Efficacy of Silexan in patients with anxiety disorders : a meta-analysis of randomized, placebo-controlled trials
© 2023. The Author(s)..
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 × 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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:273 |
|---|---|
| Enthalten in: |
European archives of psychiatry and clinical neuroscience - 273(2023), 7 vom: 30. Okt., Seite 1615-1628 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Dold, Markus [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Anti-Anxiety Agents |
|---|
| Anmerkungen: |
Date Completed 31.08.2023 Date Revised 01.09.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s00406-022-01547-w |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM352277866 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM352277866 | ||
| 003 | DE-627 | ||
| 005 | 20231226053340.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s00406-022-01547-w |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1174.xml |
| 035 | |a (DE-627)NLM352277866 | ||
| 035 | |a (NLM)36717399 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Dold, Markus |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of Silexan in patients with anxiety disorders |b a meta-analysis of randomized, placebo-controlled trials |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 31.08.2023 | ||
| 500 | |a Date Revised 01.09.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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) | ||
| 520 | |a 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 × 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Meta-Analysis | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Anxiety disorders | |
| 650 | 4 | |a Efficacy | |
| 650 | 4 | |a Lavender | |
| 650 | 4 | |a Meta-analysis | |
| 650 | 4 | |a Silexan | |
| 650 | 4 | |a Tolerability | |
| 650 | 7 | |a lavender oil |2 NLM | |
| 650 | 7 | |a ZBP1YXW0H8 |2 NLM | |
| 650 | 7 | |a Plant Oils |2 NLM | |
| 650 | 7 | |a Oils, Volatile |2 NLM | |
| 650 | 7 | |a Anti-Anxiety Agents |2 NLM | |
| 700 | 1 | |a Bartova, Lucie |e verfasserin |4 aut | |
| 700 | 1 | |a Volz, Hans-Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Seifritz, Erich |e verfasserin |4 aut | |
| 700 | 1 | |a Möller, Hans-Jürgen |e verfasserin |4 aut | |
| 700 | 1 | |a Schläfke, Sandra |e verfasserin |4 aut | |
| 700 | 1 | |a Kasper, Siegfried |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t European archives of psychiatry and clinical neuroscience |d 1996 |g 273(2023), 7 vom: 30. Okt., Seite 1615-1628 |w (DE-627)NLM012966681 |x 1433-8491 |7 nnns |
| 773 | 1 | 8 | |g volume:273 |g year:2023 |g number:7 |g day:30 |g month:10 |g pages:1615-1628 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s00406-022-01547-w |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 273 |j 2023 |e 7 |b 30 |c 10 |h 1615-1628 | ||