Enzogenol for cognitive functioning in traumatic brain injury: a pilot placebo-controlled RCT
Background and purpose Enzogenol, a flavonoid‐rich extract from Pinus radiata bark with antioxidant and anti‐inflammatory properties has been shown to improve working memory in healthy adults. In traumatic brain injury (TBI), oxidation and inflammation have been linked to poorer cognitive outcomes....
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| Veröffentlicht in: | European journal of neurology 2013-08, Vol.20 (8), p.1135-1144 |
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| container_title | European journal of neurology |
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| creator | Theadom, A. Mahon, S. Barker-Collo, S. McPherson, K. Rush, E. Vandal, A. C. Feigin, V. L. |
| description | Background and purpose
Enzogenol, a flavonoid‐rich extract from Pinus radiata bark with antioxidant and anti‐inflammatory properties has been shown to improve working memory in healthy adults. In traumatic brain injury (TBI), oxidation and inflammation have been linked to poorer cognitive outcomes. Hence, this phase II, randomized controlled trial investigated safety, compliance and efficacy of Enzogenol for improving cognitive functioning in people following mild TBI.
Methods
Sixty adults, who sustained a mild TBI, 3–12 months prior to recruitment, and who were experiencing persistent cognitive difficulties [Cognitive Failures Questionnaire (CFQ) score > 38], were randomized to receive Enzogenol (1000 mg/day) or matching placebo for 6 weeks. Subsequently, all participants received Enzogenol for a further 6 weeks, followed by placebo for 4 weeks. Compliance, side‐effects, cognitive failures, working and episodic memory, post‐concussive symptoms and mood were assessed at baseline, 6, 12 and 16 weeks. Simultaneous estimation of treatment effect and breakpoint was effected, with confidence intervals (CIs) obtained through a treatment–placebo balance‐preserving bootstrap procedure.
Results
Enzogenol was found to be safe and well tolerated. Trend and breakpoint analyses showed a significant reduction in cognitive failures after 6 weeks [mean CFQ score, 95% CI, Enzogenol versus placebo −6.9 (−10.8 to −4.1)]. Improvements in the frequency of self‐reported cognitive failures were estimated to continue until week 11 before stabilizing. Other outcome measures showed some positive trends but no significant treatment effects.
Conclusions
Enzogenol supplementation is safe and well tolerated in people after mild TBI, and may improve cognitive functioning in this patient population. This study provides Class IIB evidence that Enzogenol is well tolerated and may reduce self‐perceived cognitive failures in patients 3–12 months post‐mild TBI. |
| doi_str_mv | 10.1111/ene.12099 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1419365919</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3012525321</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4249-82c42bc354287550f67dc808a90c31bbe32b76668b762c19f445dc106e8597f53</originalsourceid><addsrcrecordid>eNqFkctqGzEUhkVoaC7toi9QBN0ki0l0n1F3wThuwbilTekqCI2sMXJlyZFmkjhPHzlOsiiUnsW5wHd-zuEH4ANGZ7jEuQ32DBMk5R44xEw0FaYUvyk95bjiGOEDcJTzEiFEaoLeggNCacMYaQ7B9Tg8xIUN0cMuJmjiIrje3VrYDcH0LgYXFtAF2Cc9rHTvDGyTLrMLyyFtPkMN187HHq69NraNlYmhT9F7O4c_RlfvwH6nfbbvn-sx-HU5vhp9qabfJl9HF9PKMMJk1ZBSW0N5OanmHHWinpsGNVoiQ3HbWkraWgjRlEwMlh1jfG4wErbhsu44PQYnO911ijeDzb1auWys9zrYOGSFGZZUcFnyf1EqJeKc0i366S90GYcUyiNbinGBGUGFOt1RJsWck-3UOrmVThuFkdrao4o96smewn58VhzalZ2_ki9-FOB8B9w5bzf_VlLj2fhFstptuNzb-9cNnf4oUdOaq9-ziRrhejYR0-_qJ30EpOmmVw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1394561420</pqid></control><display><type>article</type><title>Enzogenol