H D Sesso

Dr H D Sesso, Brigham and Women’s Hospital, Boston, MA, USA; hsesso@hsph.harvard.edu

QUESTION

In men at lower risk of cardiovascular disease (CVD), do vitamin E and vitamin C supplements reduce major CVD events?

METHODS

Design:

randomised placebo controlled trial (Physicians’ Health Study II). ClinicalTrials.gov NCT00270647.

Allocation:

unclear allocation concealment.

Blinding:

blinded (patients, clinicians, and outcome assessors)

Follow-up period:

⩽10 years (mean 8 y).

Setting:

USA.

Patients:

14 641 male physicians ⩾50 years of age (mean age 64 y). Men with a history of myocardial infarction (MI), stroke, or cancer were included. Exclusion criteria were history of cirrhosis, active liver disease, anticoagulant use, or serious illness. 5.1% of men had prevalent CVD.

Intervention:

after stratification for age, previous cancer or …