- Poster presentation
- Open Access
P02.118. Oral chamomile (Matricaria recutita) extract therapy of Generalized Anxiety Disorder (GAD): trial in progress
© Mao et al; licensee BioMed Central Ltd. 2012
- Published: 12 June 2012
- Anxiety Symptom
- Generalize Anxiety Disorder
- Clinical Global Impression
- Recurrent Generalize
- Generalize Anxiety Disorder Symptom
Chamomile is a traditional herb known for its calming effects. We are conducting a long-term, randomized, placebo-substitution study of chamomile for the prevention of recurrent Generalized Anxiety Disorder (GAD) in individuals who have responded to initial, open-label chamomile therapy. We present preliminary results from the trial’s open label phase to offer initial evidence of safety and effectiveness of chamomile in GAD.
A 38-week long-term relapse prevention trial with three phases. I: Eight weeks to determine whether individuals respond to chamomile; II: Four more weeks among responders to determine whether symptoms remain stable; III: An additional 26 weeks to determine whether chamomile is superior to placebo in preventing the recurrence of anxiety symptoms in responders. Subjects meet DSM IV-TR criteria for GAD, moderate severity. Study interventions include pharmaceutical grade chamomile extract (SHR-5) 1,500 mg daily standardized to 1.2% apigenin and comparable placebo. Primary outcome measures are the GAD-7, Hamilton Anxiety Rating (HAM-A), and Clinical Global Impression Severity (CGI/S) scales.
To date, 63 subjects have been enrolled, median age 48, range (24 to 71); 40 women, 23 men; 49 White, 6 African American, 6 Asian, 2 Other. Among the 48 subjects who completed phase I, a significant mean reduction of anxiety symptoms, as measured by GAD-7 (13.4 to 5.4, 59.7%, p≤0.001) and HAM-A (16.3 to 5.5, 66.2%, p≤0.001) have been observed. By a priori defined CGI-S and by 50% symptom reduction in GAD-7, 38 of those completing phase I (79.2%) met criteria for response. No serious adverse events were observed.
Preliminary findings are consistent with our previous RCT finding that over 50% of subjects with moderate or severe GAD symptoms respond to chamomile. The 1500mg dose of chamomile oral extract appears to be safe. More definitive and long-term relapse prevention findings await the completion of the trial.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.