TY - JOUR
T1 - Surgical interventions for the early management of Bell's palsy
AU - Menchetti, Isabella
AU - McAllister, Kerrie
AU - Walker, David
AU - Donnan, Peter T.
N1 - Funding Information:
Angela Gunn and Farhad Shokareh (FS), the Information Specialists of the Cochrane Neuromuscular Disease Group performed the searches. FS screened 2020 searches for RCTs for this update. The Managing Editor of Cochrane Neuromuscular, Ruth Brassington, assisted with updating the methods section, based on a standard protocol developed by the group from an original created by Cochrane Airways. Andrea Takeda acted as an independent systematic reviewer and extracted data for the newly included study and documented any differences between the extractions. This project was supported by the National Institute for Health Research (NIHR) via Cochrane Infrastructure funding to Cochrane Neuromuscular. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, National Health Service or the Department of Health. Cochrane Neuromuscular is also supported by the MRC Centre for Neuromuscular Disease. With thanks to Jie Zhou,?Department of Neurology, West China Hospital of Sichuan University, China and Ning Chen of West China Hospital of Sichuan University who kindly assisted with translations of Chinese studies.
Publisher Copyright:
Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/1/26
Y1 - 2021/1/26
N2 - Background: Bell's palsy is an acute unilateral facial paralysis of unknown aetiology and should only be used as a diagnosis in the absence of any other pathology. As the proposed pathophysiology is swelling and entrapment of the nerve, some surgeons suggest surgical decompression of the nerve as a possible management option; this is ideally performed as soon as possible after onset. This is an update of a review first published in 2011, and last updated in 2013. This update includes evidence from one newly identified study.Objectives: To assess the effects of surgery in the early management of Bell's palsy.Search methods: On 20 March 2020, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and WHO ICTRP. We handsearched selected conference abstracts for the original version of the review.Selection criteria: We included all randomised controlled trials (RCTs) or quasi-RCTs involving any surgical intervention for Bell's palsy. Trials compared surgical interventions to no treatment, later treatment (beyond three months), sham treatment, other surgical treatments or medical treatment.Data collection and analysis: Three review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. We used standard methodological procedures expected by Cochrane. The primary outcome was complete recovery of facial palsy at 12 months. Secondary outcomes were complete recovery at three and six months, synkinesis and contracture at 12 months, psychosocial outcomes at 12 months, and side effects and complications of treatment.Main results: Two trials with 65 participants met the inclusion criteria; one was newly identified at this update. The first study randomised 25 participants into surgical or non-surgical (no treatment) groups using statistical charts. One participant declined surgery, leaving 24 evaluable participants. The second study quasi-randomised 53 participants; however, only 41 were evaluable as 12 declined the intervention they were allocated. These 41 participants were then divided into early surgery, late surgery or non-surgical (no treatment) groups using alternation. There was no mention on how alternation was decided. Neither study mentioned if there was any attempt to conceal allocation. Neither participants nor outcome assessors were blinded to the interventions in either study. There were no losses to follow-up in the first study. The second study lost three participants to follow-up, and 17 did not contribute to the assessment of secondary outcomes. Both studies were at high risk of bias.Surgeons in both studies used a retro-auricular/transmastoid approach to decompress the facial nerve. For the outcome recovery of facial palsy at 12 months, the evidence was uncertain. The first study reported no differences between the surgical and no treatment groups. The second study fully reported numerical data, but included no statistical comparisons between groups for complete recovery. There was no evidence of a difference for the early surgery versus no treatment comparison (risk ratio (RR) 0.76, 95% confidence interval (CI) 0.05 to 11.11; P = 0.84; 33 participants; very low-certainty evidence) and for the early surgery versus late surgery comparison (RR 0.47, 95% CI 0.03 to 6.60; P = 0.58; 26 participants; very low-certainty evidence). We considered the effects of surgery on facial nerve function at 12 months very uncertain (2 RCTs, 65 participants; very low-certainty evidence).Furthermore, the second study reported adverse effects with a statistically significant decrease in lacrimal control in the surgical group within two to three months of denervation. Four participants in the second study had 35 dB to 50 dB of sensorineural hearing loss at 4000 Hz, and three had tinnitus. Because of the small numbers and trial design we also considered the adverse effects evidence very uncertain (2 RCTs, 65 participants; very low-certainty evidence).Authors' conclusions: There is very low-certainty evidence from RCTs or quasi-RCTs on surgery for the early management of Bell's palsy, and this is insufficient to decide whether surgical intervention is beneficial or harmful.Further research into the role of surgical intervention is unlikely to be performed because spontaneous or medically supported recovery occurs in most cases.
