A randomized, double-blind, placebo-controlled, cross-over pilot study on the use of a standardized hop extract to alleviate menopausal discomforts

Phytomedicine

Volumn 17, Issue 6, 2010, Pages 389-396

  Erkkola, R ^a   Vervarcke, S ^b   Vansteelandt, S ^c   Rompotti, P ^d   De Keukeleire, D ^c   Heyerick, A ^c  

^a TURKU UNIVERSITY HOSPITAL   (Finland)

^b Metagenics Belgium   (Belgium)

^c GHENT UNIVERSITY   (Belgium)

^d MaxMedica Oy ^*  (Finland)

Author keywords

Hop (Humulus lupulus L.); Kupperman index; Menopause; Menopause rating scale; Phytoestrogens; Visual analogue scale

Indexed keywords

HUMULUS LUPULUS EXTRACT; PHYTOESTROGEN; FLAVANONE DERIVATIVE; NARINGENIN; PLANT EXTRACT;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; HUMULUS LUPULUS; KUPPERMAN INDEX; MENOPAUSAL SYNDROME; MENOPAUSE RATING SCALE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VISUAL ANALOG SCALE; DRUG EFFECTS; HUMULUS; MENOPAUSE; MIDDLE AGED; PAIN MEASUREMENT; PHYTOTHERAPY; PILOT STUDY; STANDARD; STANDARDS; TREATMENT OUTCOME;

CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FEMALE; FLAVANONES; HUMANS; HUMULUS; MENOPAUSE; MIDDLE AGED; PAIN MEASUREMENT; PHYTOESTROGENS; PHYTOTHERAPY; PILOT PROJECTS; PLANT EXTRACTS; REFERENCE STANDARDS; TREATMENT OUTCOME;

HUMULUS LUPULUS;

EID: 77950299463     PISSN: 09447113     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.phymed.2010.01.007     Document Type: Article

References (42)

