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Specific expectancies are associated with symptomatic outcomes and side effect burden in a trial of chamomile extract for generalized anxiety disorder.

ABSTRACT: OBJECTIVE:Patient expectancies are hypothesized to contribute to the efficacy and side effects of psychiatric treatments, but little research has investigated this hypothesis in the context of psychopharmacological therapies for anxiety. We prospectively investigated whether expectancies predicted efficacy and adverse events in oral therapy for Generalized Anxiety Disorder (GAD), controlling for confounding patient characteristics correlating with outcomes. METHODS:Expectancies regarding treatment efficacy and side effects were assessed at baseline of an eight week open-label phase of a trial of chamomile for Generalized Anxiety Disorder (GAD). The primary outcome was patient-reported GAD-7 scores, with clinical response and treatment-emergent side-effects as secondary outcomes. Expectancies were used to predict symptomatic and side-effect outcomes. RESULTS:Very few baseline patient characteristics predicted either type of expectancy. Controlling for a patient's predicted recovery based on their baseline characteristics, higher efficacy expectancies at baseline predicted greater change on the GAD-7 (adjusted ? = -0.19, p = 0.011). Efficacy expectancies also predicted a higher likelihood of attaining clinical response (adjusted odds ratio = 1.69, p = 0.002). Patients with higher side effect expectancies reported more side effects (adjusted log expected count = 0.26, p = 0.038). Efficacy expectancies were unrelated to side effect reports (log expected count = -0.05, p = 0.680), and side effect expectancies were unrelated to treatment efficacy (? = 0.08, p = 0.306). CONCLUSIONS:Patients entering chamomile treatment for GAD with more favorable self-generated expectancies for the treatment experience greater improvement and fewer adverse events. Aligning patient expectancies with treatment selections may optimize outcomes. REGISTRATION:Trial Number NCT01072344 at ClinicalTrials.gov.

SUBMITTER: Keefe JR

PROVIDER: S-EPMC5589134 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Specific expectancies are associated with symptomatic outcomes and side effect burden in a trial of chamomile extract for generalized anxiety disorder.

Keefe John R JR Amsterdam Jay J Li Qing S QS Soeller Irene I DeRubeis Robert R Mao Jun J JJ

Journal of psychiatric research 20160930

<h4>Objective</h4>Patient expectancies are hypothesized to contribute to the efficacy and side effects of psychiatric treatments, but little research has investigated this hypothesis in the context of psychopharmacological therapies for anxiety. We prospectively investigated whether expectancies predicted efficacy and adverse events in oral therapy for Generalized Anxiety Disorder (GAD), controlling for confounding patient characteristics correlating with outcomes.<h4>Methods</h4>Expectancies re ...[more]

PMID: 27716513

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Project description:Objectives: This exploratory analysis examined the putative antidepressant effect of Matricaria chamomilla L. (chamomile) extract in subjects with generalized anxiety disorder (GAD) with or without comorbid depression. It was hypothesized that chamomile extract would demonstrate similar anxiolytic activity in both subgroups, but superior antidepressant activity in GAD subjects with comorbid depression. Design: As part of a randomized double-blind placebo-controlled trial of chamomile extract for relapse prevention of GAD, 179 subjects received initial therapy with open-label chamomile extract 1500 mg daily for 8 weeks. Linear mixed-effect models were used to identify clinically meaningful changes in anxiety and depression symptoms between diagnostic subgroups. Settings/Location: The study took place at the University of Pennsylvania in Philadelphia, PA. Subjects: Subjects were ≥18 years old with a primary DSM IV-TR diagnosis of GAD. They were subcategorized into two diagnostic groups: GAD without comorbid depression (n = 100) and GAD with comorbid depression (n = 79). Interventions: Open-label chamomile extract 1500 mg was given daily for 8 weeks. Outcome measures: Generalized anxiety disorder (GAD-7), Hamilton rating scale for anxiety, Beck anxiety inventory, Hamilton rating scale for depression (HRSD), the six-item core HRSD (items 1, 2, 3, 7, 8, and 13), and the Beck depression inventory (BDI). Results: The authors observed similar anxiolytic effects over time in both diagnostic subgroups. However, there was a greater reduction in HRSD core symptom scores (p < 0.023), and a trend level reduction in HRSD total scores (p = 0.14) and in BPI total scores (p = 0.060) in subjects with comorbid depression. Conclusions: M. chamomilla L. may produce clinically meaningful antidepressant effects in addition to its anxiolytic activity in subjects with GAD and comorbid depression. Future controlled trials in subjects with primary major depressive disorder are needed to validate this preliminary observation.

