26 2 (2005 6 ) J Korean Oriental Med 2005;26(2):182-194 World Research Trends in Hormone Replacement Therapy (HRT) for Postmenopausal Women and Traditional Korean Medicine (TKM) Research Group s Response Dong-Il Kim Dept. of Ob & Gy, College of Oriental Medicine, Dongguk Univ. Objectives : After the discontinuance of the Women s Health Initiative (WHI) clinical trial in the U.S. in July 2002, I thought that the domestic medical field would come to a crisis in hormonal treatment for perimenopausal and postmenopausal women. However, the domestic condition of HRT has barely changed. This study was designed to investigate world research trends in HRT and bring forward the response of the Traditional Korean Medicine (TKM) Research Group. Methods : I investigated recent domestic and world research trends about HRT and climacteric syndrome. Based on this analysis, I predicted western medical research trends and direction for HRT and medical care of perimenopausal and postmenopausal women. Results and Conclusions : I propose that we (TKM Research Group) have to explain the side effects of HRT for postmenopausal women and try to suggest complementary therapy for it. For that aim, the Association of Korean Medicine s effort is very important, as well as personal practitioner s actions. Key Words: Menopause, hormone replacement therapy (HRT), Traditional Korean Medicine (TKM), complementary and alternative therapy (CAM therapy) : 2005 4 28 : 2005 5 3 : 2005 5 22 : 1 37-21 (Tel..02-3416-9737, obgykdi@dongguk.ac.kr. ) (physiologic aging) (endocrine disease) estrogen (HRT, hormone replacement therapy) 2002 WHI 182
(HRT) (389) 60 HRT HERS(Heart and Estrogen/progestin Replacement Study) HRT (informed consent) HRT HRT HRT 2002 1) 37 10 54 3 0.9 1.6 2) HRT HRT 60 HRT estrogen progesterone 1998 HERS 3) FDA 2002 WHI estrogen/progestin 4) 2004 estrogen 5) 2002 WHI HRT estrogen/progestin Panacea HRT HRT HRT 6) HRT 1995 HRT 5.2 7) 2002 24.3 HRT 10.8 1) 53.6 HRT 72.2 62.2 8) HRT 183
(390) 26 2 (2005 6 ) 47 HRT 2002 HRT 2 (1946-1964 ) 9) 2002 HRT HRT 2002 WHI 1) WHI(Women s Health Initiatives) WHI Levens Willams 10) WHI 7 2 2002 9 HRT (45-65 2004 6 AMJ of Ob & Gy WHI HRT HRT 1000 1 HRT Bestul 11) 50-79 HRT 98 WHI (2001 7 9-2002 1 9 ) WHI (2002 7 9-2003 1 9 ) 8 38 80 3 HRT 2) (1) HRT HRT WHI 4 Colleges of Obstetrics and Gynecologists Carlson 12) HRT 5 5 2-3 FDA estrogen progesterone 184
(HRT) (391) 2003 13) 2002 8 1012 85.2 HRT 13.9 5 HRT 38.8 33.5 5 9.7 5-10 4.1 10-20 10.6 3.2 5 41.4 48.1 5 HRT 0.9 12.6 5 27.6 5-10 14.3 10-20 41.2 3.4 5 HRT 36.5 46.8 5 11.8 5-10 3.2 10-15 HRT 1.4 15.6 5 5-10 14.6 10-20 37.2 5.6 5 WHI HRT 1) 2002 2001 3 Korean Estrogen Deficiency Awareness(KEDA) 50-59 1201 50-54 27.4 55-59 22.2 24.3 29.8 HRT 10.8 44.3 19.1 64.3 HRT 30.6 1 28 1 3 21 3 17.7 1.6 1 21.2 27.2 3 29.8 4 6 10.1 7-12 17.1%, 13-24 25 25 2.6 HRT 63.6 28.1 7.9 3.9 185
(392) 26 2 (2005 6 ) 2.6 33.1 20.5 18.9 13.4 11.0 8.7 7.1 2.4 3.1 HRT 48.7 14.0 22.8 11.8 2.2 HRT 81.6 18.4 (2) HRT 14) Kupperman s index 15) 18 HRT 16 HRT E2 HRT 1) HRT HRT estrogen progesterone (withdrawal bleeding) HRT 6 40-60 20 (breakthrough bleeding) HRT 16) 17) HRT 5MHz probe 3 5.5 186
(HRT) (393) 5.7 3.3 8.7 4.5 HRT 5 1) HRT 33.1 ( 10.2 ) (7.9 ) (5.5 ) (2.4 ) (7.1 ) 2) HRT (1) HRT HERS 3) HRT 2002 2004 estrogen/progestin 4) estrogen 5) La Vecchia 18) HRT Maas 19) HRT (plaque) HRT HRT HRT (2) HRT estrogen progestin WHI Garbe 19) 39 HRT HRT 14 Oestreicher 20) HRT HRT 3) HRT HRT Bagger 20) 2-3 HRT (BMD) (bone mineral content, BMC) 187
(394) 26 2 (2005 6 ) ( Fast losers ) 4 HRT HRT Yamazaki 21) 49 75 50 1 50 1 8000 4 12 18 L2-L4 6 X-ray absorptiometry(dxa) Serum bone-specific alkaline phosphatase(bap) cross-linked N-terminal telopeptides of type I collagen (NTX) 1, 3, 6, 9, 12 EIA ELISA NTX 6 NTX NTX 3 12 BAP 3 NTX 12 NTX 22) (45-90 40-90 130-180 64.1 64.2 63.0 63.1kg) 402 201 T-score -1.58, 1.65 23) 2002-2003 3 144 ( 934, 2210 ) 40 8.2 19.4 3.4 15.7 188
(HRT) (395) 1 800 OPG 20, 30 ( 250, 280 ) BMP HRT 1) HRT HRT HRT 2) HRT WHI HRT (1) HRT (2) (3) HRT 1998 1998 24) 2000 25) 2002 26) 2004 27) 28) 2002 WHI 24) 75 45 60 42.7 17.6 50 50 42.7 38.7 28 18 14 22 20 19 12 189
