New Products from ABC's Herbal Education Catalog
The ABC Clinical Guide to Herbs Ed. by Mark Blumenthal et al. , Ameri can Botanical Council , 2003. How does the healthcare professional effectively respond to pati ent inquiries on the use of herbal supplements? What clinical research has been conducted? How is safety evaluated? T his science-based educati onal course answers these and other ques tions for healthcare professionals, pharmaceutical companies, health management compani es, policy makers, the dietary supplement industry and consumers. Hardcover, 512 pp. $49.95. #905 Quick Access Guide to Conditions, Herbs & Supplements by Integrative Medicine Communica ti ons, 2000. T his book has three broad categories for quick answers to consumer questio ns. T he largest section deals with co nditions and covers various treatment options incl uding herbs, supplements, drugs, and other complementary and alternative therapies. O nly alternative treatments that are considered safe and effective when used with conventional medicine are included. Additional sections on herbs and supplements cover bas ic informati on, precautions, and dosage informati on. T he Q uick Reference Guide fou nd at the end of the book shows at a glance all the herbs and supplements that are useful in treating that co ndition. Softcove r. 430 pp. $29.95. #B52 1. Special offe r $24.00! ~ Quick Access Patient Information on Conditions, Herbs I ..!~ I & Supplements ~. I by Integrative Medicine Communications. Consists of three types of monographs. Condition monographs ~ provide patients with information on standard medical care wi th additional information on nutritional ._. support and the use of alternative and complementary therapies. Herb monographs provide important info r- r marion on their use in maintaining health or treating conditions. Supplement monographs provide informa ti on on the use of dietary supplements. Thirteen Q uick Reference G uide lists allow easy and targe ted access to information by symptom, use, precautions, etc. Spiral bound. 266 pp. $49.95. #B522. Special offer $40.00! Quick Access Professional Guide to Conditions, Herbs & Supplements by Integrative Medicine Communications. Contains Condition, Herb, and Supplement Monographs with extensive info rmati on geared toward medical practitioners. T hirtee n Q ui ck References al low easy and targeted access to the information. 472 pp. H ardcover. $49.95. #B523. Special offer $40.00! Quick Access Professional Reference to Conditions, Herbs & Supplements CD-ROM by Integrative Medicine Communications. Monographs address numerous medical condi- tions, provide information on a range of treatment options, outline uses, dosages and interacti ons fo r over 11 5 herbs and supplements and present nutrition depletions associated with the most popular drugs. PC compatible. $49.95. #COOl. Special offer $40.00! Herba/Gram BackPacks Don't leave any gaps in your library. HerbalGram back iss ues provide a comprehensive store of info rma tion on herbs, book reviews, research, conference reports, and regul atory developments. BackPacks are a set of Herba fGrams from 1989, except the most current iss ue, and include a Cumul ative Index. Order a complete set of BackPacks (Volumes II, III and IV) for $95 and receive 2 slipcases to protect and store those back issues at no extra charge ($19 value).
See inside back cover for more! To order, call toll free 800/373-7105, fax 512/926-2345, email: [email protected] or order online at www.herbalgram.org to see the complete Herbal Education Catalog and to see fNIERIGAN special offers, visit us online at: BoTANICAL www.herbalgram.org/bookcatalog COUNCIL Individuals, organizations, and companies who share our vision support our goals through membership. The American Botanical Council Invites You to e r------, Yes, I want to join ABC! Pl ease detach application and mail to: o1n American Botanical Council , P.O. Box 144345, Austin, TX 78714-4345 or join online at www. herbalgra m. org To join, please fill out this form or call us at 800/373-7105 x 119 or 0 Individual - $50 fill out an application online at www.herbalgram.org 0 Academic- $ 100 0 Professional - $ 150 0 Organization - $250 Membership Level 5 Please add $20 fo r addresses outside the U.S. (Add $20 postage for international delivery for above levels.) 0 Corporate and Sponsor levels . Individual -$50 Academic - $1 00 (Contact Wayne Silverman, PhD. 512/926-4900. ext. 120.) • Subscription to our highly All Individual membership Payment instructions acclaimed journal Herbal benefits, plus 0 C harge credit card (Visa or MC only) Gram • Online access to HerbCiip # ______
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Corporate and Sponsorship co untry Small to large organizations can receive additional benefits, including the bi-weekly HerbCiip service, and also extend their support to ABC's mission through Corporate or Sponsor level membership. To learn more, please contact Wayne Silverman, PhD, at e-mail [email protected], or 800/373-71 OS x120. Advisory Board Each issue of Herba/Gram is peer reviewed by members of our Advisory Board and other qualified experts before publication. dear Cindy K. An gerhofer, Ph.D. Paul Alan Cox, Ph .D. Director of Botanical Research, Director, National Tropical Botanical Aveda Institute, Ga rd en, Ka uai, Hawaii reader Minneapolis, Minnesota Lyle E. Craker, Ph.D. John Thor Arnason, Ph.D. Professor, Departme nt of Pl ant and }\. virtual barrage of U.S. Food and Drug Administration (FDA) Professor of Biology, Department of Soil Sciences, University of Biology, University of Ottawa, Massachusetts, Amherst ..l"\.activity in the area of herbs and dietary supplements (DS) has kept both agency and industry extremely busy in the past six months. Ontario, Canada Edward M. Croom, Jr., Ph.D. In December 2002 the FDA announced a new "Consumer Health Dennis V. C. Awang, Ph .D., Scientific and Regulatory Affairs F.C. I. C. Manager, lndena USA East, Inc., Information Initiative" to implement regulations on claims for supple MediPiant Natural Products Oxford, Mississippi ments under the Dietary Supplement Health and Education Act of Consulting Services, White Rock, B.C., Wade Davis, Ph.D. 1994 (DSHEA), a move almost universally welcomed. FDA's new Canada Author, ethnobotanist, commissioner, Mark McClellan, M.D., Ph.D., a physician and econo Manuel F. Balandrin, R.Ph., Washington, D.C. mist, appears to be guiding the age ncy to work more effectively. Since Ph.D. Steven Dentali, Ph.D. January, the FDA has launched a trio of major initiatives: implementa Resea rch Scientist, NPS Vice President of Scientificand tion of the Bioterrorism Act, new label warnings for ephedra products, Pharmaceuticals, Salt Lake City, Utah Technical Affairs, American Herbal and proposed Good Manufacturing Practi ces. Bruce Barrett, M. D., Ph.D. Products Association, Silver Spring, The Bioterrorism Act and its FDA rules are Assistant Professor of Family Maryland part of the Bush Administration's War on Terror. Medicine, University ofWisconsin Hardy Eshbaugh, Ph.D The Bioterrorism Act impacts aLl foodstuffs Madison Medical School Professor of Botany & Assistant imported into the United States, including Marilyn Barrett, Ph.D. Cu rator, Willard Sherman Turrell herbal materi als for teas and dietary supple Pharmacognosy Consulting Service, Herba riu m, Miami University, ments. In this issue, Washington regulatory San Carlos, California Oxford, Ohio attorney Paul Rubin provides an in-depth look at Bradley C. Bennett, Ph.D. Ad ri ane Fugh-Berman, M. D. the ramifications on the industry and, eventually, Associate Professor of Biology, Florida Author, Assistant Clinical Professor, the consumer. International University, Miami George Washington University In February, about three weeks after the death Joseph M. Betz, Ph.D. School of Medicine, Washing ton, DC of Baltimore Orioles pitcher Steve Bechler from Director of the Dietary Supplements Joe Graedon, M.S. Methods and Reference Materials Author, syndicated colum nist, radio an ephedra-rel ated case of heatstroke, FDA proposed warnings for Program, Office of Dietary host, Durham, North Carol ina supplements that contain ephedra. Stern "black box" warnings are Supplements, National Institutes of Mary Hardy, M.D. intended for the front panel of all ephedra supplement labels. At the Health, Bethesda, Maryland Director, Cedars-Sinai Integrative same time FDA released the long-awaited report from the RAND Peggy Brevoort Medicine Medical Group, Los Corporation on the safety and efficacy of ephedra in weight loss and Co-founder and former CEO of East Angeles, California athletic performance products. We publish an article that detai ls the Earth Herb; former President, Ch ristopher Hobbs, L.Ac., AHG findings. American Herbal Products Herbalist, botanist, licensed Then, FDA finally published proposed Good Manufacturing Prac Association; Seattle, Washington acupuncturist, Davis, California tices (GMPs) forDS! Industry organizations that have been pleading for Fran cis Bri nker, N. D. David Hoffmann, B.Sc., their publication for the past 4-5 years initially hailed them as a posi Lead Instructor on Botanical M. N.I.M.H tive step. However, close r examinati on of the 5 50-page document raised Medicine for Associate Fellows, Medical herbalist, Santa Rosa, serious concerns among some technical experts in the industry. We Program for Integrative Medicine, Cali forn ia explore this key topic in this issue as well. University of Arizona, Tucson Maurice M. lwu, Ph.D. The Chinese I Ching defines "crisis" as "dangerous opportunity." Donald J. Brown, N. D. Bioresources Development and With the herb industry in crisis, and DSHEA under attack in Congress Director, Natural Products Research Conservation Program, Senior Consultants, Seattle, Washing ton and elsewhere, industry leaders Loren lsraelsen and Tom Aarrs provide Research Associate at the Division of compelling advice in this issue for industry members , presenting a Thomas J.S. Ca rlson, M.S., M. D. Experimental Therapeutics, Walter perspective beyo nd the provisions of DSHEA and the emergent realities Associate Adjunct Professor, Reed Army Institute of Research, Department of Integrative Biology; Washington, D.C. of a post-DSHEA world. This issue also features a brief account of the ceremonial use of peyote Director, Cen ter for Health, Ecology, Timothy Johns, Ph.D. Biodiversity, & Ethnobiology; Curator Professor, School of Dietetics and in Mexican Indian rituals. In indigenous cultures whose transmission of of Ethnobotany, University and Human Nutrition; Centre for knowledge is based on oral traditions, anthropologists and ethno Jepson Herbaria; University of Indigenous People's Nutrition and botanists have few mea ns to date the earliest use of a particular food, or California, Berkeley the Environmen t, McGill University, medicinal or ritual plant. Peter De Smet and Jan Bruhn provide hard Jean Carper Montreal, Canada data on what is possibly the new benchmark date for the Huichol's Author and syndicated columnist, ritual use of this fasc inating plant. Washington, D.C. We also feature the remarkable photography of Steven Foster, display Jerry Cott, Ph.D. ing some common backyard ornamental plants that are traditional Pharmacologist, U.S. Food and Drug Chinese medicines . Administration, Center for Drug Evaluation and Research Continues on page 8 Rockville, Maryland (continues)
4 I Herba iGram 58 2003 www.herbalgram .org Advisory Board HERBAIGRAM (continued) The Journal of the American Botanical Council Steven King, Ph.D. Eloy Rodriguez, Ph.D. Vice President, PS Pharmaceuticals, James Perkins Professor of Mark Blumenthal Ed itor I Publi sher Inc., South San Francisco, California Environmental Studies, School of Karen Robin Managing Editor Thomas L. Kurt, M.D., M.P.H. Agriculture &Life Sciences, Cornell Sean Barnes Art Director Oinical Professor, Department of University, Ithaca, New York Steven Foster Associate Editor Internal Medicine, University ofTexas Victor Sierpina, M.D. Maureen Jablinske Proofreader Southwestern, Dallas Associate Professor of Family Practice Sarah Jackson Editorial Intern Tieraona Low Dog, M.D. Medicine, University ofTexasMedi cal Chair: United States Pharmacopoeia Branch, Galveston Contributors Dietary Supplements/Botanicals James E. Simon, Ph.D. Thomas Aarts Jerry Cott Mehar Manku Expert Panel Professor of New Use Agriculture, Anthony Almada Peter De Smet Susan McGoldrick Clinical Asst. Professor Director of the Center for New Use Dennis Awang Subhuti Dharmananda Harald Murck Dept of Family and Community Agriculture and Natural Plant David Boal Fiona Duffy Paul Rubin Medicine, University of New Mexico Products, Rutgers University, Donald Brown Steven Foster Risa Schulman Tom Mabry, Ph.D. New Brunswick, New Jersey Jan Bruhn lain Glen Roy Upton Professor of Plant Biochemistry, Beryl Simpson, Ph.D. Stephen Buhner Diane Graves Daniel Wagner Department of Botany, University of C. L Lundell Professor of Botany, Christina Chase Amanda Green DaronWatts Texas at Austin Department of Botany, University of Loren lsraelsen Gail B. Mahady, Ph.D. Texas at Austin American Botanical Council Staff Research Assistant Professor, Depart S. H. Sohmer, Ph.D. ment of Medical Chemistry &Phar President and Director, Kathleen Coyne Gayle Engels Cecelia Thompson macognosy, College of Pharmacy, Botanical Research Institute ofTexas, Sales Coordinator Education Coordi nator Finance Coordinator University of Illinois, Chicago Fort Worth Jim Costello Lori Glenn Kim West Robin J. Maries, Ph.D. Barbara N. Timmermann, Ph.D. Gardener HerbCiip Managing Editor Membership/Development Director of the Bureau of Research Professor of Pharmacology and Coordinator Cheryl Dipper Tara Hall and Science, Natural Health Products Toxicology, College of Pharmacy, Executive Assistant Special Projects Margaret Wright Directorate, Health Products and University of Arizona,Tucson Coordinator Accounting Coordinator Stacy Elliott Food Branch, Health Canada, Ottawa Receptio nist George Solis G. H. Neil Towers, Ph.D. HerbCiip Production Dennis J. McKenna, Ph.D. Professor Emeritus, F.R.S. C., Botany Assistant Executive Director, Institute for Department, University of British Natural Products Research; Columbia,Vancouver, Canada Wayne Silverman, Ph.D. Senior Lecturer, Center for Spirituality Arthur 0. Tucker, Ph.D. Chief Adm inistrative Officer and Healing, University of Minnesota, Research Professor of Agriculture and Minneapolis Advertising Sales Natural Resources, Delaware State Daniel E. Moerman, Ph.D. University, Dover Jared Hensley. Rector-Duncan & Associates Inc. William E. Stirton Professor of Nancy Turner, Ph.D. 512/454-5262 ext. 123 • jhensle}'@rector-duncan.com Anthropology, University of Professor and Ethnobotanist Subscriptions are a benefrt of membership at every level. One year memberships: Individual $50: Michigan/Dearborn Environmental Studies Program, Academic $100: Professional $ 150: Organization $250. Add $20 for membershi ps outside of the William Obermeyer, Ph.D. University ofVictoria, British U.S. Student, Senior and Business Memberships also available. see ad in this issue. Vice-President of Research and Columbia, Canada © 2003 American Botanical Council. ISSN #0899-5648. Printed in the U.S.A. Technology, Consumerlab.com, The information in Herba/Grom is intended for educauonal purposes only and is not a subst1tut1on Daniel T. Wagner, R.Ph ., MBA, Annapolis, Maryland for the adv1ce of a qualified healthcare professional. Although we attempt to ensure that advertiSing Pharm.D. in Herba/Grom is truthful and not misleading, the publication of an ad for a product or company in Samuel W. Page, Ph.D. Owner, Nutri-Farmacy,Wildwood , Herba/Grom does not constitute an endorsement by ABC of the product or the company be1ng Director, Division of Natural Products, Pennsylvania advertised. Publication of an ad that makes a health claim or structure-function claim does not Center for Food Safety and Applied necessarily constitute an approval of that claim by ABC. Further. ABC has not reviewed any manu Andrew T. Weil, M.D. facturer's Good Manufacturing Practices. Nutlition, U.S. Food and Drug Author, Director of the Program in Administration, Washington, D.C. Integrative Medicine and Associate Joseph E. Piuomo,Jr., N.D. Director of the Division of Social Board ofTrustees President Emeritus, Bastyr University, Perspectives in Medicine, College of Mark Blumenthal (President), Founder and Executive Director Seattle, Washington Medicine, University of Michael J. Balick, Ph.D., Director and Philecology Curator. Insti Arizona,Tucson tute of Economic Botany, The New York Botanical Garden, Mark J. Plotkin, Ph .D. Bronx, New York Author, Executive Director, Bernd Wollschlaeger, M.D. james A Duke (Treasurer), Ph.D., Economic Botanist (USDA, Ethnobotany and Conservation Team, Family practice physician; Clinical ret) Author. Fulton, Maryland Arlington, Virginia Assistant Professor of Medicine and Norman R. Farnsworth (Secretary), Ph.D., Research Professor ~ERIOlN John M. Riddle, Ph.D. Family Practice, University of Miam i, of Pharmacognosy, Program for Collaborative Research in the School of Medicine, Florida BoT,ANICAL Pharmaceutical Sciences, University of Professor of History, Department of COJNCIL Illinois at Chicago History, North Carolina State ad hoc advisor: Steven Foster, President, Steven Foster Group, Inc., Fayetteville, University, Raleigh David M. Eisenberg, M.D. Educating rhe Arkansas Director, Center for Alternative Public on rhe Use Fredi Kronenberg, Ph.D., Director. Rosenthal Center for Medicine Research, Beth Israel Complementary and Alternative Medicine, Columbia University of Herbs & Hospital/Harvard Medical School, Phytomedicines College of Physicians and Surgeons, New York Boston, Massachusetts www. herbalgram .org 2003 HerbaiGram 58 I 5
New American Botanical Council Reference Work Clarifies Effective Use of Herbal Medicines for Disease Prevention and Treatment
ontinuing its tradition as one of the Asian ginseng, bilberry, black co hosh, eat's The ABC Clinical Guide to Herbs is avail Cworld's leading nonprofit education claw, cayenne, chamomile, chaste tree, cran able for $49.95 plus shipping and handling and research orga nizations on matters of berry, echinacea, eleuthero, eve ning prim- directly from ABC, or from AB C's exclusive herbal health, the American rose oil , feverfew, fl ax, worldwide trade distributor, Thieme New Botanical Council (AB C) has ---•---,- garlic, ginger, ginkgo, gold York, 800/782-3488 or 212/760-0888, Fax published its lates t in-depth, n..~Bac.Wo! .. Cowd enseal, green tea, 2 12/947-111 2,
And the debate in the herbalist community continues over whether and how to step Successfully into some type of certification process . This growing your iss ue includes another side to the discuss ion business by herbal philosopher Stephen Harrod Buhner. starts here. Finally, we wel come supplement industry ve teran Anthony Almada, who now contributes a regular column on herb patents. It has been some time since our last Plant Patents column by Karen Dean, who is busy editing Alternative and Complemen tary Therapies. Unlike Karen's column reporting on patents issued on va ri ous herbal preparations (i.e., after the formal review and approval process), Anthony's column covers patents applied for, thereby providing information on patent activity much earlier in the process. ~
8 I HerbaiGram 58 2003 www.herbalgram.org ABC Donates Young ken Herbarium to the ABC Partners with Botanical Research Institute of Texas Rector-Duncan on
he American Botanical Council recently United States Pharmacopeia Rev ision Herba/Gram Tdonated the Heber W Youngken Sr. Committee. He received the Ebert Medal in he American Botanical Council recently Herbarium to the Botanical Research Insti 1925 and 1931 from the American Phar Tentered an agreement with Rector tute of Texas (B RIT). Consisting of about maceutical Association and was named its Duncan & Associates, Inc., of Austin, 7,000 sheets of medicinal, spice, dye, and honorary president. Texas, to help produce HerbaLGram. allied plant specimens, the herbarium is T he Youngken Herbarium contains his Rector-Duncan is a 30-year old company primarily the life's work of the late Heber hand-written descriptions of the identity that offers a va ri ety of publication and non W Youngken, Sr. (1885- 1963), who is and derails of coll ection for the specimens profit organization administrati ve services, considered the father of modern pharma that he collected. An internationally known and is the largest association magazine cognosy, the science that deals with medici authori ty on the taxonomic and morpho publishing firm in Texas. nal products of natural origins, usually logic aspects of pharmacognosy, Youngken Rector-Duncan staff members will focus plants. also added other coll ectors' medicinally primarily on display adve rtising sales and Or. Youngken built the medicinal treas rel evant specimens from around the world service. Jared Hensley is the new Advertis ure house while he was professo r of phar to his renowned herbarium. ing Manager for HerbalGram advertising. macognosy at the Massachuse tts College of Wendy Browing provides sales information Pharmacy and Health Sciences (M C PHS) analysis. Kyle Montgomery, Rector in Boston (1923-1956). ABC acquired the Duncan's vice pres ident, is the lead li aison Youngken Herbarium in 2000 from between his company and HerbalGram. MC PHS. "We are grateful to have the se rvices and "ABC has a long, mutually supportive experience of Rector-Duncan to help us relationship with BRIT. When the with the publication of HerbalGram," said Youngken collection was in danger of being ABC founder and executive director Mark lost, ABC stepped forward to save it even Blumenthal, who is also editor and though maintaining herbarium samples for publisher of HerbalGram. research is not within our scope of activity," "Not only will Rector-Duncan's staff said M ark Blumenthal, executive director of assist us in generating new advertising ABC. "BRIT does an excellent job of revenue, but through its strong relations providing hi gh quality botanical research with its printer, ABC will enj oy more favor S.H. Sohmer (l eft) and Ma rk Blumen th al delight in materials and is the perfect place to house ab le printing costs for HerbaLGram. The the coll ection." the precious botanical voucher specimens from the Heber W. Young ken Sr. Herbarium at a reception to prospect of increased revenues and lower "We are excited and proud to receive the celebrate ABC's donation of the collection to the costs is urgently needed at a rime when the Youngken Herbarium," said S.H. Sohmer, Botanical Research Institute ofTexas. Photo courtesy entire economy, particularly the magazine Ph.D., BRIT's director. "A major part of of BRIT trade, is experiencing such difficult chal BRIT's research program is called 'Plants lenges," he added. "An added bonus is that and Peoples'; it focuses on documenting the Based 111 Fort Worth, Texas, BRIT's they are our neighbors, right here in Austin. plants used by different peoples of the mission is to conserve our natural heritage T his proximity wi ll faci litate and optimize world for the maintenance of human heal th by deepening our knowledge of the plant our relationship." and the treatment of human diseases. This world and achieving public understanding "We see HerbalGram is a high-quality herbarium will be a cornerstone of this of the value plants bring to life. With a publication and we understand what that program ." collection of approximately one million rakes," said Kyle Montgomery, vice-presi Youngken wrote the definitive texts used dried plant specimens represe nting most of dent of Rector-Duncan. "We look forward by two generations of upcoming pharma the earth's plant fa milies, BRIT has one of to this partnership blossoming to the bene cists and pharmacognosists, Textbook of the largest herbari a in the United States, fir of ABC and HerbalGram readers. " Pharmaceutical Botany (1914), Laboratory which is the largest independent herbarium HerbalGram will now be printed by Manual of Botany (1929), A Textbook of in the Southwest and one of the world's best Branch-Smith Printing, of Fort Worth, Pharmacognosy (1921), Laboratory Notes on collections of Texas plant specimens. Its Texas. Pharmacognosy (1927), and more than 100 botanical library houses more than 75,000 C urrent and potential advertising cl ients research papers in his field. Pharmaceutical volumes of books, periodicals, and journals should contact Jared Hensley fo r informa manufacturers often sought his opinion on from more than 90 countries. Along wi th tion about placing display ads in Herbal plant medicines and issues of adulteration. irs education program, BRIT conducts Gram. He may be reached at 5 12/454- H e also served as botanical editor of the research on plants and publishes journals 5262, ext 123, or via email 21st through 25th editions of the United (such as Sida) and books on botany. For
aturday, April 26, dawned cool and Blumenthal; and Bioregio nal Herbalism: educational materi als available through its Sbeautiful, a perfect day fo r the American the Ethical Use of N ative M edicinals, H erbal Education Catalog. A number of Botanical Council 's first ever Medicinal taught by N iki Telkes. books, including the latest and the previ H erb Fes t. T he event is part of On ABC's fro nt porch, ously published The Complete German ABC 's commitment to Aaro n Reisfeld , owner of Commission E Monographs and Herbal educate the public abo ut Sabia Botani cals, demon Medicine: Expanded Commission E Mono medicinal plants, and was strated the distillati o n of graphs were made poss ible, in part, by essential oil s, and herbalist raffl ed off, support from the H .E. Butt D o nna Squyres dem o n and A BC's G rocery Company (H -E-B) strated m edicine-making "Almost Free and Whole Foods M arket. techniques, specifi cally teas, Books" tabl e O ver 400 people visited ABC's tinctures, and salves. Both was a big hit. ho me, the Case Mill H ome used plants from A BC's By all stead in Austin, Texas, during gardens for raw materi als in accounts the the course of the day and enj oyed classes, their programs. Meanw hile, in ABC's M e dicin a l demonstrations, house and garden tours, kitchen, Rosie Cominski , from Wheatsville H erb Fest music, food, drink, and exhibits. Co-op, gave a raw foods preparation was a success Visitors were treated to tours of ABC's 15 demo nstration. and requests medicinal plant theme gardens led by to "d o it Austin herbalists Carl os H ernandez, G inger aga m next Webb, and Ell en Z immermann. A BC's year" were demonstrati o n gardens were developed as gratifying. an aspect of irs educatio nal miss ion and ABC IS provided these knowledgeabl e herbalists thankful fo r with a spectacular reaching tool. A BC staff the suppo rt Karen Mal, popular Austin musi gave tours of the rainwater coll ectio n of Blue Sky cian, entertains the crowd at system and the 1850s fa rmhouse that se rves Nat ur a l ABC's Med icina l Herb Fest. Photo as ABC's administrati on building. B e v e r a g e by Wayne Si lverman. Co., Julie D avis and Gateway M arketing, G lazier Kara Kroeger (left), herba li st, discusses the proper Distributors, Golden Temple Products, H ties of essential oils in her class on making body salt E-B, Sun H arvest Marker, Whole Foods scrubs. Photo by Wayne Silverman. M arker, Wild Oars M arker, and Yogi Tea.
