4. Discussion
burns, ovarian deficiency, ulcers, menopausal disorders
MENOPAUSAL DISORDERS, FOUNDER, ULCERS, MENOPAUSAL DISORDERS
This clinical trial was a multicenter, randomized, double-blind, parallel-group, prospective study conducted at a total of two domestic institutions. The study aimed to evaluate the comparative efficacy and safety of Unicenta compared to Melsmon in women with menopausal symptoms. The study enrolled women with menopausal symptoms, and there were no statistically significant differences observed in the Kupperman index scores, which serve as indicators of menopausal symptoms, between the treatment group and the control group. Additionally, there were no differences observed between the groups in terms of demographic characteristics. A total of 104 participants agreed to participate in the trial and completed the screening period. Among them, 102 participants in the Safety analysis group received at least one dose of the investigational drug. Six participants in the Safety group did not meet the criteria specified in the trial protocol, resulting in a final count of 96 participants (PP set). The overall dropout rate of the clinical trial was 7.69%. There were no statistically significant differences observed among the participating hospitals in terms of the number of recruited participants, age, height, weight, past medical history, current medical history, or concomitant medication use. However, there was a statistically significant difference in terms of prior medication use. Additional analysis using prior medication use as a covariate did not reveal any statistically significant differences in efficacy evaluation variables between the two groups. The primary efficacy evaluation was based on the improvement in the Kupperman index. The change in the Kupperman index score from baseline to the final evaluation at 12 days after drug administration was analyzed. In the PP set, the mean Kupperman index change from baseline to day 12 showed statistically significant improvements. The lower limit of the one-sided 97.5% confidence interval for the difference in mean Kupperman index change between the two groups confirmed non-inferiority of the test group when compared to the control group. Similar results were also observed in the ITT analysis. Secondary efficacy endpoints included changes in E2 and FSH levels, frequency, and score of daytime and nighttime hot flashes. There were no statistically significant differences observed between the test and control groups in terms of E2 change or FSH change. However, both groups showed statistically significant improvements in the frequency of daytime hot flashes, frequency of nighttime hot flashes, total score of daytime hot flashes, and score of nighttime hot flashes. These results were consistent with the PP analysis and the stratified analysis by institution. No statistically significant differences were observed in the demographic baseline characteristics that showed statistical significance, including prior medication use, test group status, and trial institution, when analyzed using covariance analysis. From these results, it is evident that Melsmon is significantly effective in improving the symptoms of menopausal disorders. Furthermore, it leads to an overall improvement.Menopausal disorders mainly occur due to abnormal secretion and dysfunction of the autonomic nervous system caused by a decline in ovarian function. Additionally, there are reports indicating that ovarian deficiency resulting from surgical castration shows differences in secretion status and biological response to external hormones. However, both cases exhibit similar symptoms and are therefore treated using the same methods. Placental extract developed by W.P. Filatov, the founder of corneal transplantation, has been treating menopausal disorders as an aging phenomenon through the activation of cellular respiration, reticulum endothelium system activation, and wound healing, based on “organizational therapy”. This approach differs from traditional medicine, which treats menopausal disorders by activating a wide range of biological processes. The endocrine function of the placenta is widely known. Trophoblast cells synthesize several hormones, such as estradiol, progesterone, and chorionic gonadotropin, which regulate fetal growth and development and maternal physiological changes during pregnancy [Views on the mechanism of action of placental preparations have been evolving [Placental extracts have been primarily used in the treatment of various pathological conditions, most commonly in surgery, neurology, gynecology, and dermatology. Pronounced positive effects have been observed in the treatment of wounds, non-healing ulcers, and burns [The use of the Kupperman index to assess menopausal symptoms was proposed by Kupperman in a study of American women [There are several limitations in the current study. First, our study did not include other races. The evaluation of possible variation according to the race could be helpful. The second limitation of this study is a relatively short duration of the study. Further study with a longer duration and diverse race is warranted to confirm the efficacy of placental extract. Last, the third limitation is the need for frequent repetitive drug administration. The development of more concentrated and long-lasting medication could increase medication compliance and promote widespread use.