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Эффективность и безопасность негормональных средств коррекции вазомоторных симптомов менопаузы. Проспективное двойное слепое плацебо-контролируемое исследование
Эффективность и безопасность негормональных средств коррекции вазомоторных симптомов менопаузы. Проспективное двойное слепое плацебо-контролируемое исследование
Радзинский В.Е., Оразов М.Р., Хамошина М.Б., Орехов Р.Е., Журавлева И.С. Эффективность и безопасность негормональных средств коррекции вазомоторных симптомов менопаузы. Проспективное двойное слепое плацебо-контролируемое исследование. Гинекология. 2023;25(2):144–152.
DOI: 10.26442/20795696.2023.2.202215
© ООО «КОНСИЛИУМ МЕДИКУМ», 2023 г.
DOI: 10.26442/20795696.2023.2.202215
© ООО «КОНСИЛИУМ МЕДИКУМ», 2023 г.
________________________________________________
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Аннотация
Цель. Оценить безопасность и эффективность негормональных средств в коррекции вазомоторных симптомов менопаузы легкой степени.
Материалы и методы. В исследование включены 173 женщины в возрасте 48–55 лет с вазомоторными симптомами легкой степени в период ранней постменопаузы. Пациенток изучаемой когорты двойным слепым методом стратифицировали на две группы. В 1-й группе (исследуемая) участницы принимали гомеопатический препарат Неоклимсал по 1 таблетке 4 раза в день сублингвально до полного растворения в течение 4 нед (n=86). Во 2-й группе (n=87) женщины получали плацебо (30 мг микрокристаллической целлюлозы) в режиме, имитирующем прием исследуемого препарата. Двадцать три пациентки выбыли из исследования в связи с нарушением условий или отказались от участия по причинам, не связанным с приемом препарата. В конечной точке исследования в обеих группах осталось по 75 участниц. Оценку терапевтической эффективности препарата производили на основании динамики баллов по шкалам Грина и MENQOL. Для оценки качества жизни пациенток применяли опросник SF-36, а для оценки динамики симптомов нарушения сна выполняли подсчет средней скорости засыпания. Для оценки безопасности приема препарата исследовали динамику М-эхо и заключений результатов маммографии через 12 мес после начала лечения по шкале BI-RADS. Дизайн исследования: проспективное двойное слепое плацебо-контролируемое.
Результаты. Курсовой прием препарата Неоклимсал, таблетки подъязычные, позволил снизить выраженность вазомоторных проявлений в 2,3 раза, выраженность депрессии – вдвое (p<0,001), причем по окончании лечения через 12 нед наблюдения терапевтический эффект не только сохранялся, но и имел тенденцию к усилению (p<0,001). Повышение качества жизни пациенток, леченных препаратом Неоклимсал, подтверждено улучшением показателей шкалы MENQOL в 1,4 раза через 1 мес после начала терапии, с сохранением достигнутого результата через 12 нед наблюдения (p<0,001). Безопасность препарата подтверждается отсутствием фактов регистрации негативных побочных эффектов и аллергических реакций, отсутствием динамики толщины эндометрия в течение 3 мес после начала лечения и оценки результатов маммографии по шкале BI-RADS через 12 мес.
Заключение. Полученные результаты свидетельствуют об эффективности негормональной терапии в купировании вазомоторных симптомов постменопаузы легкой степени при высоком профиле безопасности. Препарат оказывает благоприятное воздействие на нарушения сна, снижение выраженности ментального дистресса и способствует повышению качества жизни в целом.
Ключевые слова: климактерий, менопауза, качество жизни, вазомоторные симптомы, негормональная терапия
Materials and methods. The study included 173 females aged 48–55 with mild vasomotor symptoms during the early postmenopausal period. Patients in the study cohort were stratified into two groups by the double-blind method. In group 1 (study), the patients took the homeopathic agent Neoclimsal 1 tablet 4 times a day sublingually until completely dissolved for 4 weeks (n=86). In group 2 (n=87), the patient received a placebo (30 mg of microcrystalline cellulose) in a regimen mimicking the study treatment. Twenty-three patients withdrew from the study due to protocol violation or revoked their consents for reasons not related to medication. At the end of the study, 75 patients remained in both groups. The therapeutic efficacy was assessed based on the Greene and MENQOL scores change. The SF-36 questionnaire was used to evaluate patients' quality of life, and the average rate of falling asleep was calculated to assess the change in sleep disturbance. The change of M-echo and mammography results were reviewed using the BI-RADS scale 12 months after the start of the treatment to assess the agent's safety. Study design: A prospective, double-blind, placebo-controlled study.
Results. The course of Neoclimsal, sublingual tablets, reduced the severity of vasomotor symptoms by 2.3 times, the severity of depression by half (p<0.001), and at the end of treatment after 12 weeks of observation, the therapeutic effect not only persisted but tended to increase (p<0.001). Improvement in the quality of life of patients treated with Neoclimsal was confirmed by an improvement in the MENQOL score by 1.4 times a month after the start of therapy while maintaining the achieved result after 12 weeks of observation (p<0.001). The drug's safety is confirmed by the absence of adverse side effects and allergic reactions, the absence of endometrial thickness change within 3 months after the start of treatment, and mammography results using the BI-RADS scale at 12 months.
Conclusion. The results indicate the effectiveness of non-hormonal therapy in relieving vasomotor symptoms of mild postmenopause with a high safety profile. The drug has a beneficial effect on sleep disorders, reducing the severity of mental distress and improving the general quality of life.
Keywords: climacteric, menopause, quality of life, vasomotor symptoms, non-hormonal therapy
Материалы и методы. В исследование включены 173 женщины в возрасте 48–55 лет с вазомоторными симптомами легкой степени в период ранней постменопаузы. Пациенток изучаемой когорты двойным слепым методом стратифицировали на две группы. В 1-й группе (исследуемая) участницы принимали гомеопатический препарат Неоклимсал по 1 таблетке 4 раза в день сублингвально до полного растворения в течение 4 нед (n=86). Во 2-й группе (n=87) женщины получали плацебо (30 мг микрокристаллической целлюлозы) в режиме, имитирующем прием исследуемого препарата. Двадцать три пациентки выбыли из исследования в связи с нарушением условий или отказались от участия по причинам, не связанным с приемом препарата. В конечной точке исследования в обеих группах осталось по 75 участниц. Оценку терапевтической эффективности препарата производили на основании динамики баллов по шкалам Грина и MENQOL. Для оценки качества жизни пациенток применяли опросник SF-36, а для оценки динамики симптомов нарушения сна выполняли подсчет средней скорости засыпания. Для оценки безопасности приема препарата исследовали динамику М-эхо и заключений результатов маммографии через 12 мес после начала лечения по шкале BI-RADS. Дизайн исследования: проспективное двойное слепое плацебо-контролируемое.
Результаты. Курсовой прием препарата Неоклимсал, таблетки подъязычные, позволил снизить выраженность вазомоторных проявлений в 2,3 раза, выраженность депрессии – вдвое (p<0,001), причем по окончании лечения через 12 нед наблюдения терапевтический эффект не только сохранялся, но и имел тенденцию к усилению (p<0,001). Повышение качества жизни пациенток, леченных препаратом Неоклимсал, подтверждено улучшением показателей шкалы MENQOL в 1,4 раза через 1 мес после начала терапии, с сохранением достигнутого результата через 12 нед наблюдения (p<0,001). Безопасность препарата подтверждается отсутствием фактов регистрации негативных побочных эффектов и аллергических реакций, отсутствием динамики толщины эндометрия в течение 3 мес после начала лечения и оценки результатов маммографии по шкале BI-RADS через 12 мес.
Заключение. Полученные результаты свидетельствуют об эффективности негормональной терапии в купировании вазомоторных симптомов постменопаузы легкой степени при высоком профиле безопасности. Препарат оказывает благоприятное воздействие на нарушения сна, снижение выраженности ментального дистресса и способствует повышению качества жизни в целом.
Ключевые слова: климактерий, менопауза, качество жизни, вазомоторные симптомы, негормональная терапия
________________________________________________
Materials and methods. The study included 173 females aged 48–55 with mild vasomotor symptoms during the early postmenopausal period. Patients in the study cohort were stratified into two groups by the double-blind method. In group 1 (study), the patients took the homeopathic agent Neoclimsal 1 tablet 4 times a day sublingually until completely dissolved for 4 weeks (n=86). In group 2 (n=87), the patient received a placebo (30 mg of microcrystalline cellulose) in a regimen mimicking the study treatment. Twenty-three patients withdrew from the study due to protocol violation or revoked their consents for reasons not related to medication. At the end of the study, 75 patients remained in both groups. The therapeutic efficacy was assessed based on the Greene and MENQOL scores change. The SF-36 questionnaire was used to evaluate patients' quality of life, and the average rate of falling asleep was calculated to assess the change in sleep disturbance. The change of M-echo and mammography results were reviewed using the BI-RADS scale 12 months after the start of the treatment to assess the agent's safety. Study design: A prospective, double-blind, placebo-controlled study.
Results. The course of Neoclimsal, sublingual tablets, reduced the severity of vasomotor symptoms by 2.3 times, the severity of depression by half (p<0.001), and at the end of treatment after 12 weeks of observation, the therapeutic effect not only persisted but tended to increase (p<0.001). Improvement in the quality of life of patients treated with Neoclimsal was confirmed by an improvement in the MENQOL score by 1.4 times a month after the start of therapy while maintaining the achieved result after 12 weeks of observation (p<0.001). The drug's safety is confirmed by the absence of adverse side effects and allergic reactions, the absence of endometrial thickness change within 3 months after the start of treatment, and mammography results using the BI-RADS scale at 12 months.
Conclusion. The results indicate the effectiveness of non-hormonal therapy in relieving vasomotor symptoms of mild postmenopause with a high safety profile. The drug has a beneficial effect on sleep disorders, reducing the severity of mental distress and improving the general quality of life.
Keywords: climacteric, menopause, quality of life, vasomotor symptoms, non-hormonal therapy
Полный текст
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2. Dunneram Y, Greenwood DC, Cade JE. Diet, menopause and the risk of ovarian, endometrial and breast cancer. Proc Nutr Soc. 2019;78(3):438-48. DOI:10.1017/S0029665118002884
3. Gold EB, Colvin A, Avis N, et al. Longitudinal Analysis of the Association Between Vasomotor Symptoms and Race/Ethnicity Across the Menopausal Transition: Study of Women’s Health Across the Nation. Am J Public Health. 2006;96(7):1226-35. DOI:10.2105/AJPH.2005.066936
4. Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021;106(1):1-15. DOI:10.1210/clinem/dgaa764
5. Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018;45(4):629-40. DOI:10.1016/j.ogc.2018.07.005
6. Delamater L, Santoro N. Management of the Perimenopause. Clin Obstet Gynecol. 2018;61(3):419-32. DOI:10.1097/GRF.0000000000000389
7. Freeman EW, Sammel MD. Methods in a longitudinal cohort study of late reproductive age women: the Penn Ovarian Aging Study (POAS). Womens Midlife Health. 2016;2:1. DOI:10.1186/s40695-016-0014-2
8. Cohen LS, Soares CN, Vitonis AF, et al. Risk for new onset of depression during the menopausal transition: The Harvard study of moods and cycles. Archives of General Psychiatry. 2006;63(4):385-90. DOI:10.1001/archp syc.63.4.385
9. Kulkarni J. Perimenopausal depression – an under-recognised entity. Australian Prescriber. 2018;41(6):183-5. DOI:10.18773/ austprescr.2018.060
10. Inayat K, Danish N, Hassan L. Symptoms Of Menopause In Peri And Postmenopausal Women And Their Attitude Towards Them. J Ayub Med Coll Abbottabad. 2017;29(3):477-80.
11. Zhang GQ, Chen JL, Luo Y, et al. Menopausal hormone therapy and women's health: An umbrella review. PLoS Med. 2021;18(8):e1003731. DOI:10.1371/journal.pmed.1003731
12. Rozenberg S, Di Pietrantonio V, Vandromme J, Gilles C. Menopausal hormone therapy and breast cancer risk. Best Pract Res Clin Endocrinol Metab. 2021;35(6):101577. DOI:10.1016/j.beem.2021.101577
13. Avis NE, Crawford SL, Greendale G, et al. Duration of Menopausal Vasomotor Symptoms Over the Menopause Transition. JAMA Intern Med. 2015;175(4):531. DOI:10.1001/jamainternmed.2014.8063
14. Haimov-Kochman R, Barak-Glantz E, Arbel R, et al. Gradual discontinuation of hormone therapy does not prevent the reappearance of climacteric symptoms: a randomized prospective study. Menopause. 2007;13(3):370-6. DOI:10.1097/01.gme.0000186663.36211.c0
15. Kuiper GG, Carlsson B, Grandien K, et al. Comparison of the ligand binding specificity and transcript tissue distribution of estrogen receptors alpha and beta. Endocrinology. 1997;138(3):863-70. DOI:10.1210/endo.138.3.4979
16. Arao Y, Korach KS. The physiological role of estrogen receptor functional domains. Essays Biochem. 2021;65(6):867-75. DOI:10.1042/EBC20200167
17. Rowe IJ, Baber RJ. The effects of phytoestrogens on postmenopausal health. Climacteric. 2021;24(1):57-63. DOI:10.1080/13697137.2020.1863356
18. Canivenc-Lavier MC, Bennetau-Pelissero C. Phytoestrogens and Health Effects. Nutrients. 2023;15(2):317. DOI:10.3390/nu15020317
19. Goyal A, Verma A, Agrawal N. Dietary Phytoestrogens: Neuroprotective Role in Parkinson's Disease. Curr Neurovasc Res. 2021;18(2):254-67. DOI:10.2174/1567202618666210604121233
20. Abdi F, Rahnemaei FA, Roozbeh N, Pakzad R. Impact of phytoestrogens on treatment of urogenital menopause symptoms: A systematic review of randomized clinical trials. Eur J Obstet Gynecol Reprod Biol. 2021;261:222-35. DOI:10.1016/j.ejogrb.2021.03.039
21. Anandhi Senthilkumar H, Fata JE, Kennelly EJ. Phytoestrogens: The current state of research emphasizing breast pathophysiology. Phytother Res. 2018;32(9):1707-19. DOI:10.1002/ptr.6115
22. Clinical recommendations of the Ministry of Health of Russia ˝Menopause and climacteric condition in women˝. Moscow, 2021 (in Russian).
23. Greene JG. Greene Climacteric Scale (GCS). Constructing a standard climacteric scale. Maturitas. 1998;29(1):25-31.
24. Sydora BC, Fast H, Campbell S, et al. Use of the Menopause-Specific Quality of Life (MENQOL) questionnaire in research and clinical practice: a comprehensive scoping review. Menopause. 2016;23(9):1038-51. DOI:10.1097/GME.0000000000000636
25. Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016;4:2050312116671725. DOI:10.1177/2050312116671725
26. Raccah-Tebeka B, Boutet G, Plu-Bureau G. Alternatives non hormonales de prise en charge des bouffées vasomotrices post-ménopausiques. RPC Les femmes ménopausées du CNGOF et du GEMVi [Non-hormonal alternatives for the management of menopausal hot flushes. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines]. Gynecol Obstet Fertil Senol. 2021;49(5):373-93 (in French). DOI:10.1016/j.gofs.2021.03.020
27. Ugras SK, Layeequr Rahman R. Hormone replacement therapy after breast cancer: Yes, No or maybe? Mol Cell Endocrinol. 2021;525:111180. DOI:10.1016/j.mce.2021.111180
28. Macías-Cortés E. Menopause is more than Hot Flashes: What is Missing in Homeopathic Research? A Narrative Review. Homeopathy. 2022;111(2):79-96.
DOI:10.1055/s-0041-1733971
29. Macías-Cortés E. Menopause: Questions and Answers for Improving Homeopathic Clinical Practice. Homeopathy. 2022. DOI:10.1055/s-0042-1755362
30. Macías-Cortés EDC, Llanes-González L, Aguilar-Faisal L, Asbun-Bojalil J. Individualized Homeopathy for Depression in Climacteric Women: Comments on the Retraction by PLoS ONE. Homeopathy. 2020;109(4):267-70. DOI:10.1055/s-0040-1714741
31. Maurya VK, Kumar S, Kabir R, et al. Dark classics in chemical neuroscience: an evidence-based systematic review of belladonna. ACS Chemical Neuroscience. 2020;11(23):3937-54.
32. Cassilhas AB, Nascimento ALP, dos Santos JN, et al. Homeopatia no tratamento das alterações do climatério Homeopathy in the treatment of climacteric changes. Braz J Health Rev. 2021;4(6):28287-99.
33. Colau JC, Vincent S, Marijnen P, Allaert FA. Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes. Drugs R D. 2012;12(3):107-19.
34. Bordet MF, Colas A, Marijnen P, et al. Treating hot flushes in menopausal women with homeopathic treatment–results of an observational study. Homeopathy. 2008;97(1):10-5.
35. van den Meerschaut L, Sünder A. The homeopathic preparation Nervoheel N can offer an alternative to lorazepam therapy for mild nervous disorders. Evid Based Complement Alternat Med. 2009;6(4):507-15.
36. Tatarchuk T, Yefimenko OO, Zan'ko OV. Nonhormonal therapy of climacteric disorders. Reproductive endocrinology. 2016;30:75-80 (in Russian).
37. Guida M, Raffone A, Travaglino A, et al. Cimicifuga racemosa isopropanolic extract for menopausal symptoms: an observational prospective case-control study. Gynecol Endocrinol. 2021;37(12):1132-7.
38. Castelo-Branco C, Gambacciani M, Cano A, et al. Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms – an update on the evidence. Climacteric. 2021;24(2):109-19.
39. Smetnik VP, CHernuha GE, Marchenko LA. Otchet o klinicheskom primenenii kompleksnogo gomeopaticheskogo lekarstvennogo sredstva «Neoklimsal» pri klimaktericheskom sindrome, 2004 (in Russian).
2. Dunneram Y, Greenwood DC, Cade JE. Diet, menopause and the risk of ovarian, endometrial and breast cancer. Proc Nutr Soc. 2019;78(3):438-48. DOI:10.1017/S0029665118002884
3. Gold EB, Colvin A, Avis N, et al. Longitudinal Analysis of the Association Between Vasomotor Symptoms and Race/Ethnicity Across the Menopausal Transition: Study of Women’s Health Across the Nation. Am J Public Health. 2006;96(7):1226-35. DOI:10.2105/AJPH.2005.066936
4. Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021;106(1):1-15. DOI:10.1210/clinem/dgaa764
5. Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018;45(4):629-40. DOI:10.1016/j.ogc.2018.07.005
6. Delamater L, Santoro N. Management of the Perimenopause. Clin Obstet Gynecol. 2018;61(3):419-32. DOI:10.1097/GRF.0000000000000389
7. Freeman EW, Sammel MD. Methods in a longitudinal cohort study of late reproductive age women: the Penn Ovarian Aging Study (POAS). Womens Midlife Health. 2016;2:1. DOI:10.1186/s40695-016-0014-2
8. Cohen LS, Soares CN, Vitonis AF, et al. Risk for new onset of depression during the menopausal transition: The Harvard study of moods and cycles. Archives of General Psychiatry. 2006;63(4):385-90. DOI:10.1001/archp syc.63.4.385
9. Kulkarni J. Perimenopausal depression – an under-recognised entity. Australian Prescriber. 2018;41(6):183-5. DOI:10.18773/ austprescr.2018.060
10. Inayat K, Danish N, Hassan L. Symptoms Of Menopause In Peri And Postmenopausal Women And Their Attitude Towards Them. J Ayub Med Coll Abbottabad. 2017;29(3):477-80.
11. Zhang GQ, Chen JL, Luo Y, et al. Menopausal hormone therapy and women's health: An umbrella review. PLoS Med. 2021;18(8):e1003731. DOI:10.1371/journal.pmed.1003731
12. Rozenberg S, Di Pietrantonio V, Vandromme J, Gilles C. Menopausal hormone therapy and breast cancer risk. Best Pract Res Clin Endocrinol Metab. 2021;35(6):101577. DOI:10.1016/j.beem.2021.101577
13. Avis NE, Crawford SL, Greendale G, et al. Duration of Menopausal Vasomotor Symptoms Over the Menopause Transition. JAMA Intern Med. 2015;175(4):531. DOI:10.1001/jamainternmed.2014.8063
14. Haimov-Kochman R, Barak-Glantz E, Arbel R, et al. Gradual discontinuation of hormone therapy does not prevent the reappearance of climacteric symptoms: a randomized prospective study. Menopause. 2007;13(3):370-6. DOI:10.1097/01.gme.0000186663.36211.c0
15. Kuiper GG, Carlsson B, Grandien K, et al. Comparison of the ligand binding specificity and transcript tissue distribution of estrogen receptors alpha and beta. Endocrinology. 1997;138(3):863-70. DOI:10.1210/endo.138.3.4979
16. Arao Y, Korach KS. The physiological role of estrogen receptor functional domains. Essays Biochem. 2021;65(6):867-75. DOI:10.1042/EBC20200167
17. Rowe IJ, Baber RJ. The effects of phytoestrogens on postmenopausal health. Climacteric. 2021;24(1):57-63. DOI:10.1080/13697137.2020.1863356
18. Canivenc-Lavier MC, Bennetau-Pelissero C. Phytoestrogens and Health Effects. Nutrients. 2023;15(2):317. DOI:10.3390/nu15020317
19. Goyal A, Verma A, Agrawal N. Dietary Phytoestrogens: Neuroprotective Role in Parkinson's Disease. Curr Neurovasc Res. 2021;18(2):254-67. DOI:10.2174/1567202618666210604121233
20. Abdi F, Rahnemaei FA, Roozbeh N, Pakzad R. Impact of phytoestrogens on treatment of urogenital menopause symptoms: A systematic review of randomized clinical trials. Eur J Obstet Gynecol Reprod Biol. 2021;261:222-35. DOI:10.1016/j.ejogrb.2021.03.039
21. Anandhi Senthilkumar H, Fata JE, Kennelly EJ. Phytoestrogens: The current state of research emphasizing breast pathophysiology. Phytother Res. 2018;32(9):1707-19. DOI:10.1002/ptr.6115
22. Клинические рекомендации Минздрава России «Менопауза и климактерическое состояние у женщины». М., 2021 [Clinical recommendations of the Ministry of Health of Russia ˝Menopause and climacteric condition in women˝. Moscow, 2021 (in Russian)].
23. Greene JG. Greene Climacteric Scale (GCS). Constructing a standard climacteric scale. Maturitas. 1998;29(1):25-31.
24. Sydora BC, Fast H, Campbell S, et al. Use of the Menopause-Specific Quality of Life (MENQOL) questionnaire in research and clinical practice: a comprehensive scoping review. Menopause. 2016;23(9):1038-51. DOI:10.1097/GME.0000000000000636
25. Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016;4:2050312116671725. DOI:10.1177/2050312116671725
26. Raccah-Tebeka B, Boutet G, Plu-Bureau G. Alternatives non hormonales de prise en charge des bouffées vasomotrices post-ménopausiques. RPC Les femmes ménopausées du CNGOF et du GEMVi [Non-hormonal alternatives for the management of menopausal hot flushes. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines]. Gynecol Obstet Fertil Senol. 2021;49(5):373-93 (in French). DOI:10.1016/j.gofs.2021.03.020
27. Ugras SK, Layeequr Rahman R. Hormone replacement therapy after breast cancer: Yes, No or maybe? Mol Cell Endocrinol. 2021;525:111180. DOI:10.1016/j.mce.2021.111180
28. Macías-Cortés E. Menopause is more than Hot Flashes: What is Missing in Homeopathic Research? A Narrative Review. Homeopathy. 2022;111(2):79-96.
DOI:10.1055/s-0041-1733971
29. Macías-Cortés E. Menopause: Questions and Answers for Improving Homeopathic Clinical Practice. Homeopathy. 2022. DOI:10.1055/s-0042-1755362
30. Macías-Cortés EDC, Llanes-González L, Aguilar-Faisal L, Asbun-Bojalil J. Individualized Homeopathy for Depression in Climacteric Women: Comments on the Retraction by PLoS ONE. Homeopathy. 2020;109(4):267-70. DOI:10.1055/s-0040-1714741
31. Maurya VK, Kumar S, Kabir R, et al. Dark classics in chemical neuroscience: an evidence-based systematic review of belladonna. ACS Chemical Neuroscience. 2020;11(23):3937-54.
32. Cassilhas AB, Nascimento ALP, dos Santos JN, et al. Homeopatia no tratamento das alterações do climatério Homeopathy in the treatment of climacteric changes. Braz J Health Rev. 2021;4(6):28287-99.
33. Colau JC, Vincent S, Marijnen P, Allaert FA. Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes. Drugs R D. 2012;12(3):107-19.
34. Bordet MF, Colas A, Marijnen P, et al. Treating hot flushes in menopausal women with homeopathic treatment–results of an observational study. Homeopathy. 2008;97(1):10-5.
35. van den Meerschaut L, Sünder A. The homeopathic preparation Nervoheel N can offer an alternative to lorazepam therapy for mild nervous disorders. Evid Based Complement Alternat Med. 2009;6(4):507-15.
36. Татарчук Т., Ефименко О.О., Занько О.В. Nonhormonal therapy of climacteric disorders. Репродуктивная эндокринология. 2016;30:75-80 [Tatarchuk T, Yefimenko OO, Zan'ko OV. Nonhormonal therapy of climacteric disorders. Reproductive endocrinology. 2016;30:75-80 (in Russian)].
37. Guida M, Raffone A, Travaglino A, et al. Cimicifuga racemosa isopropanolic extract for menopausal symptoms: an observational prospective case-control study. Gynecol Endocrinol. 2021;37(12):1132-7.
38. Castelo-Branco C, Gambacciani M, Cano A, et al. Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms – an update on the evidence. Climacteric. 2021;24(2):109-19.
39. Сметник В.П., Чернуха Г.Е., Марченко Л.А. Отчет о клиническом применении комплексного гомеопатического лекарственного средства «Неоклимсал» при климактерическом синдроме, 2004 [Smetnik VP, CHernuha GE, Marchenko LA. Otchet o klinicheskom primenenii kompleksnogo gomeopaticheskogo lekarstvennogo sredstva «Neoklimsal» pri klimaktericheskom sindrome, 2004 (in Russian)].
________________________________________________
2. Dunneram Y, Greenwood DC, Cade JE. Diet, menopause and the risk of ovarian, endometrial and breast cancer. Proc Nutr Soc. 2019;78(3):438-48. DOI:10.1017/S0029665118002884
3. Gold EB, Colvin A, Avis N, et al. Longitudinal Analysis of the Association Between Vasomotor Symptoms and Race/Ethnicity Across the Menopausal Transition: Study of Women’s Health Across the Nation. Am J Public Health. 2006;96(7):1226-35. DOI:10.2105/AJPH.2005.066936
4. Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021;106(1):1-15. DOI:10.1210/clinem/dgaa764
5. Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018;45(4):629-40. DOI:10.1016/j.ogc.2018.07.005
6. Delamater L, Santoro N. Management of the Perimenopause. Clin Obstet Gynecol. 2018;61(3):419-32. DOI:10.1097/GRF.0000000000000389
7. Freeman EW, Sammel MD. Methods in a longitudinal cohort study of late reproductive age women: the Penn Ovarian Aging Study (POAS). Womens Midlife Health. 2016;2:1. DOI:10.1186/s40695-016-0014-2
8. Cohen LS, Soares CN, Vitonis AF, et al. Risk for new onset of depression during the menopausal transition: The Harvard study of moods and cycles. Archives of General Psychiatry. 2006;63(4):385-90. DOI:10.1001/archp syc.63.4.385
9. Kulkarni J. Perimenopausal depression – an under-recognised entity. Australian Prescriber. 2018;41(6):183-5. DOI:10.18773/ austprescr.2018.060
10. Inayat K, Danish N, Hassan L. Symptoms Of Menopause In Peri And Postmenopausal Women And Their Attitude Towards Them. J Ayub Med Coll Abbottabad. 2017;29(3):477-80.
11. Zhang GQ, Chen JL, Luo Y, et al. Menopausal hormone therapy and women's health: An umbrella review. PLoS Med. 2021;18(8):e1003731. DOI:10.1371/journal.pmed.1003731
12. Rozenberg S, Di Pietrantonio V, Vandromme J, Gilles C. Menopausal hormone therapy and breast cancer risk. Best Pract Res Clin Endocrinol Metab. 2021;35(6):101577. DOI:10.1016/j.beem.2021.101577
13. Avis NE, Crawford SL, Greendale G, et al. Duration of Menopausal Vasomotor Symptoms Over the Menopause Transition. JAMA Intern Med. 2015;175(4):531. DOI:10.1001/jamainternmed.2014.8063
14. Haimov-Kochman R, Barak-Glantz E, Arbel R, et al. Gradual discontinuation of hormone therapy does not prevent the reappearance of climacteric symptoms: a randomized prospective study. Menopause. 2007;13(3):370-6. DOI:10.1097/01.gme.0000186663.36211.c0
15. Kuiper GG, Carlsson B, Grandien K, et al. Comparison of the ligand binding specificity and transcript tissue distribution of estrogen receptors alpha and beta. Endocrinology. 1997;138(3):863-70. DOI:10.1210/endo.138.3.4979
16. Arao Y, Korach KS. The physiological role of estrogen receptor functional domains. Essays Biochem. 2021;65(6):867-75. DOI:10.1042/EBC20200167
17. Rowe IJ, Baber RJ. The effects of phytoestrogens on postmenopausal health. Climacteric. 2021;24(1):57-63. DOI:10.1080/13697137.2020.1863356
18. Canivenc-Lavier MC, Bennetau-Pelissero C. Phytoestrogens and Health Effects. Nutrients. 2023;15(2):317. DOI:10.3390/nu15020317
19. Goyal A, Verma A, Agrawal N. Dietary Phytoestrogens: Neuroprotective Role in Parkinson's Disease. Curr Neurovasc Res. 2021;18(2):254-67. DOI:10.2174/1567202618666210604121233
20. Abdi F, Rahnemaei FA, Roozbeh N, Pakzad R. Impact of phytoestrogens on treatment of urogenital menopause symptoms: A systematic review of randomized clinical trials. Eur J Obstet Gynecol Reprod Biol. 2021;261:222-35. DOI:10.1016/j.ejogrb.2021.03.039
21. Anandhi Senthilkumar H, Fata JE, Kennelly EJ. Phytoestrogens: The current state of research emphasizing breast pathophysiology. Phytother Res. 2018;32(9):1707-19. DOI:10.1002/ptr.6115
22. Clinical recommendations of the Ministry of Health of Russia ˝Menopause and climacteric condition in women˝. Moscow, 2021 (in Russian).
