Challenges conducting clinical trials with herbal products in oncology

Alternative and Complementary Therapies for Cancer: Integrative Approaches and Discovery of Conventional Drugs

Volumn , Issue , 2010, Pages 403-421

  Sood, Amit ^a   Prasad, Kavita ^a  

^a Mayo Clinic College of Medicine   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84885755769     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-1-4419-0020-3_17     Document Type: Chapter

References (83)

1. Yates JS, Mustian KM, Morrow G.R., et al Prevalence of complementary and alternative medicine use in cancer patients during treatment. Support Care Cancer 2005;13(10):806-11. (Pubitemid 41414021)
2. Vapiwala N, Mick R, Hampshire M.K., Metz JM, DeNittis AS Patient initiation of complementary and alternative medical therapies (CAM) following cancer diagnosis. Cancer J 2006;12(6):467-74. (Pubitemid 46026195)
3. Correa-Velez I., Clavarino A, Eastwood H. Surviving, relieving, repairing, and boosting up: reasons for using complementary/alternative medicine among patients with advanced cancer: a thematic analysis. J Palliat Med. 2005;8(5):953-61. (Pubitemid 41579237)
4. Evans M, Shaw A, Thompson EA, et al. Decisionstouse complementary and alternative medicine (CAM) by male cancer patients: information-seeking roles and types of evidence used. BMC Complement Altern Med. 2007;7:25.
5. Verhoef MJ, Balneaves LG, Boon H.S., Vroegindewey A. Reasons for and characteristics associated with complementary and alternative medicine use among adult cancer patients: a systematic review. Integr Cancer Ther. 2005; 4 (4):274-86. (Pubitemid 41698176)
6. Loprinzi CL, Levitt R, Barton D.L., et al Evaluation of shark cartilage in patients with advanced cancer: a North Central Cancer Treatment Group trial. Cancer 2005;104(1):176-82. (Pubitemid 40847766)
7. Moertel CG, Fleming TR, Rubin J, et al A clinical trial of amygdalin (Laetrile) in the treatmentof human cancer. N EnglJ Med. 1982;306(4):201-6. (Pubitemid 12163108)
8. Helyer LK, Chin S, Chui B.K., et al The use of complementary and alternative medicines among patients with locally advanced breast cancer-a descriptive study. BMC Cancer 2006;6:39.
9. Wu KM, Ghantous H, Birnkrant DB Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States. Food Chem Toxicol. 2008;46(8):2606-10.
10. NCCAM. Interim applicant guidance: product quality: biologically active agents used incomplementary and alternative medicine (CAM) and placebo materials. http://grants.nih.gov/grants/guide/notice-files/NOT-AT-05-004.html. Accessed 12 Sept 2008.
11. CDER. Guidance for industry botanical drug products. http://www.fda.gov/ CDER/guidance/4592fnl.pdf. Accessed 12 Sept 2008.
12. Cragg GM, Boyd M. Drug discovery and development at the National Cancer Institute: the role of natural products of plant origin. New York: Columbia University Press; 1996.
13. NIH N. Developmental therapeutics program. http://dtp.nci.nih.gov/docs/ dtp-search.html. Accessed 12 Sept 2008.
14. Balunas MJ, Kinghorn AD Drug discovery from medicinal plants. Life Sci. 22 Dec 2005;78(5):431-41. (Pubitemid 41653493)
15. Jachak SM, Saklani A. Challenges and opportunities in drug discovery from plants. Current Sci. 2007;92(9):7.
16. Capasso L. 5300 years ago, the Ice Man used natural laxatives and antibiotics. Lancet 5 Dec 1998;352(9143):1864. (Pubitemid 28550101)
17. Liu Y, Wang MW Botanical drugs: challenges and opportunities: contribution to Linnaeus Memorial Symposium 2007. Life Sci. 27 Feb 2008;82 (9-10):445-9.
18. Cragg GM, Boyd MR, Cardellina JH II, Newman DJ, Snader KM, McCloud TG. Ethnobotany and drug discovery: the experience of the US National Cancer Institute. Ciba Found Symp. 1994;185:178-190; discussion 190-176
19. Patwardhan B, Warude D, Pushpangadan P., Bhatt N. Ayurveda and traditional Chinese medicine: a comparative overview. Evid Based Complement Alternat Med. Dec 2005;2(4):465-73. (Pubitemid 41752482)
20. Cardellina JH II. Challenges and opportunities confronting the botanical dietary supplement industry. J Nat Prod. Jul 2002;65(7):1073-84. (Pubitemid 34830394)
21. EGb 761: Ginkgo biloba extract, Ginkor. Drugs R D 2003;4(3):188-93.
22. Pockaj BA, Loprinzi CL, Sloan J.A., et al Pilot evaluation of black cohosh for the treatment of hot flashes in women. Cancer Invest. 2004;22(4):515-21. (Pubitemid 39506871)
23. Pockaj BA, Gallagher JG, Loprinzi C.L., 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. Jun 20 2006;24(18):2836-41. (Pubitemid 46630583)
24. Rietjens IM, Slob W, Galli C., Silano V. Risk assessment of botanicals and botanical preparations intended for use in food and food supplements: emerging issues. Toxicol Lett. 15 Aug 2008;180(2):131-6.
