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Oregon Health & Science University, Portland, OR, USA.
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Editor’s note: In this review, the authors summarize the available data on the efficacy and safety of tamoxifen, raloxifene, and tibolone for reducing the risk of primary breast cancer in women in general and in specific subgroups. For analysis of comparative benefits, they included only double-blind, placebo-controlled, or head-to-head randomized controlled trials of tamoxifen, raloxifene, or tibolone to reduce the risk of breast cancer that enrolled women without preexisting breast cancer. Trials had to be designed and powered to demonstrate invasive breast cancer (IBC) incidence as a primary or secondary outcome. The US Preventive Services Task Force criteria were used to assess the quality of individual studies. The results of eligible trials were also combined to obtain more precise estimates of the major health outcomes. In order to explore whether the combined estimates differed among subpopulations, subgroup analyses were performed by age, family history of breast cancer, use of menopausal hormone therapy, menopausal state, and body mass index.