Increased Prostate Cancer Risk With Vitamin E Supplements

A study published in the Oct. 12, 2011, Journal of the American Medical Association (JAMA) concluded: “Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men.”

The study involved 34,887 men age 50 or older who were randomly assigned to one of four treatment groups: 8,752 to receive the mineral selenium; 8,737, vitamin E; 8,702, both agents; and 8,696, a placebo. At the end of the study, the only group that had a significant increase in prostate cancer was the group taking vitamin E alone, in which there was a 17 percent increase in prostate cancer compared to the group getting a placebo.

The groups getting selenium alone or selenium and vitamin E both had slight but not statistically significant increases in prostate cancer.

The October JAMA study was a follow-up to the 2009 Selenium and Vitamin E Cancer Prevention Trial (SELECT). Publicly funded through the National Cancer Institute and in part by the National Center for Complementary and Alternative Medicine, SELECT was a gold-standard randomized clinical trial designed to evaluate whether vitamin E, the mineral selenium or a combination of the two would reduce the risk of prostate cancer. The trial planned to follow the participants for a minimum of seven years and a maximum of 12 years.

SELECT began in 2001 but was stopped early in 2008 when it was clear that there was no possibility of a benefit with the combination and that there was an increase in prostate cancer risk, though not statistically significant at that time.

The JAMA follow-up study included information about 521 additional cases of prostate cancer (some occurring in all groups) that had been diagnosed between the time the trial was initially evaluated and July 5, 2011. With these additional cases, the risk of prostate cancer from taking vitamin E became statistically significant.

Compared with the placebo group, for every 1,000 men taking the following supplement(s) for one year, the absolute increase in risk of prostate cancer was 1.6 extra cases for vitamin E, 0.8 for selenium and 0.4 for the combination.

These risk increases are small, as pointed out by the purveyors of dietary and herbal supplements as treatments or preventatives for chronic diseases. However, for this level of risk to be acceptable, there must be some balancing benefit for taking the supplements that outweighs even a small increased level of risk.

Unfortunately, a scientifically valid benefit for vitamin E supplementation for any disorder, including prostate cancer, is nonexistent. The one exception is the extremely rare case of vitamin E deficiency, and vitamin E deficiency has not been known to occur solely from an inadequate diet.

In Worst Pills, Best Pills News, vitamin E has long been listed as a “Do Not Use” dietary supplement. Similarly, the JAMA article authors stated, “The lack of benefit from dietary supplementation with vitamin E or other agents with respect to preventing common health conditions and cancers or improving overall survival, and their potential for harm, underscore the need for consumers to be skeptical of health claims for unregulated over-the-counter products in the absence of strong evidence of benefit demonstrated in clinical trials.”

What You Can Do

You should not use vitamin E supplements to prevent prostate cancer or any other disorder.

Consumers may report serious adverse events with drugs or product quality problems to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by regular mail, fax or phone.

• Online: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088