Bells palsy- To Treat or Not to Treat

Bell’s Palsy:Bell’s Palsy:To Treat or Not to TreatTo Treat or Not to Treat

Road Map for the SessionRoad Map for the Session

• Historical Perspective and Introduction

• Risk Factors

• Study Proper

• Strengths and Limitations

• Review of evidence

• Risk Factors

• Study Proper

• Risk Factors

• Study Proper

• Risk Factors

• Study Proper

Early Treatment with Early Treatment with Prednisolone or Acyclovir in Prednisolone or Acyclovir in

Bell’s PalsyBell’s Palsy

Early Treatment with Early Treatment with Prednisolone or Acyclovir in Prednisolone or Acyclovir in

NEJM 2008;357;1598-607NEJM 2008;357;1598-607

Historical PerspectivesHistorical Perspectives

• Sir Charles Bell (1774-1842)– Studied facial anatomy

extensively during Battle of Waterloo

– Concluded that facial nerve controlled facial expression

– “Respiratory nerve of the Face”

• Sir Charles Bell (1774-1842)– Studied facial anatomy

extensively during Battle of Waterloo

– Concluded that facial nerve controlled facial expression

– “Respiratory nerve of the Face”

Anatomy of Facial CanalAnatomy of Facial Canal

Coker NJ. Atlas of Otologic Surgery p.339

0.68 mm

Labyrinthine1.02 mm

Tympanic1.53 mm

Mastoid1.48 mm

• Idiopathic facial paralysis• Diagnosis of Exclusion• Most common diagnosis

(> 60%) for acute facial palsy• 30 per 100,000• Generally unilateral• Rapid onset < 48 hours

• Idiopathic facial paralysis• Diagnosis of Exclusion• Most common diagnosis

(> 60%) for acute facial palsy• 30 per 100,000• Generally unilateral• Rapid onset < 48 hours

Complete RecoveryComplete Recovery

Peitersen E. Acta Otolaryngol 2002;549:4–30.

Favorable prognosis for full recovery

• Incomplete palsy• Early recovery• Young patients• Normal taste, stapedial reflex, lacrimation• Lack of post-auricular pain

Peitersen E. Acta Otolaryngol 2002;549:4–30.

• Risk Factors

• Study Proper

• Risk Factors

• Study Proper

Postulated mechanism of Bell’s Palsy

• Viral inflammatory/ immune mechanism– HSV (based on serological evidence)– HZV– Other: CMV, EBV, adenovirus, rubella virus, mumps, influenza B, and coxsackievirus

• Alternate postulated mechanisms– Ischemia of the facial nerve– Hereditary predisposition

• Viral inflammatory/ immune mechanism– HSV (based on serological evidence)– HZV– Other: CMV, EBV, adenovirus, rubella virus, mumps, influenza B, and coxsackievirus

• Alternate postulated mechanisms– Ischemia of the facial nerve– Hereditary predisposition

Diabetes MellitusDiabetes Mellitus

• Bell’s patients with DM – 14 % (Korczyn AD ’71)

– 21 % (Alford BR ’71)

– 38 % (Yasuda K ’75)

• 66% demonstrate glucose intolerance

• Functional recovery poorer in diabetics

• Bell’s patients with DM – 14 % (Korczyn AD ’71)

– 21 % (Alford BR ’71)

– 38 % (Yasuda K ’75)

• 66% demonstrate glucose intolerance

• Functional recovery poorer in diabetics

PregnancyPregnancy

• Incidence of Bell’s palsy 3-4 x higher(Hilsinger, Cohen et al.)

• Third trimester with highest risk• Higher risk of complete palsy• Lower chance of complete recovery

(Gillman et al.)

• Preeclampsia 6 x prevalence in pregnant women with facial palsy

• Incidence of Bell’s palsy 3-4 x higher(Hilsinger, Cohen et al.)

• Third trimester with highest risk• Higher risk of complete palsy• Lower chance of complete recovery

(Gillman et al.)

