Randomised controlled trialcited by the Tayebat archiveabstract only checked A-SUP-25 standard review
PHS II: multivitamins and heart disease
Multivitamins in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial.
Overview
Sesso HD et al.. JAMA 2012 · PMID 23117775 · DOI 10.1001/jama.2012.14805
No reduction in heart attacks or strokes; no increase in deaths.
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?
CV prevention.
- How was the study done?
RCT.
- How many people, animals or samples were studied?
14,641.
- What was actually found?
Null.
- How large was the observed effect?
HR 1.01.
- What do the results mean in everyday life?
Not needed for heart.
- What are the study's limitations?
Physicians.
- What does it say about Elawady's specific claim?
- Do the results apply to Germany and Europe?
Applicable.
Scientific in-depth review
1. Full reference
- Authors
- Sesso HD, Christen WG, Bubes V, Smith JP, MacFadyen J, Schvartz M, Manson JE, Glynn RJ, Buring JE, Gaziano JM
- Journal
- JAMA
- Year
- 2012
- Identifier
- PMID 23117775 DOI 10.1001/jama.2012.14805 · PMC3501249
- 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; grants: NCI NIH HHS, NHLBI NIH HHS
2. Research question
Does a daily multivitamin reduce CV events in men?
3. Study design and population
- Study design
- Randomised controlled trial – Randomised double-blind placebo-controlled trial (PHS II)
- Population
Male US physicians ≥50
- Country
USA
- Period
1997–2011; median 11.2 years
- Sample size
14,641
- Inclusion and exclusion criteria
see abstract
4. Methods and endpoints
- Exposure / intervention
Daily multivitamin
- Comparator
Placebo
- Endpoints
Major CV events
- Statistical methods
Cox
5. Actual results
- Results
Major CV events HR 1.01 (0.91–1.10); MI 0.93; stroke 1.06; CVD death 0.95; total mortality HR 0.94 (0.88–1.02).
- Absolute risks
not reported in abstract
- Authors' conclusion
No reduction in CV events after >10 years.
6. Strengths
- Long RCT
7. Weaknesses
- Healthy physicians
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
12. Transferability to Germany and Europe
High: biology and trial populations comparable to European adults.
13. Overall methodological judgement
High-quality null.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | high |
| 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
- Multivitamins, iron, folic acid, B6, magnesium, zinc and copper supplements increase mortality, and folic acid (with B12) increases cancer. – Studies contradicting or limiting 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 a daily multivitamin reduce CV events in men?
- B. What did the authors find?
Major CV events HR 1.01 (0.91–1.10); MI 0.93; stroke 1.06; CVD death 0.95; total mortality HR 0.94 (0.88–1.02).
- C. What conclusions do the authors themselves draw?
No reduction in CV events after >10 years.
- D. What does the archive derive from it?
Supports 'failed'.
- E. Is this derivation scientifically justified?
Yes; also shows no mortality harm.
- Adequacy of the interpretation (by the archive)
- correctly reported