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Research

JAMA Otolaryngology–Head & Neck Surgery | Original Investigation

Evaluation of Factors Associated With Favorable Outcomes


in Adults With Bell Palsy
Myung Chul Yoo, MD; Yunsoo Soh, MD, PhD; Jinmann Chon, MD, PhD; Jong Ha Lee, MD, PhD; Junyang Jung, MD; Sung Su Kim, MD, PhD;
Myung-Won You, MD, PhD; Jae Yong Byun, MD, PhD; Sang Hoon Kim, MD; Seung Geun Yeo, MD, PhD

IMPORTANCE Identification of the factors associated with improved facial nerve function
after treatment of Bell palsy is important to provide patients with early and effective
treatment.

OBJECTIVE To identify factors that are associated with improved treatment outcomes in
patients with Bell palsy.

DESIGN, SETTING, AND PARTICIPANTS This retrospective cohort study included 1364 patients
with Bell palsy treated at the outpatient clinic of the Department of Otolaryngology at the
Kyung Hee University Hospital, Seoul, Republic of Korea, between January 1, 2005, and
December 31, 2017. The medical records of patients admitted to this hospital for management
of acute facial palsy were reviewed by 3 otolaryngologists with more than 20 years’
experience in treating facial palsy.

MAIN OUTCOMES AND MEASURES Facial function at the initial and final visits were measured
using the House-Brackmann (H-B) grading system, which is one of several analysis tools
developed to quantify facial function and provide reproducible information. It is a widely
accepted system for grading facial function in 6 steps, from normal (H-B grade I) to total
paralysis (H-B grade VI).

RESULTS In total, 1364 patients with primary Bell palsy (718 [52.6%] women) and a mean (SD)
age of 47.7 (16.7) years were enrolled. The overall rate of favorable outcome, which was
defined as an H-B grade of I or II at the 6-month follow-up visit, was 80.6% (1099 of 1364
patients). Of 1099 patients who had a favorable outcome at 6 months, 343 (31.2%) were
younger than 40 years. Of 1364 patients, 1053 (77.2%) had moderate facial dysfunction
(H-B grade III or IV). No pathological spontaneous fibrillation activity (ie, good
electromyography [EMG] results) was detected on EMG in 937 of 1364 patients (68.7%),
492 (36.1%) had controlled hypertension, and 673 (49.3%) were treated with oral
corticosteroids alone. Multivariable analysis revealed that the following factors were
associated with favorable outcome: age younger than 40 years (odds ratio [OR], 1.56;
95% CI, 1.09-2.22), an initial H-B grade of III or IV (OR, 2.62; 95% CI, 1.93-3.57), good EMG
results after 2 weeks of treatment (OR, 3.38; 95% CI, 2.48-4.61), absence of diabetes
(OR, 1.43; 95% CI, 1.04-2.36), and control of hypertension (OR, 1.64; 95% CI, 1.16-2.33).

CONCLUSIONS AND RELEVANCE Multiple logistic regression analysis in this study suggests that
multiple clinical factors are associated with favorable outcomes in patients with Bell palsy.

Author Affiliations: Author


affiliations are listed at the end of this
article.
Corresponding Author: Seung Geun
Yeo, MD, PhD, School of Medicine,
Department of Otorhinolaryngology–
Head and Neck Surgery, Kyung Hee
University, 23 Kyung Hee Dae-ro,
Dongdaemun-gu, Seoul 02447,
JAMA Otolaryngol Head Neck Surg. doi:10.1001/jamaoto.2019.4312 Republic of Korea (yeo2park@
Published online January 23, 2020. gmail.com).

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Research Original Investigation Evaluation of Factors Associated With Favorable Outcomes in Adults With Bell Palsy

