FOLLOWUS
Review of the regulations for clinical research in herbal medicines in USA
- Chinese Journal of Integrative Medicine Vol. 20, Issue 12, Pages: 883-893(2014)
- Affiliations：
1. Herose Clinical Centre,Singapore,Singapore
2. Department of Law, School of Humanities, Inner Mongolia University of Technology,Hohhot,China
3. School of Nursing, Midwifery & Social Care, Faculty of Health, Life & Social Sciences, Edinburgh Napier University, Sighthill Campus, Sighthill Court,Edinburgh,UK
- Author bio：
- Funds：
DOI：10.1007/s11655-014-2024-y
CLC：Published：2014，
Published Online：27 November 2014，
Scan for full text
Tang, T.Y., Li, Fz. & Afseth, J. Review of the regulations for clinical research in herbal medicines in USA., Chin. J. Integr. Med. 20, 883–893 (2014). https://doi.org/10.1007/s11655-014-2024-y
Tony Yuqi Tang, Fang-zhou Li, Janyne Afseth. Review of the regulations for clinical research in herbal medicines in USA. [J]. Chinese Journal of Integrative Medicine 20(12):883-893(2014)
Tang, T.Y., Li, Fz. & Afseth, J. Review of the regulations for clinical research in herbal medicines in USA., Chin. J. Integr. Med. 20, 883–893 (2014). https://doi.org/10.1007/s11655-014-2024-y DOI：
Tony Yuqi Tang, Fang-zhou Li, Janyne Afseth. Review of the regulations for clinical research in herbal medicines in USA. [J]. Chinese Journal of Integrative Medicine 20(12):883-893(2014) DOI： 10.1007/s11655-014-2024-y.
摘要
In 2012
USA Food and Drug Administration (FDA) approved 39 new drugs
however
there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA’s industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines
authors investigate current regulation on herbal medicine clinical research
identify challenges conducting clinical trials
and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs
Veregen (sinecatechins)
green tea leaves extract
a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA
based on the findings and analysis through the literature review and Veregen case study
authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.
Abstract
In 2012
USA Food and Drug Administration (FDA) approved 39 new drugs
however
there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA’s industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines
authors investigate current regulation on herbal medicine clinical research
identify challenges conducting clinical trials
and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs
Veregen (sinecatechins)
green tea leaves extract
a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA
based on the findings and analysis through the literature review and Veregen case study
authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.
关键词
herbal medicineChinese Medicineclinical trialTraditional MedicineComplementary Medicinereview
Keywords
herbal medicineChinese Medicineclinical trialTraditional MedicineComplementary Medicinereview
references
US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research. Botanical Review Team (BRT). Available at http://www.fda.gov/AboutFDA/CentersOffices/Office of Medical ProductsandTobacco/CDER/ucm090973.htm [Accessed on 10 March 2014]
Capasso L. 5300 years ago, the Ice Man used natural laxatives and antibiotics. Lancet 1998;352(9143):1864.
Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA 1998;280:1604.
Kaptchuk TJ. Acupuncture: theory, efficacy, and practice. Ann Intern Med 2002;136:374.
Blumenthal M. The ABC clinical guide to herbs. American Botanical Council. Thieme, New York 2003
Farnsworth NR, Akerele O, Bingel AS, Soejarto DD, Guo Z. Medicinal plants in therapy. Bull World Health Organ 1985;63:965–981.
Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, 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.
Goldman P. Herbal medicines today and the roots of modern pharmacology. Ann Intern Med 2001;135:594.
Kaufman DW, Kelly JP, Rosenberg L, Anderson TE, Mitchell A. Recent patterns of medication use in the ambulatory adult population of the United States: the Slone survey. JAMA 2002;287:337.
Vapiwala N, Mick R, Hampshire MK, Metz JM, DeNittis AS. Patient initiation of complementary and alternative medical therapies (CAM) following cancer diagnosis. Cancer J 2006;12:467–474.
Kaptchuk TJ, Eisenberg DM. The persuasive appeal of alternative medicine. Ann Intern Med 1998;129:1061.
Marcus DM, Grollman AP. Botanical medicines-the need for new regulations. N Engl J Med 2002;347:2073.
Balunas MJ and Kinghorn AD. Drug discovery from medicinal plants. Life Sci 2005;78:431–441.
