AbstractObjectives Genitourinary syndrome of menopause is a common condition among postmenopausal women. Although estrogen therapy is considered an effective treatment, some women are hesitant to use it; others are advised against it medically. We previously showed that vaginal tamoxifen effectively treats genitourinary syndrome of menopause. However, because vaginal tamoxifen may have systemic effects and its impact on mental health and health-related quality of life has not been previously evaluated, we focused on anxiety, depression, and quality of life in this study, extending our earlier findings. Study design In this double-blind, randomized, placebo-controlled trial, postmenopausal women with and without breast cancer received once-weekly vaginal tamoxifen or placebo for three months. Main outcome measures Symptoms of anxiety, depression, and health-related quality of life were assessed using standardized questionnaires before and after treatment. Mixed-design ANOVAs with treatment and time as factors were conducted for the full sample and separately for women with breast cancer. Results A total of 115 postmenopausal women (23.5% with breast cancer) were included. A significant time × treatment interaction was observed for anxiety. Anxiety decreased slightly over time in the tamoxifen group but remained stable in the placebo group. However, baseline anxiety scores were below clinically relevant thresholds in both groups. Notably, vaginal tamoxifen was associated with a greater reduction in overall pain compared with placebo. No other outcomes reached significance. Conclusion Compared with placebo, weekly vaginal tamoxifen was associated with reduced anxiety symptoms and clinically relevant reduction in overall pain. Although anxiety levels were in the non-clinical range, these changes may still be meaningful for individuals. Further research is needed to clarify the mechanisms and broader benefits of vaginal tamoxifen in postmenopausal women with and without breast cancer.
Sarikaya et al. (Mon,) studied this question.