본문 바로가기
KERD
논문KCI 등재

Effect of soy isoflavones supplement on climacteric symptoms, bone biomarkers, and quality of life in Korean postmenopausal women: a randomized clinical trial

2

조회

0

다운로드

3

인용

0

참고문헌

키워드

초록

BACKGROUND/OBJECTIVES: Soy isoflavones are expected to improve menopausal symptoms and osteoporosis in women. However, their efficacy is still inconclusive, and there was limited data for postmenopausal women in South Korea. We examined the effects of soy isoflavones on climacteric symptoms, bone biomarkers, and quality of life in Korean postmenopausal women. SUBJECTS/METHODS: A randomized, double-blind study design was used. Eighty-seven participants who had undergone natural menopause were randomly administered either 70 mg/day isoflavones (n = 43) or placebo (n = 41) for 12 weeks. We assessed the Kupperman index for climacteric symptoms and the menopause-specific quality of life (MENQOL) questionnaire for quality of the life. Biomarkers of bone metabolism were also measured in serum bone-specific alkaline phosphatase (BALP), osteocalcin (OC), N- and C-terminal cross-linking telopeptides of type Ι collagen (NTx, CTx), and urine-deoxypyridinolin (u-DPD). RESULTS: Scores of the Kupperman index were decreased in both the isoflavones group (-7.0 ± 15.8, P = 0.0074) and placebo group (-6.3 ± 14.6, P = 0.0064) during the intervention, but no significant difference was noted between the groups. Regarding the bone formation markers, the level of serum BALP increased by 6.3 ± 4.1% (P = 0.004) and OC increased by 9.3 ± 6.2% (P < 0.001), meanwhile those of the placebo were not changed. For the bone resorption markers, NTx, CTx, and u-DPD were not significantly different in either group. MENQOL was significant decreased in the isoflavone group (-0.6 ± 0.5) and placebo group (-0.6 ± 0.4), with a significant difference between groups (P = 0.0228). CONCLUSIONS: Our study suggests that 70 mg isoflavones supplement has beneficial effects on bone formation markers; however, it showed no benefit compared to the placebo on climacteric symptoms or quality of life.

Abstract

BACKGROUND/OBJECTIVES: Soy isoflavones are expected to improve menopausal symptoms and osteoporosis in women. However, their efficacy is still inconclusive, and there was limited data for postmenopausal women in South Korea. We examined the effects of soy isoflavones on climacteric symptoms, bone biomarkers, and quality of life in Korean postmenopausal women. SUBJECTS/METHODS: A randomized, double-blind study design was used. Eighty-seven participants who had undergone natural menopause were randomly administered either 70 mg/day isoflavones (n = 43) or placebo (n = 41) for 12 weeks. We assessed the Kupperman index for climacteric symptoms and the menopause-specific quality of life (MENQOL) questionnaire for quality of the life. Biomarkers of bone metabolism were also measured in serum bone-specific alkaline phosphatase (BALP), osteocalcin (OC), N- and C-terminal cross-linking telopeptides of type Ι collagen (NTx, CTx), and urine-deoxypyridinolin (u-DPD). RESULTS: Scores of the Kupperman index were decreased in both the isoflavones group (-7.0 ± 15.8, P = 0.0074) and placebo group (-6.3 ± 14.6, P = 0.0064) during the intervention, but no significant difference was noted between the groups. Regarding the bone formation markers, the level of serum BALP increased by 6.3 ± 4.1% (P = 0.004) and OC increased by 9.3 ± 6.2% (P < 0.001), meanwhile those of the placebo were not changed. For the bone resorption markers, NTx, CTx, and u-DPD were not significantly different in either group. MENQOL was significant decreased in the isoflavone group (-0.6 ± 0.5) and placebo group (-0.6 ± 0.4), with a significant difference between groups (P = 0.0228). CONCLUSIONS: Our study suggests that 70 mg isoflavones supplement has beneficial effects on bone formation markers; however, it showed no benefit compared to the placebo on climacteric symptoms or quality of life.

