunnybrook grading scale at baseline and at 12 months. Complete recovery was defined as Sunnybrook score = 100. <br/><br>
<br/><br>
Results: 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&lt;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. <br/><br>
<br/><br>
Conclusion: <br/><br>
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. © 2012 Blackwell Publishing Ltd.},
  author       = {Axelsson, Sara and Thomas, Berg and Lars, Jonsson and Mats, Engström and Mervi, Kanerva and Stjernquist-Desatnik, Anna},
  issn         = {1749-4486},
  language     = {eng},
  number       = {4},
  pages        = {283--290},
  publisher    = {Wiley-Blackwell},
  series       = {Clinical Otolaryngology},
  title        = {Bell's palsy - the effect of prednisolone and/or valaciclovir versus placebo in relation to baseline severity in a randomised controlled trial.},
  url          = {http://dx.doi.org/10.1111/j.1749-4486.2012.02526.x},
  volume       = {37},
  year         = {2012},
}