Fast track — ArticlesPrednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial
Introduction
Bell's palsy presents as unilateral weakness or paralysis of the face due to acute dysfunction of the peripheral facial nerve with no readily identifiable cause.1 Bell's palsy accounts for 70% of peripheral facial palsies and the yearly incidence is about 30 per 100 000.2, 3 About 70% of patients with Bell's palsy recover completely within 6 months without treatment. The remainder have sequelae that include residual paresis, contracture, and synkinesis.2 To minimise the time to recovery and sequelae from Bell's palsy, the most effective medical therapy has to be established.
A possible cause of Bell's palsy is inflammation of the facial nerve,4, 5, 6 which might be related to the herpes virus;7, 8, 9, 10 this has led many investigators to study the efficacy of corticosteroids and antivirals to treat Bell's palsy. The Cochrane database report11 on corticosteroid therapy concluded that trials12, 13, 14, 15 that met the inclusion criteria were too small (179 patients in total) to detect the benefits of corticosteroids. Another Cochrane report assessed the efficacy of aciclovir or similar antiviral drugs.16 Three studies (246 patients) were reviewed,17, 18, 19 and a need for adequately powered clinical trials of aciclovir and valaciclovir with a follow-up of 1 year was identified.16
Our aim was to study the short-term and long-term effects of treatment with prednisolone and/or valaciclovir on the recovery of the facial nerve in a large number of patients with Bell's palsy. We also studied the side-effects of the drugs and their effects on synkinesis. Valaciclovir was chosen because it has higher bioavailability than aciclovir. To improve reliability when assessing potential treatment effects, the regional Sunnybrook20 and the gross House-Brackmann21 scales were used to grade facial function.
Section snippets
Patients
Patients with acute, unilateral, peripheral facial palsy, who were referred from general practitioners or emergency departments, or who sought care directly, were screened by physicians at 16 public otorhinolaryngological centres in Sweden and one centre in Finland. Each study centre had at least one experienced ear, nose, and throat physician with a special interest in facial palsy who was responsible for implementing the study. Patients aged 18 to 75 years with onset of palsy within 72 h were
Results
From May, 2001, to September, 2006, 1953 patients (910 women and 1043 men) with acute peripheral facial palsy were screened and registered. At the initial examination, 1114 of the 1953 patients did not meet the inclusion criteria and were registered with separate forms. Patients who were screened but not included were not registered at the Helsinki centre; thus, the number of patients who were screened was greater than 1953. Reasons for ineligibility were: more than 72 h had elapsed since the
Discussion
This large, double-blind, placebo-controlled trial assessed corticosteroid and antiviral treatment for Bell's palsy. The patients who received prednisolone had a shorter time to complete recovery, and outcomes at 12 months were more favourable in these patients than in those who did not receive prednisolone. Valaciclovir was not proven to be effective and did not affect prednisolone treatment.
In 2001, the American Academy of Neurology concluded in their practice guideline meta-analysis that
References (30)
Herpes-simplex virus as a cause of Bell's palsy
Lancet
(1972)Cortisone treatment of Bell's palsy
Lancet
(1954)- et al.
Corticosteroid treatment of childhood Bell's palsy
Pediatr Neurol
(1999) - et al.
Development of a sensitive clinical facial grading system
Otolaryngol Head Neck Surg
(1996) - et al.
Sunnybrook and House-Brackmann facial grading systems: intrarater repeatability and inter-rater agreement
Otolaryngol Head Neck Surg
(2006) - et al.
Facial nerve disorders: update 1987
Am J Otol
(1987) Bell's palsy: the spontaneous course of 2,500 peripheral facial nerve palsies of different etiologies
Acta Otolaryngol Suppl
(2002)Incidence of Bell's palsy
Ann Otol Rhinol Laryngol Suppl
(1988)- et al.
Facial nerve enhancement in Bell's palsy demonstrated by different gadolinium-enhanced magnetic resonance imaging techniques
Arch Otolaryngol Head Neck Surg
(1993) - et al.
Total intratemporal exposure of the facial nerve. Pathologic findings in Bell's palsy
Arch Otolaryngol
(1972)
Gadolinium-enhanced magnetic resonance imaging in Bell's palsy
Laryngoscope
Herpes simplex virus in idiopathic facial paralysis (Bell palsy)
JAMA
Detection of varicella-zoster virus DNA in patients with acute peripheral facial palsy by the polymerase chain reaction, and its use for early diagnosis of zoster sine herpete
J Med Virol
Bell palsy and herpes simplex virus: identification of viral DNA in endoneurial fluid and muscle
Ann Intern Med
Corticosteroids for Bell's palsy (idiopathic facial paralysis)
Cochrane Database Syst Rev
Cited by (336)
Task force of the Brazilian Society of Otology — evaluation and management of peripheral facial palsy
2024, Brazilian Journal of OtorhinolaryngologyUpdates on Evaluation and Treatment of Common Complaints in Pregnancy
2023, Obstetrics and Gynecology Clinics of North AmericaThe efficacy of corticosteroid after facial nerve neurorrhaphy: a systematic review and meta-analysis of randomized controlled trial
2023, Brazilian Journal of OtorhinolaryngologyIs facial nerve palsy an early manifestation of COVID-19? A literature review
2022, American Journal of the Medical SciencesComparison of oral versus intravenous steroid in the management of Bell’s palsy: a systematic review and meta-analysis of randomized clinical trials
2024, European Archives of Oto-Rhino-Laryngology