25. Herbal Roulette. Consumer Rep. 1995;60:698-705.
26. FDA US. Dietary supplement current good manufacturing practices (CGMPs) and interim final rule (IFR) facts. http://www.foodsafety.gov/~dms/dscgmps6. html. Accessed 12 Sept 2008.
27. White J. PC-SPES-a lesson for future dietary supplement research. J Natl Cancer Inst. 4 Sept 2002;94(17):1261-3.
28. Okada M. Chinese-herb nephropathy. Lancet 13 Nov 1999;354(9191):1732.
29. Ko RJ. Adulterants in Asian patent medicines. N Engl J Med. 17 Sept 1998;339(12):847.
30. Miller GM, Stripp R. A study of western pharmaceuticals contained within samples of Chinese herbal/patent medicines collected from New York City's Chinatown. Leg Med. (Tokyo) Sept 2007;9(5):258-64. (Pubitemid 47089057)
31. Slifman NR, Obermeyer WR, Aloi B.K., et al Contamination of botanical dietary supplements by Digitalis lanata. N Engl J Med. Sept 17 1998; 339 (12):806-11. (Pubitemid 28447454)
32. Seeff LB. Herbal hepatotoxicity. Clin Liver Dis. Aug 2007;11(3):577-96, vii. (Pubitemid 47302344)
33. Cosyns JP. Aristolochic acid and 'Chinese herbs nephropathy': a review of the evidence to date. Drug Saf. 2003;26(1):33-48.
34. 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. Nov 2003;23(5):1407-12.
35. Hirschberg AL, Edlund M, Svane G., Azavedo E, Skoog L, von Schoultz B. An isopropanolic extract of black cohosh does not increase mammographic breast density or breast cell proliferation in postmenopausal women. Menopause Jan-Feb 2007;14(1):89-96. (Pubitemid 46072009)
36. Bardia A, Tleyjeh IM, Cerhan J.R., et al Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis. Mayo Clin Proc. Jan 2008;83(1):23-34.
37. Omenn GS. Chemoprevention of lung cancers: lessons from CARET, the beta-carotene and retinol efficacy trial, and prospects for the future. Eur J Cancer Prev. Jun 2007;16(3):184-91. (Pubitemid 46597421)
38. Sugawara G, Nagino M, Nishio H., et al Perioperative synbiotic treatment to prevent postoperative infectious complications in biliary cancer surgery: a randomized controlled trial. Ann Surg. Nov 2006;244(5):706-714. (Pubitemid 44629944)
39. Besselink MG, van Santvoort HC, Buskens E, et al Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebocontrolled trial. Lancet 23 Feb 2008;371(9613):651-9.
40. Vickers AJ. How to design a phase I trial of an anticancer botanical. J Soc Integr Oncol. Winter 2006;4 1:46-51.
41. Cerchietti LC, Navigante AH, Lutteral M.A., et al Double-blinded, placebocontrolled trial on intravenous L-alanyl-L-glutamine in the incidence of oral mucositis following chemoradiotherapy in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 1 Aug 2006;65(5):1330-7. (Pubitemid 44425223)
42. Rubio IT, Cao Y, Hutchins L.F., Westbrook KC, Klimberg VS Effect of glutamine on methotrexate efficacy and toxicity. Ann Surg. May 1998; 227 (5):772-8; discussion 778-80
43. Okuno SH, Woodhouse CO, Loprinzi C.L., et al Phase III controlled evaluation of glutamine for decreasing stomatitis in patients receiving fluorouracil (5-FU)-based chemotherapy. Am J Clin Oncol. Jun 1999;22(3):258-61. (Pubitemid 30263318)
44. Ansari MS, Gupta NP Lycopene: a novel drug therapy in hormone refractory metastatic prostate cancer. Urol Oncol. Sep-Oct 2004;22(5):415-20.
