Q: Although the multivitamin component of the PHS II trial is continuing for a few more years, the vitamin C and E components are not. What can I infer about the health effects of vitamins C and E?
A: The vitamin C and E components ended right on schedule. This means that the trial has provided enough data to allow PHS investigators to determine with a high degree of certainty what the health effects of vitamin C and E supplements are. It does not imply anything—either positive or negative—about the health effects of these supplements.

Q: How will people be notified of the PHS II trial results for vitamins C and E?
A: We plan to present the trial results at a national scientific meeting and to publish them in a major medical journal. We will work with various media outlets to ensure widespread dissemination of the results. We will also summarize the findings in a future letter or newsletter to participants.

Q: What were the doses for the recently completed 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 age-related macular degeneration. My ophthalmologist has told me that I should take an antioxidant vitamin/zinc supplement to prevent my vision from getting worse. What should I do? Do I need to stop taking my PHS II study pills?
A: As always, you should follow whatever medical advice you receive from your own healthcare providers, including your ophthalmologist. Your ophthalmologist’s recommendation is likely based on the results of the Age-Related Eye Disease Study (AREDS), a 6-year randomized trial of vitamin supplements in men and women with mild to moderate age-related macular degeneration (AMD) that found that a combination of vitamin E, vitamin C, beta-carotene, and zinc slowed the progression of this condition. If you choose to take an antioxidant/zinc supplement, you do NOT need to stop taking the PHS II study pills. However, on your annual questionnaire, please let us know that you are also using an antioxidant/zinc supplement.

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.

Q: I am a PHS II participant, but I haven’t taken my study pills in a while. Is there any point in resuming now?
A: Yes! Every participant is irreplaceable. A fundamental principle of clinical trial research is summed up by the adage, “Once randomized, always analyzed.” Restating this in everyday language, every single man who was randomized to take either active agent or placebo -- even if he subsequently stopped taking his pills! -- must be classified as a member of the group to which he was assigned, and analyzed as such, to maximize the chance of obtaining a valid study result. Participants who do not take their assigned pills dilute the observed health effects of the vitamins being tested. Resuming your study pills now will help enable the PHS II to determine whether these vitamins can prevent cardiovascular events, cancer, and other diseases in men. If you wish to resume taking the study pills and need calendar packs, please call us toll-free at 1-800-633-6907.