• Preeclampsia 6 x prevalence in pregnant women with facial palsy

Role of HSV-1Role of HSV-1

Murakami: Ann Intern Med, Volume 124(1).January 1, 1996.27-30

Management of Bell’s PalsyManagement of Bell’s Palsy

• Observation• Medical Treatment

– Steroid– Anti-viral agents

• Surgery– Decompression– Dynamic vs. static reanimation

• Facial Rehabilitation

• Observation• Medical Treatment

– Steroid– Anti-viral agents

• Surgery– Decompression– Dynamic vs. static reanimation

• Facial Rehabilitation

• Risk Factors

• Study Proper

• Risk Factors

• Study Proper

HypothesisHypothesis

• To determine whether Prednisolone or Acyclovir used early in the course of Bell’s Palsy improves the chances of recovery

Selection of SubjectsSelection of Subjects

• > 16 YO age

• Males and Females

• Presenting with unilateral facial nerve weakness of no identifiable cause who could be referred to collaborating ENT within 72 hours from the onset of symptoms

• 17 hospitals throughout Scotland serving 88% of total population

• > 16 YO age

• Males and Females

• Presenting with unilateral facial nerve weakness of no identifiable cause who could be referred to collaborating ENT within 72 hours from the onset of symptoms

• 17 hospitals throughout Scotland serving 88% of total population

Exclusion CriteriaExclusion Criteria

• Pregnancy• Breast-feeding• Uncontrolled diabetes (Hgb A1C > 8%)• Peptic Ulcer Disease• Suppurative otitis media• Herpes zoster• Multiple Sclerosis• Systemic infection• Sarcoidosis and other rare conditions• Inability to provide informed consent

Study DesignStudy Design

• Double-blind, placebo-controlled, randomized, 2 x 2 factorial trial

• Conducted from 6/2004 ~ 6/2006, f/u till 3/2007 for 9 month assessments

• Patients were recruited through their family doctors, emergency departments, the national 24-hour medical telephone consultancy service, and dentists’ office

• Referrals mainly from primary care to 17 hospitals serving 88% of total population in mainland Scotland

• Collaborating senior ENT confirmed eligibility

• Double-blind, placebo-controlled, randomized, 2 x 2 factorial trial

• Conducted from 6/2004 ~ 6/2006, f/u till 3/2007 for 9 month assessments

• Patients were recruited through their family doctors, emergency departments, the national 24-hour medical telephone consultancy service, and dentists’ office

• Referrals mainly from primary care to 17 hospitals serving 88% of total population in mainland Scotland

• Collaborating senior ENT confirmed eligibility

• Patient was randomly assigned to a study group by an independent, secure, automated telephone-randomization service

• Patients underwent randomization twice which resulted in 4 study groups

– Prednisolone + Placebo– Acyclovir + Placebo– Prednisolone + Acyclovir– Placebo + Placebo

*Prednisolone (25mg PO BID)

*Acyclovir (400mg PO 5X/Day)

*Placebo (Lactose pill)• Each patient received 2 bottles of odorless capsules with an

identical appearance prepared by Tayside pharmaceuticals

• Patient was randomly assigned to a study group by an independent, secure, automated telephone-randomization service

• Patients underwent randomization twice which resulted in 4 study groups

– Prednisolone + Placebo– Acyclovir + Placebo– Prednisolone + Acyclovir– Placebo + Placebo

*Prednisolone (25mg PO BID)

*Acyclovir (400mg PO 5X/Day)

*Placebo (Lactose pill)• Each patient received 2 bottles of odorless capsules with an

identical appearance prepared by Tayside pharmaceuticals

Enrollment & OutcomesEnrollment & Outcomes

551 randomized

Acyclovir(N=272)

Placebo(N=279)

Prednisolone(N=138)

Placebo(N=141)

Prednisolone(N=134)

Placebo(N=138)

Placebo + Prednisolone127 completed Tx

Placebo + Placebo122 completed Tx

Acyclovir + Placebo123 completed Tx

Acyclovir + Prednisolone124 completed Tx

• Patients were instructed to take the first dose of the study drug before leaving the hospital and the remaining doses at home during the next 10 days

• Within 3 to 5 days after randomization, a researcher visited patients to complete a baseline assessment

• Repeat visits to assess recovery occurred at 3 months• If recovery was incomplete (> grade 2 on House-Brackmann

scale), the visit was repeated at 9 months• Compliance with the drug regimen was reviewed at the first visit

and via telephone calls on day 7 after randomization and within a week after the last scheduled dose (day 10)

