Chamomile therapy for generalized anxiety disorder

甘菊疗法治疗广泛性焦虑症

• 批准号: 7140052
• 负责人: JAY D AMSTERDAM
• 金额: $ 19.35万
• 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 2008-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7140052
• 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

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）：广泛性焦虑症 (GAD) 是一种慢性、复发性心理障碍，影响多达 20% 的美国成年人口。迄今为止，苯二氮卓类药物（BZ）已成为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用。尽管人们一直在努力开发非习惯性抗焦虑药物，但最近 5HT1A 部分激动剂的药物试验却令人失望。 本提案的主题洋甘菊是一种传统草药，具有镇静心理的作用。尽管其广泛使用和可用性，但尚未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，表明其具有抗焦虑活性。尽管 NCCAM 和 NIMH 已经研究了圣约翰草等草药的抗抑郁活性，但很少有人关注广泛性焦虑症的替代疗法。该资助旨在评估洋甘菊标准制剂治疗轻度至中度广泛性焦虑症的安全性和有效性。总共 60 名患者将参加为期 8 周的随机、双盲、平行组，对每日 220 - 440 毫克洋甘菊与安慰剂进行比较。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功效，以及（ii）生成试点数据以确定未来确定洋甘菊功效所需的最佳样本量，全功率功效试验。