Clinical and pharmacological analysis of most commonly used drugs for the pharmacotherapy of fibrocystic breast disease

Shikh E.V., Makhova A.A., Smetnik A.A.

1 I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia, Moscow, Russia; 2 Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, Moscow
Relative and absolute hyperestrogenism and a change in the estradiol/progesterone (E2/P) ratio are of great importance in the pathogenesis of fibrocystic breast disease, which justifies the choice of progesterones for pathogenetic therapy. Transdermal progesterone gel is recommended in accordance with the instruction for medical use as monotherapy for this disease. Clinical findings show that the transdermal administration of progesterone is effective in reducing not only mastalgia, but also the number of cysts. A survey of physicians has demonstrated that unregistered drugs for this indication are used to treat fibrocystic breast disease. If there are indications, pharmacotherapy should be performed strictly in accordance with the instruction for medical use, which always contains information regarding what specific benign breast disease is treated with this drug, whether it is used as alone or as part of standard combination therapy, and which specific symptom should be eliminated if the drug is used symptomatically.

Keywords

progesterone
gel
fibrocystic breast disease

References

1. Zendehdel M., Niakan B., Keshtkar A., Rafiei E., Salamat F. Subtypes of benign breast disease as a risk factor for breast cancer: a systematic review and meta-analysis protocol. Iran. J. Med. Sci. 2018; 43(1): 1-8.

2. Usman K., Ullah E., Hussain S., Shafiq S. Benign breast diseases – an experience at Victoria Hospital Bahawalpur. Pak. J. Med. Health Sci. 2012; 6(4): 877-9.

3. Dyrstad S.W., Yan Y., Fowler A.M., Colditz G.A. Breast cancer risk associated with benign breast disease: systematic review and meta-analysis. Breast Cancer Res. Treat. 2015; 149(3): 569-75.

4. Zhou W.B., Xue D.Q., Liu X.A., Ding Q., Wang S. The influence of family history and histological stratification on breast cancer risk in women with benign breast disease: a meta-analysis. J. Cancer Res. Clin. Oncol. 2011;137(7): 1053-60.

5. Андреева Е.Н., Рожкова Н.И. Эффективность трансдермального геля, содержащего микронизированный прогестерон, в лечении фиброзно-кистозной мастопатии. Результаты российского исследования. Акушерство и гинекология. 2016; 12: 131-6. [Andreeva E.N., Rozhkova N.I. Efficacy of micronized progesterone-containing transdermal gel in the treatment of fibrocystic mastopathy: Results of a Russian study. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2016; (12): 131-6. (in Russian)] http://dx.doi.org/10.18565/aig.2016.12.131-6

6. Сметник В.П., Тумилович Л.Г. Неоперативная гинекология. Руководство для врачей. 3-е изд. М.: МИА; 2005: 294-316. [Smetnik V.P., Tumilovich L.G. Non-operative gynecology. A guide for doctors. 3rd ed. Moscow: MIA; 2005: 294-316. (in Russian)]

7. Brkic M., Vujovic S., Ivanisevic M.F., Ivovic M., Gajic M.T., Marina L. et al. The influence of progesterone gel therapy in the treatment of fibrocystic breast disease. Open J. Obstet. Gynecol. 2016; 6(5): 334-41.

8. Khalid R.M. A review of mastalgia in patients with fibrocystic breast changes and the non-surgical treatment options. J. Taibah Univ. Med. Sci. 2011;6(1): 1-18.

9. Pasqualini J.R. Breast cancer and steroid metabolizing enzymes: the role of progestogens. Maturitas. 2009; 65(Suppl. 1): S17-21.

10. Chang K.J., Lee T.T., Linares-Cruz G., Fournier S., de Ligniéres B. Influences of percutaneous administration of estradiol and progesterone on human breast epithelial cell cycle in vivo. Fertil. Steril. 1995; 63(4): 785-91.

11. Каприн А.Д., Рожкова Н.И., ред. Маммология. Национальное руководство. М.: ГЭОТАР-Медиа; 2016. [Kaprin A.D., Rozhkova N.I., ed. Mammology: National Guide. Moscow: GEOTAR-Media, 2016. (in Russian)]

12. Zava D.T., Groves M.N., Stanczyk F.Z. Percutaneous absorption of progesterone. Maturitas. 2014; 77(2): 91-2.

13. Du J.Y., Sanchez P., Kim L., Azen C.G., Zava D.T., Stanczyk F.Z. Percutaneous progesterone delivery via cream or gel application in postmenopausal women: a randomized cross-over study of progesterone levels in serum, whole blood, saliva, and capillary blood. Menopause. 2013; 20(11): 1169-75.

14. Беспалов В.Г., Негусторов Ю.Ф. Маммографическая плотность как критерий эффективности лечения мастопатии и снижения риска рака молочной железы. Опухоли женской репродуктивной системы. 2017; 13(2): 33-41. [Bespalov V.G., Negustorov Yu.F. Mammographic density as a criterion for the effectiveness of treatment of mastopathy and reducing the risk of breast cancer. Opukholi zhenskoy reproduktivnoy sistemy. 2017; 13(2): 33-41. (in Russian)]

15. Коган И.Ю., Мусина Е.В. Местное применение микронизированного прогестерона у больных репродуктивного возраста с мастопатией. Акушерство и гинекология. 2012; 2: 102-6. [Kogan I.Yu., Musina E.V. Topical use of micronized progesterone in reproductive-age patients with mastopathy. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2012; 2: 102-6. (in Russian)]

16. Katz V.L., Dotters D. Breast diseases: diagnosis and treatment of benign and malignant disease. In: Lentz G.M., Lobo R.A., Gershenson D.M., Katz V.L., eds. Comprehensive gynecology. 6th ed. Philadelphia: Elsevier Mosby; 2012.