More than 25 ex hibitors were arrayed over the gro unds, each representing a wealth of knowledge on medicin al plants or related topics. Visitors purchased culinary and medicinal plant products, live plants, and alli ed materi als. Free samples and educati o nal materi als were avail able at many of the booths. Attendees treated themselves to a massage or sat at o ne of the Mark Blumenthal, ABC's fou nder and executive picnic tables to listen to music performed director, signs a copy of The ABC Clinical Guide to by local Austin musicians Darci D eaville, Herbs for Austin pharmacist Laurie Aroch. ABC Photo. Karen Mal, and the Slim Ri chey Dream Carlos Hernandez (left), longtime Austin herbalist, Band. Special activities fo r children leads an herb wa lk in ABC's medicinal demonstra C lasses in ABC's Educatio n Annex included ball oon creatures, face painting, tion ga rdens. ABC Photo. included Stress and the Immune System : and transplanting an herb to a paper pot to the Adaptogeni c H erbs, taught by Carl os take home wi th them. ABC is also very grateful to staff and H ernandez; M aking Body Salt Scrubs for A BC used the event to introduce the volunteers who gave their time and energy Kids and Adults, led by Kara Kroeger; public to irs new herbal reference and to make this such an enjoyable, entertain H erbs at the Crossroads: Q uestions of continuing educati on book, The ABC Clin ing, and educational event. --" Quali ty, Safety, and Effi cacy, with ABC's ical Guide to Herbs, its m embership -Gayle Enge ls Fo under and Executive Director M ark program, and the extensive amount of
10 I HerbaiGram 58 2003 www.herbalgram.org Practical Herbal Therapy Home Study Course launched
new course in Practical H erbal Ther introduces herbal therapeutic properties herbal medicin e. He also founded Medi Aapy, authored by Kerry Bone, is now and dosage issues, as well as case taking, Herb, an herbal medicine manufacturing ava ilable for home study. Presented on CD pharmacology, adverse reactions, interac company, where he is the director of ROM and audio CDs, the 180-hour course ti ons and contraindications for more than research and development. is conducted by the Australian College of 100 herbs. The second and third modules His books, Clinical Applications of Phytotherapy (ACP) and sponsored by the focus on therapeutic applications, based on Ayurvedic and Chinese Herbs (Phytotherapy Texas C hiropractic College (TCC). human body systems, and include indepth Press, 1996), is in its fifth print run; and Li censed healthcare professionals may earn treatment protocols for more than 70 Principles and Practice of Phytotherapy, co a Certificate of Proficiency in Practical common health iss ues. authored with Simon Mills (Churchill H erbal Therapy from TCC; unlicensed Bone, BSc(H ons), Dip Phyto, FNIMH, Livingstone, 2000) has sold more than healthcare professionals may earn a Certifi FNHAA, MC PP, AHG, is considered a 12,000 copies worldwide. Both books are cate of Attainment from TCC. highly successful herbal clinician and educa required texts for the course. The course is presented in three modules, tor. His approach combines traditional uses To obtain an enrollment form , contact each containing seven sess ions that last with modern science. He established the the TCC by telephone 800/533-9822 or eight to nine hours. The first module, Qual ACP in Warwick, Queensland, Australia, to 281/487-5656. Or email the ACP at ity and Safety Iss ues in H erbal Medicine, furth er develop profess ionalism and safety in
NAP LEX Now Tests Herbal Knowledge of Future Pharmacists
he North American Pharmacist Licen ri zes the survey results in an issue of the Phytomedicines in Today's Pharmacy. Tsure Examination® ( APLEX) now NABP Newsletter. "The NABP survey "T he real challenge to coll eges of phar includes questions about herbal products shows that the academic world understands macy is finding fac ul ty members who really and nutraceuticals. the need for students to become more have the necessa ry fa miliarity with the The shift went into effect in April 2003, knowledgeable about this topic." herbal literature and a working knowledge and is made "in an effort to maintain an In response the NRC made the following of herbal medicine," he added. ~ exam that coincides with the requirements recommendations: -Karen Robin of an entry-level practice of pharmacy," • Herbals and nutraceuticals are to be [So urces: Anon. NAPLEX ro rest herbal knowl according to the NAPLEX Review referred to as dietary supplements as edge. American Association of ColLeges of Phar Committee (NRC) on behalf of the defined by the Dietary Supplements macy. January 2003;34(1):4. Anon. Survey finds nurraceuricals being added National Association of Boards of Phar Health and Education Act of 1994 ro pharmacy curriculum. NABP Newsletter. macy (NABP). NABP is the professional (DSHEA). Ocrober/ ovember 2000: 127) association that represents the state boards • Questions are to be limited to effica of pharmacy in 49 states (excepting Califor cies, adverse effects, toxicities, and nia), the District of Columbia, Guam, drug interactions. WHO Puerto Rico, the Virgin Islands, New • The U.S. Pharmacopeia and the Monographs Zealand, eight Canadian Provinces, and National Formulary ( USP-NF) is to be three Australian states. used as the official compendia for on Selected The new materi al resulted from a January dietary supplement specificati ons. Medicinal 2000 survey by NABP of 81 schools and • Professional journals are to be used for Plants, Vol 2 colleges of pharmacy about what pharmacy information on clinically significant by rhe World Health students are being taught about dietary effic acies, adverse effe cts, toxicities, Organization. 2002. supplements. Of the 58 schools that and drug interactions. Provides an additional responded, 4 1 teach about herbal products "This is a positive step forward for Amer collection of 30 as part of a course or offer a dedicated ican pharmacy because all retail pharmacists monographs covering quality control and course. These courses, the survey elicited, and a growing number of health sys tem traditional and clinical uses of selected cover federal regulation of dietary supple pharmacists are facing the need to be medicinal plants reviewed by 120 experts ments, clinical efficacy studies, product knowledgeable about the herbal products in more rhan 50 countries, as well as by standardization and drug interacti on issues. being used by a significa nt sector of the experts through a network of relevant And many schools that were changing their public," said Mark Blumenthal, founder NGOs. Also included are two cumulative curri cula to the entry-level PharmD degree and executive director of the American indexes ro borh vo lumes. Sofrcover, 362 intended to incorporate dietary supplement Botanical Council, and editor of Herbal pp. $90 !rem #428A. information. Gram. For the past six yea rs Blumenthal has To order, call roll free 800/373-71 05, "Information about herbals and se rved as adjunct associate professor of fax 512/926-2345, nutraceuticals is widely available, but the medicinal chemistry at the College of Phar email: [email protected] or amount of information from critical studies macy at the University of Texas at Austin, order online ar www.herbalgram.org is limited," reported an article that summa- teaching an elective course, Herbs and www.herbalgram.org 2003 HerbaiGram 58 I 11 Council for Responsible Nutrition Board Appoints New President, Annette Dickinson
nnette Dickinso n, Ph.D., was background includes expertise in vitamins ence who has consistently provided not A appointed president of the Council for and minerals, and her regul atory expertise only scientific and regul atory expertise, but Responsible Nutrition (CRN) in March covers the legal and technical as pects of also highly respected leadership for the 2003 by the CRN Board of Directors. She marketing dietary supplements, including Council for Responsible Nutrition and the had held the post of acting-pres ident since provisions relating to labeli ng, advertising dietary supplement industry. " January; prior to that was CRN's vice pres and good manufacturing practices. She is Johnson, who is employed as a nutrition ent of scientific and regul atory affairs. the author of The Benefits of Nutritional industry relations director at Access Busi Dickinson repl aces Supplements (CRN, 2002), a comprehensive ness Group/Nutrilite, was elected CRN John Cordaro, who led compilation of informati on about the chairman in January. At that time other new CRN fo r 20 yea rs. She health benefi ts of vitamins and minerals, offi cers were elected to the 22-member has been wi th C RN and Before and After DSHEA (CRN, 1999), CRN Board of Directors: C huck Brice, of since its founding in a guide to the FDA's regulation of the Kemin Foods L.C., as chairman-elect; Mike 1973. Based in Wash dietary supplement industry. Doyle, of BAS F Corporation, as treas urer; ington, D .C., C RN is a "As C RN Pres ident I will work to David Morriso n, of Pharmaton Natural leading trade associa improve our industry's reputati on thro ugh Health Products, as secretary. --"" tion for the dietary emphasizing our associati on's commitment - Sara h Jackso n supplement industry, to high quality products that are safe, effec [So urces: CRN. Annette Dickinso n, Ph.D ., Dickinson and represents about 65 tive and backed by scientific research. " Dr. named president at Council fo r Responsible large supplement ingredient suppliers and D ickinso n said. "We need to do a better job N utri tion [news release]. 2003 March 3. CRN. Dickinson named acting president at manufacturers. of conveying to regulators, healthcare dietary supplement trade association [news A recognized nutrition expert and author, professionals, journalists and consumers the release]. 2003 Jan uary 2. D r. Dickinso n is currently se rving a three important ro le that dietary supplements can CRN. CRN an nounces new chairman and year term on the U.S. Food and Drug play in promoting good health and protect board officers [news release]. 2003 January 6.] Administrati on's (F DA) Food Adviso ry ing against disease. We will start by renew Committee. She also was appointed by ing our dedicati on to responsible practices. " President Bill Clinton to the Commiss ion CRN Board Chairman Byron Johnso n on Dietary Supplement Labels and is a said, "By choosing Dr. Dickinso n as C RN frequent witness before the U.S. Congress Pres ident, [the council has] selected some and at other public forums. Her scientific one with three decades of industry experi -
Grasse Institute Founds Perfumery School in Industry's Birthplace
he Grasse Institute of Perfumery now spent in supervised practical work and visit Toffers a nine-month course to develop ing factories, laboratories and growers the fu ndamental knowledge of creating a (jasmine, roses, lave nder, mimosa etc.). perfume. Launched in 2002, the course Grasse, France, is a central point of the DSEA's "Heroes Awards" Given to Supplement work includes aspects and iss ues in the world's perfume industry. Its companies Distribution Charities perfume industry such as raw materials produce more than half of French perfumed The Dietary Supplement Education Alliance (with an emphasis on natural products) , products and almost 6 percent of the "Heroes Awards" were presented to (left to rig ht) Howa rd Schiffer, president of the Vitamin terms and cl assifications, international wo rld's perfumes and toil etries. T he Grasse Angel All iance, and to Michael Morton, chair industry regul ations, and modern technol Institute of Pe rfumery is a division of man of the board of directors of the Hea lthy ogy. AFSO-G RASSE, a pro fessional training Foundation. Jon Benninger, of Virgo Publishing O nly 10 candidates are selected annually center created in 1972 on the initiative of and DSEA board of directors vice president, fo r the course. Applicants are tes ted on their the Nati onal Association of Fragrance presented the awards during Natural Products command of written and spoken Engli sh Manufacturers (PRODAROM). Special Expo West in March 2003 at Ana heim, Ca lifor nia. The two organizations were honored for (the course language), math skills, creative ized in the fie lds of fi ne chemistry, their efforts to help the worl d's hungry and ability, and olfac tory talent. Industry fragrances, and fl avors, the board of direc malnourished receive needed vitam in s and professionals and school fac ulty also inter tors is comprised of representatives of vari minerals that they would otherwise go with view candidates about their reasons for ous co mpani es . Registration forms and out. For more information, visit their applying and thei r future plans. detailed information about the school and websites,
12 I HerbaiGram 58 2003 www. herbalg ram.org First Naturopaths Appointed to Medicare Advisory Committee
oseph Pizzo rno Jr., N.D., and Pamela "The staggering number of individuals H ouse Commission on Complementary JSnider, N.D., are the first naturopathic with chronic disease is a significant and Alternative Medicine Policy. physicians ever appointed to the Medicare contributing factor in skyrocketing health In November 2002, he received Coverage Advisory Committee. The advi care costs, amounting to a national disease Founder's Award for "Excell ence tn so ry committee, made up of 100 individu debt," Snider said . "By devoting resources Complementary and Alternative Medicine" als representing a wide range of scientific to the preve ntion of these diseases, and to from the ational Foundation for Alterna and medical professions, makes recommen health promotion for all communities, we tive Medicine. And in May 2003, he was dations regarding what medical services are wi ll be able to better serve other health honored by the American Holistic Medical eligible for Medicare concerns, such as reducing costs. " Association at its 25th anniversa ry conven coverage. Snider is a co-investigator on rwo grants tion as a "Pioneer in Holi stic Medicine." "These appoint- funded by the National Center for Comple A widely published author, Pizzorno has ments are part of a mentary and Alternative Medicin e: the authored, co-authored or edited several promtsmg trend," North American Naturopathic Medical books, including Encyclopedia of Natural Pizzorno said. "Every Research Agenda, and Financing Integrative Medicine, A Textbook of Natural Medicine, opportunity for Healthcare (with the University of Wash Total Wellness, and Natural Medicine for co mplementary and ington). She also co-chairs the executive Cancer. He is executive editor of Integrative alternative medicine leadership team at the Collaboration for Medicine: A Clinician's journal. ~ and conventional H ealth Care Renewal Foundation and - Sarah Jackson medicine to work serves on the advisory committee for the [Source: Bastyr University. Bastyr University Pizzorno together translates to a Was hington State Health Professional Loan Founder and President Emeritus Honored With greater potential to solving our healthcare Repayment and Scholarship Program. National Award [press release] . September I 0, 2002. problems." Pizzo rno was named Physician of the Year Bastyr University. First aturoparhic physicians Both Pizzo rno and Snider are associated in 2002 by the American Association of appointed to Medicare Coverage Adviso ry with Bastyr University: Pizzorno is co Naturopathic Physicians (AAN P), which Committee [press release]. January 27, 2003.] founder and president emeritus, Snider is honored his lifetime achievements on behalf Associate Dean of Public and Professional of the naturopathic profess ion and his Affairs. significant work as a member of the White
Doctoral Programs in Acupuncture and Oriental Medicine Launched
Two schools - Bastyr University of educators, clinical researchers, clinic super clinical sites, including the Bastyr Center I Kenmore, Washington, and the Oregon visors, scholars, and specialists. The new for Natural Health, and the Seattle Cancer College of Oriental Medicine in Portland, doctoral program will allow us to advance Treatment and Wellness Center. Advanced Oregon - now offer clinical doctoral that goal. " clinical work in oncology will also be avail degrees in acupuncture and oriental medi Bastyr's doctoral program was approved able at the C hengdu and Shanghai Univer cine (DAOM). by the Northwest Commission on Schools si ties of Traditional Chinese Medicine in The new program at Oregon College of and Colleges, and both programs are China. Students wi ll also be required to Oriental Medicine (OCOM) begins this approved by the Accreditation Commission complete a research project. summer. Bastyr's program will begin in the for Acupuncture and Oriental Medicine. OCOM's cl inical doctoral program is an fall quarter of 2003. Terry Courtney, M.P.H., LAc., chair of intensive, rwo-year course of study of on C urrently, acupuncture and Oriental Bastyr's acupuncture and Oriental medicine campus modules in specific areas of concen medicine colleges in the United States train department, said, "Acupuncture is among trati on, clinical practicums including West general practitioners at the mas ter's degree the most frequently used modalities in ern and Eastern perspectives and method level. These new doctoral programs will complementary and al ternative medicine. ologies, education in clinical research and provide advanced knowledge, clinical skills, Yet, there has not been a doctorate program clinical research design, and specialized and specialized training in acupuncture and in the United States until now. Bastyr clinical study and practice in China. ~ Oriental medicine. University is proud to be in the forefront of - Sarah Jackson "We are delighted to have been approved expanding educational opportunities for [So urce: Bastyr University. Bastyr University ro as one of the first rwo coll eges in the U.S. to practitioners of acupuncture and Oriental offer doctorate in acupuncture and Oriental begin a clinical doctoral program in medicine." medicine [press release) . March 4, 2003.
n February 2003, the United States Phar graph being developed. toxicity, ex perimental animal studies, Imacopeia (USP) set new safety require Class 2: Articles for which the committee pharmacokinetics, therapeutic index, ments for dietary supplement monographs. is unaware of significant safety iss ues pres and presence of toxic constituents; T hese criteria provi de a framework to deter ent when the article is used and formulated • Contemporaneous extent of use in rhe mine which proposed monographs setting appropriately rh ar would prohibit a mono U.S. and globally, as well as misuse and standards for dietary supplement should be graph being developed, provided there is a abuse; and added to the United States Pharmacopeia warning statement in the labeling section. • Histori cal usage. and National Formulary (USP-NF). Class 3: Articles for which the commirree T he USP contains legally recognized USP's Dietary Supplement Information is aware of significant issues present that standards of identity, strength, quality, Expert Committee produced these criteria, would prohibit a monograph being devel purity, packaging, and labeling for drug which were approved by the Council of oped. substances, dosage forms, and other thera Experts Executive Committee. Proposed "We're aware of safety iss ues concerning peutic products, including non-botanical monographs about dietary supplements wi ll dietary supplements," said David Roll, and dietary supplements. C urrently, rhe be reviewed and class ified as foll ows: director of dietary supplements at USP. National Formulary includes standards for C lass 1: Articles for which the committee "That is why USP decided to crea te a clas excipients, botanicals, and other similar is unaware of significant safety iss ues pres sification sys tem we could use to assess products. To dare (June 2003) USP has ent when the article is used and form ulated dietary supplement safety. We wouldn't publi shed 57 monographs for herbs and appropriately that would prohibit a mono want to publish a monograph on an article herbal preparations rhar have become offi graph being developed. if there are significant safety iss ues which cial in the USP 26-NF 2 1; 32 additional Class I a: Articles for which the co mmit are not addressed." monographs are in rhe In-Process Revision tee is aware of limited human scientific data T he safety ad miss ions criteri a are: section of the Pharmacopeia Forum. --" concerning safety of the articl e, but is • Human data: safety studies, clinical - Sarah Jackson unaware of significant safety iss ues present studies, pos t-marketing surve illance, [So urce: Un ited States Pharmacopeia. USP when the article is used and formulated adverse events, and interactions; An nounces New Safety Admissions Criteria for appropriately that would prohibit a mono- • Pharmacological data: reproductive Dietary Supplements [news release] . 2003 Feb II.]
