Siegfried Kasper1, Walter E Müller2, Hans-Peter Volz3, Hans-Jürgen Möller4, Egon Koch5, Angelika Dienel5. 1. a Department of Psychiatry and Psychotherapy , Medical University of Vienna , Vienna , Austria. 2. b Department of Pharmacology Biocenter , Goethe-University , Frankfurt , Germany. 3. c Psychotherapy and Psychosomatic Medicine , Hospital for Psychiatry , Werneck , Germany. 4. d Clinic for Psychiatry and Psychotherapy , Ludwig Maximilians University , Munich , Germany. 5. e Research and Development Department, Dr. Willmar-Schwabe GmbH & Co. KG , Karlsruhe , Germany.
Abstract
OBJECTIVES: Silexan is a lavender oil preparation available in 80-mg capsules. Here we review clinical trials investigating its anxiolytic efficacy, safety and tolerability in humans, as well as preclinical investigations supporting this therapeutic use. METHODS: Besides three selected publications reporting preclinical investigations, seven clinical trials are included, of which five had a treatment duration of 6 or 10 weeks. Primary outcome measure was the HAM-A total score reduction, while single items were assessed with regard to effects on concomitant depressive symptoms and on quality of sleep. RESULTS: In patients with subthreshold (subsyndromal) anxiety or generalised anxiety disorder (GAD), an anxiolytic effect of Silexan was evident after 2 weeks. HAM-A total score reductions between baseline and end of treatment were significantly superior to placebo in patients with subthreshold anxiety and comparable with those achieved under lorazepam or paroxetine in patients with GAD. In addition, Silexan had beneficial effects on typical concomitant symptoms of anxiety disorders, such as impaired sleep, somatic complaints, co-morbid depression or decreased quality of life. Except for mild gastrointestinal symptoms, Silexan did not induce any adverse effects and did not cause drug interactions, sedation or withdrawal symptoms at daily doses of 80 or 160 mg. CONCLUSIONS: Silexan is a safe and effective treatment in anxiety disorders.
OBJECTIVES:Silexan is a lavender oil preparation available in 80-mg capsules. Here we review clinical trials investigating its anxiolytic efficacy, safety and tolerability in humans, as well as preclinical investigations supporting this therapeutic use. METHODS: Besides three selected publications reporting preclinical investigations, seven clinical trials are included, of which five had a treatment duration of 6 or 10 weeks. Primary outcome measure was the HAM-A total score reduction, while single items were assessed with regard to effects on concomitant depressive symptoms and on quality of sleep. RESULTS: In patients with subthreshold (subsyndromal) anxiety or generalised anxiety disorder (GAD), an anxiolytic effect of Silexan was evident after 2 weeks. HAM-A total score reductions between baseline and end of treatment were significantly superior to placebo in patients with subthreshold anxiety and comparable with those achieved under lorazepam or paroxetine in patients with GAD. In addition, Silexan had beneficial effects on typical concomitant symptoms of anxiety disorders, such as impaired sleep, somatic complaints, co-morbid depression or decreased quality of life. Except for mild gastrointestinal symptoms, Silexan did not induce any adverse effects and did not cause drug interactions, sedation or withdrawal symptoms at daily doses of 80 or 160 mg. CONCLUSIONS:Silexan is a safe and effective treatment in anxiety disorders.