Tibolone Effectiveness and Incidence of Adverse Effects in Postmenopausal Women. Quasi Experimental Study in Armenia, Colombia, 2012-2015
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Oct 7, 2021
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Abstract
Objective: to establish the effect of tibolone on menopausal symptoms and sexual function, as well as the incidence of adverse effects, in postmenopausal women. Material and methods: cohort study, in 127 postmenopausal women over 40 years old, with climacteric symptoms and last menstrual period at least 2 years before entering the study, with a stable partner. In a private university clinic in Armenia (Quindío), Colombia, between 2012 and 2015. The quality of life scale "Menopause Rating Scale (MRS)" and the "Female Sexual Function Index (IFSF)" were used as instruments. Simple random sampling was done. Descriptive statistics were used.
Results: the average age was 56.91 ± 7.34 years. At the end of the study, an improvement in menopausal symptoms of 94.48% (p <0.05) was achieved, with a decrease in the MRS score from 15.91 ± 3.21 to 6.18 ± 3, 75 points (p <0.05). Sexual dysfunctions reported an improvement of 86.56%; the IFSF went from 23.19 ± 6.41 points to 28.02 ± 6.63 (p <0.05). Adverse effects were present from the first 3 months of initiation of therapy, the most frequent being: amenorrhea (85.82%), mastalgia (18.89%) and edema (17.32%).
Conclusions: The administration of tibolone has a positive effect in the treatment of the symptoms of menopause, reducing both the amount and the severity of it. Associated with a clear improvement in sexual function, with mild, tolerable and transitory adverse effects. Randomized controlled clinical trials are required on its efficacy and safety in older and larger populations.
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
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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
How to Cite
Espitia De La Hoz, F. J. (2021). Tibolone Effectiveness and Incidence of Adverse Effects in Postmenopausal Women. Quasi Experimental Study in Armenia, Colombia, 2012-2015. Universitas Medica, 62(4). https://doi.org/10.11144/Javeriana.umed62-4.tibo
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