Efecto de tibolona en el mioma uterino en pacientes tratadas con análogos de la hormona liberadora de gonadotropinas

Abstract

Objectives To evaluate de effectiveness of tibolone, a synthetic steroid, as add-back therapy in patients diagnosed with leiomyoma. Tibolone has been demonstrated to be effective in inhibiting menopausal symptoms and in preventing postmenopausal bone loss. Its low estrogenic profile should not compromise the efficacy of gonadotropin-releasing hormone analogue (goserelin) in reducing the volume of uterinefibroids. Material and methods A group of 125 premenopausal women (with regular menstrual cycle) diagnosed with uterine leiomyomata suitable for surgical treatment were recruited in a randomized, prospective study that evaluated 5 treatment regimens: group 1 (control group), three doses of goserelin acetate depot (3.6 mg); group 2, 3 doses of goserelin acetate depot associated with tibolone (2.5 mg daily) from the first dose of goserelin until surgery; group 3, 3 doses of goserelin acetate depot associated with tibolone from the second dose of goserelin until surgery; group 4, 2 doses of goserelin acetate depot associated with tibolone from the second dose of goserelin until surgery, and group 5, 3 doses of goserelin acetate depot associated with conjugated equine estrogens (0.625 mg daily) from the second dose of goserelin until surgery. Modification of uterine size was evaluated with ultrasound examination and serum levels of gonadotrophins and estradiol were evaluated with the different treatment protocols. Differences were considered significant when p < 0.05. Results The mean reductions in uterine volume (%) were greater in the first 3 treatment groups (–30.1 ± 16.7; –26.4 ± 21.2; –25.1 ± 22.5; –15.6 ± 23 y –5.5 ± 15.1, respectively) and the differences were statistically significant when each group was compared with the control group (group 1). The mean concentrations of serum estradiol (pg/ml) were also significantly lower in the first 3 groups (26.2 ± 11.2; 45.7 ± 49.1; 35.9 ± 20.3; 97.9 ± 110.3; 111.4 ± 63.2, respectively). Conclusions Add-back tibolone therapy does not significantly compromise the effect of goserelin acetate in patients with uterine fibroids.