1. Atkinson C., Frankenfeld C.L., and Lampe J.W. Gut bacterial metabolism of the soy isoflavone daidzein: exploring the relevance to human health. Exp. Biol. Med. 230 (2005) 155-170
2. Bolca S., Possemiers S., Maervoet V., Huybrechts I., Heyerick A., Vervarcke S., Depypere H., De Keukeleire D., Bracke M., De Henauw S., Verstraete W., and Van de Wiele T. Microbial and dietary factors associated with the 8-prenylnaringenin producer phenotype: a dietary intervention trial with fifty healthy post-menopausal Caucasian women. Br. J. Nutr. 98 (2007) 950-959
3. Booth N.L., Piersen C.E., Banuvar S., Geller S.E., Shulman L.P., and Farnsworth N.R. Clinical studies of red clover (Trifolium pratense) dietary supplements in menopause: a literature review. Menopause 13 (2006) 251-264
4. Borrelli F., and Ernst E. Black cohosh (Cimicifuga racemosa) for menopausal symptoms: a systematic review of its efficacy. Pharmacol. Res. 58 (2008) 8-14
5. Bowe J., Li X.F., Kinsey-Jones J., Heyerick A., Brain S., Milligan S., and O'Byrne K. The hop phytoestrogen, 8-prenylnaringenin, reverses the ovariectomy-induced rise in skin temperature in an animal model of menopausal hot flushes. J. Endocrinol. 191 (2006) 399-405
6. Christoffel J., Rimoldi G., and Wuttke W. Effects of 8-prenylnaringenin on the hypothalamo-pituitary-uterine axis in rats after 3-month treatment. J. Endocrinol. 188 (2006) 397-405
7. Clerici C., Setchell K.D.R., Battezzati P.M., Pirro M., Giuliano V., Asciutti S., Castellani D., Nardi E., Sabatin G., Orlandi S., Baldoni M., Morelli O., Mannarino E., and Morelli A. Pasta naturally enriched with isoflavone aglycons from soy germ reduces serum lipids and improves markers of cardiovascular risk. J. Nutr. 137 (2007) 2270-2278
8. Col N.F., Guthrie J.R., Politi M., and Dennerstein L. Duration of vasomotor symptoms in middle-aged women: a longitudinal study. Menopause 16 (2009) 453-457
9. Cos P., De Bruyne T., Apers S., Berghe D.V., Pieters L., and Vlietinck A.J. Phytoestrogens: recent developments. Planta Med. 69 (2003) 589-599
10. Fitzmaurice G., Laird N., and Ware J. Applied Longitudinal Analysis (2004), Wiley
11. Heyerick A., Vervarcke S., Depypere H., Bracke M., and De Keukeleire D. A first prospective, randomized, double-blind, placebo-controlled study on the use of a standardized hop extract to alleviate menopausal discomforts. Maturitas 54 (2006) 164-175
12. Holzbeierlein J.M., McIntosh J., and Thrasher J.B. The role of soy phytoestrogens in prostate cancer. Curr. Opin. Urol. 15 (2005) 17-22
13. Hümpel, M., Isaksson, P., Schaefer, O., Kaufmann, U., Ciana, P., Maggi, A., Schleuning, W.D., 2005. Tissue specificity of 8-prenylnaringenin: protection from ovariectomy induced bone loss with minimal trophic effects on the uterus. J. Steroid Biochem. Mol. Biol.
14. Huntley A.L., and Ernst E. Soy for the treatment of perimenopausal symptoms - a systematic review. Maturitas 47 (2004) 1-9
15. Koetter U., Schrader E., Kaufeler R., and Brattstrom A. A randomized, double blind, placebo - Controlled, prospective clinical study to demonstrate clinical efficacy of a fixed valerian hops extract combination (Ze 91019) in patients suffering from non-organic sleep disorder. Phytother. Res. 21 (2007) 847-851
16. Krebs E.E., Ensrud K.E., MacDonald R., and Wilt T.J. Phytoestrogens for treatment of menopausal symptoms: a systematic review. Obstet. Gynecol. 104 (2004) 824-836
17. Kronenberg F., and Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann. Intern. Med. 137 (2002) 805-813
18. Kupperman H.S., Blatt M.H.G., Wiesbader H., and Filler W. Comparative evaluation of estrogenic preparations by the menopausal and amenorrheal indices. J. Clin. Endocrinol. Metab. 13 (1953) 688-703
19. Lethaby, A.E., Brown, J., Marjoribanks, J., Kronenberg, F., Roberts, H., Eden, J., 2007. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst. Rev.
20. Messina M., Ho S., and Alekel D.L. Skeletal benefits of soy isoflavones: a review of the clinical trial and epiderniologic data. Curr. Opin. Clin. Nutr. Metab. Care 7 (2004) 649-658
21. Milligan S.R., Kalita J.C., Heyerick A., Rong H., De Cooman L., and De Keukeleire D. Identification of a potent phytoestrogen in hops (Humulus lupulus L.) and beer. J. Clin. Endocrinol. Metab. 84 (1999) 2249-2252
22. Moriyama C.K., Oneda B., Bernardo F.R., Cardoso C.G., Forjaz C.L.M., Abrahao S.B., Mion D., Fonseca A.M., and Tinucci T. A randomized, placebo-controlled trial of the effects of physical exercises and estrogen therapy on health-related quality of life in postmenopausal women. Menopause 15 (2008) 613-618
