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疾病之一。它们影响了多达 25% 的美国成年人口。广泛性焦虑症（GAD）是一种慢性、复发性的疾病。尽管苯二氮卓类药物和血清素再摄取抑制剂已成为广泛性焦虑症的主要治疗方法，但这些药物通常会带来不良副作用、习惯性和戒断症状。许多人出于经济、文化或个人原因（例如精神疾病的耻辱）而拒绝使用传统药物治疗。因此，许多人会寻求替代疗法来治疗他们的焦虑症状。确定广泛性焦虑症的有效替代疗法具有特别重要的意义。在焦虑的替代疗法中，洋甘菊因其镇静作用而被用作传统草药。它具有良好的耐受性，并在焦虑动物模型中表现出药理活性。尽管洋甘菊的用途和可用性广泛，但目前只有一项关于洋甘菊治疗广泛性焦虑症的安全性和有效性的临床试验。当前的应用程序旨在建立在先前洋甘菊研究结果的基础上。在那项为期 8 周的双盲安慰剂对照试验中，我们发现洋甘菊（与安慰剂相比）在减轻广泛性焦虑症症状方面具有显着优势。我们还发现洋甘菊的耐受性非常好（与安慰剂相比）。目前的申请旨在通过对洋甘菊预防广泛性焦虑症复发进行随机、双盲、平行组、安慰剂替代、长期安全性和有效性研究来扩展这些有希望的初步结果。对于具体目标#1，我们会问：“长期洋甘菊疗法（与安慰剂相比）是否会延长广泛性焦虑症恢复后焦虑症状复发的时间？”为了回答这个问题，180 名中度至重度广泛性焦虑症患者将每天接受开放标签洋甘菊提取物 500-1,500 毫克，持续 8 周。对洋甘菊有反应的患者，如果在另外 4 周的巩固治疗中保持良好状态，将被随机分配接受每日 500-1,500 毫克洋甘菊或安慰剂的双盲继续治疗，持续另外 26 周。我们假设继续洋甘菊治疗将导致复发时间延长（与安慰剂相比）。对于具体目标#2，我们会问：“对于广泛性焦虑症康复的患者，长期洋甘菊疗法（与安慰剂相比）的相对安全性和耐受性如何？”为了回答这个问题，我们将检查以下结果指标：（i）每种治疗条件下复发的患者比例； (ii) 治疗中出现的不良事件的频率、严重程度和持续时间； (iii) 初始双盲治疗期间出现停药症状的频率； (iv) 提前终止研究的频率。我们假设洋甘菊疗法将降低焦虑复发的比例和降低研究中止率（与安慰剂相比）。我们进一步假设洋甘菊疗法会导致相似的停药症状和治疗中出现的不良事件（与安慰剂相比）。 公共健康相关性：本申请题为“广泛性焦虑症的长期洋甘菊疗法”，已根据 PA-07-070 提交给 NIH/NCCAM。我们认为，它符合 NCCAM 的意图，即确定消费者已经使用的替代疗法是否安全有效。当前的申请建立在先前题为“洋甘菊疗法治疗广泛性焦虑症”的初步研究结果（R21 AT001916）的基础上，其中短期洋甘菊疗法在减少焦虑症状方面优于安慰剂。它还发现洋甘菊具有良好的耐受性。本申请将通过研究洋甘菊在预防焦虑复发方面的长期益处来扩展这些有希望的结果。