Heart Rate Variability Biofeedback: Its Role in Asthma Therapeutics

描述（由申请人提供）：哮喘影响10%的美国人口，每年有500人死亡。大约50%的哮喘患者不服用推荐的抗炎药物，担心副作用，费用等。具有抗炎作用的非药物替代治疗可以保护这些患者免于加重。扩张气道的方法可能有助于作为补充治疗，并且一旦开始，可能会阻止恶化的进展。本研究的目的是评估心率变异性生物反馈（HRV-BF）在哮喘治疗中的作用，通过检查其对气道反应性和炎症的影响，这两个潜在的过程被认为是哮喘的中心特征。它将测试HRV-BF作为吸入性类固醇药物的替代或补充的疗效。我们以前的研究发现，它可以减少哮喘症状，改善肺功能，减少急性发作次数，减少哮喘药物的用量。本研究将通过研究其作为抗炎和支气管扩张剂的作用，研究其作为哮喘替代或补充治疗的作用，维斯吸入性类固醇维斯。在探索性分析中，我们还将估计其与推荐剂量的布地奈德相比的比例效应。为了更好地观察心率变异性对气道生物学的影响，我们将研究轻度至中度哮喘的激素依赖患者。主要结果测量将是气道反应性，通过乙酰甲胆碱激发试验进行评估。一个次要的结果测量将是呼出的一氧化氮，一个衡量气道炎症的指标。将60例轻度至中度哮喘受试者分别分配至两组中的一组，一组接受HRV-BF，另一组接受安慰剂生物反馈条件（PBO-BF）。第三组38名受试者将接受HRV-BF和一个月的标准吸入性皮质类固醇剂量（布地奈德720 mcg/天），以使我们能够估计HRV-BF产生的布地奈德效应的比例。受试者将接受10次HRV或PBO BF培训，之前进行一个月的行为导入，以更准确地评估哮喘严重程度和进行研究程序的能力。该研究将在两个合作中心进行，以确保客观性，专业知识和满足招聘目标。UMDNJ网站进行了最初的研究，并拥有主要的生物反馈专业知识，而国家犹太健康网站是一个国际知名的哮喘治疗中心，拥有主要的临床试验专业知识。我们将采取额外的探索性结局指标，评价HRV-BF对哮喘症状、肺功能（通过肺量计和强迫振荡肺描记术）、哮喘生活质量和心理应激的影响。 公共卫生相关性： 哮喘是一种影响10%人口的疾病，有效的非药物治疗对公共卫生很重要，因为近50%的哮喘患者未能服用处方类固醇药物，大大增加了残疾和费用。初步研究证明，心率变异性生物反馈使哮喘患者能够减少吸入类固醇药物，同时减轻哮喘症状和恶化并改善肺功能。本研究将使用标准和客观的研究方法验证初步结果，并将评估心率变异性生物反馈是否改变被认为是哮喘标志的两个生理标志物，即气道易激惹和气道炎症，并将确定这种治疗在多大程度上可以替代吸入性类固醇治疗，和/或它是否可以补充目前接受的一线治疗。

DESCRIPTION (provided by applicant): Asthma affects 10% of the US population, with 500 annual deaths. About 50% of asthma patients do not take recommended anti-inflammatory medication, fearing side effects, expense, etc. A nondrug alternative treatment with anti-inflammatory effects could protect these patients from exacerbations. A method that dilates the airways may be helpful as a complementary treatment, and may block progression of exacerbations,once started. The purpose of this study is to evaluate the role of heart rate variability biofeedback (HRV-BF) in asthma therapy by examining its effects on airways reactivity and inflammation, two underlying processes thought to be central characteristics of asthma. It will test the efficacy of HRV-BF as either an alternative or complement to inhaled steroid medication. Our previous research found that it decreased asthma symptoms, improved lung function, and decreased number of exacerbations, with decreased amounts of asthma medication. This study will investigate its role as an alternative or complementary treatment for asthma, vis-`- vis inhaled steroids, by studying its effects as an anti-inflammatory and a bronchodilator agent. In an exploratory analysis, we also will estimate its proportional effect compared with a recommended dose of budesonide. To best observe the effects of HRV-BF on airways biology we will study steroid-naove patients with mild to moderate asthma. The primary outcome measure will be airways reactivity, assessed by a methacholine challenge test. A secondary outcome measure will be exhaled nitric oxide, a measure of airways inflammation. Sixty subjects with mild to moderate asthma will each be assigned to one of two groups, one receiving HRV-BF and one receiving a placebo biofeedback condition (PBO-BF). A third group of 38 subjects will receive HRV-BF and one month of a standard inhaled corticosteroid dose (budesonide 720 mcg/day) to allow us to estimate the proportion of budesonide effects produced by HRV-BF. Subjects will receive 10 sessions of HRV or PBO BF training, preceded by a one-month behavioral run-in, to more accurately assess asthma severity and ability to carry out study procedures. The study will take place in two collaborating sites to insure objectivity, expertise, and meeting recruitment goals. The UMDNJ site conducted the original study and has major biofeedback expertise, while the National Jewish Health site is an internationally respected asthma treatment center, with major clinical trials expertise. We will take additional exploratory outcome measures evaluating the effect of HRV-BF on asthma symptoms, pulmonary function (through spirometry and forced oscillation pneumography), asthma quality of life, and psychological stress. PUBLIC HEALTH RELEVANCE: Effective nondrug treatment for asthma, a disease affecting 10% of the population, is important for public health because almost 50% of asthma patients fail to take prescribed steroid medications, substantially increasing disability and expense. Preliminary studies documented that heart rate variability biofeedback allows asthma patients to decrease inhaled steroid medication while decreasing asthma symptoms and exacerbations and improving lung function. This study will verify the preliminary findings using standard and objective research methodology, and will assess whether heart rate variability biofeedback changes two physiological markers considered to be hallmarks of asthma, namely airway irritability and airway inflammation, and will determine the extent to which this treatment can substitute for inhaled steroid treatment, and/or whether it can complement this currently accepted first-line treatment.