Asthma and Mindfulness-based Stress Reduction (MBSR)

描述(由申请人提供)：在美国，哮喘影响了大约7%或大约1400万成年人，估计花费了79亿美元的医疗费用，以及53亿美元的失业或上学。虽然大约40%的哮喘患者报告使用某种形式的补充和替代药物(CAM)来帮助缓解他们的症状，但几乎没有证据表明CAM对哮喘有效。有相当多的流行病学和实验证据表明，包括压力在内的心理因素在哮喘发病率中发挥了作用，并导致了已知的减轻压力的行为程序可能会影响哮喘症状及其处理的建议。我们小组的一项小型初步研究发现，在基于正念的压力减轻(MBSR)计划完成后，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，进行了为期两年的MBSR对肺功能和哮喘行为和心理方面的随机试验。这项试验目前正处于规划阶段。82名被诊断为轻度或中度哮喘的成年人将参加MBSR或健康的生活过程注意力控制条件。 大多数免疫、内分泌和神经递质以及应激反应的调节因子在哮喘相关症状的启动和持续过程中也发挥着重要作用，但目前只有一项关于哮喘相关免疫标志物的小型行为学研究。鉴于NCCAM最近表示有兴趣支持免疫机制的研究，我们提交这一竞争性补充材料，以利用母研究提供的宝贵科学机会来研究免疫标记物以及临床相关的生物标记物。哮喘是一种免疫调节性疾病，有证据表明Th1-Th2细胞因子平衡向Th2环境的改变可能在其发病机制中发挥重要作用。这项应用的目的是通过评估Th1-Th2细胞因子平衡和循环调节T细胞水平在12个月期间的变化，研究参与两组试验的受试者肺功能(两周平均晨峰呼气流量)任何观察到的差异的可能生物媒介。我们还将评估血清免疫球蛋白E的变化，这是哮喘临床相关性的一个标志。此外，样本大小足以通过检查免疫标记物、临床症状和心理社会变量之间的任何变化之间的关系，对可能的心理中介/调节因素进行探索性分析。将在四个评估点采集每位参与者的血液：研究开始(基线)、10周(干预后)、6个月和12个月随访。补充资金将用于获取和运送血液样本、用流式细胞仪进行免疫分析以及数据的录入、管理和分析方面的机构和科目相关费用。 与公共卫生相关：尽管约40%的哮喘患者报告使用某种形式的补充和替代药物(CAM)来帮助缓解他们的症状，而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随之发生变化。这些变化的存在将表明这些CAM程序在身体和大脑中运行的水平。这项研究将研究是否有免疫系统的变化与患者的肺功能和他们的哮喘症状自我报告的任何改善有关，作为参与著名的压力减轻计划的结果。这些信息对人们来说很重要，这样他们就可以就像这样的计划是否适合他们的情况做出合理的决定。

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.