Assessment of tibolone effects on menopausal symptoms and cardiovascular markers

ABSTRACT

To assess Tibolone effects on menopausal symptoms, lipid profile, serum homocysteine levels, and C-reactive protein. Fifty two healthy post menopausal women, who had been menopausal for at least one year, were recruited in this prospective randomized controlled clinical trial. They were randomly assigned into two groups. The first group received 2.5mg Tibolone tablet [Livial] for 6 month was referred to as "Tibolone group'. The second group received placebo treatment for 6 month and was referred to as "Control group. Menopausal symptoms were assessed upon enrollment and after 6 months using the Greene climacteric scale. All women had an assay of total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol, CRP, and serum homocysteine levels upon enrollment and after 6 months. After 6 months, Tibolone reduced significantly the Greene climacteric scale [median score=10, with score range=2-25] compared to the control group [median score=15, with score range=4-48. p=0.0013]. In the Tibolone group, there was significant decrease in the scale after 6 months compared to baseline. After 6 months, there was no significant difference between the 2 groups regarding the cholesterol, triglycerides, and LDL cholesterol levels. However, there was significant drop in the HDL cholesterol in the Tibolone group compared to the control group [63.33 +/- 15.41 Vs 75.80 +/- 21.11, p=0.016]. By applying the paired t-test and comparing the lipid profile values in the Tibolone group, there was a significant reduction in total cholesterol, triglyceride, and HDL levels after 6 months. There was no significant reduction in LDL cholesterol level. At baseline, there was no significant difference in the homocysteine level between the 2 groups. After 6 months, there was still no significant difference between the 2 groups. Within the Tibolone group, there was a 5.1% reduction in the serum Homocysteine level after 6 months compared to baseline, however, this was also non significant. After 6 months, CRP was significantly higher in the tibolone group compared to the control group [1.99 +/- 0.73 Vs 1.52 +/- 0.76, p<0.05]. Within the tibolone group there was significant rise in CRP level after 6 months. Tibolone is effective in controlling menopausal symptoms. Tibolone had favorable effect on total cholesterol and triglyceride levels, however, it reduced HDL. Tibolone had no effect on homocysteine levels, It was associated with a rise in CRP levels. Further long term clinical trials are needed to verify the cardiovascular effects of tiblone