B
ell palsy is an idiopathic, acute palsy of the peripheral
facial nerve supplying all muscles of the face.1 It is a rap- Key Points
idly developing unilateral facial weakness with an un-
Question Which factors are associated with improved outcomes
known cause. The condition results in a partial or complete in- in patients with Bell palsy?
ability to spontaneously move the facial muscles on the affected
Findings In this cohort study of 1364 patients diagnosed with Bell
side.2 Bell palsy is clinically easy to diagnose, does not affect
palsy between 2005 and 2017, factors that were associated with
a patient’s mortality and life expectancy, and usually has a good
improved facial function included younger age, a lower degree of
prognosis. However, patients experience mental stress until initial facial nerve paralysis as measured using the
the condition resolves, which may take some time if sequelae House-Brackmann grade, good electromyography result (absence
develop. The exact pathogenic mechanism is not well known, of pathological spontaneous fibrillation activity), absence of
and treatment methods for complete resolution of symp- diabetes, and control of hypertension.
toms have not yet been established. Recent studies have dem- Meaning The findings of this study suggest that multiple clinical
onstrated that the major cause of Bell palsy is the reactiva- factors may be associated with a favorable outcome in patients
tion of the latent herpes simplex virus type 1 or varicella zoster with Bell palsy.
virus within the geniculate ganglia.3 The pathogenesis by which
these viruses can cause neuropathy may begin with a cyto-
toxic edema induced by neuronal inflammation.4 These hy- from January 1, 2005, to December 31, 2017. The medical rec-
potheses have justified the use of corticosteroids and antivi- ords of 1756 patients admitted to the hospital were reviewed
ral agents, separately or together, in the treatment of Bell palsy. by 3 of us (J.Y.B., S.H.K., and S.G.Y.) who have more than 20
The incidence of Bell palsy is 20 to 30 cases per 100 000 years’ experience in treating facial palsy. Of 1756 patients, 392
people per year, accounting for 60% to 75% of all unilateral fa- patients were excluded based on the following exclusion cri-
cial paralyses.3,5 Men and women are equally affected and the teria: central nervous system disorders, polyneuropathy such
disease can occur at any age.6 The facial weakness usually oc- as Guillain-Barré syndrome, recurrent Bell palsy, iatrogenic fa-
curs within a maximum of 48 hours; it can be complete or par- cial nerve palsy, neoplasms, Ramsay Hunt syndrome, otitis me-
tial and is generally unilateral.7 Although most patients with dia, pregnancy, herpes zoster oticus, bilateral facial palsy, un-
Bell palsy completely recover, up to 30% of the patients de- clear timing of onset, follow-up for less than 6 months, and
velop long-term sequelae, such as a permanent facial paresis, House-Brackmann (H-B) grade II at admission. A total of 1364
synkinesis, contracture, and facial asymmetry, even with ap- patients were included in this study (Figure). This retrospec-
propriate treatment.8,9 Therefore, the resolution of Bell palsy tive study was approved by the institutional review board of
and risk of paralysis are of great concern to patients. Kyung Hee University Hospital, Seoul, Republic of Korea. The
Previous studies10-12 reported on several factors associ- requirement for written informed consent was waived by the
ated with prognosis based on a clinical evaluation of accom- Kyung Hee University Hospital owing to the retrospective na-
panying symptoms, underlying medical diseases (hyperten- ture of the study.
sion and diabetes), age, and the degree of degeneration of the Patients’ baseline characteristics were assessed before ini-
facial nerve as determined using an electrophysiological test. tiating treatment, including the findings of the otorhinolar-
Moreover, numerous studies13,14 have been conducted on the yngological examination, grading of facial function, age, sex,
epidemiology, cause, diagnosis, treatment, and prognosis of and previous history of facial palsy. All patients were admit-
Bell palsy with the goal of providing early and appropriate treat- ted to the hospital for at least 7 days. In addition, all patients
ment to achieve optimal outcomes. Current knowledge on the were prescribed an ophthalmic ointment to prevent eye dam-
prognosis of Bell palsy remains limited owing to partial re- age according to the American Academy of Otolaryngology
search of clinical factors, small study samples, and high pos- guideline.2 Except 61 patients who refused a corticosteroid
sibility of bias in multicenter studies. In addition, no clear treatment and underwent a conservative treatment instead,
guidelines have been established for treating Bell palsy with such as acupuncture or physical therapy, all other patients be-
the combination of corticosteroids and antiviral agents. Based gan treatment with an oral corticosteroid or a corticosteroid
on this background, we analyzed variables potentially associ- combined with an antiviral drug within 7 days from the onset
ated with the outcome of Bell palsy. This study aimed to evalu- of paralysis. The corticosteroid treatment consisted of oral
ate the outcomes of patients with Bell palsy and diagnosti- prednisolone for 10 days, at a dosage of 1 mg/kg per day (maxi-
cally classify specific factors that contribute to a favorable or mum, 80 mg/d) for the first 4 days followed by tapering to
unfavorable outcomes. 60 mg/d on days 5 and 6, 40 mg/d on days 7 and 8, and 20 mg/d
on days 9 and 10. The antiviral treatment consisted of oral acy-
clovir, 1000-2400 mg/d, for 5 days or famciclovir, 750 mg/d,
for 7 days. Physical therapy consisted of facial massage,
Methods facial expression practice, and treatment with an electrical
Study Design and Participants stimulator.
This retrospective cohort study included patients who were
diagnosed with acute facial palsy and were admitted to the De- Assessment of Outcome and Follow-up
partment of Otorhinolaryngology—Head and Neck Surgery at The facial function was assessed using the H-B grading
the Kyung Hee University Hospital, Seoul, Republic of Korea, system.15 The following factors were recorded: patient’s sex

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Evaluation of Factors Associated With Favorable Outcomes in Adults With Bell Palsy Original Investigation Research

Figure. Flow Diagram of the Study Design

1756 Patients with Bell palsy

392 Patients excluded


(did not meet inclusion criteria)

