Evidence map›Paper›PMID 21115589›Full record

Trial reportBMJ (Clinical research ed.)2010

Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial.

Pilar Galan, Emmanuelle Kesse-Guyot, Sébastien Czernichow, Serge Briancon, Jacques Blacher, Serge Hercberg, SU.FOL.OM3 Collaborative Group

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 189 papers, 41 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
189citing papers in PubMed, 41 pooled it
22.9field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

189 citing papers in PubMed, 41 syntheses or guidelines pooled it, 457 citations in OpenAlex.

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  9. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
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  10. Omega-3 for the prevention of cardiovascular diseases: meta-analysis and trial-sequential analysis.European journal of hospital pharmacy : science and practice · 2022
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  16. Omega-3 Polyunsaturated Fatty Acids and Stroke Burden.International journal of molecular sciences · 2019
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  20. 2018 Guidelines for the management of dyslipidemia.The Korean journal of internal medicine · 2019
    Guideline

129 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Pilar GalanUMR U557 Inserm, U1125 Inra, Cnam, Université Paris 13, CRNH IdF, F-93017 Bobigny, France. p.galan@uren.smbh.univ-paris13.fr
Emmanuelle Kesse-Guyot
Sébastien Czernichow
Serge Briancon
Jacques Blacher
Serge Hercberg
SU.FOL.OM3 Collaborative Group
Institut National de la Recherche Agronomique · MADélégation Paris 5 · FRÉcole des Hautes Études en Santé Publique · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate whether dietary supplementation with B vitamins or omega 3 fatty acids, or both, could prevent major cardiovascular events in patients with a history of ischaemic heart disease or stroke.

designDouble blind, randomised, placebo controlled trial; factorial design.

settingRecruitment throughout France via a network of 417 cardiologists, neurologists, and other physicians.

participants2501 patients with a history of myocardial infarction, unstable angina, or ischaemic stroke.

interventionDaily dietary supplement containing 5-methyltetrahydrofolate (560 μg), vitamin B-6 (3 mg), and vitamin B-12 (20 μg) or placebo; and containing omega 3 fatty acids (600 mg of eicosapentanoic acid and docosahexaenoic acid at a ratio of 2:1) or placebo. Median duration of supplementation was 4.7 years.

main outcome measuresMajor cardiovascular events, defined as a composite of non-fatal myocardial infarction, stroke, or death from cardiovascular disease.

resultsAllocation to B vitamins lowered plasma homocysteine concentrations by 19% compared with placebo, but had no significant effects on major vascular events (75 v 82 patients, hazard ratio, 0.90 (95% confidence interval 0.66 to 1.23, P=0.50)). Allocation to omega 3 fatty acids increased plasma concentrations of omega 3 fatty acids by 37% compared with placebo, but also had no significant effect on major vascular events (81 v 76 patients, hazard ratio 1.08 (0.79 to 1.47, P=0.64)).

conclusionThis study does not support the routine use of dietary supplements containing B vitamins or omega 3 fatty acids for prevention of cardiovascular disease in people with a history of ischaemic heart disease or ischaemic stroke, at least when supplementation is introduced after the acute phase of the initial event.

trial registrationCurrent Controlled Trials ISRCTN41926726.

Indexed as

AgedAged, 80 and overAngina, UnstableBiomarkersCardiovascular DiseasesDietary SupplementsDouble-Blind MethodFatty Acids, Omega-6FemaleHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPatient ComplianceStrokeBiomarkersFatty Acids, Omega-6Vitamin B Complex

Identifiers

PMID21115589
PMCPMC2993045
OpenAlexW2086847901

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.