Surgical interventions for the early management of Bell’s

palsy (Protocol)

Swan I, Donnan P, McAllister K, Walker D

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2008, Issue 4
http://www.thecochranelibrary.com

Surgical interventions for the early management of Bell’s palsy (Protocol)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Surgical interventions for the early management of Bell’s palsy (Protocol) i

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Surgical interventions for the early management of Bell’s palsy

Iain Swan1 , Peter Donnan2 , Kerrie McAllister3 , David Walker3

1 GlasgowRoyal Infirmary, Glasgow, UK. 2 Tayside Centre for General Practice, University of Dundee, Dundee, UK. 3 Department of
Otolaryngology, North Glasgow University NHS Trust, Glasgow, UK

Contact address: Iain Swan, Glasgow Royal Infirmary, Department of Otolaryngology, Royal Infirmary, Glasgow, G31 2ER, UK.
Iain@ihr.gla.ac.uk.

Editorial group: Cochrane Neuromuscular Disease Group.

Publication status and date: New, published in Issue 4, 2008.

Citation: Swan I, Donnan P, McAllister K, Walker D. Surgical interventions for the early management of Bell’s palsy. Cochrane Database
of Systematic Reviews 2008, Issue 4. Art. No.: CD007468. DOI: 10.1002/14651858.CD007468.

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
This review aims to determine the evidence for surgery in the management of Bell’s palsy and the effectiveness of surgery compared
with outcomes of medical management.

