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<?xml version="1.0"?> <!DOCTYPE PubmedArticleSet PUBLIC "-//NLM//DTD PubMedArticle, 1st January 2014//EN" "http://www.ncbi.nlm.nih.gov/corehtml/query/DTD/pubmed_140101.dtd"> <PubmedArticleSet> <PubmedArticle> <MedlineCitation Owner="NLM" Status="MEDLINE"> <PMID Version="1">19237716</PMID> <DateCreated> <Year>2009</Year> <Month>02</Month> <Day>24</Day> </DateCreated> <DateCompleted> <Year>2009</Year> <Month>03</Month> <Day>09</Day> </DateCompleted> <DateRevised> <Year>2013</Year> <Month>11</Month> <Day>21</Day> </DateRevised> <Article PubModel="Print"> <Journal> <ISSN IssnType="Electronic">1538-3679</ISSN> <JournalIssue CitedMedium="Internet"> <Volume>169</Volume> <Issue>4</Issue> <PubDate> <Year>2009</Year> <Month>Feb</Month> <Day>23</Day> </PubDate> </JournalIssue> <Title>Archives of internal medicine</Title> <ISOAbbreviation>Arch. Intern. Med.</ISOAbbreviation> </Journal> <ArticleTitle>Folic acid, pyridoxine, and cyanocobalamin combination treatment and age-related macular degeneration in women: the Women's Antioxidant and Folic Acid Cardiovascular Study.</ArticleTitle> <Pagination> <MedlinePgn>335-41</MedlinePgn> </Pagination> <ELocationID EIdType="doi" ValidYN="Y">10.1001/archinternmed.2008.574</ELocationID> <Abstract> <AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Observational epidemiologic studies indicate a direct association between homocysteine concentration in the blood and the risk of age-related macular degeneration (AMD), but randomized trial data to examine the effect of therapy to lower homocysteine levels in AMD are lacking. Our objective was to examine the incidence of AMD in a trial of combined folic acid, pyridoxine hydrochloride (vitamin B(6)), and cyanocobalamin (vitamin B(12)) therapy.</AbstractText> <AbstractText Label="METHODS" NlmCategory="METHODS">We conducted a randomized, double-blind, placebo-controlled trial including 5442 female health care professionals 40 years or older with preexisting cardiovascular disease or 3 or more cardiovascular disease risk factors. A total of 5205 of these women did not have a diagnosis of AMD at baseline and were included in this analysis. Participants were randomly assigned to receive a combination of folic acid (2.5 mg/d), pyridoxine hydrochloride (50 mg/d), and cyanocobalamin (1 mg/d) or placebo. Our main outcome measures included total AMD, defined as a self-report documented by medical record evidence of an initial diagnosis after randomization, and visually significant AMD, defined as confirmed incident AMD with visual acuity of 20/30 or worse attributable to this condition.</AbstractText> <AbstractText Label="RESULTS" NlmCategory="RESULTS">After an average of 7.3 years of treatment and follow-up, there were 55 cases of AMD in the combination treatment group and 82 in the placebo group (relative risk, 0.66; 95% confidence interval, 0.47-0.93 [P = .02]). For visually significant AMD, there were 26 cases in the combination treatment group and 44 in the placebo group (relative risk, 0.59; 95% confidence interval, 0.36-0.95 [P = .03]).</AbstractText> <AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">These randomized trial data from a large cohort of women at high risk of cardiovascular disease indicate that daily supplementation with folic acid, pyridoxine, and cyanocobalamin may reduce the risk of AMD.</AbstractText> </Abstract> <AuthorList CompleteYN="Y"> <Author ValidYN="Y"> <LastName>Christen</LastName> <ForeName>William G</ForeName> <Initials>WG</Initials> <Affiliation>Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue E, Boston, MA 02215-1204, USA. wchristen@rics.bwh.harvard.edu</Affiliation> </Author> <Author ValidYN="Y"> <LastName>Glynn</LastName> <ForeName>Robert J</ForeName> <Initials>RJ</Initials> </Author> <Author ValidYN="Y"> <LastName>Chew</LastName> <ForeName>Emily Y</ForeName> <Initials>EY</Initials> </Author> <Author ValidYN="Y"> <LastName>Albert</LastName> <ForeName>Christine M</ForeName> <Initials>CM</Initials> </Author> <Author ValidYN="Y"> <LastName>Manson</LastName> <ForeName>Joann E</ForeName> <Initials>JE</Initials> </Author> </AuthorList> <Language>eng</Language> <DataBankList CompleteYN="Y"> <DataBank> <DataBankName>ClinicalTrials.gov</DataBankName> <AccessionNumberList> <AccessionNumber>NCT00000161</AccessionNumber> </AccessionNumberList> </DataBank> </DataBankList> <GrantList CompleteYN="Y"> <Grant> <GrantID>EY 06633</GrantID> <Acronym>EY</Acronym> <Agency>NEI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>HL 46959</GrantID> <Acronym>HL</Acronym> <Agency>NHLBI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>P30 