Efficacy of isoflavones in relieving vasomotor menopausal symptoms - A systematic review

Molecular Nutrition and Food Research

Volumn 53, Issue 9, 2009, Pages 1084-1097

  Jacobs, Anja ^a   Wegewitz, Uta ^a   Sommerfeld, Christine ^a   Grossklaus, Rolf ^a   Lampen, Alfonso ^a  

^a FEDERAL INSTITUTE FOR RISK ASSESSMENT   (Germany)

Author keywords

Efficacy; Hot flushes; Isoflavone; Menopause; Soy

Indexed keywords

GENISTEIN; ISOFLAVONE DERIVATIVE; PLANT EXTRACT;

FEMALE; HOT FLUSH; HUMAN; MENOPAUSE; RANDOMIZED CONTROLLED TRIAL; REVIEW; SOYBEAN;

FEMALE; GENISTEIN; HOT FLASHES; HUMANS; ISOFLAVONES; MENOPAUSE; PLANT EXTRACTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SOYBEANS;

TRIFOLIUM PRATENSE;

EID: 70349642264     PISSN: 16134125     EISSN: 16134133     Source Type: Journal    
DOI: 10.1002/mnfr.200800552     Document Type: Review

References (75)

1. Usui, T., Pharmaceutical prospects of phytoestrogens, Endocr. J. 2006, 53, 7-20.
2. Adlercreutz, H., Mazur, W., Phyto-oestrogens and Western diseases, Ann. Med. 1997, 29, 95-120.
3. Hulem, R., Blair, R. M., Soy isoflavones for postmenopausal symptoms. An examination of evidence, Adv. Nurse Pract. 2006, 14, 32-38.
4. Kuiper, G. G., Lemmen, J. G., Carlsson, B., Corton, J. C., et al., Interaction of estrogenic chemicals and phytoestrogens with estrogen receptor beta, Endocrinology 1998, 139, 4252-4263.
5. Booth, N. L., Overk, C. R., Yao, P., Burdette, J. E., et al., The chemical and biologic profile of a red clover (Trifolium pratense L.) phase II clinical extract, J Altern. Complement Med. 2006, 12, 133-139.
6. Fugh-Berman, A., Kronenberg, F., Red clover (Trifolium pratense) for menopausal women: Current state of knowledge, Menopause 2001, 8, 333-337.
7. Freedman, R. R., Hot flashes: Behavioral treatments, mechanisms, and relation to sleep, Am. J. Med. 2005, 118 (12B), 124-130.
8. Freeman, E. W., Sherif, K., Prevalence of hot flushes and night sweats around the world: A systematic review, Climacteric 2007, 10, 197-214.
9. WHO, Research on the menopause in the 1990s. Report of a WHO scientific group, World Health Organ Tech Rep Ser. 1996, 866, 1-107.
10. National Institutes of Health, State-of-the-Science Conference statement: Management of menopause-related symptoms, Ann. Intern. Med. 2005, 142, 1003-1013.
11. Farquhar, C. M., Marjoribanks, J., Lethaby, A., Lamberts, Q., Suckling, J. A., Long term hormone therapy for perimenopausal and postmenopausalwomen, Cochrane Database Syst. Rev. 2005, CD004143. DOI: 10.1002/14651858.CD0041 43.pub2.
12. Flesch-Janys, D., Slanger, T., Mutschelknauss, E., Kropp, S. et al., Risk of different histological types of postmenopausal breast cancer by type and regimen of menopausal hormone therapy, Int. J. Cancer 2008, 123, 933-941.
13. Nagata, C., Shimizu, H., Takami, R., Hayashi, M., et al., Hot flushes and other menopausal symptoms in relation to soy product intake in Japanese women, Climacteric 1999, 2, 6-12.
14. Messina, M., Nagata, C., Wu, A. H., Estimated Asian adult soy protein and isoflavone intakes, Nutr. Cancer 2006, 55, 1-12.
15. Munro, I. C., Harwood, M., Hlywka, J. J., Stephen, A. M., et al., Soy isoflavones: A safety review, Nutr. Rev. 2003, 61, 1-33.
16. Adams, C., Cannell, S., Women's beliefs about"natural" hormones and natural hormone replacement therapy, Menopause 2001, 8, 433-440.
17. Coon, J. T., Pittler, M. H., Ernst, E., Trifolium pratense isoflavones in the treatment of menopausal hot flushes: A systematic review and meta-analysis, Phytomedicine 2007, 14, 153-159.
