Prolonged use of gonadotropin-releasing hormone agonist and tibolone as add-back therapy for the treatment of endometrial hyperplasia

Θεόδωρος Αγοραστός, Violetta Vaitsi, Minas Paschopoulos, Andromache Vakiani, Vassiliki Zournatzi-Koiou, H. Saravelos, Evanthia Kostopoulou, Theodoros C. Constantinidis, Konstantinos Dinas, Dimitrios Vavilis, Dimitrios Lolis, J. Bontis
In: Maturitas · 2003 · vol. 48(2) , pp. 125–132 · doi:10.1016/j.maturitas.2003.08.008 · PMID:15172086 · W2109640284
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This study investigated the efficacy and safety of using a GnRH agonist with tibolone as add-back therapy for treating endometrial hyperplasia.

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Abstract

ObjectivesTo investigate the response of the various hyperplastic disorders of the endometrium to a prolonged treatment with leuprolide acetate, a gonadotropin-releasing hormone agonist (GnRH-a), plus tibolone, as add-back therapy, and further to study if the tibolone addition reduces the hypoestrogenic actions of the GnRH-analogue.MethodsWe treated 26 women with histologically confirmed simple (n = 9), complex (n = 15) or atypical (n = 2) endometrial hyperplasia (EH) for 12 months with monthly injections of 1Ampulle/3.75 mg of leuprolide acetate, followed by tibolone, 2.5mg per day per os. Every woman underwent a hysteroscopic evaluation and biopsy of the endometrium after 3 (in cases with atypical EH), 6 and 12 months of treatment, as well as after 12 and 24 months of follow-up. The clinical, paraclinical and laboratory course of the disease was followed-up by using of a climacteric scoring system and by testing of various parameters.ResultsThe histopathologic evaluation of the endometria revealed regression of EH in all women after 12 months of treatment, however, during the first 2 years of follow-up EH reappeared in four women (4/21, 19%). Bone mineral density and serum parameters did not show significant changes during treatment, whereas only a mild suffering from hypoestrogenic side-effects was noted.ConclusionsIt seems that the combined GnRH-a/tibolone treatment in women with EH is a potent alternative, so far as the endometrial status and the clinical course of the disease are concerned, whereas tibolone appears to act sufficiently as add-back therapy to prolonged GnRH-a treatment. The probability of relapse of the disease during the follow-up period makes the close monitoring of the endometrium after cessation of the treatment absolutely necessary.

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