One year comparison between two add-back therapies in patients treated with a GnRH agonist for symptomatic endometriosis:: a randomized double-blind trial

被引:32
作者
Fernandez, H [1 ]
Lucas, C
Hédon, B
Meyer, JL
Mayenga, JM
Roux, C
机构
[1] Hop Antoine Beclere, AP HP, Serv Gynecol Obstet, F-92141 Clamart, France
[2] Labs Takeda, Puteaux La Defense, France
[3] Hop Univ Arnaud Villeneuve, Serv Gynecol Obstet, F-34295 Montpellier, France
[4] Beaumont Clin, F-63110 Beaumont, France
[5] Hop Jean Rostand, Serv Gynecol Obstet, F-92311 Sevres, France
[6] Univ Paris 05, Hop Cochin, Serv Rhumatol, F-75014 Paris, France
关键词
add-back therapy; bone mineral density; endometriosis; GnRH agonists; leuprorelin;
D O I
10.1093/humrep/deh250
中图分类号
R71 [妇产科学];
学科分类号
100211 [妇产科学];
摘要
BACKGROUND: It has been proposed that hormonal supplementation during prolonged GnRH agonist therapy prevents hypoestrogenic side effects, including bone loss. The optimal combination for long-term treatments with safe metabolic profile remains questionable. A norprogesterone derivative, promegestone, was assessed for the first time in a double-blind trial. METHODS: Seventy-eight patients with endometriosis with rAFS (Revised American Society for Reproductive Medicine) scores of III-IV were randomly assigned to monthly leuprorelin 3.75 mg (1 year) which, after the third injection was used in combination with promegestone 0.5 mg (P) plus either estradiol placebo (PL) or estradiol 2 mg (E) per day. Bone mineral density (BMD) was determined at baseline, 6 and 12 months, and biological and clinical quarterly assessments were performed. Analysis was by the intention to treat method. RESULTS: At month 12, BMD changes from baseline were -6.1 +/- 3.7 and -4.9 +/- 4.0% in the PL-P group, at the spine and hip, respectively. This bone loss was prevented in the E-P group: -1.9 +/- 3.1 and -1.4 +/- 2.3%, respectively (P < 0.0001 inter-group comparisons). The BMD decrease in the E-P group was explained by the changes occurring during the first 6 months of treatment. There was no deleterious change in lipid parameters. Clinical improvement was observed without an inter-group difference. CONCLUSIONS: Estradiol 2 mg and promegestone 0.5 mg per day is an effective and safe add-back therapy, which can be proposed for prolonged leuprorelin treatment over 6 months in severe endometriosis.
引用
收藏
页码:1465 / 1471
页数:7
相关论文
共 28 条
[1]
DOSAGE ASPECTS OF DANAZOL THERAPY IN ENDOMETRIOSIS - SHORT-TERM AND LONG-TERM EFFECTIVENESS [J].
BIBEROGLU, KO ;
BEHRMAN, SJ .
AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 1981, 139 (06) :645-654
[2]
Biochemical markers as predictors of bone mineral density changes after GnRH agonist treatment [J].
Borderie, D ;
Cherruau, B ;
Dougados, M ;
Ekindjian, OG ;
Roux, C .
CALCIFIED TISSUE INTERNATIONAL, 1998, 62 (01) :21-25
[3]
Canis M, 1997, FERTIL STERIL, V67, P817
[4]
Gonadotropin-releasing hormone agonist plus "add-back" hormone replacement therapy for treatment of endometriosis: a prospective, randomized, placebo-controlled, double-blind trial [J].
Franke, HR ;
van de Weijer, PHM ;
Pennings, TMM ;
van der Mooren, MJ .
FERTILITY AND STERILITY, 2000, 74 (03) :534-539
[5]
Steroidal 'Add-Back' therapy in patients treated with GnRH agonists [J].
Freundl, G ;
Gödtke, K ;
Gnoth, C ;
Godehardt, E ;
Kienle, E .
GYNECOLOGIC AND OBSTETRIC INVESTIGATION, 1998, 45 :22-30
[6]
FRIEDMAN AJ, 1993, FERTIL STERIL, V59, P448
[7]
A PROSPECTIVE, RANDOMIZED TRIAL OF GONADOTROPIN-RELEASING-HORMONE AGONIST PLUS ESTROGEN-PROGESTIN OR PROGESTIN ADD-BACK REGIMENS FOR WOMEN WITH LEIOMYOMATA UTERI [J].
FRIEDMAN, AJ ;
DALY, M ;
JUNEAUNORCROSS, M ;
REIN, MS ;
FINE, C ;
GLEASON, R ;
LEBOFF, M .
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, 1993, 76 (06) :1439-1445
[8]
Gregoriou O, 1997, INT J FERTIL WOMEN M, V42, P406
[9]
Leuprolide acetate depot and hormonal add-back in endometriosis: A 12-month study [J].
Hornstein, MD ;
Surrey, ES ;
Weisberg, GW ;
Casino, LA .
OBSTETRICS AND GYNECOLOGY, 1998, 91 (01) :16-24
[10]
GONADOTROPIN-RELEASING-HORMONE ANALOG (GOSERELIN) PLUS HORMONE REPLACEMENT THERAPY FOR THE TREATMENT OF ENDOMETRIOSIS - A RANDOMIZED CONTROLLED TRIAL [J].
HOWELL, R ;
EDMONDS, DK ;
DOWSETT, M ;
CROOK, D ;
LEES, B ;
STEVENSON, JC .
FERTILITY AND STERILITY, 1995, 64 (03) :474-481