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Silexan, an orally administered Lavandula oil preparation, is effective in the treatment of ‘subsyndromal’ anxiety disorder: a randomized, double-blind, placebo controlled trial

Kasper, Siegfrieda; Gastpar, Markusb; Müller, Walter E.c; Volz, Hans-Peterd; Möller, Hans-Jürgene; Dienel, Angelikaf; Schläfke, Sandraf

International Clinical Psychopharmacology: September 2010 - Volume 25 - Issue 5 - p 277-287
doi: 10.1097/YIC.0b013e32833b3242
ORIGINAL ARTICLES
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This study was performed to investigate the anxiolytic efficacy of silexan, a new oral lavender oil capsule preparation, in comparison to placebo in primary care. In 27 general and psychiatric practices 221 adults suffering from anxiety disorder not otherwise specified (Diagnostic and Statistical Manual of Mental disorders–IV 300.00 or International Statistical Classification of Diseases and Related Health Problems, Tenth revision F41.9) were randomized to 80 mg/day of a defined, orally administered preparation from Lavandula species or placebo for 10 weeks with visits every 2 weeks. A Hamilton Anxiety Scale (HAMA) total score ≥18 and a total score >5 for the Pittsburgh Sleep Quality Index (PSQI) were required. The primary outcome measures were HAMA and PSQI total score decrease between baseline and week 10. Secondary efficacy measures included the Clinical Global Impressions scale, the Zung Self-rating Anxiety Scale, and the SF–36 Health Survey Questionnaire. Patients treated with silexan showed a total score decrease by 16.0±8.3 points (mean±SD, 59.3%) for the HAMA and by 5.5±4.4 points (44.7%) for the PSQI compared to 9.5±9.1 (35.4%) and 3.8±4.1 points (30.9%) in the placebo group (P<0.01 one-sided, intention to treat). Silexan was superior to placebo regarding the percentage of responders (76.9 vs. 49.1%, P<0.001) and remitters (60.6 vs. 42.6%, P=0.009). Lavandula oil preparation had a significant beneficial influence on quality and duration of sleep and improved general mental and physical health without causing any unwanted sedative or other drug specific effects. Lavandula oil preparation silexan is both efficacious and safe for the relief of anxiety disorder not otherwise specified. It has a clinically meaningful anxiolytic effect and alleviates anxiety related disturbed sleep.

aDepartment of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria

bFliedner Klinik, Berlin

cPharmacological Institute for Natural Scientists, Johann-Wolfgang-Goethe University, Frankfurt

dHospital for Psychiatry, Psychotherapy and Psychosomatic Medicine, Schloss Werneck, Werneck

eClinic for Psychiatry and Psychotherapy, Ludwig Maximilians University, Munich

fDr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany

Correspondence to Professor Siegfried Kasper, MD, Department of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria

Tel: +43 1 40 400 3568; fax: +43 1 40 400 3099;

e-mail: sci-biolpsy@meduniwien.ac.at

Received 19 February 2010 Accepted 21 April 2010

© 2010 Lippincott Williams & Wilkins, Inc.