45. Ansari MS, Gupta NP A comparison of lycopene and orchidectomy vs orchidectomy alone in the management of advanced prostate cancer. BJU Int. Sept 2003;92(4):375-8; discussion 378. (Pubitemid 37100511)
46. Jatoi A, Burch P, Hillman D., et al A tomato-based, lycopene-containing intervention for androgen-independent prostate cancer: results of a Phase II study from the North Central Cancer Treatment Group. Urology Feb 2007;69(2):289-94. (Pubitemid 46274937)
47. Sparreboom A, Cox MC, Acharya M.R., Figg WD Herbal remedies in the United States: potential adverse interactions with anticancer agents. J Clin Oncol. Jun 15 2004;22(12):2489-503. (Pubitemid 41115408)
48. Yeung KS, Gubili J. Clinical guide to herb-drug interactions in oncology. J Soc Integr Oncol. Summer 2007;5(3):113-17. (Pubitemid 47555911)
49. Meijerman I, Beijnen JH, Schellens JH Herb-drug interactions in oncology: focus on mechanisms of induction. Oncologist Jul-Aug 2006;11(7):742-52. (Pubitemid 44157562)
50. McCune JS, Hatfield AJ, Blackburn A.A., Leith PO, Livingston RB, Ellis GK Potential of chemotherapy-herb interactions in adult cancer patients. Support Care Cancer Jun 2004;12(6):454-62. (Pubitemid 38797102)
51. Werneke U, Earl J, Seydel C., Horn O, Crichton P, Fannon D. Potential health risks of complementary alternative medicines in cancer patients. Br J Cancer 26 Jan 2004;90(2):408-13. (Pubitemid 38250637)
52. Cox MC, Low J, Lee J., et al Influence of garlic (Allium sativum) on the pharmacokinetics of docetaxel. Clin Cancer Res 1 Aug 2006;12(15):4636-40. (Pubitemid 44297815)
53. van Erp N.P., Baker SD, Zhao M, et al Effect of milk thistle (Silybum marianum) on the pharmacokinetics of irinotecan. Clin Cancer Res. 1 Nov 2005;11(21):7800-6. (Pubitemid 41611624)
54. Smith P, Bullock JM, Booker B.M., Haas CE, Berenson CS, Jusko WJ The influence of St. John's wort on the pharmacokinetics and protein binding of imatinib mesylate. Pharmacotherapy Nov 2004;24(11):1508-14. (Pubitemid 39426346)
55. Mathijssen RH, Verweij J, de Bruijn P, Loos WJ, Sparreboom A. Effects of St. John's wort on irinotecan metabolism. J Natl Cancer Inst. 21 Aug 2002;94(16):1247-9. (Pubitemid 34993875)
56. Wittkowsky AK. Dietary supplements, herbs and oral anticoagulants: the nature of the evidence. J Thromb Thrombol. Feb 2008;25(1):72-7.
57. Beckert BW, Concannon MJ, Henry S.L., Smith DS, Puckett CL The effect of herbal medicines on platelet function: an in vivo experiment and review of the literature. Plast Reconstr Surg. Dec 2007;120(7):2044-50. (Pubitemid 350306707)
58. Simmonds MS. Novel drugs from botanical sources. Drug Discov Today 15 Aug 2003;8(16):721-2. (Pubitemid 37011236)
59. Newman DJ, Cragg GM Natural productsassources of new drugs over the last 25 years. J Nat Prod. Mar 2007;70(3):461-77. (Pubitemid 46595760)
60. Ohwada S, Ikeya T, Yokomori T, et al. Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study. Br J Cancer 8 Mar 2004;90(5):1003-10. (Pubitemid 38495819)
61. Sakamoto J, Morita S, Oba K., et al Efficacy of adjuvant immunochemotherapy with polysaccharide K for patients with curatively resected colorectal cancer: a meta-analysis of centrally randomized controlled clinical trials. Cancer Immunol Immunother. Apr 2006;55(4):404-11. (Pubitemid 43076892)
62. Oba K, Teramukai S, Kobayashi M., Matsui T, Kodera Y, Sakamoto J. Efficacy of adjuvant immunochemotherapy with polysaccharide K for patients with curative resections of gastric cancer. Cancer Immunol Immunother. Jun 2007;56(6):905-11. (Pubitemid 46729147)
63. Cowawintaweewat S, Manoromana S, Sriplung H., et al Prognostic improvement of patients with advanced liver cancer after active hexose correlated compound (AHCC) treatment. Asian Pac J Allergy Immunol. Mar 2006;24(1):33-45. (Pubitemid 44044084)
64. Ghoneum M, Wimbley M, Salem F., McKlain A, Attallah N, Gill G. Immunomodulatory and anticancer effects of Active Hemicellulose Compound (AHCC). Int J Immunother. 1995;11:23-8.
