Lavender oil preparation Silexan is effective in generalized anxiety disorder--a randomized, double-blind comparison to placebo and paroxetine.
The anxiolytic efficacy of the orally administered lavender oil preparation Silexan was investigated in generalized anxiety disorder (GAD) in comparison to placebo and paroxetine. In this randomized, double-blind, double-dummy trial 539 adults with GAD according to DSM-5 criteria and a Hamilton Anxiety Scale (HAMA) total score ⩾ 18 points participated and received 160 or 80 mg Silexan, 20 mg paroxetine, or placebo once daily for 10 wk. The primary efficacy endpoint was the HAMA total score reduction between baseline and treatment end. The HAMA total score decreased by 14.1 ± 9.3 points for Silexan 160 mg/d, 12.8 ± 8.7 points for Silexan 80 mg/d, 11.3 ± 8.0 points for paroxetine, and 9.5 ± 9.0 points for placebo (mean ± s.d.). Silexan 160 and 80 mg/d were superior to placebo in reducing the HAMA total score (p < 0.01) whereas paroxetine showed a trend towards significance (p = 0.10) in the full analysis set. The difference between paroxetine and placebo was more pronounced in the analysis of observed cases (HAMA total score reduction: p < 0.01). In the Silexan 160 mg/d group 73/121 patients (60.3%) showed a HAMA total score reduction ⩾ 50% of the baseline value and 56 (46.3%) had a total score <10 points at treatment end, compared to 70/135 (51.9%) and 45 (33.3%) for Silexan 80 mg/d, 57/132 (43.2%) and 45 (34.1%) for paroxetine, and 51/135 (37.8%) and 40 (29.6%) for placebo. In addition, Silexan showed a pronounced antidepressant effect and improved general mental health and health-related quality of life. Incidence densities of adverse events (AEs) were 0.006 AEs/d for Silexan 160 mg/d, 0.008 AEs/d for 80 mg/d, 0.011 AEs/d for paroxetine, and 0.008 AEs/d for placebo. In GAD Silexan is more efficacious than placebo. AE rates for Silexan were comparable to placebo and lower than for the active control paroxetine.
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.
Siegfried
S
Kasper
Fliedner Klinik Berlin, Charlottenstraße 65, 10117 Berlin, Germany.
Markus
M
Gastpar
Department of Pharmacology, Biocenter Goethe-University, Max-von-Laue-Straße 9, 60438 Frankfurt, Germany.
Walter E
WE
Müller
Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine, Schloss Werneck, Balthasar-Neumann-Platz 1, 97440 Werneck, Germany.
Hans-Peter
HP
Volz
Clinic for Psychiatry and Psychotherapy, Ludwig Maximilians University, Nußbaumstraße 7, Munich, Germany.
Hans-Jürgen
HJ
Möller
Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Straße 4, 76227 Karlsruhe, Germany.
Sandra
S
Schläfke
Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Straße 4, 76227 Karlsruhe, Germany.
Angelika
A
Dienel
D000284:Administration, Oral; D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000009:adverse effects; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000523:psychology; D003863:Depression / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006801:Humans; D027523:Lavandula; D008297:Male; D008875:Middle Aged; D009822:Oils, Volatile / Q000008:administration & dosage* / Q000009:adverse effects; D017374:Paroxetine / Q000008:administration & dosage* / Q000009:adverse effects; D010938:Plant Oils / Q000008:administration & dosage* / Q000009:adverse effects; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012074:Remission Induction; D016896:Treatment Outcome
D014151:Anti-Anxiety Agents; D000928:Antidepressive Agents; D009822:Oils, Volatile; D010938:Plant Oils; D017374:Paroxetine; C045718:lavender oil