Quality assurance and standardization in botanical product-drug interaction: Evaluation and documentation

Herbal Supplements-Drug Interactions: Scientific and Regulatory Perspectives

Volumn , Issue , 2006, Pages 191-203

  Chadwick, Lucas R ^a   Fong, Harry H S ^a  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77952884844     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (54)

1. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA 1998; 280:1569-1575.
2. Dev S. Ethnotherapeutics and modern drug development: the potential of Ayurveda. Curr Sci 1997; 73:909-928.
3. Dev S. Ancient-modern concordance in Ayurvedic plants: some examples. Environ Health Perspect 1999; 107:783-789.
4. Anon. Medicinal herbs: NTP extracts the facts. Environmental Health Perspectives (NIEHS News) 1999; 107:A604-605 (accessed online at http://ehp.niehs. nih.gov/docs/1999/107-12/niehsnews.html via http://ehp.niehs.nih.gov/docs/montharch.html, 24 March, 2004).
5. Murray F. Vitamins-1. Drugs-100,000. Let’s Live. 1996; September:12.
6. Fucik H, Backlund A, Farah M. Building a computerized herbal substance register for implementation and use in the World Health Organization International Drug Monitoring Programme. Drug Information J 2002; 36:839-854.
7. Ho PC, Ghose K, Saville D, Wanwimolruk S. Effect of grapefruit juice on pharmacokinetics and pharmacodynamics of verapamil enantiomers in healthy volunteers. Eur J Clin Pharmacol 2000; 56:693-698.
8. Takanaga H, Ohnishi A, Matsuo H, et al. Pharmacokinetic analysis of felodipine-grapefruit juice interaction based on an irreversible enzyme inhibition model. Br J Clin Pharmacol 2000; 49:49-58.
9. Barone GW, Gurley BJ, Kotel BL, Abul-Ezz SR. Herbal supplements: a potential for drug interactions in transplant recipients. Transplantation 2001; 71: 239-241.
10. Broughton A, Denahm A. Hypericum and drug interactions. Eur J Herbal Med 2001; 5:19-25.
11. de Maat MM, Hoetelmans RM, Math RA, et al. Drug interaction between St. John’s wort and nevirapine. AIDS 2001; 15:420-421.
12. Ernst E. Second thoughts about safety of St. John’s wort. Lancet 1999; 354: 2014-2016.
13. Izzo AA, Ernst E. Interactions between herbal medicines and prescribed drugs: a systematic review. Drugs 2001; 61:2163-2175.
14. Johne A, Brockmoller J, Bauer S, Maurer A, Langheinrich M, Roots I. Pharmacokinetic interaction of digoxin with an herbal extract from St. John’s wort (Hypericum perforatum). Clin Pharmacol Ther 1999; 66:338-345.
15. Karliova M, Treichel U, Malago M, Frilling A, Gerken G, Broelsch CE. Interaction of Hypericum perforatum (St. John’s wort) with cyclosporin A metabolism in a patient after liver transplantation. J Hepatol 2000; 33:853-855.
16. Pennachio DL. Drug-herb interactions: How vigilant should you be? Patient Care 2000; 19:41-68.
17. Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J. Indinavir concentrations and St. John’s wort. Lancet 2000; 355:547-548.
18. Ruschitzka F, Meier PJ, Turina M, Luscher TF, Noll G. Acute heart transplant rejection due to St. John’s wort. Lancet 2000; 355:548-549.
19. Farnsworth NR. Relative safety of herbal medicines. Herbal Gram 1993; 29: 36A-36H.
20. Huang WF, Wen KC, Hsiao ML. Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan. J Clin Pharmacol 1997; 37:344-350.
21. Blumenthal M. The rise and fall of PC-SPES: new generation of herbal supplement, adulterated product, or new drug? Integrative Cancer Therapies 2002; 1:266-270.
22. Bhattacharyya PC. Herbal drugs. Curr Sci 1996; 71:341-349.
23. Ernst E, Thompson Coon J. Heavy metals in traditional Chinese medicines: a systematic review. Clin Pharmacol Therapeut 2001; 70:497-504.
24. Siegel RK. Ginseng abuse syndrome. Problems with the panacea. JAMA 1979; 241:1614-1615.
25. Awang DVC. Siberian ginseng toxicity may be case of mistaken identity. CMAJ 1996; 155:1237.
26. Fitzloff J, Yat P, Lu ZZ, et al. Perspectives on the quality assurance of ginseng products in North America. In: Huh H, Choi KJ, Kim YC, eds. Advances in Ginseng Research. 7th International Symposium on Ginseng. Seoul, Korea: The Korean Society of Ginseng, 1998:138-145.
27. Schulz V, Hubner WD, Ploch M. Clinical trials with phytopharmacological agents. Phytomedicine 1997; 4:379-387.
