Raynor, David K., Dickinson, Rebecca, Knapp, Peter, Long, Andrew F. and Nicolson, Donald J.. (2011) Buyer beware? : does the information provided with herbal products available over the counter enable safe use? BMC Medicine, Vol.9 (No.1). p. 94. ISSN 1741-7015

Preview

PDF WRAP_Nicolson_1741-7015-9-94.pdf - Published Version - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader Download (462Kb)

Abstract

Background: Herbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information. Methods: Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John’s wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St John’s wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions). Results: Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John’s wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St John’s wort) contained at least 85% of the safety messages. Conclusions: Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John’s wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products.

Item Type:	Journal Article
Subjects:	R Medicine > RM Therapeutics. Pharmacology
Divisions:	Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Herbs -- Therapeutic use -- Safety regulations
Journal or Publication Title:	BMC Medicine
Publisher:	BioMed Central Ltd.
ISSN:	1741-7015
Date:	9 August 2011
Volume:	Vol.9
Number:	No.1
Page Range:	p. 94
Identification Number:	10.1186/1741-7015-9-94
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	University of Leeds
References:	1. Public Perceptions of Herbal Medicines. [http://www.ipsos-mori.com/ Assets/Docs/Polls/public-perceptions-of-herbal-medicines-report.pdf]. 2. Committee on the Use of Complementary and Alternative Medicine by the American Public, Board on Health Promotion and Disease Prevention, Institute of Medicine: Complementary and Alternative Medicine in the United States Washington, DC: The National Academies Press; 2005. 3. Anquez-Traxler C: The legal and regulatory framework of herbal medicinal products in the European Union: a focus on the traditional herbal medicines category. Drug Info J 2011, 45:15-23. 4. Braun LA, Tiralongo E, Wilkinson JM, Spitzer O, Bailey M, Poole S, Dooley M: Perceptions, use and attitudes of pharmacy customers on complementary medicines and pharmacy practice. BMC Complement Altern Med 2010, 10:38. 5. Cramer H, Shaw A, Wye L, Weiss M: Over-the-counter advice seeking about complementary and alternative medicines (CAM) in community pharmacies and health shops: an ethnographic study. Health Soc Care Community 2010, 18:41-50. 6. Lynch N, Berry D: Differences in perceived risks and benefits of herbal, over-the-counter conventional, and prescribed conventional, medicines, and the implications of this for the safe and effective use of herbal products. Complement Ther Med 2007, 15:84-91. 7. World Health Organization: Guidelines on Developing Consumer Information on Proper Use of Traditional, Complementary and Alternative Medicine Geneva: World Health Organization; 2004. 8. Gohar F, Greenfield SM, Beevers DG, Lip GYH, Jolly K: Self-care and adherence to medication: a survey in the hypertension outpatient clinic. BMC Complement Altern Med 2008, 8:4. 9. Medicines and Healthcare products Research Agency: Herbal products: safety update. Drug Saf Update 2009, 3(1):5. 10. Anonymous: Herbal medicines: what do clinicians know? Drug Ther Bull 2010, 48:46-47. 11. Public Health Risk with Herbal Medicines: An Overview. [http://www. mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON023163& RevisionSelectionMethod=Latest]. 12. WHO Traditional Medicine Strategy 2002-2005. [http://whqlibdoc.who.int/ hq/2002/who_edm_trm_2002.1.pdf]. 13. Herbs at a Glance. [http://nccam.nih.gov/health/herbsataglance.htm]. 14. Calapai G: European legislation on herbal medicines: a look into the future. Drug Saf 2008, 31:428-431. 15. Nissen N: Practitioners of Western herbal medicine and their practice in the UK: beginning to sketch the profession. Complement Ther Clin Pract 2010, 16:181-186. 16. Routledge PA: The European Herbal Medicines Directive: could it have saved the lives of Romeo and Juliet? Drug Safety 2008, 31:416-418. 17. Herbal Medicines. [http://www.mhra.gov.uk/Howweregulate/Medicines/ Herbalmedicines/index.htm]. 18. Raynor DK: Testing, testing: the benefits of user-testing package leaflets. Regul Aff Focus 2008, 1:16-19. 19. European Herbal Medicines Directive 2004/24/EC. [http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:0090:en:PDF]. 20. Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, Dorer G, Gilbody S, Dickinson D, Maule AJ, Spoor P: A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess 2007, 11:1-160. 21. Izzo AA, Ernst E: Interactions between herbal medicines and prescribed drugs. Drugs 2009, 69:1777-1798. 22. Ernst E: The risk-benefit profile of commonly used herbal therapies: Ginkgo, St John’s Wort, Ginseng, Echinacea, Saw Palmetto, and Kava. Ann Intern Med 2002, 136:42-53. 23. Quigley G: In the pharmacy: integration is interactive. J Complement Med 2002, 1:44-45. 24. Collyer F: The corporatisation and commercialisation of CAM. In The Mainstreaming of CAM. Edited by: Tovey P. London: Routledge; 2004:198-215. 25. Barnes J, Anderson LA, Phillipson JD: Herbal Medicines: A Guide for Healthcare Professionals. 2 edition. London: Pharmaceutical Press; 2002. 26. Natural Medicines Comprehensive Database. [http://www.naturaldatabase. com/]. 27. Mills S, Bone K: The Essential Guide to Herbal Safety St Louis: Elsevier; 2005. 28. Blumenthal M, Busse WR, Goldberg A, (Eds): The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines Austin, TX: American Botanical Council/Integrative Medicine Communications; 1998. 29. European Medicines Agency: Community Herbal Monographs. [http:// www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/ document_listing/document_listing_000212.jsp&murl=menus/regulations/ regulations.jsp&mid=WC0b01ac058003380a]. 30. Clauson KA, Santamarina ML, Rutledge JC: Clinically relevant safety issues associated with St John’s wort product labels. BMC Complement Altern Med 2008, 8:42. 31. Houghton P: Regulation of herbal medicinal products. Pharm J 2009, 282:485-486. 32. Kwan D, Boon HS, Hirschkorn K, Welsh S, Jurgens T, Eccott L, Heschuk S, Griener GG, Cohen-Kohler JC: Exploring consumer and pharmacist views on the professional role of the pharmacist with respect to natural health products. BMC Complement Altern Med 2008, 8:40. 33. Vickers KA, Jolly KB, Greenfield SM: Herbal medicine: women’s views, knowledge and interaction with doctors. BMC Complement Altern Med 2006, 6:40. 34. Smith M, Boon HS: Counseling cancer patients about herbal medicine. Patient Educ Couns 1999, 38:109-120. 35. Tachjian A, Maria V, Jahangir A: Use of herbal products and potential interactions in patients with cardiovascular diseases. J Am Coll Cardiol 2010, 55:515-525. 36. Gratus C, Wilson S, Greenfield SM, Damery SL, Warmington SA, Grieve R, Steven NM, Routledge P: The use of herbal medicines by people with cancer. BMC Complement Altern Med 2009, 9:14. 37. Waiji M, Sagaram S, Sagaram D, Meric-Bernstam F, Johnson C, Mirza NQ, Bernstam EV: Efficacy of quality criteria to identify potentially harmful information: a cross-sectional survey of CAM web sites. J Med Internet Res 2004, 6:21.
URI:	http://wrap.warwick.ac.uk/id/eprint/38310

Request changes to a record

Actions (login required)

View Item