Ginkgo for elderly people with dementia and age-associated memory impairment: a randomized clinical trial
Preparations based on special extracts of the Ginkgo biloba tree are popular in various European countries. Previous studies have suggested the clinical efficacy of Ginkgo in patients with dementia, cerebral insufficiency, or related cognitive decline. However, most of these studies did not fulfill...
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| Veröffentlicht in: | Journal of clinical epidemiology 2003-04, Vol.56 (4), p.367-376 |
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| creator | Dongen, Martien van van Rossum, Erik Kessels, Alphons Sielhorst, Hilde Knipschild, Paul |
| description | Preparations based on special extracts of the
Ginkgo biloba tree are popular in various European countries. Previous studies have suggested the clinical efficacy of Ginkgo in patients with dementia, cerebral insufficiency, or related cognitive decline. However, most of these studies did not fulfill the current methodologic requirements. We assessed the efficacy of the
G. biloba special extract EGb 761 in patients with dementia and age-associated memory impairment in relation to dose and duration of treatment. Our study was a 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Study participants were elderly patients with dementia (Alzheimer disease or vascular dementia) or age-associated memory impairment (AAMI). A total of 214 participants, recruited from 39 homes for the elderly in the Netherlands, were randomly allocated to Ginkgo (either 240 mg/d or 160 mg/d) or placebo (0 mg/d). After 12 weeks, the subjects in the two Ginkgo groups were randomized to continued Ginkgo treatment or placebo treatment. Primary outcome measures in this study were the Syndrome Kurz Test (SKT; psychometric functioning), the Clinical Global Impression of change (CGI-2; psychopathology, assessed by nursing staff), and the Nuremberg Gerontopsychological Rating Scale for Activities of Daily Living (NAI-NAA; behavioral functioning). One hundred twenty-three patients received Ginkgo (
n
=
79, 240 and 160 mg/d combined) or placebo (
n
=
44) during the 24-week intervention period. We found no statistically significant differences in mean change of scores between Ginkgo and placebo. The differences were SKT: +0.4 (90% confidence interval [CI] −0.9–1.7); CGI-2: +0.1 (90% CI −0.3–0.4), and NAI-NAA: −0.4 (90% CI −1.9–1.2). A positive difference is in favor of Ginkgo. Neither the dementia subgroup (
n
=
36) nor the AAMI subgroup (
n
=
87) experienced a significant effect of Ginkgo treatment. There was no dose-effect relationship and no effect of prolonged Ginkgo treatment. The trial results do not support the view that Ginkgo is beneficial for patients with dementia or age-associated memory impairment. |
| doi_str_mv | 10.1016/S0895-4356(03)00003-9 |
| format | Article |
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Ginkgo biloba tree are popular in various European countries. Previous studies have suggested the clinical efficacy of Ginkgo in patients with dementia, cerebral insufficiency, or related cognitive decline. However, most of these studies did not fulfill the current methodologic requirements. We assessed the efficacy of the
G. biloba special extract EGb 761 in patients with dementia and age-associated memory impairment in relation to dose and duration of treatment. Our study was a 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Study participants were elderly patients with dementia (Alzheimer disease or vascular dementia) or age-associated memory impairment (AAMI). A total of 214 participants, recruited from 39 homes for the elderly in the Netherlands, were randomly allocated to Ginkgo (either 240 mg/d or 160 mg/d) or placebo (0 mg/d). After 12 weeks, the subjects in the two Ginkgo groups were randomized to continued Ginkgo treatment or placebo treatment. Primary outcome measures in this study were the Syndrome Kurz Test (SKT; psychometric functioning), the Clinical Global Impression of change (CGI-2; psychopathology, assessed by nursing staff), and the Nuremberg Gerontopsychological Rating Scale for Activities of Daily Living (NAI-NAA; behavioral functioning). One hundred twenty-three patients received Ginkgo (
n
=
79, 240 and 160 mg/d combined) or placebo (
n
=
