OBJECTIVES: To examine the effect of tibolone, a synthetic steroid with tissue-specific activity, on quality of life in a randomised, double-blind, placebo-controlled study in healthy postmenopausal women. MATERIAL AND METHODS: A total of 85 women (54.2+/-4.7 years), were randomised to 2.5 mg tibolone (Livial) or to identically appearing placebo pills daily for 12 months. Quality of life was assessed with the Nottingham Health Profile (NHP). Also, information on the occurrence of climacteric complaints and incidences of vaginal bleeding/spotting was gathered. RESULTS: Compared to baseline values, the tibolone group significantly improved on three out of six NHP domains: overall 46.8-25.3, emotional reactions 6.8-2.9 and sleep 19.0-7.2. In the placebo group a significant difference from baseline was observed on the 'physical mobility' parameter: 6.9-3.0. Significant between-group difference was only reached on the domains 'sleep': tibolone 7.2 versus placebo 15.2 and 'physical mobility': tibolone 3.8 versus placebo 3.0. The occurrence of hot flushes and nightly sweats was significantly lower in the tibolone group compared to placebo after 12 months of treatment. Throughout the study period a total of four women in the placebo, compared to 16 women in thetibolone group, reported vaginal bleeding/spotting. CONCLUSIONS: A trend favouring tibolone was observed. However, improvements from baseline were only reflected in a significant between-group difference on the domains of sleep and physical mobility. The limited sample size might have caused this ambiguity. Further research in a larger population is recommended to clear this inconsistency.
RCT Entities:
OBJECTIVES: To examine the effect of tibolone, a synthetic steroid with tissue-specific activity, on quality of life in a randomised, double-blind, placebo-controlled study in healthy postmenopausal women. MATERIAL AND METHODS: A total of 85 women (54.2+/-4.7 years), were randomised to 2.5 mg tibolone (Livial) or to identically appearing placebo pills daily for 12 months. Quality of life was assessed with the Nottingham Health Profile (NHP). Also, information on the occurrence of climacteric complaints and incidences of vaginal bleeding/spotting was gathered. RESULTS: Compared to baseline values, the tibolone group significantly improved on three out of six NHP domains: overall 46.8-25.3, emotional reactions 6.8-2.9 and sleep 19.0-7.2. In the placebo group a significant difference from baseline was observed on the 'physical mobility' parameter: 6.9-3.0. Significant between-group difference was only reached on the domains 'sleep': tibolone 7.2 versus placebo 15.2 and 'physical mobility': tibolone 3.8 versus placebo 3.0. The occurrence of hot flushes and nightly sweats was significantly lower in the tibolone group compared to placebo after 12 months of treatment. Throughout the study period a total of four women in the placebo, compared to 16 women in the tibolone group, reported vaginal bleeding/spotting. CONCLUSIONS: A trend favouring tibolone was observed. However, improvements from baseline were only reflected in a significant between-group difference on the domains of sleep and physical mobility. The limited sample size might have caused this ambiguity. Further research in a larger population is recommended to clear this inconsistency.
Authors: Steven R Cummings; Bruce Ettinger; Pierre D Delmas; Peter Kenemans; Victoria Stathopoulos; Pierre Verweij; Mirjam Mol-Arts; Lenus Kloosterboer; Lori Mosca; Claus Christiansen; John Bilezikian; Eduardo Mario Kerzberg; Susan Johnson; Jose Zanchetta; Diederich E Grobbee; Wilfried Seifert; Richard Eastell Journal: N Engl J Med Date: 2008-08-14 Impact factor: 91.245