Vortioxetine treatment for generalised anxiety disorder: a meta-analysis of anxiety, quality of life and safety outcomes.
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ABSTRACT:
Design:Systematic review and meta-analysis.
Data sources:Data mining was conducted in January 2019 across PubMed, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials Cochrane Library, Web of science and ClinicalTrials.gov.
Eligibility criteria for selecting studies:All published RCTs, which assessed the effect of vortioxetine treatment for patients with GAD when compared with a placebo group, were included.
Data extraction and synthesis:Relevant data were extracted and synthesised narratively. Results were expressed as standardised mean differences or ORs with 95% CIs.
Results:Our meta-analysis showed that multiple doses (2.5, 5 and 10?mg/day) of vortioxetine did not significantly improve the response rates, compared with placebo (OR 1.16, 95% CI 0.84 to 1.60, p=0.38; OR 1.41, 95% CI 0.82 to 2.41, p=0.21; and OR 1.05, 95% CI 0.76 to 1.46, p=0.75). Moreover, there was no statistically significant difference regarding the remission rates, discontinuation for any reason rates, discontinuation due to adverse events rates, Short-Form 36 Health Survey scores or Sheehan Disability Scale scores between administration of multiple doses (2.5, 5 and 10?mg/day) of vortioxetine and placebo.
Conclusions:Although our results suggest that vortioxetine did not improve the GAD symptoms, QoL and functional status impairment of patients with GAD, it was safe and well tolerated. Clinicians should interpret and translate our data with caution, as the meta-analysis was based on a limited number of RCTs.
SUBMITTER: Qin B
PROVIDER: S-EPMC6924794 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC3595214 | biostudies-literature
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| S-EPMC4351824 | biostudies-literature
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| S-EPMC8120527 | biostudies-literature
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| S-EPMC10289145 | biostudies-literature
Project description:BackgroundGeneralised anxiety disorder (GAD) is a chronic and pervasive condition that generates high levels of psychological stress, and it is difficult to treat in the long term. Current pharmacotherapeutic options for GAD are in some cases only modestly effective, and may elicit undesirable side effects. Through targeted actions on the gamma-aminobutyric acid (GABA) pathway, the South Pacific medicinal plant kava (Piper methysticum) is a non-addictive, non-hypnotic anxiolytic with the potential to treat GAD. The evidence for the efficacy of kava for treating anxiety has been affirmed through clinical trials and meta-analyses. Recent research has also served to lessen safety concerns regarding the use of kava due to hepatotoxic risk, which is reflected in a recent German court overturning the previous kava ban in that country (which may in turn influence a reinstatement by the European Union). The aim of current research is to assess the efficacy of an 'aqueous noble cultivar rootstock extract' of kava in GAD in a larger longer term study. In addition, we plan to investigate the pharmacogenomic influence of GABA transporters on response, effects of kava on gene expression, and for the first time, the neurobiological correlates of treatment response via functional and metabolic imaging.Methods/designThis clinical trial is funded by the Australian National Health and Medical Research Council (APP1063383) and co-funded by MediHerb (Integria Healthcare (Australia) Pty. Ltd). The study is a phase III, multi-site, two-arm, 18-week, randomised, double-blind, placebo-controlled study using an aqueous extract of noble kava cultivar (standardised to 240 mg of kavalactones per day) versus matching placebo in 210 currently anxious participants with diagnosed GAD who are non-medicated. The study takes place at two sites: the Centre for Human Psychopharmacology (Swinburne University of Technology), Hawthorn, Melbourne, Australia; and the Academic Discipline of Psychiatry (The University of Queensland) based at the Royal Brisbane and Women's Hospital, Herston, Brisbane, Australia. Written informed consent will be obtained from each participant prior to commencement in the study. The primary outcome is the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). The secondary outcomes involve a range of scales that assess affective disorder symptoms and quality of life outcomes, in addition to the study of mediating biomarkers of response (assessed via genomics and neuroimaging).DiscussionIf this study demonstrates positive findings in support of the superiority of kava over placebo in the treatment of GAD, and also is shown to be safe, then this plant-medicine can be considered a 'first-line' therapy for GAD. Genomic and neuroimaging data may reveal clinical response patterns and provide more evidence of the neurobiological activity of the plant extract.Trial registration informationClinicalTrials.gov: NCT02219880 Date: 13 August 2014:.
