Impact of dose, frequency of administration, and equol production on efficacy of isoflavones for menopausal hot flashes: A pilot randomized trial

Menopause

Volumn 20, Issue 9, 2013, Pages 936-945

  Crawford, Sybil L ^a   Jackson, Elizabeth A ^b   Churchill, Linda ^a   Lampe, Johanna W ^c   Leung, Katherine ^a   Ockene, Judith K ^a  

^a UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Equol producers; Isoflavones; Vasomotor symptoms

Indexed keywords

EQUOL; ISOFLAVONE DERIVATIVE; PLACEBO; PHYTOESTROGEN;

ADULT; AMENORRHEA; ARTICLE; BREAST TENDERNESS; CLIMACTERIUM; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; FEMALE; HEARTBURN; HOT FLUSH; HUMAN; MAJOR CLINICAL STUDY; MENOPAUSE; MENSTRUATION; NAUSEA; PILOT STUDY; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; RASH; SCORING SYSTEM; BIOSYNTHESIS; DIET SUPPLEMENTATION; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECTS; HOT FLASHES; METABOLISM; MIDDLE AGED; QUALITY OF LIFE; TREATMENT OUTCOME; WOMEN'S HEALTH;

ADULT; DIETARY SUPPLEMENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; EQUOL; FEMALE; HOT FLASHES; HUMANS; ISOFLAVONES; MENOPAUSE; MIDDLE AGED; PHYTOESTROGENS; PILOT PROJECTS; QUALITY OF LIFE; TREATMENT OUTCOME; WOMEN'S HEALTH;

EID: 84883655217     PISSN: 10723714     EISSN: 15300374     Source Type: Journal    
DOI: 10.1097/GME.0b013e3182829413     Document Type: Article

References (71)

1. Gold EB, Sternfeld B, Kelsey JL, et al. Relation of demographic and lifestyle factors to symptoms in a multi-racial/ethnic population of women 40-55 years of age. Am J Epidemiol 2000;152:463-473.
2. Kronenberg F. Hot flashes: epidemiology and physiology. Ann N Y Acad Sci 1990;592:52-86; discussion 123-133.
3. Avis NE, Crawford SL, McKinlay SM. Psychosocial, behavioral, and health factors related to menopause symptomatology. Womens Health 1997;3:103-120.
4. Grady D. Management of menopausal symptoms. N Engl J Med 2006; 355:2338-2347.
5. Guthrie JR, Dennerstein L, Taffe JR, Donnelly V. Health careYseeking for menopausal problems. Climacteric 2003;6:112-117.
6. Crandall C. Low-dose estrogen therapy for menopausal women: a review of efficacy and safety. J Womens Health (Larchmt) 2003;12:723-747.
7. North American Menopause Society. The 2012 hormone therapy position statement of The North American Menopause Society. Menopause 2012; 19:257-271.
8. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-333.
9. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004;291:1701-1712.
10. Grady D, Herrington D, Bittner V, et al. Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA 2002;288:49-57.
11. Hulley S, Furberg C, Barrett-Connor E, et al. Noncardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA 2002; 288:58-66.
12. Tsai SA, Stefanick ML, Stafford RS. Trends in menopausal hormone therapy use of US officeYbased physicians, 2000-2009. Menopause 2011;18:385-392.
13. Ettinger B, Wang SM, Leslie RS, et al. Evolution of postmenopausal hormone therapy between 2002 and 2009. Menopause 2012;19:610-615.
14. Newton KM, Buist DS, Keenan NL, Anderson LA, LaCroix AZ. Use of alternative therapies for menopause symptoms: results of a populationbased survey. Obstet Gynecol 2002;100:18-25.
15. Bair YA, Gold EB, Zhang G, et al. Use of complementary and alternative medicine during the menopause transition: longitudinal results from the Study of Women's Health Across the Nation. Menopause 2008;15:32-43.
16. Gold EB, Bair Y, Zhang G, et al. Cross-sectional analysis of specific complementary and alternative medicine (CAM) use by racial/ethnic group and menopausal status: the Study of Women's Health Across the Nation (SWAN). Menopause 2007;14:612-623.
17. Keenan N, Mark S, Fugh-Berman A, et al. Severity of menopausal symptoms and use of both conventional and complementary/alternative therapies. Menopause 2003;10:507-515.
18. North American Menopause Society. The role of soy isoflavones in menopausal health: report of The North American Menopause Society/Wulf H. Utian Translational Science Symposium in Chicago, IL, October 2010. Menopause 2011;18:732-753.
19. Guttuso T Jr. Effective and clinically meaningful non-hormonal hot flash therapies. Maturitas 2012;72:6-12.
20. Bolaños R, Del Castillo A, Francia J. Soy isoflavones versus placebo in the treatment of climacteric vasomotor symptoms: systematic review and meta-analysis. Menopause 2010;17:660-666.
21. Taku K, Melby MK. Kronenberg F, Kurzer MS. Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials. Menopause 2012;19:776-790.
22. Setchell KD, Brown NM, Desai P, et al. Bioavailability of pure isoflavones in healthy humans and analysis of commercial soy isoflavone supplements. J Nutr 2001;131(Suppl 4):1362S-1375S.
23. Setchell KD, Faughnan MS, Avades T, et al. Comparing the pharmacokinetics of daidzein and genistein with the use of C-labeled tracers in premenopausal women. Am J Clin Nutr 2003;77:411-419.
24. Klein MA, Nahin RL, Messina MJ, et al. Guidance from an NIH workshop on designing, implementing and reporting clinical studies of soy interventions. J Nutr 2010;140:1192S-1204S.
25. Washburn S, Burke GL, Morgan T, Anthony M. Effect of soy supplementation on serum lipoproteins, blood pressure, and menopausal symptoms in perimenopausal women. Menopause 1999;6:7-13.
26. Faure ED, Chantre P, Mares P. Effects of a standardized soy extract on hot flushes: a multicenter, double-blind, randomized, placebo-controlled study. Menopause 2002;9:329-334.
27. Han KK, Soares JM, Haidar MA, Rodrigues de Lima G, Baracat EC. Benefits of soy isoflavone therapeutic regimen on menopausal symptoms. Obstet Gynecol 2002;99:389-394.
28. Aso T, Uchiyama S, Matsumura Y, et al. A natural S-equol supplement alleviates hot flushes and other menopausal symptoms in equol nonproducing postmenopausal Japanese women. J Womens Health (Larchmt) 2012;21:92-100.
29. Jenks BH, Iwashita S, Nakagawa Y, et al. A pilot study on the effects of S-equol compared to soy isoflavones on menopausal hot flash frequency and other menopausal symptoms. J Women's Health (Larchmt) 2012;21: 674-682.
30. Ishiwata N, Melby MK, Mizuno S, Watanabe S. New equol supplement for relieving menopausal symptoms: randomized, placebo-controlled trial of Japanese women. Menopause 2009;16:141-148.
31. Lampe JW. Is equol the key to the efficacy of soy foods? Am J Clin Nutr 2009;89:1664S-1667S.
32. Setchell KDR, Clerici C. Equol: history, chemistry, and formation. J Nutr 2010;140:1355S-1362S.
33. Setchell KDR, Clerici C. Equol: pharmacokinetics and biological actions. J Nutr 2010;140:1363S-1368S.
34. Setchell KD, Cole SJ. Method of defining equol-producer status and its frequency among vegetarians. J Nutr 2006;136:2188-2193.
35. Setchell KDR, Brown NM, Lydeking-Olsen E. The clinical importance of the metabolite equolVa clue to the effectiveness of soy and its isoflavones. J Nutr 2002;132:3577-3584.
36. 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 different binding and biological activity through estrogen receptors > and A. Bioorg Med Chem 2004;12: 1559-1567.
37. Barnes S, Kim H. Cautions and research needs identified at the equol, soy, and menopause research leadership conference. J Nutr 2010;140: 1390S-1394S.