1364 Patients with Bell palsy

Age Sex Initial House-Brackmann Electrophysiological Underlying Treatment method


grade test disease 673 Oral steroids only
668 Combination antiviral
23 Supportive care

Evaluation of prognostic factors of Bell palsy: favorable vs unfavorable recovery

and age, the degree of initial facial nerve paralysis repre-


sented by the initial H-B grade, the presence of underlying dis- Results
eases, such as diabetes and hypertension, electrophysiologi-
cal test results, and the degree of the final facial function. Three After excluding 392 patients who did not meet the inclusion
otolaryngologists (J.Y.B., S.H.K., and S.G.Y.) assessed the ini- criteria, 1364 patients with primary Bell palsy were enrolled
tial severity of Bell palsy using the H-B grading system. The (646 men [47.4%] and 718 women [52.6%]) (Table 1). The
degree of the initial facial palsy was classified as mild (H-B grade mean (SD) patient age was 47.7 (16.7) years. Of the 1364
II), moderate (H-B grades III-IV), or severe (H-B grade ≥V). patients registered, 1053 (77.2%) had an initial H-B grade of
The degree of functional improvement was also assessed based III or IV, 1279 (94.0%) had ENoG of 10% or greater, 937
on the H-B grade at every follow-up visit (14 days, 1 month, (68.7%) had good EMG results, 179 (13.1%) had diabetes, 492
3 months, and 6 months). At the 6-month follow-up visit, we (36.1%) had controlled hypertension, 673 (49.3%) were
reevaluated the H-B grade in all patients and defined favor- treated with corticosteroids alone, 668 (49.0%) were treated
able outcome as an H-B grade of I or II and an H-B grade III or with a combination of corticosteroid and an antiviral agent,
higher as an unfavorable outcome. and 23 (1.7%) were treated with supportive care alone. The
Electroneurography (ENoG) and electromyography (EMG) overall rate of favorable outcome was 80.6% (1099 of 1364
were used for electrophysiological assessment. Electroneu- patients). Among 1099 patients who had a favorable out-
rography was performed on day 4 or 5 after the symptom on- come, 343 (31.2%) were younger than 40 years. In addition,
set, whereas needle EMG was conducted in all patients 2 weeks the initial H-B grade was III or IV in 885 of 1099 patients
after the onset of facial palsy. Electroneurography measure- (80.5%), 412 (37.5%) had controlled hypertension, and 571
ments were reported as the percentage maximal amplitude on (52.0%) were treated with corticosteroids alone.
the affected side divided by the maximal amplitude on the nor- Multivariable logistic regression analysis was performed
mal side. A poor ENoG result was defined as a loss of ampli- to identify independent factors associated with the final out-
tude greater than 90%, whereas loss of 90% or less was clas- come (Table 2). Favorable outcome (ie, H-B grade ≥III) was
sified as a good outcome.16 In addition, the presence or absence associated with age younger than 40 years (OR, 1.56; 95% CI,
of the blink reflex and the needle EMG findings were ana- 1.09-2.22), lower initial H-B grade (OR, 2.62; 95% CI, 1.93-
lyzed simultaneously to be classified as a poor or good out- 3.57), good EMG outcome after 2 weeks of treatment (OR,
come by the physical medicine and rehabilitation physician. 3.38; 95% CI, 2.48-4.61), absence of diabetes (OR, 1.43;
The absence of pathological spontaneous fibrillation activity 95% CI, 1.04-2.36), and the control of hypertension (OR,
was defined as a good outcome, whereas the presence of ab- 1.64; 95% CI, 1.16-2.33). Moreover, after controlling for
normal spontaneous activity or absence of volitional activity important demographic characteristics and baseline clinical
was classified as a poor outcome. factors (age, sex, initial H-B grade, underlying disease
such as hypertension and diabetes, and electrophysio-
Statistical Analysis logical test findings), treatment with an oral corticosteroid
Clinical data are presented as mean (SD), with effect size alone did not show any statistically significant independent
presented as the difference in rates of favorable outcome and difference in the OR compared with combination antiviral
95% CI around the difference. To evaluate the association be- therapy. Results of the multivariable logistic regression
tween baseline variables, treatment, and outcome of Bell palsy, analysis for predicting the probability of favorable outcome
multivariable logistic regression analyses were performed and (H-B grade I-II) for Bell palsy are given in Table 2. Compared
associations were reported as odds ratios (ORs) with 95% CIs. with patients who received combination antiviral therapy,

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Research Original Investigation Evaluation of Factors Associated With Favorable Outcomes in Adults With Bell Palsy

