Efficacy and safety of tibolone in postmenopausal women: systematic review of the literature

Abstract

Introduction: tibolone has shown clear improvement of climacteric discomfort, without affecting endometrial thickness, lipid profile, glycemia or cardiovascular system. The objective was to evaluate the efficacy and safety of tibolone in postmenopausal women, compared with conjugated estrogens of equine origin, 17 beta-estradiol 2 mg / norethisterone acetate 1 mg, estradiol valerate, transdermal estradiol and placebo.

Materials and methods: a systematic search of the medical literature was carried out using the following databases: Medline via PubMed, Central, CINAHL, among others. The search was limited to randomized clinical trials, meta-analyses and literature reviews, which had the full text available, in English and Spanish; published between 1980 and 2021. The outcomes evaluated included relief of climacteric syndrome, improvement of sexual activity and gratification, proportion of breast cancer and adverse events.

Results: Sixty-one studies were included. Tibolone showed significant differences against placebo in the relief of climacteric syndrome. It showed greater improvement in sexual activity and gratification, and a lower proportion of adverse events than estrogens, 17 beta-estradiol 2 mg / norethisterone acetate 1 mg combinations, and transdermal estradiol.

Conclusions: tibolone has similar efficacy in improving vasomotor syndrome with other comparators, with advantages over estrogens in improving sexual activity and gratification: and over 17 beta-estradiol 2 mg / norethisterone acetate 1 mg and transdermal estradiol combinations and in adverse events.