The effect of the indolcarbinol on cyclic mastalgia in benign mammary dysplasia in routine clinical practice ("APHRODITE" study)
Ashrafyan L.A., Rozhkova N.I., Prokopenko S.P., Meskikh E.V., Artymuk N.V., Belotserkovtseva L.D., Dolgushina V.F., Korotkikh N.V., Kuznetsova L.V., Kukarskaya I.I., Kononenko T.S., Marochko T.Yu., Sokolov K.A., Verbitskaya Yu.S.
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.
Authors’ contributions: Ashrafyan L.A., Rozhkova N.I., Prokopenko S.P., Meskikh E.V., Artymuk N.V., Belotserkovtseva L.D., Dolgushina V.F., Korotkikh N.V., Kuznetsova L.V., Kukarskaya I.I., Kononenko T.S., Marochko T.Yu., Sokolov K.A., Verbitskaya Yu.S. – developing the design of the study, obtaining data for the analysis, review of publications on the issue of the study, statistical analysis of the obtained data, writing the text of the article.
Conflicts of interest: Authors declare lack of the possible conflicts of interest.
Funding: The study was sponsored by Alcea LLC.
Ethical Approval: The study was approved by the Independent Ethics Committee in Clinical Trials and registered in the Federal State Autonomous Scientific Institution “Center for Information Technologies and Systems of Executive Authorities” of Federal Service for Supervision of Education and Science of the Russian Federation, in accordance with the Order of the Government of the Russian Federation dated March 31, 2009 No. 279.
Patient Consent for Publication: The patients provided an informed consent for the publication of their data.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Ashrafyan L.A., Rozhkova N.I., Prokopenko S.P., Meskikh E.V., Artymuk N.V., Belotserkovtseva L.D., Dolgushina V.F., Korotkikh N.V., Kuznetsova L.V., Kukarskaya I.I., Kononenko T.S., Marochko T.Yu., Sokolov K.A., Verbitskaya Yu.S. The effect of the indolcarbinol on cyclic mastalgia in benign mammary dysplasia in routine clinical practice (“APHRODITE” study).
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2024; (2): 134-142 (in Russian)
https://dx.doi.org/10.18565/aig.2024.35
Keywords
benign breast diseases
fibrocystic fibrosis
mastodynia
mastalgia
indolcarbinol
Indinol Forto
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Received 14.02.2024
Accepted 19.02.2024
About the Authors
Lev A. Ashrafyan, Academician of the Russian Academy of Sciences, Professor, Dr. Med. Sci., Head of the Institute of Oncogynecology and Mammology, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4, +7(495)531-44-44, levaa2004@yahoo.comNadezhda I. Rozhkova, Honored Scientist of the Russian Federation, Professor, Dr. Med. Sci., Head of the National Center for Oncology of the Reproductive Organs,
P. Hertsen Moscow Oncology Research Institute - branch of the National Medical Research Center of Radiology, Ministry of Health of Russia; Professor of the Department of Clinical Mammology, Radiation Diagnostics and Radiation Therapy of the FNMO MI, P. Lumumba Peoples’ Frienhip University of Russia, 117198, Russia, Moscow,
Miklukho-Maklaya str., 6, nrozhkova2013@yandex.ru, SPIN 8478-1840, https://orcid.org/0000-0003-0920-1549
Sergey P. Prokopenko, MD, PhD, Associate Professor, Head of the Department of Complex Diagnostics and Interventional Radiology in Mammology, National Center for Oncology of Reproductive Organs, P. Herzen Moscow Oncology Research Institute - branch of National Medical Research Center of Radiology, Ministry of Health of Russia; Head of the Department of Clinical Mammology, Radiation Diagnostics and Radiation Therapy of the FNMO MI, P. Lumumba Peoples’ Frienhip University of Russia,