38. Newton KM, Grady D. Soy isoflavones for prevention of menopausal bone loss and vasomotor symptoms: comment on BSoy isoflavones in the prevention of menopausal bone loss and menopausal symptoms[ Arch Intern Med 2011;171:1363-1369.
39. Shor D, Sathyapalan T, Atkin SL, Thatcher NJ. Does equol production determine soy endocrine effects? Eur J Nutr 2012;51:389-398.
40. Soules MR, Sherman S, Parrott E, et al. Executive summary: Stages of Reproductive Aging Workshop (STRAW). Fertil Steril 2001;76:874-878.
41. Tice JA, Ettinger B, Ensrud K, Wallace R, Blackwell T, Cummings SR. Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial. JAMA 2003; 290:207-214.
42. Guttuso T Jr, Kurlan R, McDermott MP, Kieburtz K. Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trial. Obstet Gynecol 2003;101:337-345.
43. van de Weijer PH, Barentsen R. Isoflavones from red clover (Promensil) significantly reduce menopausal hot flush symptoms compared with placebo. Maturitas 2002;42:187-193.
44. Newton KM, Reed SD, Grothaus L, et al. The Herbal Alternatives for Menopause (HALT) Study: background and study design. Maturitas 2005;52:134-146.
45. Albertazzi P, Pansini F, Bonaccorsi G, Zanotti L, Forini E, Aloysio DD. The effect of dietary soy supplementation on hot flushes. Obstet Gynecol 1998;91:6-11.
46. Burke GL, Legault C, Anthony M, 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.
47. StataCorp. Stata Statistical Software: Release 9. College Station, TX: StataCorp LP, 2005.
48. Griffith AP, Collison MW. Improved methods for the extraction and analysis of isoflavones from soy-containing foods and nutritional supplements by reversed-phase high-performance liquid chromatography and liquid chromatographyYmass spectrometry. J Chromatogr A 2001; 913:397-413.
49. Erdman JW Jr, Badger TM, Lampe JW, Setchell KDR, Messina M. Not all soy products are created equal: caution needed in interpretation of research results. J Nutr 2004;134:1229S-1233S.
50. Williamson-Hughes P, Flickinger BD, Messina MJ, Empie MW. Isoflavone supplements containing predominantly genistein reduce hot flash symptoms: a critical review of published studies. Menopause 2006;13: 831-839.
51. Frankenfeld CL, McTiernan A, Tworoger SS, et al. Serum steroid hormones, sex hormoneYbinding globulin concentrations, and urinary hydroxylated estrogen metabolites in post-menopausal women in relation to daidzein-metabolizing phenotypes. J Steroid Biochem Mol Biol 2004;88: 399-408.
52. Atkinson C, Newton KM, Bowles EJ, Yong M, Lampe JW. Demographic, anthropometric, and lifestyle factors and dietary intakes in relation to daidzein-metabolizing phenotypes among premenopausal women in the United States. Am J Clin Nutr 2008;87:679-687.
53. Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol 2001;19:4280-4290.
54. Carmody J, Crawford S, Salmoirago-Blotcher E, Leung K, Churchill L, Olendzki N. Mindfulness training for coping with hot flashes: results of a randomized trial. Menopause 2011;18:611-620.
55. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 1983;24:385-396.
56. Hilditch JR, Lewis J, Ross AH, et al. A comparison of the effects of oral conjugated equine estrogen and transdermal estradiol-17A combined with an oral progestin on quality of life in postmenopausal women. Maturitas 1996;24:177-184.
57. Greene JG. Constructing a standard climacteric scale. Maturitas 1998; 29:25-31.
58. Carpenter J. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage 2001;22:979-989.
59. Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis. Hoboken, NJ: Wiley, 2004.
60. Chuang-Stein C, Tong DM. The impact and implication of regression to the mean on the design and analysis of medical investigations. Stat Methods Med Res 1997;6:115-128.
61. Avis NE, Legault C, Coeytaux RR, et al. A randomized, controlled pilot study of acupuncture treatment for hot flashes. Menopause 2008;15: 1070-1078.
62. Jackson RL, Greiwe JS, Desai PB, Schwen RJ. Single-dose and steadystate pharmacokinetic studies of S-equol, a potent nonhormonal, estrogen receptor A-agonist being developed for the treatment of menopausal symptoms. Menopause 2011;18:185-193.
63. Uchiyama S, Ueno T, Masaki K, Shimizu S, Aso T, Shirota T. The cross-sectional study of the relationship between soy isoflavones, equol and the menopausal symptoms in Japanese women. J Jpn Menopause Soc 2007;15:28-37.
64. Jou HJ, Wu SC, Chang FW, Ling PY, Chu KS, Wu WH. Effect of intestinal production of equol on menopausal symptoms in women treated with soy isoflavones. Int J Gynecol Obstet 2008;102:44-49.
65. Uesugi S, Watanabe S, Ishiwata N, Uchara M, Ouchi K. Effects of isoflavone supplements on bone metabolic markers and climacteric symptoms in Japanese women. Biofactors 2004;22:221-228.
66. Huang M-H, Norris J, Han W, et al. Development of an updated phytoestrogen database for use with the SWAN Food Frequency Questionnaire: intakes and food sources in a community-based, multiethnic cohort study. Nutr Cancer 2012;64:228-244.
67. Hoey L, Rowland IR, Lloyd AS, Clarke DB, Wiseman H. Influence of soya-based infant formula consumption on isoflavone and gut microflora metabolite concentrations in urine and on faecal microflora composition and metabolic activity in infants and children. Br J Nutr 2004;91: 607-616.
68. Rafii F, Davis C, Park M, Heinze TM, Beger RD. Variations in metabolism of the soy isoflavonoid daidzein by human intestinal microfloras from different individuals. Arch Microbiol 2003;180:11-16.
69. Karr SC, Lampe JW, Hutchins AM, Slavin JL. Urinary isoflavonoid excretion in humans is dose dependent at low to moderate levels of soy-protein consumption. Am J Clin Nutr 1997;66:46-51.
70. Avis NE, Stellato R, Crawford S, et al. Is there a menopausal syndrome? Menopausal status and symptoms across racial/ethnic groups. Soc Sci Med 2001;52:345-356.
71. Guttuso T Jr, Evans M. Minimum trial duration to reasonably assess long-term efficacy of nonhormonal hot flash therapies. J Womens Health(Larchmt) 2010;19:699-702.