Effects of folic acid supplementation on overall and site-specific cancer incidence during the randomised trials: meta-analyses of data on 50 000 individuals
Identifieur interne : 004F97 ( Main/Exploration ); précédent : 004F96; suivant : 004F98Effects of folic acid supplementation on overall and site-specific cancer incidence during the randomised trials: meta-analyses of data on 50 000 individuals
Auteurs : Stein Emil Vollset [Norvège] ; Robert Clarke [Royaume-Uni] ; Sarah Lewington [Royaume-Uni] ; Marta Ebbing [Norvège] ; Jim Halsey [Royaume-Uni] ; Eva Lonn [Canada] ; Jane Armitage [Royaume-Uni] ; Joann E. Manson [États-Unis] ; Graeme J. Hankey [Australie] ; J. David Spence [Canada] ; Pilar Galan [France] ; Kaare H. B Naa [Norvège] ; Rex Jamison [États-Unis] ; J. Michael Gaziano [États-Unis] ; Peter Guarino [États-Unis] ; John A. Baron [États-Unis] ; Richard F. A. Logan [Royaume-Uni] ; Edward L. Giovannucci [États-Unis] ; Martin Den Heijer [Pays-Bas] ; Per M. Ueland ; Derrick Bennett [Royaume-Uni] ; Rory Collins [Royaume-Uni] ; Richard Peto [Royaume-Uni]Source :
- Lancet : (British edition) [ 0140-6736 ] ; 2013.
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Abstract
Background Some countries fortify flour with folic acid to prevent neural tube defects but others do not, partly because of concerns about possible cancer risks. We aimed to assess any effects on site-specific cancer rates in the randomised trials of folic acid supplementation, at doses higher than those from fortification. Methods In these meta-analyses, we sought all trials completed before 2011 that compared folic acid versus placebo, had scheduled treatment duration at least 1 year, included at least 500 participants, and recorded data on cancer incidence. We obtained individual participant datasets that included 49621 participants in all 13 such trials (ten trials of folic acid for prevention of cardiovascular disease [n=46969] and three trials in patients with colorectal adenoma [n=2652]). All these trials were evenly randomised. The main outcome was incident cancer (ignoring non-melanoma skin cancer) during the scheduled treatment period (among participants who were still free of cancer). We compared those allocated folic acid with those allocated placebo, and used log-rank analyses to calculate the cancer incidence rate ratio (RR). Findings During a weighted average scheduled treatment duration of 5.2 years, allocation to folic acid quadrupled plasma concentrations of folic acid (57.3 nmol/L for the folic acid groups vs 13.5 nmol/L for the placebo groups), but had no significant effect on overall cancer incidence (1904 cancers in the folic acid groups vs 1809 cancers in the placebo groups, RR 1.06, 95% CI 0.99-1.13, p=0.10). There was no trend towards greater effect with longer treatment. There was no significant heterogeneity between the results of the 13 individual trials (p=0.23), or between the two overall results in the cadiovascular prevention trials and the adenoma trials (p=0.13). Moreover, there was no significant effect of folic acid supplementation on the incidence of cancer of the large intestine, prostate, lung, breast, or any other specific site. Interpretation Folic acid supplementation does not substantially increase or decrease incidence of site-specific cancer during the first 5 years of treatment. Fortification of flour and other cereal products involves doses of folic acid that are, on average, an order of magnitude smaller than the doses used in these trials. Funding British Heart Foundation, Medical Research Council, Cancer Research UK, Food Standards Agency.
