Web Appendix 2. Details of included studies Data Extraction form Fujiwara 2018 Study Design Retrospective cohort study Study Period 2009-2016
Participants Location: Japan, single center
Setting of recruitment and treatment: Kurashiki Central Hospital Number of patients:
High-dose: 281
Standard-dose: 87
Participant (Baseline) characteristics:
Mean Age: 56.7
Gender (male/female): 182/186
Mean time from onset to treatment (day): 3.49
Severity of facial palsy:
House-Brackmann grade III-IV (n = 158) House-Brackmann grade V-VI (n = 210)
Inclusion criteria: Bell’s palsy patients aged 18 years or older who were prescribed corticosteroid within 1 week after disease onset
Initial severity of facial grading system is House-Brackmann III- VI
Exclusion criteria: Patients who were prescribed a step-up dose of corticosteroid (e.g., initially prescribed 1.0 mg/kg/day prednisolone and later prescribed 2.0 mg/kg/day prednisolone after a few days because of worsening facial palsy). Patient who had slight facial palsy (Grade 1-2 on House-Brackmann facial grading system); who had sequelae such as facial spasms, synkinesis, or contracture before disease onset
Duration of follow up: 6 month Lost to follow: 39
Interventions Intervention: 120 mg/day prednisolone equivalent for 3 days with a 6-day taper Comparator group: 60 mg/day prednisolone equivalent for 3 days with a 6-day taper Use of antivirals: some cases were used, not standardized
Outcomes Outcomes of interest in the review:
Primary Outcomes:
Non-recovery at 6 month (Yanagihara facial nerve grading system score < 36 or sequelae)
Secondary Outcomes:
Non-recovery at 126 month
Adverse effects: New prescriptions to counter adverse effects (proton pump inhibitord, histamine H2-recepter, sleeping pills, laxatives or softenres or medications for hiccups)
Other outcomes reported by the study:
None Funding sources Not funded
Comments This study estimated the effectiveness of high-dose corticosteroids using propensity score
Data Extraction form Furukawa 2017 Study Design Retrospective cohort study Study Period 1995-2014
Participants Location: Japan, single center
Setting of recruitment and treatment: Yamagata University Hospital Number of patients:
High-dose: 355
Standard-dose: 320
Participant (Baseline) characteristics:
Mean Age: 54.1
Gender (male/female): 298/377
Mean time from onset to treatment (day): 2.49
Severity of facial palsy:
House-Brackmann grade V (n = 140) House-Brackmann grade VI (n = 535)
Inclusion criteria: Severe (House-Brackmann grade V-VI) Bell’s palsy patients aged 15 years or older who were prescribed corticosteroid within 7 days after disease onset Initial severity of facial grading system is House-Brackmann V or VI
Exclusion criteria: Patients who had undergone decompression surgery were excluded (n 6).
Duration of follow up: 6 month Lost to follow: Uncertain
Interventions Intervention: 200 mg prednisolone equivalent for 2 days with a 8-day taper (total 895 mg prednisolone), combined with hespander and mannitol
Comparator group: 60 mg prednisolone equivalent for 5 days with a 5-day taper (total 410 mg prednisolone)
Use of antivirals: used in some cases Outcomes Outcomes of interest in the review:
Primary Outcomes:
Non-recovery at 6 month (House-Brackmann II-VI) Secondary Outcomes:
Non-recovery at 12 month
Adverse effects:
Other outcomes reported by the study:
None
Funding sources No information provided
Comments This study conducted logistic analysis to identify poor prognosis factor and revealed the association between corticosteroid dose and prognosis.
Non-recovery rate in patients with House-Brackmann VI was extracted using figure.
Data Extraction form Inamura 1992
Study Design Retrospective cohort study Study Period 1987-1990
Participants Location: Japan, single center
Setting of recruitment and treatment: Yamagata University Hospital Number of patients:
High-dose: 157
Standard-dose: 53
Participant (Baseline) characteristics:
Mean Age: 51.3
Gender (male/female): 111/97
Mean time from onset to treatment (day): not provided (≤ 7)
Severity of facial palsy:
Yanagihara score 0-20
Inclusion criteria: Bell’s palsy patients aged 15 years or older who were treated within 7 days after disease onset
Initial severity of facial grading system is Yanagihara score 20 or less
Exclusion criteria: Patients who had severe diabetes mellitus, severe renal failure, liver dysfunction, gastric ulcer, child, and old person were not treated with high-dose regimens.