18. Howes, L. G., Howes, J. B., Knight, D. C., Isoflavone therapyfor menopausal flushes: A systematic review and meta-analysis, Maturitas 2006, 55, 203-211.
19. Lethaby, A. E., Brown, J., Marjoribanks, J., Kronenberg, F., et al., Phytoestrogens for vasomotor menopausal symptoms, Cochrane Database Syst. Rev. 2007, CD001395.
20. Nelson, H. D., Vesco, K. K., Haney, E., Fu, R., et al., Nonhormonal therapies for menopausal hot flashes: Systematic review and meta-analysis, JAMA 2006, 295, 2057-2071.
21. Krebs, E. E., Ensrud, K. E., MacDonald, R., Wilt, T. J., Phytoestrogens for treatment of menopausal symptoms: A systematic review, Obstet. Gynecol. 2004, 104, 824-836.
22. Balk, E., Chung, M., Chew, P., Ip, S. et al., Effects of soy on health outcomes, Evid. Rep. Technol. Assess. (Summ.) 2005, 1-8.
23. Sloan, J. A., Loprinzi, C. L., Novotny, P. J., Barton, D. L., et al., Methodologic lessons learned from hot flash studies, J. Clin. Oncol. 2001, 19, 4280-4290.
24. Setchell, K. D., Absorption and metabolism of soy isoflavones-from food to dietary supplements and adults to infants, J. Nutr. 2000, 130, 654-655.
25. FDA HRT Working Group, Guidance for Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women, Menopause 1995, 2, 131-136.
26. Jadad, A. R., Moher, D., Klassen, T. P., Guides for reading and interpreting systematic reviews: II. How did the authors find the studies and assess their quality?, Arch Pediatr. Adolesc. Med. 1998, 152, 812-817.
27. Olivo, S. A., Macedo, L. G., Gadotti, I. C., Fuentes, J., et al., Scales to assess the quality of randomized controlled trials: A systematic review, Phys. Ther. 2008, 88, 156-175.
28. Moher, D., Schulz, K. F., Altman, D. G., The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials, Clin. Oral Investig. 2003, 7, 2-7.
29. Kunz, R., Vist, G., Oxman, A. D., Randomisation to protect against selection bias in healthcare trials, Cochrane Database Syst. Rev. 2007, MR000012.
30. Schulz, K. F., Grimes, D. A., Allocation concealment in randomised trials: Defending against deciphering, Lancet 2002, 359, 614-618.
31. Schulz, K. F., Grimes, D. A., Blinding in randomised trials: Hiding who got what, Lancet 2002, 359, 696-700.
32. Schulz, K. F., Grimes, D. A., Sample size slippages in randomised trials: Exclusions and the lost and wayward, Lancet 2002, 359, 781-785.
33. Lachin, J. M., Statistical considerations in the intent-to-treat principle, Control Clin. Trials 2000, 21, 167-189.
34. Xue, X., Niu, J., Wang, J., Ai, H., A prospective controlled study on the clinical therapeutic effect of treatment of menstrual syndrome by isoflavone of soybean, Zhongguo Zhong Xi Yi Jie He Za Zhi 2004, 24, 835-836.
35. Baber, R. J., Templeman, C., Morton, T., Kelly, G. E., West, L., Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women, Climacteric 1999, 2, 85-92.
36. Hidalgo, L. A., Chedraui, P. A., Morocho, N., Ross, S., San Miguel, G., The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: A randomized, double-blind, placebo-controlled study, Gynecol. Endocrinol. 2005, 21, 257-264.
37. Jeri, A., The use of an isoflavone supplement to relieve hot flushes, The Female Patients 2002, 27, 35-37.
38. Knight, D. C., Howes, J. B., Eden, J. A., The effect of Promensil, an isoflavone extract, on menopausal symptoms, Climacteric 1999, 2, 79-84.
39. Tice, J. A., Ettinger, B., Ensrud, K., Wallace, R., et al., Phytoestrogen supplements for the treatment of hot flashes: The Isoflavone Clover Extract (ICE) Study: A randomized controlled trial, JAMA 2003, 290, 207-214.
40. van de Weijer, P. H., Barentsen, R., Isoflavones from red clover (Promensil) significantly reduce menopausal hot flush symptoms compared with placebo, Maturitas 2002, 42, 187-193.
41. Campagnoli, C., Abba, C., Ambroggio, S., Peris, C., et al., PUFAs (PUFAs) might reduce hot flushes: An indication from two controlled trials on soy isoflavones alone and with a PUFA supplement, Maturitas 2005, 51, 127-134.
42. Marini, H., Minutoli, L., Polito, F., Bitto, A., et al., Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: A randomized trial, Ann. Intern. Med. 2007, 146, 839-847.
43. Stanosz, S., Puk, E., Grobelny, W., Stanosz, M., Kazikowska, A., Ocena dzialania i tolerancji preparatu Soyfem u kobiet we wczesnym okresie pomenopauzalnym [Evaluation of the efficacy and tolerance of Soyfem in women in the early menopausal period], Przew Lek. 2006, 5, 103-114.
44. St Germain, A., Peterson, C. T., Robinson, J. G., Alekel, D. L., Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 wks of treatment, Menopause 2001, 8, 17-26.
45. Cheng, G., Wilczek, B., Warner, M., Gustafsson, J. A., Landgren, B. M., Isoflavone treatment for acute menopausal symptoms, Menopause 2007, 14, 468-473.
46. Knight, D. C., Howes, J. B., Eden, J. A., Howes, L. G., Effects on menopausal symptoms and acceptability of isoflavonecontaining soy powder dietary supplementation, Climacteric 2001, 4, 13-18.
47. Crisafulli, A., Marini, H., Bitto, A., Altavilla, D., et al., Effects of genistein on hot flushes in early postmenopausal women: A randomized, double-blind EPT- and placebo-controlled study, Menopause 2004, 11, 400-404.
48. D'Anna, R., Cannata, M. L., Atteritano, M., Cancellieri, F., et al., Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausalwomen: A 1-year randomized, double-blind, placebo-con-trolled study, Menopause 2007, 14, 648-655.
49. Khaodhiar, L., Ricciotti, H. A., Li, L., Pan, W., et al., Daid-zein-rich isoflavone aglycones are potentially effective inreducing hot flashes in menopausal women, Menopause 2008, 15, 125-132.
50. Nahas, E. A., Nahas-Neto, J., Orsatti, F. L., Carvalho, E. P., et al., Efficacy and safety of a soy isoflavone extract in postme-nopausal women: A randomized, double-blind, and placebo-controlled study, Maturitas 2007, 58, 249-258.
51. Albertazzi, P., Pansini, F., Bonaccorsi, G., Zanotti, L., et al., The effect of dietary soy supplementation on hot flushes, Obstet. Gynecol. 1998, 91, 6-11.
52. de Sousa, R. L., Filizola, R. G., Diniz, M. d. F., E. S. S., S., de Moraes, J. L. R., Ensaio cl¡nico placebo-controlado com iso-flavonas da soja para sintomas depressivos em mulheres noclimat, rio [Placebo-controlled clinical trial with soy isoflavones for depressive symptoms in climacteric women], Rev. Bras. Ginecol. Obstet. 2006, 28, 91-100.
53. Upmalis, D. H., Lobo, R., Bradley, L., Warren, M., et al., Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: A multicenter, double-blind, randomized, placebo-controlled study, Menopause 2000, 7, 236-242.
54. Burke, G. L., Legault, C., Anthony, M., Bland, D. R. et al., Soy protein and isoflavone effects on vasomotor symptoms in peri- and postmenopausal women: The soy estrogen alternative study, Menopause 2003, 10, 147-153.
55. Duffy, R., Wiseman, H., File, S. E., Improved cognitive function in postmenopausal women after 12 wks of consumptionof a soya extract containing isoflavones, Pharmacol. Biochem. Behav. 2003, 75, 721-729.
56. Soules, M. R., Sherman, S., Parrott, E., Rebar, R., et al., Executive summary: Stages of reproductive aging workshop(STRAW), Climacteric 2001, 4, 267-272.