44) during the 24-week intervention period. We found no statistically significant differences in mean change of scores between Ginkgo and placebo. The differences were SKT: +0.4 (90% confidence interval [CI] −0.9–1.7); CGI-2: +0.1 (90% CI −0.3–0.4), and NAI-NAA: −0.4 (90% CI −1.9–1.2). A positive difference is in favor of Ginkgo. Neither the dementia subgroup (
n
=
36) nor the AAMI subgroup (
n
=
87) experienced a significant effect of Ginkgo treatment. There was no dose-effect relationship and no effect of prolonged Ginkgo treatment. The trial results do not support the view that Ginkgo is beneficial for patients with dementia or age-associated memory impairment.</description><identifier>ISSN: 0895-4356</identifier><identifier>EISSN: 1878-5921</identifier><identifier>DOI: 10.1016/S0895-4356(03)00003-9</identifier><identifier>PMID: 12767414</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>AAMI ; Activities of Daily Living ; Aged ; Alzheimer's disease ; Biological and medical sciences ; Cognitive ability ; Confidence intervals ; Data collection ; Data processing ; Dementia ; Dementia - drug therapy ; Dementia disorders ; Dose-response effects ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug dosages ; EGb 761 ; Elderly people ; Epidemiology ; Female ; Follow-Up Studies ; Free radicals ; Geriatric Assessment ; Ginkgo ; Ginkgo biloba ; Homes for the Aged ; Humans ; Male ; Medical sciences ; Memory Disorders - drug therapy ; Middle Aged ; Neuropharmacology ; Neuroprotective agent ; Neuropsychological Tests ; Nootropic Agents - therapeutic use ; Pharmacology. Drug treatments ; Phytotherapy - methods ; Plant Extracts - therapeutic use ; Psychometrics ; RCT ; Standard deviation ; Studies ; Treatment Outcome</subject><ispartof>Journal of clinical epidemiology, 2003-04, Vol.56 (4), p.367-376</ispartof><rights>2003 Elsevier Inc.</rights><rights>2003 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c471t-ca704601f4d4e6982fca48c24958b9e5737d6d67f5aaf84cdf5d6257d62e8cb13</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1033170624?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14863209$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12767414$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dongen, Martien van</creatorcontrib><creatorcontrib>van Rossum, Erik</creatorcontrib><creatorcontrib>Kessels, Alphons</creatorcontrib><creatorcontrib>Sielhorst, Hilde</creatorcontrib><creatorcontrib>Knipschild, Paul</creatorcontrib><title>Ginkgo for elderly people with dementia and age-associated memory impairment: a randomized clinical trial</title><title>Journal of clinical epidemiology</title><addtitle>J Clin Epidemiol</addtitle><description>Preparations based on special extracts of the
Ginkgo biloba tree are popular in various European countries. Previous studies have suggested the clinical efficacy of Ginkgo in patients with dementia, cerebral insufficiency, or related cognitive decline. However, most of these studies did not fulfill the current methodologic requirements. We assessed the efficacy of the
G. biloba special extract EGb 761 in patients with dementia and age-associated memory impairment in relation to dose and duration of treatment. Our study was a 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Study participants were elderly patients with dementia (Alzheimer disease or vascular dementia) or age-associated memory impairment (AAMI). A total of 214 participants, recruited from 39 homes for the elderly in the Netherlands, were randomly allocated to Ginkgo (either 240 mg/d or 160 mg/d) or placebo (0 mg/d). After 12 weeks, the subjects in the two Ginkgo groups were randomized to continued Ginkgo treatment or placebo treatment. Primary outcome measures in this study were the Syndrome Kurz Test (SKT; psychometric functioning), the Clinical Global Impression of change (CGI-2; psychopathology, assessed by nursing staff), and the Nuremberg Gerontopsychological Rating Scale for Activities of Daily Living (NAI-NAA; behavioral functioning). One hundred twenty-three patients received Ginkgo (
n
=
79, 240 and 160 mg/d combined) or placebo (
n
=
44) during the 24-week intervention period. We found no statistically significant differences in mean change of scores between Ginkgo and placebo. The differences were SKT: +0.4 (90% confidence interval [CI] −0.9–1.7); CGI-2: +0.1 (90% CI −0.3–0.4), and NAI-NAA: −0.4 (90% CI −1.9–1.2). A positive difference is in favor of Ginkgo. Neither the dementia subgroup (
