Abstract
Objective. To determine the effectiveness of the homeopathic herbal preparation Mastodynon (Bionorica SE, Germany) in treatment of benign breast diseases concurrent with mastalgia in reproductive-aged patients and its effect on the level of gonadotropins and estrogen metabolites. Subjects and methods. A prospective, open-label, monocenter study was conducted in a small group (n = 20) to assess results before and after a course of therapy. The patients mean age was 32.8 ± 3.1 years. The assessment points were a pain level on a visual analogue scale (VAS); breast tissue density determined by ultrasound; the blood levels of follicle-stimulating hormone, prolactin, and estradiol and the urinary levels of 6 estrogen metabolites (4- OHE1, 2- OHE1, 2- OHE2, 16α- OHE1, 2- OMeE1, and 4- OMeE1), as well as 2- OHE1+2- OHE2/16α-OHE1 and 2- OHE1/2- OMeE1 ratios. Results. The breast pain intensity according to VAS ranged from 40 to 95 mm (52.76 ± 15.38 mm) at baseline; 27.42 ± 11.78 mm at a month after therapy initiation (p = 0.0001) and 7.4 ± 8.5 mm after 90 days of therapy (p < 0.0001); mastalgia completely disappeared in 40% of cases. After the course of therapy, an improvement in the breast structure was noted in 80.0%, signif icantly more often in mastopathy with a predominance of the glandular component (80% and 30%; p = 0.004). All the patients had normal baseline blood estrogen concentrations however in 60% of cases it was showed a higher urinary levels of a number of estrogen metabolites; after the course of therapy, the profile of estrogen metabolites in all the patients returned to normal; the 2-OHE1+2-OHE2/16α-OHE1 ratio increased 2.4-fold(2.4 ± 1.03 and 5.76±6.9;p = 0.02). Conclusion. The 90-day use of Mastodynon in patients with benign breast diseases concurrent with mastalgia leads to a 7.1-fold decrease in its severity, to an improvement in the breast structure diagnosed by ultrasound in 80.0% of cases, and to a 2.4-fold increase in the 2-OHE1+2-OHE2/16α-OHE1 ratio.