Evidence map›Paper›PMID 23066166›Full record

Trial reportJournal of the National Cancer Institute2012

Effect of combined folic acid, vitamin B(6), and vitamin B(12) on colorectal adenoma.

Yiqing Song, Joann E Manson, I-Min Lee, Nancy R Cook, Ligi Paul, Jacob Selhub, Edward Giovannucci, Shumin M Zhang

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00000541 (Women's Antioxidant and Folic Acid Cardiovascular Study), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00000541 phase2completednot on this map

Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)

TypeinterventionalSponsorBrigham and Women's HospitalRan1993 to 2005ConditionsCardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart DiseasesArmsdietary supplements, vitamin C, vitamin E, beta-carotene, folic acid/Vitamin B6/Vitamin B12
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
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  11. Article
  12. Article
  13. Review
  14. Article
  15. Role of vitamins in gastrointestinal diseases.World journal of gastroenterology · 2015
    Review
  16. Review
  17. Following up folate and its function in colorectal carcinogenesis.Journal of the National Cancer Institute · 2012
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Yiqing SongDivision of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02215, USA.
Joann E Manson
I-Min Lee
Nancy R Cook
Ligi Paul
Jacob Selhub
Edward Giovannucci
Shumin M Zhang
Brigham and Women's Hospital · USHarvard University · US

Funding

TRIAL OF ANTIOXIDANT THERAPY OF CVD IN WOMENR01HL046959 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MANSON, JOANN ELISABETH · 1993 to 2005
$3.6M
Cysteine, Related Gene Variants and Breast Cancer RiskR01CA124857 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI WILLETT, WALTER C. · 2007 to 2010
$1.3M
Estrogen and Progesterone-related Gene Variants and Colorectal Cancer RiskR01CA123089 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI ZHANG, SHUMIN · 2006 to 2009
$1.2M
Nutritional and Genetic Markers of Breast CancerR01CA104871 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI ZHANG, SHUMIN · 2005 to 2008
$1.2M
NCI NIH HHS CA104871NCI NIH HHS CA123089NCI NIH HHS CA124857NCI NIH HHS R01 CA104871NCI NIH HHS R01 CA123089NCI NIH HHS R01 CA124857NHLBI NIH HHS HL046959NHLBI NIH HHS R01 HL046959
6 · The paper itself

Abstract

backgroundFolic acid, vitamin B(6), and vitamin B(12) act in concert in the one-carbon metabolism and may protect against colorectal neoplasia. We examined the effect of combined B-vitamin treatment on the occurrence of colorectal adenoma.

methodsThe Women's Antioxidant and Folic Acid Cardiovascular Study was a randomized, double-blind, placebo-controlled trial of 5442 female health professionals at high risk for cardiovascular disease from April 1998 through July 2005. Participants were randomly assigned to receive a combination pill of folic acid (2.5mg), vitamin B(6) (50mg), and vitamin B(12) (1mg) or placebo. This study included 1470 participants who were followed up for as long as 9.2 years and underwent an endoscopy at any point during follow-up. We estimated relative risks using a generalized linear model with a natural logarithm link function and Poisson distributed errors. All statistical tests were two-sided.

resultsThe risk of colorectal adenoma was similar among participants receiving treatment (24.3%, 180 of 741 participants) vs placebo (24.0%, 175 of 729 participants) (multivariable adjusted relative risk = 1.00, 95% confidence interval = 0.83 to 1.20). Treatment was not associated with the risk of adenoma when data were analyzed by subsite, size, stage, and the number of adenomas. There was no statistically significant effect modification by alcohol intake, history of cancer or adenoma, or baseline plasma levels or intakes of folate, vitamin B(6), or vitamin B(12).

conclusionOur results indicate no statistically significant effect of combined folic acid, vitamin B(6), and vitamin B(12) treatment on colorectal adenoma among women at high risk for cardiovascular disease.

Indexed as

AdenomaAdultAgedAnticarcinogenic AgentsCardiovascular DiseasesColorectal NeoplasmsDouble-Blind MethodDrug Therapy, CombinationFemaleFolic AcidFollow-Up StudiesHumansIncidenceLinear ModelsMaleMiddle AgedAnticarcinogenic AgentsFolic AcidVitamin B 12Vitamin B 6

Identifiers

PMID23066166
PMCPMC3611818
OpenAlexW2165640959

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.