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Эффективность и безопасность генистеина в лечении вазомоторных симптомов у женщин в постменопаузе (обзор исследований)
Эффективность и безопасность генистеина в лечении вазомоторных симптомов у женщин в постменопаузе (обзор исследований)
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Аннотация
В обзоре рассматриваются вопросы эффективности и безопасности фитоэстрогенов, преимущественно изофлавонов сои, в лечении симптомов климактерического синдрома. Особое внимание уделяется синтетическому генистеину. Наиболее высокая по сравнению с другими фитоэстрогенами эффективность генистеина подтверждается сравнительными и плацебо-контролируемыми исследованиями. Вместе с тем длительное применение генистеина не влияет на пролиферативные процессы в эндометрии и молочных железах. Генистеин можно считать достойной альтернативой гормональной терапии в случаях, когда она невозможна или нежелательна.
Ключевые слова: постменопауза, фитоэстрогены, генистеин, приливы жара, эндометрий, молочная железа, безопасность.
Key words: postmenopause, phytoestrogens genistein, hot flushes, endometrial, breast, security.
Ключевые слова: постменопауза, фитоэстрогены, генистеин, приливы жара, эндометрий, молочная железа, безопасность.
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Key words: postmenopause, phytoestrogens genistein, hot flushes, endometrial, breast, security.
Полный текст
Список литературы
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3. Maclennan AH, Broadbent JL, Lester S et al. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flashes. Cochrane Database Syst Rev 2004; 4: CD002978.
4. Beral V. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet 2003; 362: 419–27.
5. Gompel A, Rozenberg S, Barlow DH. The EMAS 2008 update on clinical recommendations on postmenopausal hormone replacement therapy. Maturitas 2008; 61: 227–32.
6. Hill DA, Hill SR. Counseling patients about hormone therapy and alternatives for menopausal symptoms. Am Fam Physician 2010; 82: 801–7.
7. Tsai SA, Stefanick ML, Stafford RS. Trends in menopausal hormone therapy use of US office-based physicians, 2000-2009. Menopause 2011; 18: 385–92.
8. Kronenberg F, Cushman LF, Wade CM et al. Race/ethnicity and women`s use of complementary and alternative medicine in the United States: results of national survey. Am J Public Health 2006; 96: 1236–42.
9. Melby MK. Chilliness: a vasomotor symptom in Japan. Menopause 2007; 14: 752–9.
10. Melby MK, Watanabe S, Whitten PL et al. Sensitive high-performance liquid chromatographic method using coulometric electrode array detection for measurement of phytoestrogens in dried blood spots. J Chromatogr B Analyt Technol Biomed Life Sci 2005; 826: 81–90.
11. Rimbach G, Boesch-Saadatmandi C, Frank J et al. Dietary isoflavones in the prevention of cardiovascular disease – a molecular perspective. Food Chem Toxicol 2008; 46: 1308–19.
12. Oseni T, Patel R, Pyle J, Jordan VC. Selective estrogen receptor modulators and phytoestrogens. Planta Med 2008; 74: 1656–65.
13. Howes LG, Howes JB, Knight DC. Isoflavone therapy for menopausal flushes: a systematic review and meta-analysis. Maturitas 2006; 55: 203–11.
14. Taku K, Melby MK, Kronenberg F et al. Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials. Menopause 2012; 19 (7): 776–90.
15. Williamson-Hughes PS, Flickinger BD, Messina MJ, Empie MW. Isoflavone supplements containing predominantly genistein reduce hot flash symptoms: a critical review of published studies. Menopause 2006; 13: 831–9.
16. Jacobs A, Wegewitz U, Sommerfeld C et al. Efficacy of isoflavones in relieving vasomotor menopausal symptoms – a systematic review. Mol Nutr Food Res 2009; 53: 1084–97.
17. Lethaby A, Brown J, Marjoribanks J et al. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst Rev 2007: CD001395.
18. Nelson HD, Vesco KK, Haney E et al. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA 2006; 295: 2057–71.
19. Krebs EE, Ensrud KE, MacDonald R et al. Phytoestrogens for treatment of menopausal symptoms: a systematic review. Obstet Gynecol 2004; 104: 824–36.
20. Nedrow A, Miller J, Walker M et al. Complementary and alternative therapies for the management of menopause-related symptoms: a systematic evidence review. Arch Intern Med 2006; 166: 1453–65.
21. Tempfer CB, Bentz EK, Leodolter S et al. Phytoestrogens in clinical practice: a review of the literature. Fertil Steril 2007; 87: 1243–9.
22. Bolanos R, Del Castillo A, Francia J. Soy isoflavones versus placebo in the treatment o climacteric vasomotor symptoms: systematic review and meta-analysis. Menopause 2010; 17: 660–6.
