Treatment for mastalgia in the presence of diffuse mastopathy in female patients during the menopausal transition period

Authors

  • Н. В. Кулагина I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia, St. Petersburg, Russian Federation

Keywords:

hyperprolactinemia, cyclical mastalgia, premenstrual syndrome, mastopathy, menopausal transition, clinical trial, Mastodynon

Abstract

Objective. To evaluate the efficacy and tolerability of Mastodynon® in the treatment of diffuse mastopathy and symptoms of premenstrual syndrome (PMS) in women in the menopausal

transition period.

Subjects and methods. A clinical prospective, parallel-group, randomized, monocenter, open-label trial with active control was conducted. The trial included 60 patients (mean age, 49.0 ± 3.1 years) who used Mastodynon® or bromocriptine for 24 weeks.

Results. Hyperprolactinemia was detected in 63.3% of the women suffering from different forms of diffuse mastopathy in the menopausal transition period. There was a statistically significant decrease in prolactin levels at 24 weeks of treatment with Mastodynon® (Δ -244 ± 95.8 mU/ml) (p < 0.001) and bromocryptine (Δ -226.4 ± 101.5 mU/ml) (p < 0.001). The results of therapy with Mastodynon® were comparable to the efficiency of that with bromocryptine (p > 0.05). Ultrasound mammography revealed positive changes in the breast structure in 67% of the patients with different forms of diffuse mastopathy treated with Mastodynon® and in 43% of those treated with bromocriptine. There was a decrease in the incidence (92% vs 37%; p < 0.001) and severity of mastalgia at month 6 of Mastodynon® treatment, the results of therapy did not differ in the two groups (p > 0.05). Treatment with Mastodynon® in patients with different forms of mastopathy concurrent with the symptoms of PMS was more effective than that with bromocryptine in relieving autonomic disorders (p < 0.05). Adverse events (AEs) occurred more commonly in the patients receiving bromocriptine (60%); AEs were noted in 7% in the Mastodynon® group (p < 0.05).

Conclusion. Mastodynon® that contains Vitex agnus-castus extract is an effective agent with a high safety profile to treat mastalgia and symptoms of PMS in patients with different forms of diffuse mastopathy during the menopausal transition period.

Author Biography

Н. В. Кулагина, I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia, St. Petersburg

MD, professor of Obstetrics and Gynecology Department

References

  1. Bespalov, V.G., Travina, M.L. “Fibrocystic disease and breast cancer risk (literature review).” Reproductive system tumors 11.4 (2015): 58–70.
  2. Onstad, M., Stuckey, A. “Benign breast disorders.” Obstet Gynecol Clin North Am 40.3 (2013): 459–73.
  3. Scurr, J., Hedger, W., Morris, P., Brown, N. “The prevalence, severity and impact of breast pain in the general population.” Breast J 20.5 (2014): 508–13.
  4. Rozhkova, N.I., Burdina, I.I., Zakirova, S.B., et al. “Treatment of diffuse benign breast disease and mastodynia.” Questions of gynecology, obstetrics and perinatology 14.4 (2015): 64–8.
  5. Fox, E.M., Andrade, J., Shupnik, M.A. “Novel actions of estrogen to promote proliferation: integration of cytoplasmic and nuclear pathways.” Steroids 74.7 (2009): 622–7.
  6. Gonzalez, L., Zambrano, A., Lazaro-Trueba, I., et al. “Activation of the unliganded estrogen receptor by prolactin in breast cancer cells.” Oncogene 28.10 (2009): 1298–308.
  7. Lychkova, A.E., Puzikov, A.M. Prolactin and serotonin. Herald of RAMS 1–2 (2014): 38–45.
  8. Wuttke, W., Seidlova-Wuttke, D., Yarri, G., Artymuk N. “Role of Vitex agnus castus in gynecological endocrinology.” Gynekology 14.1 (2011): 4–7.
  9. Radzinsky, V.E., Ordiyants, I.M. Maslennikova, M.N., Pavlova, E.A. Breast cancer and gynecological diseases: pathogenetic commonality of views to practical solutions. Moscow. StatusPraesens Editorial Board (2012): 16 p.
  10. Suturina, L.V., Popova, L.N. “The time course of changes in the clinical symptoms of antioxidandt deficiency and its correction with the herbal agent Mastodynon® in women with diffuse mastopathy.” Obstetrics and Gynecology 8.1 (2012): 56–9.
  11. Kubista, E., Muller, G., Spona, J. “Treatment of mastopathies with cyclic mastodynia. Clinical results and hormonal profiles.” Rev Fr Gynecol Obstet 82 (1987): 221–7.
  12. Halaska, M., Raus, K., Bles, P., et al. “Treatment of cyclic mastodynia using an extract of Vitex agnuscastus: results of a double blind comparison with a placebo.” Ceska Gynecol 63.5 (1988): 388–92.
  13. Wuttke, W., Jarry, H., Christoffel, V., et al. “Chaste tree (Vitex agnus castus) – pharmacology and clinical indications.” Phytomedicine 10.4 (2003): 348–57.
  14. Jarry, H., Spengler, B., Wuttke, W., Christoffel, V. “In vitro assays for bioactivityguided isolation of endocrine active compounds in Vitex agnus-castus.” Maturitas 55 Suppl 1 (2006): S26–36.
  15. Jarry, H., Leonhardt, S., Wuttke, W., et al. “Agnus castus als dopaminerges Wirkprinzip in Mastodynon®.” Z Phytother 12 (1991): 77–82.
  16. Sliutz, G., Speiser, P., Schultz, A.M., et al. “Agnus castus extracts inhibit prolactin secretion of rat pituitary cells.” Horm Metab Res 25.5 (1993): 253–5.
  17. Wuttke, W., Gorcow, C., Jarry, H. Dopaminergie compounds in Vitex agnus castus. D. Loew, N. Rietbrock, Hrsg. Phytopharmaka in Forschung und klinischer Anwendung. Darmstadt. Steinkopf (1995): 81–91.
  18. Hoberg, E., Sticher, O., Orjala, J.E., Meier, B. “Diterpene aus Agni-casti fructus und ihre Analytik.” Z Phytother 20 (1999): 140–58.
  19. Ledina, A.V., Prilepskaya, V.N. “Premenstrual syndrome: possibilities of non-hormonal treatment.” Obstetrics and Gynecology 1 (2012): 75–9.
  20. Milewicz, A., Gejdel, E., Sworen, H., et al. “Author informationVitex agnus castus extract in the treatment of luteal phase defects due to latent hyperprolactinemia. Results of a randomized placebo-controlled double-blind study.” Arzneimittelforschung 43.7 (1993): 752–6.
  21. Sotnikova, L.S., et al. “Status of hormonal regulation with fibrocystic breast.” Mother and childe 1 (2011): 342–6.

Published

2017-12-28

How to Cite

Кулагина, Н. В. (2017). Treatment for mastalgia in the presence of diffuse mastopathy in female patients during the menopausal transition period. REPRODUCTIVE ENDOCRINOLOGY, (38), 81–85. Retrieved from https://reproduct-endo.com/article/view/119842

Issue

Section

Management of menopause