THE EFFECT OF INDOLCARBINOL ON CYCLIC MASTALGIA IN BENIGN MAMMARY DYSPLASIA IN ROUTINE CLINICAL PRACTICE ("APHRODITE" STUDY)

Objective: The primary aim of the study was to evaluate the effect of Indinol Forto on pain syndrome in various benign breast diseases. The secondary aims included the assessment of the effect on the number and size of cysts in the mammary glands and evaluation of additional data on safety in routine clinical practice. Materials and methods: These are the results of a prospective observational study “APHRODITE” of the drug Indinol Forto (indolcarbinol) which was conducted in 9 research centers of the Russian Federation with the participation of 100 women over the age of 18. Results: Indolcarbinol therapy had a positive effect on reducing pain syndrome (mastodynia) after 3–6 months of treatment. The results of the ultrasound assessment and mammography showed a decrease in the total size of cysts, as well as a decrease in the proportion of women with dilated ducts of the mammary glands after 3 months of treatment. Longer use of indolcarbinol (6 months) was associated with a stronger effect. The patients tolerated indolcarbinol well and did not have undesirable or side effects. Conclusion: The results of the study showed that indolcarbinol (Indinol Forto) caused a decrease in pain syndrome in patients with mastodynia in benign mammary dysplasia after 3–6 months of treatment. Indolcarbinol also resulted in a decrease in the total size of cysts and decrease in dilated ducts of the mammary glands in some women after 3 months of treatment. Thus, indolcarbinol appeared to be the only non-hormonal drug at the moment with a proven effect on the structure of breast tissue according to the results of the BI-RADS assessment. © A group of authors, 2024.