Duration of follow up: 6 month Lost to follow: none
Interventions Intervention: 200 mg prednisolone equivalent for 2 days with a 8-day taper (total 1015 mg prednisolone), combined with hydroxyethylstarch and mannitol
Comparator group: 60 mg prednisolone equivalent initially and taper (total 220 mg prednisolone)
Use of antivirals: Not used
Outcomes Outcomes of interest in the review:
Primary Outcomes:
Non-recovery at 6 month (Yanagihara facial nerve grading system score < 36 or sequelae)
Secondary Outcomes:
Non-recovery at 12 month
Adverse effects:
Other outcomes reported by the study:
None
Funding sources No information provided
Comments This study used historically controlled design (high-dose group was treated between 1987 and 1990 and standard-dose between 1983 and 1987).
Data Extraction form Saito 2016
Study Design Retrospective cohort study Study Period 2008-2013
Participants Location: Japan, single center
Setting of recruitment and treatment: Kohsei Chuo General Hospital Number of patients:
High-dose: 11
Standard-dose: 14
Participant (Baseline) characteristics:
This study analysed patients prognosis using several factor (severity,
Mean Age: 48
Gender (male/female): 50/27
Mean time from onset to treatment (day): not provided
Severity of facial palsy:
Yanagihara score 0-8
Inclusion criteria: Bell’s palsy patients aged 15 years or older who were treated within 7 days after disease onset
Duration of follow up: Uncertain Lost to follow: Uncertain
Interventions Intervention: 200 mg prednisolone equivalent for 2 days with a 8-day tape Comparator group: 60 mg prednisolone equivalent initially and taper Use of antivirals: used in all cases
Outcomes Outcomes of interest in the review:
Primary Outcomes:
Non-recovery at 6 month (Yanagihara facial nerve grading system score < 36 or sequelae)
Secondary Outcomes:
Non-recovery at 12 month
Adverse effects:
Other outcomes reported by the study:
None
Funding sources No information provided
Comments This study analysed Bell’s palsy patients and Ramsay Hunt syndrome. This study included Bell’s patient (n = 77) and Ramsay Hunt syndrome (n = 32) with any severity. The authors provided only non-recovery rate in patients with severe Bell’s palsy. Mean age and gender was calculated using all patients’ data.
Data Extraction form Murakami 2010 Study Design Retrospective cohort study Study Period 2006-2009
Participants Location: Japan, multi-center
Setting of recruitment and treatment: Kyshu University hospital and Chidoribashi Hospital
Number of patients:
High-dose: 17
Standard-dose: 7
Participant (Baseline) characteristics:
This study analysed patients prognosis using several factor (severity,
Mean Age: 45
Gender (male/female): 13/11
Mean time from onset to treatment (day): 2.0 days
Severity of facial palsy:
Yanagihara score 0-8 (mean 5.0)
Inclusion criteria: Bell’s palsy patients aged 20 years or olde Initial severity of facial grading system is Yanagihara score 8 or less Duration of follow up: 6 month
Lost to follow: Uncertain
Interventions Intervention: 200 mg prednisolone equivalent f with a taper Comparator group: 60 mg prednisolone equivalent initially and taper Use of antivirals: used in all cases
Outcomes Outcomes of interest in the review:
Primary Outcomes:
Non-recovery at 6 month (House-Brackmann III-VI) Secondary Outcomes:
Non-recovery at 12 month
Adverse effects:
Other outcomes reported by the study:
None
Funding sources No information provided
Comments We could not extract data (for meta-analysis) from this study.
