Efficacy of estrogen plus progestin on menopausal symptoms in women with systemic lupus erythematosus: a randomized, double-blind, controlled trial

Arthritis Care Res (Hoboken). 2011 Dec;63(12):1654-63. doi: 10.1002/acr.20608.

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.

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT00392093.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Analysis of Variance
  • Chi-Square Distribution
  • Double-Blind Method
  • Estrogen Replacement Therapy* / adverse effects
  • Estrogens, Conjugated (USP) / administration & dosage*
  • Estrogens, Conjugated (USP) / adverse effects
  • Factor Analysis, Statistical
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Lupus Erythematosus, Systemic / complications*
  • Medroxyprogesterone Acetate / administration & dosage*
  • Medroxyprogesterone Acetate / adverse effects
  • Menopause / drug effects*
  • Mexico
  • Middle Aged
  • Patient Selection
  • Principal Component Analysis
  • Progestins / administration & dosage*
  • Progestins / adverse effects
  • Risk Assessment
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Vasomotor System / drug effects*
  • Vasomotor System / physiopathology

Substances

  • Estrogens, Conjugated (USP)
  • Progestins
  • Medroxyprogesterone Acetate

Associated data

  • ClinicalTrials.gov/NCT00392093