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BMJ Clinical Evidence logoLink to BMJ Clinical Evidence
. 2014 Apr 9;2014:1204.

Bell's palsy

N Julian Holland 1,#, Jonathan M Bernstein 2,#
PMCID: PMC3980711  PMID: 24717284

Abstract

Introduction

Bell's palsy is characterised by an acute, unilateral, partial, or complete paralysis of the face. Bell's palsy occurs in a lower motor neurone pattern. The weakness may be partial or complete, and may be associated with mild pain, numbness, increased sensitivity to sound, and altered taste. Bell's palsy is idiopathic, but a proportion of cases may be caused by re-activation of herpes virus at the geniculate ganglion of the facial nerve. Bell's palsy is most common in people aged 15 to 40 years, with a 1 in 60 lifetime risk. Most people make a spontaneous recovery within 1 month, but up to 30% show delayed or incomplete recovery.

Methods and outcomes

We conducted a systematic review to answer the following clinical questions: What are the effects of drug treatments for Bell's palsy in adults and children? What are the effects of physical treatments for Bell's palsy in adults and children? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2013 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 13 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review, we present information relating to the effectiveness and safety of the following interventions: antiviral treatment, corticosteroids (alone or with antiviral treatment), hyperbaric oxygen therapy, and facial re-training.

Key Points

Bell's palsy is an idiopathic, unilateral, acute paresis (partial weakness) or paralysis (complete palsy) of facial movement caused by dysfunction of the lower motor neurone of the facial nerve. Bell's palsy is a diagnosis of exclusion of other causes of facial nerve palsy.

  • Most people with paresis make a spontaneous recovery within 3 weeks. Up to 30% of people, typically those with paralysis, have a delayed or incomplete recovery.

Corticosteroids alone improve the rate of recovery and the proportion of people who make a full recovery, and reduce cosmetically disabling sequelae compared with placebo or no treatment.

Antiviral treatment alone is no more effective than placebo at improving facial motor function and reducing the risk of disabling sequelae.

We found no good evidence of significant benefit of combination corticosteroid-antiviral therapy over corticosteroid alone. However, there is a lack of data on people presenting with complete paralysis and any potential benefit of combination corticosteroid-antiviral therapy cannot be excluded.

Hyperbaric oxygen may improve the time to recovery and the proportion of people who make a full recovery compared with corticosteroids. However, the evidence for this is weak and comes from one small RCT.

Facial re-training may improve the recovery of facial motor function scores, including stiffness and lip mobility, and may reduce the risk of motor synkinesis in Bell's palsy, but the evidence is too weak to draw reliable conclusions.

About this condition

Definition

Bell's palsy is an idiopathic, unilateral, acute weakness of the face in a pattern consistent with peripheral facial nerve dysfunction, and may be partial or complete, occurring with equal frequency on either side of the face. Bell's palsy is idiopathic but there is weak evidence that Bell's palsy is cased by herpes simplex virus. Additional symptoms of Bell's palsy may include mild pain in or behind the ear, oropharyngeal or facial numbness, impaired tolerance to ordinary levels of noise, and disturbed taste on the anterior part of the tongue. Severe pain is more suggestive of herpes zoster virus infection and Ramsay Hunt syndrome. Bell's palsy is a diagnosis of exclusion. Other causes of lower motor neurone weakness include middle ear infection, parotid malignancy, malignant otitis externa, and lateral skull base tumours. Features such as sparing of movement in the upper face (central pattern), or weakness of a specific branch of the facial nerve (segmental pattern), suggest an alternative cause. Bell's palsy is less commonly the cause of facial palsy in children aged under 10 years (<50%).

Incidence/ Prevalence

The incidence is about 20 in 100,000 people a year, with about 1 in 60 lifetime risk. Bell's palsy has a peak incidence between the ages of 15 and 40 years. Men and women are equally affected, although the incidence may be higher in pregnant women.

Aetiology/ Risk factors

The cause of Bell's palsy is uncertain. It is thought that re-activated herpes virus at the geniculate ganglion of the facial nerve may play a key role in the development of Bell's palsy. Herpes simplex virus (HSV)-1 has been detected in up to 50% of cases by some researchers. However, one study demonstrated the replication of HSV, herpes zoster virus [HZV], or both, in <20% of cases. Herpes zoster-associated facial palsy more frequently presents as zoster sine herpete (without vesicles), although 6% of people develop vesicles (Ramsay Hunt syndrome). Infection of the facial nerve by HZV initially results in reversible neuropraxia, but irreversible Wallerian degeneration may occur. Treatment plans for the management of Bell's palsy should recognise the possibility of HZV infection.

Prognosis

Overall, Bell's palsy has a fair prognosis without treatment. Clinically important improvement occurs within 3 weeks in 85% of people and within 3 to 5 months in the remaining 15%. People failing to show signs of improvement by 3 weeks may have suffered severe degeneration of the facial nerve, or may have an alternative diagnosis that requires identification by specialist examination or investigations, such as CT or MRI. Overall, 71% of people will experience complete recovery in facial muscle function (i.e., 61% of people with complete paralysis, 94% of people with partial paralysis). The remaining 29% have permanent mild to severe residual facial muscle weakness, 17% with contracture, and 16% with hemifacial spasm or synkinesis. Incomplete recovery of facial expression has a long-term impact on quality of life and self-esteem. The prognosis for children with Bell's palsy is generally better, with a high rate (>90%) of spontaneous recovery, in part because of the higher frequency of paresis. However, children with paralysis have permanent facial muscle weakness as frequently as adults.