for cognitive functioning in traumatic brain injury: a pilot placebo-controlled RCT</title><source>Wiley Online Library - AutoHoldings Journals</source><source>MEDLINE</source><creator>Theadom, A. ; Mahon, S. ; Barker-Collo, S. ; McPherson, K. ; Rush, E. ; Vandal, A. C. ; Feigin, V. L.</creator><creatorcontrib>Theadom, A. ; Mahon, S. ; Barker-Collo, S. ; McPherson, K. ; Rush, E. ; Vandal, A. C. ; Feigin, V. L.</creatorcontrib><description>Background and purpose
Enzogenol, a flavonoid‐rich extract from Pinus radiata bark with antioxidant and anti‐inflammatory properties has been shown to improve working memory in healthy adults. In traumatic brain injury (TBI), oxidation and inflammation have been linked to poorer cognitive outcomes. Hence, this phase II, randomized controlled trial investigated safety, compliance and efficacy of Enzogenol for improving cognitive functioning in people following mild TBI.
Methods
Sixty adults, who sustained a mild TBI, 3–12 months prior to recruitment, and who were experiencing persistent cognitive difficulties [Cognitive Failures Questionnaire (CFQ) score > 38], were randomized to receive Enzogenol (1000 mg/day) or matching placebo for 6 weeks. Subsequently, all participants received Enzogenol for a further 6 weeks, followed by placebo for 4 weeks. Compliance, side‐effects, cognitive failures, working and episodic memory, post‐concussive symptoms and mood were assessed at baseline, 6, 12 and 16 weeks. Simultaneous estimation of treatment effect and breakpoint was effected, with confidence intervals (CIs) obtained through a treatment–placebo balance‐preserving bootstrap procedure.
Results
Enzogenol was found to be safe and well tolerated. Trend and breakpoint analyses showed a significant reduction in cognitive failures after 6 weeks [mean CFQ score, 95% CI, Enzogenol versus placebo −6.9 (−10.8 to −4.1)]. Improvements in the frequency of self‐reported cognitive failures were estimated to continue until week 11 before stabilizing. Other outcome measures showed some positive trends but no significant treatment effects.
Conclusions
Enzogenol supplementation is safe and well tolerated in people after mild TBI, and may improve cognitive functioning in this patient population. This study provides Class IIB evidence that Enzogenol is well tolerated and may reduce self‐perceived cognitive failures in patients 3–12 months post‐mild TBI.</description><identifier>ISSN: 1351-5101</identifier><identifier>EISSN: 1468-1331</identifier><identifier>DOI: 10.1111/ene.12099</identifier><identifier>PMID: 23384428</identifier><identifier>CODEN: EJNEFL</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Accidents, Traffic ; Adult ; Brain Injuries - complications ; Brain Injuries - psychology ; brain injury ; Cognition Disorders - drug therapy ; Cognition Disorders - etiology ; Cognition Disorders - psychology ; Data Interpretation, Statistical ; Dietary Supplements ; Double-Blind Method ; Female ; Flavonoids - adverse effects ; Flavonoids - therapeutic use ; Glasgow Coma Scale ; Humans ; Male ; Memory - physiology ; Middle Aged ; neurological