참고문헌 (46)

  1. Han KK, "Benefits of soy isoflavone therapeutic regimen on menopausal symptoms", Obstet Gynecol, 99, pp.389~394 (2002)
  2. Nahas EA, "Efficacy and safety of a soy isoflavone extract in postmenopausal women: a randomized, double-blind, and placebo-controlled study", Maturitas, 58, pp.249~258 (2007)
  3. Ferrari A, "Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms", J Obstet Gynaecol Res, 35, pp.1083~1090 (2009)
  4. Albertazzi P, "Effect of pure genistein on bone markers and hot flushes", Climacteric, 8, pp.371~379 (2005)
  5. Cancellieri F, "Efficacy on menopausal neurovegetative symptoms and some plasma lipids blood levels of an herbal product containing isoflavones and other plant extracts", Maturitas, 56, pp.249~256 (2007)
  6. Evans M, "The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: a multi-center, randomized, placebocontrolled study", Maturitas, 68, pp.189~196 (2011)
  7. Yamori Y, "Soybean isoflavones reduce postmenopausal bone resorption in female Japanese immigrants in Brazil: a ten-week study", J Am Coll Nutr, 21, pp.560~563 (2002)
  8. Murkies AL, "Dietary flour supplementation decreases post-menopausal hot flushes: effect of soy and wheat", Maturitas, 21, pp.189~195 (1995)
  9. Washburn S, "Effect of soy protein supplementation on serum lipoproteins, blood pressure, and menopausal symptoms in perimenopausal women", Menopause, 6, pp.7~13 (1999)
  10. Alekel DL, "Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of perimenopausal women", Am J Clin Nutr, 72, pp.844~852 (2000)
  11. Wangen KE, "Effects of soy isoflavones on markers of bone turnover in premenopausal and postmenopausal women", J Clin Endocrinol Metab, 85, pp.3043~3048 (2000)
  12. Dennerstein L, "A prospective population-based study of menopausal symptoms", Obstet Gynecol, 96, pp.351~358 (2000)
  13. Levis S, "Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial", Arch Intern Med, 171, pp.1363~1369 (2011)
  14. Dodin S, "The effects of flaxseed dietary supplement on lipid profile, bone mineral density, and symptoms in menopausal women: a randomized, double-blind, wheat germ placebo-controlled clinical trial", J Clin Endocrinol Metab, 90, pp.1390~1397 (2005)
  15. Khaodhiar L, "Daidzein-rich isoflavone aglycones are potentially effective in reducing hot flashes in menopausal women", Menopause, 15, pp.125~132 (2008)
  16. Nelson HD, "Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis", JAMA, 295, pp.2057~2071 (2006)
  17. 이민준, "Estimated dietary isoflavone intake among Korean adults", Nutrition Research and Practice, 1(3), pp.206~211 (2007), 한국영양학회
  18. de Kleijn MJ, "Intake of dietary phytoestrogens is low in postmenopausal women in the United States: the Framingham study(1-4)", J Nutr, 131, pp.1826~1832 (2001)
  19. Keinan-Boker L, "Soy product consumption in 10 European countries: the European Prospective Investigation into Cancer and Nutrition (EPIC) study", Public Health Nutr, 5, pp.1217~1226 (2002)
  20. Chun OK, "Estimated dietary flavonoid intake and major food sources of U.S. adults", J Nutr, 137, pp.1244~1252 (2007)
  21. "Clinical Research Information Service"[URL]
  22. Petri Nahas E, "Benefits of soy germ isoflavones in postmenopausal women with contraindication for conventional hormone replacement therapy", Maturitas, 48, pp.372~380 (2004)
  23. Association of Official Analytical Chemists (US), "Official Methods of Analysis of AOAC International" (2005), AOAC International
  24. "Fundamental concepts in the safety assessment of foods containing soy isoflavones for the purpose of specified health use, in Japanese" (2006)[URL]
