OBJECTIVE:Hormone replacement therapy (HRT) relieves menopausal symptoms but its effect on health related quality of life (HRQoL) is uncertain. The aim of this study was to assess the effect of three dose regimens of continuous combined HRT, consisting of estradiol valerate (E2V) and medroxyprogesterone acetate (MPA) on HRQoL in early postmenopausal women (last menstrual period 1-3 years before study entry). STUDY DESIGN: This was a 52-week, randomized, double-blind, multinational study comparing E2V (1 mg or 2 mg) plus MPA (2.5 mg or 5 mg) in different dose combinations. The intention-to-treat population comprised 459 women (average age 51.5 years). MAIN OUTCOME MEASURES: HRQoL was assessed by the Women's Health Questionnaire (WHQ), the 15D Questionnaire and a visual analogue scale (VAS). RESULTS: There were improvements on eight of the nine domains of the WHQ with all dose regimens during the first 12 weeks (P<0.0001) and an improvement in the remaining domain (menstrual symptoms) with the lower-dose regimens (P<0.05). These initial improvements in HRQoL were then maintained or augmented over the remainder of the study (P<0.0001 for change from baseline at 52 weeks for all domains and dose regimens). Mean 15D total score had improved meaningfully and significantly by 12 weeks (P<0.0001 versus baseline) in all treatment groups and this improvement was maintained thereafter. This improvement in 15D total score was most marked among previous non-users of HRT (P<0.05 versus previous users). VAS scores recorded significant (P<0.05) reductions in hot flushes, sweating and sleep disturbances in all groups after week 1 and highly significant (P<0.0001) relief of all climacteric symptoms at week 52. CONCLUSION: Continuous combined HRT was associated with pronounced improvement of vasomotor symptoms and HRQoL in this population of early postmenopausal women.
RCT Entities:
OBJECTIVE: Hormone replacement therapy (HRT) relieves menopausal symptoms but its effect on health related quality of life (HRQoL) is uncertain. The aim of this study was to assess the effect of three dose regimens of continuous combined HRT, consisting of estradiol valerate (E2V) and medroxyprogesterone acetate (MPA) on HRQoL in early postmenopausal women (last menstrual period 1-3 years before study entry). STUDY DESIGN: This was a 52-week, randomized, double-blind, multinational study comparing E2V (1 mg or 2 mg) plus MPA (2.5 mg or 5 mg) in different dose combinations. The intention-to-treat population comprised 459 women (average age 51.5 years). MAIN OUTCOME MEASURES: HRQoL was assessed by the Women's Health Questionnaire (WHQ), the 15D Questionnaire and a visual analogue scale (VAS). RESULTS: There were improvements on eight of the nine domains of the WHQ with all dose regimens during the first 12 weeks (P<0.0001) and an improvement in the remaining domain (menstrual symptoms) with the lower-dose regimens (P<0.05). These initial improvements in HRQoL were then maintained or augmented over the remainder of the study (P<0.0001 for change from baseline at 52 weeks for all domains and dose regimens). Mean 15D total score had improved meaningfully and significantly by 12 weeks (P<0.0001 versus baseline) in all treatment groups and this improvement was maintained thereafter. This improvement in 15D total score was most marked among previous non-users of HRT (P<0.05 versus previous users). VAS scores recorded significant (P<0.05) reductions in hot flushes, sweating and sleep disturbances in all groups after week 1 and highly significant (P<0.0001) relief of all climacteric symptoms at week 52. CONCLUSION: Continuous combined HRT was associated with pronounced improvement of vasomotor symptoms and HRQoL in this population of early postmenopausal women.