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14 I HerbaiGram 58 2003 www.herbalgram.org American Herbal Pharmacopoeia to WHO Publishes Produce Textbook of Botanical Microscopy Second Volume of by Roy Upton Monographs he World H ealth O rgani zation (WHO) he American Herbal Pharmacopoeia nation based on the presence of a particular Thas released irs second volume of Mono T(A HP) was recently awarded a type of trichome (a common leaf srrucrure) graphs on Selected Medicinal Plants. T he first contract from the U.S. Office of Dietary that was consistent with D. lanata bur nor volume, published in 1999, was met with Supplements (ODS) to develop a text pl antain. Follow-up chemical analys is enthusiasm by WHO member stares and book that reinrroduces the herbal prod revealed the presence of the cardiac glyco herbal researchers around the world. ucts indusrry and pharmacognosists to the sides consistent with D. lanata. Armed with This second value of botanical microscopy for ensuring this information, the suppliers could iden volume was already the identity and purity of botanicals . tify the source of the contamination, in production when Botanical microscopy was a widely used thereby helping to prevent it from occur the first was technique from the late 1800s to the ring in the future. published in 1999. 1950s and was a routine parr of the educa A seminal part of this story is rh ar the The first draft was tional curriculum of early medical doctors con raminared material reviewed and final (who were called was accepted by the qual ized in March of medical botanists at the ity assurance reams of a that year. A month time), pharmacists, and number of herbal compa- later, W HO pharmacogno s ists nies . At least one member stares mer (scientists who specialize company, Frontier in Berlin as parr of in the development of II the International H erbs, did nor accept the drugs from natural prod- material because it did Conference of Drug ucts). With major advances in chemistry, nor conform to the organoleptic (sensory) Regul atory Authorities and urged that the the value of botanical microscopy was lost characteristics of plantain. Follow-up volume be published as soon as poss ible. and slowly became less important in the microscopic analysis revealed the substance T he first volume contained 28 mono training of plant-based scientists, es pe was, in fact, D. lanata. graphs on widely used medicinal plants, cially pharmacognos isrs. selected for inclusion based on scientific C hemical analysis is an ex tremely useful Microscopy ca n be used to confirm the evidence for both safety and efficacy. The tool for the quality assessment of botanicals. presence of unique plant structures and second vo lume features 30 monographs. However, in and of itself, it often cannot characteristics as a means of identification Approximately 120 ex perts and adviso rs confirm rhe identity or purity of the plant. as well as to examine for such contaminants from more than 50 countries were involved For this, chemistry must be coupled with as dirt, insect fragments, undesired plant in rhe project. Also, more drug regulatory so me type of morphological analys is such as parts, and most importantly, adulterating authorities from different nations were botany, macroscopy, or microscopy. species of other plants. Today, few are invo lved in rh e information and research Although microscopy requires ex perience skilled in this technique. Howeve r, a gathering for the monographs, res ulting in with numerous sa mples to acquire the number of years ago, spurred by an adulter more derailed entries. necessary skills to identify plants and impu ation of English plantain (Plantago lanceo As with rh e first volume, the WHO rities, it is an extremely va luable and cost lata L., Plantaginaceae) with the cardiac monographs cover standards and medicinal effective tool that gives manufacturers more glycoside-containing Grecian foxglove uses of each herb. T he standards section to work with to ensure the safety of the (Digitalis lanata Ehrh., Scrophulariaceae), includes identity and purity rests and other herbal marker. rhe value of microscopy in pl ant identifica information relevant to proper identifica tion once again was evident. The microscopy textbook is being devel tion and quali ty control of medicinal plant oped in collaboration with rhe American materials. T he medicinal uses section A European importer of plantain H erbal Products Association and the phar includes subsecti ons on uses supported by unknowingly distributed a batch that was macognosy centers of the University of clinical data, uses fou nd in official pharma contaminated with foxglove. A woman London and University of Vienna. For copeias and traditional systems of medicine, consuming the product made from the more information on this project, contact and those found in fo lk medicine, as well as material suffered from bradycardia (slowed the AHP at PO Box 66809 I Scorrs Vall ey, pharmacology, con rraindicarions, warnings, heart rare) due to the effect of the digoxin CA 95067, telephone 831/461-6318, fax: precautions, adverse reactions, dosage glycosides contained in the foxglove. Inves 831/475-6219, or email : forms, and posology. tigational work on the parr of two U.S. . _A. T he second volume retails for US$90. Food and Drug Administration pharmacog Both are available for purchase from the nosisrs - William Obermeyer, Ph.D., and ABC Herbal Education Catalog (item Joseph Berz, Ph.D., (now of Consumer Roy Upton is an herbalist, and the executive #428A) at
he U.S. Food and Drug Administration whether the team will also review the 30- team leader. Chen joined the FDA more T (FDA) has established a ream to review day notifications of structure/function than a decade ago, and has served as a applications to marker and rest botanical claims for dietary supplements allowed medical officer and medical team leader in medicine products. under the Dietary Supplemem Health and the Division of Cardiorenal Drug Products. The ream was announced in a February Education Act of 1994 (DSHEA), or the He will be ass isted by a pharmacognosy 20, 2003, memo from John Jenkins, M.D., 75-day pre-marker notifications for dietary reviewer, Jin-Hui Dou, Ph.D, who has a director of the FDA's Office of New Drugs ingredients, also required by DSHEA. background in medicinal plant biology, in the Center for Drug Evaluation and Further, the BRT is to help implement pharmacology of herbal products, and the Research (CDER). The Botanical Review the new Guidance for Industry: Botanical clinical uses of botanical products. Leslie Team (BRT) will be placed administratively Drug Products, a forthcoming industry Vaccari, who has extensive regulatory proj in the Office of Drug Evaluation V. guidance document that will outline the ect management experience in CDER, will The BRT is intended to consolidate the FDA's science-based approach for the devel serve as a project manager. ..-' drug office's scientific and regulatory opment of botanical products as new drugs, - Mark Blumenthal expertise in botanical products, Jenkins said Jenkins said. Herba!Gram 50 published an [Sources: Reuters Health. FDA establi shes in the memo, and will serve as a resource to article about this guidance. review team for botanical products. February 21, all review reams that evaluate Investiga Shaw T. Chen, M.D., Ph.D., who has 2003 Bayne HM. FDA publishes new draft guidance tional New Drug Appli cations (IND) and been the associate director for Special Prod for botanical drug products. Herba!Gram New Drug Applications (NDA) to rest and uct Review in the Office of Drug Evalua 2000;50:68-9.] marker botanical products. It is not clear tion V since August 2000, will serve as the NCCAM Posts Policy on Research and Dietary Supplement Quality
he National Center for Complementary efficacy, and mechanisms of action of credentials of the person/organization who Tand Alternative Medicine (NCCAM) of complex natural products. NCCAM will collected and/or identified the material. the U .S. National Institutes of Health support research characterizing single The content of the test material should be (NIH) has issued policies related to the constituents extracted from complex natu described via analysis of putative active quality of natural products, including ral products if the purpose is to identify and ingredients and by chromatograms of the herbal dietary supplements, as these might standardize whole products, compare the whole material by the commercial company be used in basic and clinical research. The actions of single constituents with the or tested by an independent laboratory. policy was posted on the NCCAM website complex product, or identify mechanisms Depending on the study design, verification in November 2002
16 I HerbaiGram 58 2003 www.herbalgram.org NCCAM and ODS Fund Trial on St. John's Wort for Minor Depression
he National Institutes of Health (NIH) noticeable agitation or slowness, fatigue or SJW extract nor the conventional antide Trecently launched a four-year study to loss of energy, inappropriate feelings of pressant drug sertraline (Zolofr®, manufac determine the safety and effectiveness of St. worthlessness or guilt, diminished abi li ty to tured by Pfize r) showed any significant John's wort (Hypericum perforatum L. , concentrate, indecisive ness, and/or recur effects on patients with chroni c (grea ter Clusiaceae; SJW) for patients with minor rent thoughts of death or suicide. than two years) and moderate to severe depression. The $4 million multicenter Men and women (ages 18-85) who meet (H amilton depression scale scores of 20 or design includes a three-way comparison diagnostic criteria for minor depression higher) major depression.2·J Most European among SJW (Libramin, Cederroth Interna (Hamil ton depress ion scale sco res of clinical use of SJW and many positive tional, Upplands-Vas by, Sweden) , citalo 10-17) are eligible to participate in the res ults in clinical trials are based on patients pram hydrobromide (a conventional, orally trial. They must have ex perienced depres- with mild to moderate majo r depressio n of administered, selective serotonin reuptake inhibitor antidepressant, marketed as Celexa n.. by Forest Pharmaceuticals, Inc., St. Louis, Missouri), and a placebo. 1 The 12-week randomized, double-blind trial will be conducted at three sites with 300 participants with minor depression. Researchers will assess changes in patients' symptoms, functioning, and quality of life. Those who show no improvement wi ll receive the active treatment they hadn't been assigned, while patients with improved symptoms will take their assigned treatment for another 14 weeks for a total of 26 weeks. The collaborative study is funded by the National Institute of Mental Health, the National Center for Complementary and Alternative Medicine, and the Office of Dietary Supplements. According to a NIH press release, minor depress ion is a common disorder that may impair a person's functioning and quali ty of St. John's wort Hypericum perforatum. Photo ©2003 stevenfoster.com life and is a serious risk factor for major depression. However, it is often underdiag sive symptoms for at leas t six months, but shorter duration. T hus, this new study wi ll nosed and undertreated. Patients with less than two yea rs continuously without deal with a patient population that may be minor depression who seek treatment from meeting criteria for a major depress ive more amenable to successful treatment with family doctors are often treated with episode or dys thymia (which has a similar SJW. prescription antidepressants, if their mood definition but requires two years' duration) More information about the study is disorder is diagnosed at al l. Many people within the past yea r. Other criteria that can avai lable at
Migraine Prophylaxis Two randomized, placebo-controlled, double-blind clinical trials tested the efficacy of the standardized butterbur extract (Petadolex®, Weber & Weber International GmbH & Co., Germany) in the treatment of migraines. In the first trial, 60 migraine patients (mean age 28.7 years) were randomized to receive either 50 mg of Peradolex or placebo two times per day for 12 weeks. 11 Starting at the fourth week of treatment, the Pera dolex group had a significant reduction in the number of migrai ne attacks compared to the placebo group (P < 0.05). Compared to the placebo group, those taking Petadolex had a 60 percent reduction in the number of migraines by week 12. The number of migraine days was also reduced significantly in the Petadolex group (3.4 ± 1.6 at baseline to 1.7 ± 0.9 days after 12 weeks) compared to placebo (3.0 ± 1.3 to 2.6 ± 1.2 days, P < 0.05). While the duration and intensity of migraines was signifi Butterbur Perasires hybridus. Photo ©2003 stevenfoster.com cantly reduced at 8 weeks in the Peradolex group (P < 0.05), the difference compared to placebo was not significant at week 12. The mean number of accompanying symptoms (e.g., nausea, Active Constituents and Mechanism of Action vomiting) was significantly reduced in the Petadolex group The leaves, rhizomes, and roots of butterbur contain a mixture compared to placebo (P < 0.01). No adverse events were reported of eremophilane-type sesquiterpenes consisting primarily of at the end of the 12-week trial. perasin (also known as petasine) and isopetasin.s According to The second trial randomized 202 migraine patients (ages phytotherapy textbooks, petasin and isopetasin have both spas 19-65 years) to receive either 50 mg ofPetadolex, 75 mg ofPeta molytic and analgesic actions. 3 These active constituents also dolex, or placebo two rimes per day for 12 weeks following a four inhibit leukorriene synthesis, which may also contribute to week baseline run-in period. 12 The primary endpoint, frequency butterbur's antispasmodic and anti-inAammatory actions. G.? of migraine attacks per four weeks, was reduced by 38 percent, 44
18 I HerbaiGram 58 2003 www.herbalgram.org percent, 58 percent, and 51 ·percent in patients treated with 150 Reference: mg/day of Peradolex after 1 (baseline), 2, 3, and 4 months respec 1. Burrerbur. In: Der Marderosian A, Beutler JA, eds. The Review of tively. The 100 mg/day group had a reduction of 24 percent, 37 Natural Products. St. Louis, MO: Facts and Comparisons Publishing Co., 2002. percent, 42 percent, and 40 percent, while the placebo group was 2. McGuffin M, Karresz JT, Leung AY, Tucker AO, eds. Herbs of 19 percent, 26 percent, 26 percent, and 32 percent, res pectively. Commerce, 2nd edition. Silver Spring, MD: American Herbal Prod Treatment differences between those raking 100 mg/ day of Pera ucts Association; 2000:109. dolex were not significant compared ro placebo. H owever, those 3. Weiss RF, Finrelmann V. HerbaL Medicine. Stuttgart, Germany: raking 150 mg/day had a significant reduction in migraine count Thieme; 2000:200-2. over 3 months of treatment compared ro placebo (P < 0.001 ). The 4. Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, number of patients who had a 50 percent reduction in mean Riggins CW, Rister RS, eds. Klein S, Rister RS, trans. The Complete migraine attack frequency per month relative to baseline were German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin, American Botanical Council; 1998. considered therapy responders. The mean percent of respon TX: ders in the 150 mg/day group (68 percent) was significantly greater than those raking placebo (49 percent) (P 5 0.05). The mean three-month assessment of headache intensity also favored rhe Peradolex 150 mg/day group compared ro placebo (P = 0.01 ). Eighty participants reponed 131 adverse events- 23 patients in the placebo group and 29 patients and 28 patients in the 100 mg and 150 mg groups, respectively. The most frequently reponed adverse events in patients taking Peradolex were gastrointestinal complaints with burping being the most common complaint (reponed by approximately 20 percent of patients raking Peradolex). Recommended Use
Petadolex is a C02 extract of the burterbur rhizome (concentrated at a ratio of 28-44: 1) standardized ro 15 percent petasin and isopetasin with PAs reduced ro < 0.08 ppm in the finished product (which represents the lower limit of detection). Adults and children over the age of 12 years may rake 50 mg of rhe extract rwo ro three rimes per day. Although clinical trials have only studied continuous use for up ro 12 Butterbur Petasites japonicus. Photo ©2003 stevenfoster.com weeks, current product recommendation is for 4 ro 6 months of continuous use of the product. 5. Bisset G, Wicht! M. Herbal Drugs and Phytopharmaceuticals. Boca Side Effects/Contraindications Raton, FL: CRC Press; 1994:366-8. 6. Bickel D, Roder T, Best mann HJ, Bru ne K. Identification and char Side effects are rare with the use of the PA-free extract and have acterization of inhibitors of peptido-leukotriene synthesis from Peta consisted primarily of mild gastrointestinal complaints (nausea, sites hybridus. Planta Med 1994;60:318-22. burping, and stomach pain) with rare reporrs of vomiting, diar 7. Thorner OAR, Wiesman UN, Schapowal A, er al. Role of petasine in rhea, and skin rash. In a recent safety report on standardized rhe potential ami-inflammatory activity of a plant extract of Petasites butterbur root extract, documentation of adverse events from hybridus. Biochem Pharmacol200 1;6 1: 104 1-7. 1976 to June 30, 2002 found a rota! of 75 reporrs of suspected 8. Gruenwald J, Brendler T, Jaenicke C, eds. PDR for Herbal Medicin es. adverse reactions from Germany and 18 spontaneous reports from Montvale, NJ: Medical Economics; 2000:585-8. other countries received by the manufacturer (Weber and 9. Eaton J. Burrerbur: herbal help for migraine. Natural Pharmacy 1998;2:23-4. Weber) .13 Only 19 reports were determined ro be possibly causall y I 0. Schapowal A. Randomised controlled trial of burrerbur and ceti related ro the administration of the medication and 8 reports ro be rizi ne for treating seaso nal allergic rhinitis. BM} 2002;321: 1-4. probably causally related ro the medication by thorough evaluation 11. Grossmann M, Schmidramsl H. An extract of Petasites hybridus is by German pharmacovigilance guidelines and standard operating effective in rhe prophylax is of migraine. Inter j Clin Pharmacol Ther procedures. One case of cholesratic hepatitis was diagnosed as a 2000;38:430-5. hypersensitivity reaction with a probable causal reaction to butter 12. Lipton RB , Gobel H, Wilkes K, Mauskop A. Efficacy of Petasites (an bur. Butterbur should not be used during pregnancy or lactation extract from Petasites rhizome) 50 and 75 mg for prophylaxis of due ro lack of safety studies, nor should it be used by those who migraine: Results of a randomized, double-blind , placebo-controlled study. Neurology 2002;58(suppl 3):A472 [Presented at the 44th have suffered from hepatitis or other liver ailments. There are no Annual American Headache Society Meeting, June 22, 2002, Seattle, known drug interactions for butterbur rhizome extract. _..- WA]. 13. Danesch U, Rirringhausen R. Safety of a parented special burrerbur root extract for migraine prevention. Headache 2003;43:76-8.
www.herbalgram.org 2003 HerbaiGram 58 I 19 Clinical Update by Donald J. Brown, N.D. Saw Palmetto Extract Treats BPH as Effectively as Tamsulosin in 1-Year Clinical Trial D eference: Debruyne F, Koch G, Boyle P, et al. Comparison of Five hundred and ninety four men completed the one-year trial .l~ hytotherapeutic agent (Permixon) with an alpha-blocker (56 dropped out of the tamsulosin group and 54 from the saw (Tamsulosin) in the treatment of benign prostatic hyperplasia: A palmetto group). At 12 months, the IPSS decreased by 4.4 in !-year randomized international study. European Urology both groups with a mea n percentage change from baseline of27.5 2002;41 :497-506. percent for the tamsul osin group and 26.7 percent for the saw palmetto group. No differences were observed between groups at Summary: In a randomized clinical trial, 811 men (ages 50-85 12 months in terms of improvement in terms of irritative and years) with symptomatic benign prostatic hyperplasia (BPH) were obstructive symptoms. After one year of treatment, the adjusted recruited to compare the effects of a mean sco res for Qmax were simil ar saw palmetto (Serenoa repens (W. in both treatment groups (1.89 ml!s Bartram) Small, Arecaceae) extract or for tamsulosin and 1.79 ml/s for saw tamsulosin for the treatment of lower palmetto) . The percentage of urinary tract symptoms (LUTS). patients with an improvement of at Following a 4-week placebo run-in least 3 ml!s at 6 weeks, 3 months, period, 704 men were randomized to and 12 months was 33 percent, 35 receive either 320 mg/day of a lipos percent, 37 percent in the tamsu terolic extract of saw palmetto berry losin-treated group compared to 25 extract (Permixon®, Pierre Fabre percent, 34 percent, 34 percent in Medicament, Castres, France') (n = the saw palmetto group, respectively. 350) or 0.4 mg/day of tamsulosin Although very minor (not statisti hydrochloride (Fiomax®, Boehringer cally significant) in both groups, Ingelheim Pharmaceuticals, Ridge there was a slightly greater decrease field, CT) for one year (there was no (not statistically significant) in mean placebo group). Patients recruited for prostate volume in the saw palmetto the trial had an International Prostate group (0.99 cc) compared to the Symptom Score (IPSS) of~ 10 points tamsulosin group (0.22 cc). Neither and maximum urinary Aow rate group showed a significant change in (Qmax) of 5-15 ml/s. Patients were PSA levels between baseline and 12 evaluated at selection, at randomiza months. While total adverse events tion (day 0), and at weeks 2, 6, 13, 26, were si milar in both groups, the 39, and 52. With the exception of tamsulosin group had a significantly week 2, IPSS was assessed as well as greater incidence in "ejaculation uroAowmetry (to meas ure Qmax). disorders" than did the saw palmetto Transurethral ultrasound was group (4 .2 percent vs. 0.6 percent, P completed at selection and weeks 26 = 0.001 ). Acute urinary retention and 52 to measure prostate volume was the most serious side effect in and prostate-specific antigen (PSA, a both groups with an equal number in protein produced by the prostate, Saw palmetto Serenoa repens . Photo ©2003 stevenfoster. com both groups (tamsulosin, 8.5 higher levels of which may indicate percent; saw palmetto, 8.0 percent). prostate cancer) was measured at selec- tion and week 52. A male sexual function questionnaire to deter Comments/Opinions: With the exception of one very small mine the effect of the treatments on sexual function was also short-term trial comparing saw palmetto and alfuzosin 1 (Xatral® completed by patients pre- and post-treatment. Sanofi-Synthelabo, Paris, France), this is the first large-scale clin ical comparison of the two treatments for BPH. Although the * Permixo n® is the leading saw palmetto extract in the world , in terms trial design suffers from lack of a placebo group (the authors of the amount of clinical research that has been performed with it. acknowledge this), it is an important comparison when one The extract (liposterolic hexane extract of saw palmetto berries, co nsiders that the alpha-adrenergi c receptor blocker class of drugs comprised of free [90 percent] and es terifi ed [7 percent) fatty acids, (e.g., Cardura®, Flomax®, and Hytrin®) is far more commonly sterols, polyprenic compounds, and fl avo noids) is not marketed in used to treat LUTS associated with BPH than finasteride the Un ited States. (Proscar®). While earlier comparison trials (again, lacking placebo t The International Prostate Symptom Score is based on seven ques tions regarding urinary rract symptoms associated with benign groups) have found both the saw palmetto extract used in this prostatic hyperplasia. These symptoms include urgency of urina trial2 and a saw palmetto/nettle root extract combination tion, daytime and nighrrime urinary freque ncy, hesitancy, intermit (Prostagutt® forte, Dr. Willmar Schwabe Pharmaceuticals, Karl- rency, se nsarion of in co mpl ete voidi ng, and force of urine stream.