disorders ; Neuropsychological Tests ; Nonlinear Dynamics ; Patient Compliance ; Pilot Projects ; Pinus radiata ; Post-Concussion Syndrome - drug therapy ; Post-Concussion Syndrome - psychology ; Quercetin - adverse effects ; Quercetin - analogs & derivatives ; Quercetin - therapeutic use ; randomized clinical trial ; rehabilitation ; trauma ; Treatment Outcome ; Young Adult</subject><ispartof>European journal of neurology, 2013-08, Vol.20 (8), p.1135-1144</ispartof><rights>2013 The Author(s) European Journal of Neurology © 2013 EFNS</rights><rights>2013 The Author(s) European Journal of Neurology © 2013 EFNS.</rights><rights>European Journal of Neurology © 2013 European Federation of Neurological Societies</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4249-82c42bc354287550f67dc808a90c31bbe32b76668b762c19f445dc106e8597f53</citedby><cites>FETCH-LOGICAL-c4249-82c42bc354287550f67dc808a90c31bbe32b76668b762c19f445dc106e8597f53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fene.12099$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fene.12099$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,782,786,1419,27933,27934,45583,45584</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23384428$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Theadom, A.</creatorcontrib><creatorcontrib>Mahon, S.</creatorcontrib><creatorcontrib>Barker-Collo, S.</creatorcontrib><creatorcontrib>McPherson, K.</creatorcontrib><creatorcontrib>Rush, E.</creatorcontrib><creatorcontrib>Vandal, A. C.</creatorcontrib><creatorcontrib>Feigin, V. L.</creatorcontrib><title>Enzogenol for cognitive functioning in traumatic brain injury: a pilot placebo-controlled RCT</title><title>European journal of neurology</title><addtitle>Eur J Neurol</addtitle><description>Background and purpose
Enzogenol, a flavonoid‐rich extract from Pinus radiata bark with antioxidant and anti‐inflammatory properties has been shown to improve working memory in healthy adults. In traumatic brain injury (TBI), oxidation and inflammation have been linked to poorer cognitive outcomes. Hence, this phase II, randomized controlled trial investigated safety, compliance and efficacy of Enzogenol for improving cognitive functioning in people following mild TBI.
Methods
Sixty adults, who sustained a mild TBI, 3–12 months prior to recruitment, and who were experiencing persistent cognitive difficulties [Cognitive Failures Questionnaire (CFQ) score > 38], were randomized to receive Enzogenol (1000 mg/day) or matching placebo for 6 weeks. Subsequently, all participants received Enzogenol for a further 6 weeks, followed by placebo for 4 weeks. Compliance, side‐effects, cognitive failures, working and episodic memory, post‐concussive symptoms and mood were assessed at baseline, 6, 12 and 16 weeks. Simultaneous estimation of treatment effect and breakpoint was effected, with confidence intervals (CIs) obtained through a treatment–placebo balance‐preserving bootstrap procedure.
Results
Enzogenol was found to be safe and well tolerated. Trend and breakpoint analyses showed a significant reduction in cognitive failures after 6 weeks [mean CFQ score, 95% CI, Enzogenol versus placebo −6.9 (−10.8 to −4.1)]. Improvements in the frequency of self‐reported cognitive failures were estimated to continue until week 11 before stabilizing. Other outcome measures showed some positive trends but no significant treatment effects.