• Patients were instructed to take the first dose of the study drug before leaving the hospital and the remaining doses at home during the next 10 days

• Within 3 to 5 days after randomization, a researcher visited patients to complete a baseline assessment

• Repeat visits to assess recovery occurred at 3 months• If recovery was incomplete (> grade 2 on House-Brackmann

scale), the visit was repeated at 9 months• Compliance with the drug regimen was reviewed at the first visit

and via telephone calls on day 7 after randomization and within a week after the last scheduled dose (day 10)

Outcome MeasurementsOutcome Measurements

• Primary outcome measure– House-Brackmann grading system for facial nerve function– Assigns to one of six categories with grade 1 indicating normal

function– Assessed by documenting the facial appearance of patients in

digital photographic images in four facial expressions:• At rest• Raised eyebrows• Eyes tightly closed• Forced smile

– Graded by panel of 3 experts (ENT, Neurologist, Plastic surgeon), discrepancies were reassessed

• Primary outcome measure– House-Brackmann grading system for facial nerve function– Assigns to one of six categories with grade 1 indicating normal

function– Assessed by documenting the facial appearance of patients in

digital photographic images in four facial expressions:• At rest• Raised eyebrows• Eyes tightly closed• Forced smile

– Graded by panel of 3 experts (ENT, Neurologist, Plastic surgeon), discrepancies were reassessed

House-Brackmann Grading System

Grade Gross characteristics Motion characteristics

I. Normal Normal in all areas Normal in all areas

II. Mild dysfunction Slight weakness noticeable on close inspectionMay have slight synkinesisNormal symmetry and tone at rest

Forehead: moderate to good functionEye: complete closure with minimal effortMouth: slight asymmetry

III. Moderate dysfunction Obvious but not disfiguring difference between the two sidesNoticeable but not severe synkinesis, contracture, or hemifacial spasmNormal symmetry and tone at rest

Forehead: slight to moderate movementEye: complete closure with effortMouth: slight weak with maximum effort

IV. Mod severe dysfunction Obvious weakness and/or disfiguring asymmetryNormal symmetry and tone at rest

Forehead: noneEye: incomplete closureMouth: asymmetry at rest

V. Severe dysfunction Only barely perceptible motionAsymmetry at rest

Forehead: noneEye: incomplete closureMouth: slight movement

VI. Total paralysis No movement No movement

Outcome MeasurementsOutcome Measurements

• Secondary outcomes– Health Utilities Index Mark 3

• System for classifying health-related quality of life status in 8 dimensions: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain

• Responses converted into single score ranging from -0.36 to 1.00 with 1 indicating full health

– Derriford Appearance Scale 59 • 59 questions covering aspects of self-consciousness

and confidence• Scores range from 8 to 262 with higher scores indicating

a greater severity of distress/ dysfunction– Brief Pain Inventory

• Measures both the severity of pain and the extent to which pain interferes with normal activities

• Scores range from 0 to 110 with higher scores indicating greater severity

• Secondary outcomes– Health Utilities Index Mark 3

• System for classifying health-related quality of life status in 8 dimensions: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain

• Responses converted into single score ranging from -0.36 to 1.00 with 1 indicating full health

– Derriford Appearance Scale 59 • 59 questions covering aspects of self-consciousness

and confidence• Scores range from 8 to 262 with higher scores indicating

a greater severity of distress/ dysfunction– Brief Pain Inventory

• Measures both the severity of pain and the extent to which pain interferes with normal activities

• Scores range from 0 to 110 with higher scores indicating greater severity

Statistical AnalysisStatistical Analysis

• Compared primary outcome measure of complete recovery (grade 1 on House-Brackmann scale) at 3 months and 9 months using a two-sided Fisher’s exact test for:

– Prednisolone vs. no prednisolone

– Acyclovir vs. no acyclovir

– Prednisolone vs. Placebo

– Acyclovir vs. Placebo

– Prednisolone + Acyclovir vs. Placebo

• Prespecified secondary analyses compared scores with the use of t-tests (or Mann-Whitney tests in cases in which the data was not normally distributed)

• Compared primary outcome measure of complete recovery (grade 1 on House-Brackmann scale) at 3 months and 9 months using a two-sided Fisher’s exact test for:

