[Effectiveness and tolerance of pulsed estrogen therapy in the treatment of menopausal symptoms. Results of a Polish multicenter study].

OBJECTIVE: The main objective of the trial was to evaluate the efficacy and tolerance of a three-month pulsed estrogen therapy with intranasal 17 beta-estradiol in patients with menopausal symptoms. MATERIAL AND METHODS: Four-month, open, multicenter study (16 study centers in Poland). 309 patients with normal results of mammography and cytological examination who previously expressed informed consent for the participation in the trial were qualified to the study. Inclusion criterion was the diagnosis of at least moderate menopausal symptoms, defined as presence of night sweats disturbing sleep and hot flushes disturbing daily activity, and more than 30 points in the Green index. Exclusion criteria were: general estrogen-intake contraindications and contraindications for participation in the clinical trials. Patients included into the study were given intranasal 17 beta-estradiol 300 microg daily in continuous therapy and (patients with uterus) progestagen, according to the prescription. Main efficacy criterion was change of frequency and intensity of menopausal symptoms: night sweats and hot flushes. Additionally, Green index score was observed. Tolerance was assessed based on the adverse effects. Statistical analysis was performed using nonparametric Wilcoxon test and descriptive statistics. RESULTS: 273 patients completed the study. The night sweats were observed before the treatment in 90.5% patients with frequency of 8.8 per week. After 3 and 4 months of treatment the proportion of patients with night sweats decreased to 28.2% and 11.8% respectively, and the number of episodes to 2.7 and 2.2 per week (p < 0.0005). The hot flushes occurred before the treatment in average 12.1 times daily, after 3 months of treatment 1.3 times daily (p < 0.0005) and after 4 months of treatment 0.4 times daily (p < 0.0005). The Green index decreased from 35.6 points (before the treatment) to 11.6 points (after 3 months of treatment) (p < 0.0005) and 7.4 points (after 4 months of treatment) (p < 0.0005). During the treatment the adverse events were monitored--they occurred in 5.4% patients. The tolerance of the treatment after the end of the study was assessed by the physician as excellent or good in 96% patients. CONCLUSIONS: The results of the study give evidence for a high efficacy and very good tolerance to the treatment of menopausal symptoms using pulsed estrogen therapy with intranasal 17 beta-estradiol.