Long Term Chamomile Therapy for Anxiety
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Prior research has shown that chamomile may be an effective, short-term anti-anxiety
      treatment. This study will examine the initial and long-term benefits of chamomile extract
      therapy for the prevention of recurrent anxiety disorder.
    

Detailed description: 
      Anxiety disorders are among the most common psychiatric conditions. They affect up to 25% of
      the US adult population. Generalized anxiety disorder (GAD) is a chronic, recurrent form of
      the disorder. Although benzodiazepines and serotonin reuptake inhibitors have become the
      mainstay therapy of GAD, these drugs are often associated with unwanted side effects,
      habituation, and withdrawal symptoms. Many individuals decline using conventional drug
      therapy for financial, cultural, or personal reasons such as the stigma of mental illness. As
      a result, many individuals will seek alternative therapy for their anxiety symptoms. The
      identification of effective alternative therapies for GAD would be of particular relevance.
      Among alternative therapies for anxiety, chamomile has been used as a traditional herbal
      medicine for its calming effect. It is well tolerated and demonstrates pharmacological
      activity in animal models of anxiety. Despite its widespread use and availability, there has
      been only one clinical trial of chamomile safety and efficacy in GAD. The current application
      seeks to build upon the results of that prior chamomile study. In that 8-week, double-blind,
      placebo-controlled trial, we found a significant superiority of chamomile (vs. placebo) in
      reducing GAD symptoms. We also found chamomile to be exceedingly well tolerated (vs.
      placebo). The current application seeks to extend these promising preliminary results by
      conducting a randomized, double-blind, parallel group, placebo-substitution, long-term safety
      and efficacy study of chamomile in preventing GAD relapse. For specific aim #1 we will ask:
      "Does long-term chamomile therapy (vs. placebo) prolong the time to relapse of anxiety
      symptoms following recovery from GAD?" To answer this question, 180 patients with moderate to
      severe GAD will receive open-label chamomile extract 500-1,500 mg daily for 8 weeks.
      Responders to chamomile, who remain well for 4 additional weeks of consolidation therapy,
      will be randomized to double-blind continuation therapy with chamomile 500-1,500 mg daily or
      placebo for an additional 26 weeks. We hypothesize that continuation chamomile therapy will
      result in a prolonged time to relapse (vs. placebo). For specific aim #2 we will ask: "What
      is the relative safety and tolerability of long-term chamomile therapy (vs. placebo) in
      patients who have recovered from GAD?" To answer this question, we will examine the following
      outcome measures: (i) the proportion of patients in each treatment condition who relapse;
      (ii) the frequency, severity, and duration of treatment-emergent adverse events; (iii) the
      frequency of discontinuation symptoms during initial double-blind therapy; and, (iv) the
      frequency of early study discontinuation. We hypothesize that chamomile therapy will result
      in a lower proportion of anxiety relapses and a lower study discontinuation rate (vs.
      placebo). We further hypothesize that chamomile therapy will result in a similar frequency of
      discontinuation symptoms and treatment-emergent adverse events (vs. placebo).
    

Intervention name(s): Chamomile (Matricaria recutita)
Intervention type(s): Drug
Intervention description(s): 500 mg 3 times daily
Other intervention name(s): Chamomile
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Chamomile; Herbal Remedy; Complementary and Alternative Medicine