| S-EPMC4630875 | biostudies-literature
Project description:Background:Cognitive-behavioural therapy (CBT) is the treatment of choice for generalised anxiety disorder (GAD), yielding significant improvements in approximately 50% of patients. There is significant room for improvement in the outcomes of treatment, especially in recovery. Aims:We aimed to compare metacognitive therapy (MCT) with the gold standard treatment, CBT, in patients with GAD (clinicaltrials.gov identifier: NCT00426426). Method:A total of 246 patients with long-term GAD were assessed and 81 were randomised into three conditions: CBT (n = 28), MCT (n = 32) and a wait-list control (n = 21). Assessments were made at pre-treatment, post-treatment and at 2 year follow-up. Results:Both CBT and MCT were effective treatments, but MCT was more effective (mean difference 9.762, 95% CI 2.679-16.845, P = 0.004) and led to significantly higher recovery rates (65% v. 38%). These differences were maintained at 2 year follow-up. Conclusions:MCT seems to produce recovery rates that exceed those of CBT. These results demonstrate that the effects of treatment cannot be attributed to non-specific therapy factors. Declaration of interest:A.W. wrote the treatment protocol in MCT and several books on CBT and MCT, and receives royalties from these. T.D.B. wrote the protocol in CBT and has published several articles and chapters on CBT and receives royalties from these. All other authors declare no competing interests.
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Project description:ObjectiveGeneralised anxiety disorder (GAD) is the most common anxiety disorder in the general population and has been associated with high economic and human burden. However, it has been neglected in the health services literature. The objective of this study is to assess whether GAD leads to hospital admissions using data from the European Prospective Investigation of Cancer-Norfolk. Other aims include determining whether early-onset or late-onset forms of the disorder, episode chronicity and frequency, and comorbidity with major depressive disorder (MDD) contribute to hospital admissions.DesignLarge, population study.SettingUK population-based cohort.Participants30?445 British participants were recruited through general practice registers in England. Of these, 20?919 completed a structured psychosocial questionnaire used to identify presence of GAD. Anxiety was assessed in 1996-2000, and health service use was captured between 1999/2000 and 2009 through record linkage with large, administrative health databases. 17?939 participants had complete data on covariates.Main outcome measurePast-year GAD defined according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition.ResultsIn this study, there were 2.2% (393/17 939) of respondents with GAD. Anxiety was not independently associated with hospital admissions (incidence rate ratio (IRR)=1.04, 95%?CI 0.90 to 1.20) over 9?years. However, those whose anxiety was comorbid with depression showed a statistically significantly increased risk for hospital admissions (IRR=1.23, 95%?CI 1.02 to 1.49).ConclusionPeople with GAD and MDD comorbidity were at an increased risk for hospital admissions. Clinicians should consider that meeting criteria for a pure or individual disorder at one point in time, such as past-year GAD, does not necessarily predict deleterious health outcomes; rather different forms of the disorder, such as comorbid cases, might be of greater importance.
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Project description:BackgroundDigital interventions (DIs) are increasingly being used in mental health care, despite limited evidence regarding their value for money. This study aimed to evaluate the cost effectiveness of DIs for generalised anxiety disorder (GAD), in comparison with alternative care options, from the perspective of the UK health care system.MethodsAn open-source decision analytic cohort model was used to extrapolate the results of a network meta-analysis over a patient's lifetime and estimate the costs and outcomes (quality-adjusted life-years) of DIs and their comparators. The net monetary benefit (NMB) and probability of cost effectiveness was estimated for each comparator, and we conducted a Value of Information analysis to evaluate the scale and drivers of uncertainty.ResultsDIs were associated with lower NMB compared with medication and with group therapy, but greater NMB compared with non-therapeutic controls and with usual care. DIs that were supported by a clinician, an assistant or a lay person had higher delivery costs than purely patient-self-directed DIs, yielding a greater NMB when opportunity cost was above £3000/QALY. There was considerable uncertainty in the findings driven largely by uncertainty in the estimated treatment effects. The value of further research to establish the effectiveness of DIs for GAD was substantial, at least £12.9 billion.ConclusionsThe high uncertainty about these results does not allow for recommendations based on the cost effectiveness of DIs. However, the analysis highlights areas for future research, and demonstrates that apparent cost savings associated with DIs can be offset by reduced effectiveness.
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