Advertisement

Topics

Long Term Chamomile Therapy for Anxiety

2014-07-24 14:07:25 | BioPortfolio

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.

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Generalized Anxiety Disorder

Intervention

Chamomile (Matricaria recutita)

Location

Depression Research Unit
Philadelphia
Pennsylvania
United States
19104-3309

Status

Recruiting

Source

National Center for Complementary and Alternative Medicine (NCCAM)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:07:25-0400

Clinical Trials [1347 Associated Clinical Trials listed on BioPortfolio]

Attention Training for Generalized Anxiety Disorder

Generalized Anxiety Disorder (GAD) has high prelevance (up to 8.5%; Roy-Byrne & Wagner, 2004) and leads to functional impairment (Wittchen et al., 2002; Ballenger et al., 2001). Researcher...

Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder

The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder

A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD)

Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder

The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.

Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD)

anxiety disorder is one of the major public health problems worldwide. 25% of people experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as the most p...

PubMed Articles [6133 Associated PubMed Articles listed on BioPortfolio]

Impaired discriminative fear conditioning during later training trials differentiates generalized anxiety disorder, but not panic disorder, from healthy control participants.

Fear conditioning is implicated as a central psychopathological mechanism of anxiety disorders. People with anxiety disorders typically demonstrate reduced affective discrimination between conditioned...

Protective Effects of Matricaria chamomilla Extract on Torsion/ Detorsion-Induced Tissue Damage and Oxidative Stress in Adult Rat Testis.

There is some evidence indicating that Matricaria chamomile (MC) had protective effects on ischemiareperfusion. In the present study, a rat model was used to investigate the effect of hydroalcoholic e...

Compromised dynamic cerebral autoregulation in patients with generalized anxiety disorder: a study using transfer function analysis.

Patients with generalized anxiety disorder (GAD) usually present with various neurological symptoms, but the mechanisms remain unclear. We aimed to analyze the characteristics of dynamic cerebral auto...

Generalized anxiety disorder and associated factors in adults in the Amazon, Brazil: A population-based study.

The purpose of this study was to assess the prevalence and associated factors of generalized anxiety disorder (GAD) in adults using the seven-item GAD scale (GAD-7) and to evaluate the properties of t...

Generalized anxiety disorder in urban China: Prevalence, awareness, and disease burden.

Limited published research has quantified the Generalized Anxiety Disorder (GAD) prevalence and its burden in China. This study aimed to fill in the knowledge gap and to evaluate the burden of GAD amo...

Medical and Biotech [MESH] Definitions

A plant genus of the family ASTERACEAE that is used in folk medicine as CHAMOMILE. Other plants with similar common names include MATRICARIA; TRIPLEUROSPERMUM and ANTHEMIS.

A plant genus of the family ASTERACEAE. It is easily confused with related plants with similar common names of Chamomile and Mayweed (MATRICARIA; CHAMAEMELUM; and ANTHEMIS).

Common name for several daisy-like plants (MATRICARIA; TRIPLEUROSPERMUM; ANTHEMIS; CHAMAEMELUM) native to Europe and Western Asia, now naturalized in the United States and Australia.

Anxiety disorder characterized by the persistent and irrational fear, anxiety, or avoidance of social or performance situations.

A plant genus of the family ASTERACEAE that is similar to MATRICARIA but this has tiny chaffy bract scales between each pair of florets. Members contain sesquiterpene lactones. Other plants with similar common names include FERULA; FOENICULUM; MATRICARIA; CHAMAEMELUM and TRIPLEUROSPERMUM.

More From BioPortfolio on "Long Term Chamomile Therapy for Anxiety"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Anxiety Disorders
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...

Psychiatry
Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial