Randomised controlled trialcited by the Tayebat archiveabstract only checked A-SUP-07 standard review
Low-dose omega-3 after heart attack
n-3 fatty acids and cardiovascular events after myocardial infarction.
Overview
Kromhout D et al.. N Engl J Med 2010 · PMID 20929341 · DOI 10.1056/NEJMoa1003603
No reduction in cardiovascular events.
Does the study support the specific claim? Yes · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Omega-3 after MI.
- How was the study done?
RCT.
- How many people, animals or samples were studied?
4,837.
- What was actually found?
No effect.
- How large was the observed effect?
HR 1.01.
- What do the results mean in everyday life?
Low doses don't help.
- What are the study's limitations?
Low dose.
- What does it say about Elawady's specific claim?
Supports.
- Do the results apply to Germany and Europe?
Dutch.
- What can explicitly not be concluded from this study?
High-dose effects.
Scientific in-depth review
1. Full reference
- Authors
- Kromhout D, Giltay EJ, Geleijnse JM, Alpha Omega Trial Group
- Journal
- N Engl J Med
- Year
- 2010
- Identifier
- PMID 20929341 DOI 10.1056/NEJMoa1003603
- Verification
- verified – PubMed E-utilities efetch, 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract
2. Research question
Effect of EPA-DHA and ALA on CV events after MI
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre double-blind placebo-controlled 2×2 RCT (Alpha Omega)
- Population
Post-MI patients 60–80 years
- Country
Netherlands
- Period
40 months
- Sample size
4,837
- Inclusion and exclusion criteria
see abstract
4. Methods and endpoints
- Exposure / intervention
Margarine with ~400 mg EPA-DHA and/or 2 g ALA
- Comparator
Placebo margarine
- Endpoints
Major CV events
- Statistical methods
Cox ITT
5. Actual results
- Results
EPA-DHA HR 1.01 (0.87–1.17); ALA HR 0.91 (0.78–1.05); women ALA HR 0.73 (0.51–1.03, P=0.07).
- Absolute risks
not reported in abstract
- Authors' conclusion
Low-dose EPA-DHA or ALA did not significantly reduce major CV events.
6. Strengths
- RCT
7. Weaknesses
- Low dose via margarine
- Well-treated patients
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Simplified RoB 2.
9. Assessment of the statistical interpretation
See results.
10. Relevance to the specific claim
11. Independent contrary findings
REDUCE-IT (high dose).
12. Transferability to Germany and Europe
High: biology and trial populations comparable to European adults.
13. Overall methodological judgement
Null RCT.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | correctly reported |
14. Open questions
15. Linked fact checks
- When popular oral supplements (calcium, beta-carotene, vitamin E, omega-3, multivitamins, glucosamine, selenium, vitamin A) were tested in large long-term placebo-controlled trials, most failed to deliver the promised prevention of disease. – Studies supporting the claim
- Omega-3 capsules do not prevent cardiovascular disease and increase the risk of atrial fibrillation; Elawady rejects omega-3 capsules. – Studies supporting the claim
Use by the Tayebat archive
Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.
- What the archive says about the study
Listed in the archive bibliography of the oral-supplements rule without its own interpretation; used implicitly to support the rule summary that supplements 'failed or caused harm' in large trials.
- A. What was actually studied?
Effect of EPA-DHA and ALA on CV events after MI
- B. What did the authors find?
EPA-DHA HR 1.01 (0.87–1.17); ALA HR 0.91 (0.78–1.05); women ALA HR 0.73 (0.51–1.03, P=0.07).
- C. What conclusions do the authors themselves draw?
Low-dose EPA-DHA or ALA did not significantly reduce major CV events.
- D. What does the archive derive from it?
Supports 'omega-3 failed'.
- E. Is this derivation scientifically justified?
Yes for low-dose.
- Adequacy of the interpretation (by the archive)
- correctly reported