Long-Term Chamomile Therapy of Generalized Anxiety Disorder

长期洋甘菊治疗广泛性焦虑症

• 批准号: 7777593
• 负责人: JAY D AMSTERDAM
• 金额: $ 39.75万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7777593
• 关键词: Acute; Adult; Adverse effects; Adverse event; Affect; Alternative Therapies; Animal Model; Anxiety; Anxiety Disorders; Benzodiazepines; Chamomile; Chamomile extract; Chronic; Clinical Trials; Consolidation Therapy; Data; Disease; Double-Blind Method; Frequencies; Generalized Anxiety Disorder; Grant; Herbal Medicine; Human; Individual; Longitudinal Studies; Mental disorders; Methodology; National Center for Complementary and Alternative Medicine; Outcome Measure; Patients; Pharmaceutical Preparations; Pharmacotherapy; Placebos; Population; Prospective Studies; Randomized; Recovery; Recurrence; Relapse; Relative (related person); Safety; Selective Serotonin Reuptake Inhibitor; Severities; Stigmata; Symptoms; Time; Withdrawal Symptom; discontinuation trial; double-blind placebo controlled trial; open label; prevent; public health relevance; social stigma; treatment duration

DESCRIPTION (provided by applicant): Anxiety disorders are among the most common psychiatric conditions. They affect up to 25% of the US adult population. Generalized anxiety disorder (GAD) is a chronic, recurrent form of the disorder. Although benzodiazepines and serotonin reuptake inhibitors have become the mainstay therapy of GAD, these drugs are often associated with unwanted side effects, habituation, and withdrawal symptoms. Many individuals decline using conventional drug therapy for financial, cultural, or personal reasons such as the stigma of mental illness. As a result, many individuals will seek alternative therapy for their anxiety symptoms. The identification of effective alternative therapies for GAD would be of particular relevance. Among alternative therapies for anxiety, chamomile has been used as a traditional herbal medicine for its calming effect. It is well tolerated and demonstrates pharmacological activity in animal models of anxiety. Despite its widespread use and availability, there has been only one clinical trial of chamomile safety and efficacy in GAD. The current application seeks to build upon the results of that prior chamomile study. In that 8-week, double-blind, placebo- controlled trial, we found a significant superiority of chamomile (vs. placebo) in reducing GAD symptoms. We also found chamomile to be exceedingly well tolerated (vs. placebo). The current application seeks to extend these promising preliminary results by conducting a randomized, double-blind, parallel group, placebo- substitution, long-term safety and efficacy study of chamomile in preventing GAD relapse. For specific aim #1 we will ask: "Does long-term chamomile therapy (vs. placebo) prolong the time to relapse of anxiety symptoms following recovery from GAD?" To answer this question, 180 patients with moderate to severe GAD will receive open-label chamomile extract 500-1,500 mg daily for 8 weeks. Responders to chamomile, who remain well for 4 additional weeks of consolidation therapy, will be randomized to double-blind continuation therapy with chamomile 500-1,500 mg daily or placebo for an additional 26 weeks. We hypothesize that continuation chamomile therapy will result in a prolonged time to relapse (vs. placebo). For specific aim #2 we will ask: "What is the relative safety and tolerability of long-term chamomile therapy (vs. placebo) in patients who have recovered from GAD?" To answer this question, we will examine the following outcome measures: (i) the proportion of patients in each treatment condition who relapse; (ii) the frequency, severity, and duration of treatment-emergent adverse events; (iii) the frequency of discontinuation symptoms during initial double-blind therapy; and, (iv) the frequency of early study discontinuation. We hypothesize that chamomile therapy will result in a lower proportion of anxiety relapses and a lower study discontinuation rate (vs. placebo). We further hypothesize that chamomile therapy will result in a similar frequency of discontinuation symptoms and treatment-emergent adverse events (vs. placebo). PUBLIC HEALTH RELEVANCE: This application, entitled "Long-Term Chamomile Therapy of Generalized Anxiety Disorder," is being submitted to the NIH/NCCAM under PA-07-070. We believe that it comports with the intent of the NCCAM to determine whether available alternative therapies already in use by consumers are safe and effective. The current application builds upon preliminary findings from a prior grant (R21 AT001916) entitled "Chamomile Therapy for Generalized Anxiety Disorder" in which short-term chamomile therapy was found to be superior to placebo in reducing anxiety symptoms. It also found chamomile to be well tolerated. The present application will extend these promising results by studying the long-term benefit of chamomile in preventing relapse of anxiety.

描述（由申请人提供）：焦虑症是最常见的精神病病。它们影响多达25％的美国成年人口。普遍的焦虑症（GAD）是疾病的慢性复发形式。尽管苯二氮卓类药物和5-羟色胺再摄取抑制剂已成为GAD的主要疗法，但这些药物通常与不必要的副作用，习惯和戒断症状有关。许多人出于财务，文化或个人原因（例如精神疾病的污名）使用常规药物治疗而拒绝。结果，许多人将寻求替代疗法以解决其焦虑症状。鉴定GAD的有效替代疗法将特别相关。在焦虑的替代疗法中，洋甘菊已被用作镇静作用的传统草药。它的耐受性良好，并在动物的焦虑模型中证明了药理活性。尽管它广泛使用和可用性，但GAD中只有一项洋甘菊安全性和功效的临床试验。当前的应用程序旨在基于先前的洋甘菊研究的结果。在为期8周的双盲，安慰剂对照试验中，我们发现洋甘菊（与安慰剂）在减轻GAD症状方面具有显着优越性。我们还发现洋甘菊的耐受性非常好（与安慰剂相比）。当前的应用旨在通过进行随机，双盲，平行组，安慰剂替代，长期安全性和洋甘菊在防止GAD复发方面的长期安全性和有效性研究来扩展这些有希望的初步结果。对于特定目标＃1，我们会问：“长期的洋甘菊疗法（与安慰剂）是否延长了从GAD恢复后焦虑症状复发的时间？”为了回答这个问题，180例中度至重度GAD患者将每天500-1,500毫克的开放标签洋甘菊提取物8周。对洋甘菊的响应者的综合疗法持续了4周，他们将与洋甘菊500-1,500毫克或安慰剂持续26周。我们假设持续的洋甘菊疗法将导致复发的时间延长（与安慰剂相比）。对于特定的目标＃2，我们将问：“从GAD中恢复过来的患者，长期洋甘菊疗法（与安慰剂）的相对安全性和耐受性是什么？”为了回答这个问题，我们将研究以下结果指标：（i）每种治疗状况中复发的患者比例； （ii）治疗急性不良事件的频率，严重性和持续时间； （iii）初始双盲治疗期间停用症状的频率；以及（iv）早期研究中断的频率。我们假设洋甘菊疗法将导致焦虑复发的比例较低，而研究中断率较低（与安慰剂相比）。我们进一步假设，洋甘菊疗法将导致类似的停用症状和治疗效果不良事件（与安慰剂）。 公共卫生相关性：根据PA-07-070，该应用名为“广义焦虑症的长期洋甘菊疗法”。我们认为，确定消费者已经使用的可用替代疗法是否安全有效。目前的申请基于先前赠款（R21 AT001916）的初步发现，标题为“普遍焦虑症的洋甘菊疗法”，在减少焦虑症状方面，短期洋甘菊治疗在减少焦虑症状方面比安慰剂优于安慰剂。它还发现洋甘菊耐受性良好。本应用将通过研究洋甘菊在防止焦虑复发方面的长期益处来扩展这些有希望的结果。