Assessing safety of herbal products for menopausal complaints: An international perspective

Maturitas

Volumn 66, Issue 4, 2010, Pages 355-362

  Dog, Tieraona Low ^a   Marles, Robin ^b   Mahady, Gail ^c   Gardiner, Paula ^d   Ko, Richard ^e   Barnes, Jo ^f   Chavez, Mary L ^g   Griffiths, James ^h   Giancaspro, Gabriel ^h   Sarma, Nandakumara D ^h  

^a UNIVERSITY OF ARIZONA   (United States)

^b Natural Health Products Directorate   (Canada)

^c UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^d BOSTON UNIVERSITY MEDICAL CENTER   (United States)

^e Herbal Synergy   (United States)

^f UNIVERSITY OF AUCKLAND   (New Zealand)

^g TEXAS A AND M HEALTH SCIENCE CENTER   (United States)

^h UNITED STATES PHARMACOPEIA   (United States)

Author keywords

Herbal medicine; Regulatory; Safety; Toxicology

Indexed keywords

4 HYDROPEROXYCYCLOPHOSPHAMIDE; ALPRAZOLAM; AMFEBUTAMONE; AMITRIPTYLINE; ANESTHETIC AGENT; ANGELICA SINENSIS EXTRACT; ATORVASTATIN; BUSPIRONE; CIMICIFUGA RACEMOSA EXTRACT; DOCETAXEL; ELETRIPTAN; GLICLAZIDE; GLYCINE MAX EXTRACT; HUMULUS LUPULUS EXTRACT; HYPERICUM PERFORATUM EXTRACT; IRON; LEPIDIUM MEYENII EXTRACT; LEVOTHYROXINE; MEPHENYTOIN; MIDAZOLAM; NEFAZODONE; OMEPRAZOLE; PAROXETINE; PLANT EXTRACT; RED CLOVER EXTRACT; SERTRALINE; THEOPHYLLINE; UNCLASSIFIED DRUG; UNINDEXED DRUG; VORICONAZOLE; WARFARIN;

BENIGN TUMOR; BLOOD DISEASE; BREAST DISEASE; CONGENITAL DISORDER; CONNECTIVE TISSUE DISEASE; DRUG INTOXICATION; DRUG QUALITY; DRUG SAFETY; EAR DISEASE; ENDOCRINE DISEASE; EYE DISEASE; FAMILIAL DISEASE; GASTROINTESTINAL DISEASE; GENETIC DISORDER; HEART DISEASE; HEPATOBILIARY DISEASE; HERBAL MEDICINE; HUMAN; IMMUNOPATHOLOGY; INFECTION; INJURY; INNER EAR DISEASE; KIDNEY DISEASE; LYMPHATIC SYSTEM DISEASE; MALIGNANT NEOPLASTIC DISEASE; MENOPAUSAL SYNDROME; MENTAL DISEASE; METABOLIC DISORDER; MUSCULOSKELETAL DISEASE; NEUROPATHY; NUTRITIONAL DISORDER; PREGNANCY DISORDER; REPRODUCTIVE TOXICITY; RESPIRATORY TRACT DISEASE; REVIEW; SKIN DISEASE; SOYBEAN; SUBCUTANEOUS FAT DISORDER; URINARY TRACT DISEASE; VASCULAR DISEASE; ANIMAL; DRUG LEGISLATION; FEMALE; GOVERNMENT REGULATION; HERB DRUG INTERACTION; INTERNATIONAL COOPERATION; MENOPAUSE; PHYTOTHERAPY; PRODUCT SAFETY;

ANIMALS; CONSUMER PRODUCT SAFETY; FEMALE; GOVERNMENT REGULATION; HERB-DRUG INTERACTIONS; HUMANS; INTERNATIONALITY; LEGISLATION, DRUG; MENOPAUSE; PHYTOTHERAPY; PLANT EXTRACTS;

EID: 77955662421     PISSN: 03785122     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.maturitas.2010.03.008     Document Type: Review

References (59)