Aims of intervention

To increase the proportion of people making a full or partial recovery; to increase the speed of recovery; to prevent progression from partial to complete facial palsy; to reduce the incidence of motor synkinesis and contracture; to reduce the risk of eye injury; to minimise any side effects of treatment.

Outcomes

Recovery of motor function: grade of recovery of motor function of the face ideally at 12 months (or other time point when clearly stated); presence of sequelae ideally at 12 months including motor synkinesis, autonomic dysfunction, or hemifacial spasm; time to recovery including time to full recovery; impact on quality of life; adverse effects of treatment.

Methods

Clinical Evidence search and appraisal October 2013. The following databases were used to identify studies for this systematic review: Medline 1966 to October 2013, Embase 1980 to October 2013, and The Cochrane Database of Systematic Reviews 2013, issue 9 (1966 to date of issue). Additional searches were carried out in the Database of Abstracts of Reviews of Effects (DARE) and the Health Technology Assessment (HTA) Database. We also searched for retractions of studies included in the review. Titles and abstracts identified by the initial search, run by an information specialist, were first assessed against predefined criteria by an evidence scanner. Full texts for potentially relevant studies were then assessed against predefined criteria by an evidence analyst. Studies selected for inclusion were discussed with an expert contributor. All data relevant to the review were then extracted by an evidence analyst. Study design criteria for inclusion in this review were: published systematic reviews and RCTs, at least double-blinded and containing more than 20 individuals, of whom more than 80% were followed up. There was no minimum follow-up. We excluded all studies described as single-blinded, 'open', 'open label', or not blinded unless blinding was impossible. We included RCTs and systematic reviews of RCTs where harms of an included intervention were assessed, applying the same study design criteria for inclusion as we did for benefits. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table.

GRADE Evaluation of interventions for Bell's palsy.

Important outcomes Presence of sequelae, Recovery of motor function, Time to recovery
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of drug treatments for Bell's palsy in adults and children?
10 (1507) Recovery of motor function Corticosteroids versus placebo or no specific treatment 4 –1 0 0 0 Moderate Quality point deducted for the inclusion of some single-blinded studies in the meta-analysis
at least 3 (at least 901) Presence of sequelae Corticosteroids versus placebo or no specific treatment 4 –2 0 0 0 Low Quality points deducted for incomplete reporting of results and the inclusion of some single-blinded studies in the meta-analysis
1 (829) Time to recovery Corticosteroids versus placebo or no specific treatment 4 0 0 0 0 High
5 (1228) Recovery of motor function Antiviral agents versus placebo 4 –1 0 0 0 Moderate Quality point deducted for the inclusion of single-blinded studies in the meta-analysis
2 (at least 99) Presence of sequelae Antiviral agents versus placebo 4 –2 0 0 0 Low Quality points deducted for unclear reporting of number of people in analysis and incomplete reporting of results
3 (768) Recovery of motor function Antiviral agents versus corticosteroids 4 0 0 0 0 High
7 (1987) Recovery of motor function Corticosteroids plus antiviral treatment versus placebo/no treatment 4 –1 0 0 0 Moderate Quality point deducted for the inclusion of some single-blinded studies in the meta-analysis
9 (1504) Recovery of motor function Corticosteroids plus antiviral treatment versus corticosteroids alone 4 –1 –1 0 0 Low Quality point deducted for the inclusion of open-label studies in the meta-analysis; consistency point deducted for conflicting results depending on analysis undertaken
1 (99) Presence of sequelae Corticosteroids plus antiviral treatment versus corticosteroids alone 4 –1 0 –1 0 Low Quality point deducted for sparse data; directness point deducted for small number of events
2 (660) Recovery of motor function Corticosteroids plus antiviral treatment versus antiviral treatment alone 4 0 0 0 0 High
1 (79) Recovery of motor function Hyperbaric oxygen versus corticosteroids 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (79) Time to recovery Hyperbaric oxygen versus corticosteroids 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
What are the effects of physical treatments for Bell's palsy in adults and children?
2 (82) Recovery of motor function Facial re-training versus waiting list control 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (145) Presence of sequelae Facial re-training versus waiting list control 4 –2 0 0 0 Low Quality points deducted for sparse data and methodological weaknesses
1 (90) Time to recovery Facial re-training versus waiting list control 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
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We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.

Glossary

Hemifacial spasm

is a generalised involuntary mass contracture of the facial muscles.

High-quality evidence

Further research is very unlikely to change our confidence in the estimate of effect.

Low-quality evidence

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Moderate-quality evidence

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Neuropraxia

is reversible nerve dysfunction without the degeneration or loss of nerve axons.

