Efficacy and safety of tibolone in postmenopausal women: systematic review of the literature
[Efficacy and safety of tibolone in postmenopausal women: systematic review of the literature]Franklin José Espitia De La Hoz1
1. Director Científico, Hathor, Clínica Sexológica, Colombia ;
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Abstract
Introducción: la tibolona ha demostrado franca mejoría de las molestias del climaterio, sin afectar el grosor endometrial, el perfil lipídico, la glucemia o el sistema cardiovascular. El objetivo fue evaluar la eficacia y seguridad de la tibolona en mujeres posmenopáusicas, comparado con estrógenos conjugados de origen equino, 17 beta-estradiol 2 mg / acetato de noretisterona 1 mg, valerato de estradiol, estradiol transdérmico y placebo.
Materiales y métodos: se hizo una búsqueda sistemática de la literatura médica mediante las siguientes bases de datos: Medline vía PubMed, Central, CINAHL, entre otras. La búsqueda se limitó a ensayos clínicos aleatorizados, metaanálisis y revisiones bibliográficas, que tuvieran disponible el texto completo, en inglés y español; publicados entre 1980 y 2021. Los desenlaces evaluados incluyeron alivio del síndrome climatérico, mejora de la actividad y gratificación sexual, proporción de cáncer de mama y eventos adversos.
Resultados: se incluyeron sesenta y uno estudios. La tibolona demostró diferencias significativas frente al placebo, en el alivio del síndrome climatérico. Mostró mayor mejoría de la actividad y gratificación sexual, y menor proporción de eventos adversos que los estrógenos, las combinaciones de 17 beta-estradiol 2 mg / acetato de noretisterona 1 mg, y el estradiol transdérmico.
Conclusiones: tibolona tiene una eficacia similar para mejorar el síndrome vasomotor con otros comparadores, con ventajas frente a los estrógenos en la mejoría de la actividad y gratificación sexual: y frente a las combinaciones de 17 beta-estradiol 2 mg / acetato de noretisterona 1 mg y estradiol transdérmico y en eventos adversos.
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.
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