Jachak SM, Saklani A. Challenges and opportunities in drug discovery from plants. Current Sci 2007;92(9):7.
Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, et al. Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008;135:1924.
Chen ST, Dou JH, Temple R, Agarwal R, Wu KM, Walker S. New therapies from old medicines. Nat Biotechnol 2008;26:1077–1083.
Navarro VJ. Herbal and dietary supplement hepatotoxicity. Semin Liver Dis 2009;29:373.
Niharika S, Padmavati M, Satyahari Dey. Herbal drugs: standards and regulation. Fitoterapia 81:462–471.
Sood A and Prasad K. Challenges conducting clinical trials with herbal products in oncology. in Alaoui-Jamali M, ed. Alternative and complementary therapies for cancer: integrative approaches and discovery of conventional drugs. Springer 2010;New York:403–416.
Weinstein DH, Twaddell WS, Raufman JP, Philosophe B, Mindikoglu AL. SlimQuick?-associated hepatotoxicity in a woman with alpha-1 antitrypsin heterozygosity. World J Hepatol 2012;4:154.
Cardellina JH II. Challenges and opportunities confronting the botanical dietary supplement industry. J Nat Prod 2002;65:1073–1084.
Ernst E. Second thoughts about safety of St John’s wort. Lancet 1999;354:2014–2016.
Vanherweghem JL, Depierreux M, Tielemans C, Abramowicz D, Dratwa M, Jadoul M, et al. Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet 1993;341:387–391.
Depierreux M, Van Damme B, Vanden Houte K, Vanherweghem JL. Pathologic aspects of a newly described nephropathy related to the prolonged use of Chinese herbs. Am J Kidney Dis 1994;24:172–180.
Crone CC, Wise TN. Use of herbal medicines among consultation-liaison populations. A review of current information regarding risks, interactions, and efficacy. Psychosomatics 1998;39:43.
Newall CA, Anderson LA, Phillipson JD, eds. Herbal medicines. A guide for health-care professionals. London: The Pharmaceutical Press; 1996:6.
Saxena PK, Cole IB, Murch SJ. Approaches to quality plant basedmedicine: significance of chemical profiling. In: Verpoorte R, et al, eds. Applications of plant metabolic engineering. Netherlands: Springer; 2007:311.
Bennett DA Jr1, Phun L, Polk JF, Voglino SA, Zlotnik V, Raffa RB. Neuropharmacology of St. John’s Wort (Hypericum). Ann Pharmacother 1998;32:1201.
Müller WE, Singer A, Wonnemann M, Hafner U, Rolli M, Schäfer C. Hyperforin represents the neurotransmitter reuptake inhibiting constituent of hypericum extract. Pharmacopsychiatry 1998;31Suppl 1:16.
Singer A, Wonnemann M, Müller WE. Hyperforin, a major antidepressant constituent of St. John’s Wort, inhibits serotonin uptake by elevating free intracellular Na+1. J Pharm Exp Thera 1999;290:1363.
Gilroy CM, Steiner JF, Byers T, Shapiro H, Georgian W. Echinacea and truth in labeling. Arch Int Med 2003;163:699.
Harkey MR, Henderson GL, Gershwin ME, Stern JS, Hackman RM. Variability in commercial ginseng products: an analysis of 25 preparations. Am J Clin Nut 2001;73:1101–1106.
Brazier NC and Levine MA. Drug-herb interaction among commonly used conventional medicines: a compendium for health care professionals. Am J Thera 2003;10:163.
Estes JD, Stolpman D, Olyaei A, Corless CL, Ham JM, Schwartz JM, et al. High prevalence of potentially hepatotoxic herbal supplement use in patients with fulminant hepatic failure. Arch Surg 2003;138:852.
Tsai HH, Lin HW, Pickard AS, Tsai HY, Mahady GB. Evaluation of documented drug interactions and contraindications associated with herbs and dietary supplements: a systematic literature review. Int J Clin Pract 2012;66:1056–1078.
Kennedy J. Herb and supplement use in the US adult population. Clin Ther 2005;27:1847.
Bonkovsky HL. Hepatotoxicity associated with supplements containing Chinese green tea (Camellia sinensis). Ann Intern Med 2006;144:68.
Javaid A, Bonkovsky HL. Hepatotoxicity due to extracts of Chinese green tea (Camellia sinensis): a growing concern. J Hepatol 2006;45:334.
