Vitamin E and benign breast "disease": a double-blind, randomized clinical trial.

We report here the results of a double-blind, randomized trial of the effect of vitamin E on clinically palpable benign breast findings. Seventy-three women who attended a breast screening clinic were assigned randomly to either a daily regimen of 600 IU vitamin E (n = 37) or a placebo (n = 36). At the initial visit sociomedical information was obtained for each patient and breast examination performed, with a score ranging from 0 to 4 recorded for each quadrant of both breasts. Thirty-two women in the vitamin E group and 30 in the placebo group returned for follow-up breast examination approximately 2 months later. Scores for mean ages and breast findings at entry were similar for women in the two groups. We found no differences between the vitamin E and placebo groups in scores for changes in breast findings at the end of the study period and no differences in the proportion of women who reported feeling less premenstrual pain (40.0% and 41.4%, respectively). We conclude that in this group of women with breast findings, most of which were not currently serious enough to warrant biopsy, there was no beneficial effect of vitamin E taken during a 2-month course.