Short-term tibolone does not interfere with endothelial function: a double-blinded, randomized, controlled trial.

Objective To evaluate the effect of short-term hormone replacement therapy with tibolone 2.5 mg daily on endothelial function of healthy postmenopausal women, using flow-mediated dilation (FMD) of the brachial artery. Methods We performed a randomized, double-blinded, placebo-controlled study. A total of 100 healthy postmenopausal women were randomly allocated to receive tibolone (n = 50) or placebo (n = 50) for 28 days. Measurement of the FMD of the brachial artery was performed before and after the use of tibolone and placebo. Results A total of 31 women completed the study in the tibolone group, and 32 women completed the study in the control group. The results of the FMD measurements obtained from the women in the two groups before treatment were similar (0.018 and 0.091, for tibolone and placebo, p = 0.57). The values of the FMD in women who used tibolone and placebo, before and after the treatment, were similar in both groups. The numbers of women who presented an increase in the values of the FMD in both groups were also similar. Conclusion Our results demonstrate that the administration of 2.5 mg tibolone to healthy postmenopausal women for 28 days does not promote endothelial-dependent vasodilation, measured by FMD of the brachial artery.

The insulin-like growth factor-I system and hormone replacement therapy.

OBJECTIVE: To determine the effects of hormone replacement therapy on plasma concentrations of free and total insulin-like growth factor (IGF)-I, IGF binding protein (BP)-1, and IGFBP-3. DESIGN: Clinical study. SETTING: Gynecologic clinic at a university hospital. PATIENT(S): Seventy-one postmenopausal women. INTERVENTION(S): Six cycles of four different hormonal replacement therapy regimens: oral conjugated estrogens, transdermal estradiol, oral conjugated estrogens and norethisterone, and transdermal estradiol and norethisterone acetate. MAIN OUTCOME MEASURE(S): Blood samples were collected before and after treatment for measurement of free and total IGF-I, IGFBP-1, and IGFBP-3. RESULT(S): Conjugated estrogen replacement therapy is associated with a decrease in plasma concentration of total IGF-I and increase in concentrations of free IGF-I and IGFBP-1. Transdermal estrogens have no effect on total and free IGF-I and IGFBP-1 concentrations. Oral norethisterone plus conjugated estrogens increased free IGF-I and IGFBP-1 concentrations but did not change IGF-I concentrations. Transdermal conjugated estrogens plus norethisterone acetate increased free IGF-I concentrations but not total IGF-I or IGFBP-1 concentrations. The plasma concentration of IGFBP-3 did not change in any group. CONCLUSION(S): Alterations in total IGF-I concentration can occur depending on the route of hormone replacement therapy administration. Free IGF-I concentrations were elevated in all study groups except that treated with transdermal estrogens.

A double-blind trial of four medications to treat severe premenstrual syndrome.

OBJECTIVE: To determine the efficacy of fluoxetine (10 mg), alprazolam, propanolol and pyridoxine in the treatment of severe premenstrual syndrome (PMS). METHOD: One-hundred and twenty women were divided into four groups of 30 patients. Patients were submitted to a randomized, double-blind, placebo-controlled treatment and were given 3 months of placebo and 3 months of active drug. The active drug was pyridoxine (300 mg/day) in group 1; alprazolam (0.75 mg/day) in group 2; fluoxetine (10 mg/day) in group 3; and propanolol (20 mg/day and 40 mg during the menstrual period) in group 4. RESULTS: Fluoxetine in 10-mg doses obtained a mean reduction of 65.4% in symptoms, followed by propanolol (58.7%), alprazolam (55.6%), pyridoxine (45.3%) and placebo (39.4-46.1%). CONCLUSION: Fluoxetine in 10-mg doses presented the best results for treating premenstrual syndrome.