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Clinical Evidence of Chinese Herbal Medicine for Treatment of Idiopathic Sudden Sensorineural Hearing Loss from Chinese Literature

机译:中药治疗特发性感音神经性耳聋的临床证据

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Purpose: To provide a comprehensive summary of all clinicalevidence on Chinese herbal medicine (CHM) for idiopathicsudden sensorineural hearing loss (ISSHL) published in Chineseliterature.Methods: We systematically searched randomized clinicaltrials (RCTs), clinical controlled trials (CCTs), case series(CSs) and case reports (CRs) which reported CHM for ISSHLthrough four main Chinese electronic databases from theirinception to March 2014. We bibliometrically analyzed thestudies and assessed the methodological quality of RCTs usingthe Cochrane risk of bias tool.Results: A total of 299 clinical studies with involving 22,237participants were identified including 150 RCTs, 42 CCTs,80 CSs and 27 CRs. The number of publications increasedobviously per year from 1995, with the peak in 2011. Among145 different herbal formulae tested, the most popular prescribedherbal formulae were Longdan Xiegan decoction andTongqiao Huoxue decoction, and the top three frequently usedChinese herbs were Rhizoma Chuanxiong, Radix Bupleuri andRadix Puerariae Lobatae. The most frequently reported outcomewas improvement of hearing in 286 (95.7%), followed byimprovement of tinnitus (139, 46.5%), improvement of dizziness(99, 33.1%). Among the 150 RCTs, randomization methodswere described in only 12 trials (8.0%). No trial reported allocationconcealment and only four mentioned blinding. Among146 RCTs (97.3%) and 37 CCTs (88.1%) reporting improvementof hearing as the outcome measurement, all showed significantdifference favoring CHM. Of 16 trials reporting adverseevents, only five trials reported mild adverse events related toCHM and the remaining stated that none had occurred.Conclusion: The quantity of clinical research on CHM forISSHL is substantial, but methodological quality of RCTs isgenerally suboptimal. Future clinical studies would need toreport structurally and based on the CONSORT and TRENDStatements. Quality of life, adverse events, depression andanxiety should be addressed as outcome measures.
机译:目的:提供中文文献中针对特发性突然感觉神经性听力损失(ISSHL)的中草药(CHM)的所有临床证据的全面总结方法:我们系统地搜索了随机临床试验(RCT),临床对照试验(CCT),病例系列(从最初到2014年3月,通过四个主要的中国电子数据库报告了ISSHL的CHM的案例研究和案例报告(CR)。我们使用Cochrane偏倚风险工具对研究进行了文献计量分析,评估了RCT的方法学质量。结果:共有299项临床研究确定了22,237名参与者,包括150个RCT,42个CCT,80个CS和27个CR。从1995年开始,每年的出版物数量明显增加,2011年达到峰值。在145种不同的草药配方中,最受欢迎的中草药配方为龙胆泻肝汤和通窍活血汤,最常用的三种中草药为川iz,柴胡和葛根。 bat科。最常报告的结局是听力改善286(95.7%),其次是耳鸣改善(139,46.5%),头晕改善(99,33.1%)。在150个RCT中,只有12个试验(8.0%)描述了随机方法。没有试验报告分配隐藏,只有四个提到盲法。在146例RCT(97.3%)和37例CCT(CCT)中,听力改善作为结果测量指标,均显示出显着差异,有利于CHM。在16个报告不良事件的试验中,只有5个试验报告了与CHM相关的轻度不良事件,而其余的则没有发生。结论:临床上对ISSHL进行CHM的临床研究数量很多,但是RCT的方法学质量通常都不理想。未来的临床研究将需要根据CONSORT和TREND声明在结构上进行报告。生活质量,不良事件,抑郁和焦虑应作为结局指标。

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