Folic acid is safe - but it lacks any cardiovascular benefits - according to researchers presenting at the American Heart Association's Scientific Sessions 2008. The results from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), a 12,064-person, randomized study, were presented as a late-breaking clinical trial.
Researchers reported that 2 milligrams (mg) of folic acid (vitamin B9), a supplement most often used to prevent neural tube defects, and 1 mg of vitamin B12 per day failed to show any reduction in the primary outcome of major vascular events (MVE) compared to placebo. MVE is defined as non-fatal heart attack, coronary death, stroke or arterial revascularization.
However, the vitamins also did not increase non-vascular death rates or cancer rates during an average follow-up of 6.7 years among patients who had previously had a heart attack, said Professor Jane M. Armitage, co-principal investigator of the study and professor of clinical trials and epidemiology at the University of Oxford, England.
"There was no difference between the treatment groups in terms of vascular events, but importantly, we also didn't see any kind of safety concerns with folic acid," she said. "SEARCH throws cold water on a once-promising hypothesis, based on a well-known association between higher blood levels of the amino acid homocystine and higher cardiovascular disease (CVD) risk, that using B vitamins to reduce blood levels of homocystine would prevent CVD."
The study's finding of no excess risk of cancer or other adverse events from higher than average doses of folic acid provides reassurance for the United States, Canada and several other countries that require folic acid fortification of flour, bread and many cereals to protect newborns from neural tube defects, Armitage said.
At the same late breaking clinical trials session, Armitage's co-principal investigator, Professor Rory Collins, professor of medicine and epidemiology at the University of Oxford, presented a second randomized comparison from the SEARCH trial of 80mg versus 20mg per day of simvastatin - the largest direct comparison of more versus less intensive lowering of low-density lipoprotein cholesterol (LDL-C).