Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                

Bell's Palsy: N. Julian Holland and Jonathan M. Bernstein

Download as pdf or txt
Download as pdf or txt
You are on page 1of 21

Neurological disorders

..................................................

Bell's palsy
Search date October 2013
N. Julian Holland and Jonathan M. Bernstein

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 sen-
sitivity 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 system-
atic 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.

QUESTIONS
What are the effects of drug treatments for Bell's palsy in adults and children?. . . . . . . . . . . . . . . . . . . . . . . . . 3
What are the effects of physical treatments for Bell's palsy in adults and children? . . . . . . . . . . . . . . . . . . . . . 15

INTERVENTIONS
DRUG TREATMENTS Hyperbaric oxygen therapy . . . . . . . . . . . . . . . . . . . 14
Likely to be beneficial
Unlikely to be beneficial
Corticosteroids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Antiviral agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Unknown effectiveness
PHYSICAL TREATMENTS
Corticosteroids plus antiviral treatment versus corticos-
teroids alone (inconclusive evidence that adding antivi- Unknown effectiveness
rals to corticosteroids provides any benefit over corticos- Facial re-training . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
teroids alone) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

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 ex-
clusion 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.

DEFINITION Bell's palsy is an idiopathic, unilateral, acute weakness of the face in a pattern consistent with pe-
ripheral 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
[1]
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,
[2]
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
© BMJ Publishing Group Ltd 2014. All rights reserved. .................... 1 .................... Clinical Evidence 2014;04:1204
Neurological disorders
Bell's palsy
causes of lower motor neurone weakness include middle ear infection, parotid malignancy, malignant
[3]
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),
[4]
suggest an alternative cause. Bell's palsy is less commonly the cause of facial palsy in children
[5]
aged under 10 years (<50%).

[5]
INCIDENCE/ The incidence is about 20 in 100,000 people a year, with about 1 in 60 lifetime risk. Bell's palsy
PREVALENCE has a peak incidence between the ages of 15 and 40 years. Men and women are equally affected,
[5]
although the incidence may be higher in pregnant women.

AETIOLOGY/ The cause of Bell's palsy is uncertain. It is thought that re-activated herpes virus at the geniculate
RISK FACTORS ganglion of the facial nerve may play a key role in the development of Bell's palsy. Herpes simplex
[6]
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.
[7]
Herpes zoster-associated facial palsy more frequently presents as zoster sine herpete (without
[6]
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
[8]
HZV infection.

PROGNOSIS Overall, Bell's palsy has a fair prognosis without treatment. Clinically important improvement occurs
[5]
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
[5]
paralysis). The remaining 29% have permanent mild to severe residual facial muscle weakness,
[5]
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
[5]
of the higher frequency of paresis. However, children with paralysis have permanent facial
[9]
muscle weakness as frequently as adults.

AIMS OF To increase the proportion of people making a full or partial recovery; to increase the speed of re-
INTERVENTION covery; 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 infor-
mation 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 an-
alyst. 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, p 20 ). The categorisation
of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence
© BMJ Publishing Group Ltd 2014. All rights reserved. ........................................................... 2
Neurological disorders
Bell's palsy
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).

QUESTION What are the effects of drug treatments for Bell's palsy in adults and children?

OPTION CORTICOSTEROIDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Bell's palsy, see table, p 20 .


• 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:
[10] [11]
We found two systematic reviews (search dates 2008 and 2009 ) comparing corticosteroids versus placebo
[12] [13]
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
[14]
recommendations in this area. We also found one further analysis of the dataset included in the second large
[13]
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Recovery of motor function
[10]
1507 people Proportion of people with in- RR 0.71
complete recovery of facial
Systematic 7 RCTs in this 95% CI 0.61 to 0.83
motor function , 6–9 months
review analysis
175/754 (23%) with corticos- corticosteroids
teroids
245/753 (33%) with placebo/no
treatment

[11]
1285 people Proportion of people with un- RR 0.69
satisfactory recovery
Systematic 10 RCTs in this 95% CI 0.55 to 0.87
review analysis 102/629 (16%) with corticos- corticosteroids
P = 0.001
teroids
245/656 (37%) with control

[12]
551 people with Proportion of people with OR 3.32
Bell's palsy, moder- complete recovery , 9 months
RCT 95% CI 1.72 to 6.44
ate to severe
237/251 (94%) with prednisolone
4-armed weakness P <0.001
trial [10] [11] 200/245 (82%) with no pred- prednisolone
In review
nisolone
The 4 arms assessed: pred-
nisolone plus placebo, aciclovir
plus placebo, prednisolone plus