20 I HerbalGram 58 2003 www.herbalgram.org sruhe, Germany) 3 compared favo rably to fi nasreri de in rhe rrearmenr of symptoms ofBPH , this trial may be of greater significance when considering rhe va lue of saw palmerro exrracr for rhe rrearmenr of LUTS. As opposed ro rhe U.S. erial by Gerber and coll eagues publi shed in Uro!ogy,4 chis trial found a significant improvemenr in maximum urinary Aow for men taking saw palmetto. T he Gerber srudy (please see my review in Herba!Gram 56) used the same dose of saw palmetto exrract for 6 months and found ch ar while IPSS scores improved significantly compared to placebo, maxi mum urinary Aow did nor (in fact, the placebo group had a greater improvemenr). As was noted in my critique of ch ar study, m any of rhe men included in rhe trial had peak urinary Aow o f ~ 15 ml/s. T his new erial stud ies a more homogenous sampling of parienrs by including only those with a peak urinary Aow of 5-15 ml/s - arguably a more symptomatic parienr population. Saw palmetto Serenoa repens. Photo ©2003 stevenfoster.com Urologists have debated how to categorize men with urinary rracr symptoms and cl inicall y idenrified BPH (e.g. , a 3. Sokeland J, Albrecht J. A co mbination of Sa ba! and Urtica ex tracts versus fin asteride in BPH (s tage I to Il ace. to Aiken): a co mpari son benign enlarged prostate) versus men with urinary rract symptoms of therapeutic effi cacy in a one-yea r study. Urologe {A] 1997;36:327- in the absence of BPH. The consensus has been to use the termi 33. nology lower urinary tract symptoms (LUTS) to describe the coll ec 4. Gerber G, Kuzn etsov D, Johnso n B, Burstein JD. Randomized, tion of symptoms listed on the IPSS .5 While the consensus regard double-blind, placebo-controlled trial of saw palmetto in men with ing classification has become largely accepted , the etiology of lower urinary tract symptoms. Uro logy 2001 ;5 8:960-5. LUTS and BPH remai ns cloudy. 5. Deni s LJ. Editorial review of "Compari so n of phytotherapy (Permixo n®) wi th fin asteride in the treatment of benign prostatic As menrioned above, the drugs that have most successfully hyperplasia: A randomized international study of I 098 pati ents. " created LUTS have been the al pha-adrenergic receptor blockers. Prostate 1996;29: 241-2. T his erial fulfi ll s one item on the wish list for those who have advo 6. Fitzpatrick JM, Roehrborn CG. Editori al co mments. Eur Urol cated saw palmetto for LUTS and BPH - a head-co-head 2002;4 1:5 06-7. comparison with an al pha-blocker (in this case tamsulosin). The results of the IPSS as well as Q m ax suggest an equivalenr benefit fo r both rreatments. Whil e it has been criticized for lack of a placebo group, 6 hopefully, this trial sets rhe stage fo r a large, m ulri cenrer eri al (possibly N IH-funded) comparing rhe effi cacy of saw palmetto with an alpha-blocker in a randomized , placebo conrrolled clinical trial.
Practice Implications: Although lacking a placebo arm, this eri al suggests char a proprietary liposreroli c extract of saw palmetto berry is as effective as ra msulosin in rhe rrearmenr of symptoms and improvement of urinary Aow in men with symp romaric BPH. As shown in previous rrials, chis one-year study again dem onsrrares that saw palmetto does nor affe ct PSA levels. Fi nall y, as was the case in comparison studies with finasreride, saw palmetto is associated with a significantly lower incidence of sexual dys function. __..-
Reference: 1. Grasso M, Montesano A, Buonaguidi A, et al . Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia. Arch Exp Uro/1 995;48:97-103. 2. Carraro JC, Raynaud J P, Koch G, et al. Comparison of phytotherapy (Permixon®) with fin asteride in the treatment of benign prostati c hyperplasia. Prostate 1996;29:231-40.
www.herbalgram.org 2003 Herba iGram 58 I 21 lycopenes in the Prevention of Prostate Cancer
eviewed: Ziegler RG, Vogt TM. Toma Netherlands found that neither tomatoes difficult ro compare studies by absolute Rtoes, lycopene, and risk of prostate nor tomato juice was associated with a exposure ro tomaro products and lycopene. cancer. Pharmaceutical Biology 2002;40: decrease in risk. However, this study did not The paper cites an earlier review that noted Supplement:59-69. include processed tomato products, such as one study on lycopenes that showed a non Prostate cancer is the most commonly tomato sauce and pizza, in which lycopene statistically significant increase, while nine diagnosed cancer in males and the second and other biochemical constituents have trials (five of which were dee med ro have leading ca use of cancer mortali ty in the greater bioavailab ili ty, due to their being produced statistically significant results) United States. Some 180,000 new cases are bound in an oil base. showed a decrease in the risk of prostate diagnosed annually and approximately cancer associated with lycopene inges 32,000 men die annually according to tion. the American Cancer Society in 200 1. In addition to these epidemiological Incidence rates can vary by more than studies, several studies have examined the 50-fold among various countries . relationship between blood lycopene While individual risk facrors such as levels and prostate cancer risk. Blood age, family hisrory, and ethnicity play lycopene level is a good biomarker a ro le in the development of prostate because, unlike dietary measures, it cancer, this intern ati onal variation refl ects absorption and metabolism and points to strong lifestyle and/or envi is more closely correlated with lycopene ronmental influences that might be levels in prostate tissue. Results of the modified. Ev idence for diverse dietary three prospec tive studies of blood changes is not yet conclusive, but lyco pene levels, which integrated intake, intake of red meat, dai ry products, absorption, and metabolism, have not animal fat , saturated fa t, and calci um produced consistent results, similar to are thought ro increase ri sk, while the epidemiological studies previously vegetables, legumes, vitamins D and mentioned. However, those studies that E, selenium, and lycopene are thought reported protective effects were to reduce risk. conducted on predominantly white U.S . Recent research on the carotenoid populations, indicating the possibility of lycopene has yielded provocative but a difference in exposure, due ro dietary inconsistent information regarding its differences in lycopene intake and types role in preventing prostate cancer. of food products used as lycopene Tomatoe (Lycopersicon esculentum sources. Mill., Solanaceae), the major so urce of The authors state that it may be the major so urce of lycopene in the premature to assume that there is a diet, is also rich in a variety of nutri- causal, invers e relationship between ents and phytochemicals, such as vita- Tomato Lycopersicon esculentum. lycopene intake and incidence of prostate mins A, C, and E, folate, potassium, Photo ©2003 stevenfoste r.com cancer. It is possible that blood lycopene carotenoids, and the fl avo noid may be a biomarker for other phyto- quercetin. This review exam111 es the Similarly, the 12 case-control studies on chemicals, a healthy diet, or a prudent ev idence for lycopene, tomatoes, and intake of tomaroes, tomato products, lifestyle, all of which may contribute to tomato products in the prevention of and/or lycopene and risk of prostate cancer lower prostate cancer risk. Ultimately, while prostate cancer. produced mixed results. Of the 12, six current epidemiological research neither Of 3 prospective and 12 retrospective showed reducti ons in risk of at leas t 20 supports nor refutes the protective possibil epidemiological studies examining the rela percent, but only two of these estimates ities of tomatoes and lycopene, there is tionship between prostate cancer risk and were statistically significant for reduced risk sufficiently consistent evidence of lowered dietary intake of tomaroes, tomaro prod at the highest intake. Four studies showed prostate cancer levels in populations with ucts, and/or lycopene, approximately half no effe cts, and one seemed ro show high lycopene intake that further investiga reported reduced risk with increased intake. increased risk of at least 20 percent. Cooked tion is warranted. The authors suggest a In 1995, the results of a large cohort study tomato products co nsistently showed more variety of research avenues in the future, using a food frequency questionnaire protective effects than raw tomatoes, but including dietary and lifestyle determinants showed that lycopene was the only neither lycopene nor tomato product intake of blood lycopene levels, improved assess carotenoid associated with reduced prostate was consistently a stronger predictor of ment of tomato intake using updated cancer risk. Combined intake of four of reduced risk. Unfortunately, differences in lyco pene databases, direct meas urement of lyco pene's richest sources (tomaroes, tomato dietary assessment instruments, methods lycopene in prostate tissue, and develop sa uce, tomato juice, and pizza) were associ for measuring tomato and tomato product ment of reliable intermediate markers of ated with a 35 percent reduction in risk of consumption, and various different param prostate carcinoge nesi s. -" prostate cancer. A si milar study in the eters used in lycopene databases make it - Diane S. Graves, MPH, RD
22 I HerbaiGram 58 2003 www.herbalgram.org Trial Examines the Effects of Soy Phytoestrogen on Hot Flashes in Postmenopausal Women Who Have Had Breast Cancer
eviewed: Van Patten CL, Olivotto IA, aged approximately 7 per day. found no significant difference between soy RChambers GK, Gelman KA, Hislop A total of 123 women completed the 12- and placebo in reducing hot flashes. "Previ TG, Templeton E, et al. Effect of soy week study; 59 consumed the soy beverage ous studies that have claimed a positive phytoestrogens on hot flashes in post and 64 consumed the placebo beverage, effect of soy on hot flashes have had impor menopausal women with breast cancer: A which was made from ri ce. Subjects were tant limitations in that they have been small randomized, controlled clinical trial. jour instructed to drink nal of Clinical Oncology 2002 March 250 mL of the soy 15;20(6): 1449-55. or placebo beverage During menopause, many women experi twice each day and ence hot flashes and night sweats, which can record the actual range from mild to very uncomfortable. For amount consumed several reasons, these vasomotor symptoms in a diary. The soy (VMS) may be more frequent or severe in beverage had an women who have had breast cancer. average isoflavone Chemotherapy can cause premature content of 45 menopause, leading to VMS; the drug mg/250 mL; there tamoxifen, taken by many breast cancer fore, women in the patients, can worsen VMS. In addition, soy group some women taking hormone replacement consumed 90 mg therapy (HRT) at the time of breast cancer isofla vones dail y diagnosis may be told to stop this therapy when they drank due to concern that the hormones might the full amount. stimulate cancer growth. When HRT is Subjects in both groups reported suddenly discontinued, hot flashes and Soy Glycine max Photo ©2003 stevenfostercom night sweats typically increase. drinking 95 Safe alternatives to HRT for treating hot percent of the flashes in breast cancer patients are there recommended amount of the soy beverage or nor blinded or have found only a mini fore needed. Several alternative trea tments on average, so compliance was deemed mal reduction in hot fl as hes or a nonsignif have bee n tes ted in previous research stud excellent. Adverse effects on the gas troin icant trend toward a benefit," say the ies; in general, the treatments had limited testinal tract were more severe and frequent authors. They also note rh ar rhe dose of effectiveness. Soy foods have been studied as in the soy group than in the placebo group. phytoestrogens used in the current study an alternative to HRT because soy contains Vaginal spotting was also more common in was simil ar to that used in other studies for phytoestrogens (plant estrogens), also called the soy group than in the pl acebo group, which the dose was reported. isoflavones. In previous research, soy influ occurring in 4 subjects and I subject, In the current study and previous trials, enced blood hormone levels and reduced respectively. The five women with spotting the decrease in hot flashes in the placebo hot fl ashes in healthy women, but women were referred for evaluation and all of them group has been considerable, rangi ng from with breast cancer were not studied. fini shed the study. 25-51 percent. The authors suggest that The authors conducted a randomized, The subjects used their daily diaries to this placebo effect may result from several double- blind clinical trial to compare a soy reco rd hot fl ashes during the study. A mea n factors, including spontaneous improve beverage with a placebo beverage for treat 24-hour hot fl ash score (rating frequency ment over rime, va ri abi li ty within and ing hot flashes in postmenopausal women and intensity) was calculated by summing between subjects, and optimistic expecta with breast cancer. The mean subject age the scores for the day and night. The results tions of the subjects, especially among was 55.5 yea rs in the soy group and 54.9 showed that women in both groups experi hi ghly motivated women. years in the placebo group, and the number enced significant reductions in hot fl ashes In conclusion, wo men are seeking alter of years since breast cancer diagnosis was during the 12 weeks of treatment. The ave r natives to HRT for all eviating hot flash es 3.6 and 5.1 in the soy and placebo groups, age reduction in the 24-hour hot fl ash score and ni ght swears. "Ar present, there is insuf respectively. All subjects had finished their was 30 percent in the soy group and 40 ficient evidence to qualify soy or phytoe breast cancer treatment at least 4 months percent in the placebo group, these reduc srrogens as a viab le alternative to HRT to before the study began, although some tions were nor significantly different. treat hot fl as hes, " the authors say. Further subjects were continuing to take tamoxifen The authors conclude that "this random resea rch is needed to identify safe and effec on a long-term basis. All subjects were expe ized, placebo-controlled, double-blind clin tive treatments for VMS and evaluate the ri encing frequent, uncomfortable hot ical trial does nor support the use of a soy long-term safety of soy for breas t cancer flashes , but were not taking HRT. During beverage containing phytoesrrogens as a survivors. __.. the baseline period of 4 weeks, subjects treatment for hot fl as hes in breast cancer - Christina Chase, MS, RD recorded their hot flashes; both groups aver- survivors." Several previous studies also www.herbalgram.org 2003 HerbaiGram 58 I 23 Comparison of Traditional Ayurvedic Herb Arjuna to Conventional Drug in Treating Stable Angina
eviewed: Bharani A, Ganguli A, Mathur LK, Jamra Y, Raman ance. Patients continued all prescribed drugs, except for beta-block RPG. Efficacy of Terminalia arjuna in chronic stable angina: A ers and isosorbide mononitrate (ISMN). Isosorbide dinitrate double-blind, placebo-controlled, crossover study comparing (ISDN) was provided for use during episodes of angina. All partic Terminalia arjuna with isosorbide mononitrate. Indian Heart j our ipants had a thorough clinical evaluation including ECG, chest X nal 2002;54: 170-1 75. ray, and echocardiogram to determine baseline data. Patients were given three bottles marked "morning," "afternoon," Arjuna (Terminalia arjuna (Roxb. ex D C.) Wight & Am., and "evening" and were instructed to take one pill from each bottle Combretaceae) bark and its water extract has been used in at the des ignated time for one week. The bottles contained: Ayurvedic traditional medicine in India si nce 500 B.C.E. for the I) arjuna bark extract (IPC-53) (500 mg!tablet) in all three treatment of heart ailments, but has not been rigorously rested bottles, or scientifica lly. Some previous studies have been published, 1.2 but 2) ISMN (20 mg/rablet) in the morning and afternoon bottles were not as ri go rously controlled as this one. This carefully designed and placebo in the evening bottle, or study provides a comparison of the effi cacy of arjuna extract 3) matched placebo in all three bottles. compared to the standard drug therapy (isosorbide mononitrate) in The arjuna bark extract was prepared by concentrating and patients with stable angina (ches t pain, usually under exertion). drying both alcohol and water ex tracts and then mixing them T he study design was randomized, placebo-controlled, double together. Eve ry patient used all three treatments for one week with blind, and crossover. Included in the study were 58 male pati ents a 3-day was hout period between each treatment. At the end of each 38-79 years old wi th chronic stable angina (class II-III according week-long period of therapy, clinical, biochemical, and treadmill to the New York H eart Associati on [NYHA) functional classifica exe rcise tests were administered. The number of episodes of angina tion) and exercise-induceable ischemia (oxygen starvation of the and ISDN pills consumed was also noted. heart). Excluded were those wi th acute myocardial infarction (heart Angina improved in 47 percent of patients when on arjuna and attack), severe effort angina, unstable angin a, heart failure, chronic 53 percent of patients when on ISMN (both P < 0.005 vs. placebo), hepatic or renal disease, neuropsychiatric illness, malignancy, drug but in none when on placebo. Over half the patients had an addiction, AIDS, physical inability to exercise, or nitrate intoler- improvement of at least one NYHA class. The need for ISDN was significantly reduced in 96 percent of patients on either arjuna or ISMN (P values not given). There was a significant increase in exer cise duration, recovery time, and double products (blood press ure x peak heart rate); and a significant decrease in maximal ST depres sion with arjuna or ISMN compared to placebo (all P < 0.005). The differences between arjuna or ISMN for all these parameters were nor significant. Patients with associated diseases (diabetes, disorders of lipoprotein metabolism, high blood pressure, previous myocar dial infarction) experienced res ults similar to those in patients with out these conditions. Resting heart rate, blood pressure parameters, and blood chemistry were not different between the three treat ments. Reported adve rse effects were rare, mild, and no different between treatments and included headache, constipation, abdomi nal disco mfort, and body ache. T he treadmill test parameters used were modified from the stan dard to increase their sensitivity and accuracy. In addition, women we re excluded because the treadmill tes t is less sensitive for them. The promising results of this well-designed study prompt large scale clinical studies and research into the mechanism of action of Bas tyr is proud to be the country's first accredited institution arj una. --" to offer an herbal sciences program. Explore medicinal herbs. - Risa N. Schulman, Ph .D.
Get to the root of herbal quality issues. And be prepared for a I. Bharani A, Ganguly A, Bhargava KD. Salutary effect of Terminalia arjuna in patients with severe refracto ry heart fa ilure. lnt J Cardiol growing career in your cho ice of fields. 1995;49(3): 191-9. 2. Dwivedi S, Agarwal MP. Antianginal and cardioprotecrive effects of Termina lia arjuna, an indigenous drug, in coronary artery disease. j Assoc Physicians India 1994;42(4)287-9. 425/ 602·3330 :::: WWW .BASTYR . EDU MSTY R UN IVER SITY FO R 25 YEARS AT THE H EART OF NATURAL M E DICINE
24 I HerbaiGram 58 2003 www.herbalgram.org Korean Red Ginseng Helps Men with Erection Problems in Clinical Study
eviewed: Hong B, Ji YH, Hong JH, Nam KY, Ahn TY. A Rdouble-blind crossover study evaluating the efficacy of Korean red ginseng in patients with erectile dysfunction: A preliminary report. The journal of Urology Nov 2002; 168:2070-3. The ancient herbal remedy Asian ginseng (Panax ginseng C.A. Meye r, Araliaceae) has shown that it may be able to live up to its traditional reputation as an aphrodisiac for older men. In a recent clinical trial, Asian ginse ng (Korean red ginse ng) was shown to be safe and effective to assist men with erection problems. The trial consisted of 45 men with clinically diagnosed erectile dysfunction. T hey ingested capsules containing the powdered roots of ginseng (900 mg) or a placebo three times per day. In a double blind, placebo-controll ed, crossover study design, the men were divided into two groups. T he first group rook ginse ng for eight weeks; the second group the placebo pill. Then, after a two-week Asian ginseng Panax ginseng. Photo ©2003 stevenfostercom "washout peri od" in which the effects of the ginseng subsided, the groups crossed over; the first group rook a placebo and the second The researchers speculate that one of the reasons why the ginse ng group rook the ginseng. was effective is that ginseng is known to increase the synthes is of The study concluded that the men, who ave raged 54 years of age, nitric ox ide in the endothelium of the penis. This has the effect of significantly increased their total sexual function by 36 percent dilating the bl ood vessels of the corpus cavern osum, thereby (from a basel ine score of 28-38 for the ginseng group), co mpared enabling erection. This mechanism is also shared by Viagra, one of to a I 0.4 percent increase for the placebo group (baseline sco re of the leading pharmaceutical agents that is used extensively for erec 28-31 ). The erection scores increased by a rate of 42 percent for the tile diso rd ers. ginseng group compared to I 6 percent for the placebo group. The This study is very timely. T he past few years have seen increasing study was conducted at the University of Ulsan Coll ege of Medi public discuss ion and promotion of pharmaceutical drugs and cine's Asan Medical Center in Seoul, Korea. natural remedies to help men with erection problems. Ginse ng has Other test measurements concluded that there was a significant long had a reputation of being used for "old man's disease," as so me increase in the rigidity of the tip of the penis in the ginseng users of the traditional C hinese literature calls it, and now this study compared to those on placebo. There was no significant change in provides some preliminary scientific support for one of ginse ng's levels of testosterone, the primary male hormone, in either group, many traditionally reputed benefits . ---- suggesting that ginseng does not alter male hormone levels. -Mark Blumenth al
Systemic Review of Tea and Cardiovascular Disease
eviewed: Peters U, Poole C, Arab L. Does tea affect cardiovas After some studies were excluded, the authors selected a total of I 0 Rcular disease? A meta-analysis. American journal of Epidemiol cohort studies and seven case-control studies for the meta-analysis. ogy 2001;154(6):495-503. Statistical analyses were performed to compute a comparable estimate of relative risk from each study, to analyze va ri ations Tea ( Came!fia sinensis (L.) Kuntze, Theaceae) is a ve ry popular between studies, and to compute summary effect estimates when beverage in many countries. It is ranked the second most common possible. Some studies reported tea consumption as a continuous drink worldwide, after water. Because it is consumed so frequently, va ri able, whereas others reported it as a categorical va ri able. T he even small beneficial health effects of tea could have a major influ authors attempted to make the studies comparable by estimating ence on public health. Some studies have sugges ted that the the rel ative risk associated with an increase in tea consumption of flavonoids in tea (e.g. , catechin, epicarechin, epigallocatechin three cups/day (i.e., from 0 to 3 cups). gall ate) may reduce the ri sk of cardiovascular disease (CVD). In summarizing the res ults of the meta-analysis, the authors Many fl avo noids have antioxidant properties that have bee n found write, "Most studies suggested a decrease in the rate of CVD to prevent oxidati on of low-density li poproteins (LDL choles terol) outcomes wi th increasing rea co nsu mption." More specifical ly, nine in vitro and in vivo. However, the research evidence coll ected to of 13 studies showed dec reased ri sk (1-75 percent decrease) of date has not conclusively shown that rea consumption affects myocardial infarction or coronary heart disease with a three CVD risk. cup/day increase in rea consumption. The other four of these 13 The authors performed a meta-analys is to investi gate the poten studies found an increased risk ( 4-126 percent increase) of myocar ti al effect of tea consumption on CVD risk. Usi ng MEDLINE, the dial infarction or coronary heart disease with a three-cup/day authors located all relevant epidemiological and observational stud increase in tea intake. For stroke, a three-cup/day increase in tea ies published between 1966 and 2000. T hey defined CVD as intake was associated with a 26-66 percent decrease in risk in five including coronary heart disease, ce rebrovascular disease, stroke, of six studies. The sixth study found a 51 percent increase in stroke myocardial infarction (heart attack), and ischemic heart disease. www.herbalgram.org 2003 HerbaiGram 58 I 25 risk with a 3-cup/day increase m tea The authors discuss the issue of publica ing published," the authors state. Publica consumption. tion bias, stating "The small number of tion bias appeared especially problematic The geographic location of the studies published studies for any specific CVD for research on stroke and tea consumption. was strongly associated with the effect esti outcome severely limited the ability to The authors conclude, "The evidence of mates. Much stronger inverse relationships detect publication bias or heterogeneity." publication bias did not disprove the between tea consumption and risk of CVD Some researchers may have decided to hypothesis of a protective effect, but it (myocardial infarction and coronary heart forego publication if their data failed to tempered the strengths of the conclusion disease) were reported from continental show a strong preventive effect of tea for regarding preventive potential." They also Europe than from other areas. The average CVD. This type of publication bias might emphasize that all researchers with unpub relative risk estimates from Europe were lished results on tea and CVD risk should approximately 25 percent to 33 percent the Nine of 13 studies showed decreased come forward and make their data available. It is important to note that tea consump size of relative risk estimates from the risk (1-75 percent decrease) of United States. However, two studies from tion in countries such as the United King myocardial infarction or coronary the United Kingdom were exceptions to dom is often accompanied by added milk or heart disease with a three-cup/day this general trend. These two studies found cream, from which the proteins can bind to increase in tea consumption. moderately strong positive relationships rea tannins and precipitate, precluding their between tea consumption and coronary pharmacological activity. In the United heart disease. be more prevalent in Europe, where tea is States, lemon juice is another common When myocardial infarction and coronary more popular, than in the United States. additive to rea, the acidity of which also heart disease were combined into one However, this is only one of many possible precipitates tea tannins. Additionally, this outcome measure, three European studies scenarios, the authors say. They found meta-analysis does not consider favorable found that drinking three additional cups of evidence of publication bias occurring in data on green rea consumption found in tea per day reduces risk by 66 percent, which the reporting of research on myocardial epidemiological studies from Japan. Future is an "immense preventive effect," the infarction and stroke. "Specifically, it research should explore regional differences, authors note. In contrast, eight U.S. studies appears that smaller studies producing comparing different types and strengths of found either no beneficial effect of rea or a results inconsistent with the hypothesis of a tea to better characterize the degree of expo risk reduction of only 5 percent for every preventive effect for myocardial infarction sure to tea. __.... three-cup increase in tea consumption. may have a very low probability of becom- -Christina Chase, MS, RD
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26 I HerbaiGram 58 2003 www.herbalgram.org Hawthorn Shows Promise in Small Mild, Essential Hypertension Study
eviewed: Walker AF, Marakis G , Morris of dried, full- specuum, aqueo us-alcoholic significant changes in blood press ure, but RAP, Robinson PA. Promising hypoten extract of hawthorn leaves and fl owers. The there was a tendency (P < 0.081) toward sive effect of hawthorn extracc a random hawthorn ex tract (s upplied by lndena, of reducti on of diaswli c blood pressure after ized, double-blind pilot study of mild, Milan, Italy, and encapsul ated by Lambens I 0 weeks. T he authors suggest that the lack essential hypenension. Phytotherapy H ealthcare Ltd., of Tunbridge Well s, U. K, of statis tical signi fica nce could be due w the Research 2002; 16:48-54. who also provided the magnes ium capsul es) small sam ple size, the low dose of was standardized w prov ide at least 1. 8 hawthorn, or both. After the present study Mild hypenension is often u eated with percent vitexin-2-rhamnosides. Patiem s was perfo rmed, other researchers specul ated lifestyle modifications, including exercise were u eated for I 0 weeks. that hi gher doses of hawthorn than the dose and diet, before anti-hypenensive medica Blood pressure was meas ured at baseline, used in the present smdy are needed w u eat tions are prescribed. The recommended diet 5 weeks, and 10 weeks. Readings were hypenension effectively. is low in sodium and fa t and high in fruits, obtained at rest and after both mem al and T he u ea tments also had no significant vegetables, and whole grains, a diet that physical stress (a mem al arithmeti c task and effects on measures of well -being, as tends w be ri ch in magnesium. Several exe rcising on a bicycle, respectively). At repon ed by patients on the ques ti onnai re. epidemiological and observational smdies each visit, patiems we re we ighed w calcu "T here was a small increase in vitali ty in the have found in ve rse associati ons between late body mass index and completed a well magnesium group, but this did not reach magnes ium imake and blood press ure. being ques tionnaire w eval uate fee lings of statistical sign ificance," the authors reporL H oweve r, evidence linking magnes ium anxiety, depression, and vitali ty. D ietary Also, anxiety improved after I 0 weeks in the imake w blood pressure is inconclusive. imake was assessed at baseline with a food hawthorn-treated group, but the change Flavonoids, a class of phyw chemicals frequency ques ti onnaire. was not significanL T he authors note that often with su ong antioxidam effects, may T here we re no significam changes in res t additio nal research should be done w also lower blood pressure. Diets rich in ing diaswlic or syswlic bl ood press ure in the foll ow-up on the latter res ult, because fruits and vegetables, such as the typical groups that w ok hawthorn alone, magne hawthorn is used as a mild sedative in anti-hypen ensive diet, provide high imakes sium alone, or magnes ium and hawthorn France. of flavonoids. H awthorn ( Crataegus laevi w gether. H owever, a su ong placebo effect T he authors conclude that magnes ium gata (Poir. ) D C. and C. monogyna Jacq. , occurred, and this may have confounded supplementati on had no effect on blood Rosaceae) fruit, leaf, and flower are high in the interpretation of the results. Also, the pressure and the other variables studied, but fl avonoids. In some small studies, hawthorn study was of relativel y short durati on, hawthorn administration was associated preparati ons have demonstrated mild ami whi ch may have contri buted w the lack of with a nonsigni fica nt reducti on in res ting hypen ensive effects. "Flavonoids conuibute significant changes in blood press ure. O ther diaswli c blood press ure after I 0 weeks. to the vasodilawry acrion of hawthorn studies of longer durati on have fo und "Bearing in mind that both the numbers of extracts, which are thought w lower raised significam hypotensive effects with magne vo luntee rs in this pilot study and the dosage blood press ure through reduced peripheral si um supplementati on. In addition, the of hawthorn exu act used were low, these vascular res istance," the authors write. authors note, "Magnesium supplemema res ults show pro mise, " the authors say. T hey Extract of hawthorn leaf with fl ower is tion may benefit only hypen ensive pati ents suggest that a larger smdy would better widely used in G ermany where it is with clinical or induced magnes ium defi evaluate the potential hypotensive effects of approved by the German Commission E for ciency, for example those with prolonged hawthorn ex tract, as well as its effect on ueating patients with cardiac insufficiency diuretic treatmem or with alcohol depend anxiety. _....- according w Stage II New York H ean Asso ency. " -Christina Chase, M.S., R.D. ciation. Previous research indicates that In the groups that received hawthorn hawthorn ex u acts dilate the coronary ex tract (n = 19), there we re no statisti call y an ery, thus increasing circulati on w the hean and producing a mild hypotensive effecL T his double-blind, placebo-controlled, parallel pilot smdy was conducted w meas ure the possible hypotensive effects of HerbClip™ magnes ium and hawthorn, when give n separately or wgether. The study included T he preceding Research Reviews are drawn fro m the 2,000 36 adults (18 women and 18 men) with critical reviews ava il able online w members of ABC at the untreated mild hypenension, defin ed as Academic level and above. T he full H erbCli p Educational Mail dias wlic blood press ure of 85 w 100 mm ing Service is distributed bimomhly and incl udes 12 critical H g. T he pati ents were randomly ass igned w reviews along with many of the ori gi nal anicles drawn fro m a hv\ERIUN four different u eatmems: placebo, magne vari ety of professional and mainsu eam sources. To receive the BoTANICAL sium, hawthorn ex tract, or both magnesium full service, com act Wayne Sil verman, PhD, at 512/926-4900 COUNCIL and hawthorn. Magnes ium was given in a exL 120, or via email at
After an absence in the past several issues, HerbalGram is pleased to critical carbon dioxide fluid ex tract) was shown to have, by fa r, the ftature once again a regular column reporting on selected new patents hi ghes t total kavalactone conrent (5 0 percenr). filed for botanical products. Anthony L. Almada has worked within the dietary supplement industry since 1975. He has a B.Sc. in physiology Notes with a nutritional biochemistry minor ftom Cali In a paper presented at the Research Society on Alcoholism meet fornia State University, Long Beach, and an M .Sc. ings in May 2000, ad libitum (at will) access to uncharacterized in nutritional and exercise biochemistry from the kava extracts reduced ethanol intakes in mice. The date of this University of California at Berkeley. He is the co paper presentation is important, since the priority date for patenr is founder/past-president of Experimental and M ay 18, 2000. This study could, potentially, invalidate the patenr, Applied Sciences (EAS), ofGo lden, Colorado, and if the date of presenrati on or publication (meeting abstract) is prior is the founder/CSO of !MAGI Nutrition, Inc., of to the filing date. This paper's findings also contradict previous Laguna Niguel, California, a nutritional technol findings published in 1990,2 where kava extracts were shown to ogy creation, clinical research, and intellectual positively interact and magnifY alcohol 's hypnotic effects and kava itself p roperty-driven think tank/incubator. He has been Almada was shown to augment ethanol toxicity. This early research was cited a co-investigator on more than 60 university clin- in the British Herbal Medicine Association's submission to the ical trials, ranging from AIDSIHIV to arthritis and is currently also Committee for the Safety of Medicines in March 2002 regarding studying for the patent bar exam. -Editor kava safety and dose limits.
Kava Cuts Cocktail Cravings EP 1284745 Date of issuance: 26 February 2003 Assignee: Pernod Ricard (France) Priority date (France): 18 May 2000 Use of Piper spp. extracts for treating alcohol dependence
Background es pite conrinuing efforts by va ri ous nati ons' govern Dments against kava and its suspected hepatotoxicity, patents continue to emerge from chall enge by patenr and trademark authorities and offer new uses. This patent, written in French, was issued in the European Union patent community after an intern ati onal filing was submitted in May 2001 . Interestingly, it is ass igned to gl obal wine and spirits giant Pernod Ricard (manufac turer of such pro ducts as Wild Turkey, Seagram's gin, Glenlive t Scotch, and Wyndham Es tate wine brands), which enj oyed global sal es of almost $5 billion in 2002. Kava Piper methysticum. Photo ©2003 stevenfoster.com
Claims T he primary independent claim describes the use of ex rracts of kava (Piper methysticum G. Forst, or P wichmannii, C.DC, Piper Chocolate-dipped Aspirin aceae) for pharmaceutical preparations intended to treat alcohol dependence. The patent employed a se ri es of ex periments on rats us 6524630 who had been conditioned to prefer ethanol, first by ex posure to Date of issuance: 25 February 2003 "ethanolized" breathing air and then by ethanol drinking solutions. Assignee: Mars, Inc. (USA) Both injecti ons (intraperitoneal) and oral administration of P Date of filing: 22 March 2001 methysticum powdered extract (BWD 4622 SE, The H erbal Use of cocoa procyanidins combined with aspirin as an anti Apothecary, Leicester, U.K. ; suspended in drinking water) elicited platelet therapy notable reducti ons in ethanol preference. Additionally, using a method devel oped by Ganzera and Kh an, 1 the inve ntors undertook ars, the large, priva tely held confection manufacturer and a chemoprofilin g of several commercially available extracts of Piper M marketer, has been vigorously pursuing patents related to species: Buckton Scott H ealth Products Ltd, U.K. [P9733], H erbal biologically active constituents derived from cocoa (Theobroma Apothecary, U. K. [S115], Martin Bauer [Plantextrakt D], Euromed cacao L. , Sterculiaceae), especially with cocoa procyanidins (CP). [kava-kava soft extract], and Nature's Way [Polynesian kava kava The primary biological focus, after receiving patents on a process to root, liquid hydroethanolic ex rract). The Euromed extract (a super- conserve procyanidins in cocoa processing, has been on vasoactive
28 I HerbaiGram 58 2003 www.herbalgram .org appli cations, including nitric oxide augmentation (CP plus L-argi post-dose ASA plus CP effected only a slightly greater reduction in nine) and mitigating oxidative stress. platelet aggregation than ASA alone (not statistically significant). Inhibition at 6 hours was identical berween the ASA plus CP and Claims ASA alone groups (not mentioned in the patent). The patent The primary independent claims describe a composition for oral offered the following conclusion, "In summary, the treatment with use comprised of acetylsalicylic acid (ASA) and a cocoa procyanidin the combination of aspirin and cocoa procyanidin-enriched cocoa in a combined effective amount to treat o r prevent platelet dysfunc results in a decrease in platelet activity which is additive and prob tion, defined as an increased propensity to aggregate. T he preferred ably synergistic." From the perspective of ex vivo platelet Junction, amounts of ASA identified are "baby aspirin" doses - less than 80 the published article does not corroborate this conclusion. mg/dose. Two important elements of the first claim are: The graphical and tabular data published in the article and 1) the dose of ASA required to be effective in the combination appearing in the patent are identical. However, the design described must be lower than the amount of ASA when used alone; and in the patent (three groups described but four groups employed; no 2) the amount of CP used produces an increase in prostacyclin mention of crossover) differs from that described in the journal arti concentration in the body of a subject. cle (crossover, with 7-14 day washout berween treatments). Addi The second primary independent claim is identical, but specifies tionally, the total procyanidin content in the patent (51.1 mg/g) is a pharmaceutical composition. Most illuminating is the claim cover ing separate administration (i.e., use of one component, such as ASA) followed 2-6 hours later by CP The patent describes human studies, intending to prove the concept. In the first study 16 non-smokers (8 women and 8 men, 22-49 years) were asked to follow a diet of low phytochemicals, no alcohol, no non-steroidal anti-inflammatory drugs, no caffeine, and no theobromine. They were then divided into four groups: 1)81 mg of ASA; 2) high cocoa polyphenol beverage (18.75 g of procyanidin enriched cocoa powder derived from Sulawesi cocoa beans containing 51.1 mg/g of total procyanidins, 11 .2 percent fat, 0.092 percent caffeine, 1.618 percent theobromine) and 12.5 g of sucrose mixed with 300 ml of distilled water; 3) the same CP beverage and 81 mg of baby aspirin; or 4)ASA and a procyanidin-deficient cocoa beverage consisting of 18.75 g of cocoa powder (containing 0.45 mg/g total procyani Cacao Theobroma cacao. Photo ©2003 stevenfoster.com dins, 9.87 percent fat, 2.063 percent theobromine, 0.234 percent caffeine) and 12.5 g of sucrose mixed with 300 ml of less than that mentioned in the paper (47.8 mg/g), the latter also distilled water. including free epicatechin monomer, which is not a procyanidin. During the test period the subjects were permitted to consume Scrutiny of both documents reveals a "stretching" of the data and water, caffeine-free diet soda, bagels, low fat cream cheese, and its interpretation in the patent, and a puzzling discordance. Lastly, bananas. Blood was drawn from each of the subjects at baseline and because the invention requires the use of procyanidins, which by rwo hours and six hours post-treatment. All four treatments definition are oligomers of catechin and epicatechin, and their resulted in a reduction in platelet aggregation from baseline (P < gallic acid esters (as defined in the specification), a composition 0.05), assessed ex vivo in a platelet aggregometer. The ASA plus CP comprised of cocoa catechin monomers would likely be non-infring treatment produced a trend for greater inhibition (P < 0.08), while ing. Because catechin has demonstrated oral in vivo anti-platelet ASA plus CP-deficient beverage was not different than ASA alone effects, an obvious circumvention would be combining ASA plus (no statistical probability value provided; no numerical or graphical catechin monomers. Most challenging with this invention is prac data provided for any of these data). Additional analyses (numeri ticing it in commerce, given the U.S. Food and Drug Administra cal and graphical data provided) with the same subjects showed the tion's opposition to combining monographed drugs with dietary ASA plus CP combination to favorably affect eicosanoid metabo supplement or food ingredients ...... lites and expression of platelet surface adhesion molecules/antigens. Reference: Notes I. Ganzera M, Kh an !A. Analytical techniques for the determin ation Mars has sponsored several human studies published in reviewed of lacrones in Piper methysticum Forst. Chromatographia journals, assessing the impact of cocoa derivatives, with one paper 1999;50:649-53. 2. Jamieson DO, Duffield PH. Positive interaction of ethanol and kava characterizing the effects of CP as "aspirin-like."3 The CP used in resin in mice. Clin Exp Pharmacol Physio/1990;17:509-14. the patent's studies is named Cocoa pro"'', a cocoa beverage. 3. Rein 0, Paglieroni TG, Wun T, Pearson DA, Schmitz HH, Gosselin Notably, the results of the studies described in the current patent R, et al. Cocoa inhibits platelet activation and function . Am J Clin were published in part last May,4 wherein the data describing the Nutr 2000;72:30-5. effects of the CP-deficient cocoa extract (above, which alone 4. Pearson DA, Paglieroni TG, Rein 0, Wun T, Schramm DO, Wang JF, produced a significant reduction in platelet aggregation compared et al. The effects of flavanol-rich cocoa and aspirin on ex vivo platelet to baseline) were not included. In that journal article, at 2 hours function. Thromb Res 2002;106:191-7. www.herbalgram.org 2003 HerbaiGram 58 I 29 The Mexican Hu ichollndians are we ll -known for their story-telling yarn paintings, which are made by applying stra nds of colored wool to a wooden boa rd coated with beeswax m1xed with some resin .• This example by an unknown artist ill us trates how important peyote symbolism is in many Huichol paintings. The deified Sun in the center is surrounded by anthropomorphic fig ures (one of whom has a double head with deer antlers), serpents, and an unmistakable image of the peyote cactus itself (bottom center). Photo ©2003 Jan Bruhn
ne of the most widespread religious movements among North American natives is the peyote religion, which is centered on the ritual ingestion of the small psychoactive cactus known as peyote (Lophophora wi!Liamsii (Lem. ex Salm-Dyck) J.M. Coulter, Cactaceae). Peyote grows in the deserts of central and northern Mexico and in some areas of the adja cent United States. When the Spaniards arrived in Mexico, the religious intake of peyote was already well-established there. After the Conquest, peyote rituals withstood centuries of missionary and civil opposition in Mexico, and they are currently still found among Northern tribes, such as the Tarahumara and Huichol.
Unless indicated otherwise, the data in this article have been taken from references 1-7.
