How effective are B Vitamins in reducing the risk of stroke? VITATOPS trial: Not much!

The long awaited non commercial drug trial of VITATOPS or Vitamins to prevent stroke was published in the most recent issue of the Lancet Neurology (The Lancet Neurology 2010; 9:855-865).

Its hypothes is based on the information that high level of homocysteine is a risk factor for stroke, cardiovascular diseases and TIA. The research team was aiming to assess whether the addition of once-daily supplements of B vitamins to usual medical care would lower total homocysteine and reduce the combined incidence of non-fatal stroke, non-fatal myocardial infarction, and death attributable to vascular causes in patients with recent stroke or transient ischaemic attack of the brain or eye.

In this randomised, double-blind, parallel, placebo-controlled VITATOPS  trial, the researchers assigned patients with recent stroke or transient ischaemic attack (within the past 7 months) from 123 medical centres in 20 countries to receive one tablet daily of placebo or B vitamins (2 mg folic acid, 25 mg vitamin B6, and 0·5 mg vitamin B12). The primary endpoint was the composite of stroke, myocardial infarction, or vascular death. All patients randomly allocated to a group were included in the analysis of the primary endpoint.

The trial concluded that daily administration of folic acid, vitamin B6, and vitamin B12 to patients with recent stroke or transient ischaemic attack was safe but did not seem to be more effective than placebo in reducing the incidence of major vascular events. These results do not support the use of B vitamins to prevent recurrent stroke.

In his editorial in the same issue of the Lancet Neurology,  Professor Peter Sandercock from Clinical Neurosciences Department in Edinburgh  mentioned that the jury is still out on homocysteine reductions, at least until the present trials (There are few unfinished trials regarding the homocysteine lowering and its effect on cardiovascular diseases) are complete.