Efectividad de la tibolona e incidencia de efectos adversos en mujeres posmenopáusicas. Estudio cuasiexperimental en Armenia (Colombia), 2012-2015
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oct 7, 2021
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Objetivo: establecer el efecto de la tibolona en la sintomatología menopáusica y la función sexual, así como la incidencia de efectos adversos, en mujeres posmenopáusicas. Material y métodos: estudio de cohorte, en 127 mujeres posmenopáusicas mayores de 40 años, con síntomas climatéricos y último período menstrual al menos 2 años antes de ingresar al estudio, con pareja estable. En una clínica privada de carácter universitario en Armenia (Quindío), Colombia, entre 2012 y 2015. Se utilizaron como instrumentos la escala de calidad de vida “Menopause Rating Scale (MRS)” y el “Índice de Función Sexual Femenino (IFSF)”. Se hizo muestreo aleatorio simple. Se utilizó estadística descriptiva. Resultados: la edad promedio fue de 56,91 ± 7,34 años. Al final del estudio se alcanzó una mejoría de la sintomatología menopáusica del 94,48 % (p<0,05), con una disminución en la puntuación de la escala MRS de 15,91 ± 3,21 a 6,18 ± 3,75 puntos (p<0,05). Las disfunciones sexuales reportaron una mejoría del 86,56 %; el IFSF pasó de 23,19 ± 6,41 puntos a 28,02 ± 6,63 (p<0,05). Los efectos adversos se hicieron presentes desde los primeros 3 meses de inicio de la terapia, siendo los más frecuentes: amenorrea (85,82 %), mastalgia (18,89 %) y edema (17,32 %). Conclusiones: La administración de tibolona tiene un positivo efecto en el tratamiento de la sintomatología de la menopausia, reduciendo tanto la cantidad como la severidad de la misma. Asociándose a franca mejoría de la función sexual, con efectos adversos leves, tolerables y transitorios. Se requieren ensayos clínicos controlados aleatorizados, sobre su eficacia y seguridad en poblaciones de mayor edad y más numerosas.
Keywords
Women; Postmenopause; Signs and Symptoms; Hormone Replacement Therapy; Adverse effects; Incidence.Mujeres; Posmenopausia; Signos y Síntomas; Terapia de Reemplazo de Hormonas; Efectos adversos; Incidencia.
References
1) Baber RJ, Panay N, Fenton A; IMS Writing Group. 2016 IMS Recommendations on women's midlife health and menopause hormone therapy. Climacteric. 2016; 19(2):109-50. https://doi.org/10.3109/13697137.2015.1129166
2) Espitia De La Hoz FJ. Prevalence of genitourinary syndrome of menopause and impact on sexuality of women in Quindío (Colombia), 2013-2016. Rev Colomb Obstet Ginecol. 2018; 69(4):249-59. https://doi.org/10.18597/rcog.3111
3) Avis NE, Colvin A, Bromberger JT, Hess R, Matthews KA, Ory M, et al. Change in health-related quality of life over the menopausal transition in a multiethnic cohort of middle-aged women: Study of Women's Health Across the Nation. Menopause. 2009; 16(5):860-9. https://doi.org/10.1097/gme.0b013e3181a3cdaf
4) Jane FM, Davis SR. A practitioner's toolkit for managing the menopause. Climacteric. 2014; 17(5):564-79. https://doi.org/10.3109/13697137.2014.929651
5) McKinlay SM, Brambilla DJ, Posner JG. The normal menopause transition. Maturitas. 1992; 14(2):103-15. https://doi.org/10.1016/0378-5122(92)90003-m
6) Lewis V. Undertreatment of menopausal symptoms and novel options for comprehensive management. Curr Med Res Opin. 2009; 25(11):2689-98. https://doi.org/10.1185/03007990903240519
7) Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015; 126(4):859-76. https://doi.org/10.1097/AOG.0000000000001058.