23. Nahas E.A.P., Nahas-Neto J., Orsatti F.L., Carvalho E.P., Oliveira M., and Dias R. Efficacy and safety of a soy isoflavone extract in postmenopausal women: A randomized, double-blind, and placebo-controlled study. Maturitas 58 (2007) 249-258
24. Nielsen I.L.F., and Williamson G. Review of the factors affecting bioavailability of soy isoflavones in humans. Nutr. Cancer 57 (2007) 1-10
25. Overk C.R., Guo J., Chadwick L.R., Lantvit D.D., Minassi A., Appendino G., Chen S.N., Lankin D.C., Farnsworth N.R., Pauli G.F., van Breemen R.B., and Bolton J.L. In vivo estrogenic comparisons of Trifolium pratense (red clover) Humulus lupulus (hops), and the pure compounds isoxanthohumol and 8-prenylnaringenin. Chem. Biol. Interact. 176 (2008) 30-39
26. Palacios S., Pornel B., Bergeron C., Chantre P., Nogales F., Aubert L., Vazquez F., Eden J., and Mares P. Endometrial safety assessment of a specific and standardized soy extract according to international guidelines. Menopause 14 (2007) 1006-1011
27. Panay N. Integrating phytoestrogens with prescription medicines - A conservative clinical approach to vasomotor symptom management. Maturitas 57 (2007) 90-94
28. Possemiers S., Bolca S., Eeckhaut E., Depypere H., and Verstraete W. Metabolism of isoflavones, lignans and prenylflavonoids by intestinal bacteria: producer phenotyping and relation with intestinal community. FEMS Microbiol. Ecol. 61 (2007) 372-383
29. Possemiers S., Bolca S., Grootaert C., Heyerick A., Decroos K., Dhooge W., De Keukeleire D., Rabot S., Verstraete W., and Van de Wiele T. The prenylflavonoid isoxanthohumol from hops (Humulus lupulus L.) is activated into the potent phytoestrogen 8-prenylnaringenin in vitro and in the human intestine. J. Nutr. 136 (2006) 1862-1867
30. Possemiers S., Heyerick A., Robbens V., De Keukeleire D., and Verstraete W. Activation of proestrogens from hops (Humulus lupulus L.) by intestinal microbiota; Conversion of isoxanthohumol into 8-prenylnaringenin. J. Agric. Food Chem. 53 (2005) 6281-6288
31. Rad M., Humpel M., Schaefer O., Schoemaker R.C., Schleuning W.D., Cohen A.F., and Burggraaf J. Pharmacokinetics and systemic endocrine effects of the phyto-oestrogen 8-prenylnaringenin after single oral doses to postmenopausal women. Br. J. Clin. Pharmacol. 62 (2006) 288-296
32. Reed S.D., Newton K.M., LaCroix A.Z., Grothaus L.C., Grieco V.S., and Ehrlich K. Vaginal, endometrial, and reproductive hormone findings: randomized, placebo-controlled trial of black cohosh, multibotanical herbs, and dietary soy for vasomotor symptoms: the Herbal Alternatives for Menopause (HALT) Study. Menopause 15 (2008) 51-58
33. Rodstrom K., Bengtsson C., Lissner L., Milsom I., Sundh V., and Bjorkelund C. A longitudinal study of the treatment of hot flushes: the population study of women in Gothenburg during a quarter of a century. Menopause 9 (2002) 156-161
34. Rong H., Zhao Y., Lazou K., De Keukeleire D., Milligan S.R., and Sandra P. Quantitation of 8-prenylnaringenin, a novel phytoestrogen in hops (Humulus lupulus L.), hop products, and beers, by benchtop HPLC-MS using electrospray ionization. Chromatographia 51 (2000) 545-552
35. Santoro N.F., Clarkson T.B., Freedman R.R., Fugh-Berman A.J., Loprinzi C.L., Reame N.K., and Board Trustees N.A.M.S. Treatment of menopause-associated vasomotor symptoms: position statement of The North American Menopause Society. Menopause 11 (2004) 11-33
36. Schneider H.P.G., Rosemeier H.P., Schnitker J., Gerbsch S., and Turck R. Application and factor analysis of the menopause rating scale [MRS] in a post-marketing surveillance study of Climen (R). Maturitas 37 (2000) 113-124
37. Tamura M. Effects of intestinal flora on the metabolism and absorption of isoflavones. Japan Agri. Res. Quart. 40 (2006) 45-50
38. Tempfer C.B., Bentz E.K., Leodolter S., Tscherne G., Reuss F., Cross H.S., and Huber J.C. Phytoestrogens in clinical practice: a review of the literature. Fertil. Steril. 87 (2007) 1243-1249
39. Valiati B., Capp E., Edelweiss M.I., de Freitas F.M., and Wender M.C.O. Effect of raloxifene and low-dose percutaneous 17 beta-estradiol on menopause symptoms and endometrium - A randomized controlled trial. Maturitas 62 (2009) 81-84
40. Verbeke G., and Molenberghs G. Linear Mixed Models for Longitudinal Data (2000), Springer-Verlag
41. Wu A.H., Yu M.C., Tseng C.C., and Pike M.C. Epidemiology of soy exposures and breast cancer risk. Br. J. Cancer 98 (2008) 9-14
42. Ye Y.B., Tang X.Y., Verbruggen M.A., and Su Y.X. Soy isoflavones attenuate bone loss in early postmenopausal Chinese women - A single-blind randomized, placebo-controlled trial. Eur. J. Nutr. 45 (2006) 327-334