Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial
|Jun J Mao1,2,3*, Qing S Li1, Irene Soeller1, Kenneth Rockwell4, Sharon X Xie2 and Jay D Amsterdam5|
|1Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|2Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|3Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|4Penn Investigational Drug Service, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|5Depression Research Unit, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA|
|Corresponding Author :||Jun J Mao, MD, MSCE
Department Of Family Medicine and Community Health
University Of Pennsylvania, 227 Blockley Hall
423 Guardian Drive, Philadelphia, Pennsylvania 19104, USA
E-mail: [email protected]hs.upenn.edu
|Received July 30, 2014; Accepted October 07, 2014; Published October 09, 2014|
|Citation: Mao JJ, Li QS, Soeller I, Rockwell K, Xie SX, et al. (2014) Long- Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Trials 4:188. doi:10.4172/2167-0870.1000188|
|Copyright: © 2014 Mao JJ, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
Background: Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile (Matricaria recutita) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and longterm
safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD).
Methods/Design: 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500-1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500-1,500 mg daily or placebo for an additional 26 weeks.
The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy.
Discussion: Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD.
Trial Registration: ClinicalTrials.gov Trials Register NCT01072344.