[Ovarian stimulation by a new therapeutic principle for the treatment of complications of the climacteric. Results of a double-blind crossover study with a defined spleen dialysate].
In a placebo-controlled double-blind cross-over study (test period 8 weeks) the spleen dialysate Solcosplen is tested for effectiveness and tolerance in 40 women, i.e. 14 pre- resp. 26 postmenopausal women in two consecutive periods (test periods I and II). The treatment begins in the first week of each test period with 2 ampoules i.m. t.i.d. and is to be continued for the following 7 weeks with 2 dragees b.i.d. Besides the incidence of clinical symptoms there intensity is summarized in a graded form to the Kupperman index. For further objectifying the therapeutic results vaginal-cytological examinations and radioimmunological analyses of estradiol (E2), LH, FSH and DHEA-S are carried out. The courses of therapy are frequented on a balanced basis. The progress of clinical symptoms shows in respect of incidence of appearance and intensity measured in Kupperman index in Phase I as well as in the cross-over statistically clear reciprocity, which demonstrates - with homogeneous prefindings - significantly differing results of treatment in favour of the dialysate. In the intraindividual comparison of judging the effectiveness by the physician and patient yields significant preferences for the verum. Side-effects were not observed. The proven effectiveness of the spleen dialysate within this study is explained by the stimulation of the ovarian residual function during menopause. It is discussed and compared to the presently applied monotherapeutic E2-substitution.