“Silexan, an Orally Administered Lavandula Oil Preparation, Is Effective in the Treatment of ‘Subsyndromal’ Anxiety Disorder: a Randomized, Double-Blind, Placebo Controlled Trial”, 2010-09 (; backlinks):
[note: Kasper-authored] 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 80mg/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 statistically-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.
[Keywords: anxiety disorder, clinical trial, efficacy, Lavandula oil preparation, oral administration]
…Acknowledgments: The authors wish to thank Dr. Stephan Klement of Schwabe Pharmaceuticals for providing writing assistance for this manuscript. Professor Dr Kasper has received grant/research support from Eli Lilly, Lundbeck, Bristol-Myers Squibb, GlaxoSmithKline, Organon, Sepracor and Servier; has served as a consultant or on advisory boards for AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Lundbeck, Pfizer, Organon, Schwabe, Sepracor, Servier, Janssen, and Novartis; and has served on speakers’ bureaus for AstraZeneca, Eli Lily, Lundbeck, Schwabe, Sepracor, Servier, Pierre Fabre, and Janssen. Professor Dr Gastpar has served as member of advisory boards for Astra-Zeneca, Lundbeck, Schwabe, Servier and Wyeth. Professor Dr Muller received grant support from Sanofi-Aventis, UCB, Schwabe, CasellaMed and Novartis. He works as consultant for Bayer, Boehringer Ingelheim, CasellaMed, Jansson-Cilag, Lundbeck, Pfizer, Organon, Schwabe, UCB and Wyeth. As speaker he recently gave scientific presentations for Astra-Zeneca, Glaxo Smith Kline, Lundbeck, Pfizer, Eli-Lilly, UCB, Schwabe, Jansson-Cilag, Bristol Myers Squibb and Novartis. Professor Dr Volz has served as a consultant or on advisory boards for Astra/Zeneca, Eli Lilly, Lundbeck, Pfizer, Schwabe, Janssen, Otsuka, Merz, Wyeth and has serves on speakers’ bureaus for Astra/Zeneca, Eli Lilly, Lundbeck, Schwabe, Janssen, Merz, Wyeth. Lichtwer, Steigerwald, Hormosan, and Bristol-Myers Squibb. Professor Dr Moller has received grants or is a consultant for and on the speakership bureaus of AstraZeneca, Bristol-Myers Squibb, Eisai, Eli Lilly, GlaxoSmithKline, Janssen Cilag, Lundbeck, Schwabe, Merck, Novartis, Organon, Pfizer, Sanofi-Aventis, Sepracor, Servier and Wyeth.
Dr Dienel is an employee of Dr Willmar Schwabe GmbH & Co. KG. S Schlafke is an employee of Dr. Willmar Schwabe GmbH & Co. KG. Professor Dr Kasper, Professor Dr Gastpar, Professor Dr Muller, Professor Dr Volz, Professor Dr Moller and Dr Dienel are members of an advisory board to Schwabe Pharmaceuticals, manufacturer of the Lavandula oil preparation investigated in this trial, for the planning and interpretation of studies in anxiety disorders. This research was funded by Dr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.