30 I HerbaiGram 58 2003 www.herbalgram.org D************iffusion of peyote use and preparation (peyote contains numerous alkaloids other than In the second half of the 19th century, the use of peyote spread mescaline that might contribute to its overall effects), the cultural to the Plains Indians in the United States, such as the Kiowa, differences between an ex perimental subject and a peyotist can be Comanche, and Plains Apache. The route enormous. Many peyotists have never experienced visions, and of diffusion was probably via the those who seek them do not find them important for their own sake. They nomadic Lipan and Mescalero Apache of ln other words. the essence uL~ the Southwest. These groups developed a search for meanings in the vis ions, and it pey( ,tt~ ceremony is not the experience new peyote ceremony, which incorpo is these meanings that make the visions rated Christian elements and symbols, ~ls such. but the personal si<~nitlc~~nce important. For instance, if people fall ill , bur remained firmly based on native that can be ~1ttached to it. their reactions to the peyote and other concepts of powers and healing. events during the ceremony may give Although derails of the North American them an understanding of why they are peyote ceremony may va ry from group to group, it basicall y ill and how they may become well again. In other words, the consists of an all-night ritual, often in a tipi, with singing, chant essence of a peyote ceremony is not the experi ence as such, but the ing, meditation, praye r, usually a short se rmon by the leader, and personal significance that can be attached to it. I(ppS-8 ) ending in the morning with a communal meal. T he two principal Native American Church officiants are the road man (who leads the ritual) and the fire man (who si ts opposite the road man near the doorway and is responsi Despite fierce opposition, Native Americans have retained the ble for maintaining the ritual fire) . The road man is usually fl anked ri ght to use peyote religiously. In 1918, Cheyenne, Kiowa, Ponca, by two additional officials, the drum man (who beats the water Otoe and Comanche leaders succeeded in incorporating the drum) and the cedar man (who is responsible for the cedar incense Native American Church in Oklahoma, with peyote use as a sacra that curls up to the Almighty). mental observance. To defend themselves against the ceaseless The dissemination of the peyote ceremony among the Indians of attacks from missionaries, government officials, and politicians, the Plains started at the height of the persecution and destruction they had alli ed with anthropologists and civi l libertari ans to seek of native culture by European settlers. It was probably furthered by protection under the constitutional guarantees of religious free the reputation of peyote as a powerful medicine and by its impres dom. The new church soon spread to other states and to Canada, sive capacity to produce psychoactive effects. and today it has hundreds of thousands of members in North America. S(ppBS-6).7(pp20-2) Effects of peyote T he Native American C hurch has proved itself to be a durable When taken in sufficient amounts, peyote can produce brilliant movement of great vitali ty. The latest threat arose in 1990, when colored visions, which are often accompanied by hallucinations of the U.S. Supreme Court ruled against two Native Americans of the other se nses. Biomedical scientists attribute these effects to the Oregon, who had been fired from their jobs because they had used presence of the alkaloid mescaline. Just like lyse rgic acid diethy peyote ceremonially. When they applied for unemployment insur lamide-25 (LSD), mescaline can ance, the state of Oregon refused, produce the three successive visions of giving the reason that peyo te use is deep trance-like experiences: IO from illegal. T he Supreme Court ruled that geometric forms (first and lightest denying benefits because of peyote stage) and culturally determined use was constitutional, but suggested images (second stage) to transforma that O regon pass a state law protect tions into another being (third and ing its use in traditional ceremoni es. deepest stage). Mescaline and LSD do Four years later, the U.S. Congress not only affect se nsory perceptions, passed an amendment to the Ameri but have equally profound effects on can Indian Rel igious Act that explic thought and mood. For this reason, itly protects the right of Native Amer some scholars argue that it is less icans to possess, transport, and use appropriate to des ignate these peyote in the course of traditional compounds "hallucinogens."s religious ceremonies. I2 Numerous detailed descriptions in Dine ceremonies the literature ex plore the visionary effects of experimental mescaline in T he largest customers of the peyote non-native subjects. Famous examples trade in the United States are the are the Doors ofP erception and Heaven Navaho (or Dine, as they call them and HeLL, two essays by Aldous selves, which means "The People"). Huxley. 11 Such experimental reports This is not surprising, si nce they are are not necessarily representative for the largest native group in the coun experiences in peyote ceremonies. try. It is estimated that 80 percent of Besides biomedical differences in Kupuri, the active principle of life, pours out of three peyote cactus the peyote sold is go ing to Dine heads9!pBI in this yarn painting by an unknown Mexican Huichol dosage (native doses may vary greatly) peyorisrs. The peyote rel igion reached Indian artist Photo ©2003 Peter DeSmet www.herbalgra m.org 2003 Herba iGram 58 I 31 Dine territory*** in the 1930s when spreading south from the Southern Utes, where it had already been practiced for some years. Its ideology differed from traditional Dine views: it offered an Almighty who was not immanent in nature, but who tran scended and controlled it, and it shifted emphas is from strict adherence to rituals and formulas to inspirati on and power through peyote. As a res ult, the movement met with strong oppo sition among the Dine themselves. Around 1950, it still had no appeal to more than 80 percent of the people. Many Dine felt that it was non-traditional and could have negative effects on one's health, behavior, economic status, and social rel ationships. While allegations about adverse consequences for one's health or economics may have been exaggerated, J(pp399·40S).J3 concerns that the movement was nor traditional were undoubtedly correct. In recent rimes, there have been attempts to integrate the peyote religion with the old rituals of the Dine, thereby disarming its aggressive divergence.6(pJ 44) T he Dine most often hold peyote meetings for curing. These meetings can be for any conceivable phys ical complaint, but also for people suffering from mental illness. The cure in these cere monies is nor only due to the spiritual power of peyote or to the communication with the Almighty. The prayers of the road man, the other participants, and the patient, the singing and the drum ming, and the ingestion of peyote by the patient and the others are all contributory to the cure. And although Dine peyorisrs claim many cures, they do not refrain in most cases from the use of traditional or biomedical curing practices.*
Antiquity of psychotropic practices Archaeologists have recovered psychotropic mescal beans (Sophora secundiflora (Orr .) Lag. ex D.C., Fabaceae) from several sires in the lower Pecos area of Southwest Texas and Northeast Mexico. T he oldest of these finds has been dated to more than 8000 years B.C.E.i7·18 Ancient samples of peyote "buttons" have also been retrieved from sites in this area. One of the authors of this paper analyzed peyote "buttons" that had been found in the form of a necklace in Coahuila, North Mexico, and that could be Carbon-14 dated to 810-1070 C.E. Mescaline and four related alkaloids were still present.19 Recently, the authors demonstrated that 2 percent of mescaline was still present in two peyote "buttons" from the collection of the Witte Museum in San Anto nio and that both specimens could be Carbon-1 4 dated to 3700 B.C.E. 20 Although the museum documentation is not very specific, the most likely origi n of these "buttons" is one of the Shumla caves, in the lower Pecos region, or another archaeologi cal rock shelter in Southwes tern Texas. 18·21 An exciting aspect of this finding is that these peyote "buttons" may be the oldest plant drug ever to yield a major bioactive compound upon modern chemical analys is. More importantly, however, the authors'
* Besides peyote ceremonies, Dine healing practices include traditional healing (diagnosis by a medicine man or wo man, who typically refers the patient to a chanter for ceremon ial chants, prayers, dances, and sand paintings) as well as Christian fa ith heal ing (provided by Pentecostal ministers, and usuall y based in communal prayer groups, weekly ch urch services, or seasonal revival meetings). A discussion of these different forms of healing amo ng the Dine and their rel ationships with each other and with biomedical healing practices is beyo nd the scope of this paper. Interested readers are referred to references 14-16.
2003 www.herbalgram .org Carbon-14 ****dating and identification of mescaline in this material has strengthened the evidence that Native North Americans already recog nized and valued the psychotropic properties of peyote as long as 5,700 years ago.
Peter A.G.M. DeSmet, Pharm.D., Ph.D., is a staff member ofthe Scien tific !nstitute Dutch Pharmacists, The Hague, and a p roftssor in Quality Pharmaceutical Care at the Department of Clinical Pharmacy, University Medical Centre St Radboud, Nijmegen, The Netherlands. Jan G. Bruhn, Pharm. D., Ph.D., is a staff member of the !nstitute for Bioactive Natural Products, Uppsala Science Park, and a university Lecturer at the Division of Pharmacognosy, Uppsala University, Sweden.
Acknowledgements The authors would like to express sincere thanks to Bobbie McGregor and Elisa Phelps, who provided samples and documentation of the early peyote "buttons" in the Witte Museum in San Antonio, Texas.
Reference: I. Aberle DF. The peyote religion among the Navaho. New York: Wrenner-Gren Foundation for Anthropological Research; 1966. 2. La Barre W. The Peyote Cult. New York: Schocken Books; 1975. 3. Schultes RE, H ofmann A. The Botany and Chemistry of Hallucinogens. Springfield: Charles C. Thomas Publisher; 1980:192-223. 4. De Smet PAGM. Ritual enemas and snuffs in the Americas. Ph.D. Thesis. Latin America Studies no. 33, Centro de £studios y Documentacfon Lati noamericanos. Dordrecht: Faris Publications; 1985:38-9. 5. Ott J. Pharmacotheon. Entheogenic drugs, their plant sources and history. Kennewick, WA: Natural Products Co; 1993: 15-6, 81-115. 6. Hultkrantz A. Shamanic Healing and Ritual Drama. Health and Medicine in Native North American Religious Traditions. New York: The Crossroad Publishing Company; 1997 :1 4 1-6. 7. Swan DC. Peyote Religio us Art: Symbols ofFaith and Belief Jackson: Univer sity Press of Mississippi; 1999. 8. Berrin K, ed. Art of the Huichol !ndians. New York: H arry N . Abrams, Inc.; 1978. 9. Schultes RE, Hofmann A. Pflanzen der Cotter. Die magischen Krdfte der Rausch- und Giftgewdchse. Bern: H allwag Verlag; 1980. 10. Lewis-Williams JD. Upper Paleolithic art in the 1990s: a so uthern African perspective. South African j ournal ofScience 1991 ;87 :422-9. 11. Huxley A. The Doors of Perception and Heaven and Hell. London: Granada Publishing; 1977 12. Anonymous. Peyo te Bill Signed - November 1994. Accessed Ocr 2, 1999. Avai lable ar:
www.herbalgram .org 2003 A SAMPLE CHAPTER FROM The ABC Clinical Guide to Herbs
erbalGram is proud to present a sample chapter from of Naturopathic Examiners, Commission on Dietetic Registra the American Botanical Council's latest book, The tion (CDR) of the American Dietetic Association through H ABC Clinical Guide to Herbs. Each of the 29 in-depth Southwest Texas University, the American Council on Pharma monographs includes an overview, description, clinical uses, ceutical Education through the Texas Pharmacy Association, dosage, duration of administration, actions, contraindications, and the American Nurses Credentialing Center's Commission side effects, herb-drug interactions, safety ratings, regulatory on Accreditation through the Texas Nurses Association. Upon status, and a detailed chart that completion of this module, participants should be able to meet
---111--..,- reviews the clinical studies the following learning objectives: The~Bocanila!Counci conducted to date and brand l' H ~ A B 'C 1. Identify the 29 most popular medicinal herbs CLIN)CAL .. names of products used in the available to consumers in the U.S. market. GU I DE TO.· clinical studies. A separate HERBS chapter covers proprietary 2. Explain the common therapeutic indications of herbal products that have the leading herbs. undergone clinical studies. 3. Provide an overview of the clinical study research The sample here is identical to of the leading herbs. what is published in The 4. Identify potential drug interactions and side effects. Guide, except that HerbalGram took the liberty of restoring the 5. Evaluate the safety issues and contraindications. color to the photographs. The 6. Interpret product labels for indications of clinical book itself is printed in black efficacy. and white. 7. Distinguish different types of brands on the CE Credit for Healthcare Professionals marketplace which are backed by clinical research. The ABC Clinical Guide to Herbs is accredited for Continuing 8. Understand the implications of government Education credit in the United States for physicians, naturo regulations on the clinical use of herbs. pathic physicians, physician assistants, pharmacists, nurses, and dietitians. This activity has been planned and implemented in Citation: accordance with the Essential Areas and Policies of the Accred Blumenthal M, Hall T, Goldberg A, Kunz T, Dinda K, Brinckmann J, et itation Council for Continuing Medical Education (ACCME) al., eds. The ABC Clinical Guide to Herbs. Austin (TX): American Botan through the joint sponsorship of the Texas Medical Association ical Council; 2003:51-60. and ABC The other accredited providers are the Oregon Board
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34 I HerbaiGram 58 2003 www.herbalgram.org Clinical Overview Chamomile, German Matricaria recutita L. (syn. Chamomilla recutita [L.] Rauschert; M. chamomilla L.; M. suaveolens L.) [Fam. Asteraceae]
OVERVIEW DOSAGE AND Chamomile is one of the most widely ADMINISTRATION used ingredients in herbal teas world Internal and External wide. The amount of chamomile Caution patients to report any acute imported into the U.S. each year is complaints that last more than one between 750,000 and one million week, or recur periodically. pounds, with an estimated 90% used in teas. In the U.S. and Europe, chamomile Internal is also a popular ingredient for external DRIED FLOWER HEADS : 2-4 g, 3 times use in health and beauty aids. In daily; 5 g single dose. commerce, chamomile is often called INF US ION: The German Commission E German chamomile or Hungarian dosage: 150 ml boiling water poured chamomile, which should not be over approximately 3 g dried flower and confused with the rarer, and more costly, steeped, covered, for 5-10 minutes, 3-4 Roman or English chamomile (Anthemis times daily between meals for gastroin nobilis syn. Chamaemelum nobile). testinal complaints. The official Swiss tea infusion dosage for the same indication is PRIMARY USES 900 mg, 3-5 times daily. Internal F LUID EXT RACT: 1:1 (g!m[) , 38-53% • Gastrointestinal spasms ethanol (vlv) , containing minimum • Inflammatory diseases of the 0.3% (mlm) blue volatile oil, 1-4 ml, 3 Photo © 2003 stevenfosteccom gastrointestinal tract times daily. • Indigestion, flatulence, and/or excess gas production, TI NCTURE: 1:5 (glm[), 45% ethanol, 3-10 ml, 3 times daily. bloating The Kamillosan® Konzentrat product has an approximately External 1:4.0-4.5 (wlv) ratio in 42.8% ethanol; each 100 ml contains • Inflammatory dermatosis 150-300 mg essential oil, 150-300 mg apigenin-7 -glucoside, and 50 mg (-)-a-bisabolol. Adults: 5 ml in 100 ml warm • Neurodermatitis water, 4 times daily. Children: 2.5 ml, 4 times daily. • Wound treatment after dermabrasion for tattoo removal External • Ana-genital inflammation (baths and irrigation) BATH ADDITIVE: 50 g dried flower added to 10 liters (about 2.5 gallons) water, as a bath for ana-genital inflammation. OTHER POTENTIAL USES GARGLE: 100 ml boiling water poured over 3-1 0 g dried • Diarrhea in children flower and steeped, covered, for 5-10 minutes. The tea infu • Common cold symptoms sion used as a wash or gargle for inflammation of the mucous • Alleviation of mucositis induced by radiation and membranes of the mouth and throat. Or, 5 ml tincture chemotherapy poured into 100 ml warm water and gargled 3 or more times daily. PHARMACOLOGICAL ACTIONS INHALATION : 100 ml boiling water poured over 3-10 g dried Anti-inflammatory; muscle relaxant; antispasmodic; promotes flower and steeped, covered, for 5-10 minutes. Or, 15 ml wound-healing; deodorant; antibacterial and bacteriostatic; tincture poured into 0.5 liter boiled water, 1-3 times daily. stimulates skin metabolism; mild sedative; carminative. Steam vapor inhaled for inflammation of the upper respira tory tract.
www.herbalgram.org 2003 HerbaiGram 58 I 35 Clinical Overview
PO ULTICE: Semisolid paste or plaster containing 3-10% (mlm) CLINICAL REVIEW of flower heads. Of 10 clinical studies on German chamomile extract (8,668 RI NSE: Hot aqueous rinse containing 3-10% infusion. total participants), all but 1 demonstrated positive effects for NOTE: Do not apply the infusion near the eyes. indications including dermatological, neurological, and respira tory conditions. Three studies focused on the use of chamomile CONTRAINDICATIONS as a mouthwash for stomatitis and for its astringent and cooling Known hypersensitivity to plants of the Asteraceae (Compositae) effects. One stomatitis study did not notice significant improve family such as arnica flower (Arnica spp.), chamomil e flower ment. Dermatological studies included a controlled, bilateral, (Matricaria spp.), marigold flower (Calendula officinalis), and comparative study investigating a chamomile cream against yarrow flower (Achillea spp.); ragweed (Ambrosia spp.); asters inflammatory dermatoses, and a double-blind (DB) study on (Aster tataricus); and chrysanthemums (Chrysanthemum spp.). use of a chamomile extract to promote wound-healing after dermabrasion. Other studies demonstrating positive results PREGNANCY AND LACTATION : No known restrictions. included inhalation of the steam vapor of chamomile extract to ADVERSE EFFECTS treat respiratory tract conditions related to the common cold, Minor side effects have been recorded. In rare cases, a contact inhalation of the volatile oil to determine the effect of olfactory allergy may occur. Washing the eyes with chamomile tea may stimulation on mood, and oral ingestion of the aqueous infusion cause allergic conjunctivitis in rare cases. The highly concen to investigate cardiac effects after ventricular catheterization. In trated hot tea has been reported to act as an emetic. The a study of 8,058 mothers in childbirth conducted over a period unprocessed, crude flower is free from any toxic effects. Rarely, of eight years, two essential oils, clary sage (Salvia sclarea) and anaphylactic reactions can occur. Case reports have documented chamomile, were shown to be effective in alleviating pain during contact dermatitis and urticaria as well as one fatal anaphylaxis labor. A recent DB, placebo-controlled study investigated the after a chamomile-containing enema was given during labor. use of a chamomile fluid extract and apple pectin combination product for treating yo ung children with acute, non-compli DRUG INTERACTIONS cated diarrhea. No known interactions. Fluid extract may prevent ethyl alcohol induced ulcer formation. Potential interactions with warfarin have been cautioned.
36 I HerbaiGram 58 2003 www.herbalgram.org Chamomile, German Matricaria recutita L. (syn Chamomilla recutita [L.] Rauschert; M chamomilla L.; M suaveo/ens L.) [Fam. Asteraceae]
O VERVIEW In the U.S., chamomile is one of the most widely used herbal ingredients in teas as wel l as in cosmetic, health, and beauty aid products. The amount of chamomile imported into the U .S. each year is between 750,000 and one million pounds, with an estimated 90% used in teas. In commerce, chamomil e is often call ed German chamomile or Hungarian chamomile, which should not be confused with the rare, and more costly, Roman or English chamomile (Anthemis nobilis syn. Chamaemelum nobile).
USES Internal Indiges tion; fl atulence (gas); bloating; gastrointestinal spas ms; inflammatory diseases of the gastrointestinal tract. External Inflammatory skin conditions; scaly patches of skin resulting from an itch that is irritated when scratched; wound treatment after dermabrasion for tattoo removal; inflamed anal and genital areas (baths and irrigation).
DOSAGE lllustra~on © 2003 Peggy Duke For acute complaints that last more than one week, or recur periodically, consult yo ur healthcare provider. CONTRAINDICATIONS Individuals allergic to plants in the same family (includ Internal ing arnica, marigold, yarrow, chrysanthemum, and FLUID EXTRACT: 1--4 ml, 3 times daily. ragweed, for example) may experience a simil ar reaction T I CTURE: Adults: 5 ml in 100 ml warm water, 4 times to chamomile. daily. Children: 2.5 ml, 4 times daily. PREGNANCY AND lACTATIO : There are no known restric External ti ons for usage during pregnancy or while breast-feeding. BATH ADDITIVE: Add 50 g dried flower per 10 liters (approximately 2.5 gall ons) water. Bathe in the infusion ADVERSE EFFECTS for ano-genital inflammation. Rare cases of allergic reactions to chamomile used as an GARGLE: Pour 100 ml boiling water over 3-10 g dried eyewash have been reported. A fa tal, poss ibly all ergic, flower and steep, covered, for 5-10 minutes. Use the tea reaction occurred during labor after a chamomil e enema infusion as a wash or gargle for inflammation of the was used. H ighl y concentrated hot tea may cause vomit mucous membranes of the mouth and throat, or pour ing. Other adverse effects include dermatitis and urticari a. 5 ml tincture into 100 ml warm water, and gargle 3 or D RUG INTERACTIONS more times daily. The fluid extract may prevent ulcers caused by alcohol INHALATION : Pour 100 ml boiling water over 3-10 g dried consumption. Potential interactions with the anticoagu flower and steep, covered, for 5-10 minutes, or pour lating drug warfarin have been speculated. 15 ml tincture into approximately 2 cups boil ed water, 1-3 times daily. Inhale steam vapor for inflammation of the upper respiratory tract.
