Q: Was June 1, 2011 really the last day of pill taking?
A: Yes! If you haven't already done so, please stop your study pills now, and, if you choose, resume your personal use of multivitamins. You will receive a brief questionnaire during the month of June asking for updated medical information through June 1, 2011. Please fill out and return this questionnaire as soon as possible, as this will allow us to complete our analyses of the role of multivitamins in the prevention of chronic disease. Within a few months of your return of this questionnaire, we will send you a letter notifying you whether you were assigned to take active multivitamin or its placebo.
Q: Now that pill taking is over, will I still receive yearly questionnaires?
A: We hope so. Although pill taking is over, we would like to continue to use and build upon the wealth of information collected during the past three decades. To this end, we have submitted a grant proposal to the National Institutes of Health to allow us to continue sending yearly questionnaires to all participants. We will, of course, keep you informed of the status of this proposed observational follow-up study.
Q: Did the vitamin E and vitamin C components of the PHS II trial find these vitamin supplements to be helpful or harmful with respect to major cardiovascular events or cancer?
A: Long-term supplementation with vitamin E or vitamin C did not decrease or increase the risk for major cardiovascular events or cancer in the PHS II.
Q: What were the doses for the vitamin C and vitamin E components of the PHS II?
A: The dose for the vitamin C (orange pill) component was 500 mg, which was taken every day. The dose for the vitamin E (brown capsule) component was 400 IU, which was taken every other day. (Thus, the vitamin E dose was equivalent to 200 IU per day.)
Q: I have had multiple sclerosis for 20 years. Why have you never asked any questions about this condition?
A: To keep the annual health questionnaires as short as possible, we ask specific questions only about diseases and conditions that are the primary focus of the PHS and that are thought to be related to the interventions being tested. However, because we also are interested in obtaining a complete picture of the health status of study participants, we include an item on every questionnaire asking about “other conditions requiring medical treatment.” In response to that item, please provide information about your multiple sclerosis (e.g., diagnosis date, progression of disease, and treatment).
Q: Why was beta carotene dropped from the PHS II trial?
A: We decided not to continue the beta-carotene component of the trial because the important scientific questions regarding the health effects of beta-carotene supplementation have been satisfactorily answered. Based on two decades’ worth of data contributed by PHS participants, beta carotene did not reduce the risk of total cardiovascular disease, total cancer, or total mortality. You will be reassured to learn that no serious adverse health effects of beta-carotene supplementation were observed in the PHS, even among men who took the vitamin for the longest periods of time.
Q: I recently suffered a myocardial infarction. Am I out of the study?
A: No! Although one of the main goals of the PHS is to test whether vitamin supplements can reduce the risk of developing MI, there are many other outcomes being examined in the study. While the health and risk factor information that we collect from you after your MI will not be used to study which factors predict the development of a first MI, this information will still be very important in analyzing the effect of vitamin supplements (as well as other exposures) on cardiovascular outcomes other than MI (such as stroke) and on noncardiovascular outcomes (such as cancer and eye disease). It is therefore crucial that we continue to include your health experience as the study progresses.