Affiliations:
- Australie, Canada, France, Norvège, Pays-Bas, Royaume-Uni, États-Unis
- Angleterre, Gueldre, Nottinghamshire, Ontario, Oxfordshire, Île-de-France
- Bobigny, Hamilton (Ontario), Nimègue, Nottingham, Oxford, Paris
- Université McMaster, Université Paris 13, Université d'Oxford, Université de Nottingham
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Manson</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Medicine, Harvard Medical School, Brigham and Women's Hospital</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Boston, MA</wicri:noRegion></affiliation></author><author><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Neurology, Royal Perth Hospital</s1><s2>Perth, WA</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Perth, WA</wicri:noRegion></affiliation></author><author><name sortKey="Spence, J David" sort="Spence, J David" uniqKey="Spence J" first="J. David" last="Spence">J. David Spence</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Neurology, Robarts Research Institute, University of Western Ontario</s1><s2>London, ON</s2><s3>CAN</s3><sZ>10 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>London, ON</wicri:noRegion></affiliation></author><author><name sortKey="Galan, Pilar" sort="Galan, Pilar" uniqKey="Galan P" first="Pilar" last="Galan">Pilar Galan</name><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Research Unit on Nutritional Epidemiology, INSERM U557, Inra, CNAM Université Paris 13, CRNH Idf</s1><s2>Bobigny</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Bobigny</settlement><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris 13</orgName></affiliation></author><author><name sortKey="B Naa, Kaare H" sort="B Naa, Kaare H" uniqKey="B Naa K" first="Kaare H." last="B Naa">Kaare H. B Naa</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Heart Disease, University Hospital of Northern Norway</s1><s2>Tromsø</s2><s3>NOR</s3><sZ>12 aut.</sZ></inist:fA14><country>Norvège</country><wicri:noRegion>Tromsø</wicri:noRegion></affiliation></author><author><name sortKey="Jamison, Rex" sort="Jamison, Rex" uniqKey="Jamison R" first="Rex" last="Jamison">Rex Jamison</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Medicine, Veterans Affairs Palo Alto Health Care System and Stanford University School of Medicine</s1><s2>Palo Alto, CA</s2><s3>USA</s3><sZ>13 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Palo Alto, CA</wicri:noRegion></affiliation></author><author><name sortKey="Michael Gaziano, J" sort="Michael Gaziano, J" uniqKey="Michael Gaziano J" first="J." last="Michael Gaziano">J. Michael Gaziano</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Massachusetts Veterans Epidemiology Research and Information Centre, VA Boston Healthcare System</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>14 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Boston, MA</wicri:noRegion></affiliation></author><author><name sortKey="Guarino, Peter" sort="Guarino, Peter" uniqKey="Guarino P" first="Peter" last="Guarino">Peter Guarino</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Cooperative Studies Program, Department of Veterans Affairs, Connecticut VA Healthcare System</s1><s2>West Haven, CT</s2><s3>USA</s3><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>West Haven, CT</wicri:noRegion></affiliation></author><author><name sortKey="Baron, John A" sort="Baron, John A" uniqKey="Baron J" first="John A." last="Baron">John A. Baron</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Department of Medicine, University of North Carolina</s1><s2>Chapel Hill, NC</s2><s3>USA</s3><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Chapel Hill, NC</wicri:noRegion></affiliation></author><author><name sortKey="Logan, Richard F A" sort="Logan, Richard F A" uniqKey="Logan R" first="Richard F. A." last="Logan">Richard F. A. Logan</name><affiliation wicri:level="4"><inist:fA14 i1="14"><s1>Division of Epidemiology and Public Health, University of Nottingham</s1><s2>Nottingham</s2><s3>GBR</s3><sZ>17 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Nottingham</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Nottinghamshire</region></placeName><orgName type="university">Université