Preliminary Clinical Trial of New Therapy for Patients with Severe Tinnitus

描述(申请人提供)：耳鸣是一个常见的问题，没有普遍有效的治疗方法。现有的最佳估计表明，10%-15%的成年人报告有耳鸣症状，但在报告耳鸣的人中，只有20%的人患有耳鸣并随后寻求治疗。1只有美国退伍军人事务部(VA)正式报告，耳鸣的经济影响被认为是巨大的。退伍军人管理局在2004年报告称，289,159名退伍军人因耳鸣而获得伤残补偿，年度补偿总额超过3.455亿美元。2持续性严重耳鸣患者无法适应耳鸣的声音，这种声音很可能源于中枢听觉系统(CAS)，以应对外周损伤。在一项被广泛引用的研究中，人们假设缺乏习惯化是感觉信息异常处理的次要因素。具体地说，在皮质唤醒水平升高和应对机制不足的患者中，边缘系统和自主神经系统的处理明显异常。3、4在耳鼻喉科和听力学诊所，“基于声音的教育疗法”(SBE)是目前大多数疗法的重点，并利用增强的声音输入到CAS。虽然SBE治疗可能为耳鸣治疗提供一个很好的起点，但额外的治疗方案是必要的，特别是对于那些有明显的非听觉方面的耳鸣(例如，焦虑、抑郁、干扰日常生活)的人以及那些SBE没有显著改善的人。5此外，常用的SBE[例如耳鸣再训练疗法(TRT)]可能需要一年多的时间才能生效，并且不能用于听力太差而无法通过声音输入改变的患者。根据寻求治疗的耳鸣患者的患病率数据和对常用治疗方法无反应的已知百分比，5我们估计120万人根本无法从目前广泛使用的治疗策略中受益。一种增加目前使用的耳鸣的新策略可以使患者能够在不使用药物、昂贵的设备(如Neuromonics设备)或扩展程序(如TRT)的情况下对他们的耳鸣症状进行控制。对于不是SBE候选人的患者和那些反应不佳的患者，另一种策略可能是有用的。综合医学方法提供了一种可能的解决方案。到目前为止，还没有关于中西医结合方法治疗严重耳鸣的益处的系统研究，特别是对于耳鸣症状的非听觉方面。这项拟议的研究的目标是确定与目前常用的SBE疗法相比，以耳鸣非听觉方面的治疗为目标的中西医结合方法是否在缓解耳鸣症状方面更有效。如果成功，这种方法将在未来的研究中应用于更大的患者群体，以测试该效果的普适性和持久性。我们的最终目标是开发一种简化的方法，根据症状和患者特征个性化治疗耳鸣，并可广泛应用于普通医疗实践。 与公共卫生相关：耳鸣是一种常见问题，目前还没有普遍有效的治疗方法。耳鸣的经济影响被认为是巨大的，退伍军人管理局的资料显示，仅在2004年，289 159名退伍军人就因耳鸣获得了残疾赔偿金，年度赔偿总额超过3.455亿美元。目前的治疗方法并不能帮助每个人，至少有120万耳鸣患者可以从新的治疗中受益。在这项研究中，我们检查了一种新的治疗方法的反应，如果成功的话，可以广泛用于治疗这一问题的综合医学方法。

DESCRIPTION (provided by applicant): Tinnitus is a common problem for which there is no universally effective treatment. The best available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but only 20% of those who report tinnitus suffer from it and subsequently seek treatment. 1 Only formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans received a disability award for their tinnitus amounting to a total annual compensation amount of over $345.5 million.2 Individuals with persistent severe tinnitus are unable to habituate to the tinnitus sound that most likely originates in the central auditory system (CAS) in response to peripheral injury. In a widely referenced study, it has been hypothesized that lack of habituation is secondary to abnormal processing of sensory information. Specifically, processing by the limbic system and autonomic nervous system is apparently abnormal in patients with increased levels of cortical arousal and inadequate coping mechanisms. 3,4 In otolaryngology and audiology clinics, 'sound-based and educational therapies' (SBE) are the focus of most current therapies, and utilize enhanced sound input to the CAS. While SBE treatments may well provide a starting point for tinnitus treatment, additional treatment options are necessary particularly for those with significant non-auditory aspects of tinnitus (e.g., anxiety, depression, interference with daily life) as well as for those who do not experience significant improvement with SBE. 5 Furthermore, commonly used forms of SBE [e.g.,Tinnitus Retraining Therapy (TRT)] can require over a year to become effective and may not be used in patients with hearing that is too poor to be modified by sound input. Based on prevalence data from tinnitus sufferers who seek treatment and the known percentage who do not respond to commonly used therapies,5 we estimate that 1.2 million individuals are not able to benefit at all from current, widely used treatment strategies. A new strategy to augment those currently used could empower patients to exert control over their tinnitus symptoms without the use of medications, expensive devices such as the Neuromonics device, or extended programs such as TRT. An alternative strategy may be useful both for patients who are not candidates for SBE and for those who respond poorly. An Integrative Medicine approach provides a likely solution. To date, there has been no systematic study of the benefits of an Integrative Medicine approach for severe tinnitus, particulary for non-auditory aspects of tinnitus symptoms. The goal of the proposed study is to determine if an integrative medicine approach which targets treatment of the non- auditory aspects of tinnitus suffering is more effective in alleviating tinnitus symptoms when added to current commonly applied SBE therapies, compared with SBE alone. If successful, this approach will be applied to a larger patient population in future studies to test the generalizability and the durability of the effect. Our eventual goal is to develop a streamlined approach that individualizes tinnitus treatment based on symptoms and patient characteristics, and that can be widely applied in general medical practice. PUBLIC HEALTH RELEVANCE: Tinnitus is a common problem for which there is no universally effective treatment. Economic impact of tinnitus is thought to be substantial, with information from the Veterans Administration showing that, in 2004 alone, 289,159 veterans received a disability award for their tinnitus amounting to a total annual compensation amount of over $345.5 million. Current therapeutic approaches do not help everyone, and there are at least 1.2 million tinnitus sufferers who could benefit from new treatment. In this study we examine response to a new treatment utilizing integrative medicine approaches that, if successful, could be widely used to treat this problem.