© BMJ Publishing Group Ltd 2014. All rights reserved. ........................................................... 3


Neurological disorders
Bell's palsy
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
aciclovir, and placebo plus
placebo
All participants started treatment
within 72 hours (54% within 24
hours)
Complete recovery defined as
House-Brackmann grade 1
Final outcome data were avail-
able for 496/551 (90%) people

[13]
839 people with Proportion of people with fully ARR 15%
Bell's palsy, moder- recovered facial function , 12
RCT 95% CI 8% to 21%
ate to severe months
4-armed weakness P <0.0001
300/416 (72%) with prednisolone
trial [10] [11]
In review (5 days of treatment then a 5-day
taper)
237/413 (57%) with placebo
The remaining arms assessed prednisolone
valaciclovir and prednisolone plus
valaciclovir
Treatment started within 72 hours
of palsy onset
Fully recovered facial func-
tion = Sunnybrook score of 100
points

-
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Presence of sequelae
[10]
901 people Synkinesis and autonomic RR 0.60
dysfunction
Systematic 3 RCTs in this 95% CI 0.44 to 0.81
review analysis 56/455 (12%) with corticosteroids corticosteroids
P = 0.0008
92/446 (21%) with placebo/no
treatment

[11]
Number of people Synkinesis and autonomic RR 0.48
not reported dysfunction
Systematic 95% CI 0.36 to 0.65
review with corticosteroids
P <0.001 corticosteroids
with control
NNT 7
Absolute results not reported
95% CI 6 to 10

[12]
551 people with Quality of life , 9 months P = 0.04
Bell's palsy, moder-
RCT with prednisolone The RCT found no significant dif-
ate to severe
ference between groups at 3
4-armed weakness with no prednisolone
months (P = 0.4)
trial [10] [11]
In review Absolute results not reported
The 4 arms assessed: pred-
nisolone plus placebo, aciclovir placebo
plus placebo, prednisolone plus
aciclovir, and placebo plus
placebo
All participants started treatment
within 72 hours (54% within 24
hours)

© BMJ Publishing Group Ltd 2014. All rights reserved. ........................................................... 4


Neurological disorders
Bell's palsy
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Final outcome data were avail-
able for 496/551 (90%) people

[13]
743 people with Synkinesis , 12 months ARR –15%
Bell's palsy, moder-
RCT 51/370 (14%) with prednisolone 95% CI –21% to –9%
ate to severe
3-armed weakness 107/373 (29%) with placebo P <0.0001
trial [10] [11] prednisolone
In review The remaining arms assessed
valaciclovir and prednisolone plus
valaciclovir
Treatment started within 72 hours

-
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Time to recovery
[13]
839 people with Median time to recovery HR 1.40
Bell's palsy, moder-
3-armed 75 days with prednisolone 95% CI 1.18 to 1.64
ate to severe
trial
weakness 104 days with placebo P <0.0001
[10] [11]
In review The remaining arm assessed
valaciclovir prednisolone
829 people anal-
ysed Treatment started within 72 hours
Fully recovered facial func-
tion = Sunnybrook score of 100
points

-
[10] [11] [12]
No data from the following reference on this outcome.

-
Adverse effects

-
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Adverse effects
[10]
Number of people Adverse effects The review did not pool results of
not reported adverse effects data; see Further
Systematic with corticosteroids
information on studies
review
with placebo/no treatment
Absolute results not reported

[11]
Number of people Major adverse effects RR 0.56
not reported
Systematic with corticosteroids 95% CI 0.09 to 3.39
review Not significant
with control P = 0.44
Absolute results not reported

[11]
Number of people Minor adverse effects RR 1.23
not reported
Systematic with corticosteroids 95% CI 0.93 to 1.64
review Not significant
with control P = 0.15
Absolute results not reported

© BMJ Publishing Group Ltd 2014. All rights reserved. ........................................................... 5


Neurological disorders
Bell's palsy
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
[12] [13]
1390 people Minor adverse effects Both large RCTs included in the
reviews reported minor adverse
RCT with prednisolone
effects in up to 11% of partici-
Not significant
with placebo pants, but there was no signifi-
cant difference between corticos-
Absolute numbers not reported teroids and placebo

-
-
Corticosteroids versus aciclovir:
See option on Antiviral treatment, p 7 .

-
-
Corticosteroids versus plus antiviral treatment versus either treatment alone:
See option on Corticosteroids plus antiviral treatment, p 9 .

-
-
-
Further information on studies
[10]
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 indi-
cated. Facial weakness is much less likely to be caused by Bell’s Palsy in children (<50% of cases)
and urgent specialist evaluation is warranted.