Project description:BackgroundGeneralized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects.PurposeTo evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse.MethodsOutpatients from primary care practices and local communities with a primary diagnosis of moderate-to-severe GAD were enrolled for this two-phase study at a large US academic medical center. During Phase 1, eligible participants received 12 weeks of open-label therapy with chamomile pharmaceutical grade extract 1500mg (500mg capsule 3 times daily). During Phase 2, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo in a double-blinded, placebo-substitution design. The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Secondary outcomes included the proportion who relapsed, treatment-emergent adverse events, and vital sign changes. This study is registered at ClinicalTrials.gov, identifier NCT01072344.ResultsBetween March 1, 2010, and June 30, 2015, we enrolled 179 participants. Of those, 93 (51.9%) were responders and agreed to continue in the double-blind randomized controlled trial. A numerically greater number of placebo-switched (n=12/47; 25.5%) versus chamomile-continuation (n = 7/46; 15.2%) participants relapsed during follow-up. Mean time to relapse was 11.4 ± 8.4 weeks for chamomile and 6.3 ± 3.9 weeks for placebo. Hazard of relapse was non-significantly lower for chamomile (hazard ratio, 0.52; 95% CI, 0.20-1.33; P = 0.16). During follow-up, chamomile participants maintained significantly lower GAD symptoms than placebo (P = 0.0032), with significant reductions in body weight (P = 0.046) and mean arterial blood pressure (P = 0.0063). Both treatments had similar low adverse event rates.ConclusionsLong-term chamomile was safe and significantly reduced moderate-to-severe GAD symptoms, but did not significantly reduce rate of relapse. Our limited sample size and lower than expected rate of placebo group relapse likely contributed to the non-significant primary outcome finding. Possible chamomile superiority over placebo requires further examination in large-scale studies.

Project description:BACKGROUND:Conventional drug treatments for Generalized Anxiety Disorder (GAD) are often accompanied by substantial side effects, dependence, and/or withdrawal syndrome. A prior controlled study of oral chamomile (Matricaria chamomilla L.) extract showed significant efficacy versus placebo, and suggested that chamomile may have anxiolytic activity for individuals with GAD. HYPOTHESIS:We hypothesized that treatment with chamomile extract would result in a significant reduction in GAD severity ratings, and would be associated with a favorable adverse event and tolerability profile. STUDY DESIGN:We report on the open-label phase of a two-phase randomized controlled trial of chamomile versus placebo for relapse-prevention of recurrent GAD. METHODS:Subjects with moderate to severe GAD received open-label treatment with pharmaceutical-grade chamomile extract 1500mg/day for up to 8 weeks. Primary outcomes were the frequency of clinical response and change in GAD-7 symptom scores by week 8. Secondary outcomes included the change over time on the Hamilton Rating Scale for Anxiety, the Beck Anxiety Inventory, and the Psychological General Well Being Index. Frequency of treatment-emergent adverse events and premature treatment discontinuation were also examined. RESULTS:Of 179 subjects, 58.1% (95% CI: 50.9% to 65.5%) met criteria for response, while 15.6% prematurely discontinued treatment. Significant improvement over time was also observed on the GAD-7 rating (?=-8.4 [95% CI=-9.1 to -7.7]). A similar proportion of subjects demonstrated statistically significant and clinically meaningful reductions in secondary outcome ratings of anxiety and well-being. Adverse events occurred in 11.7% of subjects, although no serious adverse events occurred. CONCLUSION:Chamomile extract produced a clinically meaningful reduction in GAD symptoms over 8 weeks, with a response rate comparable to those observed during conventional anxiolytic drug therapy and a favorable adverse event profile. Future comparative effectiveness trials between chamomile and conventional drugs may help determine the optimal risk/benefit of these therapies for patients suffering from GAD.

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Specific expectancies are associated with symptomatic outcomes and side effect burden in a trial of chamomile extract for generalized anxiety disorder.

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Specific expectancies are associated with symptomatic outcomes and side effect burden in a trial of chamomile extract for generalized anxiety disorder.

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