Hormone replacement therapy and vigilance: double-blind, placebo-controlled EEG-mapping studies with an estrogen-progestogen combination (Climodien, Lafamme) versus estrogen alone in menopausal syndrome patients.

摘要: Abstract The aim of the double-blind, placebo-controlled study was to investigate effects a continuous combined estrogen–progestogen treatment (Climodien®, Lafamme®) as compared with estrogen alone on vigilance in insomniac postmenopausal syndrome patients, objectified by EEG mapping. Methods: In 3-arm, 2-month parallel group design phase, patients received combination estradiol valerate 2 mg and novel progestogen dienogest 3 (Climodien 2/3) or placebo. subsequent open-label all mg+dienogest 2/2). mapping carried out before after double-blind phase well treatment. Results: As placebo, Climodien 2/3 induced marked highly significant increase absolute power frequency bands, specifically alpha-2 activity. Moreover, relative power, decrease delta beta an acceleration dominant alpha centroids suggested improvement vigilance. contrast, under alone, only slight augmentation attenuation occurred, suggesting Thus, increased effect, which also confirmed statistical evaluation differences between (augmentation alpha-2, beta, frequency). 2/2 markedly decreased beta-2 accelerated centroid. Finally, comparing 2/2, there even dose–efficacy relation. Conclusions: Estradiol improves slightly, thereby confirming previous findings. additional administration does not minimize effect estrogen, but contrary increases it, makes superior both placebo alone. Vigilance may be great therapeutic benefit menopausal at time when adaptability is needed adjust increasing sexual, marital, occupational social difficulties known occur this period life.