Pharmavite LLC Says Vitamin B Study Published In JAMA Is Flawed; Vitamins Meant For Prevention, Not Disease Treatment

Main Category: Preventive Medicine
Also Included In: Nutrition / Diet
Article Date: 21 Aug 2008 - 4:00 PST

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Pharmavite LLC, maker of Nature Made® vitamins, urged caution against making final judgment on B vitamins for prevention and heart health. The most recent study titled "Mortality and Cardiovascular Events in Patients Treated with Homocysteine-Lowering B Vitamins After Coronary Angiography," is published in the August 20, 2008 edition of the Journal of American Medical Association (JAMA).

"Vitamins are meant to be taken for preventative measures to support long-term good health, rather than treat disease," said Carroll Reider, MS, RD, Pharmavite scientific affairs. "This study is a Randomized Controlled Trial (RTC), which has become the gold standard for establishing the efficacy of drugs. Unfortunately, it is poorly suited to the evaluation of the effects of nutrients. This type of study is doomed to fail since nutrients and drugs have two different mechanisms."

Reider identified several major problems in the trial design:

- Length of Treatment: Nutrients work best in studies that look at their effect on health over a five to ten year period (and even longer) to see how they promote good health. They cannot correct a disease that was caused by lifelong poor health, especially in a short period of time. Although they work best in prevention, they can be very effective in diseases that were caused by the nutrient deficiency, such as people with cardiovascular disease (CVD) due to high homocysteine, which is a B vitamin deficiency.

- Patient Population: This study evaluated the effects of B vitamins on a population that had existing cardiovascular heart disease and other health conditions and were on multiple medications. The intent was to see if the B vitamins would reduce their homocysteine which would result in a reduction of future cardiovascular events.

- Homocysteine Levels: The findings of this study are not surprising given outcomes of similarly designed RTC studies: lowering homocysteine in patients with existing cardiovascular disease does not appear to reduce the risk of subsequent cardiovascular events. The major criticism of this study was most of the population did not have high homocysteine to begin with. The mean homocysteine went from 10.8 nmoles/L (normal) to 7.6 nmoles/L (normal). Essentially, researchers treated a population who didn't have high homocysteine (that is, that was not the cause of their heart disease) with a homocysteine lowering therapy. Had patients with much higher homocysteine levels been included in the trial, or they isolated the groups with high homocysteine, an even greater reduction in homocysteine levels would likely have been observed.

Previous vitamin B studies are consistent in showing that they can help lower homocysteine levels and maintain cardiovascular health. For example, one major study suggests that a 25 percent decrease in homocysteine is associated with an approximate 10 percent decrease in the risk of coronary heart disease and a 20 percent decrease in the risk of stroke1.

"The bottom line," said Reider. "Eat a healthy diet, exercise and take your B vitamins as needed. Research shows B vitamins support heart health cognitive function and provide many other benefits when taken long-term as part of an overall healthy plan."

About Pharmavite

For more than 35 years, Pharmavite has earned and maintained the trust of pharmacists, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well various state and local regulatory agencies. As a leader in the dietary supplement industry, Pharmavite swiftly adopted the FDA-released Good Manufacturing Practices (GMPs) introduced in June 2007, which sets rigorous manufacturing standards for the supplement industry.

http://www.pharmavite.com

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