Use of a multibotanical (Nutrafem) for the relief of menopausal vasomotor symptoms: A double-blind, placebo-controlled study

Menopause

Volumn 17, Issue 2, 2010, Pages 303-308

  Tan Garcia, Joan ^a   Gonzaga, Florante ^b   Tan, Delfin ^c   Yaa Ng, Toon ^d   Ling Oei, Pau ^e   Chan, Cathryn W B ^e  

^a ST LUKE S MEDICAL CENTER   (Philippines)

^b Medical City ^*  (Philippines)

^c United Doctors Medical Center   (Philippines)

^d Bionutra Pte Ltd   (Singapore)

^e GLENEAGLES HOSPITAL   (Singapore)

Author keywords

Botanical; Eucommia ulmoides; Hot flush; Menopause; Night sweat; Vasomotor symptom; Vigna radiata

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; EUCOMMIA ULMOIDES EXTRACT; HERBACEOUS AGENT; NUTRAFEM; PLACEBO; UNCLASSIFIED DRUG;

ADULT; APPLICATION SITE REACTION; ARTICLE; BARK; BREAST DISEASE; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EAR DISEASE; FEMALE; GASTROINTESTINAL DISEASE; GYNECOLOGICAL EXAMINATION; HEMATOLOGICAL PARAMETERS; HUMAN; HYPERCHOLESTEROLEMIA; IMMUNOPATHOLOGY; INFECTION; INFESTATION; INNER EAR DISEASE; MAJOR CLINICAL STUDY; MEDIASTINUM DISEASE; MENOPAUSAL SYNDROME; MENTAL DISEASE; MUNG BEAN; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; PHASE 2 CLINICAL TRIAL; PHILIPPINES; PHYSICAL EXAMINATION; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SINGAPORE; SKIN DISEASE; THORAX DISEASE; TREATMENT OUTCOME; UROGENITAL TRACT DISEASE; VASOMOTOR DISORDER; VITAL SIGN;

ADMINISTRATION, ORAL; DOUBLE-BLIND METHOD; DRUGS, CHINESE HERBAL; EUCOMMIACEAE; FABACEAE; FEMALE; HOT FLASHES; HUMANS; MIDDLE AGED; PHYTOTHERAPY; PLANT EXTRACTS; PLANT LEAVES; POSTMENOPAUSE; SEEDS; SINGAPORE; TREATMENT OUTCOME; VASOMOTOR SYSTEM;

EID: 77949390613     PISSN: 10723714     EISSN: None     Source Type: Journal    
DOI: 10.1097/gme.0b013e3181bf8e92     Document Type: Article

References (46)

