An Independent Review of Neuromonics Tinnitus Treatment Controlled Clinical Trials

J. Henry, J. Istvan
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引用次数: 9

Abstract

Traditional methods for the clinical management of tinnitus generally involve some combination of three common elements: education/counseling, stress reduction, and use of therapeutic sound. Neuromonics Tinnitus Treatment (NTT), which originated in Australia and recently has gained visibility in the United States, comprises a new variation of traditional tinnitus therapies. NTT uses a proprietary wearable audio player as its primary treatment modality. NTT is unique amongst tinnitus treatments in that a corporate entity controls all operations, including clinician training, provision of sound therapy devices, and oversight of the clinical activities involved in this trademarked therapy. We review here the three published con - trolled clinical trials of NTT. Observations are offered regarding limitations of these trials with respect to the Consolidated Standards of Reporting Trials (CONSORT) and the CONSORT supplement for nonpharmacologic treatments. The CONSORT standards provide rigorous review criteria for randomised clinical trials. The lack of methodological transparency, and the proprietary nature of NTT limits the ability of independent investigators to evaluate the merits of this clinical approach.
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神经性耳鸣治疗对照临床试验的独立回顾
耳鸣的传统临床治疗方法通常包括三个常见元素的组合:教育/咨询、减轻压力和使用治疗性声音。神经性耳鸣治疗(NTT)起源于澳大利亚,最近在美国获得了知名度,它是传统耳鸣治疗的一种新变体。NTT使用专有的可穿戴音频播放器作为其主要治疗方式。NTT在耳鸣治疗中是独一无二的,因为公司实体控制所有操作,包括临床医生培训,提供声音治疗设备,并监督该商标治疗中涉及的临床活动。我们在此回顾三个已发表的NTT对照临床试验。针对这些试验在报告试验综合标准(CONSORT)和CONSORT非药物治疗补充方面的局限性,提出了观察。CONSORT标准为随机临床试验提供了严格的评审标准。缺乏方法的透明度和NTT的专有性质限制了独立研究人员评估这种临床方法优点的能力。
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