Conclusions
Enzogenol supplementation is safe and well tolerated in people after mild TBI, and may improve cognitive functioning in this patient population. This study provides Class IIB evidence that Enzogenol is well tolerated and may reduce self‐perceived cognitive failures in patients 3–12 months post‐mild TBI.</description><subject>Accidents, Traffic</subject><subject>Adult</subject><subject>Brain Injuries - complications</subject><subject>Brain Injuries - psychology</subject><subject>brain injury</subject><subject>Cognition Disorders - drug therapy</subject><subject>Cognition Disorders - etiology</subject><subject>Cognition Disorders - psychology</subject><subject>Data Interpretation, Statistical</subject><subject>Dietary Supplements</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Flavonoids - adverse effects</subject><subject>Flavonoids - therapeutic use</subject><subject>Glasgow Coma Scale</subject><subject>Humans</subject><subject>Male</subject><subject>Memory - physiology</subject><subject>Middle Aged</subject><subject>neurological disorders</subject><subject>Neuropsychological Tests</subject><subject>Nonlinear Dynamics</subject><subject>Patient Compliance</subject><subject>Pilot Projects</subject><subject>Pinus radiata</subject><subject>Post-Concussion Syndrome - drug therapy</subject><subject>Post-Concussion Syndrome - psychology</subject><subject>Quercetin - adverse effects</subject><subject>Quercetin - analogs & derivatives</subject><subject>Quercetin - therapeutic use</subject><subject>randomized clinical trial</subject><subject>rehabilitation</subject><subject>trauma</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1351-5101</issn><issn>1468-1331</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkctqGzEUhkVoaC7toi9QBN0ki0l0n1F3wThuwbilTekqCI2sMXJlyZFmkjhPHzlOsiiUnsW5wHd-zuEH4ANGZ7jEuQ32DBMk5R44xEw0FaYUvyk95bjiGOEDcJTzEiFEaoLeggNCacMYaQ7B9Tg8xIUN0cMuJmjiIrje3VrYDcH0LgYXFtAF2Cc9rHTvDGyTLrMLyyFtPkMN187HHq69NraNlYmhT9F7O4c_RlfvwH6nfbbvn-sx-HU5vhp9qabfJl9HF9PKMMJk1ZBSW0N5OanmHHWinpsGNVoiQ3HbWkraWgjRlEwMlh1jfG4wErbhsu44PQYnO911ijeDzb1auWys9zrYOGSFGZZUcFnyf1EqJeKc0i366S90GYcUyiNbinGBGUGFOt1RJsWck-3UOrmVThuFkdrao4o96smewn58VhzalZ2_ki9-FOB8B9w5bzf_VlLj2fhFstptuNzb-9cNnf4oUdOaq9-ziRrhejYR0-_qJ30EpOmmVw</recordid><startdate>201308</startdate><enddate>201308</enddate><creator>Theadom, A.</creator><creator>Mahon, S.</creator><creator>Barker-Collo, S.</creator><creator>McPherson, K.</creator><creator>Rush, E.</creator><creator>Vandal, A. C.</creator><creator>Feigin, V. L.</creator><general>Blackwell Publishing Ltd</general><general>John Wiley & Sons, Inc</general><scope>BSCLL</scope><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>7TK</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201308</creationdate><title>Enzogenol for cognitive functioning in traumatic brain injury: a pilot placebo-controlled RCT</title><author>Theadom, A. ; Mahon, S. ; Barker-Collo, S. ; McPherson, K. ; Rush, E. ; Vandal, A. C. ; Feigin, V. L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4249-82c42bc354287550f67dc808a90c31bbe32b76668b762c19f445dc106e8597f53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Accidents, Traffic</topic><topic>Adult</topic><topic>Brain Injuries - complications</topic><topic>Brain Injuries - psychology</topic><topic>brain injury</topic><topic>Cognition Disorders - drug therapy</topic><topic>Cognition Disorders - etiology</topic><topic>Cognition Disorders - psychology</topic><topic>Data Interpretation, Statistical</topic><topic>Dietary Supplements</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Flavonoids - adverse effects</topic><topic>Flavonoids - therapeutic use</topic><topic>Glasgow Coma Scale</topic><topic>Humans</topic><topic>Male</topic><topic>Memory - physiology</topic><topic>Middle Aged</topic><topic>neurological disorders</topic><topic>Neuropsychological Tests</topic><topic>Nonlinear Dynamics</topic><topic>Patient Compliance</topic><topic>Pilot Projects</topic><topic>Pinus radiata</topic><topic>Post-Concussion Syndrome - drug therapy</topic><topic>Post-Concussion Syndrome - psychology</topic><topic>Quercetin - adverse effects</topic><topic>Quercetin - analogs & derivatives</topic><topic>Quercetin - therapeutic use</topic><topic>randomized clinical trial</topic><topic>rehabilitation</topic><topic>trauma</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Theadom, A.