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。约50%的哮喘患者不服用推荐的消炎药，担心副作用、费用等。一种具有抗炎作用的非药物替代治疗可以保护这些患者免受病情恶化。一种扩张气道的方法可能有助于作为一种补充治疗，并可能阻止恶化的进展，一旦开始。本研究的目的是通过检查其对气道反应性和炎症的影响来评估心率变异性生物反馈（HRV-BF）在哮喘治疗中的作用，这两个潜在的过程被认为是哮喘的核心特征。它将测试HRV-BF作为吸入类固醇药物的替代或补充的功效。我们之前的研究发现，它减少了哮喘症状，改善了肺功能，减少了哮喘发作的次数，减少了哮喘药物的用量。本研究将通过研究其作为抗炎剂和支气管扩张剂的作用，来研究其作为哮喘的替代或补充治疗的作用，而不是吸入类固醇。在探索性分析中，我们还将估计其与推荐剂量布地奈德的比例效应。为了更好地观察HRV-BF对气道生物学的影响，我们将研究未使用类固醇的轻中度哮喘患者。主要结果测量将是气道反应性，通过甲胆碱激发试验评估。第二项指标是呼出的一氧化氮，这是气道炎症的指标。60名轻度至中度哮喘患者将被分为两组，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皮质类固醇剂量（布地奈德720微克/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训练，在此之前进行一个月的行为训练，以更准确地评估哮喘的严重程度和执行研究程序的能力。研究将在两个合作地点进行，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，并具有主要的生物反馈专业知识，而国家犹太健康网站是国际上受人尊敬的哮喘治疗中心，具有主要的临床试验专业知识。我们将采取额外的探索性结果测量，评估HRV-BF对哮喘症状、肺功能（通过肺活量测定和强迫振荡肺造影）、哮喘生活质量和心理压力的影响。

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.