Study of the optimal regimen for the use of the dietary supplement “Imaston” in diffuse benign mammary dysplasia. Interim results of the clinical trial PRIMA-024

Background. A common manifestation of breast diseases is mastodynia. Quite a large number of drugs are used to correct these symptoms, but it is the use of indole-3-carbinol that is pathogenetically determined. Aim. To study the effect of the dietary supplement “Imaston” on the course of diffuse benign breast dysplasia accompanied by mastodynia. Materials and methods. 130 patients of reproductive age from 18 to 53 years old, with preserved menstrual function, were examined and treated. The patients were randomized in a 1:1 ratio with stratification by the presence of surgical interventions on the pelvic organs or breast. Results. Against the background of the ongoing therapy of the dietary supplement “Imaston”, a decrease in pain syndrome was noted. The criterion for the effectiveness of therapy was the reduction of pain syndrome by 2 points or more. According to this criterion, 100 % effectiveness of therapy was obtained in both groups. In therapy group 1, the dynamics of pain reduction was higher. At the time of control visit 3, 71.2 % of patients in therapy group 1 had pain syndrome of 2 points or less, while 66.1 % in the control group. Ultrasound evaluation showed a decrease in the total number and volume of cysts by 23.2 %. There was also a decrease in the thickness of the mammary parenchyma by 16.22 %, compared with the initial values. At the same time, the dynamics in therapy group 1 was more pronounced than in the control group: 16.2 % versus 15.8 %. There was a marked decrease in the diameter of the ducts by 61.2 % against the background of the use of dietary supplements “Imaston” 1 capsule 2 times a day. Conclusion. The study proved the effectiveness of the dietary supplement “Imaston” , containing 200 mg of indole-3-carbinol and 60 mg of trans-resveratrol in 1 capsule, in the treatment of diffuse breast dysplasia, in particular accompanied by pain syndrome.