– Prednisolone vs. no prednisolone

– Acyclovir vs. no acyclovir

– Prednisolone vs. Placebo

– Acyclovir vs. Placebo

– Prednisolone + Acyclovir vs. Placebo

• Prespecified secondary analyses compared scores with the use of t-tests (or Mann-Whitney tests in cases in which the data was not normally distributed)

Characteristic Prednisolone (N=251)

No Prednisolone (N=245)

Acyclovir (N=247)

No Acyclovir (N=249)

Total (N=496)

Sex – no. (%) Male Female

135 (53.8)

116 (46.2)

118 (48.2)

127 (51.8)

119 (48.2)

128 (51.8)

134 (53.8)

115 (46.2)

253 (51.0)

243 (49.0)

Age - year 43.2±16.2 44.9±16.6 45.0±16.6 43.0±16.1 44.0±16.4

House-Brackmann Scale 3.5±1.2 3.8±1.3 3.6±1.3 3.7±1.2 3.6±1.3

Health Utilities Index Mark 3Derriford Appearance Scale 59Brief Pain Inventory

0.80±0.22

71±37

10±18

0.78±0.21

75±41

16±21

0.79±0.21

72±39 12±18

0.78±0.22

74±38

14±21

0.79±0.22

73±39

13±20

Time between onset of Sx and Tx – no. (%) Within 24 hours >24 to ≤48 hours >48 to ≤72 hours Unknown (but ≤72 hours)

120 (47.8)

95 (37.8)

25 (10.0)

11 (4.4)

147 (60.0)

64 (26.1)

18 (7.3)

16 (6.5)

137 (55.5)

75 (30.4)

25 (10.1)

10 (4.0)

130 (52.2)

84 (33.7)

18 (7.2)

17 (6.8)

267 (53.8)

159 (32.1)

43 (8.7)

27 (5.4)

Study PopulationBaseline Characteristics of the Patients

Adjusted Outcome DataPrimary and Secondary Outcomes at 3 Months

and 9 Months

Adjusted Outcome DataPrimary and Secondary Outcomes at 3 Months

and 9 MonthsVariable Prednisolone

(N=251)No Prednisolone (N=245)

Adjusted Odds Ratio (95% CI)

P Value Acyclovir (N=247)

No Acyclovir (N=249)

Adjusted Odds Ratio (95% CI)

P Value

Primary Outcome Measure1 No./Total No. (%) No./Total No. (%)

Grade 1 on House-Brackmann Scale At 3 Months At 9 Months

205/247 (83.0)

237/251 (94.4)

152/239 (63.6)

200/245 (81.6)

2.44 (1.55–3.84)

3.32 (1.72–6.44)

<0.001

173/243 (71.2)

211/247 (85.4)

184/243 (75.7)

226/249 (90.8)

0.86 (0.55–1.34)

0.61 (0.33–1.11)

Seconday outcome Measures2 Unadjusted Mean Adjusted Beta Unadjusted Mean Adjusted Beta

Health Utilities Index Mark 3 At 3 Months At 9 Months

0.91±0.17

0.84±0.26

0.91±0.13 0.88±0.16

−0.01±0.01

−0.06±0.03

0.90±0.16

0.86±0.21

0.92±0.14

0.88±0.19

−0.01±0.01

−0.02±0.03

Derriford Appearance Scale 59 At 3 Months At 9 Months

42.4±32.3

40.0±36.1

43.2±33.4

49.9±35.5

1.72±2.88

−2.40±5.71

44.2±35.0

49.4±35.2

41.4±30.4

43.2±36.6

3.08±2.85

8.53±5.36

Brief Pain Inventory At 3 Months At 9 Months

1.51±6.41

1.36±5.29

2.04±8.14

1.83±6.37

−0.12±0.67

−0.08±1.02

1.83±7.00

1.61±5.87

1.72±7.62

1.72±6.19

0.13±0.66

0.05±0.96

1. For the primary outcome measure, odds ratios and P values have been adjusted for age, sex, the baseline score on the House-Brackmann scale, the receipt or nonreceipt of acyclovir and prenisolone, and the interval between the onset of symptoms and the initiation of a study drug

2. For the secondary outcome measures, odds ratios and P values have been adjusted for baseline measurement of age, sex, score on the House-Brackmann scale, the receipt or nonreceipt of acyclovir and prenisolone, and the time from the onset of symptoms to the initiation of treatment.**Beta regression coefficients were calculated by adjusted multiple regression analysis.

