Andrew K. Diehl, MD, MSc
In women at high risk for cardiovascular (CV) disease, does combined therapy with folic acid and vitamins B6 and B12 affect cancer risk?
Randomized placebo-controlled trial (Women’s Antioxidant and Folic Acid Cardiovascular Study [WAFACS]). ClinicalTrials.gov NCT00000541.
Unclear allocation concealment.*
Blinded (patients, clinicians, and outcome assessors).*
5442 women > 40 years of age (mean age 63 y) who were postmenopausal or had no intention of becoming pregnant and had CV disease or ≥ 3 coronary risk factors. Exclusion criteria were history of cancer (except nonmelanoma skin cancer) in the past 10 years, serious non-CV illness, and use of warfarin or anticoagulants.
Combination of folic acid, 2.5 mg/d, vitamin B6, 50 mg/d, and vitamin B12, 1 mg/d (n = 2721), or matching placebo (n = 2721).
Newly diagnosed total invasive cancer, breast cancer, cancer-related mortality, and all-cause mortality. The study had 82% power to detect a 25% risk reduction in cancer.
93% for morbidity and 90% for mortality (intention-to-treat analysis).
The folic-acid-plus-vitamin B group did not differ from placebo for total invasive cancer, breast cancer, cancer-related mortality, or all-cause mortality (Table).
Combined therapy with folic acid and vitamins B6 and B12 did not affect cancer risk in women at high risk for cardiovascular disease.
Combination therapy with folic acid plus vitamins B6 and B12 vs placebo in women at high-risk for cardiovascular disease†
†Abbreviations defined in Glossary. RRR, NNT, and CI calculated from control event rates and hazard ratios in article.
Diehl AK. Combined therapy with folic acid and vitamins B6 and B12 did not affect cancer risk in women at high risk for CV disease. Ann Intern Med. ;150:JC3–9. doi: 10.7326/0003-4819-150-6-200903170-02009
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Published: Ann Intern Med. 2009;150(6):JC3-9.
Cancer Screening/Prevention, Cardiology, Hematology/Oncology, Prevention/Screening.
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