Effect of an herbal medicine on the level of gonadotropins and estrogen metabolites in patients with benign breast diseases concurrent with mastalgia
Objective. To determine the effectiveness of the homeopathic herbal preparation Mastodynon (Bionorica SE, Germany) in treatment of benign breast diseases concurrent with mastalgia in reproductive-aged patients and its effect on the level of gonadotropins and estrogen metabolites.Yavorskaya S.D., Sycheva M.S., Korenovsky Yu.V.
Subjects and methods. A prospective, open-label, monocenter study was conducted in a small group (n = 20) to assess results before and after a course of therapy. The patients mean age was 32.8 ± 3.1 years. The assessment points were a pain level on a visual analogue scale (VAS); breast tissue density determined by ultrasound; the blood levels of follicle-stimulating hormone, prolactin, and estradiol and the urinary levels of 6 estrogen metabolites (4-OHE1, 2-OHE1, 2-OHE2, 16α-OHE1, 2-OMeE1, and 4-OMeE1), as well as 2-OHE1+2-OHE2/16α-OHE1 and 2-OHE1/2-OMeE1 ratios.
Results. The breast pain intensity according to VAS ranged from 40 to 95 mm (52.76 ± 15.38 mm) at baseline; 27.42 ± 11.78 mm at a month after therapy initiation (p = 0.0001) and 7.4 ± 8.5 mm after 90 days of therapy (p < 0.0001); mastalgia completely disappeared in 40% of cases. After the course of therapy, an improvement in the breast structure was noted in 80.0%, significantly more often in mastopathy with a predominance of the glandular component (80% and 30%; p = 0.004). All the patients had normal baseline blood estrogen concentrations
however in 60% of cases it was showed a higher urinary levels of a number of estrogen metabolites; after the course of therapy, the profile of estrogen metabolites in all the patients returned to normal; the 2-OHE1+2-OHE2/16α-OHE1 ratio increased 2.4-fold (2.4 ± 1.03 and 5.76±6.9; p = 0.02).
Conclusion. The 90-day use of Mastodynon in patients with benign breast diseases concurrent with mastalgia leads to a 7.1-fold decrease in its severity, to an improvement in the breast structure diagnosed by ultrasound in 80.0% of cases, and to a 2.4-fold increase in the 2-OHE1+2-OHE2/16α-OHE1 ratio.
Keywords
mastalgia
benign breast disease
phytotherapy
estrogen metabolites
References
- Приказ Министерства здравоохранения РФ от 1 ноября 2012 г. N 572н «Об утверждении Порядка оказания медицинской помощи по профилю “акушерство и гинекология (за исключением использования вспомогательных репродуктивных технологий)”. [Order of the Ministry of Health of the Russian Federation of November 1, 2012 N 572n “On approval of the Procedure for rendering medical care in the profile” obstetrics and gynecology (except for the use of assisted reproductive technologies). (in Russian)]
- Беспалов В.Г., Травина М.Л. Фиброзно-кистозная болезнь и риск рака молочной железы (обзор литературы). Опухоли женской репродуктивной системы. 2015;11(4): 58-70. [Bespalov V.G., Travin M.L. Fibrocystic disease and risk of breast cancer (literature review). Tumors of the female reproductive system. 2015; 11 (4): 58-70. (in Russian)]
- Рожкова Н.И., Каприн А.Д., ред. Профилактика – приоритет клинической маммологии. М.: СИМК; 2016.188с. [N.I. Rozhkova, A. Kaprin, ed. Prevention is the priority of clinical mammology. M .: SIMK; 2016.188p. (in Russian)]
- Хасанов А.А. Современные принципы лечения заболеваний молочных желез у гинекологических больных. Практическая медицина. 2013; 7: 231-4. [Khasanov A.A. Modern principles of treatment of diseases of the mammary glands in gynecological patients. Practical medicine. 2013; (7): 231-4. (in Russian)]
- Евсеева Е.В. Оптимизация системы комплексного клинико-радиологического скрининга заболеваний молочной железы. М.; 2015. 16с. [Evseeva E.V. Optimization of the system of complex clinical and radiological screening of breast diseases. M.; 2015. 16p. (in Russian)]
- Чечулина О.В. Заболевания молочных желез, как фактор нарушения репродуктивной функции женщин. Практическая медицина. 2012; 9: 223-6. [Chechulina O.V. Diseases of the mammary glands, as a factor in violation of the reproductive function of women. Practical medicine. 2012; (9): 223-6. (in Russian)]
- Доброкачественные дисплазии молочных желез. Клинические рекомендации (протокол лечения). М.; 2018. 50с. [Benign breast dysplasia. Clinical recommendations (treatment protocol). M.; 2018. 50p. (in Russian)]