Surgical interventions for the early management of Bell’s palsy (Protocol) 1

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
BACKGROUND
Bell’s palsy is an acute paralysis of one side of the face due to a lesion
of the facial nerve first described by Sir Charles Bell, a Scottish
surgeon (1774 to 1842). Its cause is not known and it should only
be used as a diagnosis in the absence of any other pathology. It was
proposed in 1919 (Antoni 1919) that the underlying pathology
was that of a viral neuropathy. Herpes simplex virus has been
suggested as the likely pathogen (McCormick 1972) and animal
studies have suggested that reactivation of the virus may lead to
demyelination of the nerve leading to reduced function (Adour
1975, Stjernquist 2006).
The condition affects 25 to 35 people per 100 000 of the popula-
tion per year and is most common in the 30 to 45 age group. It is
also more common in pregnant women, people with diabetes or
people with a respiratory tract infection (Theil 2001). Recovery
in most patients can be expected to be good. It has been shown
in a large review (Peitersen 2002) that over 70% of patients will
have normal function restored and of the remainder 25% will have
slight or mild sequelae and only 4% will have severe sequelae.
Contractures, facial disfigurement, with associated psychological
difficulties, and facial pain (Morgenlander 1990) remain the most
common long-term problems.
A number of studies have looked into identifying which popula-
tion might benefit most from surgery. In addition to simple clin-
ical assessment of disease using the House-Brackmann scale or
similar, many studies have tried to assess the electrical function of
the facial nerve. Electroneurography (ENOG) has been the most
popular technique employed (Esslen 1977; Fisch 1984). In this
the degree of muscle response to an electrically evoked stimulus is
assessed. It was shown (Esslen 1977; Fisch 1984) that when 95%
of the nerve had degenerated the patient had a 50% chance of a
poor outcome, that is stood a less than 50% chance of recovery
to House-Brackmann grade 1 or 2 and would potentially benefit
from surgical intervention (Sillman 1992).
Although it is a common condition, in the absence of an estab-
lished aetiology, treatment continues to be based upon the pre-
sumed pathophysiology of swelling and entrapment of the nerve.
There is however continued controversy and variation in manage-
ment. The most common management involves a combination
of prednisolone with aciclovir although up until recently the evi-
dence was weak and two recent Cochrane reviews found insuffi-
cient evidence to support either or both treatments (Salinas 2004;
Allen 2004). A more recent double blinded randomised controlled
study (Sullivan 2007) has shown that early treatment with pred-
nisolone significantly improves the chances of complete recovery
at three and nine months. At three months 83% had recovered
facial function whilst this figure rose to 94% at nine months. Pa-
tients who did not receive prednisolone had recovery of 64% and
81% over similar time scales. This study also showed that there
was no benefit in giving aciclovir either alone or in combination
with prednisolone.
Surgical interventions for the early management of Bell’s palsy (Protocol)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
As the proposed pathophysiology involves entrapment of the
nerve, this has led some surgeons to suggest that surgical decom-
pression of the nerve is a suitable management option. The first
recorded attempt at surgical decompression of the facial nerve
for Bell’s palsy was in 1932 (Ballance 1932). They recommended
slitting the sheath in the distal descending segment of the nerve.
This was consistent with theories of the site of the lesion at that
time. Over the next few decades the proposed site for the surgery
has migrated from the distal 1 cm at the stylomastoid foramen (
Ballance 1932) to the entrance of the fallopian canal medially (
Fisch 1972). The timing also varied from three months to imme-
diately on onset (May 1972). In the early 1970s it was proposed
that the most likely site of compression was at the entrance to the
fallopian canal (Fisch 1972). Intraoperative evoked electromyog-
raphy (EMG) and an oedematous swelling at this point proximal
to the geniculate ganglion was noted in up to 94% of their pa-
tients. In this study transmastoid/middle cranial fossa approaches
were used to allow decompression of the nerve and geniculate gan-
glion. Other studies (May 1984) suggested that a transmastoid
approach to decompression of the labyrinthine segment was of
benefit. Two further studies published around the same time gave
evidence both for (Giancarlo 1970) and against (McNeill 1974)
surgery. Given the natural history of the condition and the good
outcomes of the condition without treatment and with medical
management and also the potential for damage to the facial nerve
and other ear structures during surgery, there has been a continued
debate as to whether surgery has a role in the management of Bell’s
palsy (Adour 2002; Friedman 2000).
Despite the debate on different surgical approaches there is a
paucity of level one evidence regarding facial nerve decompres-
sion surgery for acute Bell’s palsy. Few large studies have been
carried out. Of these one (May 1985) convinced many surgeons
that surgery did not have a place in the management of Bell’s
palsy. More recently (Gantz 1999) found that when selected using
ENOG, those patients who would have had a bad outcome as
predicted by ENOG had a better outcome if surgically managed
compared with those who were not. Currently most patients are