Ramsay Hunt syndrome

is characterised by acute facial paralysis with herpetic (herpes zoster virus) blisters of the skin of the ear canal or tongue. Other symptoms may include vertigo, ipsilateral hearing loss, and tinnitus.

Wallerian degeneration

describes the sequelae of axonal injury and subsequent removal of axonal and myelin debris by Schwann cells and invading macrophages.

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

Contributor Information

N. Julian Holland, Waitemata District Health Board, Auckland, New Zealand.

Jonathan M. Bernstein, University Health Network, Toronto, Canada.

References

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BMJ Clin Evid. 2014 Apr 9;2014:1204.

Corticosteroids

Summary

Corticosteroids alone improve rate of recovery and the proportion of people who make a full recovery, and reduce motor synkinesis and autonomic dysfunction compared with placebo or no treatment.

Good evidence exists that corticosteroid therapy improves facial palsy in people with Bell's palsy independent of severity at presentation. Treatment is likely to be more effective when started within 72 hours of onset.

Contraindications to corticosteroid therapy exist, and adverse effects are more likely following 7 days of treatment.

The potential adverse effects of corticosteroid treatment include diabetes, hypertension, glaucoma, psychosis, fluid and electrolyte disturbances, gastrointestinal tract haemorrhage, and avascular necrosis of the femoral head. The increased incidence of abnormal glucose tolerance in people with Bell's palsy warrants caution.

Benefits and harms

Corticosteroids versus placebo or no specific treatment:

We found two systematic reviews (search dates 2008 and 2009) comparing corticosteroids versus placebo or no specific treatment using different inclusion criteria. We also report the outcomes of the two large RCTs (included in both systematic reviews) that have enabled the meta-analyses and influenced the changed treatment recommendations in this area. We also found one further analysis of the dataset included in the second large RCT; it did not include any different outcomes or time points to those included in the original RCT and, therefore, has not been reported further here.

Recovery of motor function

Corticosteroids compared with placebo or no specific treatment Corticosteroids seem more effective than placebo or no treatment at improving the recovery of facial motor function up to 12 months (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recovery of motor function

Systematic review		 1507 people
7 RCTs in this analysis		 Proportion of people with incomplete recovery of facial motor function 6–9 months
175/754 (23%) with corticosteroids
245/753 (33%) with placebo/no treatment
RR 0.71
95% CI 0.61 to 0.83 		Small effect size corticosteroids

Systematic review		 1285 people
10 RCTs in this analysis		 Proportion of people with unsatisfactory recovery
102/629 (16%) with corticosteroids
245/656 (37%) with control
RR 0.69
95% CI 0.55 to 0.87
P = 0.001 		Small effect size corticosteroids

RCT
4-armed trial 		551 people with Bell's palsy, moderate to severe weakness
In review 		Proportion of people with complete recovery 9 months
237/251 (94%) with prednisolone
200/245 (82%) with no prednisolone
OR 3.32
95% CI 1.72 to 6.44
P <0.001 		Moderate effect size prednisolone

RCT
4-armed trial 		839 people with Bell's palsy, moderate to severe weakness
In review 		Proportion of people with fully recovered facial function 12 months
300/416 (72%) with prednisolone (5 days of treatment then a 5-day taper)
237/413 (57%) with placebo
ARR 15%
95% CI 8% to 21%
P <0.0001 		Effect size not calculated prednisolone
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Presence of sequelae

Corticosteroids compared with placebo or no specific treatment Corticosteroids may be more effective than placebo or no treatment at reducing motor synkinesis, and autonomic dysfunction at 6 to 12 months, but we don't know about improving quality of life (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Presence of sequelae

Systematic review		 901 people
3 RCTs in this analysis		 Synkinesis and autonomic dysfunction
56/455 (12%) with corticosteroids
92/446 (21%) with placebo/no treatment
RR 0.60
95% CI 0.44 to 0.81
P = 0.0008 		Small effect size corticosteroids

Systematic review		 Number of people not reported Synkinesis and autonomic dysfunction
with corticosteroids
with control
Absolute results not reported
RR 0.48
95% CI 0.36 to 0.65
P <0.001
NNT 7
95% CI 6 to 10 		Moderate effect size corticosteroids

RCT
4-armed trial 		551 people with Bell's palsy, moderate to severe weakness
In review 		Quality of life 9 months
with prednisolone
with no prednisolone
Absolute results not reported
P = 0.04
The RCT found no significant difference between groups at 3 months (P = 0.4) 		Effect size not calculated placebo

RCT
3-armed trial 		743 people with Bell's palsy, moderate to severe weakness
In review 		Synkinesis 12 months
51/370 (14%) with prednisolone
107/373 (29%) with placebo
ARR –15%
95% CI –21% to –9%
P <0.0001 		Effect size not calculated prednisolone
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Time to recovery

Corticosteroids compared with placebo or no specific treatment Prednisolone is more effective than placebo or no treatment at reducing the time to recovery of facial nerve function (high-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Time to recovery

