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Eur Arch Psychiatry Clin Neurosci. 2019 Mar;269(2):183-193. doi: 10.1007/s00406-017-0852-4. Epub 2017 Nov 17.

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

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Clinic and Polyclinic for Psychiatry and Psychotherapy, Ludwig Maximilian University, Munich, Germany.
Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine Schloss Werneck, Werneck, Germany.
Department of Clinical Research 1, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
Department of Biostatistics, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.


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.


Lavender oil; Meta-analysis; Silexan; Subthreshold anxiety; Treatment efficacy

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