de Nottingham</orgName></affiliation></author><author><name sortKey="Giovannucci, Edward L" sort="Giovannucci, Edward L" uniqKey="Giovannucci E" first="Edward L." last="Giovannucci">Edward L. Giovannucci</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Departments of Epidemiology and Nutrition, Harvard School of Public Health</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>18 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Boston, MA</wicri:noRegion></affiliation></author><author><name sortKey="Den Heijer, Martin" sort="Den Heijer, Martin" uniqKey="Den Heijer M" first="Martin" last="Den Heijer">Martin Den Heijer</name><affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Department of Endocrinology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>19 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Nimègue</settlement><region type="province" nuts="2">Gueldre</region></placeName></affiliation></author><author><name sortKey="Ueland, Per M" sort="Ueland, Per M" uniqKey="Ueland P" first="Per M." last="Ueland">Per M. Ueland</name></author><author><name sortKey="Bennett, Derrick" sort="Bennett, Derrick" uniqKey="Bennett D" first="Derrick" last="Bennett">Derrick Bennett</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Collins, Rory" sort="Collins, Rory" uniqKey="Collins R" first="Rory" last="Collins">Rory Collins</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Peto, Richard" sort="Peto, Richard" uniqKey="Peto R" first="Richard" last="Peto">Richard Peto</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement 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type="wicri:Area/Main/Exploration">004F97</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Effects of folic acid supplementation on overall and site-specific cancer incidence during the randomised trials: meta-analyses of data on 50 000 individuals</title><author><name sortKey="Emil Vollset, Stein" sort="Emil Vollset, Stein" uniqKey="Emil Vollset S" first="Stein" last="Emil Vollset">Stein Emil Vollset</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Norwegian Institute of Public Health and Department of Public Health and Primary Health Care, University of Bergen</s1><s2>Bergen</s2><s3>NOR</s3><sZ>1 aut.</sZ></inist:fA14><country>Norvège</country><wicri:noRegion>Bergen</wicri:noRegion></affiliation></author><author><name sortKey="Clarke, Robert" sort="Clarke, Robert" uniqKey="Clarke R" first="Robert" last="Clarke">Robert Clarke</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Lewington, Sarah" sort="Lewington, Sarah" uniqKey="Lewington S" first="Sarah" last="Lewington">Sarah Lewington</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Ebbing, Marta" sort="Ebbing, Marta" uniqKey="Ebbing M" first="Marta" last="Ebbing">Marta Ebbing</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Heart Disease, Haukeland University Hospital</s1><s2>Bergen</s2><s3>NOR</s3><sZ>4 aut.</sZ></inist:fA14><country>Norvège</country><wicri:noRegion>Bergen</wicri:noRegion></affiliation></author><author><name sortKey="Halsey, Jim" sort="Halsey, Jim" uniqKey="Halsey J" first="Jim" last="Halsey">Jim Halsey</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Lonn, Eva" sort="Lonn, Eva" uniqKey="Lonn E" first="Eva" last="Lonn">Eva Lonn</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Population Health Research Institute and Department of Medicine, Division of Cardiology, McMaster University</s1><s2>Hamilton, ON</s2><s3>CAN</s3><sZ>6 aut.</sZ></inist:fA14><country>Canada</country><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName><orgName type="university">Université McMaster</orgName></affiliation></author><author><name sortKey="Armitage, Jane" sort="Armitage, Jane" uniqKey="Armitage J" first="Jane" last="Armitage">Jane Armitage</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Manson, Joann E" sort="Manson, Joann E" uniqKey="Manson J" first="Joann E." last="Manson">Joann E. Manson</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Medicine, Harvard Medical School, Brigham and Women's Hospital</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Boston, MA</wicri:noRegion></affiliation></author><author><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Neurology, Royal