3-armed trial 		839 people with Bell's palsy, moderate to severe weakness
In review 		Median time to recovery
75 days with prednisolone
104 days with placebo
HR 1.40
95% CI 1.18 to 1.64
P <0.0001 		Small effect size prednisolone
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No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review		 Number of people not reported Adverse effects
with corticosteroids
with placebo/no treatment
Absolute results not reported
The review did not pool results of adverse effects data; see Further information on studies

Systematic review		 Number of people not reported Major adverse effects
with corticosteroids
with control
Absolute results not reported
RR 0.56
95% CI 0.09 to 3.39
P = 0.44 		Not significant

Systematic review		 Number of people not reported Minor adverse effects
with corticosteroids
with control
Absolute results not reported
RR 1.23
95% CI 0.93 to 1.64
P = 0.15 		Not significant

RCT		 1390 people Minor adverse effects
with prednisolone
with placebo
Absolute numbers not reported
Both large RCTs included in the reviews reported minor adverse effects in up to 11% of participants, but there was no significant difference between corticosteroids and placebo 		Not significant
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Corticosteroids versus aciclovir:

See option on Antiviral treatment.

Corticosteroids versus plus antiviral treatment versus either treatment alone:

See option on Corticosteroids plus antiviral treatment.

Further information on studies

The review found that three included RCTs reported no adverse effects, one included a trial that reported three participants receiving prednisolone suffered from temporary sleep disturbances, and four included trials that gave a detailed account of 177 non-serious adverse effects with no significant difference between those receiving corticosteroids and those receiving placebo.

Comment

Clinical guide:

Bell's palsy is a diagnosis of exclusion. Other causes of lower motor neurone facial weakness such as middle ear infection, parotid malignancy, malignant otitis externa, and lateral skull base tumours should be considered.

In people presenting with mild facial paresis from Bell's palsy, there is a high rate of spontaneous resolution without treatment.

Good evidence exists that corticosteroid therapy improves facial palsy in people with Bell's palsy independent of severity at presentation.

Corticosteroid therapy is likely to be more effective when started within 72 hours of onset.

Contraindications to corticosteroid therapy exist, and adverse effects are more likely following 7 days of treatment.

The potential adverse effects of corticosteroid treatment include diabetes, hypertension, glaucoma, psychosis, fluid and electrolyte disturbances, gastrointestinal tract haemorrhage, and avascular necrosis of the femoral head. The increased incidence of abnormal glucose tolerance in people with Bell's palsy warrants caution.

All children presenting with facial palsy and adults with delayed recovery should be referred for assessment by an otolaryngologist - head and neck surgeon or other appropriate specialist.

Specialist management is required when a specific cause of the facial weakness is identified (i.e. not Bell’s palsy) such as acute otitis media, cholesteatoma, parotid malignancy, tumour, Lyme disease, or malignant otitis externa. Ramsay Hunt syndrome (herpes zoster oticus) is suggested by otalgia, vesicles in the ear or mouth, and hearing loss or imbalance and antiviral therapy is indicated. Facial weakness is much less likely to be caused by Bell’s Palsy in children (<50% of cases) and urgent specialist evaluation is warranted.

Substantive changes

No new evidence

BMJ Clin Evid. 2014 Apr 9;2014:1204.

Antiviral agents

Summary

Antiviral treatment alone is no more effective than placebo at improving recovery of facial motor function and reducing the risk of motor synkinesis or crocodile tears, and is also less effective than corticosteroid treatment at improving recovery of facial motor function.

Benefits and harms

Antiviral agents versus placebo:

We found two systematic reviews (search date 2009, 7 RCTs, 1987 people; and search date 2009, 18 RCTs – 7 of which are reported in the first review, 2786 people), which compared antiviral treatment versus placebo or corticosteroids. We also found one further analysis of the dataset of an RCT included in the first review. It did not include any different outcomes or time points to those included in the original RCT and, therefore, has not been reported further here.

Recovery of motor function

Antiviral agents compared with placebo Antiviral treatment seems no more effective than placebo at increasing the rate of complete recovery at the end of treatment (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recovery of motor function

Systematic review		 1228 people
5 RCTs in this analysis		 Proportion of people with incomplete recovery end of trial
73/625 (11%) with antivirals
95/603 (16%) with placebo
RR 0.71
95% CI 0.48 to 1.05
P = 0.08 		Not significant

Systematic review		 631 people included in the 2 largest trials in the review
2 RCTs in this analysis
Subgroup analysis		 Proportion of people with incomplete recovery end of trial
101/303 (33%) with antivirals
91/328 (28%) with placebo
RR 1.14
95% CI 0.80 to 1.62
P = 0.48 		Not significant
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No data from the following reference on this outcome.

