Quality of life during sequential hormone replacement therapy -- a placebo-controlled study.

OBJECTIVE -- The purpose of the study was to determine the efficacy of sequential 17 beta-estradiol and norethindrone acetate (Trisequens) in the relief of vasomotor symptoms by comparing the quality of life data from questionnaires, number and severity of symptoms, and the dropout rate versus placebo treatment. STUDY DESIGN -- Women 40 to 60 years old, who spontaneously complained of menopausal symptoms, were randomly allocated to four consecutive cycles with Trisequens (n = 40) or placebo (n = 42). Analysis of variance and two-tailed tests (P < .05) for all comparisons were used. RESULTS -- The mean number of pretreatment vasomotor symptoms per day was 7 (1.3 severe) for Trisequens and 6 (1.8 severe) for placebo, whereas posttreatment a reduction to 1.3 (0.1 severe) versus 4.2 (1.8 severe), respectively, was observed. Quality of life scores, utilizing the Kupperman Scale, 3-Factor Green Index, and Beck Depression Inventory all produced statistically significant differences (P = 0.0015, 0.0037, 0.0026, 0.0003, 0.0242, respectively). The dropout rate difference between groups was significant (P = 0.028): 12 from the Trisequens group and 23 from the placebo group. CONCLUSION -- Trisequens significantly improves vasomotor symptoms. Quality of life rating scales provide additional data to support the utility of sequential estrogen/progestin treatment for menopause therapy.

RCT Entities:   Population Interventions Outcomes