Symptom reporting and quality of life in the Estonian Postmenopausal Hormone Therapy Trial

BACKGROUND: The aim of the study was to determine the effect of postmenopausal hormone therapy on women's symptom reporting and quality of life in a randomized trial. METHODS: 1823 women participated in the Estonian Postmenopausal Hormone Therapy (EPHT) Trial between 1999 and 2004. Women were randomized to open-label continuous combined hormone therapy or no treatment, or to blind hormone therapy or placebo. The average follow-up period was 3.6 years. Prevalence of symptoms and quality of life according to EQ-5D were assessed by annually mailed questionnaires. RESULTS: In the hormone therapy arms, less women reported hot flushes (OR 0.20; 95% CI: 0.14–0.28), sweating (OR 0.56; 95% CI: 0.44–0.72), and sleeping problems (OR 0.66; 95% CI: 0.52–0.84), but more women reported episodes of vaginal bleeding (OR 19.65; 95% CI: 12.15–31.79). There was no difference between the trial arms in the prevalence of other symptoms over time. Quality of life did not depend on hormone therapy use. CONCLUSION: Postmenopausal hormone therapy decreased vasomotor symptoms and sleeping problems, but increased episodes of vaginal bleeding, and had no effect on quality of life. TRIAL REGISTRATION NUMBER: ISRCTN35338757