Effects of tibolone on abdominal subcutaneous fat, serum leptin levels, and anthropometric indices: A 6-month, prospective, randomized, placebo-controlled, double-blind study

Abstract

This study was undertaken to evaluate the effects of tibolone on abdominal subcutaneous fat, serum leptin levels (SLLs), and anthropometric indices, and to investigate potential relationships between SLLs, subcutaneous abdominal fat thickness, and anthropometric indices in postmenopausal women. In a 6-mo, prospective, randomized, double-blind, placebo-controlled study, 40 healthy postmenopausal women aged 42 to 67 y (mean: 50+/-4.7 y) were randomly assigned to 1 of 2 groups; during a 6-mo treatment period, the first group received tibolone (Livial tablet; Organon, The Netherlands; 2.5 mg/d; n=19) and the other group was given placebo (n=21). Fasting SLLs determined by enzyme-linked immunosorbent assay, subcutaneous abdominal fat thickness assessed by ultrasound, and anthropometric indices of body weight, body mass index, waist and hip circumference, and waist-to-hip ratio (WHR) were recorded at the beginning and the end of the study. Statistical analyses were performed with Mann-Whitney, Wilcoxon, and Spearman tests. P values <.05 were considered significant. No significant differences between the 2 groups were reported in terms of all baseline characteristics. After 6 mo, body weight (+0.77+/-0.43 kg) and SLLs (+14.7+/-6.4 ng/mL) increased in the placebo control group, whereas waist circumference (-2.6+/-3.0 cm), hip circumference (-3.6+/-3.5 cm), and subcutaneous abdominal fat thickness (-4.3+/-4.8 cm) decreased significantly in the tibolone group (P<.05). At the end of the study, group comparisons revealed significant differences in waist and hip circumference and subcutaneous abdominal fat thickness (P<.05). At baseline, SLLs were correlated with subcutaneous abdominal fat thickness and all anthropometric indices except WHR (P<.05). Subcutaneous abdominal fat thickness was also highly correlated with all indices except WHR (P<.0001). Tibolone was found to decrease waist and hip circumference, as well as subcutaneous abdominal fat thickness. Also, tibolone appeared to attenuate weight gain and leptin increase. SLLs and subcutaneous abdominal fat thickness were positively correlated with all anthropometric indices except WHR.