College of Medicine, University of Saint Andrews, Fife, UK.
Department of Otolaryngology, North Glasgow University NHS Trust, Glasgow, UK.
Cochrane Database Syst Rev. 2021 Jan 26;1(1):CD007468. doi: 10.1002/14651858.CD007468.pub4.
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.
To assess the effects of surgery in the early management of Bell's palsy.
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.
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.
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.
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.
贝尔氏麻痹是一种病因不明的急性单侧面部麻痹,在没有其他任何病理情况下仅作为诊断使用。由于提出的病理生理学是神经肿胀和受压,因此一些外科医生建议作为可能的治疗选择对神经进行手术减压;这在发病后尽快进行是理想的。这是 2011 年首次发表的综述的更新版本,最后一次更新于 2013 年。此次更新包括一项新确定的研究的证据。
评估手术在贝尔氏麻痹早期管理中的作用。
2020 年 3 月 20 日,我们检索了 Cochrane 神经肌肉专业登记册、CENTRAL、MEDLINE、Embase、ClinicalTrials.gov 和 WHO ICTRP。我们还对手动搜索了原始综述的选定会议摘要。
我们纳入了所有涉及贝尔氏麻痹任何手术干预的随机对照试验(RCT)或准 RCT。试验将手术干预与无治疗、后期治疗(超过三个月)、假手术、其他手术治疗或药物治疗进行比较。
三位综述作者独立评估试验纳入标准、评估偏倚风险并提取数据。我们使用了 Cochrane 预期的标准方法学程序。主要结局是 12 个月时面神经麻痹完全恢复。次要结局是 3 个月和 6 个月时完全恢复、12 个月时出现面肌痉挛和挛缩、12 个月时社会心理结局,以及治疗的副作用和并发症。
两项纳入 65 名参与者的试验符合纳入标准;其中一项是本次更新新发现的。第一项研究使用统计图表将 25 名参与者随机分配到手术或非手术(无治疗)组。一名参与者拒绝手术,留下 24 名可评估的参与者。第二项研究准随机分配了 53 名参与者;然而,只有 41 名参与者有评估价值,因为 12 名参与者拒绝了他们被分配的干预措施。这 41 名参与者随后通过交替被分为早期手术、晚期手术或非手术(无治疗)组。没有提到如何进行交替。两项研究都没有提到是否尝试隐瞒分组。在两项研究中,参与者和结局评估者都没有对干预措施进行盲法。第一项研究没有参与者失访。第二项研究有 3 名参与者失访,17 名参与者没有参与次要结局的评估。两项研究均有很高的偏倚风险。两项研究中的外科医生均采用耳后/乳突入路对面神经进行减压。对于 12 个月时面神经麻痹恢复的结局,证据不确定。第一项研究报告手术组与无治疗组之间无差异。第二项研究充分报告了数值数据,但未对完全恢复进行组间统计学比较。早期手术与无治疗比较(风险比(RR)0.76,95%置信区间(CI)0.05 至 11.11;P = 0.84;33 名参与者;极低确定性证据)和早期手术与晚期手术比较(RR 0.47,95%CI 0.03 至 6.60;P = 0.58;26 名参与者;极低确定性证据)均无差异。我们认为手术对面神经功能的影响在 12 个月时非常不确定(2 项 RCT,65 名参与者;极低确定性证据)。此外,第二项研究报告了手术后的不良反应,在神经失神经后 2 至 3 个月内,手术组的泪液控制有统计学显著下降。第二项研究中的 4 名参与者在 4000 Hz 时的听力损失为 35 dB 至 50 dB,3 名参与者有耳鸣。由于参与者数量少和试验设计,我们也认为不良反应的证据非常不确定(2 项 RCT,65 名参与者;极低确定性证据)。
从 RCT 或准 RCT 中获得了关于贝尔氏麻痹早期管理中手术的极低确定性证据,不足以确定手术干预是否有益或有害。由于大多数情况下会出现自发性或医学支持的恢复,因此不太可能进一步研究手术干预的作用。