B12 Doesn't Save Heart Patients

(August 20, 2008) - B vitamins and folic acid (Read about "Vitamins & Minerals") don't appear to be a life saving treatment for heart patients. (Read about "Coronary Heart Disease") In a large clinical trial involving patients with coronary artery disease, use of B vitamins was not effective for preventing death or cardiovascular events, according to a study published in JAMA.

"Observational studies have demonstrated that the concentration of total homocysteine (Read about "Homocysteine") in blood is associated with risk of coronary artery disease and stroke," the authors provide as background information. Plasma total homocysteine levels can be lowered by oral administration of folic acid and vitamin B12. In this study, the authors' objective was "to evaluate the effects of homocysteine-lowering treatment with folic acid plus vitamin B12 on mortality and cardiovascular events."

Researchers conducted a randomized controlled study with 3,096 patients over seven years. Patients were randomly assigned to one of four groups receiving a daily oral dose of one of the following treatments: folic acid, 0.8mg, plus vitamin B12, 0.4mg, plus vitamin B6, 40mg; folic acid plus vitamin B12; vitamin B6 alone; or placebo. Patients were scheduled for follow-up visits with an interview, clinical examination and blood sampling at one month, one year, and at a final study visit.

The study was stopped early because of concerns among the participants about preliminary results from another similar study suggesting no benefits from the treatment and an increased risk of cancer (Read about "Cancer: What It Is") from the B vitamins.

"We could not detect any preventive effect of intervention with folic acid plus vitamin B12 or with vitamin B6 on mortality or major cardiovascular events among patients with stable coronary artery disease undergoing intensive conventional treatment. We found a numerically lower incidence of stroke (Read about "Stroke") and higher incidence of cancer in the groups receiving folic acid, but these observations were not statistically significant," the authors conclude.