Asthma and Mindfulness-based Stress Reduction (MBSR)

哮喘影响美国约7%或约1400万成年人，估计花费79亿美元用于医疗保健，53亿美元用于失去工作或学校。虽然大约40%的哮喘患者报告使用某种形式的补充和替代医学（CAM）来帮助缓解症状，但几乎没有证据表明CAM对哮喘的有效性。有相当多的流行病学和实验证据表明，心理因素，包括压力，在哮喘发病率中发挥作用，并导致了这样的建议，即已知的减少压力的行为计划可能会影响哮喘症状及其管理。我们小组的一项小型初步研究发现，在完成正念减压（MBSR）计划后，哮喘相关的生活质量、控制点、压力和焦虑立即得到改善，我们现在已经获得资助，进行为期两年的MBSR肺功能和哮喘行为和心理方面的随机试验。审判目前处于规划阶段。82名被诊断为轻度或中度哮喘的成年人将参加正念减压疗法或健康生活课程注意力控制条件。 大多数免疫、内分泌和神经元介质和应激反应调节剂在哮喘相关症状的发生和持续中也起着重要作用，但只有一个小的哮喘相关免疫标记物的行为研究。鉴于NCCAM最近表示有兴趣支持免疫机制的研究，我们提交了这份竞争性补充材料，以利用母研究提供的宝贵科学机会来研究免疫标志物以及临床相关的生物标志物。哮喘是一种免疫调节性疾病，有证据表明Th 1-Th 2细胞因子平衡向Th 2环境的变化可能在其发病机制中起重要作用。本申请的目的是通过评价12个月期间Th 1-Th 2细胞因子平衡和循环调节性T细胞水平的变化，研究参与两组受试者中任何观察到的肺功能差异（两周平均早晨呼气峰流量）的可能生物介质。我们还将评估血清IgE的变化，这是哮喘临床相关性的标志物。此外，样本量足以通过检查免疫学标志物、临床症状和心理社会变量的任何变化之间的相关性，对可能的心理介导者/调节者进行探索性分析。将在四个评估点中的每一个点从每一个参与者采集血液：研究进入（基线）、10周（干预后）、6个月和12个月随访。补充资金将用于获得和运输血液样本、流式细胞术免疫学测定以及所获数据的录入、管理和分析的机构和受试者相关费用。 公共卫生相关性：虽然大约40%的哮喘患者报告使用某种形式的补充和替代医学（CAM）来帮助缓解症状，并且研究表明放松可以改善他们的呼吸功能，但没有证据表明他们的免疫系统会发生相应的变化。这种变化的存在将表明这些CAM程序在身体和心灵中运作的水平。这项研究将检查是否有免疫系统的变化与任何改善患者的肺功能和他们的哮喘症状的自我报告，作为一个众所周知的减压计划的结果。这些信息对人们来说很重要，这样他们就可以做出正确的决定，决定像这样的程序是否适合他们的情况。

DESCRIPTION (provided by applicant): Asthma affects about 7% or roughly 14 million adults in the United States and costs an estimated 7.9 billion dollars in medical care, and 5.3 billion dollars in lost work or school. Although approximately 40% of asthmatics report using some form of complementary and alternative medicine (CAM) to help alleviate their symptoms, there is little evidence for the effectiveness of CAM for asthma. There is considerable epidemiological and experimental evidence that psychological factors, including stress, play a role in asthma morbidity, and has led to the suggestion that behavioral programs known to reduce stress may affect asthma symptoms and their management. A small preliminary study by our group found improvements in asthma- related quality of life, locus of control, stress, and anxiety immediately following the completion of a Mindfulness-Based Stress Reduction (MBSR) program, and we have now been funded for a two-year randomized trial of MBSR for lung function and the behavioral and psychological aspects of asthma. This trial is presently in the planning stages. Eighty-two adults with a diagnosis of mild or moderate asthma will participate in either MBSR, or a Healthy Living Course attention control condition. Most of the immunological, endocrine and neuronal mediators and moderators of the stress response also play important roles in the initiation and perpetuation of the symptoms associated with asthma, but there has been only one small behavioral study of asthma-related immune markers. Given NCCAM's recently stated interest in supporting studies of immune mechanisms, we are submitting this competitive supplement in order to take advantage of the valuable scientific opportunity provided by the parent study to investigate immune markers as well as clinically-relevant biomarkers. Asthma is an immunoregulatory disease and there is evidence that a change in Th1 - Th2 cytokine balance toward a Th2 environment may play an important role in its pathogenesis. The aims of this application are to investigate possible biological mediators of any observed differences in lung function (two-week average morning peak expiratory flow) in subjects participating in the two arms, by evaluating changes in Th1 - Th2 cytokine balance and levels of circulating regulatory Tcells, over a 12-month period. We will also evaluate changes in serum IgE, a marker of clinical relevance in asthma. Also, the sample size is sufficient for exploratory analyses for possible psychological mediators/moderators by examining associations between any changes in immunological markers, clinical symptoms and psychosocial variables. Blood will be collected from each of the participants at each of the four assessment points: study entry (baseline), 10-week (post-intervention), 6- and 12-month follow-up. Supplemental funds will be applied to the institutional and subject-related expenses in obtaining and shipping the blood samples, the immunological assays by flow cytometry, and the entering, management and analysis of the data obtained. Public Health Relevance: Although approximately 40% of asthmatics report using some form of complementary and alternative medicine (CAM) to help alleviate their symptoms, and studies show that relaxation improves their respiratory function, there is no evidence to show that there are accompanying changes in their immune systems. The presence of such changes would indicate the level that these CAM programs operate at in the body and the mind. This study will examine whether there are immune system changes associated with any improvements in patients' lung function and their self-reports of asthma symptoms as a result of participating in a well-known stress reduction program. This information is important for people to know so that they can make sound decisions about whether programs such as this one are right for their circumstances.