Presence of sequelae

Antiviral treatment compared with placebo Antiviral treatment may be no more effective than placebo at reducing the risk of motor synkinesis or crocodile tears at the end of treatment (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Presence of sequelae

Systematic review		 99 people
Data from 1 RCT		 Motor synkinesis or crocodile tears
7/53 (13%) with antivirals
13/46 (28%) with placebo
RR 0.47
95% CI 0.20 to 1.07
P = 0.07 		Not significant

Systematic review		 Number of people not reported
2 RCTs in this analysis		 Motor synkinesis or crocodile tears
with antivirals
with placebo
Absolute results not reported
RR 0.75
95% CI 0.51 to 1.11
P = 0.15 		Not significant
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Time to recovery

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review		 1544 women
3 RCTs in this analysis		 Adverse effects
97/774 (13%) with antivirals
92/770 (12%) with placebo
RR 1.06
95% CI 0.81 to 1.38
P = 0.67 		Not significant

Systematic review		 Number of people not reported Major adverse effects
with antivirals
with placebo
Absolute results not reported
RR 0.97
95% CI 0.27 to 3.74
P = 0.67 		Not significant

Systematic review		 Number of people not reported Minor adverse effects
with antivirals
with placebo
Absolute results not reported
RR 1.02
95% CI 0.79 to 1.33
P = 0.87 		Not significant
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Antiviral agents versus corticosteroids:

We found two systematic reviews (search date 2009, 7 RCTs, 1987 people; and search date 2009, 18 RCTs – 7 of which are reported in the first review, 2786 people), which compared antiviral treatment versus placebo or corticosteroids.

Recovery of motor function

Antiviral agents compared with corticosteroids Antiviral treatment is less effective than corticosteroids at reducing the proportion of people with incomplete recovery at the end of treatment (high-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recovery of motor function

Systematic review		 768 people
3 RCTs in this analysis		 Proportion of people with incomplete recovery end of trial
113/384 (29%) with antivirals
58/384 (15%) with corticosteroids
RR 2.82
95% CI 1.09 to 7.32
P = 0.03 		Moderate effect size corticosteroids
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No data from the following reference on this outcome.

Presence of sequelae

No data from the following reference on this outcome.

Time to recovery

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review		 667 people
2 RCTs in this analysis		 Adverse effects
42/330 (13%) with antivirals
45/337 (13%) with corticosteroids
RR 0.96
95% CI 0.65 to 1.14
P = 0.82 		Not significant
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No data from the following reference on this outcome.

Antiviral agents plus corticosteroids versus either treatment alone:

See option on Corticosteroids plus antiviral treatment.

Further information on studies

The second review supported the findings of the first review in rates of incomplete facial recovery for antiviral agents versus placebo, as it analysed the same two large RCTs assessed by the first review. The review included some single-blinded studies in the meta-analysis.

Comment

Aciclovir is taken five times per day and demonstrates poorer bioavailability than valaciclovir (a pro-drug of aciclovir). Valaciclovir is more effective in the management of shingles. In pregnant women, antiviral treatments such as aciclovir should only be prescribed under the guidance of an obstetrician.

Substantive changes

No new evidence

BMJ Clin Evid. 2014 Apr 9;2014:1204.

Corticosteroids plus antiviral treatment

Summary

For people with paresis, there is good evidence that corticosteroid monotherapy, started as soon as practicable, is appropriate in the absence of specific contraindications. For people in this group, such a high proportion fully recover that any potential benefit of antiviral therapy is unlikely to be clinically significant.

We found no good evidence of significant benefit of combination corticosteroid-antiviral therapy over corticosteroid alone. However, there is a lack of data on people presenting with complete paralysis and any potential benefit of combination corticosteroid-antiviral therapy cannot be excluded.

There is good evidence that people presenting with paralysis should also be offered corticosteroid monotherapy in absence of specific contraindications. Combination corticosteroid/antiviral therapy may be considered, as a lack of an important additional benefit of combination therapy could not be conclusively ruled out by the three largest trials, and the risk of adverse effects of oral antiviral therapy is very low.

A proportion of people will progress from paresis to paralysis and therapy recommendations may warrant review if this occurs. This is particularly relevant if the person develops signs of Ramsay Hunt syndrome.

Benefits and harms

Corticosteroids plus antiviral treatment versus placebo/no treatment:

We found three systematic reviews (search dates 2009 ), which assessed the effects of corticosteroids plus antiviral treatment compared with placebo, no treatment, or either corticosteroids or antivirals alone in people with Bell's palsy. All the reviews included different RCTs in their meta-analyses; only one review reported our outcomes of interest.

Recovery of motor function

Corticosteroids plus antiviral treatment compared with placebo Corticosteroids plus antiviral treatment seem more effective than placebo at reducing the risk of incomplete recovery of facial function at the end of treatment (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recovery of motor function

Systematic review		 1987 people
7 RCTs in this analysis		 Proportion of people with incomplete recovery end of trial
51/330 (15%) with corticosteroids plus antiviral treatment
91/328 (28%) with placebo
RR 0.56
95% CI 0.41 to 0.76
P = 0.002 		Moderate effect size corticosteroids plus antiviral treatment
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No data from the following reference on this outcome.

Presence of sequelae

No data from the following reference on this outcome.

Time to recovery

No data from the following reference on this outcome.

Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review		 658 people
2 RCTs in this analysis		 Adverse effects
52/330 (16%) with corticosteroids plus antiviral treatment
45/328 (14%) with placebo
RR 1.15
95% CI 0.79 to 1.66
P = 0.46 		Not significant
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No data from the following reference on this outcome.