23. Greene JG. Greene Climacteric Scale (GCS). Constructing a standard climacteric scale. Maturitas. 1998;29(1):25-31.
24. Sydora BC, Fast H, Campbell S, et al. Use of the Menopause-Specific Quality of Life (MENQOL) questionnaire in research and clinical practice: a comprehensive scoping review. Menopause. 2016;23(9):1038-51. DOI:10.1097/GME.0000000000000636
25. Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016;4:2050312116671725. DOI:10.1177/2050312116671725
26. Raccah-Tebeka B, Boutet G, Plu-Bureau G. Alternatives non hormonales de prise en charge des bouffées vasomotrices post-ménopausiques. RPC Les femmes ménopausées du CNGOF et du GEMVi [Non-hormonal alternatives for the management of menopausal hot flushes. Postmenopausal women management: CNGOF and GEMVi clinical practice guidelines]. Gynecol Obstet Fertil Senol. 2021;49(5):373-93 (in French). DOI:10.1016/j.gofs.2021.03.020
27. Ugras SK, Layeequr Rahman R. Hormone replacement therapy after breast cancer: Yes, No or maybe? Mol Cell Endocrinol. 2021;525:111180. DOI:10.1016/j.mce.2021.111180
28. Macías-Cortés E. Menopause is more than Hot Flashes: What is Missing in Homeopathic Research? A Narrative Review. Homeopathy. 2022;111(2):79-96.
DOI:10.1055/s-0041-1733971
29. Macías-Cortés E. Menopause: Questions and Answers for Improving Homeopathic Clinical Practice. Homeopathy. 2022. DOI:10.1055/s-0042-1755362
30. Macías-Cortés EDC, Llanes-González L, Aguilar-Faisal L, Asbun-Bojalil J. Individualized Homeopathy for Depression in Climacteric Women: Comments on the Retraction by PLoS ONE. Homeopathy. 2020;109(4):267-70. DOI:10.1055/s-0040-1714741
31. Maurya VK, Kumar S, Kabir R, et al. Dark classics in chemical neuroscience: an evidence-based systematic review of belladonna. ACS Chemical Neuroscience. 2020;11(23):3937-54.
32. Cassilhas AB, Nascimento ALP, dos Santos JN, et al. Homeopatia no tratamento das alterações do climatério Homeopathy in the treatment of climacteric changes. Braz J Health Rev. 2021;4(6):28287-99.
33. Colau JC, Vincent S, Marijnen P, Allaert FA. Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes. Drugs R D. 2012;12(3):107-19.
34. Bordet MF, Colas A, Marijnen P, et al. Treating hot flushes in menopausal women with homeopathic treatment–results of an observational study. Homeopathy. 2008;97(1):10-5.
35. van den Meerschaut L, Sünder A. The homeopathic preparation Nervoheel N can offer an alternative to lorazepam therapy for mild nervous disorders. Evid Based Complement Alternat Med. 2009;6(4):507-15.
36. Tatarchuk T, Yefimenko OO, Zan'ko OV. Nonhormonal therapy of climacteric disorders. Reproductive endocrinology. 2016;30:75-80 (in Russian).
37. Guida M, Raffone A, Travaglino A, et al. Cimicifuga racemosa isopropanolic extract for menopausal symptoms: an observational prospective case-control study. Gynecol Endocrinol. 2021;37(12):1132-7.
38. Castelo-Branco C, Gambacciani M, Cano A, et al. Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms – an update on the evidence. Climacteric. 2021;24(2):109-19.
39. Smetnik VP, CHernuha GE, Marchenko LA. Otchet o klinicheskom primenenii kompleksnogo gomeopaticheskogo lekarstvennogo sredstva «Neoklimsal» pri klimaktericheskom sindrome, 2004 (in Russian).
Авторы
В.Е. Радзинский*, М.Р. Оразов, М.Б. Хамошина, Р.Е. Орехов, И.С. Журавлева
ФГАОУ ВО «Российский университет дружбы народов», Москва, Россия
*radzinsky@mail.ru
People’s Friendship University of Russia (RUDN University), Moscow, Russia
*radzinsky@mail.ru
ФГАОУ ВО «Российский университет дружбы народов», Москва, Россия
*radzinsky@mail.ru
________________________________________________
People’s Friendship University of Russia (RUDN University), Moscow, Russia
*radzinsky@mail.ru
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