Tags

Type your tag names separated by a space and hit enter

Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep--A randomized, placebo-controlled trial.
Eur Neuropsychopharmacol. 2015 Nov; 25(11):1960-7.EN

Abstract

The anxiolytic effect of Silexan, a patented active substance with an essential oil produced from Lavandula angustifolia flowers, was investigated in patients with anxiety-related restlessness and disturbed sleep. 170 out-patients with a diagnosis of restlessness (ICD-10 R45.1), a Hamilton Anxiety Scale (HAMA) total score ≥18 points and ≥2 points for HAMA items 'Tension' and 'Insomnia' participated in this randomized, double-blind trial and received 80mg Silexan or placebo once daily for 10 weeks. Patients with clinically important other psychiatric or neurological disorders potentially interfering with the assessment of treatment efficacy were excluded. Outcome variables were the HAMA as well as the Pittsburgh Sleep Quality Index (PSQI), the Zung Self-rating Anxiety Scale, a State Check inventory and the Clinical Global Impressions questionnaire. In the Silexan group the HAMA total score decreased from an average of 25.5±6.0 points at baseline to 13.7±7.0 points at treatment end, compared to a decrease from 26.5±6.1 to 16.9±9.8 for placebo, corresponding to decreases of 12.0 and 9.3 points (marginal means), respectively (group difference: p=0.03, ANCOVA with factor treatment and baseline value as covariate). In all outcome measures the treatment effect of Silexan was more pronounced than with placebo. According to the HAMA, 48.8% and 33.3% of the patients were responders (Silexan, placebo; reduction ≥50%; p=0.04) and 31.4% and 22.6% achieved remission (HAMA<10; p=0.20). 33.7% (Silexan) and 35.7% (placebo) of the participants reported adverse events. The study confirms the calming and anxiolytic efficacy of Silexan.

Authors+Show Affiliations

Department of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria. Electronic address: sci-biolpsy@meduniwien.ac.at.Privat-Nerven-Klinik Dr. med. Kurt Fontheim, Liebenburg, Germany.Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26293583

Citation

Kasper, Siegfried, et al. "Efficacy of Orally Administered Silexan in Patients With Anxiety-related Restlessness and Disturbed sleep--A Randomized, Placebo-controlled Trial." European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology, vol. 25, no. 11, 2015, pp. 1960-7.
Kasper S, Anghelescu I, Dienel A. Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep--A randomized, placebo-controlled trial. Eur Neuropsychopharmacol. 2015;25(11):1960-7.
Kasper, S., Anghelescu, I., & Dienel, A. (2015). Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep--A randomized, placebo-controlled trial. European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology, 25(11), 1960-7. https://doi.org/10.1016/j.euroneuro.2015.07.024
Kasper S, Anghelescu I, Dienel A. Efficacy of Orally Administered Silexan in Patients With Anxiety-related Restlessness and Disturbed sleep--A Randomized, Placebo-controlled Trial. Eur Neuropsychopharmacol. 2015;25(11):1960-7. PubMed PMID: 26293583.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep--A randomized, placebo-controlled trial. AU - Kasper,Siegfried, AU - Anghelescu,Ion, AU - Dienel,Angelika, Y1 - 2015/08/07/ PY - 2015/03/31/received PY - 2015/07/16/revised PY - 2015/07/28/accepted PY - 2015/8/22/entrez PY - 2015/8/22/pubmed PY - 2016/8/27/medline KW - Anxiety KW - Clinical trial KW - Lavender KW - Restlessness KW - Silexan KW - Treatment efficacy SP - 1960 EP - 7 JF - European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology JO - Eur Neuropsychopharmacol VL - 25 IS - 11 N2 - The anxiolytic effect of Silexan, a patented active substance with an essential oil produced from Lavandula angustifolia flowers, was investigated in patients with anxiety-related restlessness and disturbed sleep. 170 out-patients with a diagnosis of restlessness (ICD-10 R45.1), a Hamilton Anxiety Scale (HAMA) total score ≥18 points and ≥2 points for HAMA items 'Tension' and 'Insomnia' participated in this randomized, double-blind trial and received 80mg Silexan or placebo once daily for 10 weeks. Patients with clinically important other psychiatric or neurological disorders potentially interfering with the assessment of treatment efficacy were excluded. Outcome variables were the HAMA as well as the Pittsburgh Sleep Quality Index (PSQI), the Zung Self-rating Anxiety Scale, a State Check inventory and the Clinical Global Impressions questionnaire. In the Silexan group the HAMA total score decreased from an average of 25.5±6.0 points at baseline to 13.7±7.0 points at treatment end, compared to a decrease from 26.5±6.1 to 16.9±9.8 for placebo, corresponding to decreases of 12.0 and 9.3 points (marginal means), respectively (group difference: p=0.03, ANCOVA with factor treatment and baseline value as covariate). In all outcome measures the treatment effect of Silexan was more pronounced than with placebo. According to the HAMA, 48.8% and 33.3% of the patients were responders (Silexan, placebo; reduction ≥50%; p=0.04) and 31.4% and 22.6% achieved remission (HAMA<10; p=0.20). 33.7% (Silexan) and 35.7% (placebo) of the participants reported adverse events. The study confirms the calming and anxiolytic efficacy of Silexan. SN - 1873-7862 UR - https://neuro.unboundmedicine.com/medline/citation/26293583/Efficacy_of_orally_administered_Silexan_in_patients_with_anxiety_related_restlessness_and_disturbed_sleep__A_randomized_placebo_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -