Double-blind, Placebo-controlled Psychometric Studies on the Effects of a Combined Estrogen-progestin Regimen versus Estrogen Alone on Performance, Mood and Personality of Menopausal Syndrome Patients

The influence of a combined estrogen progestin regimen (Climodien®) on noo psyche, thymopsyche, personality and psychophysiological measures of meno pausal syndrome patients was investi gated in a double blind, placebo con trolled, comparative, randomized 3 arm trial phase (Climodien 2/3 = estradiol val erate (CAS 979-32-8) 2 mg + the proges tin dienogest (CAS 65928-58-7) 3 mg = re gimen A, estradiol valerate 2 mg = regi men EV, and placebo = regimen P) fol lowed by an open label phase in which all patients received Climodien 2/2 (estra diol valerate 2 mg + dienogest 2 mg) = re gimen A*. 49 women (16, 17, 16 valid patients per arm) aged between 46 and 67 years (mean 58, 58, 56 years, respec tively) with the diagnoses of insomnia (G 47.0) related to postmenopausal syn drome (N 95.1) were included in the anal ysis of the double blind phase. Both the double blind and the open label phase lasted 2 months. Noopsychic investigations demon strated an improvement in associative verbal memory after 2 months of regi men A, which was significant as com pared with both baseline and placebo. Re garding visual memory, regimen A* in duced an improvement, which was signif icantly different from the decline in correct reproductions in the Benton Test observed under estradiol. Errors in the Benton Test decreased significantly after regimen A* as compared with regimen EV. These findings suggest that hormone replacement therapy with estradiol, and even more in combination with dieno-gest, improves verbal and visual memory, which is in line with the improvement in information processing speed and capacity objectified by event-related potentials (ERP). Thymopsychic investigations demonstrated a significant improvement in somatic complaints and trait anxiety after both regimen A and regimen EV as compared with baseline. State anxiety decreased significantly under regimen A* as compared with EV. The Freiburger Personality Inventory showed an improvement in aggressivity after regimen A* as compared with the preceding placebo as well as an improvement in striving after dominancy after both regimen A and regimen EV as compared with pre-treatment, but also after regimen A* as compared with regimen EV. Extraversion increased after 2 months of regimen A as compared to regimen P. Psychophysiological findings including pupillary and skin conductance variables were not significant.