</creatorcontrib><creatorcontrib>Mahon, S.</creatorcontrib><creatorcontrib>Barker-Collo, S.</creatorcontrib><creatorcontrib>McPherson, K.</creatorcontrib><creatorcontrib>Rush, E.</creatorcontrib><creatorcontrib>Vandal, A. C.</creatorcontrib><creatorcontrib>Feigin, V. L.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Theadom, A.</au><au>Mahon, S.</au><au>Barker-Collo, S.</au><au>McPherson, K.</au><au>Rush, E.</au><au>Vandal, A. C.</au><au>Feigin, V. L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Enzogenol for cognitive functioning in traumatic brain injury: a pilot placebo-controlled RCT</atitle><jtitle>European journal of neurology</jtitle><addtitle>Eur J Neurol</addtitle><date>2013-08</date><risdate>2013</risdate><volume>20</volume><issue>8</issue><spage>1135</spage><epage>1144</epage><pages>1135-1144</pages><issn>1351-5101</issn><eissn>1468-1331</eissn><coden>EJNEFL</coden><abstract>Background and purpose
Enzogenol, a flavonoid‐rich extract from Pinus radiata bark with antioxidant and anti‐inflammatory properties has been shown to improve working memory in healthy adults. In traumatic brain injury (TBI), oxidation and inflammation have been linked to poorer cognitive outcomes. Hence, this phase II, randomized controlled trial investigated safety, compliance and efficacy of Enzogenol for improving cognitive functioning in people following mild TBI.
Methods
Sixty adults, who sustained a mild TBI, 3–12 months prior to recruitment, and who were experiencing persistent cognitive difficulties [Cognitive Failures Questionnaire (CFQ) score > 38], were randomized to receive Enzogenol (1000 mg/day) or matching placebo for 6 weeks. Subsequently, all participants received Enzogenol for a further 6 weeks, followed by placebo for 4 weeks. Compliance, side‐effects, cognitive failures, working and episodic memory, post‐concussive symptoms and mood were assessed at baseline, 6, 12 and 16 weeks. Simultaneous estimation of treatment effect and breakpoint was effected, with confidence intervals (CIs) obtained through a treatment–placebo balance‐preserving bootstrap procedure.
Results
Enzogenol was found to be safe and well tolerated. Trend and breakpoint analyses showed a significant reduction in cognitive failures after 6 weeks [mean CFQ score, 95% CI, Enzogenol versus placebo −6.9 (−10.8 to −4.1)]. Improvements in the frequency of self‐reported cognitive failures were estimated to continue until week 11 before stabilizing. Other outcome measures showed some positive trends but no significant treatment effects.
Conclusions
Enzogenol supplementation is safe and well tolerated in people after mild TBI, and may improve cognitive functioning in this patient population. This study provides Class IIB evidence that Enzogenol is well tolerated and may reduce self‐perceived cognitive failures in patients 3–12 months post‐mild TBI.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>23384428</pmid><doi>10.1111/ene.12099</doi><tpages>10</tpages></addata></record> |
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| subjects | Accidents, Traffic Adult Brain Injuries - complications Brain Injuries - psychology brain injury Cognition Disorders - drug therapy Cognition Disorders - etiology Cognition Disorders - psychology Data Interpretation, Statistical Dietary Supplements Double-Blind Method Female Flavonoids - adverse effects Flavonoids - therapeutic use Glasgow Coma Scale Humans Male Memory - physiology Middle Aged neurological disorders Neuropsychological Tests Nonlinear Dynamics Patient Compliance Pilot Projects Pinus radiata Post-Concussion Syndrome - drug therapy Post-Concussion Syndrome - psychology Quercetin - adverse effects Quercetin - analogs & derivatives Quercetin - therapeutic use randomized clinical trial rehabilitation trauma Treatment Outcome Young Adult |
| title | Enzogenol for cognitive functioning in traumatic brain injury: a pilot placebo-controlled RCT |
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