© BMJ Publishing Group Ltd 2014. All rights reserved. ........................................................... 6


Neurological disorders
Bell's palsy
OPTION ANTIVIRAL AGENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Bell's palsy, see table, p 20 .


• 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:
[15]
We found two systematic reviews (search date 2009, 7 RCTs, 1987 people; and search date 2009, 18 RCTs –
[11]
7 of which are reported in the first review, 2786 people ), which compared antiviral treatment versus placebo or
[14] [13] [15]
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Recovery of motor function
[15]
1228 people Proportion of people with in- RR 0.71
complete recovery , end of trial
Systematic 5 RCTs in this 95% CI 0.48 to 1.05
Not significant
review analysis 73/625 (11%) with antivirals
P = 0.08
95/603 (16%) with placebo

[15]
631 people includ- Proportion of people with in- RR 1.14
ed in the 2 largest complete recovery , end of trial
Systematic 95% CI 0.80 to 1.62
trials in the review
review 101/303 (33%) with antivirals
P = 0.48 Not significant
2 RCTs in this
91/328 (28%) with placebo
analysis
Subgroup analysis

-
[11]
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Presence of sequelae
[15]
99 people Motor synkinesis or crocodile RR 0.47
tears
Systematic Data from 1 RCT 95% CI 0.20 to 1.07
Not significant
review 7/53 (13%) with antivirals
P = 0.07
13/46 (28%) with placebo

[11]
Number of people Motor synkinesis or crocodile RR 0.75
not reported tears
Systematic 95% CI 0.51 to 1.11
review 2 RCTs in this with antivirals Not significant
P = 0.15
analysis
with placebo
Absolute results not reported

-
Time to recovery
-
© BMJ Publishing Group Ltd 2014. All rights reserved. ........................................................... 7
Neurological disorders
Bell's palsy
-
[11] [15]
No data from the following reference on this outcome.

-
Adverse effects

-
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Adverse effects
[15]
1544 women Adverse effects RR 1.06
Systematic 3 RCTs in this 97/774 (13%) with antivirals 95% CI 0.81 to 1.38 Not significant
review analysis
92/770 (12%) with placebo P = 0.67

[11]
Number of people Major adverse effects RR 0.97
not reported
Systematic with antivirals 95% CI 0.27 to 3.74
review
with placebo P = 0.67
Absolute results not reported
Not significant
The review did not use a sub-
group analysis for antivirals ver-
sus placebo, so these results are
based on all antiviral trials in the
review

[11]
Number of people Minor adverse effects RR 1.02
not reported
Systematic with antivirals 95% CI 0.79 to 1.33
review
with placebo P = 0.87
Absolute results not reported
Not significant
The review did not use a sub-
group analysis for antivirals ver-
sus placebo, so these results are
based on all antiviral trials in the
review

-
-
Antiviral agents versus corticosteroids:
[15]
We found two systematic reviews (search date 2009, 7 RCTs, 1987 people; and search date 2009, 18 RCTs –
[11]
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Recovery of motor function
[15]
768 people Proportion of people with in- RR 2.82
complete recovery , end of trial
Systematic 3 RCTs in this 95% CI 1.09 to 7.32
corticosteroids
review analysis 113/384 (29%) with antivirals
P = 0.03
58/384 (15%) with corticosteroids

-
[11]
No data from the following reference on this outcome.

© BMJ Publishing Group Ltd 2014. All rights reserved. ........................................................... 8


Neurological disorders
Bell's palsy
Presence of sequelae
-
-
[11] [15]
No data from the following reference on this outcome.

-
Time to recovery
-
-
[11] [15]
No data from the following reference on this outcome.

-
Adverse effects

-
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Adverse effects
[15]
667 people Adverse effects RR 0.96
Systematic 2 RCTs in this 42/330 (13%) with antivirals 95% CI 0.65 to 1.14 Not significant
review analysis
45/337 (13%) with corticosteroids P = 0.82

-
[11]
No data from the following reference on this outcome.

-
-
Antiviral agents plus corticosteroids versus either treatment alone:
See option on Corticosteroids plus antiviral treatment, p 9 .

-
-
-
Further information on studies
[11]
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
[16]
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.

OPTION CORTICOSTEROIDS PLUS ANTIVIRAL TREATMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Bell's palsy, see table, p 20 .


