E A Nijland1, W C M Weijmar Schultz, S R Davis. 1. Department of Obstetrics and Gynecology, Academisch Ziekenhuis Groningen, 9713 GZ Groningen, The Netherlands. e.nijland2@kpnplanet.nl
Abstract
OBJECTIVES: Study to compare the effects of tibolone and raloxifene on health-related quality of life, sexuality and vaginal atrophy. METHODS: A double-blind, randomized study was conducted in 308 osteopenic, but otherwise healthy, postmenopausal women (mean age 66 years) who receivedtibolone 1.25mg/day or raloxifene 60 mg/day for 2 years. Health-related quality of life was assessed by the women's health questionnaire (WHQ), sexual function by the McCoy female sexuality questionnaire (MFSQ) and vaginal atrophy by assessing the karyopycnotic index (KI) and vaginal maturation (VM). RESULTS: At week 104, the tibolone group showed a trend towards an improved health-related quality of life (HRQoL) mean score in eight out of nine WHQ domains. HRQoL scores approximated values for premenopausal women, being pre-defined as "clinically relevant". The raloxifene group showed a trend to a diminished HRQoL mean score from baseline to week 104. No difference could be assessed between the tibolone and raloxifene group in mean total score and separate domains' scores of the MFSQ, except for the vaginal lubrication domain (p=0.037). The increase in KI and VM was statistically significantly greater with tibolone than with raloxifene (for both KI and VM p<0.0001). Tibolone and raloxifene were equally well tolerated. CONCLUSIONS: In older postmenopausal women, tibolone treatment showed a trend towards an improvement in quality of life and sexuality when compared to raloxifene.
RCT Entities:
OBJECTIVES: Study to compare the effects of tibolone and raloxifene on health-related quality of life, sexuality and vaginal atrophy. METHODS: A double-blind, randomized study was conducted in 308 osteopenic, but otherwise healthy, postmenopausal women (mean age 66 years) who received tibolone 1.25mg/day or raloxifene 60 mg/day for 2 years. Health-related quality of life was assessed by the women's health questionnaire (WHQ), sexual function by the McCoy female sexuality questionnaire (MFSQ) and vaginal atrophy by assessing the karyopycnotic index (KI) and vaginal maturation (VM). RESULTS: At week 104, the tibolone group showed a trend towards an improved health-related quality of life (HRQoL) mean score in eight out of nine WHQ domains. HRQoL scores approximated values for premenopausal women, being pre-defined as "clinically relevant". The raloxifene group showed a trend to a diminished HRQoL mean score from baseline to week 104. No difference could be assessed between the tibolone and raloxifene group in mean total score and separate domains' scores of the MFSQ, except for the vaginal lubrication domain (p=0.037). The increase in KI and VM was statistically significantly greater with tibolone than with raloxifene (for both KI and VM p<0.0001). Tibolone and raloxifene were equally well tolerated. CONCLUSIONS: In older postmenopausal women, tibolone treatment showed a trend towards an improvement in quality of life and sexuality when compared to raloxifene.