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. ? ? ?
Pbert, Lori; Madison, J Mark; Druker, Susan et al. (2012) Effect of mindfulness training on asthma quality of life and lung function: a randomised controlled trial. Thorax 67:769-76 |
Dave, Ninabahen D; Xiang, Lianbin; Rehm, Kristina E et al. (2011) Stress and allergic diseases. Immunol Allergy Clin North Am 31:55-68 |
Marshall Jr, Gailen D (2011) The adverse effects of psychological stress on immunoregulatory balance: applications to human inflammatory diseases. Immunol Allergy Clin North Am 31:133-40 |