AB - Background: Bell's palsy is an acute unilateral facial paralysis of unknown aetiology and should only be used as a diagnosis in the absence of any other pathology. As the proposed pathophysiology is swelling and entrapment of the nerve, some surgeons suggest surgical decompression of the nerve as a possible management option; this is ideally performed as soon as possible after onset. This is an update of a review first published in 2011, and last updated in 2013. This update includes evidence from one newly identified study.Objectives: To assess the effects of surgery in the early management of Bell's palsy.Search methods: On 20 March 2020, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and WHO ICTRP. We handsearched selected conference abstracts for the original version of the review.Selection criteria: We included all randomised controlled trials (RCTs) or quasi-RCTs involving any surgical intervention for Bell's palsy. Trials compared surgical interventions to no treatment, later treatment (beyond three months), sham treatment, other surgical treatments or medical treatment.Data collection and analysis: Three review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. We used standard methodological procedures expected by Cochrane. The primary outcome was complete recovery of facial palsy at 12 months. Secondary outcomes were complete recovery at three and six months, synkinesis and contracture at 12 months, psychosocial outcomes at 12 months, and side effects and complications of treatment.Main results: Two trials with 65 participants met the inclusion criteria; one was newly identified at this update. The first study randomised 25 participants into surgical or non-surgical (no treatment) groups using statistical charts. One participant declined surgery, leaving 24 evaluable participants. The second study quasi-randomised 53 participants; however, only 41 were evaluable as 12 declined the intervention they were allocated. These 41 participants were then divided into early surgery, late surgery or non-surgical (no treatment) groups using alternation. There was no mention on how alternation was decided. Neither study mentioned if there was any attempt to conceal allocation. Neither participants nor outcome assessors were blinded to the interventions in either study. There were no losses to follow-up in the first study. The second study lost three participants to follow-up, and 17 did not contribute to the assessment of secondary outcomes. Both studies were at high risk of bias.Surgeons in both studies used a retro-auricular/transmastoid approach to decompress the facial nerve. For the outcome recovery of facial palsy at 12 months, the evidence was uncertain. The first study reported no differences between the surgical and no treatment groups. The second study fully reported numerical data, but included no statistical comparisons between groups for complete recovery. There was no evidence of a difference for the early surgery versus no treatment comparison (risk ratio (RR) 0.76, 95% confidence interval (CI) 0.05 to 11.11; P = 0.84; 33 participants; very low-certainty evidence) and for the early surgery versus late surgery comparison (RR 0.47, 95% CI 0.03 to 6.60; P = 0.58; 26 participants; very low-certainty evidence). We considered the effects of surgery on facial nerve function at 12 months very uncertain (2 RCTs, 65 participants; very low-certainty evidence).Furthermore, the second study reported adverse effects with a statistically significant decrease in lacrimal control in the surgical group within two to three months of denervation. Four participants in the second study had 35 dB to 50 dB of sensorineural hearing loss at 4000 Hz, and three had tinnitus. Because of the small numbers and trial design we also considered the adverse effects evidence very uncertain (2 RCTs, 65 participants; very low-certainty evidence).Authors' conclusions: There is very low-certainty evidence from RCTs or quasi-RCTs on surgery for the early management of Bell's palsy, and this is insufficient to decide whether surgical intervention is beneficial or harmful.Further research into the role of surgical intervention is unlikely to be performed because spontaneous or medically supported recovery occurs in most cases.
KW - Bell Palsy
KW - Decompression, Surgical
KW - Facial Nerve
KW - Randomized Controlled Trials as Topic
UR - http://www.scopus.com/inward/record.url?scp=85100523575&partnerID=8YFLogxK
U2 - 10.1002/14651858.CD007468.pub4
DO - 10.1002/14651858.CD007468.pub4
M3 - Review article
C2 - 33496980
SN - 1469-493X
VL - 2021
JO - The Cochrane database of systematic reviews
JF - The Cochrane database of systematic reviews
IS - 1
M1 - CD007468
ER -