• 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
© BMJ Publishing Group Ltd 2014. All rights reserved. ........................................................... 9
Neurological disorders
Bell's palsy
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:
[11] [15] [17]
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
[15]
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Recovery of motor function
[15]
1987 people Proportion of people with in- RR 0.56
complete recovery , end of trial
Systematic 7 RCTs in this 95% CI 0.41 to 0.76
corticosteroids plus
review analysis 51/330 (15%) with corticosteroids
P = 0.002 antiviral treatment
plus antiviral treatment
91/328 (28%) with placebo

-
[11] [17]
No data from the following reference on this outcome.

-
Presence of sequelae
-
-
[11] [15] [17]
No data from the following reference on this outcome.

-
Time to recovery
-
-
[11] [15] [17]
No data from the following reference on this outcome.

-
Adverse effects

-
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Adverse effects
[15]
658 people Adverse effects RR 1.15
Systematic 2 RCTs in this 52/330 (16%) with corticosteroids 95% CI 0.79 to 1.66
Not significant
review analysis plus antiviral treatment
P = 0.46
45/328 (14%) with placebo

-
[11] [17]
No data from the following reference on this outcome.

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 10


Neurological disorders
Bell's palsy
-
Corticosteroids plus antiviral treatment versus corticosteroids alone:
[11] [15] [17] [18]
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
[14]
they all had some RCTs in common, so we report all three here. We also found one further analysis of an RCT
[13] [15]
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Recovery of motor function
[15]
1228 people Proportion of people with in- RR 0.64
complete recovery
Systematic 6 RCTs in this 95% CI 0.50 to 0.82
review analysis with corticosteroids plus antiviral
There are issues surrounding in-
treatment
terpretation of these data (see
with corticosteroids alone Comments) corticosteroids plus
antiviral treatment
Absolute results not reported
There was significant heterogene-
ity in the included data and the
antiviral regimen differed between
studies

[11]
1298 people Proportion of people with un- RR 0.75
satisfactory facial recovery ,
Systematic 8 RCTs in this 95% CI 0.56 to 1.00
end of trial
review analysis
P = 0.05
88/662 (13%) with corticosteroids corticosteroids plus
plus antiviral treatment Significance was borderline antiviral treatment
117/636 (18%) with corticos- There are issues surrounding in-
teroids alone terpretation of these data (see
Comments)

[17]
1145 people Proportion of people with par- OR 1.50
tial facial recovery , longest
Systematic 6 RCTs in this 95% CI 0.83 to 2.69
follow-up time
review analysis
P = 0.18
521/571 (91%) with corticos-
5 RCTs were in-
teroids plus antiviral treatment The OR favoured combination
cluded in both pre-
therapy in 4 trials, but the CIs
viously reported 506/574 (88%) with corticos-
crossed 1 in 3 of these trials. The Not significant
reviews teroids alone
2 highest quality trials had ORs
that were <1, favouring corticos-
teroids alone
There are issues surrounding in-
terpretation of these data (see
Comments)

[19]
829 people with Proportion of people with ARR –1%
severe palsy complete recovery
RCT 95% CI –17% to +18%
(House-Brackmann
39/60 (65%) with valaciclovir (for
grade 5 or 6) P = 1.00
1 week) plus prednisolone (for 10
[15]
In review days) Not significant
Subgroup analysis 40/61 (66%) with corticosteroids
alone
Complete recovery defined as
House-Brackmann grade 1

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 11


Neurological disorders
Bell's palsy
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
[18]
206 people with Complete recovery , 6 months P = 0.01
severe palsy
RCT 82/99 (83%) with with methylpred-
nisolone (tapered for 10 days) famciclovir plus
plus famciclovir (7 days) prednisolone
71/107 (66%) with methylpred-
nisolone (tapered for 10 days)

-
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Presence of sequelae
[15]
99 people Motor synkinesis or crocodile RR 0.47
tears , end of trial
Systematic Data from 1 RCT 95% CI 0.20 to 1.07
review 7/53 (13%) with corticosteroids
P = 0.07 Not significant
plus antiviral treatment
13/46 (28%) with corticosteroids
alone

-
[11] [17] [18]
No data from the following reference on this outcome.

-
Time to recovery
-
-
[11] [15] [17] [18]
No data from the following reference on this outcome.

-
Adverse effects

-
-
[11] [15] [17] [18]
No data from the following reference on this outcome.

-
-
Corticosteroids plus antiviral treatment versus antiviral treatment alone:
[11] [15] [17]
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
[11]
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).

