Treatment for mastalgia in the presence of diffuse mastopathy in female patients during the menopausal transition period
Keywords:hyperprolactinemia, cyclical mastalgia, premenstrual syndrome, mastopathy, menopausal transition, clinical trial, Mastodynon
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
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.
- Bespalov, V.G., Travina, M.L. “Fibrocystic disease and breast cancer risk (literature review).” Reproductive system tumors 11.4 (2015): 58–70.
- Onstad, M., Stuckey, A. “Benign breast disorders.” Obstet Gynecol Clin North Am 40.3 (2013): 459–73.
- 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.
- 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.
- 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.
- 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.
- Lychkova, A.E., Puzikov, A.M. Prolactin and serotonin. Herald of RAMS 1–2 (2014): 38–45.
- Wuttke, W., Seidlova-Wuttke, D., Yarri, G., Artymuk N. “Role of Vitex agnus castus in gynecological endocrinology.” Gynekology 14.1 (2011): 4–7.
- 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.
- 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.
- 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.
- 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.
- Wuttke, W., Jarry, H., Christoffel, V., et al. “Chaste tree (Vitex agnus castus) – pharmacology and clinical indications.” Phytomedicine 10.4 (2003): 348–57.
- 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.
- Jarry, H., Leonhardt, S., Wuttke, W., et al. “Agnus castus als dopaminerges Wirkprinzip in Mastodynon®.” Z Phytother 12 (1991): 77–82.
- 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.
- 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.
- Hoberg, E., Sticher, O., Orjala, J.E., Meier, B. “Diterpene aus Agni-casti fructus und ihre Analytik.” Z Phytother 20 (1999): 140–58.
- Ledina, A.V., Prilepskaya, V.N. “Premenstrual syndrome: possibilities of non-hormonal treatment.” Obstetrics and Gynecology 1 (2012): 75–9.
- 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.
- Sotnikova, L.S., et al. “Status of hormonal regulation with fibrocystic breast.” Mother and childe 1 (2011): 342–6.
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