QUALITY OF LIFE DURING SEQUENTIAL HORMONE REPLACEMENT THERAPY - A PLACEBO-CONTROLLED STUDY

Objective-The purpose of the study was to determine the efficacy of se quential 17 beta-estradiol and norethindrone acetate (Trisequens(R)) i n the relief of vasomotor symptoms by comparing the duality of life da ta from questionnaires, number and severity of symptoms, and the dropo ut rate versus placebo treatment. Study Design-Women 40 to 60 years ol d, who spontaneously complained of menopausal symptoms, were randomly allocated to four consecutive cycles with Trisequens (n = 40) or place bo (n = 42). Analysis of variance and two-tailed tests (P <.05) for al l comparisons were used. Results-The mean number of pretreatment vasom otor symptoms per day was 7 (1.3 severe) for Trisequens and 6 (1.8 sev ere) 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 differenc es (P = 0.0015, 0.0037, 0.0026, 0.0003, 0.0242, respectively). The dro pout rate difference between groups was significant (P = 0.028): 12 fr om the Trisequens group and 23 from the placebo group. Conclusion-Tris equens significantly improves vasomotor symptoms. Quality of life rati ng scales provide additional data to support the utility of sequential estrogen/progestin treatment for menopause therapy.