Chamomile therapy for generalized anxiety disorder

描述（由申请人提供）：广泛性焦虑症（GAD）是一种慢性，复发性心理障碍，影响高达20%的美国成年人口。迄今为止，苯二氮卓类药物（BZs）一直是焦虑症的主要治疗药物。然而，BZ疗法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。虽然一直在努力开发非习惯性抗焦虑药物，但最近使用5 HT 1A部分激动剂的药物试验令人失望。 洋甘菊，这个建议的主题，是一种传统的草药，用于其心理镇静作用。尽管其广泛使用和可用性，但没有试验评估其作为人类抗焦虑剂的有效性。洋甘菊的耐受性非常好，在动物研究中显示出药理活性，表明具有抗焦虑活性。虽然像圣约翰草这样的草药已经被NCCAM和NIMH研究了其抗抑郁活性，但很少有人关注GAD的替代疗法。这项资助旨在评估标准洋甘菊制剂治疗轻度至中度广泛性焦虑症的安全性和有效性。共有60名患者将参加一个随机、双盲、平行组，每天220 - 440 mg洋甘菊与安慰剂进行为期8周的比较。该补助金的主要目的是（i）检查洋甘菊治疗GAD的安全性和抗焦虑疗效概况，以及（ii）生成试点数据，以确定在未来的充分效力试验中确定洋甘菊疗效所需的最佳样本量。

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.