Perth Hospital</s1><s2>Perth, WA</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Perth, WA</wicri:noRegion></affiliation></author><author><name sortKey="Spence, J David" sort="Spence, J David" uniqKey="Spence J" first="J. David" last="Spence">J. David Spence</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Neurology, Robarts Research Institute, University of Western Ontario</s1><s2>London, ON</s2><s3>CAN</s3><sZ>10 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>London, ON</wicri:noRegion></affiliation></author><author><name sortKey="Galan, Pilar" sort="Galan, Pilar" uniqKey="Galan P" first="Pilar" last="Galan">Pilar Galan</name><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Research Unit on Nutritional Epidemiology, INSERM U557, Inra, CNAM Université Paris 13, CRNH Idf</s1><s2>Bobigny</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Bobigny</settlement><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris 13</orgName></affiliation></author><author><name sortKey="B Naa, Kaare H" sort="B Naa, Kaare H" uniqKey="B Naa K" first="Kaare H." last="B Naa">Kaare H. B Naa</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Heart Disease, University Hospital of Northern Norway</s1><s2>Tromsø</s2><s3>NOR</s3><sZ>12 aut.</sZ></inist:fA14><country>Norvège</country><wicri:noRegion>Tromsø</wicri:noRegion></affiliation></author><author><name sortKey="Jamison, Rex" sort="Jamison, Rex" uniqKey="Jamison R" first="Rex" last="Jamison">Rex Jamison</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Medicine, Veterans Affairs Palo Alto Health Care System and Stanford University School of Medicine</s1><s2>Palo Alto, CA</s2><s3>USA</s3><sZ>13 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Palo Alto, CA</wicri:noRegion></affiliation></author><author><name sortKey="Michael Gaziano, J" sort="Michael Gaziano, J" uniqKey="Michael Gaziano J" first="J." last="Michael Gaziano">J. Michael Gaziano</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Massachusetts Veterans Epidemiology Research and Information Centre, VA Boston Healthcare System</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>14 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Boston, MA</wicri:noRegion></affiliation></author><author><name sortKey="Guarino, Peter" sort="Guarino, Peter" uniqKey="Guarino P" first="Peter" last="Guarino">Peter Guarino</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Cooperative Studies Program, Department of Veterans Affairs, Connecticut VA Healthcare System</s1><s2>West Haven, CT</s2><s3>USA</s3><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>West Haven, CT</wicri:noRegion></affiliation></author><author><name sortKey="Baron, John A" sort="Baron, John A" uniqKey="Baron J" first="John A." last="Baron">John A. Baron</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Department of Medicine, University of North Carolina</s1><s2>Chapel Hill, NC</s2><s3>USA</s3><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Chapel Hill, NC</wicri:noRegion></affiliation></author><author><name sortKey="Logan, Richard F A" sort="Logan, Richard F A" uniqKey="Logan R" first="Richard F. A." last="Logan">Richard F. A. Logan</name><affiliation wicri:level="4"><inist:fA14 i1="14"><s1>Division of Epidemiology and Public Health, University of Nottingham</s1><s2>Nottingham</s2><s3>GBR</s3><sZ>17 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Nottingham</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Nottinghamshire</region></placeName><orgName type="university">Université de Nottingham</orgName></affiliation></author><author><name sortKey="Giovannucci, Edward L" sort="Giovannucci, Edward L" uniqKey="Giovannucci E" first="Edward L." last="Giovannucci">Edward L. Giovannucci</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Departments of Epidemiology and Nutrition, Harvard School of Public Health</s1><s2>Boston, MA</s2><s3>USA</s3><sZ>18 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Boston, MA</wicri:noRegion></affiliation></author><author><name sortKey="Den Heijer, Martin" sort="Den Heijer, Martin" uniqKey="Den Heijer M" first="Martin" last="Den Heijer">Martin Den Heijer</name><affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Department of Endocrinology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>19 aut.