Randomised controlled trialcited by the Tayebat archiveabstract only checked A-SUP-10 standard review
STRENGTH: high-dose omega-3
Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.
Overview
Nicholls SJ et al.. JAMA 2020 · PMID 33190147 · DOI 10.1001/jama.2020.22258
No benefit vs corn oil; more GI side effects.
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?
High-dose omega-3.
- How was the study done?
RCT.
- How many people, animals or samples were studied?
13,078.
- What was actually found?
Null.
- How large was the observed effect?
HR 0.99.
- What do the results mean in everyday life?
Not useful.
- What does it say about Elawady's specific claim?
Supports.
- Do the results apply to Germany and Europe?
Applicable.
- What can explicitly not be concluded from this study?
Why REDUCE-IT differs.
Scientific in-depth review
1. Full reference
- Authors
- Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, Davidson MH, Kastelein JJP, Koenig W, McGuire DK, Mozaffarian D, Ridker PM, Ray KK, Katona BG, Himmelmann A, Loss LE, Rensfeldt M, Lundström T, Agrawal R, Menon V, Wolski K, Nissen SE
- Journal
- JAMA
- Year
- 2020
- Identifier
- PMID 33190147 DOI 10.1001/jama.2020.22258 · PMC7667577
- 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
Does 4 g/d omega-3 carboxylic acid reduce MACE in high-risk patients?
3. Study design and population
- Study design
- Randomised controlled trial – Double-blind randomised multicentre trial (STRENGTH)
- Population
Statin-treated, high CV risk, hypertriglyceridaemia, low HDL
- Country
22 countries
- Period
2014–2020; halted early
- Sample size
13,078
- Inclusion and exclusion criteria
see abstract
4. Methods and endpoints
- Exposure / intervention
4 g/d omega-3 CA
- Comparator
Corn oil
- Endpoints
MACE composite
- Statistical methods
Cox
5. Actual results
- Results
Primary end point 12.0% vs 12.2%, HR 0.99 (0.90–1.09); GI adverse events 24.7% vs 14.7%.
- Absolute risks
not reported in abstract
- Authors' conclusion
No significant difference in MACE; does not support use.
6. Strengths
- Large RCT
7. Weaknesses
- Stopped for futility
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 (I-SUP-09).
12. Transferability to Germany and Europe
High: biology and trial populations comparable to European adults.
13. Overall methodological judgement
Null; conflicts with REDUCE-IT.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | high |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | mixed |
| 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?
Does 4 g/d omega-3 carboxylic acid reduce MACE in high-risk patients?
- B. What did the authors find?
Primary end point 12.0% vs 12.2%, HR 0.99 (0.90–1.09); GI adverse events 24.7% vs 14.7%.
- C. What conclusions do the authors themselves draw?
No significant difference in MACE; does not support use.
- D. What does the archive derive from it?
Supports.
- E. Is this derivation scientifically justified?
Yes, though REDUCE-IT differs.
- Adequacy of the interpretation (by the archive)
- correctly reported