Corticosteroids plus antiviral treatment versus corticosteroids alone:

We found three systematic reviews (search dates 2009 ) and one subsequent RCT, which assessed the effects of corticosteroids plus antiviral treatment compared with placebo, no treatment, or either corticosteroids or antivirals alone in people with Bell's palsy. All the reviews included different RCTs in their meta-analyses, although they all had some RCTs in common, so we report all three here. We also found one further analysis of an RCT included in the first systematic review. It did not include any different outcome or time points to those included in the original RCT and, therefore, has not been reported further here.

Recovery of motor function

Corticosteroids plus antiviral treatment compared with corticosteroids alone We don't know whether corticosteroids plus antiviral treatment are more effective than corticosteroids alone at reducing the risk of incomplete recovery of facial function at the end of treatment (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recovery of motor function

Systematic review		 1228 people
6 RCTs in this analysis		 Proportion of people with incomplete recovery
with corticosteroids plus antiviral treatment
with corticosteroids alone
Absolute results not reported
RR 0.64
95% CI 0.50 to 0.82
There are issues surrounding interpretation of these data (see Comments) 		Small effect size corticosteroids plus antiviral treatment

Systematic review		 1298 people
8 RCTs in this analysis		 Proportion of people with unsatisfactory facial recovery end of trial
88/662 (13%) with corticosteroids plus antiviral treatment
117/636 (18%) with corticosteroids alone
RR 0.75
95% CI 0.56 to 1.00
P = 0.05
Significance was borderline
There are issues surrounding interpretation of these data (see Comments) 		Moderate effect size corticosteroids plus antiviral treatment

Systematic review		 1145 people
6 RCTs in this analysis		 Proportion of people with partial facial recovery longest follow-up time
521/571 (91%) with corticosteroids plus antiviral treatment
506/574 (88%) with corticosteroids alone
OR 1.50
95% CI 0.83 to 2.69
P = 0.18
The OR favoured combination therapy in 4 trials, but the CIs crossed 1 in 3 of these trials. The 2 highest quality trials had ORs that were <1, favouring corticosteroids alone
There are issues surrounding interpretation of these data (see Comments) 		Not significant

RCT		 829 people with severe palsy (House-Brackmann grade 5 or 6)
In review
Subgroup analysis		 Proportion of people with complete recovery
39/60 (65%) with valaciclovir (for 1 week) plus prednisolone (for 10 days)
40/61 (66%) with corticosteroids alone
ARR –1%
95% CI –17% to +18%
P = 1.00 		Not significant

RCT		 206 people with severe palsy Complete recovery 6 months
82/99 (83%) with with methylprednisolone (tapered for 10 days) plus famciclovir (7 days)
71/107 (66%) with methylprednisolone (tapered for 10 days)
P = 0.01 		Effect size not calculated famciclovir plus prednisolone
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Presence of sequelae

Corticosteroids plus antiviral treatment compared with corticosteroids alone We don't know whether corticosteroids plus antiviral treatment and corticosteroids alone differ in effectiveness at reducing the risk of motor synkinesis or crocodile tears at the end of treatment (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Presence of sequelae

Systematic review		 99 people
Data from 1 RCT		 Motor synkinesis or crocodile tears end of trial
7/53 (13%) with corticosteroids plus antiviral treatment
13/46 (28%) with corticosteroids alone
RR 0.47
95% CI 0.20 to 1.07
P = 0.07 		Not significant
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No data from the following reference on this outcome.

Time to recovery

No data from the following reference on this outcome.

Adverse effects

No data from the following reference on this outcome.

Corticosteroids plus antiviral treatment versus antiviral treatment alone:

We found three systematic reviews (search dates 2009 ), which assessed the effects of corticosteroids plus antiviral treatment compared with placebo, no treatment, or either corticosteroids or antivirals alone in people with Bell's palsy. All the reviews included different RCTs in their meta-analyses; only one review reported our outcomes of interest.

Recovery of motor function

Corticosteroids plus antiviral treatment compared with antiviral treatment alone Corticosteroids plus antiviral treatment are more effective than corticosteroids alone at reducing the risk of incomplete recovery of facial function at the end of treatment (high-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recovery of motor function

Systematic review		 660 people
2 RCTs in this analysis		 Proportion of people with unsatisfactory facial recovery end of trial
51/330 (15%) with corticosteroids plus antiviral treatment
101/330 (31%) with antiviral treatment alone
RR 0.48
95% CI 0.29 to 0.79
P = 0.04 		Moderate effect size corticosteroids plus antiviral treatment
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No data from the following reference on this outcome.

Presence of sequelae

No data from the following reference on this outcome.

Time to recovery

No data from the following reference on this outcome.

Adverse effects

No data from the following reference on this outcome.