23. Messina M, Hughes C. Efficacy of soyfoods and soybean isoflavone supplements for alleviating menopausal symptoms is positively related to initial hot flush frequency. J Med Food 2003; 6: 1–11.
24. De Cremoux P, This P, Leclercq G, Jacquot Y. Controversies concerning the use of phytoestrogens in menopause management: bioavailability and metabolism. Maturitas 2010; 65 (4): 334–9.
25. Newton KM, Reed SD, LaCroix AZ et al. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med 2006; 145: 869–79.
26. Geller SE, Shulman LP, van Breemen RB et al. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause 2009; 16: 1156–66.
27. Grady D. Clinical practice. Management of menopausal symptoms. N Engl J Med 2006; 355: 2338–47.
28. Nelson HD. Menopause. Lancet 2008; 371: 760–70.
29. Muthyala RS, Ju YH, Sheng S et al. Equol, a natural estrogenic metabolite from soy isoflavones: convenient preparation and resolution of R- and
S-equols and their differing binding and biological activity through estrogen receptors alpha and beta. Bioorg Med Chem 2004; 12: 1559–67.
30. Takeuchi S, Takahashi T, Sawada Y et al. Comparative study on the nuclear hormone receptor activity of various phytochemicals and their metabolites by reporter gene assays using Chinese hamster ovary cells. Biol Pharm Bull 2009; 32: 195–202.
31. Crisafulli A, Marini H, Bitto A et al. Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebocontrolled study. Menopause 2004; 11: 400–4.
32. Albertazzi P, Steel SA, Bottazzi M. Effect of pure genistein on bone markers and hot flushes. Climacteric 2005; 8: 371–9.
33. D’Anna R, Cannata ML, Atteritano M et al. Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study. Menopause 2007; 14: 648–55.
34. Messina M, Nagata C, Wu AH. Estimated Asian adult soy protein and isoflavone intakes. Nutr Cancer 2006; 55: 1–12.
35. Ullmann U, Oberwittle H, Grossmann M, Riegger C. Repeated oral once daily intake of increasing doses of the novel synthetic genistein product Bonistein in healthy volunteers. Planta Med 2005; 71: 891–6.
36. Ullmann U, Metzner J, Frank T et al. Safety, tolerability, and pharmacokinetics of single ascending doses of synthetic genistein (Bonistein) in healthy volunteers. Adv Ther 2005; 22: 65–78.
37. Ullmann U, Bendik I, Fllehmann B. Bonistein (synthetic genistein), a food component in development for a bone health nutraceutical. J Physiol Pharmacol 2005; 56: 79–95.
38. Metzner JE, Frank T, Kunz I et al. Study on the pharmacokinetics of synthetic genistein after multiple oral intake in post-menopausal women. Drug Res Arzneimittelforschung 2009; 59 (10): 513–20.
39. Evans M, Elliott JG, Sharma P et al. The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: A multi-center, randomized, placebo-controlled study. Maturitas 2011; 68: 196–214.
40. Marini H, Minutoli L, Polito F et al. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med 2007; 146: 839–47.
41. Marini H, Minutoli L, Polito F et al. OPG and sRANKL serum concentrations in osteopenic, postmenopausal women after 2-year genistein administration. J Bone Miner Res 2008; 23: 715–20.
42. Marini H, Bitto A, Altavilla D et al. Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study. J Clin Endocrinol Metab 2008; 93 (12): 4787–96.
43. Hooper L, Ryder JJ, Kurzer MS et al. Effects of soy protein and isoflavones on circulating hormone concentrations in pre- and post-menopausal women: a systematic review and meta-analysis. Hum Reprod Update 2009; 15: 423–40.
44. Tempfer CB, Froese G, Heinze G et al. Side effects of phytoestrogens: a meta-analysis of randomized trials. Am J Med 2009; 122: 939–46, e9.
45. Unfer V, Casini ML, Costabile L et al. Endometrial effects of long-term treatment with phytoestrogens: a randomized, doubleblind, placebo-controlled study. Fertil Steril 2004; 82: 145–8.
46. Foth D, Nawroth F. Effect of phytoestrogens on the endometrium? Fertil Steril 2005; 83: 256–7 [author reply 7], National Toxicology Program UDoHaHS. Center for the Evaluation of Risks to Human Reproduction. NTP-CERHR expert panel report on the reproductive and developmental toxicity of soy formula. http://cerhrniehsnihgov; 2006.
47. Alekel DL, van Loan MD, Koehler KJ et al. The Soy Isoflavones for Reducing Bone Loss. (SIRBL) Study: a 3-y randomized controlled trial in postmenopausal women. Am J Clin Nutr 2009; 91: 218–30.
48. Horn-Ross PL, John EM, Canchola SL et al. Phytoestrogen intake and endometrial cancer risk. J Natl Cancer Inst 2003; 95: 1158–64.
49. McClain RM, Wolz E, Davidovich A et al. Acute, subchronic and chronic safety studies with genistein in rats. Food Chem Toxicol 2006; 44: 56–80.
50. McClain RM, Wolz E, Davidovich A et al. Reproductive safety studies with genistein in rats. Food Chem Toxicol 2007; 45: 1319–32.
51. McClain RM, Wolz E, Davidovich A et al. Subchronic and chronic safety studies with genistein in dogs. Food Chem Toxicol 2005; 43: 161–82.
52. McClain RM, Wolz E, Davidovich A et al. Genetic toxicity studies with genistein. Food Chem Toxicol 2006; 44: 42–55.
53. Sammartino A, Di Carlo C, Mandato VD et al. Effects of genistein on the endometrium: ultrasonographic evaluation. Gynecol Endocrinol 2003; 17: 45–9.
54. Helferich WG, Andrade JE, Hoagland MS. Phytoestrogens and breast cancer: a complex story. Inflammopharmacology 2008; 16: 219–26.
55. Messina MJ, Wood CE. Soy isoflavones, estrogen therapy, and breast cancer risk: analysis and commentary. Nutr J 2008; 7: 17.
56. Shu XO, Zheng Y, Cai H et al. Soy food intake and breast cancer survival. JAMA 2009; 302: 2437–43.
57. Guha N, Kwan ML, Quesenberry CP et al. Soy isoflavones and risk of cancer recurrence in a cohort of breast cancer survivors: the life after cancer epidemiology study. Breast Cancer Res Treat 2009; 118: 395–405.
2. Nelson HD, Haney E, Humphrey et al. Management of menopause-related symptoms. Summary, Evidence Report/Technology Assessment No. 120 (Prepared by the Oregon Evidence-based Practice Center, under contract No. 290-02-0024). AHRQ Pub. No. 05-E016-1. Rockville, MD: Agency for Health Research Quality, 2005.
3. Maclennan AH, Broadbent JL, Lester S et al. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flashes. Cochrane Database Syst Rev 2004; 4: CD002978.
4. Beral V. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet 2003; 362: 419–27.
5. Gompel A, Rozenberg S, Barlow DH. The EMAS 2008 update on clinical recommendations on postmenopausal hormone replacement therapy. Maturitas 2008; 61: 227–32.
6. Hill DA, Hill SR. Counseling patients about hormone therapy and alternatives for menopausal symptoms. Am Fam Physician 2010; 82: 801–7.
7. Tsai SA, Stefanick ML, Stafford RS. Trends in menopausal hormone therapy use of US office-based physicians, 2000-2009. Menopause 2011; 18: 385–92.
8. Kronenberg F, Cushman LF, Wade CM et al. Race/ethnicity and women`s use of complementary and alternative medicine in the United States: results of national survey. Am J Public Health 2006; 96: 1236–42.
9. Melby MK. Chilliness: a vasomotor symptom in Japan. Menopause 2007; 14: 752–9.
10. Melby MK, Watanabe S, Whitten PL et al. Sensitive high-performance liquid chromatographic method using coulometric electrode array detection for measurement of phytoestrogens in dried blood spots. J Chromatogr B Analyt Technol Biomed Life Sci 2005; 826: 81–90.
11. Rimbach G, Boesch-Saadatmandi C, Frank J et al. Dietary isoflavones in the prevention of cardiovascular disease – a molecular perspective. Food Chem Toxicol 2008; 46: 1308–19.
12. Oseni T, Patel R, Pyle J, Jordan VC. Selective estrogen receptor modulators and phytoestrogens. Planta Med 2008; 74: 1656–65.
13. Howes LG, Howes JB, Knight DC. Isoflavone therapy for menopausal flushes: a systematic review and meta-analysis. Maturitas 2006; 55: 203–11.
14. Taku K, Melby MK, Kronenberg F et al. Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials. Menopause 2012; 19 (7): 776–90.
15. Williamson-Hughes PS, Flickinger BD, Messina MJ, Empie MW. Isoflavone supplements containing predominantly genistein reduce hot flash symptoms: a critical review of published studies. Menopause 2006; 13: 831–9.
16. Jacobs A, Wegewitz U, Sommerfeld C et al. Efficacy of isoflavones in relieving vasomotor menopausal symptoms – a systematic review. Mol Nutr Food Res 2009; 53: 1084–97.
17. Lethaby A, Brown J, Marjoribanks J et al. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst Rev 2007: CD001395.
18. Nelson HD, Vesco KK, Haney E et al. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA 2006; 295: 2057–71.
19. Krebs EE, Ensrud KE, MacDonald R et al. Phytoestrogens for treatment of menopausal symptoms: a systematic review. Obstet Gynecol 2004; 104: 824–36.
20. Nedrow A, Miller J, Walker M et al. Complementary and alternative therapies for the management of menopause-related symptoms: a systematic evidence review. Arch Intern Med 2006; 166: 1453–65.
21. Tempfer CB, Bentz EK, Leodolter S et al. Phytoestrogens in clinical practice: a review of the literature. Fertil Steril 2007; 87: 1243–9.
22. Bolanos R, Del Castillo A, Francia J. Soy isoflavones versus placebo in the treatment o climacteric vasomotor symptoms: systematic review and meta-analysis. Menopause 2010; 17: 660–6.
23. Messina M, Hughes C. Efficacy of soyfoods and soybean isoflavone supplements for alleviating menopausal symptoms is positively related to initial hot flush frequency. J Med Food 2003; 6: 1–11.
24. De Cremoux P, This P, Leclercq G, Jacquot Y. Controversies concerning the use of phytoestrogens in menopause management: bioavailability and metabolism. Maturitas 2010; 65 (4): 334–9.
25. Newton KM, Reed SD, LaCroix AZ et al. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med 2006; 145: 869–79.
26. Geller SE, Shulman LP, van Breemen RB et al. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause 2009; 16: 1156–66.
27. Grady D. Clinical practice. Management of menopausal symptoms. N Engl J Med 2006; 355: 2338–47.
28. Nelson HD. Menopause. Lancet 2008; 371: 760–70.
29. Muthyala RS, Ju YH, Sheng S et al. Equol, a natural estrogenic metabolite from soy isoflavones: convenient preparation and resolution of R- and
S-equols and their differing binding and biological activity through estrogen receptors alpha and beta. Bioorg Med Chem 2004; 12: 1559–67.
30. Takeuchi S, Takahashi T, Sawada Y et al. Comparative study on the nuclear hormone receptor activity of various phytochemicals and their metabolites by reporter gene assays using Chinese hamster ovary cells. Biol Pharm Bull 2009; 32: 195–202.
31. Crisafulli A, Marini H, Bitto A et al. Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebocontrolled study. Menopause 2004; 11: 400–4.
32. Albertazzi P, Steel SA, Bottazzi M. Effect of pure genistein on bone markers and hot flushes. Climacteric 2005; 8: 371–9.
33. D’Anna R, Cannata ML, Atteritano M et al. Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study. Menopause 2007; 14: 648–55.
34. Messina M, Nagata C, Wu AH. Estimated Asian adult soy protein and isoflavone intakes. Nutr Cancer 2006; 55: 1–12.
35. Ullmann U, Oberwittle H, Grossmann M, Riegger C. Repeated oral once daily intake of increasing doses of the novel synthetic genistein product Bonistein in healthy volunteers. Planta Med 2005; 71: 891–6.
36. Ullmann U, Metzner J, Frank T et al. Safety, tolerability, and pharmacokinetics of single ascending doses of synthetic genistein (Bonistein) in healthy volunteers. Adv Ther 2005; 22: 65–78.
37. Ullmann U, Bendik I, Fllehmann B. Bonistein (synthetic genistein), a food component in development for a bone health nutraceutical. J Physiol Pharmacol 2005; 56: 79–95.
38. Metzner JE, Frank T, Kunz I et al. Study on the pharmacokinetics of synthetic genistein after multiple oral intake in post-menopausal women. Drug Res Arzneimittelforschung 2009; 59 (10): 513–20.
39. Evans M, Elliott JG, Sharma P et al. The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: A multi-center, randomized, placebo-controlled study. Maturitas 2011; 68: 196–214.
40. Marini H, Minutoli L, Polito F et al. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med 2007; 146: 839–47.
41. Marini H, Minutoli L, Polito F et al. OPG and sRANKL serum concentrations in osteopenic, postmenopausal women after 2-year genistein administration. J Bone Miner Res 2008; 23: 715–20.
42. Marini H, Bitto A, Altavilla D et al. Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study. J Clin Endocrinol Metab 2008; 93 (12): 4787–96.
43. Hooper L, Ryder JJ, Kurzer MS et al. Effects of soy protein and isoflavones on circulating hormone concentrations in pre- and post-menopausal women: a systematic review and meta-analysis. Hum Reprod Update 2009; 15: 423–40.
44. Tempfer CB, Froese G, Heinze G et al. Side effects of phytoestrogens: a meta-analysis of randomized trials. Am J Med 2009; 122: 939–46, e9.
45. Unfer V, Casini ML, Costabile L et al. Endometrial effects of long-term treatment with phytoestrogens: a randomized, doubleblind, placebo-controlled study. Fertil Steril 2004; 82: 145–8.
46. Foth D, Nawroth F. Effect of phytoestrogens on the endometrium? Fertil Steril 2005; 83: 256–7 [author reply 7], National Toxicology Program UDoHaHS. Center for the Evaluation of Risks to Human Reproduction. NTP-CERHR expert panel report on the reproductive and developmental toxicity of soy formula. http://cerhrniehsnihgov; 2006.
47. Alekel DL, van Loan MD, Koehler KJ et al. The Soy Isoflavones for Reducing Bone Loss. (SIRBL) Study: a 3-y randomized controlled trial in postmenopausal women. Am J Clin Nutr 2009; 91: 218–30.
48. Horn-Ross PL, John EM, Canchola SL et al. Phytoestrogen intake and endometrial cancer risk. J Natl Cancer Inst 2003; 95: 1158–64.
49. McClain RM, Wolz E, Davidovich A et al. Acute, subchronic and chronic safety studies with genistein in rats. Food Chem Toxicol 2006; 44: 56–80.
50. McClain RM, Wolz E, Davidovich A et al. Reproductive safety studies with genistein in rats. Food Chem Toxicol 2007; 45: 1319–32.
51. McClain RM, Wolz E, Davidovich A et al. Subchronic and chronic safety studies with genistein in dogs. Food Chem Toxicol 2005; 43: 161–82.
52. McClain RM, Wolz E, Davidovich A et al. Genetic toxicity studies with genistein. Food Chem Toxicol 2006; 44: 42–55.
53. Sammartino A, Di Carlo C, Mandato VD et al. Effects of genistein on the endometrium: ultrasonographic evaluation. Gynecol Endocrinol 2003; 17: 45–9.
54. Helferich WG, Andrade JE, Hoagland MS. Phytoestrogens and breast cancer: a complex story. Inflammopharmacology 2008; 16: 219–26.
55. Messina MJ, Wood CE. Soy isoflavones, estrogen therapy, and breast cancer risk: analysis and commentary. Nutr J 2008; 7: 17.
56. Shu XO, Zheng Y, Cai H et al. Soy food intake and breast cancer survival. JAMA 2009; 302: 2437–43.
57. Guha N, Kwan ML, Quesenberry CP et al. Soy isoflavones and risk of cancer recurrence in a cohort of breast cancer survivors: the life after cancer epidemiology study. Breast Cancer Res Treat 2009; 118: 395–405.
2. Nelson HD, Haney E, Humphrey et al. Management of menopause-related symptoms. Summary, Evidence Report/Technology Assessment No. 120 (Prepared by the Oregon Evidence-based Practice Center, under contract No. 290-02-0024). AHRQ Pub. No. 05-E016-1. Rockville, MD: Agency for Health Research Quality, 2005.
3. Maclennan AH, Broadbent JL, Lester S et al. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flashes. Cochrane Database Syst Rev 2004; 4: CD002978.
4. Beral V. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet 2003; 362: 419–27.
5. Gompel A, Rozenberg S, Barlow DH. The EMAS 2008 update on clinical recommendations on postmenopausal hormone replacement therapy. Maturitas 2008; 61: 227–32.
6. Hill DA, Hill SR. Counseling patients about hormone therapy and alternatives for menopausal symptoms. Am Fam Physician 2010; 82: 801–7.
7. Tsai SA, Stefanick ML, Stafford RS. Trends in menopausal hormone therapy use of US office-based physicians, 2000-2009. Menopause 2011; 18: 385–92.
8. Kronenberg F, Cushman LF, Wade CM et al. Race/ethnicity and women`s use of complementary and alternative medicine in the United States: results of national survey. Am J Public Health 2006; 96: 1236–42.
9. Melby MK. Chilliness: a vasomotor symptom in Japan. Menopause 2007; 14: 752–9.
10. Melby MK, Watanabe S, Whitten PL et al. Sensitive high-performance liquid chromatographic method using coulometric electrode array detection for measurement of phytoestrogens in dried blood spots. J Chromatogr B Analyt Technol Biomed Life Sci 2005; 826: 81–90.
11. Rimbach G, Boesch-Saadatmandi C, Frank J et al. Dietary isoflavones in the prevention of cardiovascular disease – a molecular perspective. Food Chem Toxicol 2008; 46: 1308–19.
12. Oseni T, Patel R, Pyle J, Jordan VC. Selective estrogen receptor modulators and phytoestrogens. Planta Med 2008; 74: 1656–65.
13. Howes LG, Howes JB, Knight DC. Isoflavone therapy for menopausal flushes: a systematic review and meta-analysis. Maturitas 2006; 55: 203–11.
14. Taku K, Melby MK, Kronenberg F et al. Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials. Menopause 2012; 19 (7): 776–90.
