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Efficacy and safety of silexan, a new, orally administered lavender oil preparation, in subthreshold anxiety disorder – evidence from clinical trials

Wirksamkeit und Verträglichkeit von Silexan, einer neuen, oral verabreichten Zubereitung aus Lavendelöl, bei subsyndromaler Angststörung – Evidenz aus klinischen Prüfungen

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Diese Übersichtsarbeit untersucht die Wirksamkeit und Verträglichkeit von Silexan, einer neuartigen Zubereitung aus Lavendelöl zur oralen Anwendung, bei der Behandlung von Angsterkrankungen und verwandten Krankheitsbildern unter besonderer Berücksichtigung unterschwelliger Angststörungen. Es wurden 3 randomisierte Doppelblindstudien identifiziert, die die anxiolytische Wirksamkeit von Silexan bei subsyndromaler Angststörungen (vs. Plazebo; Behandlungsdauer 10 Wochen), bei generalisierten Angststörungen (GAS, vs. Lorazepam; 6 Wochen) und bei Unruhe und Agitiertheit (vs. Plazebo; 10 Wochen) gemäß DSM-IV- und ICD-10-Kriterien untersuchten. Zur Messung des Angstniveaus dienten die Hamilton Angstskala (HAMA). Insgesamt erhielten 280 Patienten 80 mg/Tag Silexan; 37 wurden mit 0,5 mg/Tag Lorazepam und 192 mit Placebo behandelt. Bei Behandlungsbeginn lag der HAMA-Gesamtwert in den Behandlungsgruppen zwischen 24,7 und 27,1 Punkten. Unter Silexan zeigten sich Abnahmen zwischen 10,4 ± 7,1 und 12,0 ± 7,2 Punkten nach 6 Wochen und zwischen 11,8 ± 7,7 und 16,0 ± 8,3 Punkten nach 10 Wochen. Bei Patienten mit GAS war die HAMA-Gesamtwert-Abnahme unter Silexan und Lorazepam vergleichbar (90 % KI für die Mittelwertsdifferenz: −2,3; 2,8 Punkte).


We review the data on the efficacy and tolerability of silexan, a novel preparation from lavender oil for oral use, in the treatment of anxiety disorders and related condition with particular attention to subthreshold generalized anxiety disorder (GAD). Three randomized, double-blind clinical trials were identified which investigated the efficacy of silexan in subsynromal anxiety disorder (vs. placebo; 10 weeks' treatment), in GAD (vs. lorazepam; 6 weeks), and in restlessness and agitation (vs. placebo; 10 weeks) according to DSM-IV and ICD-10 criteria. All trials assessed the participants' anxiety levels using the Hamilton Anxiety Scale (HAMA). Across all trials 280 patients were exposed to silexan 80 mg/day, 37 were treated with lorazepam 0.5 mg/day and 192 received placebo. Average within group HAMA total scores at baseline ranged between 24.7 and 27.1 points. Patients treated with silexan showed average HAMA total score decreases by between 10.4 ± 7.1 and 12.0 ± 7.2 points at week 6 and by between 11.8 ± 7.7 and 16.0 ± 8.3 points at week 10. In GAD silexan and lorazepam showed comparable HAMA total score reductions (90% CI for mean value difference: −2.3; 2.8 points).

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Kasper, S., Gastpar, M., Müller, W. et al. Efficacy and safety of silexan, a new, orally administered lavender oil preparation, in subthreshold anxiety disorder – evidence from clinical trials. Wien Med Wochenschr 160, 547–556 (2010).

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