August 3rd, 2010
Vitamin B Trial Finds No Clinically Significant Benefit
Larry Husten, PHD
The VITATOPS (The VITAmins TO Prevent Stroke) Trial randomized 8164 patients with recent stroke or TIA to either placebo or B vitamins. After a median followup of 3.4 years, the primary endpoint — the combined incidence of stroke, MI, or vascular death — occurred in 616 patients in the B vitamin group and 678 in the placebo group, for an absolute risk reduction of 1.56%. The modest 9% reduction in relative risk, with a 95% confidence interval ranging from 0% to 18%, led the authors to write in their report in Lancet Neurology that “our findings do not definitively confirm that supplementation with B vitamins has a clinically significant beneficial effect on major vascular events.”
In an accompanying “Reflection and Reaction,” Peter Sandercock writes that the results are not “sufficiently robust” enough to support usage of vitamin B supplements, however, one cannot rule out the possibility that “B vitamins could still be potentially worthwhile.” He notes, however, that it may be difficult if not impossible “in the present regulatory environment” to successfully mount a clinical trial for this sort of non-commercial intervention.
In general B vitamins do not appear to prevent vascular events, else thedietary sources of vitamins should heve been sufficient to prevent CV events. It may be so that aparticular vitamin of B series in a particular dose may do that.