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 12


Neurological disorders
Bell's palsy
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Recovery of motor function
[11]
660 people Proportion of people with un- RR 0.48
satisfactory facial recovery ,
Systematic 2 RCTs in this 95% CI 0.29 to 0.79
end of trial
review analysis
P = 0.04 corticosteroids plus
51/330 (15%) with corticosteroids
antiviral treatment
plus antiviral treatment
101/330 (31%) with antiviral
treatment alone

-
[15] [17]
No data from the following reference on this outcome.

-
Presence of sequelae
-
-
[11] [15] [17]
No data from the following reference on this outcome.

-
Time to recovery
-
-
[11] [15] [17]
No data from the following reference on this outcome.

-
Adverse effects

-
-
[11] [15] [17]
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 incor-
porate small and historical trials seem to show potential benefit of combination therapy, and publi-
[20]
cation 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
[21]
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'
[22]
concentrations for HZV. In summary, the 'Scottish study' provides good evidence that aciclovir
[12]
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
[13] [19]
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 evi-
dence 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.
© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 13
Neurological disorders
Bell's palsy
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.

OPTION HYPERBARIC OXYGEN THERAPY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Bell's palsy, see table, p 20 .


• 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
[23]
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 evi-
dence).

Ref Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Recovery of motor function
[23]
79 people with Proportion of people with P value not reported
Bell's palsy complete recovery of facial
RCT
palsy
40/42 (95%) with hyperbaric oxy-
gen therapy (HBOT)
28/37 (76%) with prednisolone
Prednisolone group also received
placebo
HBOT (dives achieving a normal
partial pressure of oxygen only)
HBOT was administered at
2.8 atmospheres for 60 minutes
twice-daily, 5 days a week, with
dives discontinued when facial
function returned to normal
(maximum of 30 dives)

-
Presence of sequelae
-
-
[23]
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).

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 14


Neurological disorders
Bell's palsy
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Time to recovery
[23]
79 people with Time to recovery P <0.001
Bell's palsy
RCT 22 days with hyperbaric oxygen
therapy (HBOT)
34.4 days with prednisolone
Prednisolone group also received
placebo
HBOT (dives achieving a normal HBOT
partial pressure of oxygen only)
HBOT was administered at
2.8 atmospheres for 60 minutes
twice-daily, 5 days a week, with
dives discontinued when facial
function returned to normal
(maximum of 30 dives)

-
Adverse effects

-
-
[23]
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 in-
[24]
sertion 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.

QUESTION What are the effects of physical treatments for Bell's palsy in adults and children?

OPTION FACIAL RE-TRAINING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Bell's palsy, see table, p 20 .


• 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:
[25] [26]
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
[27]
remaining RCT below. The second review (6 RCTs, including the RCT previously reported, 547 people with Bell's
[26]
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

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 15


Neurological disorders
Bell's palsy
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Recovery of motor function
[27]
48 people with pe- Mean change in physical Facial P <0.02
ripheral facial Disability Index (FDI) score , 3
RCT
paralysis for at months
least 9 months
From 56.8 to 73.5 with mime
[25]
In review therapy
From 63.2 to 59.6 with waiting list
control mime therapy
Improvement in social and physi-
cal aspects of facial disability
were measured using the FDI
questionnaire. The FDI uses a
100-point scale, with a higher
score indicating less handicap
and less impairment

[28]
48 people with pe- Mean change in social FDI P <0.01
ripheral facial scores
RCT
paralysis for at
From 68.6 to 80.7 with mime
least 9 months
therapy
[25]
In review
From 72.6 to 66.2 with waiting list
control
mime therapy
Improvement in social and physi-
cal aspects of facial disability
were measured using the FDI
questionnaire. The FDI uses a
100-point scale, with a higher
score indicating less handicap
and less impairment

[28]
48 people with pe- Mean change in stiffness P <0.001
ripheral facial scores , 3 months
RCT
paralysis for at
From 3.72 to 2.37 with mime
least 9 months
therapy
[25]
In review mime therapy
From 3.68 to 3.54 with waiting list
control
Facial stiffness was patient-as-
sessed on a 5-point scale (1 = no
stiffness and 5 = very stiff)

[28]
48 people with pe- Mean change in pout score , 3 P <0.001
ripheral facial months
RCT
paralysis for at
From 14.7 to 21.0 with mime
least 9 months
therapy
[25]
In review mime therapy
From 16.3 to 15.7 with waiting list
control
Lip mobility was physician-as-
sessed by measuring the pout
and lip-length indices

[28]
48 people with pe- Mean change in lip-length P <0.03
ripheral facial score , 3 months
RCT
paralysis for at mime therapy
From 17.6 to 23.7 with mime
least 9 months
therapy
[25]
In review