Table 1. Demographic, Clinical, Electrophysiological, and Treatment Variables


Associated With Favorable Outcomes in Patients With Bell Palsya
All Patients, Favorable Outcome, Effect Size Difference
Variable No. (%) N = 1364 No. (%) n = 1099 (95% CI), %
Sex
Male 646 (47.4) 523 (47.6)
0.74 (−3.46 to 4.94)
Female 718 (52.6) 576 (52.4)
Age, y
<40 407 (29.8) 343 (31.2)
5.28 (0.90 to 9.66)
≥40 957 (70.2) 756 (68.8)
Initial H-B grade
III-IV 1053 (77.2) 885 (80.5)
15.24 (9.63 to 20.84)
V-VI 311 (22.8) 214 (19.5)
Electroneurography results
≥10% (Good) 1279 (94.0) 1034 (94.1)
4.37 (−4.9 to 13.65)
<10% (Poor) 85 (6.0) 65 (5.9)
Electromyography resultsb
Good 937 (68.7) 818 (74.4)
21.49 (16.51 to 26.47)
Poor 427 (31.3) 281 (25.6)
Controlled hypertension
Yes 492 (36.1) 412 (37.5)
4.96 (0.71 to 9.20)
No 872 (63.9) 687 (62.5)
Diabetes
No 1185 (86.9) 964 (87.7)
5.93 (−0.75 to 12.62) Abbreviation: H-B grade,
Yes 179 (13.1) 135 (12.3) House-Brackmann grade.
Treatment method a
Favorable outcome was defined
Oral corticosteroids alone 673 (49.3) 571 (52.0) as an H-B grade of II or lower.
b
Combination antiviral therapy 668 (49.0) 512 (46.6) 15.28 (1.48 to 34.86) Good results were defined as the
absence of pathological
Supportive care alone 23 (1.7) 16 (1.4)
spontaneous fibrillation activity.

those who received only supportive care had lower odds of The present study used the H-B grading system, which is
having a favorable outcome (OR, 0.47; 95% CI, 0.17-1.26). most frequently used to assess the degree of facial function
However, the CI was wide, indicating low precision of this in Bell palsy. In other studies,19-21 H-B grade I was set as the
estimate, and included the null value; therefore, no defini- threshold for a favorable outcome according to stricter crite-
tive conclusion could be made. ria; in the present study, an H-B grade of II or lower is be-
lieved to indicate favorable outcomes in the context of nor-
mal function in daily life.19,22 Fujiwara et al23 reported that the
facial grading score at 1 week after treatment was associated
Discussion with an unfavorable outcome of Bell palsy at 6 months. They
Several factors were evaluated, including age, sex, initial H-B examined clinical variables associated with long-term out-
grade, underlying disease, such as hypertension and diabe- comes in patients with idiopathic facial nerve paralysis, in-
tes, electrophysiological test findings, and treatment method. cluding the Yanagihara facial grading system. Mantsopoulos
Several previous studies have reported on factors associated et al18 reported that the most important factor in the long-
with better outcomes in patients with Bell palsy. Peitersen8 re- term outcome (2-6 years) after the idiopathic nerve paralysis
ported that patient age at the time of complete or incomplete was the initial severity of facial weakness. In our study, the re-
paralysis was associated with treatment outcome for Bell palsy. sults were consistent with those of previous reports; patients
Children younger than 14 years had a favorable outcome, and with Bell palsy had favorable outcomes when the initial H-B
older patients had the worst outcome. However, other stud- grade was IV or lower.
ies have found that age was not associated with treatment out- Generally, uncontrolled hypertension is associated with
come of Bell palsy. Takemoto et al17 reported little correlation facial palsy. The association between severe hypertension
between age and treatment outcome. Mantsopoulos et al18 also and peripheral facial palsy has been described primarily in
showed that age was not a significant prognostic factor for a children. Arterial hypertension is diagnosed after a substan-
favorable outcome in Bell palsy. The association between age tial delay. Adequate antihypertensive treatment is associated
and outcome of Bell palsy may seem to be controversial; age with a favorable outcome, and prognosis is good in patients
less than 40 years was associated with favorable outcomes in with hypertension controlled by medication.24 Hypertension
this study. may increase the risk of Bell palsy among patients aged older

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Evaluation of Factors Associated With Favorable Outcomes in Adults With Bell Palsy Original Investigation Research