8) The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2018; 25(11):1362-87. https://doi.org/10.1097/GME.0000000000001241
9) Panay N, Hamoda H, Arya R, Savvas M; British Menopause Society and Women's Health Concern. The 2013 British Menopause Society & Women's Health Concern recommendations on hormone replacement therapy. Menopause Int. 2013; 19(2):59-68. https://doi.org/10.1177/1754045313489645
10) Rossouw JE, Manson JE, Kaunitz AM, Anderson GL. Lessons learned from the Women's Health Initiative trials of menopausal hormone therapy. Obstet Gynecol. 2013; 121(1):172-6. https://doi.org/10.1097/aog.0b013e31827a08c8
11) Ross LA, Alder EM. Tibolone and climacteric symptoms. Maturitas. 1995; 21(2):127-36. https://doi.org/10.1016/0378-5122(94)00888-e
12) Hardiman P, Nihoyannopoulos P, Kicovic P, Ginsburg J. Cardiovascular effects of Org OD 14--a new steroidal therapy for climacteric symptoms. Maturitas. 1991; 13(3):235-42. https://doi.org/10.1016/0378-5122(91)90198-y
13) Lindsay R, Hart DM, Kraszewski A. Prospective double-blind trial of synthetic steroid (Org OD 14) for preventing postmenopausal osteoporosis. Br Med J. 1980; 280(6225):1207-9. https://doi.org/10.1136/bmj.280.6225.1207
14) Espitia De La Hoz FJ. Terapia de reemplazo hormonal combinada con testosterona para el tratamiento del trastorno del deseo sexual hipoactivo en mujeres en climaterio. Arch Med (Manizales) 2020; 20(1):71-85. https://doi.org/10.30554/archmed.20.1.3388.2020
15) Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, et al. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004; 2:45. https://doi.org/10.1186/1477-7525-2-45
16) Sadiq U, Baig KB, Mustafa N. Translation and reliability analysis of menopause rating scale (MRS) in Urdu language. J Pak Med Assoc. 2019; 69(2):224-9.
17) Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000; 26(2):191-208. https://doi.org/10.1080/009262300278597
18) Sánchez-Sánchez B, Navarro-Brazález B, Arranz-Martín B, Sánchez-Méndez Ó, de la Rosa-Díaz I, Torres-Lacomba M. The Female Sexual Function Index: Transculturally Adaptation and Psychometric Validation in Spanish Women. Int J Environ Res Public Health. 2020; 17(3):994. https://doi.org/10.3390/ijerph17030994
19) Espitia De La Hoz FJ. Prevalence and characterization of sexual dysfunctions in women, in 12 Colombian cities, 2009-2016. Rev Colomb Obstet Ginecol. 2018; 69(1):9-21. https://doi.org/10.18597/rcog.3035
20) Potthoff P, Heinemann LA, Schneider HP, Rosemeier HP, Hauser GA. Menopause-Rating-Skala (MRS II): Methodische Standardisierung in der deutschen Bevölkerung [The Menopause Rating Scale (MRS II): methodological standardization in the German population]. Zentralbl Gynakol. 2000; 122(5):280-6.
21) Schneider HP, Rosemeier HP, Schnitker J, Gerbsch S, Turck R. Application and factor analysis of the menopause rating scale [MRS] in a post-marketing surveillance study of Climen. Maturitas. 2000; 37(2):113-24. https://doi.org/10.1016/s0378-5122(00)00177-8
22) Hammar ML, van de Weijer P, Franke HR, Pornel B, von Mauw EM, Nijland EA; TOTAL Study Investigators Group. Tibolone and low-dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability. BJOG. 2007; 114(12):1522-9. https://doi.org/10.1111/j.1471-0528.2007.01537.x
23) Nijland EA, Weijmar Schultz WC, Nathorst-Boös J, Helmond FA, Van Lunsen RH, Palacios S, et al. Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial. J Sex Med. 2008; 5(3):646-56. https://doi.org/10.1111/j.1743-6109.2007.00726.x
24) Laan E, van Lunsen RH, Everaerd W. The effects of tibolone on vaginal blood flow, sexual desire and arousability in postmenopausal women. Climacteric. 2001; 4(1):28-41.
25) Nathorst-Böös J, Hammar M. Effect on sexual life--a comparison between tibolone and a continuous estradiol-norethisterone acetate regimen. Maturitas. 1997; 26(1):15-20. https://doi.org/10.1016/s0378-5122(96)01069-9
26) Kenemans P, Bundred NJ, Foidart JM, Kubista E, von Schoultz B, Sismondi P, et al. Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: a double-blind, randomised, non-inferiority trial. Lancet Oncol. 2009; 10(2):135-46. https://doi.org/10.1016/S1470-2045(08)70341-3
27) Bjarnason NH, Bjarnason K, Haarbo J, Bennink HJ, Christiansen C. Tibolone: influence on markers of cardiovascular disease. J Clin Endocrinol Metab. 1997; 82(6):1752-6. https://doi.org/10.1210/jcem.82.6.3995
28) Archer DF, Hendrix S, Gallagher JC, Rymer J, Skouby S, Ferenczy A, den Hollander W, Stathopoulos V, Helmond FA. Endometrial effects of tibolone. J Clin Endocrinol Metab. 2007; 92(3):911-8. https://doi.org/10.1210/jc.2006-2207
29) Cummings SR, Ettinger B, Delmas PD, Kenemans P, Stathopoulos V, Verweij P, et al. The effects of tibolone in older postmenopausal women. N Engl J Med. 2008; 359(7):697-708. https://doi.org/10.1056/NEJMoa0800743
30) Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Collaborative Group on Hormonal Factors in Breast Cancer. Lancet. 1997; 350(9084):1047-59. Erratum in: Lancet 1997; 350(9089):1484.