n
=
36) nor the AAMI subgroup (
n
=
87) experienced a significant effect of Ginkgo treatment. There was no dose-effect relationship and no effect of prolonged Ginkgo treatment. The trial results do not support the view that Ginkgo is beneficial for patients with dementia or age-associated memory impairment.</description><subject>AAMI</subject><subject>Activities of Daily Living</subject><subject>Aged</subject><subject>Alzheimer's disease</subject><subject>Biological and medical sciences</subject><subject>Cognitive ability</subject><subject>Confidence intervals</subject><subject>Data collection</subject><subject>Data processing</subject><subject>Dementia</subject><subject>Dementia - drug therapy</subject><subject>Dementia disorders</subject><subject>Dose-response effects</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug dosages</subject><subject>EGb 761</subject><subject>Elderly people</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Free radicals</subject><subject>Geriatric Assessment</subject><subject>Ginkgo</subject><subject>Ginkgo biloba</subject><subject>Homes for the Aged</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Memory Disorders - drug therapy</subject><subject>Middle Aged</subject><subject>Neuropharmacology</subject><subject>Neuroprotective agent</subject><subject>Neuropsychological Tests</subject><subject>Nootropic Agents - therapeutic use</subject><subject>Pharmacology. Drug treatments</subject><subject>Phytotherapy - methods</subject><subject>Plant Extracts - therapeutic use</subject><subject>Psychometrics</subject><subject>RCT</subject><subject>Standard deviation</subject><subject>Studies</subject><subject>Treatment Outcome</subject><issn>0895-4356</issn><issn>1878-5921</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkV1rFDEUhoNY7Fr9CUpAFHsxmu9kvBEpWoWCF-p1yCYnNXVmMk1mle2vN9tdWvDG3ASS57wcnhehZ5S8oYSqt9-I6WUnuFSvCT8l7fCuf4BW1GjTyZ7Rh2h1hxyjx7VeEUI10fIROqZMKy2oWKF0nqZflxnHXDAMAcqwxTPkeQD8Jy0_cYARpiU57KaA3SV0rtbsk1sg4BHGXLY4jbNLZYe9ww6XBuYx3bR_P6QpeTfgpSQ3PEFH0Q0Vnh7uE_Tj08fvZ5-7i6_nX84-XHReaLp03mkiFKFRBAGqNyx6J4xnopdm3YPUXAcVlI7SuWiED1EGxWR7ZGD8mvIT9GqfO5d8vYG62DFVD8PgJsibajXnnFFjGvjiH_Aqb8rUdrOUcN5cKSYaJfeUL7nWAtHOJY2ubBtkd03Y2ybsTrMl3N42Yfs29_yQvlmPEO6nDuob8PIAuNokxSbOp3rPCaM4I7ug93sOmrTfCYqtPsHkIaQCfrEhp_-s8hfzcKWM</recordid><startdate>20030401</startdate><enddate>20030401</enddate><creator>Dongen, Martien van</creator><creator>van Rossum, Erik</creator><creator>Kessels, Alphons</creator><creator>Sielhorst, Hilde</creator><creator>Knipschild, Paul</creator><general>Elsevier Inc</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</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>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7T2</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20030401</creationdate><title>Ginkgo for elderly people with dementia and age-associated memory impairment: a randomized clinical trial</title><author>Dongen, Martien van ; van Rossum, Erik ; Kessels, Alphons ; Sielhorst, Hilde ; Knipschild, Paul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c471t-ca704601f4d4e6982fca48c24958b9e5737d6d67f5aaf84cdf5d6257d62e8cb13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>AAMI</topic><topic>Activities of Daily Living</topic><topic>Aged</topic><topic>Alzheimer's disease</topic><topic>Biological and medical sciences</topic><topic>Cognitive ability</topic><topic>Confidence intervals</topic><topic>Data collection</topic><topic>Data processing</topic><topic>Dementia</topic><topic>Dementia - drug therapy</topic><topic>Dementia disorders</topic><topic>Dose-response effects</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug dosages</topic><topic>EGb 761</topic><topic>Elderly people</topic><topic>Epidemiology</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Free radicals</topic><topic>Geriatric Assessment</topic><topic>Ginkgo</topic><topic>Ginkgo biloba</topic><topic>Homes for the Aged</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Memory Disorders - drug therapy</topic><topic>Middle Aged</topic><topic>Neuropharmacology</topic><topic>Neuroprotective agent</topic><topic>Neuropsychological Tests</topic><topic>Nootropic Agents - therapeutic use</topic><topic>Pharmacology. Drug treatments</topic><topic>Phytotherapy - methods</topic><topic>Plant Extracts - therapeutic