A major international clinical trial published in the March 16, 2005 Journal of the American Medical Association found that 400 International Units (IU) of natural vitamin E (alpha-tocopherol) taken daily did not reduce the overall risk of cancer or cardiovascular disease in men and women ages 50 to 75 that had existing cardiovascular disease or diabetes. Actually, there was an increase in the risk of heart failure in the patients taking vitamin E.
The trial is named the Heart Outcomes...
A major international clinical trial published in the March 16, 2005 Journal of the American Medical Association found that 400 International Units (IU) of natural vitamin E (alpha-tocopherol) taken daily did not reduce the overall risk of cancer or cardiovascular disease in men and women ages 50 to 75 that had existing cardiovascular disease or diabetes. Actually, there was an increase in the risk of heart failure in the patients taking vitamin E.
The trial is named the Heart Outcomes Prevention Evaluation Study Extension and goes by the acronym HOPE-TOO. It involved over 7,000 patients and lasted seven years.
The HOPE-TOO researchers were mainly interested in examining cancer incidence, cancer deaths, and major cardiovascular events such as heart attack, stroke, and cardiovascular death. They were also interested in other outcomes such as heart failure, unstable angina (chest pain), and the need for surgical procedures such as in insertion of a stent to keep blood vessels in the heart open.
Each of the above outcomes is examined below:
Cancer Incidence
There were 552 patients (11.6%) in the vitamin E group compared to 586 (12.3%) in the placebo group who developed cancer. This is a difference of less than one percent (0.7%) that is not statistically significant.
Cancer Deaths
There were 156 (3.3%) cancer deaths in patients taking vitamin E compared to 178 (3.7%) deaths in the placebo group. This is a non-statistically significant difference of 0.4 percent between the two treatments.
Major Cardiovascular Events Such as Heart Attack, Stroke, and Cardiovascular Death
A major cardiovascular event was experienced by 1022 (21.5%) of the vitamin E patients compared to 985 (20.6%) of the patients taking a placebo. This is a difference of 0.9 percent, a difference that is not statistically significant.
Heart Failure
Patients in the vitamin E group had a significantly higher risk of heart failure than those taking the placebo. There were 641 (13.5%) cases of heart failure in the vitamin E group compared to 578 (12.1%) in the placebo group. This a difference of 1.4 percent, which is a statistically significant result.
Hospitalization for Unstable Angina
There were 565 patients (16.1%) given vitamin E that were hospitalized for unstable angina compared to 547 patients (15.6%) in the placebo group. This is a difference of 0.5 percent which is not statistically significant.
The authors of the study concluded by saying:
Our study also has wider implications. There is a tendency to accept “natural products” (e.g., vitamins) as being safe, even if they have not been proven to be effective. However, our findings emphasize the need to thoroughly evaluate all vitamins, other natural products, and complementary medicines in appropriately designed trials before they are widely used for presumed health benefits.
The editorial appearing in the same issue of The Journal of the American Medical Association as the HOPE-TOO trial that was written by scientists from the
In the past decade, a number of prospective, randomized, placebo-controlled, 3- to 6-year clinical trials have been published, testing the effect of vitamin E and other antioxidant vitamins or their combinations on clinical manifestations of cardiovascular disease and cancer. These trials have surprisingly yet consistently shown that commonly used antioxidant vitamin regimens (vitamins E, C, beta carotene, or a combination) do not significantly reduce overall cardiovascular events or cancer.
The authors of the editorial offered an answer that physicians can give their patients when asked about vitamin E:
In nearly 68,000 patients studied to date, there is no compelling evidence that higher doses of vitamin E reduce cardiovascular risk or cancer; there are even some hints that vitamin E, in excess of normal daily intake, may slightly increase the risk of ischemic events or of heart failure. You may hear that vitamin E is a “natural” yet effective, way to prevent heart disease or cancer, but this has proven to be a false hope. You should not be misled into neglecting other proven methods of prevention.
The editorial also remarked that:
... this report effectively closes the door on the prospect of a major protective effect of long-term exposure to this supplement, taken in moderately high dosage, against complications of atherosclerosis and overall cancer incidence.
We agree. Enough is enough.
We listed vitamin E as a DO NOT USE product 17 years ago in the first edition of Worst Pills, Best Pillsand also in subsequent editions of the book. A number of articles have appeared over the years in Worst Pills, Best Pills News repeating the message that when studied for cardiovascular disease and cancer using the scientific “gold standard” method, a randomized controlled clinical trial, vitamin E offers only a cost without benefit and perhaps some harm.