Abstract：
OBJECTIVE: Although corticosteroids and other treatments for idiopathic sudden sensorineural hearing loss (ISSNHL) have been described, understanding its prognosis without intervention provides valuable information for patient management. The objective of this study is to provide a comprehensive, quantitative statistical analysis of the natural history of untreated idiopathic sudden sensorineural hearing loss (ISSNHL).
UNASSIGNED: A systematic review and meta-analyses.
METHODS: Two independent searches of PubMed, Scopus, Web of Science, and Cochrane Library databases up to June 30, 2022, were performed. Adults with idiopathic sudden sensorineural hearing loss who received placebo or were untreated and had audiometric outcome measures in all study types were reviewed. These data indicative of the natural history of ISSNHL were analyzed, as were study characteristics related to risk of bias. Heterogeneity as assessed via I2 and random effects analyses were performed.
RESULTS: Six studies meeting the inclusion criteria yielded 319 untreated patients whose natural history could be assessed. Heterogeneity among studies was moderate, with a variety of reported outcomes. A hearing improvement of at least 30 dB HL was observed in 36% (95% CI 0.28-0.44) of untreated patients, and of at least 10 dB HL was observed in 70% (95% CI 0.57-0.82) of untreated patients at 3 months. The mean hearing gain among untreated patients was 24.0 dB HL (95% CI 2.65-45.37) at 2-3 months.
CONCLUSIONS: The observed natural history of ISSNHL suggests that patients can regain some hearing without active treatment. In the absence of future studies collecting prospective natural history data from untreated or placebo-treated ISSNHL patients, the data presented here provide the best available historical control data for reconsideration of results in past ISSNHL studies, as well as a roadmap for design and interpretation of future ISSNHL treatment clinical trials. Furthermore, knowing there is a statistically significant mean hearing gain of 24.0 dB HL in the untreated/placebo group provides an ethical basis for future placebo study of ISSNHL. The current status on ISSNHL management calls for a multi-institutional, randomized, double-blind placebo-controlled trial with validated outcome measures to provide science-based treatment guidance. Laryngoscope, 134:S1-S15, 2024.
UNASSIGNED: A systematic review and meta-analyses.
METHODS: Two independent searches of PubMed, Scopus, Web of Science, and Cochrane Library databases up to June 30, 2022, were performed. Adults with idiopathic sudden sensorineural hearing loss who received placebo or were untreated and had audiometric outcome measures in all study types were reviewed. These data indicative of the natural history of ISSNHL were analyzed, as were study characteristics related to risk of bias. Heterogeneity as assessed via I2 and random effects analyses were performed.
RESULTS: Six studies meeting the inclusion criteria yielded 319 untreated patients whose natural history could be assessed. Heterogeneity among studies was moderate, with a variety of reported outcomes. A hearing improvement of at least 30 dB HL was observed in 36% (95% CI 0.28-0.44) of untreated patients, and of at least 10 dB HL was observed in 70% (95% CI 0.57-0.82) of untreated patients at 3 months. The mean hearing gain among untreated patients was 24.0 dB HL (95% CI 2.65-45.37) at 2-3 months.
CONCLUSIONS: The observed natural history of ISSNHL suggests that patients can regain some hearing without active treatment. In the absence of future studies collecting prospective natural history data from untreated or placebo-treated ISSNHL patients, the data presented here provide the best available historical control data for reconsideration of results in past ISSNHL studies, as well as a roadmap for design and interpretation of future ISSNHL treatment clinical trials. Furthermore, knowing there is a statistically significant mean hearing gain of 24.0 dB HL in the untreated/placebo group provides an ethical basis for future placebo study of ISSNHL. The current status on ISSNHL management calls for a multi-institutional, randomized, double-blind placebo-controlled trial with validated outcome measures to provide science-based treatment guidance. Laryngoscope, 134:S1-S15, 2024.
摘要：
目的：尽管已经描述了皮质类固醇和其他治疗特发性突发性感音神经性耳聋（ISSNHL）的方法，了解其预后无干预为患者管理提供了有价值的信息。这项研究的目的是提供一个全面的，对未经治疗的特发性突发性感音神经性耳聋（ISSNHL）的自然史进行定量统计分析。
■系统评价和荟萃分析。
方法：PubMed的两个独立搜索，Scopus,WebofScience,和Cochrane图书馆数据库截至2022年6月30日进行。对所有研究类型的特发性突发性感觉神经性听力损失的成人接受安慰剂或未经治疗，并进行了听力测量结果评估。分析了这些指示ISSNHL自然史的数据，与偏倚风险相关的研究特征也是如此。进行了通过I2和随机效应分析评估的异质性。
结果：符合纳入标准的6项研究产生了319名未经治疗的患者，其自然史可以评估。研究之间的异质性是中等的，与各种报告的结果。36％（95％CI0.28-0.44）未经治疗的患者的听力改善至少30dBHL，在3个月时，未治疗的患者中有70％（95％CI0.57-0.82）观察到至少10dBHL。未经治疗的患者在2-3个月时的平均听力增益为24.0dBHL（95％CI2.65-45.37）。
结论：观察到的ISSNHL自然史表明，患者无需积极治疗即可恢复部分听力。在未来的研究没有收集来自未经治疗或安慰剂治疗的ISSNHL患者的前瞻性自然史数据，此处提供的数据为重新考虑过去ISSNHL研究的结果提供了最佳的历史控制数据，以及未来ISSNHL治疗临床试验的设计和解释路线图。此外，在未治疗组/安慰剂组中,平均听力增益为24.0dBHL的统计学显著性,为未来的ISSNHL安慰剂研究提供了伦理依据.ISSNHL管理的现状要求多机构，随机化，双盲安慰剂对照试验,采用经过验证的结局指标,提供基于科学的治疗指导.喉镜,2024.
■系统评价和荟萃分析。
方法：PubMed的两个独立搜索，Scopus,WebofScience,和Cochrane图书馆数据库截至2022年6月30日进行。对所有研究类型的特发性突发性感觉神经性听力损失的成人接受安慰剂或未经治疗，并进行了听力测量结果评估。分析了这些指示ISSNHL自然史的数据，与偏倚风险相关的研究特征也是如此。进行了通过I2和随机效应分析评估的异质性。
结果：符合纳入标准的6项研究产生了319名未经治疗的患者，其自然史可以评估。研究之间的异质性是中等的，与各种报告的结果。36％（95％CI0.28-0.44）未经治疗的患者的听力改善至少30dBHL，在3个月时，未治疗的患者中有70％（95％CI0.57-0.82）观察到至少10dBHL。未经治疗的患者在2-3个月时的平均听力增益为24.0dBHL（95％CI2.65-45.37）。
结论：观察到的ISSNHL自然史表明，患者无需积极治疗即可恢复部分听力。在未来的研究没有收集来自未经治疗或安慰剂治疗的ISSNHL患者的前瞻性自然史数据，此处提供的数据为重新考虑过去ISSNHL研究的结果提供了最佳的历史控制数据，以及未来ISSNHL治疗临床试验的设计和解释路线图。此外，在未治疗组/安慰剂组中,平均听力增益为24.0dBHL的统计学显著性,为未来的ISSNHL安慰剂研究提供了伦理依据.ISSNHL管理的现状要求多机构，随机化，双盲安慰剂对照试验,采用经过验证的结局指标,提供基于科学的治疗指导.喉镜,2024.