Comment

We have reported the results of a number of recent systematic reviews with meta-analyses to demonstrate that trial selection may influence conclusions. Only the systematic reviews that incorporate small and historical trials seem to show potential benefit of combination therapy, and publication bias, with loss of negative trials, may be contributing to this finding. Browning (2010) concluded that meta-analyses of combination therapy only suggest a marginal benefit when small poorer-quality trials are included and that antivirals (in combination with corticosteroids) should only be considered when a viral aetiology is suspected (i.e., Ramsay Hunt syndrome). Debate continues about whether the recent multicentre trials were underpowered to demonstrate a benefit in the paralysis subgroup (type II error). This concern is further exacerbated by significant variation in dosing of the antivirals in the included trials and, particularly, the variable bioavailability of aciclovir. Whether people with evidence of herpes zoster virus (HZV) replication (zoster sine herpete) or people with paralysis benefit from higher doses of antiviral drug requires further research. Even the maximum dose studied (valaciclovir 1 g three times daily) may only achieve 'partial inhibitory' concentrations for HZV. In summary, the 'Scottish study' provides good evidence that aciclovir 2000 mg daily offers no significant additional benefit to corticosteroids for most people. The 'Swedish study' confirms that even a considerably higher dose of antivirals still seems not to offer benefit, even when a subgroup analysis of severe palsies was undertaken.

Clinical guide:

For most people with Bell's palsy with paresis at presentation (about 70%), we found no good evidence of a clinically important additive effect of combination therapy (corticosteroid plus antivirals). For people with paralysis at presentation (about 30%), further research is required to assess whether combination therapy (antivirals plus corticosteroids) has a significant additive or synergistic effect. People with complete palsies or those with features suggestive of herpes zoster infection (i.e., zoster sine herpete) should be informed of the weak evidence of potential benefit from antivirals in addition to corticosteroids and be allowed to make an informed decision. Antiviral dosing would need to be adequate to treat HZV infection (e.g., 1 g valaciclovir three times daily).

A proportion of people will progress from paresis to paralysis and therapy recommendations may warrant review if this occurs. This is particularly relevant if the person develops signs of Ramsay Hunt syndrome.

Substantive changes

Corticosteroids plus antiviral treatment: New evidence added. Evidence re-evaluated, categorisation changed from likely to be beneficial to unknown effectiveness.

BMJ Clin Evid. 2014 Apr 9;2014:1204.

Hyperbaric oxygen therapy

Summary

Hyperbaric oxygen may improve time to recovery and the proportion of people who make a full recovery compared with corticosteroids; however, the evidence for this is weak and comes from one small RCT.

Benefits and harms

Hyperbaric oxygen versus corticosteroids:

We found one double-blind RCT (79 people with Bell's palsy) comparing hyperbaric oxygen therapy (HBOT) plus placebo tablets (42 people) versus prednisolone plus placebo HBOT (dives achieving a normal partial pressure of oxygen only, 37 people).

Recovery of motor function

Hyperbaric oxygen compared with corticosteroids We don't know whether hyperbaric oxygen is more effective than corticosteroids at increasing complete recovery rates at 9 months, as the RCT did not test the significance of differences between groups. However, absolute rates of recovery were higher in the hyperbaric oxygen group (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recovery of motor function

RCT		 79 people with Bell's palsy Proportion of people with complete recovery of facial palsy
40/42 (95%) with hyperbaric oxygen therapy (HBOT)
28/37 (76%) with prednisolone
P value not reported
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Presence of sequelae

No data from the following reference on this outcome.

Time to recovery

Hyperbaric oxygen compared with corticosteroids Hyperbaric oxygen may be more effective than corticosteroids at reducing time to recovery (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Time to recovery

RCT		 79 people with Bell's palsy Time to recovery
22 days with hyperbaric oxygen therapy (HBOT)
34.4 days with prednisolone
P <0.001 		Effect size not calculated HBOT
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Adverse effects

No data from the following reference on this outcome.

Comment

One prospective observational study (82 people receiving long-term hyperbaric oxygen therapy [HBOT] for chronic conditions) found that complications and adverse effects of HBOT included barotrauma to the ear, round window blowout, 'sinus squeeze', visual refractive changes, numb fingers, dental problems, and claustrophobia. Severe adverse effects tended to be rare but may require specific intervention (e.g., seizures, pulmonary oxygen toxicity, altered drug metabolism, and pneumothorax). People with known poor Eustachian tube function may warrant grommet insertion to reduce the risks of barotrauma to the ear.

Clinical guide:

HBOT is expensive and the repeated therapies are inconvenient for the person. Grommet insertion will be required in some people. Further research is warranted and this might focus on people in whom corticosteroids are contraindicated or as adjuvant therapy with corticosteroids for dense facial palsy to try to decrease the rate of incomplete recovery.

Substantive changes

No new evidence

BMJ Clin Evid. 2014 Apr 9;2014:1204.

Facial re-training

Summary

Facial re-training may improve recovery of facial motor function scores, including stiffness and lip mobility, and may reduce the risk of motor synkinesis in Bell's palsy, but the evidence is too weak to draw reliable conclusions.