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 16


Neurological disorders
Bell's palsy
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
From 21.6 to 19.6 with waiting list
control
Lip mobility was physician-as-
sessed by measuring the pout
and lip-length indices

[26]
34 people with Recovery of facial grading Mean difference 20.40
chronic Bell's palsy
Systematic with exercises 95% CI 8.76 to 32.04
review Data from 1 RCT
with waiting list control
Absolute results not reported
exercises
Facial grading measured by
Sunnybrook scale (0 to 100
points), fully recovered facial
function = Sunnybrook score of
100 points

[26]
34 people with Recovery on the FDI social do- Mean difference 14.50
chronic Bell's palsy main (0 to 100)
Systematic 95% CI 4.85 to 24.15
review Data from 1 RCT with exercises
with waiting list control
Absolute results not reported
Improvement in social and physi- exercises
cal aspects of facial disability
were measured using the FDI
questionnaire
The FDI uses a 100-point scale,
with a higher score indicating less
handicap and less impairment

[26]
34 people with Recovery on the FDI physical Mean difference +10.30
chronic Bell's palsy domain
Systematic 95% CI –1.37 to +21.97
review Data from 1 RCT with exercises
with waiting list control
Absolute results not reported
Improvement in social and physi- Not significant
cal aspects of facial disability
were measured using the FDI
questionnaire
The FDI uses a 100-point scale,
with a higher score indicating less
handicap and less impairment

[26]
145 people; uncer- Proportion of people with in- RR 0.61
tain duration of complete recovery , 3 months
Systematic 95% CI 0.21 to 1.17
Bell's palsy
review 6/85 (7%) with exercises Not significant
Data from 1 RCT
7/60 (12%) with waiting list con-
trol

-
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Presence of sequelae
[26]
145 people with Motor synkinesis RR 0.24
chronic Bell's palsy
Systematic 4/85 (5%) with exercises 95% CI 0.08 to 0.69
exercises
review Data from 1 RCT
12/60 (20%) with waiting list con-
trol

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 17


Neurological disorders
Bell's palsy
-
[25]
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 Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Time to recovery
[26]
90 people with un- Mean time to beginning of re- Mean difference –0.59 weeks
certain duration of covery (weeks)
Systematic 95% CI –1.01 to –0.17 weeks
Bell's palsy
review with exercises exercises
Data from 1 RCT
with conventional treatment
Absolute results not reported

[26]
90 people with un- Mean time to complete recov- Mean difference –0.91 weeks
certain duration of ery (weeks)
Systematic 95% CI –1.49 to –0.34 weeks
Bell's palsy
review with exercises exercises
P = 0.01
Data from 1 RCT
with conventional treatment
Absolute results not reported

-
[25]
No data from the following reference on this outcome.

-
Adverse effects

-
-
[25] [26]
No data from the following reference on this outcome.

-
-
-
Further information on studies
[25]
The authors of the review concluded that, because of lack of evidence, it was not possible to conclude if phys-
iotherapy 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.

GLOSSARY
Hemifacial spasm is a generalised involuntary mass contracture of the facial muscles.
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.
High-quality evidence Further research is very unlikely to change our confidence in the estimate of effect.

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 18


Neurological disorders
Bell's palsy
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.

SUBSTANTIVE CHANGES
[18]
Corticosteroids plus antiviral treatment: New evidence added. Evidence re-evaluated, categorisation changed
from likely to be beneficial to unknown effectiveness.