- Радзинский В.Е., ред. Медицина молочной железы и гинекологические болезни. 2-е изд. М.: Редакция журнала StatusPraesens; 2017. 352с. [Radzinsky V.E., ed. Breast medicine and gynecological diseases. 2nd ed. M.: Editorial Board of StatusPraesens; 2017. 352p. (in Russian)]
- Инструкция по медицинскому применению препарата Мастодинон таблетки от 15.10.2015; капли для приема внутрь от 08.04.2013. [Instructions for medical use of the drug Mastodinon pills from 10/15/2015; drops for oral administration from 04/08/2013. (in Russian)]
- Ледина А.В., Прилепская В.Н. Мастодинон в лечении масталгии, возникшей при приеме комбинированных пероральных контрацептивов. Акушерство и гинекология. 2011; 7-1: 63-8. [Ledina A.V., Prilepskaya V.N.Mastodinone in the treatment of matsalgia, which arose when taking combined oral contraceptives. Obstetrics and gynecology. 2011; (7-1): 63-8.(in Russian)]
- Кулагина Н.В. Лечение диффузной дисгормональной дисплазии молочных желез у пациенток в периоде менопаузального перехода. Акушерство и гинекология. 2016; 11: 136-42. [Kulagina N.V. Treatment of diffuse dyshormonal dysplasia of the mammary glands in patients during the menopausal transition. Obstetrics and gynecology. 2016; (11): 136-42.(in Russian)]
- Солодкой В.А., Рожкова Н.И., ред. Диффузные доброкачественные заболевания молочных желез. Диагностика и лечение. Руководство для врачей. М.: СИМК; 2012. 124с. [Solodka V.A., Rozhkova N.I., ed. Diffuse benign breast disease. Diagnosis and treatment. A guide for doctors. M .: SIMK; 2012. 124p. (in Russian)]
- Сутурина Л.В., Попова Л.Н. Динамика клинических симптомов и коррекция антиоксидантной недостаточности у женщин с диффузной мастопатией при использовании препарата Мастодинон. Акушерство и гинекология. 2012; 8-1: 56-9. [Suturina L.V., Popova L.N. Dynamics of clinical symptoms and correction of antioxidant deficiency in women with diffuse mastopathy when using the drug Mastodinon. Obstetrics and gynecology. 2012; (8-1): 56-9. (in Russian)]
- Webster D.E., He Y., Chen S.N., Pauli G.F., Farnsworth N.R., Wang Z.J. Opioidergic mechanisms underlying the actions of Vitex agnus-castus L. Biochem. Pharmacol. 2011; 81(1): 170-7.
- Barba M., Yang L., Schünemann H.J., Sperati F., Grioni S., Stranges S. et al. Urinary estrogen metabolites and prostate cancer: a case-control study and meta-analysis. J. Exp. Clin. Cancer Res. 2009; 28: 135.
- Ghisari M., Long M., Røge D.M., Olsen J., Bonefeld-Jørgensen E.C. Polimorphism in xenobiotic and estrogen metabolizing genes, exposure to perfluorinated compounds and subsrguent bresast cancer risk: A nested case-control study in the Danish National Birth Cohort. Environ Res. 2017; 154: 325-33.
- Mackey R.H., Fanelli T.J., Modugno F., Cauley J.A., McTigue K.M., Brooks M.M. et al. Hormone therapy, estrogen metabolism, and risk of breast cancer in the Women’s Health Initiative Hormone Therapy Trial. Cancer Epidemiol. Biomarkers Prev. 2012; 21(11): 2022-32.
- Элькад Е.В., Сотникова Л.С., Тонких О.С., Оккель Ю.В., Федосова Л.Н., Степанов И.А., Удут Е.В., Насырова Р.Ф., Драничникова О.С. Состояние гормональной регуляции при фибрознокистозной мастопатии. Мать и дитя в Кузбассе. 2011; Спецвыпуск 1: 342-6. [Elkad E.V., Sotnikova L.S., Tonkikh O.S., Okkel Yu.V., Fedosova L.N., Stepanov I.A., Udut E.V., Nasyrova R.F., Dranichnikova O.S. State of hormonal regulation in fibrocystic mastopathy. Mother and child in Kuzbass. 2011; Special issue 1: 342-6. (in Russian)]
Received 29.11.2018
Accepted 07.12.2018
About the Authors
Yavorskaya, Svetlana D., MD, professor of the department of obstetrics and gynecology with the course of DPO FSBEI of HE Altai state medical University of Ministryof health, Russia.
656038, Russia, Altai Krai, Barnaul, Lenin ave. 40. Tel.: +73852368587. E-mail: L2001@bk.ru
Sycheva, Maria S., student of the medical faculty of the Altai state medical University of the Ministry of health, Russia.
656038, Russia, Altai Krai, Barnaul, Lenin ave. 40. Tel.: +79069449320. E-mail: sy4eva.mariya@yandex.ru
Korenovsky, Yuri V., PhD, head of the department of general and biological chemistry, clinical laboratory diagnostics of DPO FSBEI of HE Altai state medical University
of Ministry of health, Russia. 656038, Russia, Altai Krai, Barnaul, Lenin ave. 40. Tel.: +73852241392. E-mail: timidin@gmail.com
For citations: Yavorskaya S.D., Sycheva M.S., Korenovsky Yu.V. Effect of an herbal medicine on the level of gonadotropins and estrogen metabolites in patients with benign breast diseases concurrent with mastalgia. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2019; (1): 126-32. (in Russian)
http://dx.doi.org/10.18565/aig.2019.1.126-132