65. Demidov LV, Manziuk LV, Kharkevitch G.Y., Pirogova NA, Artamonova EV Adjuvant fermented wheat germ extract (Avemar) nutraceutical improves survival of high-risk skin melanoma patients: a randomized, pilot, phase II clinical study with a 7-year follow-up. Cancer Biother Radiopharm. Aug 2008;23(4):477-82.
66. Jakab F, Shoenfeld Y, Balogh A., et al A medical nutriment has supportive value in the treatment of colorectal cancer. Br J Cancer 4 Aug 2003; 89 (3):465-9. (Pubitemid 37026426)
67. Yang H, Chen D, Cui Q.C., Yuan X., Dou QP Celastrol, a triterpene extracted from the Chinese "Thunder of God Vine," is a potent proteasome inhibitor and suppresses human prostate cancer growth in nude mice. Cancer Res 1 May 2006;66(9):4758-65.
68. Tao X, Younger J, Fan F.Z., Wang B., Lipsky PE Benefit of an extract of Tripterygium Wilfordii Hook F in patients with rheumatoid arthritis: a double-blind, placebo-controlled study. Arthritis Rheum. Jul 2002; 46 (7):1735-43. (Pubitemid 34774504)
69. Rebbeck TR, Troxel AB, Norman S, et al A retrospective case-control study of the use of hormone-related supplements and association with breast cancer. Int J Cancer 1 Apr 2007;120(7):1523-8. (Pubitemid 46355388)
70. Zepelin HH, Meden H, Kostev K., Schroder-Bernhardi D, Stammwitz U, Becher H. Isopropanolic black cohosh extract and recurrence-free survival after breast cancer. Int J Clin Pharmacol Ther. Mar 2007;45(3):143-54. (Pubitemid 46416082)
71. Klassen TP, Pham B, Lawson M.L., Moher D. For randomized controlled trials, the quality of reports of complementary and alternative medicine was as good as reports of conventional medicine. J Clin Epidemiol. Aug 2005;58(8):763-8. (Pubitemid 40966833)
72. Li N, Sun Z, Han C., Chen J. The chemopreventive effects of tea on human oral precancerous mucosa lesions. Proc Soc Exp Biol Med. Apr 1999; 220 (4):218-24.
73. Manusirivithaya S, Sripramote M, Tangjitgamol S., et al Antiemetic effect of ginger in gynecologic oncology patients receiving cisplatin. Int J Gynecol Cancer Nov-Dec 2004;14(6):1063-9. (Pubitemid 39603348)
74. Bloom BS, Retbi A, Dahan S., Jonsson E. Evaluation of randomized controlled trials on complementary and alternative medicine. Int J Technol Assess Health Care Winter 2000;16(1):13-21. (Pubitemid 30263199)
75. Lawson ML, Pham B, Klassen T.P., Moher D. Systematic reviews involving complementary and alternative medicine interventions had higher quality of reporting than conventional medicine reviews. J Clin Epidemiol. Aug 2005;58(8):777-84. (Pubitemid 40966835)
76. Pittler MH, Ernst E. Feverfew for preventing migraine. Cochrane Database Syst Rev. 2004(1):CD002286.
77. Vickers AJ, Kuo J, Cassileth BR Unconventional anticancer agents: a systematic review of clinical trials. J Clin Oncol. 1 Jan 2006;24(1):136-40. (Pubitemid 46630504)
78. Daugherty CK, Ratain MJ, Emanuel E.J., Farrell AT, Schilsky RL Ethical, scientific, and regulatory perspectives regarding the use of placebos in cancer clinical trials. J Clin Oncol. 10 Mar 2008;26(8):1371-8.
79. Pecking AP. Evaluation by lymphoscintigraphy of the effect of a micronized flavonoid fraction (Daflon 500 mg) in the treatment of upper limb lymphedema. Int Angiol. Sep 1995;14(3 Suppl 1):39-43. (Pubitemid 26047743)
80. Pecking AP, Fevrier B, Wargon C., Pillion G. Efficacy of Daflon 500 mg in the treatment of lymphedema (secondary to conventional therapy of breast cancer). Angiology Jan 1997;48(1):93-8.
81. Carl W, Emrich LS Management of oral mucositis during local radiation and systemic chemotherapy: a study of 98 patients. J Prosthet Dent. Sep 1991;66(3):361-9.
82. Mazokopakis EE, Vrentzos GE, Papadakis J.A., Babalis DE, Ganotakis ES Wild chamomile (Matricaria recutita L.) mouthwashes in methotrexateinduced oral mucositis. Phytomedicine Jan 2005;12(1-2):25-7. (Pubitemid 40174325)
83. Gagnier JJ, Boon H, Rochon P., Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med. 7 Mar 2006;144(5):364-7. (Pubitemid 46768190)