The women's health initiative: lessons learned.
The Women's Health Initiative (WHI) was initiated in 1992 as a major disease-prevention research program among postmenopausal women. The program includes a randomized controlled intervention trial involving 68,132 women and four distinct interventions: conjugated equine estrogens, alone or in combination with medroxyprogesterone acetate, for coronary heart disease prevention with breast cancer as an anticipated adverse effect; a low-fat eating pattern for breast and colorectal cancer prevention; and calcium and vitamin D supplementation for hip fracture prevention. Results from this multifaceted trial have made a substantial impact in clinical practice. A companion cohort study among 93,676 women serves as a source for new risk factor information and provides a comparative observational assessment of the clinical trial interventions. A specimen repository and quality-controlled outcome data for a range of diseases are among the resources that support the ongoing research program. WHI clinical trial contributions and challenges are reviewed and discussed.
Prentice
Ross L
RL
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA. rprentic@whi.org
Anderson
Garnet L
GL
D000368:Aged; D001943:Breast Neoplasms / Q000517:prevention & control*; D002136:Calcium, Dietary / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000517:prevention & control*; D003327:Coronary Disease / Q000517:prevention & control*; D018752:Diet, Fat-Restricted; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D005260:Female; D006620:Hip Fractures / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011322:Primary Prevention / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014807:Vitamin D / Q000008:administration & dosage; D016387:Women's Health
D002136:Calcium, Dietary; D014807:Vitamin D