  25. Lee SK, "Estimated isoflavone intake from soy products in Korean middle-aged women", J Korean Soc Food Sci Nutr, 29, pp.948~956 (2000)
  26. "USDA database on the isoflavone content of selected food: release 2.0" (2008)[URL]
  27. Wakai K, "Dietary intake and sources of isoflavones among Japanese", Nutr Cancer, 33, pp.139~145 (1999)
  28. Kim MS, "A study on the menopause management practice and the quality of life in climacteric women", J Korean Soc Matern Child Health, 3, pp.75~87 (1999)
  29. Hilditch JR, "A menopause-specific quality of life questionnaire: development and psychometric properties", Maturitas, 24, pp.161~175 (1996)
  30. Moher D, "The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials", Lancet, 357, pp.1191~1194 (2001)
  31. Ye YB, "Soy germ isoflavones improve menopausal symptoms but have no effect on blood lipids in early postmenopausal Chinese women: a randomized placebo-controlled trial", Menopause, 19, pp.791~798 (2012)
  32. Taku K, "Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials", Menopause, 19, pp.776~790 (2012)
  33. Taku K, "Effects of soy isoflavone supplements on bone turnover markers in menopausal women: systematic review and meta-analysis of randomized controlled trials", Bone, 47, pp.413~423 (2010)
  34. Morabito N, "Effects of genistein and hormone-replacement therapy on bone loss in early postmenopausal women: a randomized double-blind placebo-controlled study", J Bone Miner Res, 17, pp.1904~1912 (2002)
  35. Choi EM, "Soybean ethanol extract increases the function of osteoblastic MC3T3-E1 cells", Phytochemistry, 56, pp.733~739 (2001)
  36. Kanno S, "Effects of phytoestrogens and environmental estrogens on osteoblastic differentiation in MC3T3-E1cells", Toxicology, 196, pp.137~145 (2004)
  37. Sugimoto T, "Serum levels of insulin-like growth factor (IGF) I, IGF-binding protein (IGFBP)-2, and IGFBP-3 in osteoporotic patients with and without spinal fractures", J Bone Miner Res, 12, pp.1272~1279 (1997)
  38. Dalais FS, "The effects of soy protein containing isoflavones on lipids and indices of bone resorption in postmenopausal women", Clin Endocrinol (Oxf), 58, pp.704~709 (2003)
  39. Védrine N, "One-month exposure to soy isoflavones did not induce the ability to produce equol in postmenopausal women", Eur J Clin Nutr, 60, pp.1039~1045 (2006)
  40. Thomas AJ, "Effects of isoflavones and amino acid therapies for hot flashes and co-occurring symptoms during the menopausal transition and early postmenopause: a systematic review", Maturitas, 78, pp.263~276 (2014)
  41. Wu J, "Cooperative effects of isoflavones and exercise on bone and lipid metabolism in postmenopausal Japanese women: a randomized placebo-controlled trial", Metabolism, 55, pp.423~433 (2006)
  42. Hall WL, "Soy-isoflavoneenriched foods and inflammatory biomarkers of cardiovascular disease risk in postmenopausal women: interactions with genotype and equol production", Am J Clin Nutr, 82, pp.1260~1268 (2005)
  43. Tousen Y, "Natural S-equol decreases bone resorption in postmenopausal, non-equolproducing Japanese women: a pilot randomized, placebo-controlled trial", Menopause, 18, pp.563~574 (2011)
  44. Loprinzi CL, "Newer antidepressants and gabapentin for hot flashes:an individual patient pooled analysis", J Clin Oncol, 27, pp.2831~2837 (2009)
  45. "Guidance for industry estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms: recommendations for clinical evaluation" (2003)[URL]
  46. Enck P, "Novel study designs to investigate the placebo response", BMC Med Res Methodol, 11, pp.90~ (2011)

관련 논문AI추천

이 간행물의 다른 논문 (9건)