Randomized trial of side effects of standard- and low-dose tamoxifen in healthy women

Adherence to adjuvant tamoxifen is suboptimal, and acceptance of tamoxifen for primary prevention is poor. The KARISMA trial at Karolinska Institute (Stockholm, Sweden) randomized healthy women to six months of daily intake of 5 different doses of tamoxifen or placebo. Among 48 predefined symptoms, five were associated with tamoxifen exposure (hot flashes, night sweats, cold sweats, vaginal discharge, and muscle cramps). In premenopausal, but not in postmenopausal women, mean Likert score change was 34% lower in the low-dose tamoxifen group than in the high-dose tamoxifen group. The authors conclude that symptoms related to tamoxifen therapy are influenced by menopausal status.