Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial
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...
Gespeichert in:
| Veröffentlicht in: | European neuropsychopharmacology 2015-11, Vol.25 (11), p.1960-1967 |
|---|---|
| Hauptverfasser: | , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1967 |
|---|---|
| container_issue | 11 |
| container_start_page | 1960 |
| container_title | European neuropsychopharmacology |
| container_volume | 25 |
| creator | Kasper, Siegfried Anghelescu, Ion Dienel, Angelika |
| description | 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 80 mg 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 |
| doi_str_mv | 10.1016/j.euroneuro.2015.07.024 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1735331418</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S0924977X15002424</els_id><sourcerecordid>1735331418</sourcerecordid><originalsourceid>FETCH-LOGICAL-c496t-d4b822a6c777ffc9e579a16b4293dabc66e28eda60933ce3c4ed50b38aa76cca3</originalsourceid><addsrcrecordid>eNqNkkFu1TAQhiMEoo_CFcBLFiTYcRInG6SnqgWkSiwKEjvLsSfCDycOtlOarrgDnJCTMNErXbBiYXsx3_zjmX-y7AWjBaOseX0oYAl-2q6ipKwuqChoWT3IdqwVPBdtUz7MdrQrq7wT4vNJ9iTGA0WQ8-5xdlI2Zcfrlu-yX-fDYLXSK_ED8UE5txJlRjvZmCCAIVfWwY2aiJ3IrJKFKUXy3aYvRE03FtKaB3AqIRggJgcxTngwaIhBiSX0GIoOYCa_f_wkexIw5Ed7C-YVmZ3S0Ptc-ykF7xyiKVjlnmaPBuUiPLt7T7NPF-cfz97llx_evj_bX-a66pqUm6pvy1I1WggxDLqDWnSKNX2FzRnV66aBsgWjGtpxroHrCkxNe94qJRqtFT_NXh515-C_Lfh_OdqowTk1gV-iZILjwFjFWkTFEdXBxxhgkHOwowqrZFRulsiDvLdEbpZIKiRagpnP74os_QjmPu-vBwjsjwBgq9cWgowa56zB2AA6SePtfxR584-GduihVu4rrBAPfgkTTlIyGUtJ5dW2GdtisJpiOgr8AWwlvGQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1735331418</pqid></control><display><type>article</type><title>Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial</title><source>MEDLINE</source><source>Access via ScienceDirect (Elsevier)</source><creator>Kasper, Siegfried ; Anghelescu, Ion ; Dienel, Angelika</creator><creatorcontrib>Kasper, Siegfried ; Anghelescu, Ion ; Dienel, Angelika</creatorcontrib><description>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 80 mg 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.</description><identifier>ISSN: 0924-977X</identifier><identifier>EISSN: 1873-7862</identifier><identifier>DOI: 10.1016/j.euroneuro.2015.07.024</identifier><identifier>PMID: 26293583</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Administration, Oral ; Adult ; Aged ; Anti-Anxiety Agents - administration & dosage ; Anti-Anxiety Agents - adverse effects ; Anxiety ; Anxiety Disorders - complications ; Anxiety Disorders - drug therapy ; Anxiety Disorders - physiopathology ; Clinical trial ; Double-Blind Method ; Female ; Humans ; Internal Medicine ; Lavender ; Male ; Middle Aged ; Oils, Volatile - administration & dosage ; Oils, Volatile - adverse effects ; Patient Compliance ; Plant Oils - administration & dosage ; Plant Oils - adverse effects ; Psychiatric Status Rating Scales ; Psychiatry ; Psychomotor Agitation - drug therapy ; Psychomotor Agitation - etiology ; Psychomotor Agitation - physiopathology ; Restlessness ; Severity of Illness Index ; Silexan ; Sleep - drug effects ; Sleep Aids, Pharmaceutical - administration & dosage ; Sleep Aids, Pharmaceutical - adverse effects ; Sleep Wake Disorders - drug therapy ; Sleep Wake Disorders - etiology ; Sleep Wake Disorders - physiopathology ; Treatment efficacy ; Treatment Outcome ; Young Adult</subject><ispartof>European neuropsychopharmacology, 2015-11, Vol.25 (11), p.1960-1967</ispartof><rights>Elsevier B.V. and ECNP</rights><rights>2015 Elsevier B.V. and