diabetes is known to affect the facial nerve fibers, which could


Table 2. Multivariable Logistic Regression Analysis
for Favorable Outcome for Bell Palsya cause considerable delays in the blink reflex on both sides of
the face.32,33 This finding suggests that diabetes may have nega-
Variable OR (95% CI)
tive consequences on outcomes in patients’ peripheral facial
Gender
paralysis. The present study demonstrated that the OR for fa-
Male 1.04 (0.78-1.38)
vorable outcomes was higher in patients without diabetes than
Female 1 [Reference]
in those with diabetes. Moreover, we found that the absence
Age, y
of diabetes was statistically significantly associated with fa-
<40 1.56 (1.09-2.22)
vorable outcomes.
≥40 1 [Reference]
Electrophysiological tests, such as ENoG and EMG, were
Initial H-B grade
originally introduced by Esslen and Fisch.34,35 Both tests have
III-IV 2.62 (1.93-3.57)
been used to assess the severity of facial nerve injury and are
V-VI 1 [Reference]
electrophysiological measures that indirectly quantify the fa-
Electroneurography results
cial nerve function by recording the motor unit action poten-
≥10% (Good) 1.29 (0.73-2.28)
tials and/or compound muscle action potentials.36 By com-
<10% (Poor) 1 [Reference]
paring the peak-to-peak amplitude of the compound muscle
Electromyography resultsb
action potentials from the affected side with the response am-
Good 3.38 (2.48-4.61)
plitude from the nonaffected side, an estimate of the amount
Poor 1 [Reference]
of the degenerated nerve could be presented. Electroneurog-
Controlled hypertension
raphy is useful for investigating the risk of poor outcomes in
Yes 1.64 (1.16-2.33)
the early stages of acute facial palsy. In patients with Bell palsy,
No 1 [Reference]
ENoG combined with a conduction block and assessment of
Diabetes
axonal degeneration can be used to evaluate the degenerated
No 1.43 (1.04-2.36)
portion of the axons.35 It is considered the most valuable test
Yes 1 [Reference]
for investigating the risk of unfavorable outcomes in patients
Treatment method
with Bell palsy.17,18,37 Patients with more than 90% degenera-
Oral corticosteroids only 1.13 (0.82-1.54)
tion on the affected side within 14 days after onset of facial pa-
Combination antiviral therapy 1 [Reference]
ralysis are considered to have poor outcome.10 The treatment
Only supportive care 0.47 (0.17-1.26)
effects were assessed separately in patients with good (ENoG
Abbreviations: H-B, House-Brackmann; OR, odds ratio. results ≥10%) vs poor (ENoG results <10%) outcomes.38,39
a
Favorable outcome was defined as an H-B grade of II or lower. In the present study, the ENoG was performed at 4 to 5 days
b
Good electromyography results were defined as the absence of pathologic after symptom onset, and the needle EMG was performed
spontaneous fibrillation activity.
2 weeks later. Abnormal ENoG responses, such as wallerian
degeneration, usually occur within 72 hours after nerve
than 40 years.25 Controlled hypertension was a major factor injury; ENoG should never be performed before that time.
for favorable outcomes in patients with Bell palsy.26 It has Tojima et al37 found that ENoG results could reveal the extent
long been reported that hemorrhages into the facial canal are of wallerian degeneration 7 days after symptom onset in pa-
responsible for facial paralysis with severe hypertension.27,28 tients with Bell palsy. In the present study, ENoG was per-
Previous studies have shown that the incidence of Bell palsy formed at 4 to 5 days after the onset of facial paralysis. Tests
is higher in patients with uncontrolled hypertension owing performed this soon after onset did not yield clinically mean-
to poor compliance with medication. In 3 adult case studies ingful results.
with known chronic hypertension, facial palsy occurred dur- The results of EMG obtained 2 weeks after onset of Bell
ing the exacerbation of the hypertension owing to nonadher- palsy have been found to be a reliable factor associated with
ence of medication.29-31 Facial palsy immediately resolved the outcome. In studies showing the use of EMG in treating fa-
after better blood pressure control, suggesting an association cial nerve injuries,40,41 the detection of abnormal spontane-
between the controlled hypertension and resolution of facial ous activity on needle EMG is known to be a factor associated
palsy. Lee et al26 demonstrated that the initial severity of the with unfavorable outcomes. Abnormal spontaneous activity,
facial paralysis and controlled hypertension were factors including positive sharp waves and fibrillation potentials,
associated with favorable outcome. In the present study, are well accepted as signs of axonal degeneration.42 In the
appropriate control of blood pressure owing to adequate present study, the results of EMG performed 2 weeks after the
antihypertensive treatment was associated with a good out- onset of Bell palsy were considered important for assessing out-
come after the development of facial palsy. comes, and this finding is consistent with those of other
Diabetes has been reported to contribute to a poor out- studies.36,43
come in patients with Bell palsy. Takemoto et al17 found that To our knowledge, no definitive treatment guidelines
diabetes was significantly associated with unfavorable out- have been established for Bell palsy owing to the high spon-
come. Moreover, Peitersen8 showed that vascular insuffi- taneous recovery rate (up to 85.2%) and unknown cause.13
ciency and diabetic polyneuropathy were associated with The American Academy of Otolaryngology treatment guide-
poorer outcomes. Long-term hyperglycemia in patients with lines for Bell palsy suggest that treatment with oral cortico-