15. Williamson-Hughes PS, Flickinger BD, Messina MJ, Empie MW. Isoflavone supplements containing predominantly genistein reduce hot flash symptoms: a critical review of published studies. Menopause 2006; 13: 831–9.
16. Jacobs A, Wegewitz U, Sommerfeld C et al. Efficacy of isoflavones in relieving vasomotor menopausal symptoms – a systematic review. Mol Nutr Food Res 2009; 53: 1084–97.
17. Lethaby A, Brown J, Marjoribanks J et al. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst Rev 2007: CD001395.
18. Nelson HD, Vesco KK, Haney E et al. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA 2006; 295: 2057–71.
19. Krebs EE, Ensrud KE, MacDonald R et al. Phytoestrogens for treatment of menopausal symptoms: a systematic review. Obstet Gynecol 2004; 104: 824–36.
20. Nedrow A, Miller J, Walker M et al. Complementary and alternative therapies for the management of menopause-related symptoms: a systematic evidence review. Arch Intern Med 2006; 166: 1453–65.
21. Tempfer CB, Bentz EK, Leodolter S et al. Phytoestrogens in clinical practice: a review of the literature. Fertil Steril 2007; 87: 1243–9.
22. Bolanos R, Del Castillo A, Francia J. Soy isoflavones versus placebo in the treatment o climacteric vasomotor symptoms: systematic review and meta-analysis. Menopause 2010; 17: 660–6.
23. Messina M, Hughes C. Efficacy of soyfoods and soybean isoflavone supplements for alleviating menopausal symptoms is positively related to initial hot flush frequency. J Med Food 2003; 6: 1–11.
24. De Cremoux P, This P, Leclercq G, Jacquot Y. Controversies concerning the use of phytoestrogens in menopause management: bioavailability and metabolism. Maturitas 2010; 65 (4): 334–9.
25. Newton KM, Reed SD, LaCroix AZ et al. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med 2006; 145: 869–79.
26. Geller SE, Shulman LP, van Breemen RB et al. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause 2009; 16: 1156–66.
27. Grady D. Clinical practice. Management of menopausal symptoms. N Engl J Med 2006; 355: 2338–47.
28. Nelson HD. Menopause. Lancet 2008; 371: 760–70.
29. Muthyala RS, Ju YH, Sheng S et al. Equol, a natural estrogenic metabolite from soy isoflavones: convenient preparation and resolution of R- and
S-equols and their differing binding and biological activity through estrogen receptors alpha and beta. Bioorg Med Chem 2004; 12: 1559–67.
30. Takeuchi S, Takahashi T, Sawada Y et al. Comparative study on the nuclear hormone receptor activity of various phytochemicals and their metabolites by reporter gene assays using Chinese hamster ovary cells. Biol Pharm Bull 2009; 32: 195–202.
31. Crisafulli A, Marini H, Bitto A et al. Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebocontrolled study. Menopause 2004; 11: 400–4.
32. Albertazzi P, Steel SA, Bottazzi M. Effect of pure genistein on bone markers and hot flushes. Climacteric 2005; 8: 371–9.
33. D’Anna R, Cannata ML, Atteritano M et al. Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study. Menopause 2007; 14: 648–55.
34. Messina M, Nagata C, Wu AH. Estimated Asian adult soy protein and isoflavone intakes. Nutr Cancer 2006; 55: 1–12.
35. Ullmann U, Oberwittle H, Grossmann M, Riegger C. Repeated oral once daily intake of increasing doses of the novel synthetic genistein product Bonistein in healthy volunteers. Planta Med 2005; 71: 891–6.
36. Ullmann U, Metzner J, Frank T et al. Safety, tolerability, and pharmacokinetics of single ascending doses of synthetic genistein (Bonistein) in healthy volunteers. Adv Ther 2005; 22: 65–78.
37. Ullmann U, Bendik I, Fllehmann B. Bonistein (synthetic genistein), a food component in development for a bone health nutraceutical. J Physiol Pharmacol 2005; 56: 79–95.
38. Metzner JE, Frank T, Kunz I et al. Study on the pharmacokinetics of synthetic genistein after multiple oral intake in post-menopausal women. Drug Res Arzneimittelforschung 2009; 59 (10): 513–20.
39. Evans M, Elliott JG, Sharma P et al. The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: A multi-center, randomized, placebo-controlled study. Maturitas 2011; 68: 196–214.
40. Marini H, Minutoli L, Polito F et al. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med 2007; 146: 839–47.
41. Marini H, Minutoli L, Polito F et al. OPG and sRANKL serum concentrations in osteopenic, postmenopausal women after 2-year genistein administration. J Bone Miner Res 2008; 23: 715–20.
42. Marini H, Bitto A, Altavilla D et al. Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study. J Clin Endocrinol Metab 2008; 93 (12): 4787–96.
