MF101, a selective estrogen receptor β modulator for the treatment of menopausal hot flushes: a phase II clinical trial

被引：49

作者：

Grady, Deborah ^{[1
,2
]}

Sawaya, George F. ^{[1
]}

Johnson, Karen C. ^{[3
]}

Koltun, William ^{[4
]}

Hess, Rachel ^{[5
]}

Vittinghoff, Eric ^{[1
]}

Kristof, Margaret ^{[1
]}

Tagliaferri, Mary ^{[6
]}

Cohen, Isaac ^{[6
]}

Ensrud, Kristine E. ^{[7
,8
]}

机构：

[1] Univ Calif San Francisco, San Francisco, CA 94115 USA

[2] San Francisco Dept Vet Affairs Med Ctr, San Francisco, CA USA

[3] Univ Tennessee, Ctr Hlth Sci, Memphis, TN 38163 USA

[4] Med Ctr Clin Res, San Diego, CA USA

[5] Univ Pittsburgh, Pittsburgh, PA USA

[6] Bionovo, Emeryville, CA USA

[7] Univ Minnesota, Minneapolis, MN USA

[8] Minneapolis VA Med Ctr, Minneapolis, MN USA

来源：

MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY | 2009年 / 16卷 / 03期

关键词：

Menopause; Hot flush; Estrogen receptor beta selective estrogen; POSTMENOPAUSAL WOMEN; RISK; FLASHES; LESSONS;

D O I：

10.1097/gme.0b013e31818e64dd

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

Objective: To determine the optimal dose, safety, and efficacy of an estrogen receptor beta selective Chinese herbal extract, menopausal formula 101 (MF101), for treating hot flushes. Methods: A randomized, blinded trial in 217 postmenopausal women with hot flushes randomized to 5 or 10 g/day of MF101 or placebo for 12 weeks. Results: The effects of 5 g/day of MF 10 1 did not differ from those of placebo. After 12 weeks, the mean percent decrease in frequency of hot flushes in the 10 g/day group was 12.9% greater than that in the placebo group (P = 0.15), the median percent decrease was 11.7% greater than that in the placebo group (P = 0.05), and the proportion of women with at least a 50% reduction in hot flushes was 16.2% greater than that in the placebo group (P = 0.03). Conclusions: Treatment with 10 g/day of MF 10 1 reduces the frequency of hot flushes. Trials with higher doses are planned.

引用

页码：458 / 465

页数：8

共 21 条

[1] Effects of conjugated, equine estrogen in postmenopausal women with hysterectomy - The women's health initiative randomized controlled trial [J].

Anderson, GL ;

Limacher, M ;

Assaf, AR ;

Bassford, T ;

Beresford, SAA ;

Black, H ;

Bonds, D ;

Brunner, R ;

Brzyski, R ;

Caan, B ;

Chlebowski, R ;

Curb, D ;

Gass, M ;

Hays, J ;

Heiss, G ;

Hendrix, S ;

Howard, BV ;

Hsia, J ;

Hubbell, A ;

Jackson, R ;

Johnson, KC ;

Judd, H ;

Kotchen, JM ;

Kuller, L ;

LaCroix, AZ ;

Lane, D ;

Langer, RD ;

Lasser, N ;

Lewis, CE ;

Manson, J ;

Margolis, K ;

Ockene, J ;

O'Sullivan, MJ ;

Phillips, L ;

Prentice, RL ;

Ritenbaugh, C ;

Robbins, J ;

Rossouw, JE ;

Sarto, G ;

Stefanick, ML ;

Van Horn, L ;

Wactawski-Wende, J ;

Wallace, R ;

Wassertheil-Smoller, S .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2004, 291 (14) :1701-1712

[2]

[Anonymous], ANN NY ACAD SCI

[3] Estrogen receptor β1 and the β2/βcx isoforms in nonneoplastic endometrium and in endometrioid carcinoma [J].

Chakravarty, D. ;

Srinivasan, R. ;

Ghosh, S. ;

Gopalan, S. ;

Rajwanshi, A. ;

Majumdar, S. .

INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 2007, 17 (04) :905-913

[4] Selective activation of estrogen receptor-β transcriptional pathways by an herbal extract [J].

Cvoro, Aleksandra ;

Paruthiyil, Sreenivasan ;

Jones, Jeremy O. ;

Tzagarakis-Foster, Christina ;

Clegg, Nicola J. ;

Tatomer, Deirdre ;

Medina, Roanna T. ;

Tagliaferri, Mary ;

Schaufele, Fred ;

Scanlan, Thomas S. ;

Diamond, Marc I. ;

Cohen, Isaac ;

Leitman, Dale C. .

ENDOCRINOLOGY, 2007, 148 (02) :538-547

[5] Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene -: Results from a 3-year randomized clinical trial [J].

Ettinger, B ;

Black, DM ;

Mitlak, BH ;

Knickerbocker, RK ;

Nickelsen, T ;

Genant, HK ;

Christiansen, C ;

Delmas, PD ;

Zanchetta, JR ;

Stakkestad, J ;

Glüer, CC ;

Krueger, K ;

Cohen, FJ ;

Eckert, S ;

Ensrud, KE ;

Avioli, LV ;

Lips, P ;

Cummings, SR .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1999, 282 (07) :637-645

[6] Relation of demographic and lifestyle factors to symptoms in a multi-racial/ethnic population of women 40-55 years of age [J].

Gold, EB ;

Sternfeld, B ;

Kelsey, JL ;

Brown, C ;

Mouton, C ;

Reame, N ;

Salamone, L ;

Stellato, R .

AMERICAN JOURNAL OF EPIDEMIOLOGY, 2000, 152 (05) :463-473

[7] HORMONE REPLACEMENT THERAPY AND ENDOMETRIAL CANCER RISK - A METAANALYSIS [J].

GRADY, D ;

GEBRETSADIK, T ;

KERLIKOWSKE, K ;

ERNSTER, V ;

PETITTI, D .

OBSTETRICS AND GYNECOLOGY, 1995, 85 (02) :304-313

[8] Management of menopausal symptoms [J].

Grady, Deborah .

NEW ENGLAND JOURNAL OF MEDICINE, 2006, 355 (22) :2338-2347

[9] Lessons in estrogen biology from knockout and transgenic animals [J].

Hewitt, SC ;

Harrell, JC ;

Korach, KS .

ANNUAL REVIEW OF PHYSIOLOGY, 2005, 67 :285-308

[10] A menopause-specific quality of life questionnaire: Development and psychometric properties [J].

Hilditch, JR ;

Lewis, J ;

Peter, A ;

vanMaris, B ;

Ross, A ;

Franssen, E ;

Guyatt, GH ;

Norton, PG ;

Dunn, E .

MATURITAS, 1996, 24 (03) :161-175

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