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Research Original Investigation Evaluation of Factors Associated With Favorable Outcomes in Adults With Bell Palsy

steroids within 72 hours of symptom onset is highly likely to with severe palsy (H-B grade ≥V) was 22.8%, suggesting that
be effective in patients with new-onset Bell palsy with or the different outcome might be attributed to the large propor-
without the use of concurrent antiviral therapy.2 Although tion of patients with mild to moderate Bell palsy. de Ru et al48
there is a consensus that early use of prednisolone is effec- also reported that a large number of patients with mild paraly-
tive, prescription of antiviral agents remains controversial. sis recovered spontaneously, and the positive treatment ef-
The treatment effect of prednisolone suggests that inflam- fect of the antiviral drugs may have been diluted. If the study
mation by neural edema of the facial nerve is part of the included only those patients with severe Bell palsy, the com-
pathogenesis in Bell palsy.44 bination of corticosteroid and antiviral agents might have been
The use of additional antiviral treatment is based on the different. Some studies suggested that the combination of cor-
hypothesis that a simple herpes virus infection could cause ticosteroid and antiviral agents is more effective than cortico-
inflammation of the facial nerve. Antiviral agents cannot steroids alone, particularly in patients with severe Bell palsy.
destroy viruses that have already replicated; these drugs Lee et al49 showed that combined treatment with a cortico-
inhibit viral replication by interfering with the viral DNA steroid and an antiviral agent (prednisolone plus famciclovir)
polymerase. Numerous studies that have compared gluco- resulted in better outcomes than those of corticosteroid treat-
corticoid treatment with placebo in patients with Bell palsy ment alone for treating severe Bell palsy (H-B grade ≥V). In the
have demonstrated considerable improvement in symptoms present study, multivariable logistic regression analyses re-
with the use of glucocorticoids. Sullivan and colleagues13 vealed that treatment with corticosteroids alone was associ-
performed a large, randomized, controlled, and double-blind ated with a slightly higher odds (1.13) of favorable outcome than
study with predefined and specified outcome measures and the combination antiviral therapy (1.13 [95% CI, 0.82-1.54] vs
a follow-up at 9 months. They noted that an antiviral agent 1.00 [reference]), and the upper bound of the CI (1.54) sug-
was not beneficial in improving outcomes of facial paralysis. gested that the true difference may be clinically meaningful.
Engström et al20 aimed to compare the efficacy of predniso- Because the lower bound of the CI was 0.82, combination an-
lone and valacyclovir for resolution of facial paralysis. They tiviral therapy could also be more beneficial than corticoste-
concluded that treatment with prednisolone alone reduced roids alone. Thus, these results indicate that a prospective, ran-
the time to resolution of symptoms, whereas valacyclovir domized, controlled, double-blind study with adequate sample
did not, indicating that prednisolone alone is sufficient to size to detect clinically meaningful differences between treat-
treat patients with Bell palsy. In contrast, Hato et al 45 ments should be conducted for patients with severe Bell palsy.
reported that combination antiviral therapy was more effec- The present study investigated the factors associated
tive in treating Bell palsy, excluding zoster sine herpete, than with favorable outcomes in patients with Bell palsy. Many
the conventional prednisolone therapy and described the studies evaluated the association between several factors
importance of an early treatment with valacyclovir and and outcomes of Bell palsy. Prior studies that included larger
prednisolone. This result is in accordance with those of a numbers of patients than those included in the present
previous study by Adour and colleagues46 who showed that analysis were meta-analyses. Therefore, intervariability
treatment with acyclovir-prednisone is superior to that with in the assessment process may be lower in our monocentric
prednisone alone in treating patients with Bell palsy. study. To our knowledge, few studies with more than 1300
In discussing the treatment effects of antiviral agents, sev- patients have been conducted on the outcomes of Bell palsy.
eral factors should be considered. In the study by Hato et al,45
the mean Yanagihara score was approximately 15, which cor- Strengths and Limitations
responds to H-B grades IV and V. The study also examined pa- A strength of our study was its presentation of factors, base-
tients with more severe facial paralysis compared with of the line characteristics, and outcomes for a large number of pa-
patients in the study by Sullivan et al,13 who had a mean H-B tients assessed for more than 10 years. This study also has some
grade of 3.6 of 6. The Yanagihara facial nerve grading system47 limitations. First, we performed the ENoG at 4 to 5 days after
was developed as a representative regional scale in Japan and symptom onset. The timing of the ENoG testing, one of the im-
was standardized to facial function classes in Japan and sev- portant factors associated with outcomes of Bell palsy, was not
eral other countries. The Yanagihara system measures 10 in- properly implemented. Second, we could not conduct a double-
dividual aspects of various facial functions. The score for each blind, placebo-controlled, randomized study to evaluate the
feature can be 0 (complete palsy), 2 (partial palsy), or 4 (al- effectiveness of the treatment method. Because of its retro-
most normal), with a maximum total score of 40. The total spective design, the analysis of the optimal method for treat-
score provides information on the degree of facial nerve dys- ing patients with Bell palsy was inferior to that of high-
function. The patients in the study by Sullivan et al13 seemed quality randomized clinical trials. Furthermore, although the
to have milder facial palsy than those in the study by Hato initial severity of Bell palsy was assessed by 3 otolaryngolo-
et al.45 The mean H-B grade for the patients in our study was gists, the evaluators were not blinded, which may have intro-
similar to the mean H-B grade in the study by Sullivan et al13 duced selection bias. Third, we used the H-B grading system
(3.59 vs 3.6) In addition, Engström et al20 reported that only to assess the severity of palsy, but, we did not evaluate synki-
30% of patients (245 of 829) had severe palsy (H-B grade ≥V), nesis, a risk factor for poor outcome and a major complica-
and the H-B grade in patients treated with prednisolone plus tions of Bell palsy. To overcome these limitations, further re-
placebo and prednisolone plus valacyclovir were 3.7 and 3.8, search is needed to validate our results on the effectiveness
respectively. In the present study, the proportion of patients of the treatments for idiopathic peripheral facial palsy.

