Open AccessEffect of combined oral estrogen/progestogen preparation (Kliogest ® ) on bone mineral density, plasma lipids and postmenopausal symptoms in HRT‐naïve Thai women
Author(s) -
Jirapinyo Mayuree,
Theppisai Urusa,
Maai Jittima,
Suchartwatnachai Charnchai,
Jorgensen Lars Nelleman
Publication year - 2003
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1034/j.1600-0412.2003.00185.x
Subject(s) - medicine , bone mineral , estrone , placebo , progestogen , endocrinology , estrogen , bone density , hormone replacement therapy (female to male) , gastroenterology , osteoporosis , testosterone (patch) , alternative medicine , pathology
Background. Kliogest ® is commonly prescribed for the relief of acute postmenopausal symptoms and prevention of postmenopausal bone loss. However, there have been few data on its effect in Asian women. Methods. This 1‐year, single‐center, randomized, double‐blind and placebo‐controlled study evaluated the efficacy and safety of Kliogest ® in hormone replacement therapy (HRT)‐naïve Thai women. The subjects were 120 healthy Thai women aged between 45 and 65 years, with intact uterus, and who had been amenorrheic for at least 1 year. Results. Kliogest ® increased spine (+ 6%, p < 0.01) and hip (+2%, p < 0.01) bone mineral density (BMD), and lowered plasma total cholesterol (TC) (−16%, p < 0.05) and low density lipoprotein cholesterol (LDL‐C) (−16%, p < 0.05) concentrations. However, Kliogest ® also resulted in a decrease in high density lipoprotein cholesterol (HDL‐C) concentration (−18%, p < 0.05). Compared to placebo, the reduction in menopausal symptoms by Kliogest ® was not statistically significant. The frequency and severity of treatment‐related uterine bleeding decreased with the duration of Kliogest ® treatment. Furthermore, there was a fairly strong relationship between the change in serum estrone concentration and the average monthly weighted bleeding scores over the first 6 months (Spearman's correlation r = 0.54; p < 0.001), which became weaker over the entire treatment period (Spearman's correlation r = 0.27; p < 0.01). Although there was a small to moderate relationship between baseline estrone concentration and both lumbar ( r = 0.23, p < 0.02) and hip ( r = 0.20, p < 0.05) BMD, there was no significant relationship between Kliogest ® ‐induced change in estrone concentration and change in lumbar and hip BMD. Conclusions. Continuous treatment with Kliogest ® for 1 year reversed the potential postmenopausal bone loss in HRT‐naïve Thai postmenopausal women. However, its effect on cardiovascular risk is uncertain. Furthermore, Kliogest ® is safe but appears to have no significant effect on climacteric symptoms in the patients in the present study.