</sZ></inist:fA14><country>Pays-Bas</country><placeName><settlement type="city">Nimègue</settlement><region type="province" nuts="2">Gueldre</region></placeName></affiliation></author><author><name sortKey="Ueland, Per M" sort="Ueland, Per M" uniqKey="Ueland P" first="Per M." last="Ueland">Per M. Ueland</name></author><author><name sortKey="Bennett, Derrick" sort="Bennett, Derrick" uniqKey="Bennett D" first="Derrick" last="Bennett">Derrick Bennett</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Collins, Rory" sort="Collins, Rory" uniqKey="Collins R" first="Rory" last="Collins">Rory Collins</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Peto, Richard" sort="Peto, Richard" uniqKey="Peto R" first="Richard" last="Peto">Richard Peto</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ><sZ>5 aut.</sZ><sZ>7 aut.</sZ><sZ>21 aut.</sZ><sZ>22 aut.</sZ><sZ>23 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author></analytic><series><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Lancet : (British edition)</title><title level="j" type="abbreviated">Lancet : (Br. ed.)</title><idno type="ISSN">0140-6736</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical trial</term><term>Epidemiology</term><term>Evidence-based medicine</term><term>Folic acid</term><term>Human</term><term>Incidence</term><term>Malignant tumor</term><term>Metaanalysis</term><term>Nutrition</term><term>Rapid technique</term><term>Site specificity</term><term>Supplementation</term><term>Vitamin</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Acide folique</term><term>Vitamine</term><term>Nutrition</term><term>Tumeur maligne</term><term>Supplémentation</term><term>Technique rapide</term><term>Site spécifique</term><term>Incidence</term><term>Epidémiologie</term><term>Essai clinique</term><term>Métaanalyse</term><term>Médecine factuelle</term><term>Homme</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vitamine</term><term>Nutrition</term><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background Some countries fortify flour with folic acid to prevent neural tube defects but others do not, partly because of concerns about possible cancer risks. We aimed to assess any effects on site-specific cancer rates in the randomised trials of folic acid supplementation, at doses higher than those from fortification. Methods In these meta-analyses, we sought all trials completed before 2011 that compared folic acid versus placebo, had scheduled treatment duration at least 1 year, included at least 500 participants, and recorded data on cancer incidence. We obtained individual participant datasets that included 49621 participants in all 13 such trials (ten trials of folic acid for prevention of cardiovascular disease [n=46969] and three trials in patients with colorectal adenoma [n=2652]). All these trials were evenly randomised. The main outcome was incident cancer (ignoring non-melanoma skin cancer) during the scheduled treatment period (among participants who were still free of cancer). We compared those allocated folic acid with those allocated placebo, and used log-rank analyses to calculate the cancer incidence rate ratio (RR). Findings During a weighted average scheduled treatment duration of 5.2 years, allocation to folic acid quadrupled plasma concentrations of folic acid (57.3 nmol/L for the folic acid groups vs 13.5 nmol/L for the placebo groups), but had no significant effect on overall cancer incidence (1904 cancers in the folic acid groups vs 1809 cancers in the placebo groups, RR 1.06, 95% CI 0.99-1.13, p=0.10). There was no trend towards greater effect with longer treatment. There was no significant heterogeneity between the results of the 13 individual trials (p=0.23), or between the two overall results in the cadiovascular prevention trials and the adenoma trials (p=0.13). Moreover, there was no significant effect of folic acid supplementation on the incidence of cancer of the large intestine, prostate, lung, breast, or any other specific site. Interpretation Folic acid supplementation does not substantially increase or decrease incidence of site-specific cancer during the first 5 years of treatment. Fortification of flour and other cereal products involves doses of folic acid that are, on average, an order of magnitude smaller than the doses used in these trials. Funding British Heart Foundation, Medical Research Council, Cancer Research UK, Food Standards Agency.