Molinari M, Watt KD, Kruszyna T, Nelson R, Walsh M, Huang WY, et al. Acute liver failure induced by green tea extracts: case report and review of the literature. Liver Transpl 2006;12:1892.
Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J. Indinavir concentrations and St John’s wort. Lancet 2000;355:547–548.
Knüppel L and Linde K. Adverse effects of St. John’s Wort: a systematic review. J Clin Psych 2004;65:1470.
Johne A, Brockmöller 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.
Moore LB, Goodwin B, Jones SA, Wisely GB, Serabjit-Singh CJ, Willson TM, et al. St. John’s wort induces hepatic drug metabolism through activation of the pregnane X receptor. Proc Natl Acad Sci USA. 2000;97:7500–7502.
Sugimoto K, Ohmori M, Tsuruoka S, Nishiki K, Kawaguchi A, Harada K, et al. Different effects of St John’s wort on the pharmacokinetics of simvastatin and pravastatin. Clin Pharmacol Ther 2001;70:518–524.
Mathijssen RH, Verweij J, de Bruijn P, Loos WJ, Sparreboom A, et al. Effects of St. John’s wort on irinotecan metabolism. J Natl Cancer Inst 2002;94:1247–1249.
Mueller SC, Majcher-Peszynska J, Uehleke B, Klammt S, Mundkowski RG, Miekisch W, et al. The extent of induction of CYP3A by St. John’s wort varies among products and is linked to hyperforin dose. Eur J Clin Pharmacol 2006;62:29–36.
Gordon RY, Becker DJ, Rader DJ. Reduced efficacy of rosuvastatin by St. John’s Wort. Am J Med 2009;122:e1.
Nieminen TH, Hagelberg NM, Saari TI, Neuvonen M, Laine K, Neuvonen PJ, et al. St John’s wort greatly reduces the concentrations of oral oxycodone. Eur J Pain 2010;14:854–859.
Blendon RJ, DesRoches CM, Benson JM, Brodie M, Altman DE. Americans’ views on the use and regulation of dietary supplements. Arch Intern Med 2001;161:805–810.
Sadovsky R, Collins N, Tighe AP, Brunton SA, Safeer R. Patient use of dietary supplements: a clinician’s perspective. Curr Med Res Opin. 2008;24:1209–1216.
Glisson JK, Walker LA. How physicians should evaluate dietary supplements. Am J Med 2010;123:577–582.
Peng T. Convergence: where West meets East. Nature 2011;480:S84–S86.
Wadman M. Centre turns away from healing herbs. Nature News. 2009;7. Doi:10.1038/462711a. Published online 07 December 2009
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;46:2606–2610.
Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, et al. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-ell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol 2010;28:744–752.
Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004;350:2129–2139.
Paez JG, Jänne PA, Lee JC, Tracy S, Greulich H, Gabriel S, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497–1500.
van Wietmarschen HA, Yuan K, Lu C, Gao P, Wang J, Xiao C, et al. Systems biology guided by Chinese medicine reveals new markers for sub-typing rheumatoid arthritis patients. J Clin Rheumatol 2009;15:330–337
van Wietmarschen HA, Reijmers TH, van der Kooij AJ, Schroën J, Wei H, Hankemeier T, et al. Sub-typing of rheumatic diseases based on a systems diagnosis questionnaire. PLoS One 2011;6:e24846.
van Wietmarschen HA, Dai W, van der Kooij AJ, Reijmers TH, Schroën Y, Wang M, et al. Characterization of rheumatoid arthritis subtypes using symptom profiles, clinical chemistry and metabolomics measurements. PLoS One 2012;7:e44331.
Koren MJ. Statin use in a “real-world” clinical setting: aggressive lipid lowering compared with usual care in the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial. Am J Med 2005;118Suppl:16–21.
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 2006;144:364–367.
0
Views
768
Downloads
11
CSCD
- Meta-XMLDownload
- BibTeXDownload
- EndnoteDownload
- RefMan Download
- NoteExpressDownload
- NoteFirstDownload
Publicity Resources
Related Articles
Related Author
Related Institution
- Address：1 Caochang, xiyuan, Beijing, People's Republic of China Postal code：100091
- Tel：010-62886827, 62877592 Fax：010-62874291
- Technical support is provided by Beijing Founder electronics co., LTD 京ICP备05067934号-1
京公网安备11010802024621 - It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
- Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.