managed medically with steroids with or without aciclovir as dis-
cussed above. Surgery, certainly in the UK, is rarely undertaken (
Sullivan 2007).
OBJECTIVES
This review aims to determine the evidence for surgery in the man-
agement of Bell’s palsy and the effectiveness of surgery compared
with outcomes of medical management.
METHODS
2
Criteria for considering studies for this review
Types of studies
We will assess randomised and quasi-randomised controlled trials
in the main review. Other studies, including case series will be
included in the discussion section of the final review. Case series
must have three consecutive cases with follow-up for one year
using similar outcome measures.
Types of participants
We will include any participant (adult or child) who presented with
an idiopathic facial palsy which was diagnosed as Bell’s palsy. Those
who were diagnosed as having herpes zoster, who had a traumatic
aetiology or other identified aetiology will be excluded from the
review. This includes any cases of recurrent and familial Bell’s palsy
or Melkerson-Rosenthal syndrome, which will be excluded.
Types of interventions
We will include any surgical intervention carried out for Bell’s
palsy within the acute phase (within 3 weeks of presentation). The
outcomes and evidence for different surgical interventions will be
considered. Any concurrent medical management will be assessed.
Types of outcome measures
Primary outcomes
The primary outcome measure will be the degree of recovery of
facial nerve function and resolution of symptoms at 12 months
as measured using the House-Brackmann scale, the Sunnybrook
scale, the Yanigahara scale or other similar scale. The results from
studies using different follow-up periods will be standardised to
their six month equivalents for meta-analyses including them all.
Secondary outcomes
Secondary outcome measures are:
1. Complete recovery at three and six months.
2. Synkinesis and contracture at 12 months.
3. Psychosocial outcomes at 12 months.
4. Side effects and complications of treatment.
Search methods for identification of studies
Electronic searches
See: Cochrane Neuromuscular Disease Group methods used in
reviews.
Surgical interventions for the early management of Bell’s palsy (Protocol)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
We will search the Cochrane Neuromuscular Disease Group Trials
Register using the following search terms ’Bell’s palsy’ ’facial palsy’
or ’idiopathic facial paralysis’. We will also search the Cochrane
Central Register of Controlled Trials (CENTRAL) (The Cochrane
Library, Issue 3 2008). We will adapt this strategy to search MED-
LINE (from January 1950 to the present) and EMBASE (from
January 1947 to the present).
The following phrases, adapted to each database as appropriate,
will be used:
#1 (Bell’s palsy) OR (Bell palsy) OR (idiopathic facial paralysis)
OR (facial paralysis) OR (facial palsy) OR (facial nerve)
AND
#2 (surgery) OR (surg*) OR (operative) OR (operat*) OR (de-
compression) OR (decompres*).
See Appendix 1 and Appendix 2.
Searching other resources
1. We will review the bibliographies of all trials identified.
2. We will contact the authors of all included trials for further
additional information or information on unpublished trials.
3. We will perform a search for conferences regarding latest
research in this area and, if appropriate, contact known experts in
this field for clarification on latest unpublished data.
Data collection and analysis
Selection of studies
Two review authors (Walker, McAllister) will review titles and ab-
stracts identified by the search strategy. The review authors will
obtain full text for all relevant studies and will assess them in-
dependently. Two review authors (Walker, McAllister) will assess
whether each trial meets the inclusion criteria. Disagreement be-
tween the review authors will be resolved by discussion with the
lead author (Swan) if required.
Assessment of risk of bias in included studies
An assessment of risk of bias will be made on all included studies
included and a risk of bias table will be completed according to
Cochrane guidelines. If randomised controlled trials are identi-
fied we will assess for randomisation sequence generation, alloca-
tion concealment, blinding (participants, personnel and outcome
assessors), incomplete outcome data, selective outcome reporting
and other sources of bias. We will then make a judgement on each
of these criteria relating to the risk of bias using ’Yes’ indicating
low risk of bias, ’No’ high risk of bias and ’Unclear’ unclear or
unknown risk of bias. Two authors (Walker, McAllister) will assess
quality independently. Disagreement between the authors will be
resolved by discussion with the lead author (Swan) if required.
3
Data extraction and management
The data extracted will include study participants, methods, inter-
ventions used, outcomes along with 95% confidence intervals and
results. The main outcome measure is degree of recovery of facial
function and residual disability. Two authors will extract these data
independently and enter them onto a specifically designed form.
We will obtain missing data where possible from the authors.
Measures of treatment effect
We will enter data into the Review Manager (RevMan) software
and will analyse data using the standard statistical methods. For
continuously measured outcomes we will use means to obtain
mean differences (MDs) with 95% confidence intervals (CI), for
dichotomous outcome data the pooled relative risk with 95 % CI
will be estimated from study log relative risks.The number needed
to treat (NNT) will be calculated if possible. If little trial evidence
