Study shows no cancer or heart protection from long-term Vitamin E supplements and an increased risk for heart failure

After following nearly 4000 patients for seven years, researchers have found no difference in cancer or heart disease in those taking a daily 400 units Vitamin E pill and those who received a placebo.

Patients in the study were at least 55 years old and had a history of diabetes or vascular disease. Over 9,500 were originally enrolled in the HOPE (Heart Outcomes Prevention and Evaluation) trial and 4,000 continued in the HOPE-TOO extension.

There was no difference in heart attack, stroke, angina, or death from heart disease between those taking vitamin E and those on placebo. There was also no significant difference in the number of people who got cancer or who died from it. The lack of a protective effect extended to specific incidence and death from breast, colon, prostate, oral, and gastrointestinal cancers.

However, there was an increase in hospitalizations and deaths from heart failure among patients on the vitamin supplements.

Eva Lonn, MD, and her colleagues report their findings in the March 16, 2005 Journal of the American Medical Association.

In an editorial accompanying the JAMA article, two professors from the University of Washington said that this may be the final word on the protective effects of daily vitamin E supplementation. Looking at all the previous vitamin E studies, B Greg Brown, MD, PhD, a cardiologist, and John Crowley, PhD, a biostatistician wrote, "In nearly 68,000 patients studied to date there is no compelling evidence that higher doses of vitamin E reduce cardiovascular risk or cancer."

Read the study abstract in the Journal of the American Medical Association.

Read more about the study from the American Cancer Society.

Read an article from the Associated Press.

Health care providers improve colon cancer screening rates when they have support in communicating about screening with patients and active follow-up of their individual screening results.

A randomized trial of a program to increase colorectal screening at two Veterans Affairs Medical Centers demonstrated improved screening rates for patients of health care providers who participated in workshops to improve their communication skills and actively follow-up their screening rates.

Colorectal cancer screening was recommended to 76% of the patients of providers in the active intervention group compared to 69.4% of controls. 41.3% of patients in the active group actually completed screening, compared to 32.4% of those in the control group.

In the active group, 55.7% of patients with low health literacy (less than 9th grade reading skills) completed screening, compared to 30% of controls.

A team led by M Rosario Ferreia, MD of the Veterans Affairs Midwest Center for Health Services and Policy research reported their findings in the March 1, 2005 Journal of Clinical Oncology.

Read an abstract of the article in the Journal of Clinical Oncology.

Response to Phase I cancer clinical trials is higher than originally reported

Researchers at the National Institutes of Health have found that patient response to Phase I clinical trials testing new drugs for cancer is higher than previously reported. In addition, deaths from toxic side effects are low -- less than half of one percent. Previous reviews had found response rates between 4 and 6 percent.

The study looked at all adult Phase I trials sponsored by the Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute from 1999 through 2002. More than 12,000 patients were involved in 460 trials.

Overall, 10.6% of patients had either complete or partial responses to treatment. The lowest responses were in classic trials that involved only one investigational drug. Responses in these more traditional phase 1 trials was 4.4%, close to what has previously been reported. These represented only 20% of all the trials.

Almost half of trials involved drug combinations where at least one drug was FDA approved. In these cases, response was 17.8% with an additional 34% of patients whose cancer remained stable during the trial.

Overall, 0.49% of patients died from a toxic side effect. Not all patients were evaluated for grade 3 and 4 side effects, but of those who were 14.3% had at least one such serious toxic event.

Christine Brady, R.N., Ph.D. led a team at the National Institutes of Health in developing the study. Their results are published in the March 3, 2005 issue of the New England Journal of Medicine.

Read the abstract in The New England Journal of Medicine.