31) de Gooyer ME, Kleyn GT, Smits KC, Ederveen AG, Verheul HA, Kloosterboer HJ. Tibolone: a compound with tissue specific inhibitory effects on sulfatase. Mol Cell Endocrinol. 2001; 183(1-2):55-62. https://doi.org/10.1016/s0303-7207(01)00606-2
32) Formoso G, Perrone E, Maltoni S, Balduzzi S, Wilkinson J, Basevi V, et al. Short-term and long-term effects of tibolone in postmenopausal women. Cochrane Database Syst Rev. 2016; 10(10):CD008536. https://doi.org/10.1002/14651858.CD008536.pub3
33) Modelska K, Cummings S. Tibolone for postmenopausal women: systematic review of randomized trials. J Clin Endocrinol Metab. 2002; 87(1):16-23. https://doi.org/10.1210/jcem.87.1.8141
2) Espitia De La Hoz FJ. Prevalence of genitourinary syndrome of menopause and impact on sexuality of women in Quindío (Colombia), 2013-2016. Rev Colomb Obstet Ginecol. 2018; 69(4):249-59. https://doi.org/10.18597/rcog.3111
3) Avis NE, Colvin A, Bromberger JT, Hess R, Matthews KA, Ory M, et al. Change in health-related quality of life over the menopausal transition in a multiethnic cohort of middle-aged women: Study of Women's Health Across the Nation. Menopause. 2009; 16(5):860-9. https://doi.org/10.1097/gme.0b013e3181a3cdaf
4) Jane FM, Davis SR. A practitioner's toolkit for managing the menopause. Climacteric. 2014; 17(5):564-79. https://doi.org/10.3109/13697137.2014.929651
5) McKinlay SM, Brambilla DJ, Posner JG. The normal menopause transition. Maturitas. 1992; 14(2):103-15. https://doi.org/10.1016/0378-5122(92)90003-m
6) Lewis V. Undertreatment of menopausal symptoms and novel options for comprehensive management. Curr Med Res Opin. 2009; 25(11):2689-98. https://doi.org/10.1185/03007990903240519
7) Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015; 126(4):859-76. https://doi.org/10.1097/AOG.0000000000001058.
8) The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2018; 25(11):1362-87. https://doi.org/10.1097/GME.0000000000001241
9) Panay N, Hamoda H, Arya R, Savvas M; British Menopause Society and Women's Health Concern. The 2013 British Menopause Society & Women's Health Concern recommendations on hormone replacement therapy. Menopause Int. 2013; 19(2):59-68. https://doi.org/10.1177/1754045313489645
10) Rossouw JE, Manson JE, Kaunitz AM, Anderson GL. Lessons learned from the Women's Health Initiative trials of menopausal hormone therapy. Obstet Gynecol. 2013; 121(1):172-6. https://doi.org/10.1097/aog.0b013e31827a08c8
11) Ross LA, Alder EM. Tibolone and climacteric symptoms. Maturitas. 1995; 21(2):127-36. https://doi.org/10.1016/0378-5122(94)00888-e
12) Hardiman P, Nihoyannopoulos P, Kicovic P, Ginsburg J. Cardiovascular effects of Org OD 14--a new steroidal therapy for climacteric symptoms. Maturitas. 1991; 13(3):235-42. https://doi.org/10.1016/0378-5122(91)90198-y
13) Lindsay R, Hart DM, Kraszewski A. Prospective double-blind trial of synthetic steroid (Org OD 14) for preventing postmenopausal osteoporosis. Br Med J. 1980; 280(6225):1207-9. https://doi.org/10.1136/bmj.280.6225.1207
14) Espitia De La Hoz FJ. Terapia de reemplazo hormonal combinada con testosterona para el tratamiento del trastorno del deseo sexual hipoactivo en mujeres en climaterio. Arch Med (Manizales) 2020; 20(1):71-85. https://doi.org/10.30554/archmed.20.1.3388.2020
15) Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, et al. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004; 2:45. https://doi.org/10.1186/1477-7525-2-45
16) Sadiq U, Baig KB, Mustafa N. Translation and reliability analysis of menopause rating scale (MRS) in Urdu language. J Pak Med Assoc. 2019; 69(2):224-9.
17) Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000; 26(2):191-208. https://doi.org/10.1080/009262300278597
18) Sánchez-Sánchez B, Navarro-Brazález B, Arranz-Martín B, Sánchez-Méndez Ó, de la Rosa-Díaz I, Torres-Lacomba M. The Female Sexual Function Index: Transculturally Adaptation and Psychometric Validation in Spanish Women. Int J Environ Res Public Health. 2020; 17(3):994. https://doi.org/10.3390/ijerph17030994
19) Espitia De La Hoz FJ. Prevalence and characterization of sexual dysfunctions in women, in 12 Colombian cities, 2009-2016. Rev Colomb Obstet Ginecol. 2018; 69(1):9-21. https://doi.org/10.18597/rcog.3035
20) Potthoff P, Heinemann LA, Schneider HP, Rosemeier HP, Hauser GA. Menopause-Rating-Skala (MRS II): Methodische Standardisierung in der deutschen Bevölkerung [The Menopause Rating Scale (MRS II): methodological standardization in the German population]. Zentralbl Gynakol. 2000; 122(5):280-6.
21) Schneider HP, Rosemeier HP, Schnitker J, Gerbsch S, Turck R. Application and factor analysis of the menopause rating scale [MRS] in a post-marketing surveillance study of Climen. Maturitas. 2000; 37(2):113-24. https://doi.org/10.1016/s0378-5122(00)00177-8
22) Hammar ML, van de Weijer P, Franke HR, Pornel B, von Mauw EM, Nijland EA; TOTAL Study Investigators Group. Tibolone and low-dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability. BJOG. 2007; 114(12):1522-9. https://doi.org/10.1111/j.1471-0528.2007.01537.x
23) Nijland EA, Weijmar Schultz WC, Nathorst-Boös J, Helmond FA, Van Lunsen RH, Palacios S, et al. Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial. J Sex Med. 2008; 5(3):646-56. https://doi.org/10.1111/j.1743-6109.2007.00726.x
24) Laan E, van Lunsen RH, Everaerd W. The effects of tibolone on vaginal blood flow, sexual desire and arousability in postmenopausal women. Climacteric. 2001; 4(1):28-41.
25) Nathorst-Böös J, Hammar M. Effect on sexual life--a comparison between tibolone and a continuous estradiol-norethisterone acetate regimen. Maturitas. 1997; 26(1):15-20. https://doi.org/10.1016/s0378-5122(96)01069-9
26) Kenemans P, Bundred NJ, Foidart JM, Kubista E, von Schoultz B, Sismondi P, et al. Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: a double-blind, randomised, non-inferiority trial. Lancet Oncol. 2009; 10(2):135-46. https://doi.org/10.1016/S1470-2045(08)70341-3
27) Bjarnason NH, Bjarnason K, Haarbo J, Bennink HJ, Christiansen C. Tibolone: influence on markers of cardiovascular disease. J Clin Endocrinol Metab. 1997; 82(6):1752-6. https://doi.org/10.1210/jcem.82.6.3995
28) Archer DF, Hendrix S, Gallagher JC, Rymer J, Skouby S, Ferenczy A, den Hollander W, Stathopoulos V, Helmond FA. Endometrial effects of tibolone. J Clin Endocrinol Metab. 2007; 92(3):911-8. https://doi.org/10.1210/jc.2006-2207
29) Cummings SR, Ettinger B, Delmas PD, Kenemans P, Stathopoulos V, Verweij P, et al. The effects of tibolone in older postmenopausal women. N Engl J Med. 2008; 359(7):697-708. https://doi.org/10.1056/NEJMoa0800743
30) Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Collaborative Group on Hormonal Factors in Breast Cancer. Lancet. 1997; 350(9084):1047-59. Erratum in: Lancet 1997; 350(9089):1484.
31) de Gooyer ME, Kleyn GT, Smits KC, Ederveen AG, Verheul HA, Kloosterboer HJ. Tibolone: a compound with tissue specific inhibitory effects on sulfatase. Mol Cell Endocrinol. 2001; 183(1-2):55-62. https://doi.org/10.1016/s0303-7207(01)00606-2
32) Formoso G, Perrone E, Maltoni S, Balduzzi S, Wilkinson J, Basevi V, et al. Short-term and long-term effects of tibolone in postmenopausal women. Cochrane Database Syst Rev. 2016; 10(10):CD008536. https://doi.org/10.1002/14651858.CD008536.pub3
33) Modelska K, Cummings S. Tibolone for postmenopausal women: systematic review of randomized trials. J Clin Endocrinol Metab. 2002; 87(1):16-23. https://doi.org/10.1210/jcem.87.1.8141
Cómo citar
Espitia De La Hoz, F. J. (2021). Efectividad de la tibolona e incidencia de efectos adversos en mujeres posmenopáusicas. Estudio cuasiexperimental en Armenia (Colombia), 2012-2015. Universitas Medica, 62(4). https://doi.org/10.11144/Javeriana.umed62-4.tibo
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