is found observational relative risks will be combined.
Assessment of heterogeneity
A Chi2 test for homogeneity will be carried out. If significant
heterogeneity is found, then an attempt will be made to find the
cause of this based on the characteristics of the studies included.
REFERENCES
Additional references
Adour 1975
Adour KK, Bell DN, Hilsinger RL Jr. Herpes simplex virus in
idiopathic facial paralysis (Bell palsy). Journal of the American
Medical Association 1975;233(6):527–30.
Adour 2002
Adour KK. Decompression for Bell’s palsy: why I don’t do it.
European Archives of Oto-Rhino-Laryngology 2002;259(1):40–7.
Allen 2004
Allen D, Dunn L. Aciclovir or valaciclovir for Bell’s palsy
(idiopathic facial paralysis). Cochrane Database of Systematic Reviews
2004, Issue 3. [: CD001869]
Antoni 1919
Antoni N. [Herpes zoster med forlamming (med sarskild hansyn ill
f.k. polyneuritis cerebali Meniereformis)]. Hygeiea 1919;81:
340–53.
Ballance 1932
Ballance C, Duel AB. The operative treatment of facial palsy: by
the introduction of nerve grafts into the fallopian canal and by
other intratemporal methods. Archives of Otolaryngology - Head and
Neck Surgery 1932;15:1–70.
Surgical interventions for the early management of Bell’s palsy (Protocol)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Assessment of reporting biases
Publication bias will be assessed through a funnel plot.
Data synthesis
Initially, a fixed-effect model will be used and the test for hetero-
geneity carried out. Random-effects models such as DerSimonian
and Laird account for more uncertainty and these will also be
utilised, especially if there is heterogeneity (DerSimonian 1986).
Subgroup analysis and investigation of heterogeneity
A sensitivity analysis will be performed omitting studies of lower
quality of methodology. In addition, quality could be incorporated
into mixed models simultaneously allowing for differences in qual-
ity using Bayesian methods, utilised in WinBUGS (Spiegelhalter
2000).
Economic issues
If there is inadequate information from the trials identified, adverse
events and cost effectiveness will be considered in the discussion
in the full review taking into account observational studies.
ACKNOWLEDGEMENTS
None
DerSimonian 1986
DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled
Clinical Trials. 1986;7(3):177–88.
Esslen 1977
Esslen E. The acute facial palsies: investigations on the localization
and pathogenesis of meato-labyrinthine facial palsies.
Schriftenreihe Neurologie - Neurology Series. Springer Verlag
Berlin, Heidelberg, New York, 1977; Vol. 18:1–164.
Fisch 1972
Fisch U, Esslen E. Total intratemporal exposure of the facial nerve.
Pathologic findings in Bell’s palsy. Archives of Otolaryngology - Head
and Neck Surgery 1972;95(4):335–41.
Fisch 1984
Fisch U. Prognostic value of electrical tests in acute facial paralysis.
American Journal of Otology 1984;5(6):494–8.
Friedman 2000
Friedman RA. The surgical management of Bell’s Palsy: a review.
American Journal of Otology 2000;21(2):139–44.
Gantz 1999
Gantz BJ, Rubinstein JT, Gidley P, Woodworth GG. Surgical
management of Bell’s Palsy. Laryngoscope 1999;109(8):1177–88.
4
Giancarlo 1970 Salinas 2004
Giancarlo HR, Mattucci KF. Facial palsy. Facial nerve Salinas RA, Alvarez G, Ferreira J. Corticosteroids for Bell’s palsy
decompression. Archives of Otolaryngology - Head and Neck Surgery (idiopathic facial paralysis). Cochrane Database of Systematic Reviews
1970;91(1):31–6. 2004, Issue 4. [: CD001942][Art. No.: CD001942. DOI:
May 1972 10.1002/14651858.CD001942.pub3]
May M, Hawkins CD. Bell’s palsy: results of surgery; salivation test Sillman 1992
versus nerve excitability test as a basis of treatment. Laryngoscope Sillman JS, Niparko JK, Lee SS, Kileny PR. Prognostic value of
1972;82(7):1337–48. evoked and standard electromyography in acute facial paralysis.
May 1984 Otolaryngology - Head and Neck Surgery. 1992;107(3):377–81.
May M, Blumenthal F, Taylor FH. Bell’s palsy: surgery based upon Spiegelhalter 2000
prognostic indicators and results. Laryngoscope 1984;91(12): Spiegelhalter DJ, Thomas A, Best NG. WinBUGS Version 1.2.
2092–103. User Manual. WinBUGS Version 1.2. User Manual. Cambridge,
May 1985 MRC Biostatistics Unit, 2000.
May M, Klein SR, Taylor FH. Idiopathic (Bell’s) facial palsy:
Stjernquist 2006
natural history defies steroid or surgical treatment. Laryngoscope
Stjernquist-Desatnik A, Skoog E, Aurelius E. Detection of herpes
1985;95(4):406–9.
simplex and varicella-zoster viruses in patients with Bell’s palsy by
McCormick 1972 the polymerase chain reaction technique. Annals of Otology,
McCormick DP. Herpes-simplex virus as a cause for Bell’s palsy. Rhinology, and Laryngology 2006;115(4):306–11.
Lancet 1972;1(7757):937–9.
Sullivan 2007
McNeill 1974
Sullivan FM, Swan IRC, Donnan PT, Morrison JM, Smith BH,
McNeill R. Facial nerve decompression. Journal of Laryngology and
McKinstry B, et al.Early treatment with prednisolone or acyclovir
Otology 1974;88(5):445–55.
in Bell’s palsy. New England Journal of Medicine 2007;357(16):
Morgenlander 1990 1598–607.
Morgenlander JC, Massey EW. Bell’s Palsy: ensuring the best Theil 2001
possible outcome. Postgraduate Medicine 1990;88(5):157–62. Theil D, Arbusow V, Derfuss T, Strupp M, Pfeiffer M, Mascolo A,
Peitersen 2002 et al.Prevalence of HSV-1 LAT in human trigeminal, geniculate,
Peitersen E. Bell’s palsy: the spontaneous course of 2,500 peripheral and vestibular ganglia and its implication for cranial nerve
facial nerve palsies of different etiologies. Acta Oto-laryngologica syndromes. Brain Pathology 2001;11(4):408–13.
Supplement 2002;549:4–30. ∗
Indicates the major publication for the study

