title: Efficacy of estrogen plus progestin on menopausal symptoms in women with systemic lupus erythematosus: a randomized, double-blind, controlled trial.
abstract: OBJECTIVE
  To define the effects of continuous sequential estrogen plus progestin therapy on menopausal symptoms in women with systemic lupus erythematosus (SLE).
  
  
  METHODS
  We performed a randomized, double-blind, 24-month clinical trial involving 106 women with SLE who were in the menopausal transition or early or late postmenopause. Patients received continuous sequential estrogen plus progestin (n = 52) or placebo (n = 54). Menopausal symptoms were assessed using the Greene Climacteric Scale at 0, 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 months. A new factor analysis of the scale reduced 21 items to 5 factors. The primary outcome was improvement of menopausal symptoms throughout the followup period. Results were analyzed by the intent-to-treat principle.
  
  
  RESULTS
  At baseline, demographic and disease characteristics were similar in both groups. Fifteen of 21 menopausal symptoms had a prevalence of ≥50%, with a similar distribution between groups. Vasomotor factor scores decreased over time in both groups (P = 0.002), but in the estrogen plus progestin group the reduction was more pronounced than in the placebo group (1.5-2.0 versus 0.35-0.8 points on a scale of 0-6; P = 0.03). Maximum effects were observed among the most symptomatic women. Psychological, subjective-somatic, and organic-somatic factors scores also improved along time (P < 0.001), but the treatment and placebo arms improved to a similar degree. Thromboses occurred in 3 patients receiving estrogen plus progestin and in 1 patient receiving placebo.
  
  
  CONCLUSIONS
  Menopausal symptoms are highly prevalent in peri- and postmenopausal lupus patients. Estrogen plus progestin improved vasomotor symptoms at a clinically significant level, but not other menopausal symptoms. Given the thrombotic risks of menopausal hormone therapy, this should be used only in women with significant vasomotor symptoms.
authors: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, México DF, México. mcravioto@prodigy.net.mx
authors: María-Del-Carmen
authors: MD
authors: Cravioto
authors: Marta
authors: M
authors: Durand-Carbajal
authors: Luisa
authors: L
authors: Jiménez-Santana
authors: Pilar
authors: P
authors: Lara-Reyes
authors: Armando H
authors: AH
authors: Seuc
authors: Jorge
authors: J
authors: Sánchez-Guerrero
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage* / Q000009:adverse effects; D005163:Factor Analysis, Statistical; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008180:Lupus Erythematosus, Systemic / Q000150:complications*; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage* / Q000009:adverse effects; D008593:Menopause / Q000187:drug effects*; D008800:Mexico; D008875:Middle Aged; D018579:Patient Selection; D025341:Principal Component Analysis; D011372:Progestins / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014666:Vasomotor System / Q000187:drug effects* / Q000503:physiopathology
chemical_list: D004966:Estrogens, Conjugated (USP); D011372:Progestins; D017258:Medroxyprogesterone Acetate