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li><li>Norvège</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Gueldre</li><li>Nottinghamshire</li><li>Ontario</li><li>Oxfordshire</li><li>Île-de-France</li></region><settlement><li>Bobigny</li><li>Hamilton (Ontario)</li><li>Nimègue</li><li>Nottingham</li><li>Oxford</li><li>Paris</li></settlement><orgName><li>Université McMaster</li><li>Université Paris 13</li><li>Université d'Oxford</li><li>Université de Nottingham</li></orgName></list><tree><noCountry><name sortKey="Ueland, Per M" sort="Ueland, Per M" uniqKey="Ueland P" first="Per M." last="Ueland">Per M. Ueland</name></noCountry><country name="Norvège"><noRegion><name sortKey="Emil Vollset, Stein" sort="Emil Vollset, Stein" uniqKey="Emil Vollset S" first="Stein" last="Emil Vollset">Stein Emil Vollset</name></noRegion><name sortKey="B Naa, Kaare H" sort="B Naa, Kaare H" uniqKey="B Naa K" first="Kaare H." last="B Naa">Kaare H. B Naa</name><name sortKey="Ebbing, Marta" sort="Ebbing, Marta" uniqKey="Ebbing M" first="Marta" last="Ebbing">Marta Ebbing</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Clarke, Robert" sort="Clarke, Robert" uniqKey="Clarke R" first="Robert" last="Clarke">Robert Clarke</name></region><name sortKey="Armitage, Jane" sort="Armitage, Jane" uniqKey="Armitage J" first="Jane" last="Armitage">Jane Armitage</name><name sortKey="Bennett, Derrick" sort="Bennett, Derrick" uniqKey="Bennett D" first="Derrick" last="Bennett">Derrick Bennett</name><name sortKey="Collins, Rory" sort="Collins, Rory" uniqKey="Collins R" first="Rory" last="Collins">Rory Collins</name><name sortKey="Halsey, Jim" sort="Halsey, Jim" uniqKey="Halsey J" first="Jim" last="Halsey">Jim Halsey</name><name sortKey="Lewington, Sarah" sort="Lewington, Sarah" uniqKey="Lewington S" first="Sarah" last="Lewington">Sarah Lewington</name><name sortKey="Logan, Richard F A" sort="Logan, Richard F A" uniqKey="Logan R" first="Richard F. A." last="Logan">Richard F. A. Logan</name><name sortKey="Peto, Richard" sort="Peto, Richard" uniqKey="Peto R" first="Richard" last="Peto">Richard Peto</name></country><country name="Canada"><region name="Ontario"><name sortKey="Lonn, Eva" sort="Lonn, Eva" uniqKey="Lonn E" first="Eva" last="Lonn">Eva Lonn</name></region><name sortKey="Spence, J David" sort="Spence, J David" uniqKey="Spence J" first="J. David" last="Spence">J. David Spence</name></country><country name="États-Unis"><noRegion><name sortKey="Manson, Joann E" sort="Manson, Joann E" uniqKey="Manson J" first="Joann E." last="Manson">Joann E. Manson</name></noRegion><name sortKey="Baron, John A" sort="Baron, John A" uniqKey="Baron J" first="John A." last="Baron">John A. Baron</name><name sortKey="Giovannucci, Edward L" sort="Giovannucci, Edward L" uniqKey="Giovannucci E" first="Edward L." last="Giovannucci">Edward L. Giovannucci</name><name sortKey="Guarino, Peter" sort="Guarino, Peter" uniqKey="Guarino P" first="Peter" last="Guarino">Peter Guarino</name><name sortKey="Jamison, Rex" sort="Jamison, Rex" uniqKey="Jamison R" first="Rex" last="Jamison">Rex Jamison</name><name sortKey="Michael Gaziano, J" sort="Michael Gaziano, J" uniqKey="Michael Gaziano J" first="J." last="Michael Gaziano">J. Michael Gaziano</name></country><country name="Australie"><noRegion><name sortKey="Hankey, Graeme J" sort="Hankey, Graeme J" uniqKey="Hankey G" first="Graeme J." last="Hankey">Graeme J. Hankey</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Galan, Pilar" sort="Galan, Pilar" uniqKey="Galan P" first="Pilar" last="Galan">Pilar Galan</name></region></country><country name="Pays-Bas"><region name="Gueldre"><name sortKey="Den Heijer, Martin" sort="Den Heijer, Martin" uniqKey="Den Heijer M" first="Martin" last="Den Heijer">Martin Den Heijer</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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