57. Han, K. K., Soares, J. M., Jr., Haidar, M. A., de Lima, G. R., Baracat, E. C., Benefits of soy isoflavone therapeutic regimenon menopausal symptoms, Obstet. Gynecol. 2002, 99, 389-394.
58. Penotti, M., Fabio, E., Modena, A. B., Rinaldi, M., et al., Effect of soy-derived isoflavones on hot flushes, endometrialthickness, and the pulsatility index of the uterine and cerebralarteries, Fertil. Steril. 2003, 79, 1112-1117.
59. Faure, E. D., Chantre, P., Mares, P., Effects of a standardizedsoy extract on hot flushes: A multicenter, double-blind, randomized, placebo-controlled study, Menopause 2002, 9, 329-334.
60. Morabito, N., Crisafulli, A., Vergara, C., Gaudio, A., et al., Effects of genistein and hormone-replacement therapy on bone loss in early postmenopausal women: A randomizeddouble-blind placebo-controlled study, J. Bone Miner Res.2002, 17, 1904-1912.
61. Jacobe, H. T., Leitenberger, J. J., Bergstresser, P. R., Understanding clinical trial outcomes: Design, analysis, and interpretation, Dermatol. Ther. 2007, 20, 77-85.
62. Schulz, K. F., Grimes, D. A., Multiplicity in randomised trials II: Subgroup and interim analyses, Lancet 2005, 365, 1657-1661.
63. Williamson-Hughes, P. S., Flickinger, B. D., Messina, M. J., Empie, M. W., Isoflavone supplements containing predominantly genistein reduce hot flash symptoms: A critical review of published studies, Menopause 2006, 13, 831-839.
64. Gold, E. B., Colvin, A., Avis, N., Bromberger, J., 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, 1226-1235.
65. Alder, E., The Blatt-Kupperman menopausal index: A critique, Maturitas 1998, 29, 19-24.
66. Simon, J. A., Stevens, R. E., Ayres, S. A., Phelps, K. V., Perimenopausal women in estrogen vasomotor trials: Contribution to placebo effect and efficacy outcome, Climacteric 2001, 4, 19-27.
67. Cassidy, A., Albertazzi, P., Lise, N. I., Hall, W., et al., Critical review of health effects of soyabean phyto-oestrogens in postmenopausalwomen, Proc. Nutr. Soc. 2006, 65, 76-92.
68. Manach, C., Williamson, G., Morand, C., Scalbert, A., Remesy, C., Bioavailability and bioefficacy of polyphenols in humans. I. Review of 97 bioavailability studies, Am. J. Clin. Nutr. 2005, 81, 230S-242S.
69. Setchell, K. D., Faughnan, M. S., Avades, T., Zimmer-Nechemias, L. et al., Comparing the pharmacokinetics of daidzein and genistein with the use of 13C-labeled tracers in premenopausalwomen, Am. J. Clin. Nutr. 2003, 77, 411-419.
70. Setchell, K. D., Brown, N. M., Desai, P., Zimmer-Nechemias, L., et al., Bioavailability of pure isoflavones in healthy humans and analysis of commercial soy isoflavone supplements, J. Nutr. 2001, 131, 1362-1375.
71. Setchell, K. D., Brown, N. M., Lydeking-Olsen, E., The clinical importance of the metabolite equol-a clue to the effectiveness of soy and its isoflavones, J. Nutr. 2002, 132, 3577-3584.
72. Yuan, J. P., Wang, J. H., Liu, X., Metabolism of dietary soy isoflavones to equol by human intestinal microflora-implications for health, Mol. Nutr. Food Res. 2007, 51, 765-781.
73. Jou, H. J., Wu, S. C., Chang, F. W., Ling, P. Y., et al., Effect of intestinal production of equol on menopausal symptoms in women treated with soy isoflavones, Int. J. Gynaecol. Obstet. 2008, 102, 44-49.
74. Colacurci, N., Zarcone, R., Borrelli, A., De Franciscis, P., et al., Effects of soy isoflavones on menopausal neurovegetative symptoms, Minerva Ginecol. 2004, 56, 407-412.
75. Messina, M., The safety and benefits of soybean isoflavones. A natural alternative to conventional hormone therapy?, Menopause 2007, 14, 958; author reply 958-959.