Li Peifan, Che Chenhao, Wu Yongzhen, Sun Shan
Department of Otorhinolaryngology, Eye and E.N.T. Hospital, Fudan University, Shanghai, China.
Department of Otorhinolaryngology, Eye and E.N.T. Hospital, Fudan University, Shanghai, China
BMJ Open. 2025 May 28;15(5):e096995. doi: 10.1136/bmjopen-2024-096995.
This study aims to compare the outcomes of different pharmacotherapies for subjective tinnitus patients using a comprehensive network meta-analysis.
Systematic review and network meta-analysis.
PubMed, EMBASE, Web of Science and CINAHL Complete databases were searched from inception until 6 March 2025.
Randomised controlled trials (RCTs) comparing pharmacotherapy treatment effects for subjective tinnitus patients were included with tinnitus severity as the primary outcome, and annoyance and tinnitus loudness as secondary outcomes.
Two reviewers independently retrieved and screened full articles using a standardised and prepiloted Excel form. Network meta-analysis was conducted with heterogeneity, study risk of bias (ROB), risk of publication bias and certainty of evidence examined using I, τ, ROB2, funnel plots and Grading of Recommendations, Assessment, Development, and Evaluation assessments.
Sixty full-text RCTs from 21 countries were included in the analysis with 22% low ROB, 58% some concerns and 20% high ROB. The heterogeneity parameter I was 0.67 (95% CI 0.33 to 0.84), 0 (95% CI 0 to 0.9) and 0.63 (95% CI 0 to 0.89) for the severity, annoyance and loudness network analysis, respectively. The only significant publication bias assessment by Egger's test was detected in the loudness network analysis (p<0.05). Ginkgo biloba with vitamin (standardised mean differences (SMD): -3.11, 95% CI (-4.15 to -2.06)), acamprosate (SMD: -0.88, 95% CI (-1.81 to -0.04)) and fluoxetine (SMD: -3.28, 95% CI (-4.23 to -2.34)) ranked first in severity, annoyance and loudness, respectively, compared with placebo. There are three significant inconsistent comparisons observed in the severity network and ranked with very low certainty of evidence by GRADE assessment.
This meta-analysis found that antioxidant supplementation, such as Ginkgo biloba, and vitamins and gamma-aminobutyric acid agonists, represented by acamprosate, could be promising treatments for subjective tinnitus. Further trials with rigorous design and larger sample sizes are necessary to supplement the current evidence.
INPLASY202480066.
本研究旨在通过全面的网络荟萃分析比较主观耳鸣患者不同药物治疗的效果。
系统评价和网络荟萃分析。
检索了PubMed、EMBASE、Web of Science和CINAHL Complete数据库，检索时间从建库至2025年3月6日。
纳入比较主观耳鸣患者药物治疗效果的随机对照试验（RCT），以耳鸣严重程度作为主要结局，耳鸣困扰和耳鸣响度作为次要结局。
两名研究者使用标准化的预试验Excel表格独立检索和筛选全文。进行网络荟萃分析，采用I、τ、ROB2、漏斗图以及推荐分级、评估、制定与评价（GRADE）评估来检验异质性、研究偏倚风险（ROB）、发表偏倚风险和证据确定性。
分析纳入了来自21个国家的60篇全文RCT，其中22%的研究偏倚风险低，58%存在一些问题，20%的研究偏倚风险高。在严重程度、困扰和响度网络分析中，异质性参数I分别为0.67（95%可信区间0.33至0.84）、0（95%可信区间0至0.9）和0.63（95%可信区间0至0.89）。在响度网络分析中，通过Egger检验仅检测到显著的发表偏倚评估（p<0.05）。与安慰剂相比，银杏叶加维生素（标准化均数差（SMD）：-3.11，95%可信区间（-4.15至-2.06））、阿坎酸（SMD：-0.88，95%可信区间（-1.81至-0.04））和氟西汀（SMD：-3.28，95%可信区间（-4.23至-2.34））在严重程度、困扰和响度方面分别排名第一。在严重程度网络中观察到3个显著不一致的比较，根据GRADE评估，证据确定性非常低。
这项荟萃分析发现，补充抗氧化剂，如银杏叶，以及以阿坎酸为代表的维生素和γ-氨基丁酸激动剂，可能是治疗主观耳鸣的有前景的方法。需要进一步进行设计严谨、样本量更大的试验来补充现有证据。
INPLASY202480066。