43. Hooper L, Ryder JJ, Kurzer MS et al. Effects of soy protein and isoflavones on circulating hormone concentrations in pre- and post-menopausal women: a systematic review and meta-analysis. Hum Reprod Update 2009; 15: 423–40.
44. Tempfer CB, Froese G, Heinze G et al. Side effects of phytoestrogens: a meta-analysis of randomized trials. Am J Med 2009; 122: 939–46, e9.
45. Unfer V, Casini ML, Costabile L et al. Endometrial effects of long-term treatment with phytoestrogens: a randomized, doubleblind, placebo-controlled study. Fertil Steril 2004; 82: 145–8.
46. Foth D, Nawroth F. Effect of phytoestrogens on the endometrium? Fertil Steril 2005; 83: 256–7 [author reply 7], National Toxicology Program UDoHaHS. Center for the Evaluation of Risks to Human Reproduction. NTP-CERHR expert panel report on the reproductive and developmental toxicity of soy formula. http://cerhrniehsnihgov; 2006.
47. Alekel DL, van Loan MD, Koehler KJ et al. The Soy Isoflavones for Reducing Bone Loss. (SIRBL) Study: a 3-y randomized controlled trial in postmenopausal women. Am J Clin Nutr 2009; 91: 218–30.
48. Horn-Ross PL, John EM, Canchola SL et al. Phytoestrogen intake and endometrial cancer risk. J Natl Cancer Inst 2003; 95: 1158–64.
49. McClain RM, Wolz E, Davidovich A et al. Acute, subchronic and chronic safety studies with genistein in rats. Food Chem Toxicol 2006; 44: 56–80.
50. McClain RM, Wolz E, Davidovich A et al. Reproductive safety studies with genistein in rats. Food Chem Toxicol 2007; 45: 1319–32.
51. McClain RM, Wolz E, Davidovich A et al. Subchronic and chronic safety studies with genistein in dogs. Food Chem Toxicol 2005; 43: 161–82.
52. McClain RM, Wolz E, Davidovich A et al. Genetic toxicity studies with genistein. Food Chem Toxicol 2006; 44: 42–55.
53. Sammartino A, Di Carlo C, Mandato VD et al. Effects of genistein on the endometrium: ultrasonographic evaluation. Gynecol Endocrinol 2003; 17: 45–9.
54. Helferich WG, Andrade JE, Hoagland MS. Phytoestrogens and breast cancer: a complex story. Inflammopharmacology 2008; 16: 219–26.
55. Messina MJ, Wood CE. Soy isoflavones, estrogen therapy, and breast cancer risk: analysis and commentary. Nutr J 2008; 7: 17.
56. Shu XO, Zheng Y, Cai H et al. Soy food intake and breast cancer survival. JAMA 2009; 302: 2437–43.
57. Guha N, Kwan ML, Quesenberry CP et al. Soy isoflavones and risk of cancer recurrence in a cohort of breast cancer survivors: the life after cancer epidemiology study. Breast Cancer Res Treat 2009; 118: 395–405.
________________________________________________
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25. Newton KM, Reed SD, LaCroix AZ et al. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med 2006; 145: 869–79.
26. Geller SE, Shulman LP, van Breemen RB et al. Safety and efficacy of black cohosh and red clover for the management of vasomotor symptoms: a randomized controlled trial. Menopause 2009; 16: 1156–66.
27. Grady D. Clinical practice. Management of menopausal symptoms. N Engl J Med 2006; 355: 2338–47.
28. Nelson HD. Menopause. Lancet 2008; 371: 760–70.
29. Muthyala RS, Ju YH, Sheng S et al. Equol, a natural estrogenic metabolite from soy isoflavones: convenient preparation and resolution of R- and
S-equols and their differing binding and biological activity through estrogen receptors alpha and beta. Bioorg Med Chem 2004; 12: 1559–67.
30. Takeuchi S, Takahashi T, Sawada Y et al. Comparative study on the nuclear hormone receptor activity of various phytochemicals and their metabolites by reporter gene assays using Chinese hamster ovary cells. Biol Pharm Bull 2009; 32: 195–202.
31. Crisafulli A, Marini H, Bitto A et al. Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebocontrolled study. Menopause 2004; 11: 400–4.
32. Albertazzi P, Steel SA, Bottazzi M. Effect of pure genistein on bone markers and hot flushes. Climacteric 2005; 8: 371–9.
33. D’Anna R, Cannata ML, Atteritano M et al. Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study. Menopause 2007; 14: 648–55.
34. Messina M, Nagata C, Wu AH. Estimated Asian adult soy protein and isoflavone intakes. Nutr Cancer 2006; 55: 1–12.
35. Ullmann U, Oberwittle H, Grossmann M, Riegger C. Repeated oral once daily intake of increasing doses of the novel synthetic genistein product Bonistein in healthy volunteers. Planta Med 2005; 71: 891–6.
