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Efficacy of estrogen plus progestin on menopausal symptoms in women with systemic lupus erythematosus: A randomized, double‐blind, controlled trial
Author(s) -
Cravioto MaríadelCarmen,
DurandCarbajal Marta,
JiménezSantana Luisa,
LaraReyes Pilar,
Seuc Armando H.,
SánchezGuerrero Jorge
Publication year - 2011
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.20608
Subject(s) - medicine , progestin , placebo , estrogen , menopause , vasomotor , climacteric , randomized controlled trial , gynecology , gastroenterology , alternative medicine , pathology
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.