1. Hill K. The demography of menopause. Maturitas 1996;23:113-127.
2. Williams RE, Kalilani L, DiBenedetti DB, et al. Frequency and severity of vasomotor symptoms among peri-and postmenopausal women in the United States. Climacteric 2008;11:32-43.
3. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Fehnel SE, Clark RV. Healthcare seeking and treatment for menopausal symptoms in the United States. Maturitas 2007;58:348-358.
4. Kronenberg F, Barnard RM. Modulation of menopausal hot flashes by ambient temperature. J Therm Biol 1992;17:43-49.
5. Zaborowska E, Brynhildsen J, Damberg S, et al. Effects of acupuncture, applied relaxation, estrogens and placebo on hot flushes in postmeno-pausal women: an analysis of two prospective, parallel, randomized studies. Climacteric 2007;10:38-45.
6. Nelson HD. Commonly used types of postmenopausal estrogen for treatment of hot flashes: scientific review. JAMA 2004;291:1610-1620.
7. Nedrow A, Miller J, Walker M, Nygren P, Huffman LH, Nelson HD. Complementary and alternative therapies for the management of menopause-related symptoms: a systematic evidence review. Arch Intern Med 2006;166:1453-1465.
8. Writing Group for the Women's Health Initiative Investigators. 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. 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.
10. 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.
11. Morabia A, Costanza MC. Recent reversal of trends in hormone therapy use in a European population. Menopause 2006;13:111-115.
12. Haas JS, Kaplan CP, Gerstenberger EP, Kerlikowske K. Changes in the use of postmenopausal hormone therapy after the publication of clinical trial results. Ann Intern Med 2004;140:184-188.
13. MacLennan AH, Gill TK, Broadbent JL, Taylor AW. Continuing decline in hormone therapy use: population trends over 17 years. Climacteric 2009;12:122-130.
14. Mahady GB, Parrot J, Lee C, Yun GS, Dan A. Botanical dietary supplement use in peri-and postmenopausal women. Menopause 2003;10:65-72.
15. Kaufert P, Boggs PP, Ettinger B, Woods NF, Utian WH. Women and menopause: beliefs, attitudes, and behaviors. The North American Menopause Society 1997 Menopause Survey. Menopause 1998;5:197-202.
16. Pocock SJ. Clinical Trials: A Practical Approach. New York, NY: Wiley, 1983.
17. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Lancet 1997;350: 1047-1059.
18. Beral V; Million Women Study Collaborators. Breast cancer, hormone replacement therapy in the Million Women Study. Lancet 2003;362: 419-427.
19. 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.
20. Manson JE, Hsia J, Johnson KC, et al. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med 2003;349:523-534.
21. Stearns V, Beebe KL, Iyengar M, Dube E. Paroxetine controlled release in the treatment of menopausal hot flashes: a randomized controlled trial. JAMA 2003;289:2827-2834.
22. Speroff L, Gass M, Constantine G, Olivier S; Study 315 Investigators. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol 2008;111:77-87.
23. Loprinzi CL, Kugler JW, Sloan JA, et al. Venlafaxine in management of hot flushes in survivors of breast cancer: a randomised controlled trial. Lancet 2000;356:2059-2063.
24. Nelson HD, Vesco KK, Haney E, et al. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA 2006;295:2057-2071.
25. 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 Gynaecol Obstet 2008;102:44-49.
26. Osmers R, Friede M, Liske E, et al. Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms. Obstet Gynecol 2005; 105:1074-1083.
27. 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 2003;44:S67-S77.
28. Frei-Kleiner S, Schaffner W, Rahlfs VW, Bodmer C, Birkhauser M. Cimicifuga racemosa dried ethanolic extract in menopausal disorders: a double-blind placebo-controlled clinical trial. Maturitas 2005;51:397-404.
29. Whiting PW, Clouston A, Kerlin P. Black cohosh and other herbal remedies associated with acute hepatitis. Med J Aust 2002;177:440-443.
30. Joy D, Joy J, Duane P. Black cohosh: a cause of abnormal postmeno-pausal liver function tests. Climacteric 2008;11:84-88.
31. Pockaj BA, Gallagher JG, Loprinzi CL, et al. Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG Trial N01CC1. J Clin Oncol 2006; 24:2836-2841.
32. Newton KM, Reed SD, LaCroix AZ, Grothaus LC, Ehrlich K, Guiltinan J. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo: a randomized trial. Ann Intern Med 2006;145:869-879.
33. Hidalgo LA, Chedraui PA, Morocho N, Ross S, San Miguel G. The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: a randomized, double-blind, placebo-controlled study. Gynecol Endocrinol 2005;21:257-264.
34. Atkinson C, Warren RM, Sala E, et al. Red-clover-derived isoflavones and mammographic breast density: a double-blind, randomized, placebo-controlled trial. Breast Cancer Res 2004;6:R170-R179.
35. Knight DC, Howes JB, Eden JA. The effect of Promensil, an isoflavone extract, on menopausal symptoms. Climacteric 1999;2:79-84.
36. 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.
37. 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.
38. Anwar F, Latif S, Przybylski R, Sultana B, Ashraf M. Chemical composition and antioxidant activity of seeds of different cultivars of mungbean. J Food Sci 2007;72:S503-S510.
39. Hien TV, Huong NB, Hung PM, Duc NB. Radioprotective effects of Vitexina for breast cancer patients undergoing radiotherapy with cobalt-60. Integr Cancer Ther 2002;1:34-38.
40. Deyama T, Nishibe S, Nakazawa Y. Constituents and pharmacological effects of Eucommia and Siberian ginseng. Acta Pharmacol Sin 2001; 22:1057-1070.
41. Lang C, Liu Z, Taylor HW, Baker DG. Effect of Eucommia ulmoides on systolic blood pressure in the spontaneous hypertensive rat. Am J Chin Med 2005;33:215-230.
42. Ho JN, Lee YH, Park JS, et al. Protective effects of aucubin isolated from Eucommia ulmoides against UVB-induced oxidative stress in human skin fibroblasts. Biol Pharm Bull 2005;28:1244-1248.
43. Hsieh CL, Yen GC. Antioxidant actions of du-zhong (Eucommia ulmoides Oliv.) toward oxidative damage in biomolecules. Life Sci 2000;66:1387-1400.
44. Recio MC, Giner RM, Máñez S, Ŕios JL. Structural considerations on the iridoids as anti-inflammatory agents. Planta Med 1994;60:232-234.
45. Li Y, Kamo S, Metori K, Koike K, Che QM, Takahashi S. The promoting effect of eucommiol from Eucommiae cortex on collagen synthesis. Biol Pharm Bull 2000;23:54-59.
46. Zhang R, Liu ZG, Li C, et al. Du-Zhong (Eucommia ulmoides Oliv.) cortex extract prevent OVX-induced osteoporosis in rats. Bone 2009; 45:553-559.