Comments
When using a dietary supplement, purchase it from a reliable source. The information contained on rhis sheer has been For best results, use the same brand of product throughout the period excerpted from The ABC Clinical G«ide to Herbs of use. As with all medications and dietary supplements, please inform © 2003 by the American Botanical Council (ABC). your healrhcare provider of all herbs and medications you are raking. ABC is an independent member-based educational Interactions may occur between medications and herbs or even among organization focusing on the medicinal use of herbs. different herbs when raken ar the sa me time. Treat your herbal supple For more detailed information about rhis herb please ment wirh care by taking ir as directed, storing it as advised on the consult the healthcare provider who gave you this sheet. label, and keeping it out of the reach of children and pets. Consult your To order The ABC Clinical G«ide to Herbs or become a healthcare provider with any questions. member of ABC, visit their website ar www.herbalgram.org. www.herbalgram.org 2003 HerbaiGram 58 I 37 Chamomile, German Matricaria recutita L. (syn. Chamomilla recutita [L.] Rauschert; M. chamomilla L. ; M. suaveolens L.) [Fam. Asteraceae]
OVERVIEW External hamomile is one of the most widely used ingredients in Dermatology herbal teas worldwide. The amount of chamomile • Inflammatory dermatosis and neurodermatitis (Aengeerts Cimported into the U.S. each year is between 750,000 eta!., 1985) and one million pounds, with an estimated 90% used in teas • Wound treatment after dermabrasion for tattoo removal (Keating, 2001). In the U.S. and Europe, chamomile is also a (Glowania eta!., 1987) popular ingredient for external use in health and beauty aids. In • Ano-genital inflammation (baths and irrigation) (Blumen commerce, chamomile is often called German chamomile or thal eta!. , 1998; Braun eta!., 1996) Hungarian chamomile, which should not be confused with the rarer, and more costly, Roman or English chamomile (Anthemis OTHER POTENTIAL USES nobilis syn. Chamaemelum nobile). • Diarrhea in children (de Ia Motte eta!., 1997) • Common cold symptoms (Saller eta!., 1990) Oncology • Alleviation of radiation and chemotherapy induced mucositis (Carl and Emrich, 1991)
DosAGE Internal Crude Preparations DRIED FLOWER HEADS: 2-4 g, 3 times daily (Bradley, 1992), 5 g single dose (CCRUM, 1992). INFUS ION: The German Commission E dosage is 150 ml boil ing water poured over approximately 3 g dried flower and steeped, covered, for 5-10 minutes, 3-4 times daily between meals for gastrointestinal complaints (Blumenthal et a/., 1998; Braun et a/., 1996). The official Swiss tea infusion dosage for
Photo © 2003 stevenfoster.com the same indication is 900 mg, 3-5 times daily (Morant and Ruppanner, 200 1). FLUID EXTRACT: 1:1 (glm~, 38-53% ethanol (vlv), containing DESCRIPTION minimum 0.3% (wlw) blue volatile oil, 1-4 ml, 3 times daily Chamomile preparations consist of the fresh or dried flower (Bradley, 1992). heads of Matricaria recutita L. (syn. Chamomilla recutita [L.] Rauschert; M . chamomilla L. ; M . suaveolens L.) [Fam. Aster TINCTURE: 1:5 (glm~ , 45% ethanol, 3-10 ml, 3 times daily aceae]. Pharmacopeia! grade chamomile must contain no less (Bradley, 1992). than 0.4% of blue volatile oil, and no less than 0.3% of TINCTURE: 1:4.0-4.5 (wlv) ratio in 42.8% ethanol. Adults: 5 ml apigenin-7 -glucoside (US P, 2002). Pharmacopeia! grade in 100 ml warm water, 4 times daily. Children: 2.5 ml, 4 times chamomile fluid extract contains not less than 0.3% of blue daily (Asta Medica, 1998; Gelbe Liste Pharmindex, 2000). residual oil with an ethanol content of 38%-53% (vlv) External (Ph.Eur., 2001). Crude Preparations BATH ADDITIVE: 50g dried flower added per 10 liters (ca. 2.5 PRIMARY USES gallons) water as a bath for ano-genital inflammation (Blumen Internal thal eta!. , 1998; Braun eta/. , 1996). • Gastrointestinal spasms, inflammatory diseases of the GARGLE: 100 ml boiling water poured over 3-10 g dried flower gastrointestinal tract (Morant and Ruppanner, 2001; and steeped, covered, for 5-10 minutes (Braun eta!., 1996). Blumenthal eta!., 1998; Bradley, 1992; Braun eta!., The tea infusion is used as a wash or gargle for inflammation of 1996) the mucous membranes of the mouth and throat (Blumenthal • Indigestion, flatulence and/or excess gas production, eta!., 1998; Braun eta!., 1996). Or 5 ml tincture poured into bloating (Health Canada, 1996) 100 ml warm water and gargled 3 or more times daily (Asta Medica, 1998) . INHALATION: 100 ml boiling water poured over 3-10 g dried
38 I HerbaiGram 58 2003 www.herbalgram.org flower and steeped, covered, for 5-10 min. (Braun eta!., Animal 1996). Or 15 ml tincture poured into 0.5 liter boiled water, Anti-inflammatory (Carle and Gomaa, 1991 ,92; Tubaro et 1-3 times daily (Asta Medica, 1998). Steam vapor inhaled al., 1984; WHO, 1999). for inflammation of the upper respiratory tract. POULTICE: Semisolid paste or plaster containing 3-1 Oo/o MECHANISM OF ACTION (mlm) of flower heads (Blumenthal eta!., 1998). • Whole plant extracts of chamomile have demonstrated antispasmodic action, though the mechanism of action RINSE: Hot aqueous rinse containing 3-10% infusion was unclear (Forster eta!., 1980). Antispasmodic effects (Blumenthal eta!., 1998). are due mainly to chamomile's water-soluble NOTE: Do not apply infusion near eyes (Braun eta!., 1996). constituents (Carle and Gomaa, 1991,92) such as the flavonoids apigenin and apigenin-? -0-glucoside and DURATION OF ADMINISTRATION the volatile oil (- )-a-bisabolol, which act similarly to Internal and external papaverine (Bruneton, 1999; WHO, 1999). For acure complaints that last more than one week, or recur • Sedative effects are attributed to the flavonoids, includ periodically, consult a healthcare provider (Braun eta!., 1996). ing apigenin, which acts as a ligand for the central CHEMISTRY benzodiazepine receptors. Apigenin competitively inhibits the binding of flunitrazepam, thus providing a Chamomile contains from 6-8% flavonoids (Hansel eta!., molecular basis for possible weak CNS-depressing 1999; Bruneton, 1999; Dolle et a!., 1985), composed of activity of water-based preparations (e .g., teas) (Viola et flavone glycosides including apigenin ?-glucoside and its 6' a!., 1995). acetylated derivative and flavonols including luteolin gluco sides, quercetin glycosides, and isorhamnetin (Bruneton, • Apigenin may be an anti-inflammatory constituent 1999); up to 1O o/o mucilage polysaccharides (Carle and Isaac, (Hadley and Petry, 1999), due to the water-soluble and 1985; Meyer-Buchtela, 1999); 0.4-2.0% volatile oil, lipophilic components. The flavones block the arachi composed of bisabolane sesquiterpenes (up to 50%) and donic acid pathway by inhibiting phospholipase A, chamazulene (1-15%); sesquiterpene lactones (matricin and cyclo-oxygenase, and lipoxygenase pathways. The matricarin) (Bruneton, 1999; Carle and Isaac, 1985); and up volatile oil components, chamazulene and a-bisabolol, to 0.3% choline (Schilcher, 1987). have also demonstrated anti-inflammatory action by interfering with 5-lipoxygenase and cyclo-oxygenase PHARMACOLOGICAL ACTIONS production (Carle and Gomaa, 1991,92). According to the German Commission E, chamomile is • The azulene components of the volatile oil have anti anti-inflammatory; muscle relaxant; antispasmodic; allergenic and anti-inflammatory actions, though the promotes wound-healing; deodorant; antibacterial; bacterio mechanism of action was unclear (Farnsworth and static; stimulates skin metabolism (Blumenthal eta!., 1998). Morgan, 1972). Internal • Azulene may prevent histamine discharge from tissue Human by activating the pituitary-adrenal system, causing the Sedative (Bradley, 1992; Gould et a!., 1973; Mann and release of cortisone (Stern and Milin, 1956); or azulene Staba, 1986); carminative (CCRUM, 1992). may prevent allergic seizures caused by histamine Animal release, activating cellular resistance and speeding the Inhibits ulceration (Szelenyi et a!., 1979); relaxes smooth process of healing (Meer and Meer, 1960). muscle (Carle and Gomaa, 1991,92); depresses central nerv • Chamomile extract accelerates wound-healing, report ous system (CNS) (Della Loggia et a!., 1982). Apigenin edly by reducing inflammation and promoting tissue binds to central benzodiazepine receptors, producing anxi granulation and regeneration on topical application olytic effects in mice but without any sedative or myorelax (Carle and Isaac, 1987). ant effects (Viola eta!., 1995). A subsequent study reports, in contrast, that apigenin has sedative action without anxiolytic CONTRAINDICATIONS and/or myorelaxant effect. The study links the sedative Known hypersensitivity to plants of the Asteraceae (Composi action of chamomile extracts not to an activation of GABAA tae) family such as arnica flower (Arnica spp.), chamomile receptors by apigenin, but to other compounds with benzo flower (Matricaria spp.), marigold flower (Calendula offici diazepine-like activity (Avallone eta!., 2000). na/is L. ), and yarrow flower (Achillea spp.) (Braun et a!., In vitro 1996); ragweed (Am brosia spp.); asters (Aster tataricus L. f. ); Antipeptic (reduces proteolytic activity of pepsin by 50%) and chrysanthemums (Chrysanthemum spp.) (WHO, 1999). (Thiemer eta!., 1972; Isaac and Thiemer, 1975); prevents PREGNANCY AND LACTATION: No known restrictions in preg and relieves inflammation (Ammon and Sabieraj, 1996). nancy or lactation (De Smet eta!., 1992; McGuffin eta!., External 1997). No adverse teratogenic effects have been reported in Human vivo (WHO, 1999). Anti-inflammatory (Ae rtgeerts eta!., 1985); astringent; cool ADVERSE EFFECTS ing (Nasemann, 1975); promotes wound-healing (Glowania Minor side effects are recorded by several references (McGuf eta!., 1987). fin eta!., 1997). There is empirical evidence of extremely rare contact allergy (Bradley, 1992; Brinker, 2001). Eye washing www.herbalgram.org 2003 HerbaiGram 58 I 39 with chamomile tea may induce allergic co njunctivitis in rare revealed a median inhibitory concentration (IC50) of a cases (Subiza et al., 1990). Highly concentrated hot tea has been chamomile extract ranging from 1-2%. This might have impli reported to act as an emetic (Chadha, 1952-1988). The cations for predicting the likelihood of potential herb-drug unprocessed crude flower is free from any toxic effects interactions (Budzinski et al., 2000), although such reactions (CCRUM, 1992). Case reports describing contact dermatitis have not been reported. Potential interactions with warfarin and urticaria have been documented (Fori et al., 2000; Gior have been reported, and caution regarding their concomitant use dano-Labadie, 2000; Rodriguez-Serna et al., 1998; Pereira, has been suggested (Heck et al., 2000), although this remains 1997; McGeorge and Steele, 1991 ; van Ketel, 1982). A case speculative. report regarding a fatal outcome of anaphylaxis when a chamomile-containing enema was given during labor has been AMERICAN HERBAL PRODUCTS AsSOCIATION documented Oensen-Jarolim et al., 1998). Rarely, anaphylactic (AHPA) SAFETY RATING reactions can occur (Casterline, 1980; Subiza et al., 1989). CLASS 1: Herbs that can be safely consumed when used appro There have been several reports in the literature of suspected priately (McGuffin et al., 1997). anaphylaxis associated with the use of chamomile. One author itative source, reviewing the available literature from over almost REGULATORY STATUS 100 years, concluded, "This rather remote possibility may have AUSTRIA: Official in the Austrian Pharmacopoeia (0AB) been greatly overemphasized in the nonmedical literature. Only (Wicht!, 1997). five cases of allergy specifically attributed to German chamomile BELGIUM: Herbal medicine for oral or external use for specific were identified worldwide between 1887 and 1982; however, a indication (Bradley, 1992; Van Hellemont, 1986; WHO, 1998). recent report indicates that a German chamomile ether extract CANADA: Permitted as a Traditional Herbal Medicine (THM) or used in allergic patch testing from 1985 to 1990 in 3,851 tested homeopathic drug for oral use. Requires premarket authoriza individuals produced an allergic reaction in sixty-six patients or tion and assignment of a Drug Identification Number (DIN) if 1.7%." (Robbers and Tyler, 1999). One of the reports receiving labeled as a THM or homeopathic drug (Health Canada, 1996). widespread attention in the medical press was based on a misin Food, if no claim statement is made. terpretation of the taxonomic identity of the so-called "chamomile" (Anon., 1979). This article warned readers to COUNCIL OF EUROPE: Dried flower, essential oil and fluid extract avoid teas made from the Composite family, including official in European Pharmacopoeia, 3rd edition (Ph.Eur., 2001). chamomile, goldenrod (Solidago virgaurea), marigold, and FRANCE: Traditional Herbal Medicine (THM) for oral and yarrow. The article cited a paper tided "Anaphylactic reaction to external use for specific indications (Bradley, 1992; Bruneton, chamomile tea" (Benner and Lee, 1973), which does not specify 1999). Official in the French Pharmacopoeia, 1Oth edition the genus or species of the purported chamomile material impli (Ph.Fr.X) (WHO, 1999). cated in the single case described, a 35-year old woman who GERMANY: Approved nonprescription drug of the German suffered from ragweed hay fever and who developed anaphylaxis Commission E for oral and external use (Blumenthal et al., fo ll owing ingestion of one cup of the purported "chamomile tea" 1998). Tea infusion form is an approved nonprescription drug in (Awang, 1990). The incident was incorrectly inferred to be the the German Standard License monographs (Braun et al., 1996). popular German or Hungarian chamomile (M. recutita) . The The alcoholic fluid extract and the volatile oil forms are official actual case was based on ingestion of dog fennel (Anthemis in the German Pharmacopoeia (DAB, 1999). cotula), a plant not widely used in commercial products, and INDIA: Licensed si ngle drug in Unani system of medicine generally unavailable in the U.S. Dog fennel is a member of the (CCRUM, 1992). Also listed in compound formulations official genus Anthemis, the same as Roman or English chamomile (A. in the National Formulary of Unani Medicine (NFUM I) with nobilis, syn. Chamaemelum nobile) - hence the erroneous standards approved by the Unani Pharmacopoeia Committee appellation "chamomile" by the authors of the case reports (UPC) (NFUM, 1983). (Lewis, 1992). Dog fennel contains a higher level of antheco tulid, a sesquiterpene lactone that has demonstrated activity in ITALY: Listed in the Italian Pharmacopoeia (Newall et al., 1996). primary irritant contact dermatitis (Hausen et al., 1984). RuSSIAN FEDERATION: Official in the USSR X (Bradley, 1992; However, there have been some recent reports of anaphylaxis to Newall eta!., 1996). German chamomile (M. recutita). In one study, 10 our of 14 SWEDEN: Natural remedy for self-medication. Requires market patients with a history of allergy to chamomile, spices, or ing authorization by the Medical Products Agency (WHO, "weeds" rested positive to chamomile in a skin prick/RAST rest 1998). (Reider et al., 2000). Curiously, chamazulene in German SWITZERLAND: Official in the Swiss Pharmacopoeia (Ph.Helv.) chamomile has anti-allergenic and anti-inflammatory activity, (Wichd, 1997). Creams, fluid extracts, powders, sprays, and rea and another constituent, an EN-IN-dicycloerher, has demon infusions are Category D non-prescription drugs with sale strated anti-inflammatory, anti-anaphylactic, spasmolytic, and limited to pharmacies and drugstores (Morant and Ruppanner, bacteriostatic activity (Farnsworth and Morgan, 1972). 2001; Asta Medica, 2000; WHO, 1998). DRUG INTERACTIONS U.K.: Herbal medicine specified in the General Sale List, Sched ule 1 (medicinal products requiring a full product li cense), Table According to the German Commission E, no interactions are A (internal or external use) (GSL, 1990). known (Blumenthal et al., 1998). The fluid extract may prevent ethyl alcohol-induced ulcer formation (Brinker, 2001). In vitro U.S.: Generally recognized as safe (GRAS) (US FDA, 1998). studies of the inhibitory effect of ethanolic herbal extracts and Food or dietary supplement, depending on the claim statement tinctures on the cytochrome P450 3A4 (CYP3A4) system (USC, 1994). Listed in the Official Monographs of the U.S.
40 I HerbaiGram 58 2003 www.herbalgram.org National Formulary, 19th edition (USP, 2002). Tincture of per 100 ml fluid extract contammg a mm1mum of 3 mg the whole flower plant, 1:10 (wlv) in 45% alcohol (vlv), is a chamazulene and 50 mg a-bisabolol. Class C over-the-counter (OTC) drug of the Ho meopathic Kneipp® Kamillen-Konzentrat: Kneipp Werke / 105-107 Pharmacopoeia ofthe United States (HPUS, 1990). Stonehurst Court I Northvale, NJ 07647 I U.S.A. I Tel: (20 1) 750-0600 I Fax: (201 ) 750-2070 I www.kneipp.com. CLINICAL REviEW Hydroalcoholic fluid extract. Ten studies are outlined in the following table, "Clinical American equi valents, if any, are found in the Product Table Studies on German Chamomile," including a total of 8,668 beginning on page 398. participants. All but one of the studies (Fidler et al., 1996) demonstrated positive effects for indications including REFERENCES dermatological, neurological, and respiratory conditions. Aertgeerts P, AIb ri ng M, Kl asch ka F, eta!. Comparative res ting of Kami ll osa n® Three studies (Fidler et al., 1996; Carl and Emrich, 1991 ; crea m and steroidal (0.25% hydrocortisone, 0.75% Auocortin butyl ester) Nasemann, 1975) focused on the the use of chamomile as a and non-steroidal (5 % bufexamac) dermatologic agents in maintenance ther mouthwash for its astringent and cooling effects, stomatitis, apy of eczematous diseases. [in German]. Z Hautkr 1985;60(3) :270-7. and mucositis (Fidler et al., 1996; Carl and Emrich, 1991 ; Ammon HPT, Sabieraj J. Kamill e: Mechanismus der antiphlogisri schen Wirkung vo n Kamillenextrakten und - inhaltsstoffen. Deutsche Apotheker Nasemann, 1975). One stomatitis study did not notice Zeitung 1996; 136(22): 17. significant improvement (Fidler et al. , 1996). Other derma Anon. Toxic reactions ro plant products sold in health food srores . Abramowicz tological studies included one controlled, bilateral, compara M (ed. ). Medical Letter on D rugs and Therapeutics 1979;2 1( 7):29-32. tive study investigating a chamomile cream against inflam Asta Medica. Fachinformation: Kamillosan® Konzentrat. Frankfurt, Germany: matory dermatoses (Aertgeerts et al., 1985), and a DB study Asta Medica AG; March 1998. Asra Medica. Kamillosan® Produkteiibersicht. Frankfurt, Germany: Asra Medica, on using a chamomile extract to promote wound-healing Division of Degussa-Huls Group; 2000. after dermabrasion (G lowania et al., 1987). Other studies Avallone R, Zanoli P, Pu ia G , et a/. Pharmacological profile of apigenin, a demonstrating positive results included inhalation of the fl avonoid isolated from Matricaria chamomilla. Biochem Pharmacal 2000; steam vapor of chamomile extract to treat respiratory trac t 59: 1387-94. conditions related to the common cold (Saller et al. , 1990); Aw ang DVC. C hamomile, all ergy and anaphylac ti c shock. [unpublished] Feb. I , 1990. inhalation of volatile oil to determine the effect of olfactory Benner MH, Lee HJ . Anaphylactic reaction to chamomil e rea.} Allergy Clin stimulation on mood (Roberts and Williams, 1992); and oral lmmunol 1973 Nov;52(5):307-8. ingestion of the aqueous infusion to investigate cardiac Blumenthal M, Busse W R, Gold berg A, G ruenwald J, H all T, Ri ggins CW, effects after ventricular catheterization (Gould et al., 1973). Rister RS (eds.) . Kl ein S, Rister RS (trans.). The Complete German Commis sion E Monographs-Therapeutic Guide to Herbal Medicines. Austin, T X: In a study of 8,058 mothers in childbirth conducted over a America n Botanical Council ; Boston: Integrati ve Medi cine Communicati on; period of eight years, two essential oils, clary sage (Salvia 1998; I 08. sclarea L.) and chamomile were shown to be effective in alle Bradley P (ed.). British Herbal Compendium, Vo l. I. Bournemouth, U K: British viating pain during labor (Burns et al., 2000). A recent Herbal Medicine Association; 1992; 154-7. DB,PC study investigated the use of a chamomile fluid Braun R, Surmann P, Wendt R, et a! (eds.). Standardzulassungen fiir Ferti garzneimittel-Text and Kommentar. Stuttga rt, Germany: Deutscher extract and apple pectin combination product for treating Apotheker Verl ag; 1996. young children with acute, non-complicated diarrhea (de Ia Brinker F. Herb Contraindications and Drug Interactions, 3rd ed. Sa ndy, OR: Motte et al., 1997). Eclectic Medical Publicati ons; 200 I ;62. Bruneton ). Pharmacognosy, Phytochemistry, Medicinal Plants, 2nd ed. Pari s: BRANDED PRODUCTS Lavoisier Publishing; 1999;520-3. Budzinski J, Foster B, Va nden hoek S, Am aso n J. An in vitro evaluation of Diarrhoesan® Chamomile fluidextract: Dr. Loges & Co. human cytochrome P450 3A4 inhibition by selected commercial herbal GmbH I Postfach 1262 I Schiltzenstrasse 5 I 21 423 Winsen extracts and tinctures. Phytomed 2000 Jul;7(4):273- 82. I Germany I Tel.: +49-041-71-7070 I Fax: +49-041-71- Burns E, Blamey C, Ersser S, Barnerso n L, Lloyd A. The use of aroma therapy in 707 1-00 I Email: [email protected]. Each 100 ml of solution intrapartum midwifery practice an observa tional study. } Altern Complement contains 2.5 ml of chamomile fluidextract (1: 1),eluent: M ed 2000 Apr;6{2) : 14 1-7. Carl W, Emrich L. Management of oral mucositis during loca l radiatio n and ethanol 55% and 3.2 g of apple pectin. systemic chemotherapy: a study of 98 patients. j Prosthet Dent Kamillosan® Creme: VIATRIS GmbH & Co. KG I Weis 199 1;6 6(3):36 1- 9. milllerstrasse., 45 I D-603 14 Frankfurt/Main I Germany I Carl e R, Gomaa K. Chamomile: a pharmaco logica l and clinica l profile. Drugs ofToday 1992;28:559-65. Tel: +49-69-400 1 2811 I Fax: +49-69-400 1 2951 I Email: Carl e R, Gomaa K. The medicinal use of Marri ca ri ae Aos. Br} Phytother [email protected] I www.viatris.com (formerl y known as 199 1/92;2(4) : 147-53. ASTA Medica AG). One gram cream contains 20 mg Carl e R, Isaac 0. Chamomile-Effect and Efficacy: Comments to the mono ethanolic dry extract (2.75: 1) in a fatty ointment base. The graph. Mar ri cariae fl os (Chamomile fl owers) . [in German]. Z Phytother extract contains no less than 0.2 mg volatile oil and a mini 1987;8:67-77. Carl e R, Isaac 0 . Adva nces in chamomile research between 1974- 1984. [in mum of 0.07 mg (-)-a-bisabolol. German]. Dtsch Apoth Ztg 1985; 125(43, Sup pi 1):2-8. Kamillosan® Konzentrat: VIATRIS GmbH & Co. KG. Casterlin e C. Allergy to chamomile tea [letter] . }AMA 1980 July;244(4):330- l. Hydroalcoholic tincture extracted with 38.5% (mlm) CCRUM . See: Central Council for Resea rch in Unani Medic ine. Central Counc il for Resea rch in Unani Medicine (CCRUM ). Standardisation of ethanol; drug-to-extract ratio of approximately 1: 4. 0-4.5 Single Drugs in Unani Medicine, Part II. New Delhi, India: CCCRUM (w/v), in 42.8% ethanol. Each 100 ml of tincture contains Ministry of Health & Family Welfa re Government of India; 1992; 141 -7. 150-300 mg essential oil; 150-300 mg apigenin-7-glucoside Chadha Y et al. {eds.). The Wealth ofI ndia (Raw Materi als). II vols. New Delhi, and 50 mg (-)-a-bisabolol. India: Publications and Information Directorate, CSIR; 1952-1988. DAB. See: Deutsches Arzneibuch. Kamillosan® Liquidum: VIATRIS GmbH & Co. KG. Stan de Ia Motte S, Bose-O'Reillly S, Heinisch M , Harrison F. Doppelblind-Vergle dardized hydroalcoholic fluid extract; 150 mg of essential oil ich zwischen ei nem Apfelpekrin/Kamillenextrakr-Praparat und Plazebo bei