36. Ullmann U, Metzner J, Frank T et al. Safety, tolerability, and pharmacokinetics of single ascending doses of synthetic genistein (Bonistein) in healthy volunteers. Adv Ther 2005; 22: 65–78.
37. Ullmann U, Bendik I, Fllehmann B. Bonistein (synthetic genistein), a food component in development for a bone health nutraceutical. J Physiol Pharmacol 2005; 56: 79–95.
38. Metzner JE, Frank T, Kunz I et al. Study on the pharmacokinetics of synthetic genistein after multiple oral intake in post-menopausal women. Drug Res Arzneimittelforschung 2009; 59 (10): 513–20.
39. Evans M, Elliott JG, Sharma P et al. The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: A multi-center, randomized, placebo-controlled study. Maturitas 2011; 68: 196–214.
40. Marini H, Minutoli L, Polito F et al. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med 2007; 146: 839–47.
41. Marini H, Minutoli L, Polito F et al. OPG and sRANKL serum concentrations in osteopenic, postmenopausal women after 2-year genistein administration. J Bone Miner Res 2008; 23: 715–20.
42. Marini H, Bitto A, Altavilla D et al. Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study. J Clin Endocrinol Metab 2008; 93 (12): 4787–96.
43. Hooper L, Ryder JJ, Kurzer MS et al. Effects of soy protein and isoflavones on circulating hormone concentrations in pre- and post-menopausal women: a systematic review and meta-analysis. Hum Reprod Update 2009; 15: 423–40.
44. Tempfer CB, Froese G, Heinze G et al. Side effects of phytoestrogens: a meta-analysis of randomized trials. Am J Med 2009; 122: 939–46, e9.
45. Unfer V, Casini ML, Costabile L et al. Endometrial effects of long-term treatment with phytoestrogens: a randomized, doubleblind, placebo-controlled study. Fertil Steril 2004; 82: 145–8.
46. Foth D, Nawroth F. Effect of phytoestrogens on the endometrium? Fertil Steril 2005; 83: 256–7 [author reply 7], National Toxicology Program UDoHaHS. Center for the Evaluation of Risks to Human Reproduction. NTP-CERHR expert panel report on the reproductive and developmental toxicity of soy formula. http://cerhrniehsnihgov; 2006.
47. Alekel DL, van Loan MD, Koehler KJ et al. The Soy Isoflavones for Reducing Bone Loss. (SIRBL) Study: a 3-y randomized controlled trial in postmenopausal women. Am J Clin Nutr 2009; 91: 218–30.
48. Horn-Ross PL, John EM, Canchola SL et al. Phytoestrogen intake and endometrial cancer risk. J Natl Cancer Inst 2003; 95: 1158–64.
49. McClain RM, Wolz E, Davidovich A et al. Acute, subchronic and chronic safety studies with genistein in rats. Food Chem Toxicol 2006; 44: 56–80.
50. McClain RM, Wolz E, Davidovich A et al. Reproductive safety studies with genistein in rats. Food Chem Toxicol 2007; 45: 1319–32.
51. McClain RM, Wolz E, Davidovich A et al. Subchronic and chronic safety studies with genistein in dogs. Food Chem Toxicol 2005; 43: 161–82.
52. McClain RM, Wolz E, Davidovich A et al. Genetic toxicity studies with genistein. Food Chem Toxicol 2006; 44: 42–55.
53. Sammartino A, Di Carlo C, Mandato VD et al. Effects of genistein on the endometrium: ultrasonographic evaluation. Gynecol Endocrinol 2003; 17: 45–9.
54. Helferich WG, Andrade JE, Hoagland MS. Phytoestrogens and breast cancer: a complex story. Inflammopharmacology 2008; 16: 219–26.
55. Messina MJ, Wood CE. Soy isoflavones, estrogen therapy, and breast cancer risk: analysis and commentary. Nutr J 2008; 7: 17.
56. Shu XO, Zheng Y, Cai H et al. Soy food intake and breast cancer survival. JAMA 2009; 302: 2437–43.
57. Guha N, Kwan ML, Quesenberry CP et al. Soy isoflavones and risk of cancer recurrence in a cohort of breast cancer survivors: the life after cancer epidemiology study. Breast Cancer Res Treat 2009; 118: 395–405.
Авторы
И.В.Кузнецова
ГБОУ ВПО Первый МГМУ им. И.М.Сеченова Минздрава РФ; ГОУ ВПО Российский университет дружбы народов, Москва
ГБОУ ВПО Первый МГМУ им. И.М.Сеченова Минздрава РФ; ГОУ ВПО Российский университет дружбы народов, Москва
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