Dynamics of clinical symptoms of fibrocystic breast disease in the course of the transdermal gel of micronized progesterone monotherapy: results of the Russian multicenter observational study BREAST

Objective. To assess the dynamics offibrocystic mastopathy symptoms regression when applying monotherapy with transdermal gel of micronized progesterone continuously for 3 and 6 months under conditions of routine clinical practice. Materials and methods. The study included 1044female patients of 34.8 ± 0.2 years of age diagnosed with diffuse mastopathy with predominant glandular component and diffuse fibrocystic mastopathy with predominant cystic component. All the patients received therapy with transdermal gel of micronized progesterone (Progestogel product) for 3and 6 months. The data related to dynamics of the disease symptoms were evaluated: clinical examination of the lacteal gland was performed, ultrasound and mammography examinations were performed, with assessment according to Bi-RADS categories. Intensity of the pain sense modality was evaluated in dynamics using visual analog scale (VAS) of pain. Statistical analysis of the collected data was carried out using IBM SPSS 23 software. Results. In 3-6 months of the continuous use of Progestogel product, a significant reduction in the amount of the earlier revealed thickened tissue areas was observed during ultrasound examination, including the areas of 1-2 cm and those exceeding 2 cm (hyperplastic lobules, cysts). According to the analysis of the mammographic conclusions, in the course of the therapy the signs of the fat involution build-up were observed as reducing from 9.1% to 1.3%, the signs of focal fibrosis reduced from 12.9% to 5.3%; the proportion of the patients with diffuse fibrocystic mastopathy with predominant cystic component reduced by 22.4% (from 56.6% to 34.2%). Significant improvement of the disease course is as well demonstrated by the dynamics of the changes as per the assessment according to Bi-RADS categories (p < 0.05). The intensity of the pain in the mammary glands significantly reduced in the therapy dynamics; before treatment it was 62.22 ± 0.84 scores, in 3 months 27.33 ± 0.70 scores (p < 0.001), in 6 months 9.33 ± 0.46scores (p < 0.001). Conclusion. The data obtained show the improvement of the life quality and reduction in the pain syndrome intensity in patients with mastalgia/mastodynia.

benign mammary gland dysplasia, f ibrocystic mastopathy, micronized progesterone