1. For the primary outcome measure, odds ratios and P values have been adjusted for age, sex, the baseline score on the House-Brackmann scale, the receipt or nonreceipt of acyclovir and prenisolone, and the interval between the onset of symptoms and the initiation of a study drug

2. For the secondary outcome measures, odds ratios and P values have been adjusted for baseline measurement of age, sex, score on the House-Brackmann scale, the receipt or nonreceipt of acyclovir and prenisolone, and the time from the onset of symptoms to the initiation of treatment.**Beta regression coefficients were calculated by adjusted multiple regression analysis.

Summary of Table 2Summary of Table 2

• Statistically significant recovery rate between Prednisolone comparison groups at 3 months

• At 9 months, the rates of complete recovery were 94.4% for patients who received Prednisolone and 81.6% for those who did not, a difference of 12.8% points (95% CI, 7.2 to 18.4; P<0.001)

• No significant difference in complete recovery rates between the Acyclovir comparison groups

• For patients receiving double Placebo, 64.7% were fully recovered after 3 months, and 85.2% after 9 months

• Generally there were no significant differences among the groups in secondary outcome measures, including patients who received Prednisolone

• Statistically significant recovery rate between Prednisolone comparison groups at 3 months

• At 9 months, the rates of complete recovery were 94.4% for patients who received Prednisolone and 81.6% for those who did not, a difference of 12.8% points (95% CI, 7.2 to 18.4; P<0.001)

• No significant difference in complete recovery rates between the Acyclovir comparison groups

• For patients receiving double Placebo, 64.7% were fully recovered after 3 months, and 85.2% after 9 months

• Generally there were no significant differences among the groups in secondary outcome measures, including patients who received Prednisolone

Proportion of normal facial function

at baseline, at 3 months, and at 9 months

Proportion of normal facial function

at baseline, at 3 months, and at 9 months

• Full recovery was defined as grade 1 on the House-Brackmann facial nerve grading scale, which ranges from 1 to 6, with higher grades indicating worse facial paralysis.

Figure 2.NEJM 2008;357;1605

Adjusted Outcome DataComplete Recovery at 3 Months and 9

Months

Adjusted Outcome DataComplete Recovery at 3 Months and 9

Months

• Significance testing for comparisons at 3 and 9 months had the following results: – combination therapy versus prednisolone only, P = 0.18 (3 months) and P = 0.28 (9

months)– combination therapy versus acyclovir only, P = 0.004 (3 months) and P = 0.001 (9 months)– acyclovir only versus double placebo, P = 0.79 (3 months) and P = 0.19 (9 months) – prednisolone only versus double placebo, P<0.001 (3 months) and P = 0.004 (9 months)

** P values are for the comparison with double placebo

• Conclusion: Prednisolone was highly effective, both separately and in combination with Acyclovir. Acyclovir was ineffective, both separately and as an addition to Prednisolone.

• Significance testing for comparisons at 3 and 9 months had the following results: – combination therapy versus prednisolone only, P = 0.18 (3 months) and P = 0.28 (9

months)– combination therapy versus acyclovir only, P = 0.004 (3 months) and P = 0.001 (9 months)– acyclovir only versus double placebo, P = 0.79 (3 months) and P = 0.19 (9 months) – prednisolone only versus double placebo, P<0.001 (3 months) and P = 0.004 (9 months)

** P values are for the comparison with double placebo

• Conclusion: Prednisolone was highly effective, both separately and in combination with Acyclovir. Acyclovir was ineffective, both separately and as an addition to Prednisolone.