APPENDICES

Appendix 1. OVID MEDLINE search strategy

1 randomized controlled trial.pt.
2 controlled clinical trial.pt.
3 randomized controlled trials/
4 random allocation/
5 double-blind method/
6 single-blind method/
7 or/1-6
8 animals/ not humans/
9 7 not 8
10 clinical trial.pt.
11 exp clinical trial/
12 (clin$ adj25 trial$).ti,ab.
13 ((singl$ or doubl$ or tripl$ or trebl$) adj25 (blind$ or mask$)).ti,ab.
14 placebos/
15 placebo$.ti,ab.
Surgical interventions for the early management of Bell’s palsy (Protocol) 5
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
16 random$.ti,ab.
17 research design/
18 or/10-17
19 18 not 8
20 19 not 9
21 comparative study/
22 exp evaluation studies/
23 follow up studies/
24 prospective studies/
25 (control$ or prospectiv$ or volunteer$).ti,ab.
26 or/21-25
27 26 not 8
28 27 not (9 or 20)
29 9 or 20 or 28
30 bell palsy/ or facial paralysis/ or hemifacial spasm/
31 ((bell$ or facial or hemifacial$) adj3 (pals$ or paralys$ or paresi$ or spasm$)).mp.
32 30 or 31
33 surgery/ or (surg$ or operat$ or decompres$).mp.
34 32 and 33
35 29 and 34

Appendix 2. OVID EMBASE search strategy

1 Randomized Controlled Trial/
2 Clinical Trial/
3 Multicenter Study/
4 Controlled Study/
5 Crossover Procedure/
6 Double Blind Procedure/
7 Single Blind Procedure/
8 exp RANDOMIZATION/
9 Major Clinical Study/
10 PLACEBO/
11 Meta Analysis/
12 phase 2 clinical trial/ or phase 3 clinical trial/ or phase 4 clinical trial/
13 (clin$ adj25 trial$).tw.
14 ((singl$ or doubl$ or tripl$ or trebl$) adj25 (blind$ or mask$)).tw.
15 placebo$.tw.
16 random$.tw.
17 control$.tw.
18 (meta?analys$ or systematic review$).tw.
19 (cross?over or factorial or sham? or dummy).tw.
20 ABAB design$.tw.
21 or/1-20
22 human/
23 nonhuman/
24 22 or 23
25 21 not 24
26 21 and 22
27 25 or 26
28 Randomized Controlled Trial/
29 Clinical Trial/
Surgical interventions for the early management of Bell’s palsy (Protocol) 6
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
30 Multicenter Study/
31 Controlled Study/
32 Crossover Procedure/
33 Double Blind Procedure/
34 Single Blind Procedure/
35 exp RANDOMIZATION/
36 Major Clinical Study/
37 PLACEBO/
38 Meta Analysis/
39 phase 2 clinical trial/ or phase 3 clinical trial/ or phase 4 clinical trial/
40 (clin$ adj25 trial$).tw.
41 ((singl$ or doubl$ or tripl$ or trebl$) adj25 (blind$ or mask$)).tw.
42 placebo$.tw.
43 random$.tw.
44 control$.tw.
45 (meta?analys$ or systematic review$).tw.
46 (cross?over or factorial or sham? or dummy).tw.
47 ABAB design$.tw.
48 or/28-47
49 human/
50 nonhuman/
51 49 or 50
52 48 not 51
53 48 and 49
54 52 or 53
55 Bell Palsy/
56 Facial Nerve Paralysis/
57 HEMIFACIAL SPASM/
58 ((bell$ or facial or hemifacial$) adj3 (pals$ or paralys$ or paresi$ or spasm$)).mp.
59 55 or 56 or 57 or 58
60 surgery/ or (surg$ or operat$ or decompres$).mp.
61 59 and 60
62 54 and 61

HISTORY
Protocol first published: Issue 4, 2008

CONTRIBUTIONS OF AUTHORS
Mr I Swan suggested the review and supervised the writing of the protocol.
Mr P Donnan provided statistical knowledge and expertise required for the protocol.
Miss K McAllister devised the search strategy and wrote the primary version of the protocol.
Mr D Walker devised the search strategy and wrote the primary version of the protocol.

Surgical interventions for the early management of Bell’s palsy (Protocol) 7

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DECLARATIONS OF INTEREST
None

Surgical interventions for the early management of Bell’s palsy (Protocol) 8

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.