Effect of an herbal medicine on the level of gonadotropins and estrogen metabolites in patients with benign breast diseases concurrent with mastalgia

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.

mastalgia, benign breast disease, phytotherapy, estrogen metabolites