Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG trial N01CC

Journal of Clinical Oncology

Volumn 24, Issue 18, 2006, Pages 2836-2841

  Pockaj, Barbara A ^a   Gallagher, James G ^a   Loprinzi, Charles L ^a   Stella, Philip J ^a   Barton, Debra L ^a   Sloan, Jeff A ^a   Lavasseur, Beth I ^a   Rao, Radha M ^a   Fitch, Tom R ^a   Rowland, Kendrith M ^a   Novotny, Paul J ^a   Flynn, Patrick J ^a   Richelson, Elliott ^a   Fauq, Abdul H ^a  

^a MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CIMICIFUGA RACEMOSA EXTRACT; PLACEBO; PLANT MEDICINAL PRODUCT;

ARTHRALGIA; ARTICLE; CHILL; CIMICIFUGA RACEMOSA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG CAPSULE; FEMALE; HEADACHE; HOT FLUSH; HUMAN; HYPERHIDROSIS; LEG HEAVINESS; LEG INJURY; MAJOR CLINICAL STUDY; MOOD CHANGE; MORBIDITY; MYALGIA; NAUSEA; NEGATIVE MOOD SWING; NERVOUSNESS; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH CRAMP; STOMACH PAIN; ADULT; AGED; BREAST TUMOR; CIMICIFUGA; MENOPAUSE; MIDDLE AGED; PHYTOTHERAPY;

ADULT; AGED; BREAST NEOPLASMS; CIMICIFUGA; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FEMALE; HOT FLASHES; HUMANS; MENOPAUSE; MIDDLE AGED; PHYTOTHERAPY; PLANT PREPARATIONS;

EID: 33745569000     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.05.4296     Document Type: Article

References (31)

1. Clemons M, Goss P: Estrogen and the risk of breast cancer. N Engl J Med 344:276-285, 2001
2. North American Menopause Society: Recommendations for estrogen and progestogen use in peri-and postmenopausal women: October 2004 position statement of The North American Menopause Society. Menopause 11:589-600, 2004
3. 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 288:321-333, 2002
4. Wade C, Kronenberg F, Kelly A, et al: Hormone-modulating herbs: Implications for women's health. J Am Med Womens Assoc 54:181-183, 1999
5. Top-Selling Medicinal Herbs in the U.S., 1999-2003, in World Almanac & Book of Facts. New York, World Almanac Education Group, 2005, pp 99
6. Lieberman S: A review of the effectiveness of Cimicifuga racemosa (black cohosh) for the symptoms of menopause. Journal of Women's Health 7:525-529, 1998
7. Stoll W: Phytopharmacon influences atrophic vaginal epithelium double-blind study: Cimifuga vs. estrogenic stubstances. Therapeutikon 1:23-31, 1987
8. Jacobson JS, Troxel AB, Evans J, et al: Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer. J Clin Oncol 19:2739-2745, 2001
9. Wuttke W, Seidlova-Wuttke D, Gorkow C: The Cimicifuga preparation BNO 1055 vs. conjugated estrogens in a double-blind placebo-controlled study: Effects on menopause symptoms and bone markers. Maturitas 44:14, 2003
10. Osmers R, Friede M, Liske E, et al: Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms. Obstet Gynecol 105:1074-1083, 2005
11. Pockaj BA, Loprinzi CL, Sloan JA, et al: Pilot evaluation of black cohosh for the treatment of hot flashes in women. Cancer Invest 22:515-521, 2004
12. Sloan JA, Loprinzi CL, Novotny PJ, et al: Methodologic lessons learned from hot flash studies. J Clin Oncol 19:4280-4290, 2001
13. Loprinzi C, Michalak J, Quella SK, et al: Megestrol acetate for the prevention of hot flashes. N Engl J Med 331:347-352, 1994
14. Loprinzi C, Kugler JW, Sloan J, et al: Venlafaxine in management of hot flashes in survivors of breast cancer: A randomised controlled trial. Lancet 356:2059-2063, 2000
15. Pocock SJ, Simon R: Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31:103-115, 1975
16. Therneau TM: How many stratification factors are "too many" to use in a randomization plan? Control Clin Trials 14:98-108, 1993
17. Moses LE, Emerson JD, Hosseini H: Analyzing data from ordered categories. N Engl J Med 311:442-448, 1984
18. Morrison D: Multivariate Statistical Methods. New York, McGraw-Hill, 1976
19. Liang K, Zeger S: Longitudinal data analysis using generalized linear models. Biometrika 73:13-22, 1986
20. Shapiro S, Wilk M: An analysis of variance test for normality (complete samples). Biometrika 52: 591-610, 1965
21. Sloan JA, Novotny P, Loprinzi CL, et al: Graphical and analytical tools for two-period crossover clinical trials. SUGI proceedings 22:1312-1317, 1997
22. Adler E: The Blatt-Kupperman menopausal index: A critique. Maturitas 29:19-24, 1998
23. Nappi RE, Malavasi B, Brundu B, et al: Efficacy of Cimicifuga racemose on climacteric complaints: A randomized study versus low-dose transdermal estradio. Gynecol Endocrinol 20:30-35, 2005
24. Liu J, Burdette JE, Xu H, et al: Evaluation of estrogenic activity of plant extracts for the potential treatment of menopausal symptoms. J Agri Food Chem 49:2472-2479, 2001
25. Lupu R, Mehmi I, Atlas E, et al: Black cohosh, a menopausal remedy, does not have estrogenic activity and does not promote breast cancer cell growth. Int J Oncol 23:1407-1412, 2003
26. Pepping J: Black cohosh: Cimicifuga racemosa. American Journal of Health System Pharmacy 56:1400-1402, 1999
27. Borrelli F, Izzo AA, Ernst E: Pharmacological effects of Cimicifuga racemosa. Life Sci 73:1215-1229, 2003
28. Burdette JE, Liu J, Chen SN, et al: Black cohosh acts as a mixed competitive ligand and partial agonist of the serotonin receptor. Journal of Agricultural & Food Chemistry 51:5661-5670, 2003
29. Messina MJ, Loprinzi CL: Soy for breast cancer survivors: A critical review of the literature. J Nutr 131:3095S-3108S, 2001 (suppl)
30. Guttuso T Jr, Kurlan R, McDermott MP, et al: Gabapentin's effects on hot flashes in postmenopausal women: A randomized controlled trial. Obstet Gynecol 101:337-345, 2003
31. Stearns V, Beebe K, Igenger M: Paroxetine controlled release in the treatment of menopausal hot flashes: A randomized controlled trial. JAMA 289: 2827-2834, 2003