Benefits and harms

Facial re-training versus waiting list control:

We found two systematic reviews (search dates 2007 and 2008), which assessed the effects of physiotherapy in people with Bell's palsy. In the first review (4 RCTs, 132 people), three of the included RCTs did not fulfil Clinical Evidence inclusion criteria (<20 people) and, therefore, will not be discussed further here. We report results from the remaining RCT below. The second review (6 RCTs, including the RCT previously reported, 547 people with Bell's palsy) compared either electrostimulation or exercises versus waiting list control. Only the three trials comparing exercises versus waiting list controls met the inclusion criteria for this review and we report their results below. One of the trials included people with acute Bell's palsy; in one trial, published in Chinese, the starting point is unclear (possibly Bell's palsy for <9 months); and one RCT included chronic patients with failure to recover at 9 months only).

Recovery of motor function

Facial re-training compared with waiting list control Facial re-training using mime therapy or exercise may be more effective than waiting list control at improving facial function scores at 3 months, but may be no more effective at reducing the risk of incomplete recovery at 3 months. However, evidence was weak (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Recovery of motor function

RCT		 48 people with peripheral facial paralysis for at least 9 months
In review 		Mean change in physical Facial Disability Index (FDI) score 3 months
From 56.8 to 73.5 with mime therapy
From 63.2 to 59.6 with waiting list control
P <0.02 		Effect size not calculated mime therapy

RCT		 48 people with peripheral facial paralysis for at least 9 months
In review 		Mean change in social FDI scores
From 68.6 to 80.7 with mime therapy
From 72.6 to 66.2 with waiting list control
P <0.01 		Effect size not calculated mime therapy

RCT		 48 people with peripheral facial paralysis for at least 9 months
In review 		Mean change in stiffness scores 3 months
From 3.72 to 2.37 with mime therapy
From 3.68 to 3.54 with waiting list control
P <0.001 		Effect size not calculated mime therapy

RCT		 48 people with peripheral facial paralysis for at least 9 months
In review 		Mean change in pout score 3 months
From 14.7 to 21.0 with mime therapy
From 16.3 to 15.7 with waiting list control
P <0.001 		Effect size not calculated mime therapy

RCT		 48 people with peripheral facial paralysis for at least 9 months
In review 		Mean change in lip-length score 3 months
From 17.6 to 23.7 with mime therapy
From 21.6 to 19.6 with waiting list control
P <0.03 		Effect size not calculated mime therapy

Systematic review		 34 people with chronic Bell's palsy
Data from 1 RCT		 Recovery of facial grading
with exercises
with waiting list control
Absolute results not reported
Mean difference 20.40
95% CI 8.76 to 32.04 		Effect size not calculated exercises

Systematic review		 34 people with chronic Bell's palsy
Data from 1 RCT		 Recovery on the FDI social domain (0 to 100)
with exercises
with waiting list control
Absolute results not reported
Mean difference 14.50
95% CI 4.85 to 24.15 		Effect size not calculated exercises

Systematic review		 34 people with chronic Bell's palsy
Data from 1 RCT		 Recovery on the FDI physical domain
with exercises
with waiting list control
Absolute results not reported
Mean difference +10.30
95% CI –1.37 to +21.97 		Not significant

Systematic review		 145 people; uncertain duration of Bell's palsy
Data from 1 RCT		 Proportion of people with incomplete recovery 3 months
6/85 (7%) with exercises
7/60 (12%) with waiting list control
RR 0.61
95% CI 0.21 to 1.17 		Not significant
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Presence of sequelae

Facial re-training compared with waiting list control Facial re-training exercises may be more effective than waiting list control at reducing the risk of motor synkinesis (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Presence of sequelae

Systematic review		 145 people with chronic Bell's palsy
Data from 1 RCT		 Motor synkinesis
4/85 (5%) with exercises
12/60 (20%) with waiting list control
RR 0.24
95% CI 0.08 to 0.69 		Moderate effect size exercises
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No data from the following reference on this outcome.

Time to recovery

Facial re-training compared with conventional treatment Facial re-training exercises may be more effective than conventional treatment at reducing the mean time to beginning and completion of recovery (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Time to recovery

Systematic review		 90 people with uncertain duration of Bell's palsy
Data from 1 RCT		 Mean time to beginning of recovery (weeks)
with exercises
with conventional treatment
Absolute results not reported
Mean difference –0.59 weeks
95% CI –1.01 to –0.17 weeks 		Effect size not calculated exercises

Systematic review		 90 people with uncertain duration of Bell's palsy
Data from 1 RCT		 Mean time to complete recovery (weeks)
with exercises
with conventional treatment
Absolute results not reported
Mean difference –0.91 weeks
95% CI –1.49 to –0.34 weeks
P = 0.01 		Effect size not calculated exercises
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No data from the following reference on this outcome.

Adverse effects

No data from the following reference on this outcome.

Further information on studies

The authors of the review concluded that, because of lack of evidence, it was not possible to conclude if physiotherapy was effective for the treatment of Bell's palsy.

Comment

Clinical guide:

There is limited evidence that physical facial re-training, such as mime therapy, can improve both the function and quality of life of people with long-standing facial nerve palsies. Optimal outcomes are likely to be achieved in a multidisciplinary clinic setting, which would facilitate coordination of medical, surgical, physical, and psychological services.

Substantive changes

No new evidence

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