TREATMENT FOR MASTALGIA IN THE PRESENCE OF DIFFUSE MASTOPATHY IN FEMALE PATIENTS DURING THE MENOPAUSAL TRANSITION PERIOD


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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 60patients (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.

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About the authors

Natalia V. Kulagina

Email: dr.kulagina@mail.ru
MD, professor of obstetrics and gynecology, I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia. 191015, Russia, St. Petersburg, Kirochnaya str. 41

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