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European Archives of Psychiatry and Clinical Neuroscience

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Open Access 01-03-2019 | Original Paper

Efficacy of Silexan in subthreshold anxiety: meta-analysis of randomised, placebo-controlled trials

Authors: Hans-Jürgen Möller, Hans-Peter Volz, Angelika Dienel, Sandra Schläfke, Siegfried Kasper

Published in: European Archives of Psychiatry and Clinical Neuroscience | Issue 2/2019

Abstract

Subthreshold psychiatric disorders do not fully meet the diagnostic criteria of syndromal disorders but may be associated with comparable disability. To investigate the anxiolytic effect of Silexan, an active substance from lavender oil for oral administration, in patients with subthreshold anxiety, a meta-analysis that included all published trials with Silexan in this indication was performed. Three randomised, placebo-controlled trials in subthreshold anxiety disorders (anxiety disorder not otherwise specified, restlessness and agitation, mixed anxiety and depressive disorder) were included. Eligible participants with a baseline Hamilton Anxiety Rating Scale (HAMA) total score ≥ 18 points received 1 × 80 mg/day Silexan or placebo for 10 weeks. Outcomes included the HAMA, the Pittsburgh Sleep Quality Index, the Zung Self-rating Anxiety Scale, the Clinical Global Impressions questionnaire and the SF-36 health status inventory. Data were analysed using meta-analysis based on pooled raw data of individual patients (random effects models). A total of 697 patients were assessed for efficacy. Silexan was superior to placebo in reducing the HAMA total score during 10 weeks’ treatment [mean value difference, 95% confidence interval: 3.83 (1.28; 6.37) points]. Superiority was comparably pronounced for psychic and somatic anxiety as well as for observer- and self-rated anxiety. Silexan had a beneficial effect on sleep (secondary to the anxiolytic effect) without causing sedation and improved the patients’ health-related quality of life. Adverse event incidence in both treatment groups was comparable [risk ratio: 1.06 (0.85; 1.33)]. Silexan has a significant and clinically meaningful anxiolytic effect in subthreshold anxiety. The results cannot be generalised to other lavender oil products.

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Title: Efficacy of Silexan in subthreshold anxiety: meta-analysis of randomised, placebo-controlled trials
Authors: Hans-Jürgen Möller
Hans-Peter Volz
Angelika Dienel
Sandra Schläfke
Siegfried Kasper
Publication date: 01-03-2019
Publisher: Springer Berlin Heidelberg
Published in: European Archives of Psychiatry and Clinical Neuroscience / Issue 2/2019
Print ISSN: 0940-1334
Electronic ISSN: 1433-8491
DOI: https://doi.org/10.1007/s00406-017-0852-4

At a glance: The STEP trials

Springer Medicine

Efficacy of Silexan in subthreshold anxiety: meta-analysis of randomised, placebo-controlled trials

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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