(396) 26 2 (2005 6 ) 10.7 12 33.3 1-2 90 60 29) Kupperman s index 40 60 30) 31) 32) ( ) 1) (1) Kupperman s index, Menopause Rating Scale(MRS) 33) MRS Heinemann 34) Kupperman s index MRS the Greene Climacteric Scale 35) the Won s Health Assessment Scale Quality of Life Scale 36) 29) (Evidence-based medicine, EBM) (randomized controlled trials, RCT) 190
(HRT) (397) FSH (2) RCT Teoman 37) 6 38) 39) (3) 2) (1) WHI (2) (3) HRT 3) 4) 191
(398) 26 2 (2005 6 ) estrogen FSH WHI HRT HRT 1 2002; 8(1):3-18 2. 2003;9(1):36-43. 3. Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B. et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement study(hers) Research Group. JAMA. 1998;280:605-613. 4. Women s Health Initiative Investigators. Risk and Benefits of Estrogen plus Progestin in healthy postmenopausal women. JAMA. 2002;288(3):321-333. 5. Anderson et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women s Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1769-1771. 6. 2003:17(2):224-237. 7. 1995;38(7):1244-1252. 8. 5 2004;17(3): 116-132. 9. Dawn Misra. A Profile of Women s Health in the United States. The Women s Health Data Book. Washington, D.C.;2001:3-4. 10. Levens E, Williams RS. Current opinions and understandings of menopausal women about hormone replacement therapy (HRT)-the University of Florida experience. Am J Obstet Gynecol. 2004 Aug;191(2):641-646. 11. Bestul MB, McCollum M, Hansen LB, Saseen JJ. Impact of the women s health initiative trial results on hormone replacement therapy Pharmacotherapy. 2004 Apr;24 (4):495-499. 12. Carlson KJ. Menopause Management after the Women s Health Initiative(WHI). Pri- Med South Conference, FT. Lauderdale, FL. February 14, 2003. 13. 2003;9(3):273-279. 14 4 192
(HRT) (399) 2002;45(8):1330-1335 15. Pan B, Kato Y, Sengoku K, Takuma N, Niizeki N, Ishikawa M. Treatment of climacteric symptoms with herbal formulas of traditional Chinese medicine. Gynecol Obstet Invest. 2004;57(3):144-148. 16. Nachtigall LE. Enhancing patient compliance with hormone replacement therapy at menopause. Obset Gynecol 1990;75:77-80. 17. 7 2002;8(1):68-75. 18. La Vecchia C. Oral contraceptives, menopause hormone replacement therapy, and risk of stroke. Maturitas. 2004 Apr 15;47(4):255-258. 19. Garbe E, Levesque L, Suissa S. Variability of breast cancer risk in observational studies of hormone replacement therapy: a metaregression analysis. Maturitas. 2004 Mar 15;47(3):175-183. 20. Bagger YZ, Tanko LB, Alexandersen P, Hansen HB, Mollgaard A, Ravn P, Qvist P, Kanis JA, Christiansen C. Acta Obstet Gynecol Scand. Bone. 2004 May;83(5):476-481 21. Yamazaki S, Ichimura S, Iwamoto J, Takeda T, Toyama Y. Effect of walking exercise on bone metabolism in postmenopausal women with osteopenia/osteoporosis. J Bone Miner Metab. 2004;22(5):500-508. 22. Soo Lim et. al. Body composition changes with age have gender-specific impacts on bone mineral density. Bone. 2004;35:792-798. 23. Aesun Shin et. al. Prevalence and risk factors of distal radius and calcaneus bone mineral density in Korean population. Osteoporos Int. 2004 Aug;15(8):639-644. 24. 1998;11(1):23-29. 25 2000;13(2):418-436 26. 15 3 2002:75-81. 27. 5 2004; 17(3):116-132. 28. Kim Dongil. After July 2002, What can we do for menopausal women-a review of recent research about HRT and its alternative therapies- 2004;17 (3): 105-115. 29. 5 50 2002; 15(2):144-154. 30. 1998; 11(2):229-236. 31.2001; 14(2):195-202. 32. DITI 2001;14(3):58-69 33. Menopause Rating Scale. http://www.m enopause-rating-scale.info. 34. Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Thai DM. The Menopause Rating Scale (MRS) scale: A methodological review. 193
(400) 26 2 (2005 6 ) Health Qual Life Outcomes. 2004 Sep 2;2(1):45. 35. Barentensen R. et al.climacteric symptoms in a representative Dutch population sample as measured with the Greene Climacteric scale, Maturitas Apr 20;38(2):123-8, 2001 36. Li S, Holm K et al. Perimenopause and the quality of life, Clin Nurs R Feb;(9):6-23, 2000 37. Teoman N, Ozcan A, Acar B. The effect of exercise on physical fitness and quality of life in postmenopausal women. Life Sci. 2004 Jan 30;74(11):1325-1335. 38. 2003;7(3):235-240. 39. 2003;17(2):65-74. 194