PMID- 36717399 OWN - NLM STAT- MEDLINE DCOM- 20230831 LR - 20230901 IS - 1433-8491 (Electronic) IS - 0940-1334 (Print) IS - 0940-1334 (Linking) VI - 273 IP - 7 DP - 2023 Oct TI - Efficacy of Silexan in patients with anxiety disorders: a meta-analysis of randomized, placebo-controlled trials. PG - 1615-1628 LID - 10.1007/s00406-022-01547-w [doi] AB - INTRODUCTION: We report on a meta-analysis of Silexan, a proprietary active substance produced from Lavandula angustifolia, in subthreshold anxiety, mixed anxiety and depressive disorder (MADD), and generalized anxiety disorder (GAD). METHODS: The present analyses are based on all currently completed 5 double-blind, randomized, placebo-controlled trials investigating Silexan in adult out-patients who received Silexan 1 x 80 mg/day or placebo for ten weeks according to random assignment (n = 1213). Efficacy was assessed based on the Hamilton Anxiety Rating Scale (HAMA), several anxiety self-rating scales, the Clinical Global Impression (CGI) scale, and the Short Form-36 (SF-36) health status questionnaire. RESULTS: After ten weeks' treatment, Silexan was significantly superior to placebo in reducing the HAMA total score (including the psychic and somatic anxiety sub-scores) and self-rated anxiety. Based on a >/= 50% HAMA total score reduction, the responder rate ratio was 1.34 favoring Silexan, and the rate ratio of subjects much or very much improved according to the CGI was 1.51. Silexan was also significantly superior in improving the physical and mental health summary scores of the SF-36. There were no significant between-group differences concerning the occurrence of adverse events (AEs), serious AEs, and premature withdrawal due to AEs. CONCLUSIONS: This meta-analysis demonstrates that Silexan exerts significant anxiolytic effects in subthreshold anxiety, GAD and MADD that were consistently reflected in investigator ratings and patient-reported outcomes, including improvement of health-related life-quality, while showing favorable tolerability and safety. CI - (c) 2023. The Author(s). FAU - Dold, Markus AU - Dold M AUID- ORCID: 0000-0001-8914-2192 AD - Department of Psychiatry and Psychotherapy, Medical University of Vienna, Wahringer Gurtel 18-20, 1090, Vienna, Austria. FAU - Bartova, Lucie AU - Bartova L AD - Department of Psychiatry and Psychotherapy, Medical University of Vienna, Wahringer Gurtel 18-20, 1090, Vienna, Austria. FAU - Volz, Hans-Peter AU - Volz HP AD - Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine Schloss Werneck, Balthasar-Neumann-Platz 1, 97440, Werneck, Germany. FAU - Seifritz, Erich AU - Seifritz E AD - Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital of the University of Zurich, Zurich, Switzerland. FAU - Moller, Hans-Jurgen AU - Moller HJ AD - Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University Munich, Nussbaumstrasse 7, 80336, Munich, Germany. FAU - Schlafke, Sandra AU - Schlafke S AD - Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Strasse 4, 76227, Karlsruhe, Germany. FAU - Kasper, Siegfried AU - Kasper S AD - Center of Brain Research, Medical University of Vienna, Spitalgasse 4, 1090, Vienna, Austria. siegfried.kasper@meduniwien.ac.at. LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20230130 PL - Germany TA - Eur Arch Psychiatry Clin Neurosci JT - European archives of psychiatry and clinical neuroscience JID - 9103030 RN - ZBP1YXW0H8 (lavender oil) RN - 0 (Plant Oils) RN - 0 (Oils, Volatile) RN - 0 (Anti-Anxiety Agents) SB - IM MH - Adult MH - Humans MH - Plant Oils MH - *Oils, Volatile MH - Anxiety Disorders/drug therapy/chemically induced MH - *Lavandula MH - *Anti-Anxiety Agents/adverse effects MH - Double-Blind Method MH - Treatment Outcome MH - Randomized Controlled Trials as Topic PMC - PMC10465640 OTO - NOTNLM OT - Anxiety disorders OT - Efficacy OT - Lavender OT - Meta-analysis OT - Silexan OT - Tolerability COIS- MD has received travel grants and consultant/speaker honoraria from Medizin Medien Austria and Janssen. Within the last three years, LB has received travel grants and consultant/speaker honoraria from Medizin Medien Austria, Universimed, Schwabe Austria, Janssen and Angelini. Within the last three years, HPV has served as a consultant or on advisory boards for Astra/Zeneca, Eli Lilly, Lundbeck, Pfizer, Schwabe, Janssen, Otsuka, Angelini, and Sage and has served on speakers' bureaus for Astra/Zeneca, Eli Lilly, Lundbeck, Schwabe, Janssen, Bayer, Recordati and neuraxpharm. ES received in the last three years honoraria and grants for advice and educational lectures from Lundbeck Switzerland, Schwabe Switzerland and Germany, Janssen Switzerland, Otsuka Switzerland, Mepha Pharma Switzerland, Otsuka Pharma Switzerland, Ricordati Switzerland and Sunovion Pharma UK and Angelini. HJM has received grant/research support, consulting fees and honoraria within the last years from AstraZeneca, Lundbeck, Otsuka, and Schwabe. SS is employee of Dr. Willmar Schwabe GmbH & Co. KG. SK has received grant/research support from Lundbeck; he has served as a consultant or on advisory boards for Angelini, Biogen, Esai, Janssen, IQVIA, Lundbeck, Mylan, Recordati, Sage and Schwabe; and he has served on speakers bureaus for Aspen Farmaceutica S.A., Angelini, Biogen, Janssen, Lundbeck, Neuraxpharma, Recordati, Sage, Sanofi, Schwabe, Servier and Sun Pharma. EDAT- 2023/01/31 06:00 MHDA- 2023/08/31 06:42 PMCR- 2023/01/30 CRDT- 2023/01/30 23:13 PHST- 2022/07/07 00:00 [received] PHST- 2022/12/19 00:00 [accepted] PHST- 2023/08/31 06:42 [medline] PHST- 2023/01/31 06:00 [pubmed] PHST- 2023/01/30 23:13 [entrez] PHST- 2023/01/30 00:00 [pmc-release] AID - 10.1007/s00406-022-01547-w [pii] AID - 1547 [pii] AID - 10.1007/s00406-022-01547-w [doi] PST - ppublish SO - Eur Arch Psychiatry Clin Neurosci. 2023 Oct;273(7):1615-1628. doi: 10.1007/s00406-022-01547-w. Epub 2023 Jan 30.