28. Busse W. The processing of botanicals. In: Eskinazi D, Blumenthal M, Farnsworth NR, Riggins CW, eds. Botanical Medicine -Efficacy, Quality Assurance and Regulation. Larchmont, NY: Mary Ann Liebert Inc., 1999:143-145.
29. Flaster T. Shipping, handling, receipt, and short-term storage of raw plant materials. In: Eskinazi D, Blumenthal M, Farnsworth NR, Riggins CW, eds. Botanical Medicine -Efficacy, Quality Assurance and Regulation. Larchmont, NY: Mary Ann Liebert Inc., 1999:139-142.
30. McChesney JD. Environmental issues and methodology for detecting environmental contaminants. In: Eskinazi D, Blumenthal M, Farnsworth NR, Riggins CW, eds. Botanical Medicine -Efficacy, Quality Assurance and Regulation. Larchmont, NY: Mary Ann Liebert Inc., 1999:127-131.
31. Reichling J, Saller R. Quality control in the manufacturing of modern herbal remedies. Quarterly Review of Natural Medicine 1998; Spring:21-28.
32. Simon JE. Domestication and production considerations in quality control of botanicals. In: Eskinazi D, Blumenthal M, Farnsworth NR, Riggins CW, eds. Botanical Medicine -Efficacy, Quality Assurance and Regulation. Larchmont, NY: Mary Ann Liebert Inc., 1999:133-137.
33. Southwell IA, Campbell MH. Hypericin content variation in Hypericum perforatum in Australia. Phytochemistry 1991; 30:475-478.
34. Campbell MH, May CE, Southwell IA, Tomlinson JD, Michael PW. Variation in Hypericum perforatum L. (St. John’s wort) in New South Wales. Plant Protection Quart 1997; 12:64-66.
35. Bauer R. Echinacea: biological effects and active principles. In: Lawson LD, Bauer R, eds. Phytomedicines of Europe. Chemistry and Biological Activity. Washington, D.C.: American Chemical Society, 1988:140-157.
36. Bauer R, Wagner H. Echinacea species as potential immunostimulatory drugs. In: Wagner H, Farnsworth NR, eds. Economic and Medicinal Plant Research. Vol. 5. New York: Academic Press, 1991:253-321.
37. James WO. Alkaloids in the plants. In: Manske RHF, Holmes HL, eds. The Alkaloids. Vol. 1. New York: Academic Press, 1950:16-86.
38. Manske RHF. Sources of alkaloids and their isolation. In: Manske RHF, Holmes HL, eds. The Alkaloids. Vol. 1. New York: Academic Press, 1950:1-11.
39. Hammouda FM, Ismail SI, Hassan NM, Zaki AK, Kamel A. Evaluation of the silymarin content in Silybum marianum (L.) Gaertn. cultivated under different agricultural conditions. Phytother Res 1993; 7:90-91.
40. Espinosa EO, Mann MJ, Bleadsdell B. Toxic metals in selected traditional Chinese medicinals. J Forensic Sci 1996; 41:453-456.
41. Awang DVC. Quality control and good manufacturing practices: safety and efficacy of commercial herbs. Food Drug Law J 1997; 52:341-344.
42. Slifman NR, Obermeyer WR, Aloi BK, et al. Contamination of botanical dietary supplements by Digitalis lanata. N Engl J Med 1998; 339:806-811.
43. Mahady GB, Fong HHS, Farnsworth NR. Botanical Dietary Supplements: Quality, Safety and Efficacy. Lisse, Netherlands: Swets & Zeitlinger, 2001.
44. Miller MJS. Herbal medicine standardization. Problems and possibilities. J Am Nutraceut Assoc 2001; 3:1-2.
45. Bone K. Standardized extracts: Neither poison nor panacea. Herbal Gram 2001; 53:50-55.
46. Anon. Regulatory Situation of Herbal Medicines: A Worldwide Review. Geneva, Switzerland: World Health Organization, 1998.
47. Anon. Federal Register March 28, 2003 (Volume 68, Number 60). Accessed online 24 March, 2004 at http://www.cfsan.fda.gov/lrd/fr030328.html.
48. Anon. WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Geneva, Switzerland: World Health Organization, 2003.
49. Anon. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines. Manila, Philippines: World Health Organization, Regional Office for the Western Pacific, 1993.
50. Anon. Guidelines for the assessment of herbal medicines. WHO Technical Report Series No. 863. Geneva, Switzerland: World Health Organization, 1996: 178-184.
51. Anon. Quality Control Methods for Medicinal Plant Materials. Geneva, Switzerland: World Health Organization, 1998.
52. Houghton PJ. Establishing identification criteria for botanicals. Drug Inform J 1998; 32:461-469.
53. Anon. Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Herbal Medicinal Products. WHO Technical Report Series No. 863. Geneva, Switzerland: World Health Organization, 1996:109-113.
54. Nortier JL, Martinez MC, Schmeiser HH, et al. Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). N Engl J Med 2000; 342:1686-1692.