ECNP</rights><rights>Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c496t-d4b822a6c777ffc9e579a16b4293dabc66e28eda60933ce3c4ed50b38aa76cca3</citedby><cites>FETCH-LOGICAL-c496t-d4b822a6c777ffc9e579a16b4293dabc66e28eda60933ce3c4ed50b38aa76cca3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.euroneuro.2015.07.024$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,781,785,3551,27926,27927,45997</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26293583$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kasper, Siegfried</creatorcontrib><creatorcontrib>Anghelescu, Ion</creatorcontrib><creatorcontrib>Dienel, Angelika</creatorcontrib><title>Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial</title><title>European neuropsychopharmacology</title><addtitle>Eur Neuropsychopharmacol</addtitle><description>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 80 mg 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.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Aged</subject><subject>Anti-Anxiety Agents - administration & dosage</subject><subject>Anti-Anxiety Agents - adverse effects</subject><subject>Anxiety</subject><subject>Anxiety Disorders - complications</subject><subject>Anxiety Disorders - drug therapy</subject><subject>Anxiety Disorders - physiopathology</subject><subject>Clinical trial</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Lavender</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Oils, Volatile - administration & dosage</subject><subject>Oils, Volatile - adverse effects</subject><subject>Patient Compliance</subject><subject>Plant Oils - administration & dosage</subject><subject>Plant Oils - adverse effects</subject><subject>Psychiatric Status Rating Scales</subject><subject>Psychiatry</subject><subject>Psychomotor Agitation - drug therapy</subject><subject>Psychomotor Agitation - etiology</subject><subject>Psychomotor Agitation - physiopathology</subject><subject>Restlessness</subject><subject>Severity of Illness Index</subject><subject>Silexan</subject><subject>Sleep - drug effects</subject><subject>Sleep Aids, Pharmaceutical - administration & dosage</subject><subject>Sleep Aids, Pharmaceutical - adverse effects</subject><subject>Sleep Wake Disorders - drug therapy</subject><subject>Sleep Wake Disorders - etiology</subject><subject>Sleep Wake Disorders - physiopathology</subject><subject>Treatment efficacy</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0924-977X</issn><issn>1873-7862</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkkFu1TAQhiMEoo_CFcBLFiTYcRInG6SnqgWkSiwKEjvLsSfCDycOtlOarrgDnJCTMNErXbBiYXsx3_zjmX-y7AWjBaOseX0oYAl-2q6ipKwuqChoWT3IdqwVPBdtUz7MdrQrq7wT4vNJ9iTGA0WQ8-5xdlI2Zcfrlu-yX-fDYLXSK_ED8UE5txJlRjvZmCCAIVfWwY2aiJ3IrJKFKUXy3aYvRE03FtKaB3AqIRggJgcxTngwaIhBiSX0GIoOYCa_f_wkexIw5Ed7C-YVmZ3S0Ptc-ykF7xyiKVjlnmaPBuUiPLt7T7NPF-cfz97llx_evj_bX-a66pqUm6pvy1I1WggxDLqDWnSKNX2FzRnV66aBsgWjGtpxroHrCkxNe94qJRqtFT_NXh515-C_Lfh_OdqowTk1gV-iZILjwFjFWkTFEdXBxxhgkHOwowqrZFRulsiDvLdEbpZIKiRagpnP74os_QjmPu-vBwjsjwBgq9cWgowa56zB2AA6SePtfxR584-GduihVu4rrBAPfgkTTlIyGUtJ5dW2GdtisJpiOgr8AWwlvGQ</recordid><startdate>20151101</startdate><enddate>20151101</enddate><creator>Kasper, Siegfried</creator><creator>Anghelescu, Ion</creator><creator>Dienel, Angelika</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20151101</creationdate><title>Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial</title><author>Kasper, Siegfried ; Anghelescu, Ion ; Dienel, Angelika</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c496t-d4b822a6c777ffc9e579a16b4293dabc66e28eda60933ce3c4ed50b38aa76cca3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Aged</topic><topic>Anti-Anxiety Agents - administration & dosage</topic><topic>Anti-Anxiety Agents - adverse effects</topic><topic>Anxiety</topic><topic>Anxiety Disorders - complications</topic><topic>Anxiety Disorders - drug therapy</topic><topic>Anxiety Disorders - physiopathology</topic><topic>Clinical trial</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Lavender</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Oils, Volatile - administration & dosage</topic><topic>Oils, Volatile - adverse effects</topic><topic>Patient Compliance</topic><topic>Plant Oils - administration & dosage</topic><topic>Plant Oils - adverse effects</topic><topic>Psychiatric Status Rating Scales</topic><topic>Psychiatry</topic><topic>Psychomotor Agitation - drug therapy</topic><topic>Psychomotor Agitation - etiology</topic><topic>Psychomotor Agitation - physiopathology</topic><topic>Restlessness</topic><topic>Severity of Illness Index</topic><topic>Silexan</topic><topic>Sleep - drug effects</topic><topic>Sleep Aids, Pharmaceutical - administration & dosage</topic><topic>Sleep Aids, Pharmaceutical - adverse effects</topic><topic>Sleep Wake Disorders - drug therapy</topic><topic>Sleep Wake Disorders - etiology</topic><topic>Sleep Wake Disorders - physiopathology</topic><topic>Treatment efficacy</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kasper, Siegfried</creatorcontrib><creatorcontrib>Anghelescu, Ion</creatorcontrib><creatorcontrib>Dienel, Angelika</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European neuropsychopharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kasper, Siegfried</au><au>Anghelescu, Ion</au><au>Dienel, Angelika</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial</atitle><jtitle>European neuropsychopharmacology</jtitle><addtitle>Eur Neuropsychopharmacol</addtitle><date>2015-11-01</date><risdate>2015</risdate><volume>25</volume><issue>11</issue><spage>1960</spage><epage>1967</epage><pages>1960-1967</pages><issn>0924-977X</issn><eissn>1873-7862</eissn><abstract>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 80 mg 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.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>26293583</pmid><doi>10.1016/j.euroneuro.2015.07.024</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0924-977X |
| ispartof | European neuropsychopharmacology, 2015-11, Vol.25 (11), p.1960-1967 |
| issn | 0924-977X 1873-7862 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1735331418 |
| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Administration, Oral Adult Aged Anti-Anxiety Agents - administration & dosage Anti-Anxiety Agents - adverse effects Anxiety Anxiety Disorders - complications Anxiety Disorders - drug therapy Anxiety Disorders - physiopathology Clinical trial Double-Blind Method Female Humans Internal Medicine Lavender Male Middle Aged Oils, Volatile - administration & dosage Oils, Volatile - adverse effects Patient Compliance Plant Oils - administration & dosage Plant Oils - adverse effects Psychiatric Status Rating Scales Psychiatry Psychomotor Agitation - drug therapy Psychomotor Agitation - etiology Psychomotor Agitation - physiopathology Restlessness Severity of Illness Index Silexan Sleep - drug effects Sleep Aids, Pharmaceutical - administration & dosage Sleep Aids, Pharmaceutical - adverse effects Sleep Wake Disorders - drug therapy Sleep Wake Disorders - etiology Sleep Wake Disorders - physiopathology Treatment efficacy Treatment Outcome Young Adult |
| title | Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-18T06%3A57%3A41IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20of%20orally%20administered%20Silexan%20in%20patients%20with%20anxiety-related%20restlessness%20and%20disturbed%20sleep%20%E2%80%93%20A%20randomized,%20placebo-controlled%20trial&rft.jtitle=European%20neuropsychopharmacology&rft.au=Kasper,%20Siegfried&rft.date=2015-11-01&rft.volume=25&rft.issue=11&rft.spage=1960&rft.epage=1967&rft.pages=1960-1967&rft.issn=0924-977X&rft.eissn=1873-7862&rft_id=info:doi/10.1016/j.euroneuro.2015.07.024&rft_dat=%3Cproquest_cross%3E1735331418%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1735331418&rft_id=info:pmid/26293583&rft_els_id=1_s2_0_S0924977X15002424&rfr_iscdi=true |