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Evaluation of Factors Associated With Favorable Outcomes in Adults With Bell Palsy Original Investigation Research

palsy, including younger age, lower initial H-B grade, good


Conclusions EMG result, absence of diabetes, and control of hyperten-
sion. Therefore, the present study may help identify patients
The rate of favorable outcome (H-B grade ≤II) in patients likely to have favorable outcomes based on specific factors,
with Bell palsy was 80.6%. Multiple clinical factors were which may aid clinicians in selecting patients for therapeutic
associated with favorable outcomes in patients with Bell clinical trials.

ARTICLE INFORMATION and muscle. Ann Intern Med. 1996;124(1, pt 1):27-30. multivariate analysis followed by receiver operating
Accepted for Publication: November 29, 2019. doi:10.7326/0003-4819-124-1_Part_1-199601010- characteristic and Kaplan-Meier analyses. Otol
00005 Neurotol. 2011;32(6):1031-1036. doi:10.1097/MAO.
Published Online: January 23, 2020. 0b013e31822558de
doi:10.1001/jamaoto.2019.4312 4. Lagalla G, Logullo F, Di Bella P, Provinciali L,
Ceravolo MG. Influence of early high-dose steroid 18. Mantsopoulos K, Psillas G, Psychogios G,
Author Affiliations: Department of Physical treatment on Bell’s palsy evolution. Neurol Sci. Brase C, Iro H, Constantinidis J. Predicting the
Medicine & Rehabilitation, School of Medicine, 2002;23(3):107-112. doi:10.1007/s100720200035 long-term outcome after idiopathic facial nerve
Kyung Hee University, Seoul, Republic of Korea paralysis. Otol Neurotol. 2011;32(5):848-851.
(Yoo, Soh, Chon, Lee); School of Medicine, 5. Adour KK, Byl FM, Hilsinger RL Jr, Kahn ZM,
Sheldon MI. The true nature of Bell’s palsy: analysis doi:10.1097/MAO.0b013e31821da2c6
Department of Anatomy and Neurobiology, Kyung
Hee University, Seoul, Republic of Korea (Jung); of 1,000 consecutive patients. Laryngoscope. 1978; 19. Berg T, Marsk E, Engström M, Hultcrantz M,
Medical Research Center for Bioreaction to 88(5):787-801. doi:10.1002/lary.1978.88.5.787 Hadziosmanovic N, Jonsson L. The effect of study
Reactive Oxygen Species and Biomedical Science 6. Katusic SK, Beard CM, Wiederholt WC, design and analysis methods on recovery rates in
Institute, School of Medicine, Graduate School, Bergstralh EJ, Kurland LT. Incidence, clinical Bell’s palsy. Laryngoscope. 2009;119(10):2046-2050.
Kyung Hee University, Seoul, Republic of Korea features, and prognosis in Bell’s palsy, Rochester, doi:10.1002/lary.20626
(S. S. Kim); School of Medicine, Department of Minnesota, 1968-1982. Ann Neurol. 1986;20(5): 20. Engström M, Berg T, Stjernquist-Desatnik A,
Radiology, Kyung Hee University, Seoul, Republic of 622-627. doi:10.1002/ana.410200511 et al. Prednisolone and valaciclovir in Bell’s palsy:
Korea (You); School of Medicine, Department of 7. Teixeira LJ, Valbuza JS, Prado GF. Physical a randomised, double-blind, placebo-controlled,
Otorhinolaryngology–Head and Neck Surgery, therapy for Bell’s palsy (idiopathic facial paralysis). multicentre trial. Lancet Neurol. 2008;7(11):
Kyung Hee University, Seoul, Republic of Korea Cochrane Database Syst Rev. 2011;(12):CD006283. 993-1000. doi:10.1016/S1474-4422(08)70221-7
(Byun, S. H. Kim, Yeo). doi:10.1002/14651858.CD006283.pub3 21. Prakash KM, Raymond AA. The use of nerve
Author Contributions: Drs Yoo and Yeo had full 8. Peitersen E. Bell’s palsy: the spontaneous course conduction studies in determining the short-term
