Chamomile therapy for generalized anxiety disorder

甘菊疗法治疗广泛性焦虑症

• 批准号: 6965796
• 负责人: JAY D AMSTERDAM
• 金额: $ 19.81万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2007-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6965796
• 关键词: alternative medicine; anxiety disorders; behavior test; clinical research; clinical trials; data collection methodology /evaluation; dosage; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; interview; mental disorder chemotherapy; outcomes research; patient oriented research; plant extracts; psychological tests; statistics /biometry; tranquilizer; alternative medicine; anxiety disorders; behavior test; clinical research; clinical trials; data collection methodology /evaluation; dosage; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; interview; mental disorder chemotherapy; outcomes research; patient oriented research; plant extracts; psychological tests; statistics /biometry; tranquilizer

DESCRIPTION (provided by applicant): Generalized anxiety disorder (GAD) is a chronic, recurrent psychological disorder that affects up to 20% of the US adult population. To date, benzodiazepines (BZs) have been the mainstay therapy of anxiety disorders. However, the substantial addictive potential and troubling withdrawal symptoms of BZ therapy limits its therapeutic utility. Although efforts have been underway to develop non-habituating anti-anxiety agents, recent pharmaceutical trials with 5HT1A partial agonists have been disappointing. Chamomile, the subject of this proposal, is a traditional herbal medicine used for its psychological calming effect. Despite its widespread use and availability there have been no trials evaluating its effectiveness as an anti-anxiety agent in humans. Chamomile is exceedingly well tolerated, and demonstrates pharmacological activity in animal studies that suggest a profile of anti-anxiety activity. Although herbal agents like St John's Wort have been studied for their antidepressant activity by the NCCAM and NIMH, little attention has been given to alternative therapies for GAD. This grant seeks to evaluate the safety and efficacy of a standard preparation of chamomile for the treatment of mild to moderate GAD. A total of 60 patients will participate in a randomized, double blind, parallel group, 8-week comparison of chamomile 220 - 440 mg daily versus placebo. The primary aims of this grant are to (i) examine the safety and anti-anxiety efficacy profile of chamomile therapy for GAD, and (ii) generate pilot data to determine the optimum sample size necessary to establish the efficacy of chamomile in a future, fully powered efficacy trial.

描述（由申请人提供）：广义焦虑症（GAD）是一种慢性，经常性的心理障碍，影响美国成年人群的20％。迄今为止，苯二氮卓类药物（BZ）一直是焦虑症的主要疗法。但是，BZ治疗的巨大成瘾潜力和令人不安的戒断症状限制了其治疗效用。尽管正在努力开发非投放抗焦虑药，但最近使用5HT1A部分激动剂的药物试验令人失望。 该提案的主题是洋甘菊，是一种用于心理镇静作用的传统草药。尽管它广泛使用和可用性，但仍未进行过试验来评估其作为人类抗焦虑药的有效性。洋甘菊的耐受性极高，并在动物研究中表现出了药理学活性，这表明抗焦虑活性的特征。尽管NCCAM和NIMH像St John's Wert这样的草药剂对其抗抑郁活性进行了研究，但对GAD的替代疗法几乎没有关注。该赠款旨在评估洋甘菊在轻度到中度GAD治疗的标准制备的安全性和功效。共有60名患者将参加一个随机，双盲，平行组，每天为期8周的洋甘菊比较，每天与安慰剂相比。该赠款的主要目的是（i）检查洋甘菊疗法对GAD的安全性和抗焦虑功效，以及（ii）生成先导数据，以确定在将来，在将来建立洋甘菊疗效所必需的最佳样本量，该样本量完全由将来，全功能效率试验。