17. Булаев В.М., Ших Е.В., Сычев Д.А. Современная фитотерапия. М.: Медпресс-информ; 2011. [Bulaev V.M., Shikh E.V., Sychev D.A. Modern phytotherapy. Мoscow: Medpress-inform; 2011. (in Russian)]

18. Киселев В.И., Сметник В.П., Сутурина Л.В., Селиванов С.П., Рудакова Е.Б., Рахматуллина И.Р., Андреева Е.Н., Фадеева Н.И., Хасанов Р.Ш., Кулагина Н.В., Рожкова Н.И., Артымук Н.В., Гависова А.А., Муйжнек Е.Л., Кузнецов И.Н., Друх В.М. Индолкарбинол (Индинол Форто) – метод мультитаргетной терапии при циклической мастодинии. Акушерство и гинекология. 2013; 7: 56-62. [Kiselev V.I., Smetnik V.P., Suturina L.V., Selivanov S.P., Rudakova E.B., Rakhmatullina I.R., Andreyeva E.N., Fadeyeva N.I., Khasanov R.Sh., Kulagina N.V., Rozhkova N.I., Artymuk N.V., Gavisova A.A., Muizhnek E.L., Kuznetsov I.N., Drukh V.M. Indole carbinol (Indinol Forto) is a multitargeted therapy option for cyclic mastodynia. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2013; 7: 56-62. (in Russian)]

19. Сметник А.А., Сметник В.П., Киселев В.И. Отечественный и международный опыт применения индол-3-карбинола в лечении заболеваний молочной железы и профилактике рака молочной железы. Акушерство и гинекология. 2017; 2: 106-12. [Smetnik A.A., Smetnik V.P., Kiselev V.I. Experience with indole-3-carbinol used to treat diseases of the breast and to prevent breast cancer. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2017; (2): 106-12. (in Russian)] http://dx.doi.org/10.18565/aig.2017.2.106-12

20. Thomas E.R., Abdissa N., Chlebowski R.T., Lasser N.L., McTiernan A., Schenken R.S. et al. Estrogen plus progestin and risk of benign proliferative breast disease. Cancer Epidemiol. Biomarkers Prev. 2008; 17(9): 2337-43.

21. Carbonaro A., Ciotta L., Stracquadanio M., Formuso C., Giunta M.R., Agati A.D. Oral contraception and benign breast diseases. Am. J. Nurs. Sci. 2012; 1(1): 1-4.

22. Ших Е.В., Махова А.А. Витамины в клинической практике. Кукес В.Г., ред. М.: Практическая медицина; 2014. 368с. [Shikh E.V., Mahova A.A. Vitamins in clinical practice. Kukes V.G., ed. Мoscow: Practical medicine; 2014. 368p. (in Russian)]

23. Ших Е., Махова А. Каротиноиды и заболевания молочной железы с позиций доказательной медицины. Врач. 2015; 12: 2-6. [Shikh E., Makhova A. Carotenoids and diseases of the breast from the standpoint of evidence-based medicine. Vrach. 2015; 12: 2-6. (in Russian)]

24. Махова А.А., Шумянцева В.В., Ших Е.В., Булко Т.В., Супрун Е.В., Кузиков А.В., Кукес В.Г., Арчаков А.И. Регуляция активности ферментов метаболизма лекарственных препаратов — цитохромов Р450 3А4 и 2С9 — биологически активными соединениями. Молекулярная медицина. 2013; 5: 49-53. [Makhova A.A., Shumyantseva V.V., Shikh E.V., Bulko T.V., Suprun E.V., Kuzikov A.V., Kukes V.G., Archakov A.I. Regulation of activity of enzymes of metabolism of drugs - cytochromes P450 3A4 and 2C9 - biologically active compounds. Molekulyarnaya meditsina. 2013; 5: 49-53. (in Russian)]

Received 08.06.2018

Accepted 22.06.2018

About the Authors

Shikh, Evgenia V., MD, professor, head of the Department of Clinical Pharmacology and Propaedeutics of Internal Diseases, I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia. 119991, Russia, Moscow, Bolshaya Pirogovskaya str. 2, bld. 4. E-mail: chih@mail.ru
Makhova, Anna A., Ph.D., Associate Professor of the Department of Clinical Pharmacology and Propaedeutics of Internal Diseases, I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia. 119991, Russia, Moscow, Bolshaya Pirogovskaya str. 2, bld. 4. E-mail: annabramova@gmail.com
Smetnik, Antonina A., PhD, Senior Researcher, Department of Gynecological Endocrinology, National Medical Research Center of Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of Russia. 117997, Russia, Moscow, Ac. Oparina str. 4. Tel.: +74955314444, ext. 1543. E-mail: a_smetnik@oparina4.ru

For citations: Shikh E.V., Makhova A.A., Smetnik A.A. Clinical and pharmacological analysis of most commonly used drugs for the pharmacotherapy of fibrocystic breast disease. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2018; (9): 158-64. (in Russian)
https://dx.doi.org/10.18565/aig.2018.9.158-164

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