access to all of the data in the study and take of 2,500 peripheral facial nerve palsies of different outcome of Bell’s palsy. Med J Malaysia. 2003;58
responsibility for the integrity of the data and the etiologies. Acta Otolaryngol Suppl. 2002;(549):4-30. (1):69-78.
accuracy of the data analysis. doi:10.1080/000164802760370736 22. Yeo SW, Lee DH, Jun BC, Chang KH, Park YS.
Concept and design: Yoo, Soh, Chon, Lee, Jung, Analysis of prognostic factors in Bell’s palsy and
S. H. Kim, Yeo. 9. Morgenlander JC, Massey EW. Bell’s palsy.
Ensuring the best possible outcome. Postgrad Med. Ramsay Hunt syndrome. Auris Nasus Larynx. 2007;
Acquisition, analysis, or interpretation of data: Yoo, 34(2):159-164. doi:10.1016/j.anl.2006.09.005
Soh, S. S. Kim, You, Byun, Yeo. 1990;88(5):157-161, 164. doi:10.1080/00325481.
Drafting of the manuscript: Yoo, Soh, Chon, You, 1990.11716398 23. Fujiwara T, Hato N, Gyo K, Yanagihara N.
Yeo. 10. Lee DH. Clinical efficacy of electroneurography Prognostic factors of Bell’s palsy: prospective
Critical revision of the manuscript for important in acute facial paralysis. J Audiol Otol. 2016;20(1):8-12. patient collected observational study. Eur Arch
intellectual content: Yoo, Lee, Jung, S. S. Kim, Byun, doi:10.7874/jao.2016.20.1.8 Otorhinolaryngol. 2014;271(7):1891-1895. doi:10.1007/
S. H. Kim, Yeo. s00405-013-2676-9
11. Kudoh A, Ebina M, Kudo H, Matsuki A. Delayed
Statistical analysis: Yoo, Soh, Jung, You, Byun. recovery of patients with Bell’s palsy complicated 24. Jörg R, Milani GP, Simonetti GD, Bianchetti MG,
Obtained funding: Jung, S. S. Kim, Yeo. by non-insulin-dependent diabetes mellitus and Simonetti BG. Peripheral facial nerve palsy in severe
Administrative, technical, or material support: Yoo, hypertension. Eur Arch Otorhinolaryngol. 1998;255 systemic hypertension: a systematic review. Am J
Soh, Byun, S. H. Kim, Yeo. (3):166-167. doi:10.1007/s004050050036 Hypertens. 2013;26(3):351-356. doi:10.1093/ajh/
Supervision: Soh, Chon, Lee, S. S. Kim, S. H. Kim, hps045
Yeo. 12. Akcan FA, Dundar Y, Uluat A, Korkmaz H,
Ozdek A. Clinical prognostic factors in patients with 25. Savadi-Oskouei D, Abedi A, Sadeghi-Bazargani
Conflict of Interest Disclosures: None reported. idiopathic peripheral facial nerve paralysis (Bell’s H. Independent role of hypertension in Bell’s palsy:
Funding/Support: This work was supported by palsy). Eur Res J. 2017;3(2):170-174. doi:10.18621/ a case-control study. Eur Neurol. 2008;60(5):
grant KHU-20191237 from Kyung Hee University in eurj.293246 253-257. doi:10.1159/000151701
2019 (Dr Yeo). 13. Sullivan FM, Swan IR, Donnan PT, et al. Early 26. Lee HY, Byun JY, Park MS, Yeo SG. Effect of
Role of the Funder/Sponsor: The funder had no treatment with prednisolone or acyclovir in Bell’s aging on the prognosis of Bell’s palsy. Otol Neurotol.
role in the design and conduct of the study; palsy. N Engl J Med. 2007;357(16):1598-1607. 2013;34(4):766-770. doi:10.1097/MAO.
collection, management, analysis, and doi:10.1056/NEJMoa072006 0b013e3182829636
interpretation of the data; preparation, review, or 14. Monini S, Lazzarino AI, Iacolucci C, Buffoni A, 27. Moxon W. Apoplexy into canal of Fallopius in a
approval of the manuscript; and decision to submit Barbara M. Epidemiology of Bell’s palsy in an Italian case of Bright’s disease, causing facial paralysis.
the manuscript for publication. Health District: incidence and case-control study. Trans Pathol Soc London. 1869;20:420-422.
Acta Otorhinolaryngol Ital. 2010;30(4):198-204. 28. Matsumoto Y, Pulec JL, Patterson MJ,
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