Long-Term Chamomile Therapy of Generalized Anxiety Disorder

长期洋甘菊治疗广泛性焦虑症

• 批准号: 7935164
• 负责人: JAY D AMSTERDAM
• 金额: $ 39.35万
• 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/7935164
• 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。他们影响了多达25%的美国成年人。广泛性焦虑症（GAD）是一种慢性、复发性焦虑症。虽然苯二氮卓类药物和5 -羟色胺再摄取抑制剂已成为广泛性焦虑症的主要治疗方法，但这些药物通常与不良副作用、习惯化和戒断症状有关。许多人由于经济、文化或个人原因（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将具有特别的意义。在治疗焦虑的替代疗法中，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显示出药理活性。尽管它的广泛使用和可用性，只有一个临床试验洋甘菊在广泛性焦虑症的安全性和有效性。目前的应用程序旨在建立在先前的洋甘菊研究的结果。在这项为期8周的双盲安慰剂对照试验中，我们发现洋甘菊（相对于安慰剂）在减轻广泛性焦虑症症状方面具有显著优势。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开展一项随机、双盲、平行组、安慰剂替代、洋甘菊预防广泛性焦虑症复发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。对于具体目标#1，我们会问：“长期洋甘菊治疗（与安慰剂相比）是否延长了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接受开放标签的洋甘菊提取物500- 1500毫克，每天服用8周。对洋甘菊有反应的患者，在4周的巩固治疗中保持良好，将随机分为双盲继续治疗组，每天服用500- 1500毫克洋甘菊或安慰剂，再服用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）。对于特定目标#2，我们会问：“长期洋甘菊治疗（与安慰剂相比）对广泛性焦虑症恢复的患者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)在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）最初双盲治疗期间停药症状的频率；（四）早期中止研究的频率。我们假设洋甘菊治疗将导致更低比例的焦虑复发和更低的研究中断率（与安慰剂相比）。我们进一步假设洋甘菊治疗将导致相似频率的停药症状和治疗中出现的不良事件（与安慰剂相比）。