title: Clinical effect of hormonal replacement therapy with estradiol associated with noretisterone or drospirenone. A prospective randomized placebo controlled study.
abstract: The study was performed to compare the clinical effect of a hormone replacement therapy (HRT) with two different progestins. Postmenopausal women (PMW) with climacteric symptoms (CS) randomly received for 12 months orally, either placebo (n = 20), 1 mg estradiol (E) plus 0.5 mg noretisterone acetate (NETA; n = 40), or 2 mg drospirenone (DRSP; n = 40), a testosterone- and spironolactone-derived molecule, respectively. Weight (W) declined only during E/DRSP (p < 0.04 versus placebo). Fat mass (FM) decreased, similarly, during E/NETA and E/DRSP. Intracellular water (ICW) did not change, while extracellular water (ECW) decreased during E/DRSP (p < 0.0001) (p < 0.002 versus E/NETA). During E/NETA and E/DRSP, similar decreases were observed for insulin resistance (IR) by the homeostatic model assessment for IR (HOMA-IR) (p < 0.0001 versus placebo for both), systolic (p < 0.04 versus placebo for both) and diastolic (p < 0.002) blood pressure (BP). Lipids did not change. In comparison to placebo CS, by the Kupperman Index (KI), significantly declined (p < 0.0001) during E/NETA or E/DRSP. Menopause-specific Quality of Life (MENQoL) significantly declined versus placebo (p < 0.04) during both E/NETA and E/DRSP. In conclusion, differences between the two progestins are mainly limited to body composition (BC), where the addition of DRSP decreases ECW and body W (BW).
authors.affiliation: Department of Obstetrics and Gynecology, University Of Cagliari, Policlinico Universitario Duilio Casula, Monserrato , Cagliari , Italy .
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Paoletti
authors.forename: Angelo
authors.initials: A
authors.lastname: Cagnacci
authors.forename: Costantino
authors.initials: C
authors.lastname: Di Carlo
authors.forename: Marisa Margherita
authors.initials: MM
authors.lastname: Orrù
authors.forename: Manuela
authors.initials: M
authors.lastname: Neri
authors.forename: Maurizio Nicola
authors.initials: MN
authors.lastname: D'Alterio
authors.forename: Gian Benedetto
authors.initials: GB
authors.lastname: Melis
mesh_terms: D000273:Adipose Tissue; D000736:Androstenes / Q000627:therapeutic use*; D001823:Body Composition; D001834:Body Water; D001835:Body Weight; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000627:therapeutic use*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D007333:Insulin Resistance; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use; D009640:Norethindrone / Q000627:therapeutic use*; D017698:Postmenopause; D045167:Progesterone Congeners / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000736:Androstenes; D004967:Estrogens; D000451:Mineralocorticoid Receptor Antagonists; D045167:Progesterone Congeners; D004958:Estradiol; C035144:drospirenone; D009640:Norethindrone
keywords: Body composition; HRT; NETA; climacteric symptoms; drospirenone; insulin resistance; menopause; metabolism