Effect of abrupt discontinuation versus gradual dose reduction of postmenopausal hormone therapy on hot flushes

Abstract

Objective To compare the effects of the abrupt discontinuation of postmenopausal hormone therapy (HT) and reduction of the daily dosage of the hormone on climacteric symptoms.

Methods The study included Brazilian postmenopausal women who were using estrogen–progestogen hormone therapy in full doses previously prescribed for vasomotor symptoms. The patients were randomized to receive one of three treatments: placebo for 6 months; estradiol (E2) 1 mg/day + norethisterone acetate (NETA) 0.5 mg/day for 2 months, followed by placebo for 4 months; or E2 1 mg/day + NETA 0.5 mg/day for 4 months, followed by placebo for 2 months. The climacteric symptoms were assessed by the Blatt–Kupperman Menopausal Index at baseline and at 2, 4 and 6 months. Statistical evaluation was performed using the χ² or Fisher's test for categorical data, the Kruskal–Wallis test for numerical data, and ANOVA for time and group relationship with the Blatt–Kupperman Menopausal Index.

Results We randomized 60 women (20 in each group), and 54 completed the study. It was observed that both the full Blatt–Kupperman Menopausal Index and the hot flush score did not change significantly in the HT group during low-dose therapy compared with baseline; however, the evaluation performed at 2 months after low-dose-HT cessation showed that the full Blatt–Kupperman Menopausal Index and the hot flush score were similar to those of the group who stopped HT abruptly and significantly higher than at baseline (hot flush scores: p < 0.001 for all three groups at months 2, 4 and 6, respectively, vs. baseline).

Conclusion Discontinuation of HT by reducing the daily dose of estrogen for a period of 2 or 4 months did not differ in its effect from that of abrupt cessation with regard to vasomotor symptoms.

Key words:

• HOT FLUSHES
• HORMONE THERAPY
• TREATMENT DISCONTINUATION
• MENOPAUSE
• LOW-DOSE POSTMENOPAUSAL HORMONE THERAPY

Conflict of interest  All the medication in this study was provided by Biolab Sanus Farmacêutica Ltda (São Paulo, Brazil). L. M. Pompei is an occasional speaker for Merck-Serono SA and Novartis Biociências SA, and member of an advisory board for Sanofi-Aventis Farmacêutica Ltda.; J. A. S. Ferreira is an occasional speaker for Novartis Biociências SA; C. E. Fernandes is an occasional speaker for Sanofi-Aventis Farmacêutica Ltda., Merck-Serono SA and Novartis Biociências SA., and member of an advisory board for Sanofi-Aventis Farmacêutica Ltda. The other authors have no conflict of interest to declare. The authors alone are responsible for the content and writing of the paper.

Source of funding  This study was in part financially supported by institutional resources, which were complemented with resources provided by the investigators themselves. All the medication in this study was provided by Biolab Sanus Farmacêutica Ltda (São Paulo, Brazil).