1. J.E. Rossouw, G.L. Anderson, and R.L. Prentice, 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 3 2002 321 333
2. D.M. Upchurch, L. Chyu, and G.A. Greendale, et al. Complementary and alternative medicine use among American women: findings from The National Health Interview Survey J Womens Health (Larchmt) 16 2007 102 113
3. K. Vickers, K.B. Jolly, and S.M. Greenfield Herbal medicine: women's views, knowledge and interaction with doctors: a qualitative study BMC Complement Altern Med 6 2006 40
4. S.A. Jordan, D.G. Cunningham, and R.J. Marles Assessment of herbal medicinal products: challenges and opportunities to increase the knowledge base for safety assessment Toxicol Appl Pharmacol December 14, 2009 [Epub ahead of print]
5. P. Gardiner, D.N. Sarma, and T. Low Dog, et al. The state of dietary supplement adverse event reporting in the United States Pharmacoepidemiol Drug Saf 17 10 2008 962 970
6. W.N. Kelly, F.M. Arellano, and J. Barnes, et al. International Society for Pharmacoepidemiology; International Society of Pharmacovigilance. Guidelines for submitting adverse event reports for publication Drug Saf 30 5 2007 367 373
7. WHO Guidelines on safety monitoring of herbal medicines in pharmacovigilance systems 2004 World Health Organization Geneva, Switzerland
8. C.A. Naranjo, U. Busto, and E.M. Sellers A method for estimating the probability of adverse drug reactions Clin Pharmacol Ther 30 1981 239 245 (Pubitemid 12149145)
9. J.K. Jones Adverse drug reactions in the community health setting: approaches to recognizing, counseling, and reporting Fam Community Health 5 1982 58 67
10. M.S. Kramer, J.M. Leventhal, T.A. Hutchinson, and A.R. Feinstein An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use JAMA 242 1979 623 632
11. T.B. Agbabiaka, J. Savović, and E. Ernst Methods for causality assessment of adverse drug reactions: a systematic review Drug Saf 31 1 2008 21 37
12. Institute of Medicine & National Research Council Dietary supplements: a framework for evaluating safety 2005 The National Academies Press Washington, DC
13. Government of Canada. Natural Health Products Regulations; 2009. Available at: http://laws.justice.gc.ca/en/showtdm/cr/SOR-2003-196//?showtoc= &instrumentnumber=SOR-2003-196 [accessed November 22, 2009].
14. R.B. Saper, R.S. Phillips, and A. Sehgal, et al. Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet JAMA 300 8 2008 915 923 Erratum in: JAMA 2008;300(14):1652
15. T.P. Cheung, C. Xue, and K. Leung, et al. Aristolochic acids detected in some raw Chinese medicinal herbs and manufactured herbal products - a consequence of inappropriate nomenclature and imprecise labeling? Clin Toxicol (Phila) 44 4 2006 371 378
16. K.Y. Yap, S.Y. Chan, Y. Weng Chan, and C. Sing Lim Overview on the analytical tools for quality control of natural product-based supplements: a case study of ginseng Assay Drug Dev Technol 3 6 2005 683 699
17. R.J. Marles, S. Jordan, and M. Murty, et al. Herb misidentification in a black cohosh product adverse reaction case Presented at the 5th annual natural health products research conference Toronto, Ontario, Canada, March 2008 [abstract]
18. Health Canada. Drug recall listings - sorted by trade name (from July 2009 to September 2009); 2009. Available from: http://www.hc-sc.gc.ca/dhp-mps/ compli-conform/recall-retrait/-list/rec-ret-drugs-med-trade-marque-july-sept- 2009-eng.php [accessed November 22, 2009].
19. G.B. Mahady, T.L. Dog, and M.L. Barrett, et al. United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity Menopause 15 2008 628 638
20. S. Satchithanandam, E. Grundel, and J. Roach, et al. Alkaloids and saponins in dietary supplements of blue cohosh (Caulophyllum thalictroides) J AOAC Int 91 1 2008 21 32