use</topic><topic>Psychometrics</topic><topic>RCT</topic><topic>Standard deviation</topic><topic>Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dongen, Martien van</creatorcontrib><creatorcontrib>van Rossum, Erik</creatorcontrib><creatorcontrib>Kessels, Alphons</creatorcontrib><creatorcontrib>Sielhorst, Hilde</creatorcontrib><creatorcontrib>Knipschild, Paul</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical epidemiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dongen, Martien van</au><au>van Rossum, Erik</au><au>Kessels, Alphons</au><au>Sielhorst, Hilde</au><au>Knipschild, Paul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ginkgo for elderly people with dementia and age-associated memory impairment: a randomized clinical trial</atitle><jtitle>Journal of clinical epidemiology</jtitle><addtitle>J Clin Epidemiol</addtitle><date>2003-04-01</date><risdate>2003</risdate><volume>56</volume><issue>4</issue><spage>367</spage><epage>376</epage><pages>367-376</pages><issn>0895-4356</issn><eissn>1878-5921</eissn><abstract>Preparations based on special extracts of the
Ginkgo biloba tree are popular in various European countries. Previous studies have suggested the clinical efficacy of Ginkgo in patients with dementia, cerebral insufficiency, or related cognitive decline. However, most of these studies did not fulfill the current methodologic requirements. We assessed the efficacy of the
G. biloba special extract EGb 761 in patients with dementia and age-associated memory impairment in relation to dose and duration of treatment. Our study was a 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Study participants were elderly patients with dementia (Alzheimer disease or vascular dementia) or age-associated memory impairment (AAMI). A total of 214 participants, recruited from 39 homes for the elderly in the Netherlands, were randomly allocated to Ginkgo (either 240 mg/d or 160 mg/d) or placebo (0 mg/d). After 12 weeks, the subjects in the two Ginkgo groups were randomized to continued Ginkgo treatment or placebo treatment. Primary outcome measures in this study were the Syndrome Kurz Test (SKT; psychometric functioning), the Clinical Global Impression of change (CGI-2; psychopathology, assessed by nursing staff), and the Nuremberg Gerontopsychological Rating Scale for Activities of Daily Living (NAI-NAA; behavioral functioning). One hundred twenty-three patients received Ginkgo (
n
=
79, 240 and 160 mg/d combined) or placebo (
n
=
44) during the 24-week intervention period. We found no statistically significant differences in mean change of scores between Ginkgo and placebo. The differences were SKT: +0.4 (90% confidence interval [CI] −0.9–1.7); CGI-2: +0.1 (90% CI −0.3–0.4), and NAI-NAA: −0.4 (90% CI −1.9–1.2). A positive difference is in favor of Ginkgo. Neither the dementia subgroup (
n
=
36) nor the AAMI subgroup (
n
=
87) experienced a significant effect of Ginkgo treatment. There was no dose-effect relationship and no effect of prolonged Ginkgo treatment. The trial results do not support the view that Ginkgo is beneficial for patients with dementia or age-associated memory impairment.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>12767414</pmid><doi>10.1016/S0895-4356(03)00003-9</doi><tpages>10</tpages></addata></record> |
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| ispartof | Journal of clinical epidemiology, 2003-04, Vol.56 (4), p.367-376 |
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| subjects | AAMI Activities of Daily Living Aged Alzheimer's disease Biological and medical sciences Cognitive ability Confidence intervals Data collection Data processing Dementia Dementia - drug therapy Dementia disorders Dose-response effects Dose-Response Relationship, Drug Double-Blind Method Drug dosages EGb 761 Elderly people Epidemiology Female Follow-Up Studies Free radicals Geriatric Assessment Ginkgo Ginkgo biloba Homes for the Aged Humans Male Medical sciences Memory Disorders - drug therapy Middle Aged Neuropharmacology Neuroprotective agent Neuropsychological Tests Nootropic Agents - therapeutic use Pharmacology. Drug treatments Phytotherapy - methods Plant Extracts - therapeutic use Psychometrics RCT Standard deviation Studies Treatment Outcome |
| title | Ginkgo for elderly people with dementia and age-associated memory impairment: a randomized clinical trial |
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