Data Extraction form Yasumura 2002 Study Design Retrospective cohort study Study Period 1984-2001
Participants Location: Japan, single-center
Setting of recruitment and treatment: Toyama University hospital Number of patients:
High-dose: 5
Standard-dose: 23
Participant (Baseline) characteristics:
This study analysed patients prognosis using several factor (severity,
Mean Age: 51
Gender (male/female): 71/48
Mean time from onset to treatment (day): Not provided
Severity of facial palsy:
Yanagihara score 0-8
Inclusion criteria: Bell’s palsy patients whose initial severity of facial grading system is Yanagihara score 8 or less.
Duration of follow up: 6 month Lost to follow: 54.6%
In meta-analysis, only 41 patients (7 in high-dose and 34 in standard-dose were available) Interventions Intervention: 200 mg prednisolone equivalent f with a taper
Comparator group: 60 mg prednisolone equivalent initially and taper Use of antivirals: Not used
Outcomes Outcomes of interest in the review:
Primary Outcomes:
Non-recovery at 6 month (Yanagihara facial nerve grading system score < 36 or sequelae)
Secondary Outcomes:
Non-recovery at 12 month
Adverse effects:
Other outcomes reported by the study:
None
Funding sources No information provided
Comments This study included patients severe Bell’s palsyand Ramsay Hunt syndrome who had corticosteroid with/without decompression surgery (n = 119). We extracted Bell’s palsy patients who did not have decompression surgry (n= 28).
Data Extraction form Suzuki 2012
Study Design Retrospective cohort study Study Period 1995-2006
Participants Location: Japan, single-center
Setting of recruitment and treatment: Iwate Medical University Hospital Number of patients:
High-dose: 86
Standard-dose: 201
Non-steroid: 14
Participant (Baseline) characteristics:
This study analysed patients prognosis using several factor (severity,
Mean Age: 50.6
Gender (male/female): 144/147 (unclear = 10)
Mean time from onset to treatment (day): 3.36
Severity of facial palsy:
Any severity (mean Yanagihara score 11.3)
Inclusion criteria: Bell’s palsy patients with any severity who were treated within 14 days.
Duration of follow up: 6 month Lost to follow: Not provided
Interventions Intervention: 120-160 mg prednisolone equivalent initially and taper Comparator group: 40-60 mg prednisolone equivalent initially and taper Use of antivirals: Used in some cases
Outcomes Outcomes of interest in the review:
Primary Outcomes:
Non-recovery at 6 month (Yanagihara facial nerve grading system score < 36 or sequelae)
Secondary Outcomes:
Non-recovery at 12 month
Adverse effects:
Other outcomes reported by the study:
None
Funding sources No information provided
Comments Suzuki 2012 included Bell’s palsy (91.0 %) and Ramsay Hunt syndrome (9.0 %). We could not extracted the data separately.
Data Extraction form Kubota 2011
Study Design Retrospective cohort study Study Period 2006-2009
Participants Location: Japan, single-center
Setting of recruitment and treatment: Iwate Medical University Hospital Number of patients:
High-dose: 12
Standard-dose: 8
Participant (Baseline) characteristics:
This study analysed patients prognosis using several factor (severity,
Mean Age: 50.6
Gender (male/female): 31/31
Mean time from onset to treatment (day): 2.9
Severity of facial palsy:
Any severity (mean Yanagihara score 12.2)
Inclusion criteria: Bell’s palsy patients with any severity who were treated within 20 days.
Duration of follow up: 6 month Lost to follow: Not provided
Interventions Intervention: 200 mg prednisolone equivalent initially and taper Comparator group: 60 mg prednisolone equivalent initially and taper Use of antivirals: Valacyclovir 1000 mg/day for 5 days
Outcomes Outcomes of interest in the review:
Primary Outcomes:
Non-recovery at 6 month (Yanagihara facial nerve grading system score < 36 or sequelae)
Secondary Outcomes:
Non-recovery at 12 month
Adverse effects:
Other outcomes reported by the study:
None
Funding sources No information provided
Comments Kubota 2011 included patients who had been treated from 2006 to 2009. The severity of the patients treated from 2006 to 2007 were uncertain and we extracted the data from patients treated from 2008-2009.
Kubota 2011 included patients with severe and moderate facial palsy, but we could extracted only severe cases.