Preliminary Clinical Trial of New Therapy for Patients with Severe Tinnitus

描述（申请人提供）：耳鸣是一种常见问题，目前尚无普遍有效的治疗方法。最好的估计表明，10 - 15%的成年人报告有耳鸣症状，但只有20%的人报告耳鸣，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。退伍军人事务部在2004年报告说，289，159名退伍军人因耳鸣而获得残疾赔偿金，每年的赔偿总额超过3.455亿美元。2患有持续性严重耳鸣的人无法习惯于耳鸣声音，这种耳鸣声音很可能起源于中枢听觉系统（CAS），以响应外周损伤。在一项被广泛引用的研究中，有人假设缺乏习惯是继发于感觉信息的异常处理。具体来说，在皮质唤醒水平增加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，“声音和教育疗法”（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治疗可以很好地提供耳鸣治疗的起点，但额外的治疗选择是必要的，特别是对于那些具有显著的耳鸣非听觉方面的人（例如，焦虑、抑郁、干扰日常生活）以及SBE没有显著改善的患者。5此外，SBE的常用形式[例如，耳鸣再训练疗法（TRT）]可能需要一年以上才能生效，并且可能不用于听力太差而无法通过声音输入进行调整的患者。根据寻求治疗的耳鸣患者的患病率数据以及对常用疗法没有反应的已知百分比，我们估计有120万人无法从目前广泛使用的治疗策略中获益。一种新的策略，以增加目前使用的可以使患者能够控制他们的耳鸣症状，而不使用药物，昂贵的设备，如神经元设备，或扩展程序，如TRT。另一种策略可能对不适合SBE的患者和反应不佳的患者都有用。综合医学方法提供了一个可能的解决方案。目前，还没有系统的研究中西医结合治疗严重耳鸣的益处，特别是对于耳鸣症状的非听觉方面。所提出的研究的目的是确定与单独使用SBE相比，将针对耳鸣痛苦的非听觉方面的治疗的中西医结合方法添加到当前常用的SBE疗法中时，是否更有效地缓解耳鸣症状。如果成功，这种方法将在未来的研究中应用于更大的患者人群，以测试效果的普遍性和持久性。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进行个性化耳鸣治疗，并可广泛应用于一般医疗实践。 公共卫生相关性：耳鸣是一个普遍存在的问题，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，退伍军人管理局的信息显示，仅在2004年，就有289，159名退伍军人因耳鸣而获得残疾奖，每年的赔偿总额超过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，我们研究了一种新的治疗方法，利用中西医结合的方法，如果成功，可以广泛用于治疗这个问题的反应。

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.