117198, Russia, Moscow, Miklukho-Maklaya str., 6, prokopenkosp@gmail.com, SPIN 6987-9294, Scopus author ID 7004120546, https://orcid.org/0000-0002-0369-5755
Elena V. Meskikh, Dr. Med. Sci., Professor of the Department of X-ray Radiology, Pirogov Russian National Research Medical University, Ministry of Health of Russia; doctor of the highest category, Chief Researcher at X-ray Radiological Laboratory, Russian Scientific Center of Roentgenoradiology, Ministry of Health of Russia,
117997, Russia, Moscow, Profsoyuznaya str., 86, meskihelena@rambler.ru
Natalia V. Artymuk, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology named after Professor G.A. Ushakova, Kemerovo State Medical University, Ministry of Health of Russia, 650060, Russia, Kemerovo, Voroshilova str., 22a, artymuk@gmail.com
Larisa D. Belotserkovtseva, Dr. Med. Sci., Professor, Honored Doctor of the Russian Federation, President of the Surgut District Clinical Center for Maternal and Child Health; Head of Department of Obstetrics and Gynecology, Medical institute, Surgut State University, 628403, Russia, Khanty-Mansiysk Autonomous Okrug – Ugra, Surgut,
Lenin Ave., 1, Lbelotserkovtseva@gmail.com
Valentina F. Dolgushina, Professor, Dr. Med. Sci., Head of the Department of Obstetrics and Gynecology, South Ural State Medical University, Ministry of Health of Russia, 454092, Russia, Chelyabinsk, Vorovskogo str., 64, dolgushinavf@yandex.ru
Natalia V. Korotkikh, MD, PhD, Associate Professor of Oncology Department, N.N. Burdenko Voronezh State Medical University, Ministry of Health of Russia, 394036, Russia, Voronezh, Studencheskaya str., 10; Head of the Department, Voronezh Regional Clinical Oncology Dispensary, 394036, Russia, Voronezh, Vaitsekhovskogo str., 4, kornat78@mail.ru
Lyubov V. Kuznetsova, MD, PhD, Associate Professor of the Department of Obstetrics and Gynecology with the clinic of the institute of medical education, Head of the Research laboratory of Reproduction and Women’s Health, Almazov National Medical Research Center, Ministry of Health of Russia,
197341, Russia, St. Petersburg, Akkuratova str., 2, Krivo73@mail.ru
Irina I. Kukarskaya, Dr. Med. Sci., Professor of the Department of Obstetrics, Gynecology and Reanimatology with a Course of Clinical Laboratory Diagnostics, Tyumen State Medical University, 625023, Russia, Tyumen, Odesskaya str., 54; Chief Physician, Tyumen Regional Perinatal Center; Chief specialist in obstetrics and gynecology, Department of Health of the Tyumen Region, Honored doctor of the Russian Federation, Honorary healthcare worker of the Tyumen region, kukarskaya@mail.ru
Tatyana S. Kononenko, MD, PhD, Assistant of the Department of Obstetrics, Gynecology and Perinatology, Faculty of Education and Training, Kuban State Medical University, Ministry of Health of Russia, 350063, Russia, Krasnodar, Mitrofan Sedin str., 4 (Central microdistrict), kononenkotc@yandex.ru
Tatiana Yu. Marochko, MD, PhD, Associate Professor of the Department of Obstetrics and Gynecology named after Professor G.A. Ushakova, Kemerovo State Medical University, Ministry of Health of Russia, 650060, Russia, Kemerovo, Voroshilova str., 22a, marochko.2006.68@mail.ru
Kirill A. Sokolov, MD, obstetrician-gynecologist, Medical Director, Alcea LLC, 129110, Russia, Moscow, Olimpiysky Ave., 16, bld. 5, kirill.sokolov@alceapharma.ru,
https://orcid.org/0000-0002-8358-3963
Yulia S. Verbitskaya, MD, PhD, Medical Advisor, Alcea LLC, 129110, Russia, Moscow, Olimpiysky Ave., 16, bld. 5, Yulia.verbitskaya@alceapharma.ru,
https://orcid.org/0000-0002-8358-3963
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