Chamomile therapy for generalized anxiety disorder

描述(申请人提供)：广泛性焦虑症(GAD)是一种慢性、反复发作的心理障碍，影响多达20%的美国成年人口。到目前为止，苯二氮类药物(BZS)一直是焦虑症的主要治疗方法。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果。尽管一直在努力开发非习惯性抗焦虑药物，但最近用5HT1A部分激动剂进行的药物试验一直令人失望。 这项提案的主题是洋甘菊，它是一种传统草药，具有镇静心理的作用。尽管它被广泛使用和获得，但还没有试验评估它作为抗焦虑剂在人类身上的有效性。洋甘菊具有极好的耐受性，在动物研究中显示出药理活性，这表明它具有抗焦虑活性。尽管NCCAM和NIMH已经研究了圣约翰草等草药的抗抑郁活性，但很少有人关注GAD的替代疗法。这笔赠款旨在评估一种治疗轻度至中度广泛性焦虑症的标准制剂洋甘菊的安全性和有效性。总共60名患者将参加随机、双盲、平行组，每天服用220-440毫克洋甘菊与服用安慰剂进行为期8周的比较。这笔赠款的主要目的是(I)检查洋甘菊疗法治疗广泛性焦虑症的安全性和抗焦虑疗效概况，以及(Ii)产生试点数据，以确定在未来的全功率疗效试验中确定洋甘菊功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.