Division of Otolaryngology, Department of Surgery, University of British Columbia, British Columbia, Canada.
Division of Otolaryngology-Head and Neck Surgery, Vancouver General Hospital, Vancouver, British Columbia, Canada.
JAMA Otolaryngol Head Neck Surg. 2022 Jan 1;148(1):5-11. doi: 10.1001/jamaoto.2021.2685.
Sudden sensorineural hearing loss (SSNHL) is an acute, usually unilateral deficit. Systemic and intratympanic steroids are accepted treatments. Although evidence suggests that hyperbaric oxygen therapy (HBOT) may be beneficial, it is not widely offered.
To review and evaluate recent evidence of the association of HBOT with hearing outcomes in SSNHL and to determine if HBOT should be a single or part of a combination treatment regimen.
Cochrane Central Register of Controlled Trials, PubMed, EMBASE, CINAHL, Web of Science, CAB, ICTRP, Google Scholar, Clinicaltrials.gov, and ISRCTN databases were searched for randomized controlled trials (RCTs) published in English from January 1, 2000, and April 30, 2020.
Prospective RCTs involving only adult participants (≥18 years) with SSNHL and comparing HBOT, as a single or combination therapy, with control therapies, such as steroids and/or placebo. Only RCTs that used the American Academy of Otolaryngology-Head and Neck Surgery's diagnostic criteria for SSNHL were included.
Data were extracted independently by 2 researchers. A fixed-effects model was used for analysis and performed from November 30, 2020, to May 20, 2021.
The mean difference in absolute hearing gain recorded by pure-tone audiometric (PTA) thresholds averaged across 4 low (0.5, 1, 2, and 3 or 4 kHz) or 3 high (3 or 4, 6, and 8 kHz) frequencies was the primary outcome. The secondary outcomes were the odds ratio of hearing recovery defined as a hearing gain of ≥10 decibels (dB) in PTA average and treatment-related adverse effects.
Of the 826 records initially identified, 358 duplicates and 451 articles were excluded based on article type, title, and abstract. The full texts of 17 articles were reviewed, of which 14 were excluded because they were either not prospective RCTs (11 articles), the participants were less than 18 years old (2 articles), or the PTA was not reported at frequencies of interest (1 article). Three prospective RCTs with a total of 88 participants who received HBOT in the intervention groups and 62 participants who received only medical therapy in the control groups were studied. The intergroup difference in mean absolute hearing gain (mean difference, 10.3 dB; 95% CI, 6.5-14.1 dB; I2 = 0%) and the odds ratio of hearing recovery (4.3; 95% CI, 1.6-11.7; I2 = 0%) favored HBOT over the control therapy.
In this systematic review and meta-analysis, HBOT as part of a combination treatment was significantly associated with improved hearing outcomes in patients with SSNHL over control treatments.
PROSPERO Identifier: CRD42020193191.
重要性:突发性聋(SSNHL)是一种急性的、单侧听力损失。全身和鼓室内类固醇治疗已被认可。虽然有证据表明高压氧治疗(HBOT)可能是有益的,但它并未广泛应用。
目的:回顾和评估近期关于 HBOT 与 SSNHL 听力结果关联的证据,并确定 HBOT 是否应作为单一治疗或联合治疗方案的一部分。
数据来源:检索了 Cochrane 中心对照试验注册库、PubMed、EMBASE、CINAHL、Web of Science、CAB、ICTRP、Google Scholar、Clinicaltrials.gov 和 ISRCTN 数据库,纳入了 2000 年 1 月 1 日至 2020 年 4 月 30 日发表的英文随机对照试验(RCT)。
研究选择:前瞻性 RCT,仅纳入成人(≥18 岁)SSNHL 患者,比较 HBOT 作为单一或联合治疗与对照组治疗(如类固醇和/或安慰剂)。仅纳入使用美国耳鼻喉科学会-头颈外科学会 SSNHL 诊断标准的 RCT。
数据提取和综合:由 2 名研究人员独立提取数据。使用固定效应模型进行分析,分析时间为 2020 年 11 月 30 日至 2021 年 5 月 20 日。
主要结局和指标:主要结局是纯音听阈(PTA)平均记录的绝对听力增益,该值平均横跨 4 个低频(0.5、1、2 和 3 或 4 kHz)或 3 个高频(3 或 4、6 和 8 kHz)频率。次要结局是听力恢复的优势比,定义为 PTA 平均听力增益增加≥10 分贝(dB),以及与治疗相关的不良反应。
结果:最初确定的 826 条记录中,有 358 条重复记录和 451 条文章根据文章类型、标题和摘要被排除。对 17 篇文章的全文进行了审查,其中 14 篇因不是前瞻性 RCT(11 篇)、参与者年龄小于 18 岁(2 篇)或 PTA 未报告感兴趣的频率(1 篇)而被排除。共纳入了 3 项前瞻性 RCT,每组分别有 88 名接受 HBOT 干预的患者和 62 名仅接受药物治疗的患者。与对照组治疗相比,HBOT 组的平均绝对听力增益(平均差异,10.3 dB;95%CI,6.5-14.1 dB;I2=0%)和听力恢复的优势比(4.3;95%CI,1.6-11.7;I2=0%)更有优势。
结论和相关性:在这项系统评价和荟萃分析中,HBOT 作为联合治疗的一部分,与对照组治疗相比,显著改善了 SSNHL 患者的听力结果。
试验注册:PROSPERO 标识符:CRD42020193191。