21. USP United States Pharmacopeia 32/National Formulary 27 2009 The United States Pharmacopeial Convention Rockville, MD
22. K. He, B. Zhen, and C.H. Kim, et al. Direct analysis and identification of triterpene glycosides by LC/MS in Black Cohosh, Cimicifuga racemeosa, and in several commercially available Black Cohosh products Planta Med 66 7 2000 635 640
23. K. He, G.F. Pauli, and B. Zheng, et al. Cimicifuga species identification by high performance liquid chromatography-photodiode array/mass spectrometric/evaporative light scattering detection for quality control of Black Cohosh products J Chromatogr A 1112 1-2 2006 241 254
24. N.J.C. Zerega, S. Mori, and C. Lindqvist, et al. Using amplified fragment length polymorphisms (AFLP) to identify Black Cohosh (Actaea racemosa) Econ Bot 56 2 2002 154 164
25. B. Jiang, F. Kronenberg, and P. Nuntanakorn, et al. Evaluation of the botanical authenticity and phytochemical profile of Black Cohosh products by high-performance liquid chromatography with selected ion monitoring liquid chromatography-mass spectrometry J Agric Food Chem 54 2006 3242 3253
26. B. Avula, Z. Ali, and I.A. Khan Chemical fingerprinting of Actaea racemosa (Black Cohosh) and its comparison study with closely related Actaea species (A. pachypoda, A. podocarpa, A. rubra) by HPLC Chromatographia 66 9/10 2007 757 762
27. EDQM European Pharmacopoeia 6.5 ed. 2009 Directorate for the Quality of Medicines & HealthCare of the Council of Europe Strasbourg, France
28. British Pharmacopoeia Commission on Human Medicines 2008 Department of Health Great Britain, London
29. USP. Admission Criteria and Safety Classification for Dietary Supplements Guideline. http://www.usp.org/pdf/EN/USPNF/2009-10- 21AdmissionDSGuidelineFinal1.0.pdf [accessed November 16, 2009].
30. EMEA. European Medicines Agency. Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome. http://www.emea.europa.eu/pdfs/human/hmpc/ cimicifugae-rhizoma/60071707en.pdf [accessed November 16, 2009].
31. Health Canada. Black cohosh. Single ingredient monographs for natural health products; 2009. http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id= 24&lang=eng [accessed November 16, 2009].
32. WHO Guidelines for assessing quality of herbal medicines with reference to contaminants and residues 2007 World Health Organization Geneva, Switzerland
33. WHO Guidelines on good manufacturing practices (GMP) for herbal medicines 2007 World Health Organization Geneva, Switzerland
34. WHO Guidelines on good agricultural and collection practices (GACP) for medicinal plants 2003 World Health Organization Geneva, Switzerland
35. WHO Quality control methods for medicinal plant materials 1998 World Health Organization Geneva, Switzerland
36. DSC USP Dietary Supplements Compendium 2009 The United States Pharmacopeial Convention Rockville, MD
37. WHO International Regulatory Cooperation for Herbal Medicines (IRCH); 2009. http://www.who.int/medicines/areas/traditional/geninfo/en/index.html [accessed October 02, 2009].
38. F. Borrelli, and A.A. Izzo Herb-drug interactions with St John's Wort (Hypericum perforatum): an update on clinical observations AAPS J 2009 October 27 [Epub ahead of print]
39. NCI. National Cancer Institute. Hypericum perforatum (St. John's Wort) in relieving hot flashes in postmenopausal women with non-metastatic breast cancer; 2009. http://clinicaltrials.gov/ct2/show/NCT00110136 [accessed December 28, 2009].
40. C.B. Klein, and A.A. King Genistein genotoxicity: critical considerations of in vitro exposure dose Toxicol Appl Pharmacol 224 1 2007 1 11
