Randomised controlled trialcited by the Tayebat archiveabstract only checked A-SUP-19 standard review
HOPE-2: B vitamins in vascular disease
Homocysteine lowering with folic acid and B vitamins in vascular disease.
Overview
Lonn E et al.. N Engl J Med 2006 · PMID 16531613 · DOI 10.1056/NEJMoa060900
No reduction in major CV events; fewer strokes.
Does the study support the specific claim? Partly · 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?
5,522.
- What was actually found?
Null primary.
- How large was the observed effect?
RR 0.95.
- What do the results mean in everyday life?
Not for CV prevention.
- What does it say about Elawady's specific claim?
Mixed.
- Do the results apply to Germany and Europe?
Applicable.
Scientific in-depth review
1. Full reference
- Authors
- Lonn E, Yusuf S, Arnold MJ, Sheridan P, Pogue J, Micks M, McQueen MJ, Probstfield J, Fodor G, Held C, Genest J, Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators
- Journal
- N Engl J Med
- Year
- 2006
- Identifier
- PMID 16531613 DOI 10.1056/NEJMoa060900
- Verification
- verified – PubMed E-utilities efetch, 2026-10-25
- Retracted
- no
- Corrections
PubMed lists: ErratumIn (N Engl J Med. 2006 Aug 17;355(7):746)
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract
2. Research question
Does homocysteine lowering reduce CV events?
3. Study design and population
- Study design
- Randomised controlled trial – Randomised placebo-controlled trial (HOPE-2)
- Population
Vascular disease or diabetes, ≥55 years
- Country
Multinational
- Period
mean 5 years
- Sample size
5,522
- Inclusion and exclusion criteria
see abstract
4. Methods and endpoints
- Exposure / intervention
Folic acid 2.5 mg, B6 50 mg, B12 1 mg
- Comparator
Placebo
- Endpoints
CV death, MI, stroke
- Statistical methods
RR
5. Actual results
- Results
Primary 18.8% vs 19.8%, RR 0.95 (0.84–1.07); stroke RR 0.75 (0.59–0.97); unstable angina hospitalisation RR 1.24 (1.04–1.49).
- Absolute risks
not reported in abstract
- Authors' conclusion
B vitamins did not reduce major CV events.
6. Strengths
- RCT
7. Weaknesses
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
Stroke reduction.
12. Transferability to Germany and Europe
High: biology and trial populations comparable to European adults.
13. Overall methodological judgement
Null primary; mixed secondary.
| 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) | essentially correct but incomplete |
14. Open questions
15. Linked fact checks
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 homocysteine lowering reduce CV events?
- B. What did the authors find?
Primary 18.8% vs 19.8%, RR 0.95 (0.84–1.07); stroke RR 0.75 (0.59–0.97); unstable angina hospitalisation RR 1.24 (1.04–1.49).
- C. What conclusions do the authors themselves draw?
B vitamins did not reduce major CV events.
- D. What does the archive derive from it?
Supports 'supplements failed'.
- E. Is this derivation scientifically justified?
Yes for primary outcome; the archive omits fewer strokes.
- Adequacy of the interpretation (by the archive)
- essentially correct but incomplete