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A 5-year study on the effect of hormone therapy, tibolone and raloxifene on vaginal bleeding and endometrial thickness.
Maturitas 2006; 53(4):413-23M

Abstract

OBJECTIVES

To study the effect of standard and low-dose estrogen-progestin therapy (EPT), tibolone and raloxifene on the incidence of vaginal spotting/bleeding and endometrial thickness over a 5-year period.

METHODS

Seven hundred eighty-six postmenopausal women were studied in an open prospective design. Vaginal spotting/bleeding and endometrial thickness as assessed by transvaginal ultrasonography was compared between six categories of women over a 5-year period: three categories in women on continuous combined estrogen-progestin therapy, one category under tibolone, one category under raloxifene and one under no treatment. More specifically, women received tibolone 2.5 mg (N = 204), raloxifene HCl 60 mg (N = 137), conjugated equine estrogens 0.625 mg/medroxyprogesterone acetate 5mg (N = 122), 17beta-estradiol 2mg/norethisterone acetate 1mg (N = 58), 17beta-estradiol 1mg/norethisterone acetate 0.5mg (N = 76) or no therapy (controls, N = 189). Women with suspected endometrial pathology were referred for hysteroscopy.

RESULTS

Bleeding/spotting incidence was highest among standard dose EPT users (conjugated equine estrogens 0.625 mg/medroxyprogesterone acetate 5mg: 40.1%, 17beta-estradiol 2mg/norethisterone acetate 1mg: 44.8%, p < 0.001 compared to controls). Low-dose EPT associated with lower incidence of spotting/bleeding (34.1%). The incidence under tibolone and raloxifene was 22.5% and 2.9%, respectively, while 3.2% of women not receiving therapy reported vaginal spotting/bleeding. Mean endometrial thickness was not significantly affected in any of the groups studied. The drop-out rate due to spotting/bleeding was higher in the two higher dose EPT regimens. After logistic regression analysis, age at baseline was the only significant predictor of subsequent spotting/bleeding (b = -0.25, S.E. = 0.09, p = 0.006), while menopausal age and pre-treatment serum FSH had marginal significance.

CONCLUSIONS

EPT, tibolone and raloxifene do not appear to associate with significant changes in endometrial thickness in the majority of cases. The low-dose EPT regimen associated with a decreased incidence of unscheduled spotting/bleeding compared to the standard dose regimens. Tibolone expressed a favorable endometrial profile, as seen in its effect on unscheduled spotting/bleeding and mean endometrial thickness. Raloxifene associated with the lowest incidence in S/B and the lowest drop-out rate.s.

Authors+Show Affiliations

2nd Department of Obstetrics and Gynecology, University of Athens, Aretaieion Hospital, 27 Themistokleous Street, GR-14578 Dionysos, Athens, Greece.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16140483

Citation

Christodoulakos, George E., et al. "A 5-year Study On the Effect of Hormone Therapy, Tibolone and Raloxifene On Vaginal Bleeding and Endometrial Thickness." Maturitas, vol. 53, no. 4, 2006, pp. 413-23.
Christodoulakos GE, Botsis DS, Lambrinoudaki IV, et al. A 5-year study on the effect of hormone therapy, tibolone and raloxifene on vaginal bleeding and endometrial thickness. Maturitas. 2006;53(4):413-23.
Christodoulakos, G. E., Botsis, D. S., Lambrinoudaki, I. V., Papagianni, V. D., Panoulis, C. P., Creatsa, M. G., ... Creatsas, G. C. (2006). A 5-year study on the effect of hormone therapy, tibolone and raloxifene on vaginal bleeding and endometrial thickness. Maturitas, 53(4), pp. 413-23.
Christodoulakos GE, et al. A 5-year Study On the Effect of Hormone Therapy, Tibolone and Raloxifene On Vaginal Bleeding and Endometrial Thickness. Maturitas. 2006 Mar 20;53(4):413-23. PubMed PMID: 16140483.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 5-year study on the effect of hormone therapy, tibolone and raloxifene on vaginal bleeding and endometrial thickness. AU - Christodoulakos,George E, AU - Botsis,Dimitrios S, AU - Lambrinoudaki,Irene V, AU - Papagianni,Vasiliki D, AU - Panoulis,Constantinos P, AU - Creatsa,Maria G, AU - Alexandrou,Andreas P, AU - Augoulea,Areti D, AU - Dendrinos,Spyros G, AU - Creatsas,George C, Y1 - 2005/09/02/ PY - 2005/04/21/received PY - 2005/06/13/revised PY - 2005/07/07/accepted PY - 2005/9/6/pubmed PY - 2006/7/29/medline PY - 2005/9/6/entrez SP - 413 EP - 23 JF - Maturitas JO - Maturitas VL - 53 IS - 4 N2 - OBJECTIVES: To study the effect of standard and low-dose estrogen-progestin therapy (EPT), tibolone and raloxifene on the incidence of vaginal spotting/bleeding and endometrial thickness over a 5-year period. METHODS: Seven hundred eighty-six postmenopausal women were studied in an open prospective design. Vaginal spotting/bleeding and endometrial thickness as assessed by transvaginal ultrasonography was compared between six categories of women over a 5-year period: three categories in women on continuous combined estrogen-progestin therapy, one category under tibolone, one category under raloxifene and one under no treatment. More specifically, women received tibolone 2.5 mg (N = 204), raloxifene HCl 60 mg (N = 137), conjugated equine estrogens 0.625 mg/medroxyprogesterone acetate 5mg (N = 122), 17beta-estradiol 2mg/norethisterone acetate 1mg (N = 58), 17beta-estradiol 1mg/norethisterone acetate 0.5mg (N = 76) or no therapy (controls, N = 189). Women with suspected endometrial pathology were referred for hysteroscopy. RESULTS: Bleeding/spotting incidence was highest among standard dose EPT users (conjugated equine estrogens 0.625 mg/medroxyprogesterone acetate 5mg: 40.1%, 17beta-estradiol 2mg/norethisterone acetate 1mg: 44.8%, p < 0.001 compared to controls). Low-dose EPT associated with lower incidence of spotting/bleeding (34.1%). The incidence under tibolone and raloxifene was 22.5% and 2.9%, respectively, while 3.2% of women not receiving therapy reported vaginal spotting/bleeding. Mean endometrial thickness was not significantly affected in any of the groups studied. The drop-out rate due to spotting/bleeding was higher in the two higher dose EPT regimens. After logistic regression analysis, age at baseline was the only significant predictor of subsequent spotting/bleeding (b = -0.25, S.E. = 0.09, p = 0.006), while menopausal age and pre-treatment serum FSH had marginal significance. CONCLUSIONS: EPT, tibolone and raloxifene do not appear to associate with significant changes in endometrial thickness in the majority of cases. The low-dose EPT regimen associated with a decreased incidence of unscheduled spotting/bleeding compared to the standard dose regimens. Tibolone expressed a favorable endometrial profile, as seen in its effect on unscheduled spotting/bleeding and mean endometrial thickness. Raloxifene associated with the lowest incidence in S/B and the lowest drop-out rate.s. SN - 0378-5122 UR - https://www.unboundmedicine.com/medline/citation/16140483/A_5_year_study_on_the_effect_of_hormone_therapy_tibolone_and_raloxifene_on_vaginal_bleeding_and_endometrial_thickness_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5122(05)00181-7 DB - PRIME DP - Unbound Medicine ER -