REFERENCES
1. Murakami S, Mizobuchi M, Nakashiro Y, et al. Bell's palsy and herpes simplex 15. Lockhart P, Daly F, Pitkethly M, et al. Antiviral treatment for Bell's palsy (idiopathic
virus: identification of viral DNA in endoneurial fluid and muscle. Ann Intern Med facial paralysis). In: The Cochrane Library, Issue 9, 2013. Chichester, UK: John
1996;124:27–30.[PubMed] Wiley & Sons, Ltd. Search date 2008.[PubMed]
2. Adour KK. Current concepts in neurology: diagnosis and management of facial 16. de Miranda P, Blum MR. Pharmacokinetics of acyclovir after intravenous and
paralysis. N Engl J Med 1982;307:348–351.[PubMed] oral administration. J Antimicrob Chemother 1983;12 (suppl B):29–37.
3. Bernstein JM, Holland NJ, Porter GC, et al. Resistance of Pseudomonas to 17. Quant EC, Jeste SS, Muni RH, et al. The benefits of steroids versus steroids
ciprofloxacin: implications for the treatment of malignant otitis externa. J Laryngol plus antivirals for treatment of Bell's palsy: a meta-analysis. BMJ
Otol 2007;121:118–123.[PubMed] 2009;339:b3354.[PubMed]
4. Holland NJ, Weiner GM. Recent developments in Bell's palsy. BMJ 18. Lee HY, Byun JY, Park MS, et al. Steroid-antiviral treatment improves the recovery
2004;329:553–557.[PubMed] rate in patients with severe Bell's palsy. Am J Med 2013;126:336–341.[PubMed]
5. Peitersen E. Bell's palsy: the spontaneous course of 2,500 peripheral facial nerve 19. Engstrom M, Berg M, Stjernquist-Desatnik A, et al. Is antiviral medication for
palsies of different etiologies. Acta Otolaryngol Suppl 2002;549:4–30.[PubMed] severe Bell's palsy still useful? Lancet Neurol 2009;8:510.[PubMed]
6. Furuta Y, Ohtani F, Kawabata H, et al. High prevalence of varicella-zoster virus 20. de Almeida JRA, Nedzelski JMC. Combined corticosteroid and antiviral treatment
reactivation in herpes simplex virus-seronegative patients with acute peripheral for Bell palsy: a systematic review and meta-analysis. JAMA
facial palsy. Clin Infect Dis 2000;30:529–533.[PubMed] 2009;302:985–993.[PubMed]
7. Kawaguchi K, Inamura H, Abe Y, et al. Reactivation of herpes simplex virus type 21. Browning GG. Bell's palsy: a review of three systematic reviews of steroid and
1 and varicella-zoster virus and therapeutic effects of combination therapy with anti-viral therapy. Clin Otolaryngol 2010;35:56–58.[PubMed]
prednisolone and valacyclovir in patients with Bell's palsy. Laryngoscope 22. Lycke J, Malmestrom C, Stahle L. Acyclovir levels in serum and cerebrospinal
2007;117:147–156.[PubMed] fluid after oral administration of valacylcovir. Antimicrob Agents Chemother
8. Adour KK, Byl FM, Hilsinger RL Jr, et al. The true nature of Bell's palsy: analysis 2003;47:2438–2441.[PubMed]
of 1,000 consecutive patients. Laryngoscope 1978;88:787–801.[PubMed] 23. Racic G, Denoble PJ, Sprem N, et al. Hyperbaric oxygen as a therapy of Bell's
9. Prescott CA. Idiopathic facial nerve palsy in children and the effect of treatment palsy. Undersea Hyperb Med 1997;24:35–38.[PubMed]
with steroids. Int J Pediatr Otorhinolaryngol 1987;13:257–264.[PubMed] 24. Blanshard J, Toma A, Bryson P, et al. Middle ear barotrauma in patients under-
10. Salinas RA, Alvarez G, Daly F, et al. Corticosteroids for Bell's palsy (idiopathic going hyperbaric oxygen therapy. Clin Otolaryngol Allied Sci
facial paralysis). In: The Cochrane Library, Issue 9, 2013. Chichester, UK: John 1996;21:400–403.[PubMed]
Wiley & Sons, Ltd. Search date 2008.[PubMed] 25. Cardoso JR, Teixeira EC, Moreira MD, et al. Effects of exercises on Bell's palsy:
11. de Almeida JR, Al Khabori M, Guyatt GH, et al. Combined corticosteroid and systematic review of randomized controlled trials. Otol Neurotol
antiviral treatment for bell palsy: a systematic review and meta-analysis. JAMA 2008;29:557–560.[PubMed]
2009;302:985–993.[PubMed] 26. Teixeira LJ, Valbuza JS, Prado GF. Physical therapy for Bell's palsy (idiopathic
12. Sullivan FM, Swan IR, Donnan PT, et al. Early treatment with prednisolone or facial paralysis). In: The Cochrane Library, Issue 9, 2013. Chichester, UK: John
acyclovir in Bell's palsy. N Engl J Med 2007;357:1598–1607.[PubMed] Wiley & Sons, Ltd. Search date 2011.[PubMed]
13. Engstrom M, Berg T, Stjernquist-Desatnik A, et al. Prednisolone and valaciclovir 27. Beurskens CH, Heymans PG. Positive effects of mime therapy on sequelae of
in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial. facial paralysis: stiffness, lip mobility, and social and physical aspects of facial
Lancet Neurol 2008;7:993–1000.[PubMed] disability. Otol Neurotol 2003;24:677–681.[PubMed]
14. Berg T, Bylund N, Marsk E, et al. The effect of prednisolone on sequelae in Bell's 28. Beurskens CHG, Heymans PG, Oostendorp RAB. Stability of benefits of mime
palsy. Arch Otolaryngol Head Neck Surg 2012;138:445–449.[PubMed] therapy in sequelae of facial nerve paresis during a 1-year period. Otol Neurotol
2006;27:1037–1042.[PubMed]

N. Julian Holland
Consultant Otolaryngologist, Head and Neck Surgeon
Waitemata District Health Board
Auckland
New Zealand

Jonathan M. Bernstein
Fellow, Head and Neck Surgical Oncology
University Health Network
Toronto
Canada

Competing interests: NJH and JMB declare that they have no competing interests.