Table 3.NEJM 2008;357;1604

Variable (+) Prednisolone () Prednisolone

Odds Ratio (95% CI) P Value Odds Ratio (95% CI) P Value

At 3 Months(+) Acyclovir() Acyclovir

1.73 (0.96–3.12)

2.58 (1.37–4.88)

0.85 (0.49–1.47)

At 9 Months(+) Acyclovir() Acyclovir

1.76 (0.74–4.16)

3.23 (1.13–9.22)

0.58 (0.29–1.16)

DiscussionDiscussion

• For patients receiving double Placebo, 64.7% of patients fully recovered at 3 months and 85.2% at 9 months, which shows a generally favorable outcome without treatment

• Early treatment (within 72 hours from onset of symptoms) with Prednisolone increased the rate of complete recovery to 83.0% at 3 months and 94.4% at 9 months

• Acyclovir produced no benefit over Placebo and there was no benefit in its addition to Prednisolone

• No benefits observed with respect to secondary outcome measures in any study group

• For patients receiving double Placebo, 64.7% of patients fully recovered at 3 months and 85.2% at 9 months, which shows a generally favorable outcome without treatment

• Early treatment (within 72 hours from onset of symptoms) with Prednisolone increased the rate of complete recovery to 83.0% at 3 months and 94.4% at 9 months

• Acyclovir produced no benefit over Placebo and there was no benefit in its addition to Prednisolone

• No benefits observed with respect to secondary outcome measures in any study group

DiscussionDiscussion

• A total of 426 patients (86%) returned pill containers. Of these patients,

– 383 (90%) returned empty containers, indicating complete compliance

– 32 (8%) returned doses for 5 days or less– 11 (3%) patients returned doses for 6 days or more

• Dizziness was the most reported adverse reaction in all four study groups

• A total of 426 patients (86%) returned pill containers. Of these patients,

– 383 (90%) returned empty containers, indicating complete compliance

– 32 (8%) returned doses for 5 days or less– 11 (3%) patients returned doses for 6 days or more

• Dizziness was the most reported adverse reaction in all four study groups

• Risk Factors

• Study Proper

• Risk Factors

• Study Proper

StrengthsStrengths

• Most patients recruited from primary care practices, thus reducing selection bias in hospital-based studies

• High rate of acceptance of randomization and low dropout rate during the study

• Since the study design was factorial, the power was the same for each pairwise comparison of treatment

• Drugs used in this study are relatively inexpensive and readily available

• Most patients recruited from primary care practices, thus reducing selection bias in hospital-based studies

• High rate of acceptance of randomization and low dropout rate during the study

• Since the study design was factorial, the power was the same for each pairwise comparison of treatment

• Drugs used in this study are relatively inexpensive and readily available

LimitationsLimitations

• Application in some populations with prevalent genetic polymorphisms?

• Could other environmental factors such as diet alter the response?• House-Brackmann scale has been criticized for insufficient sensitivity

to change and difficulty in assigning grades in patients with contrasting degrees of function in different parts of the face

• Previous h/o Bell’s Palsy (recurrence)?• Drug compliance with Acyclovir?• Age of study population?• Outbreak of HSV or any signs of other viral infection prior to Bell’s

Palsy?• Any underlying diseases/ illnesses and possible drug interactions?

• Application in some populations with prevalent genetic polymorphisms?

• Could other environmental factors such as diet alter the response?• House-Brackmann scale has been criticized for insufficient sensitivity

to change and difficulty in assigning grades in patients with contrasting degrees of function in different parts of the face

• Previous h/o Bell’s Palsy (recurrence)?• Drug compliance with Acyclovir?• Age of study population?• Outbreak of HSV or any signs of other viral infection prior to Bell’s

Palsy?• Any underlying diseases/ illnesses and possible drug interactions?

• Risk Factors

• Study Proper

• Risk Factors

• Study Proper

Cochrane review on Efficacy of steroids

• 4 trials of 179 patients• Trial 1: Cortisone vs. placebo• Trial 2: Prednisone + vitamins vs. vitamins• Trial 3: High dose prednisone vs. saline• Trial 4: Methylprednisolone• Primary endpoint: VII recovery @ 6 mos• Conclusions: NO significant benefit for giving steroids to Bell’s palsy patients• Drawbacks: Individual studies underpowered. Steroid regimens differ.

Efficacy of Steroid treatmentEfficacy of Steroid treatment

• Prospective RCT• 56 patients• Arm I: Steroids• Arm II: Placebo• Success = HB I or II• F/u @ 3 and 6 weeks• No significant difference in response in the

2 groups

• Prospective RCT• 56 patients• Arm I: Steroids• Arm II: Placebo• Success = HB I or II• F/u @ 3 and 6 weeks• No significant difference in response in the

2 groups

Turk-Boru U et al. Kulak Burun Bogaz Ihtis Derg. 2005;14(3-4):62-6.