DK040561-13</GrantID> <Acronym>DK</Acronym> <Agency>NIDDK NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 EY006633-11</GrantID> <Acronym>EY</Acronym> <Agency>NEI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 EY006633-12</GrantID> <Acronym>EY</Acronym> <Agency>NEI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 EY006633-13</GrantID> <Acronym>EY</Acronym> <Agency>NEI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 EY006633-14</GrantID> <Acronym>EY</Acronym> <Agency>NEI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 HL046959-07</GrantID> <Acronym>HL</Acronym> <Agency>NHLBI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 HL046959-08</GrantID> <Acronym>HL</Acronym> <Agency>NHLBI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 HL046959-09</GrantID> <Acronym>HL</Acronym> <Agency>NHLBI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 HL046959-10</GrantID> <Acronym>HL</Acronym> <Agency>NHLBI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 HL046959-11</GrantID> <Acronym>HL</Acronym> <Agency>NHLBI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 HL046959-12</GrantID> <Acronym>HL</Acronym> <Agency>NHLBI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>R01 HL046959-13</GrantID> <Acronym>HL</Acronym> <Agency>NHLBI NIH HHS</Agency> <Country>United States</Country> </Grant> <Grant> <GrantID>Z99 EY999999</GrantID> <Acronym>EY</Acronym> <Agency>NEI NIH HHS</Agency> <Country>United States</Country> </Grant> </GrantList> <PublicationTypeList> <PublicationType>Journal Article</PublicationType> <PublicationType>Randomized Controlled Trial</PublicationType> <PublicationType>Research Support, N.I.H., Extramural</PublicationType> <PublicationType>Research Support, Non-U.S. Gov't</PublicationType> </PublicationTypeList> </Article> <MedlineJournalInfo> 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Diseases</DescriptorName> <QualifierName MajorTopicYN="N">complications</QualifierName> <QualifierName MajorTopicYN="Y">prevention &amp; control</QualifierName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Double-Blind Method</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Drug Therapy, Combination</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Endpoint Determination</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Female</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Folic Acid</DescriptorName> <QualifierName MajorTopicYN="Y">therapeutic use</QualifierName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Follow-Up Studies</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Humans</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Incidence</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Macular Degeneration</DescriptorName> <QualifierName MajorTopicYN="N">complications</QualifierName> <QualifierName MajorTopicYN="Y">drug therapy</QualifierName> <QualifierName MajorTopicYN="Y">prevention &amp; control</QualifierName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Middle Aged</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Proportional Hazards Models</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Pyridoxine</DescriptorName> <QualifierName MajorTopicYN="Y">therapeutic use</QualifierName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Risk Factors</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Treatment Outcome</DescriptorName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Vitamin B 12</DescriptorName> <QualifierName MajorTopicYN="Y">therapeutic use</QualifierName> </MeshHeading> <MeshHeading> <DescriptorName MajorTopicYN="N">Vitamin B Complex</DescriptorName> <QualifierName MajorTopicYN="Y">therapeutic use</QualifierName> </MeshHeading> </MeshHeadingList> <OtherID Source="NLM">NIHMS75966</OtherID> <OtherID Source="NLM">PMC2648137</OtherID> </MedlineCitation> <PubmedData> <History> <PubMedPubDate PubStatus="entrez"> <Year>2009</Year> <Month>2</Month> <Day>25</Day> <Hour>9</Hour> <Minute>0</Minute> </PubMedPubDate> <PubMedPubDate PubStatus="pubmed"> <Year>2009</Year> <Month>2</Month> <Day>25</Day> <Hour>9</Hour> <Minute>0</Minute> </PubMedPubDate> <PubMedPubDate PubStatus="medline"> <Year>2009</Year> <Month>3</Month> <Day>10</Day> <Hour>9</Hour> <Minute>0</Minute> </PubMedPubDate> </History> <PublicationStatus>ppublish</PublicationStatus> <ArticleIdList> <ArticleId IdType="pii">169/4/335</ArticleId> <ArticleId IdType="doi">10.1001/archinternmed.2008.574</ArticleId> <ArticleId IdType="pubmed">19237716</ArticleId> <ArticleId IdType="pmc">PMC2648137</ArticleId> <ArticleId IdType="mid">NIHMS75966</ArticleId> </ArticleIdList> </PubmedData> </PubmedArticle> </PubmedArticleSet>