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, inci-
dental or consequential, resulting from the application of the information in this publication.

© BMJ Publishing Group Ltd 2014. All rights reserved. .......................................................... 19


Neurological disorders
Bell's palsy
GRADE Evaluation of interventions for Bell's palsy.
-
Important out-
comes Presence of sequelae, Recovery of motor function, Time to recovery
Studies (Partici- Type of Consisten- Direct- Effect
pants) Outcome Comparison evidence Quality cy ness size GRADE Comment
What are the effects of drug treatments for Bell's palsy in adults and children?
[10] [11]
10 (1507) Recovery of motor Corticosteroids versus placebo 4 –1 0 0 0 Moderate Quality point deducted for the inclusion
[12] [13]
function or no specific treatment of some single-blinded studies in the
meta-analysis
at least 3 (at least Presence of sequelae Corticosteroids versus placebo 4 –2 0 0 0 Low Quality points deducted for incomplete
[10] [11] [12]
901) or no specific treatment reporting of results and the inclusion of
[13]
some single-blinded studies in the meta-
analysis
[13]
1 (829) Time to recovery Corticosteroids versus placebo 4 0 0 0 0 High
or no specific treatment
[15]
5 (1228) Recovery of motor Antiviral agents versus placebo 4 –1 0 0 0 Moderate Quality point deducted for the inclusion
function of single-blinded studies in the meta-
analysis
[11]
2 (at least 99) Presence of sequelae Antiviral agents versus placebo 4 –2 0 0 0 Low Quality points deducted for unclear report-
[15]
ing of number of people in analysis and
incomplete reporting of results
[15]
3 (768) Recovery of motor Antiviral agents versus corticos- 4 0 0 0 0 High
function teroids
[15]
7 (1987) Recovery of motor Corticosteroids plus antiviral 4 –1 0 0 0 Moderate Quality point deducted for the inclusion
function treatment versus placebo/no of some single-blinded studies in the
treatment meta-analysis
[11] [15]
9 (1504) Recovery of motor Corticosteroids plus antiviral 4 –1 –1 0 0 Low Quality point deducted for the inclusion
[17] [18]
function treatment versus corticosteroids of open-label studies in the meta-analy-
alone sis; consistency point deducted for con-
flicting results depending on analysis
undertaken
[15]
1 (99) Presence of sequelae Corticosteroids plus antiviral 4 –1 0 –1 0 Low Quality point deducted for sparse data;
treatment versus corticosteroids directness point deducted for small
alone number of events
[11]
2 (660) Recovery of motor Corticosteroids plus antiviral 4 0 0 0 0 High
function treatment versus antiviral treat-
ment alone
[23]
1 (79) Recovery of motor Hyperbaric oxygen versus corti- 4 –2 0 0 0 Low Quality points deducted for sparse data
function costeroids and incomplete reporting of results
[23]
1 (79) Time to recovery Hyperbaric oxygen versus corti- 4 –2 0 0 0 Low Quality points deducted for sparse data
costeroids and incomplete reporting of results
What are the effects of physical treatments for Bell's palsy in adults and children?

© BMJ Publishing Group Ltd 2014. All rights reserved. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20


Neurological disorders
Bell's palsy
Important out-
comes Presence of sequelae, Recovery of motor function, Time to recovery
Studies (Partici- Type of Consisten- Direct- Effect
pants) Outcome Comparison evidence Quality cy ness size GRADE Comment
[25] [26]
2 (82) Recovery of motor Facial re-training versus waiting 4 –2 0 0 0 Low Quality points deducted for sparse data
function list control and incomplete reporting of results
[26]
1 (145) Presence of sequelae Facial re-training versus waiting 4 –2 0 0 0 Low Quality points deducted for sparse data
list control and methodological weaknesses
[26]
1 (90) Time to recovery Facial re-training versus waiting 4 –2 0 0 0 Low Quality points deducted for sparse data
list control and incomplete reporting of results
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.

© BMJ Publishing Group Ltd 2014. All rights reserved. ............................................................................................................ 21

You might also like