41. S.F. Zhou, C.C. Xue, X.Q. Yu, and G. Wang Metabolic activation of herbal and dietary constituents and its clinical and toxicological implications: an update Curr Drug Metab 8 6 2007 526 553
42. P. Moutsatsou The spectrum of phytoestrogens in nature: our knowledge is expanding Hormones (Athens) 6 3 2007 173 193
43. T. Sakamoto, H. Horiguchi, E. Oguma, and F. Kayama Effects of diverse dietary phytoestrogens on cell growth, cell cycle and apoptosis in estrogen-receptor-positive breast cancer cells J Nutr Biochem 2009 [Epub ahead of print]
44. J.J. Casciari, M.G. Hollingshead, and M.C. Alley, et al. Growth and chemotherapeutic response of cells in a hollow-fiber in vitro solid tumor model J Natl Cancer Inst 86 24 1994 1846 1852
45. L.A. Hall, C.M. Krauthauser, and R.S. Wexler, et al. The hollow fiber assay: continued characterization with novel approaches Anticancer Res 20 2A 2000 903 911
46. M.G. Hollingshead, M.C. Alley, and R.F. Camalier, et al. In vivo cultivation of tumor cells in hollow fibers Life Sci 57 2 1995 131 141
47. G. Imre, V. Gekeler, and A. Leja, et al. Histone deacetylase inhibitors suppress the inducibility of nuclear factor-kappaB by tumor necrosis factor-alpha receptor-1 down-regulation Cancer Res 66 10 2006 5409 5418
48. R. LeBlanc, L.P. Catley, and T. Hideshima, et al. Proteasome inhibitor PS-341 inhibits human myeloma cell growth in vivo and prolongs survival in a murine model Cancer Res 62 17 2002 4996 5000
49. Q. Mi, D. Lantvit, and E. Reyes-Lim, et al. Evaluation of the potential cancer chemotherapeutic efficacy of natural product isolates employing in vivo hollow fiber tests J Nat Prod 65 6 2002 842 850
50. Q. Mi, B. Cui, and D. Lantvit, et al. Pervilleine F. A new tropane alkaloid aromatic ester that reverses multidrug resistance Anticancer Res 23 5A 2003 3607 3615
51. B.J. Doyle, J. Frasor, and L.E. Bellows, et al. Estrogenic effects of herbal medicines from Costa Rica used for the management of menopausal symptoms Menopause 16 4 2009 748 755
52. J. Frasor, A.E. Weaver, M. Pradhan, and K. Metha Synergistic up-regulation of prostaglandin E synthase expression in breast cancer cells by 17[beta]-estradiol and pro-inflammatory cytokines Endocrinology 149 2008 6272 6279
53. C.R. Overk, P. Yao, and L.R. Chadwick, et al. Comparison of the in vitro estrogenic activities of compounds from hops (Humulus lupulus) and red clover (Trifolium pratense) J Agric Food Chem 53 16 2005 6246 6253
54. C.R. Overk, J. Guo, and L.R. Chadwick, et al. In vivo estrogenic comparisons of Trifolium pratense (red clover) Humulus lupulus (hops), and the pure compounds isoxanthohumol and 8-prenylnaringenin Chem Biol Interact 176 1 2008 30 39
55. J. Frasor, J.M. Danes, and B. Komm, et al. Profiling of estrogen up- and down-regulated gene expression in human breast cancer cells: insights into gene networks and pathways underlying estrogenic control of proliferation and cell phenotype Endocrinology 144 2003 4562 4574
56. E.C. Chang, J. Frasor, B. Komm, and B.S. Katzenellenbogen Impact of estrogen receptor [beta] on gene networks regulated by estrogen receptor [alpha] in breast cancer cells Endocrinology 147 2006 4831 4842
57. R.B. Duda, B. Taback, and B. Kessel, et al. pS2 expression induced by American ginseng in MCF-7 breast cancer cells Ann Surg Oncol 3 6 1996 515 520
58. M.L. King, S.R. Adler, and L.L. Murphy Extraction-dependent effects of American ginseng (Panax quinquefolium) on human breast cancer cell proliferation and estrogen receptor activation Integr Cancer Ther 5 3 2006 236 243
59. D.M. Qato, G.C. Alexander, and R.M. Conti, et al. Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States JAMA 300 24 2008 2867 2878