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.
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