Steroids in Complete paralysisSteroids in Complete paralysis

• Meta-analysis of 3 prospective trials – 230 patients with HB VI

• Treatment within 7 days of onset• Total prednisone dose > 400 mg

(405-425 mg)• Complete Recovery: HB VI I

– Steroid group has 17% higher rate of CR than control (placebo/ no treatment)

• Meta-analysis of 3 prospective trials – 230 patients with HB VI

• Treatment within 7 days of onset• Total prednisone dose > 400 mg

(405-425 mg)• Complete Recovery: HB VI I

– Steroid group has 17% higher rate of CR than control (placebo/ no treatment)

Ramsey MJ et al. Laryngoscope 2000; 110: 335-341

Steroid vs. Steroid + AcyclovirSteroid vs. Steroid + Acyclovir• Double-blind RCT • 99 Bell’s palsy patients

– 53 treated with acyclovir- prednisone– 46 with placebo – prednisone– Prednisone dose 400 mg five times daily x 10 days

• Combined therapy is better in terms of:– Return of muscle motion– Prevention of partial nerve degeneration

• Double-blind RCT • 99 Bell’s palsy patients

– 53 treated with acyclovir- prednisone– 46 with placebo – prednisone– Prednisone dose 400 mg five times daily x 10 days

• Combined therapy is better in terms of:– Return of muscle motion– Prevention of partial nerve degeneration

Adour KK 1996 Ann Otol Rhinol Laryngol. 1996 May;105(5):371-8

• Prospective RCT of 150 patients

• Prednisolone (20 tid x 5d, 10 tid x 3 d, 10 qD x 2 d)

• Predisolone + Valacyclovir (500 bid x 5 d)

• No significant difference in recovery

• Prospective RCT of 150 patients

• Prednisolone (20 tid x 5d, 10 tid x 3 d, 10 qD x 2 d)

• Predisolone + Valacyclovir (500 bid x 5 d)

• No significant difference in recovery

Steroid vs. Steroid + AcyclovirSteroid vs. Steroid + Acyclovir

Kawaguchi: Laryngoscope, Volume 117(1).January 2007.147-156

Prednisolone

Prednisolone +Valacyclovir

History of Surgical DecompressionHistory of Surgical Decompression

Adour KK. 2002 Jan;259(1):40-7

Controversy over Surgical Decompression

• In favor of:– Gantz BJ ’99– Sillman JS ’92– Huges GB ’88– Goin DW ’82– Fisch U ’81– Brackmann DE ’80– Giancarlo HR ’70

• Against:– Adour KK ’01

– Aoyagi M ’88

– May M ’84

– Gacek RR ’81

– McNeill R ’94

– Adour KK ’91

– Mechelse K ’98

• Against:– Adour KK ’01

– Aoyagi M ’88

– May M ’84

– Gacek RR ’81

– McNeill R ’94

– Adour KK ’91

– Mechelse K ’98

Applications to Clinical PracticeApplications to Clinical Practice

• No data are available regarding how best to treat patients who present more than 72 hours from the onset of symptoms, so all patients with suspected Bell’s Palsy should be assessed as early as possible

• Withholding treatment will remain an appropriate strategy for some patients as most patients recover fully without any treatment

• No data are available regarding how best to treat patients who present more than 72 hours from the onset of symptoms, so all patients with suspected Bell’s Palsy should be assessed as early as possible

• Withholding treatment will remain an appropriate strategy for some patients as most patients recover fully without any treatment

Future StudiesFuture Studies

• Use of Valcyclovir 1g PO TID x 7 days since higher absorption and serum levels are possible than Acyclovir

• Exclusion of recurrent Bell’s Palsy • Study in populations with prevalent

genetic polymorphisms

• Use of Valcyclovir 1g PO TID x 7 days since higher absorption and serum levels are possible than Acyclovir

• Exclusion of recurrent Bell’s Palsy • Study in populations with prevalent

genetic polymorphisms

ANY QUESTIONS???ANY QUESTIONS???

Bells palsy- To Treat or Not to Treat

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