www.herbalgram.org 2003 HerbaiGram 58 I 41 Kindem mit Diarrhoe. Arzneimittelforschung 1997;47(11):1247-9. Germany: Deutscher Apotheker Verlag; 1999. De Smer P, Keller K, Hansel R, Chandler R (eds.) . Adverse Effects ofHerbal Drugs 1. Morant J, Ruppanner H (eds.). Asta Medica Kamillosan®; Sidroga® Kamillenblii New York, NY: Springer Verlag; 1992;243-7. tentee. In Arzneimittel-Kompendium der Schweiz® 2001. Basel, Switzerland: De Smer P, Keller K, Hansel R, Chandler R (eds.). Adverse Effects ofHerbal Drugs 2. Documed AG . 200 1. New York, NY: Springer Verlag; 1993;55. Nasemann T. Kamillosan®-(Chamomile) Applications in dermatology. [in Della Loggia R, Traversa U, Scarcia V, Tubaro A. Depressive effects of Chamomilla German]. Z Allgemeinmed 1975;5 1(25): II 05-6. recutita (L.) Rausch, tubular flowers, on central nervous system in mice. Phar National Formulary of Unani Medicine (NFUM I) Parr I (English Edition). New macal Res Commun 1982;14(2):153--62. Delhi, India. Government of India Department oflndian Systems of Medicine & Della Loggia R. Evaluation of the ami-inflammatory activity of chamomile prepara Homeopathy, Ministry of Health & Family Welfare; 1983. tions. Planta Medica 1990;56:657-8. Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A Guide for Health-care Deutsches Arzneibuch. (DAB) . Stuttgart, Germany: Deutscher Aporheker Verlag; Professionals. London, UK: T he Pharmaceutical Press; 1996;69-71. 1999. NFUM. See: National Formulary ofUnani Medicine. Dolle B, Carle R, Muller W. Flavonoidbesrimmung in Kamillenexrrakrprapararen. Pereira F, Santos R, Pereira A. Contact dermatitis from chamomile rea. Contact DtschApothZtg 1985; 125(Suppl. 1):14-9. Dermatitis 1997;36(6):307. European Pharmacopoeia (Ph.Eur. 3rd edition, Supplement 2001). Srrasbourg: Ph.Eur. See: European Pharmacopoeia. Council of Europe; 200 I; II 02-3. Ph.Fr.X. See: Pharmacopte Franraise. Farnsworth N, Morgan B. Herb drinks: Camomile rea [letter]. 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Germany: Available at: l992;65(Pr2): 197-9. http:/ /www.gelbe-lisre.de. Rodriguez-Serna M, Sanchez-Marilla J, Ramon R, Aliaga A. Allergic and systemic General Sale List (GSL). Statutory Instrument (S.I.) The Medicines (Products Other contact dermatitis from Matricaria chamomilla rea. Contact Dermatitis Than Veterinary Drugs) Amendment Order 1990; No. 1129. London, U.K.: Her 1998;39(4):192-3. Majesty's Stationery Office (HMSO). 1990. Saller R, Beschorner M, Hellenbrechr D, Biihring M. Dose-dependency of sympto Giordano-Labadie F, Schwarze H, Bazex J. Allergic contact dermatitis from matic relief of complaints by chamomile steam inhalation in patients with chamomile used in phyrorherapy. Contact Dermatitis 2000 Apr;42(4):247. common cold [Abstract]. Eur J Pharmaco/1990;183:728-9. Glowania H , Raulin C, Swoboda M. The effect of chamomile on wound healing Schilcher H. Die Kamille. In: Handbook for Arzte, Apotheker und andere Naturwis a controlled clinical-experimental double-blind study. [in German]. Z Hautkr senschaftler. Stuttgart, Germany: Wissenschafdiche Verlagsgesellschafr; 1987. 1987;62(17):1262, 1267-71. Stern P, Milin R. Anti-allergic and anti-in fl ammatory effect of azulenes. [in Gould L, Reddy C, Gomprechr R. Cardiac effects of chamomile tea. J Clin Phar German]. Arzneimittelforschung 1956;6:445-50. maco/1973;13(11):475-9. Subiza J, Subiza JL, Alonso M, et al. Allergic conjunctivitis to chamomile rea. Ann GSL. See: General Sale List. Allergy 1990;65(2): 127-32. Hadley S, Perry J. Medicinal herbs: A primer for primary care. Hosp Pract Subiza J, Subiza J, Hinojosa M, et al. Anaphylactic reaction after the ingestion of 1999;34(6):109-12, 115-6. chamomile rea: A study of cross-reactivity with other composite pollens. J Allergy Hansel R, Sricher 0, Sreinegger E. Pharmakognosie-Phytopharmazie, 6th ed. Berlin, Clin /mmuno/!989;84(3):353-8. Germany: Springer Verlag; 1999;699. Szelenyi I, Isaac 0 , Thiemer K. Pharmacological assessment of chamomile extracts. 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The Chemistry, Pharmacology, and Commercial Formulations of effects. Planta Med 1995;61(3):213-6. Chamomile. In: Craker L, Simon J (eds.). Herbs, Spices, and Medicinal Plants WHO. See: World Health Organization. Recent Advances in Botany, Horticulture, and Pharmacology. Phoenix, AZ: Oryx Wicht! M (ed.). Teedrogen und Phytopharmaka, 3. Auf/age: Ein Handbuch for die Press; 1986;235-80. Praxis auf wissenschaftlicher Grundlage. Stuttgart, Germany: Wissenschaftliche McGeorge B, Steele M. Allergic contact dermatitis of the nipple from Roman Verlagsgesellschaft GmbH; 1997;375-95. chamomile ointment. Contact Dermatitis 1991 Feb;24(2): 139-40. World Health Organization (WHO). Regulatory Status of Herbal Medicines: A McGuffin M., Hobbs C, Upton R, Goldberg A (eds.). American Herbal Product Worldwide Review. Geneva, Switzerland: World Health Organization Traditional Associations Botanical Safety Handbook. Boca Raton, FLA: CRC Press; 1997;74. Medicine Programme; 1998. 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42 I HerbaiGram 58 2003 www.herbalgram.org Clinical Studies on Chamomile (Matricaria recutita L.) Oral/Gastrointestinal Aut hor/Year Subject Design Duration Dosage Preparation Results/C onclusio n Fidler et a/. , Stomatitis Phase Ill, DB, 2 weeks 30 drops Kamillosan® Chamomile mouthwash administered in addition to 1996 PC , R extract in Konzentrat. cryotherapy did not significantly alleviate 5 flourouracil n=l64 100 ml water diluted in (5- FU)-induced stomatitis (p=0.32). However, subset as mouthwash water analysis based on gender did reveal unexpected differen- 3x/day vs. tial effects, suggesting that chamomile might be benefi- placebo cial for males but detrimental for females. This could not be explained by reasons other than chance.
Carl and Stomatitis and u Varying Oral rinse Kamillosan® Chamomile oral rinse decreased stomatitis and was Emrich, 1991 mucositis n=98 durations for during Liquidum found to be beneficial in the treatment of mucositis different repeated resulting from radiation and cancer chemotherapeutic treatment cycles agents. The resolution of mucositis appeared to be groups accelerated by the chamomile rinse. Prophylactic oral care appeared to modify oral environment favorably and maintain tissue integrity.
Nasemann, Astringent DB 18 months Mouth wash, Kamillosan® With exception of patients with glossodynia, extract 1975 and cooling n=36 5-'>x/day showed astringent and cooling action. ~ effect 0 ::l 0 C1G '"1 ~ Dermatological "0 Author/Year Subject Design Duration Dosage Preparation Results/Conclusio n ::r
Glowania et Dermabrasion R, PC , DB 14 days Chamomile Chamomile Objective parameters were used to evaluate epithelial a/., 1987 n=l4 extract extract and drying effect of chamomile preparation applied topi- healthy males compresses standardized cally to weeping wound area after dermabrasion from with abrasions for I hour, to 3 mg tattoo removal. Chamomile extract significantly of tattoos on 3x/day until chamazulene decreased weeping wound size, and sped up healing the arms with wounds are and 50 mg time by enhancing drying of oozing wounds. Derma Ill completely levomenol equipment dry (1.5 mm depth)
Aertgeerts et Inflammatory Cn, Cm, MC 3-4 weeks Chamomile Kamillosan® Chamomile cream showed more or less equally effec- a/., 1985 dermatoses n=l61 cream Creme tive therapeutic results as hydrocortisone for treatment vs. 0.25% of inflammatory dermatoses. It proved superior to the hydrocorti- nonsteroidal, anti-inflammatory agent 5% bufexamac as sene, 0.75% well as to 0.75% fluocortin butyl ester. For treatment of fluocortin neurodermatitis, chamomile cream was therapeutically butyl ester, comparable to hydrocortisone and superior to other 5% bufexamac tested products.
KEY: C - controlled, CC -case-control. C H -cohort, Cl -confidence interval, C m -comparison, C O - crossover. CS - cross-sectional, DB - double-bli nd , E - epidemiological, LC- longitudinal cohort, MA- meta-analysis, MC - multi-center, n - number of patients, 0 - open, 08 - observational, O L - open label , O R - odds ratio, P - prospective, PB - patient-blind, PC - placebo-controlled, PG - parallel group, PS - pilot study, R - randomized, RC - reference-controlled, RCS - retrospective cross-sectional. RS - retrospective, S - surveillance. 5 8 - single-blind, SC - single-center, U - uncontrolled, UP - unpublished, VC - vehicle-controlled. www.herbalgram.org 2003 HerbaiGram 58 I 43 Clinical Studies on Chamomile (Matricaria recutita L.) (cont.)
Other AuthorfYear Subject Design Duration Dosage Preparation Results/Conclusion de Ia Motte et Acute P.DB, R,MC, 3 days I st dose Diarrhoesan® After 3 days of treatment, diarrhea in the a/., 1997 diarrhea in PG , PC 10 ml, Chamomile pectin/chamomile group had ended significantly (p<0.05) children n=79 children, followed by fluid extract more frequently than placebo. Pectin/chamomile 6 months to 5 ml/hour, up (0.035 mglg reduced duration of diarrhea significantly (p<0.05) by at 5.5 years to 60 ml/day chamazulene least 5.2 hours. Parents documented subjects' well-being and O.S mglg in a diary twice daily and , compared to placebo, a trend (-)-a- of continuous improvement was observed in the bisabolol) pectin/chamomile group. combined with apple pectin
Roberts and Neurology, PC I day lx exposure Chamomile Patients were asked to visualize positive and negative Williams, 1992 psychiatry n=22 vs. placebo flower volatile phrases following olfactory stimulation by chamomile oil oil or placebo. Chamomile oil significantly increased latency for all images, and shifted mood ratings and frequency judgments in a more positive direction, suggesting a possible mode of action.
Sailer et al., Respiratory PC , R I day Steam Kneipp® Steam inhalation, below a towel, with chamomile extract 1990 n=60 inhalation, Kamillen- in hot water reduced the severity of common cold lx/5 hours Konzentrat, symptoms in a pronounced and dose-dependent alcoholic manner. Onset of action occurred within 15 minutes fluidextract and reached maximum effect between 30-120 minutes; diluted in then efficacy declined after 2- 3 hours. boiled water
Gould et al., Cardia- u I day 2 tea bags in Chamomile Significant increase in mean brachial artery pressure 1973 vascular n=l2 6 ounces flower tea from 91 to 98 mm Hg (p<0.05). No other significant effects hospitalized boiled water, infusion hemodynamic changes were observed. Blood pressure patients lx (brand not and cardiac output were meas ured prior to drinking tea stated) and 30 minutes later. Average cardiac index showed only slight decrease, and average stroke index was essentially unchanged. I 0 of the 12 patients fell into deep sleep I 0 minutes after ingestion, lasting until end of cardiac catheterization approximately 90 minutes.
Combination Product with Chamomile (Essential Oil) AuthorfYear Subject Design Duration Dosage Preparation Results/Conclusion
Burns et al., Pain during 0 8 years Not stated 10 essential The study found that aromatherapy with 2 of the tested 2000 childbirth n=8,058 oils, including essent ial oils, clary sage and chamomile, reduced mater chamomile nal anxiety. fear, and/or pain during labor. The use of aromatherapy was found to reduce the use of systemic opioids in the study center, from 6% in 1990 per woman to 0.4% in 1997.
KEY: C -controlled, CC - case-control, CH - cohort, Cl -confidence interval, Cm -comparison, CO - crossover, CS - cross-sectional, DB - double-blind, E - epidemiological, LC - longitudinal cohort. MA - meta-analysis, MC - multi-center, n - number of patients, 0 - open, OB - observational, OL - open label, OR - odds ratio, P - prospective, PB - patient-blind, PC - placebo-controlled, PG - parallel group, PS - pilot study, R - randomized, RC - re ference-controlled, RCS - retrospective cross-sectional, RS - retrospective , S - surveillance , SB - single-bl ind, SC - single-center, U - uncontrolled, UP - unpublished, VC - vehicle-controlled.
44 I HerbaiGram 58 2003 www.herbalgram.org The..__~~ ;r. H i\> A B ·c; Get the Facts with . .' CLINlCAL .. .- _ HERii s ~ The ABC Clinical Guide to Herbs For consumers, researchers, and healthcare professionals, it clarifies the evidence concerning the safe and effective use of herbs for prevention and treatment of conditions and diseases. Continuing Education C redit available. This reference work delivers information about 29 commonly used herbs: • Comprehensive therapeutic monographs, including tables of clinical studies • Clinical overviews
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A Photo Essay of Chinese Herbs Grown in American Gardens By Steven Foster
he term ben cao roughly translates to materia altissima (Mill.) Swingle, Simaroubaceae), crape myrtle medica, or herbal (i.e., an herbal text) in the (Lagerstroemia indica L., Lythraceae), matrimony vine Western sense. The term first came into use in (Lycium chinense Mill., Solanceae), and gardenia (Garde Tthe later Han Dynasty (about 2,000 years ago), nia augusta Merr., syn. G. jasminoides ]. Ellis, Rubiaceae), which, according to Bensky and Gamble, 1 then referred to name a few. to the materia medica and the knowledge required to The major objective of most Western botanists in obtain the materia medica. In this brief photo essay, we China has been the introduction of useful plants, espe introduce a few common garden plants that are well cially ornamental flowers, shrubs, and trees, hardy in known as garden ornamentals but little known among northern climates. Of all parts of the world from which gardeners as Chinese plants may be introduced to medicinal plants. We hope Europe and North America, to heighten appreciation of temperate East Asia has held the history and introduc the most promise because of tion of these Asian herbs similar climates and great into American horticulture. diversity of plants. With an Details on their use in estimated 30,000 species of Traditional Chinese Medi flowering plants, China cine (TCM) can be found possesses one of the most in numerous English diverse and rich floras of the language books on the temperate zones. Most plant subject. introductions, grown for Since the explorations of curiosity or ornament, Marco Polo in the thir arrived from East Asia teenth century and the through Jesuit, Swedish, landing in China by Russian, Portuguese, Portuguese sea traders in English, or French collec the sixteenth century, there tors during the previous two has been a steady flow of centuries. Indeed, American plant introductions from flower gardens, fields, East to West. When forests, and parks are now a Linnaeus' famous Species rich source of introduced Plantarum was published in Chinese medicinal plants. 1753, 100 spectes of At least 5,000 plant Chinese plants were species in China can be described in this seminal Belamcanda Belamcanda chinensis. Photo ©2003 stevenfoster.com documented as being botanical work. By the late utilized as medicinal plants eighteenth century, in Chinese tradition. At Britain's Royal Botanical Gardens at Kew was actively least 500 plant species serve as medicinal herbs in introducing Chinese plants. When the first volume of modern TCM. Many of these herbs are used as foods. William Aiton's Hortus Kewensis, or catalog of plants More than 1,000 species of Chinese medicinal plants are cultivated in the Royal Gardens at Kew, was published in known in American horticulture - but not necessarily as 1789, Chinese plants in English gardens included the medicinal plants. Many Chinese medicinal plants are hollyhock (Alee a rose a L., Malvaceae), camellia (Camellia better known to the vast majority of Americans as orna japonica L., Theaceae), golden rain tree, (Koelreutaria mental garden perennials, among them daylily, forsythia, paniculata Laxm., Sapindaceae), tree of heaven (Ailanthus peony, balloonflower, blackberry lily, and cockscomb.
46 I HerbaiGram 58 2003 www.herbalgram .org Daylily Hemerocallis fulva, (L.) L., Liliaceae; xuan cao ew Asian plants have become as integral a parr of American horticul ture as the daylily. Oaylily hybrids come in numerous color patterns Fand almost every color. More than 30,000 named cultivars have been produced in the last 60 years. A 1583 work of Charles de l'Ecluse or Clusius (1526--1609) mentions the occurrence of daylily in Hungary. 2 Clusius is credited with introducing daylilies from Eastern to Western Europe in the late sixteenth century. How and exactly when daylilies arrived from East Asia to Eastern Europe is unknown. What is known is that daylilies were rare in castle gardens of Eastern Europe in 1554. They were not known in the gardens of Western Europe until the 1580s, after which they are mentioned in numerous Western European herbals. In the 1597 edition of Gerard's Herbal!, Gerard becomes the first English author to use the English name daylily which has remained with us since.3 Never an official drug but regarded more as a folk medicine, the roots and rhizome of daylilies (xuan cao gen) , which are roxie, have been used in the treatment of edema, poor or difficult urination, and many other conditions. The dried flower buds or petals (jin zhen caz) are edible and common in Chinese cuisine.
Below and right: Daylily Hemerocallis fulva. Photos ©2003 stevenfoster.com Platycodon Platycodon grandiflorum (Jacq.) A. DC., Campanulaceae;jie geng (root) latycodon, also known by the common names of ball oon fl ower and Chinese or Japanese bellflower, is a member of the bellflower fa mily. Its introducti on to the West is attributed to Robert Fortune P(1 81 2-1880), a Scottish botanist. He opened a new era of Western botanical explorati on of C hina in 1843. Prior to Fortune's co ll ections, most European botanical collecti ons from C hina came fro m Beijing, and coastal port cities. Fortune published several books on his Chinese ventures. 4" In the beginning of 1844, Fortune se nt ro ots of the plant to the Horticultural Society at Chiswick, introducing the first live ball oon fl ower plants to England. In his 1853 publicati on, Lindley ca ll ed balloon fl ower (under the name P chinensis) the fin es t herba ceous specimen sent by Fo rtune from China. 2 The plant is a popular ornamental in Ameri can gardens, though it is little known as a medicinal and food plant. The dried roots can be fo und in any Korea n grocery, as a soup base. In TCM it is va lued in prescriptions for throat and lung ailments, among many other uses .
Platycodon Platycodon grandiflorum. Photo ©2003 stevenfoster.com Belamcanda Belamcanda chinensis Photo ©2003 stevenfoster.com Belamcanda
Belamcanda chinensis (L.) DC., lridaceae, she gan (rhizome) elamcanda, or blackberry lily, is rh e source of the Chinese herbal ingredient she-gan (rhizo me) . Though commonly referred ro as "blackberry lil y," belamcanda is nor a lily, bur a member of the iris fam ily. Seeds of the Bplant were collected by Jesuit miss ionaries in C hina and sent ro Europe by the 1730s. It was cultiva ted in the Linnaeus botanical garden in Uppsala by 1748, and in English gardens by at least 1759. In 1802 the Swiss botanist, Augustin Pyramus de Candoll e (1 778-1841) named the plant Belamcanda chinensis. Belamcanda derives from irs East Indian name. The plant was known in Ameri can gardens as ea rl y as 1825. It had become widely naturalized in the east ern United States by the late nineteenth century. She gan is used in TCM prescriptions for swelling and pai n in the throat, and cough with asthma, among many other uses, including the sharp barking cough associated with croup.
www.herbalg ram .org 2003 HerbaiGram 58 I 49 vessels of the day. Fortune used wardian cases (solariums) to trans port the plants. Before setting sail, cuttings or plants were placed in soil within the solarium, then sealed in glass and put into a protected hold in the ship, where they would not be subjected to salt spray. In his writings, Fortune stated that "large vessels with poops" were the best means of transportation from the Orient. The "poop," or deep hold, helped to protect the plants from the elements. Much of the forsythia seen in American horticulture is a hybrid between F suspensa, which also is commonly called golden bells, and F viridissima, known as F x intermedia. They do not produce fruits. The fruits (seed capsules) have been used primarily in prescriptions for an anti-febrile and anti-inflammatory effect, both internally and externally, and as an anti-viral medicine in upper respi ratory infections. It is also used to reduce blood heat causing rashes or red eruptions. It can be used topi cally to reduce infection.
Left and below: Forsythia Forsythia suspenso. Photos ©2003 stevenfoster.com
Forsythia
Forsythia suspensa (Thunb.) Vahl., Oleaceae; /ian qiao (fruit) orsythia, a member of the olive family, is named in Fhonor of William Forsyth (1737-1804), a prominent Scottish horticulturist/botanist. Robert Fortune is credited with bringing forsythias from the East to Europe in 1844.6 In those days, trips from China to England had to go around "The Horn" of South America, and the trip rook four to five months. It was extremely difficult to transport plants under the adverse, unrefrig erated storage conditions of sai ling
50 I HerbaiGram 58 Cockscomb Celosia argentea L. var. cristata (L.) Kuntze, Amaranthaceae;ji guan hua (flower) he flaming red, orange, or yellow broad-triangular fl ower T heads of cockscomb are a fa mil iar sight in gardens throughout the world. T he fl owerhead of crested cockscomb (a cultivar, or cultivated variety not known fro m the wild) is known as ji guan hua, and is valued for its astringency. C. argentea, known as feather cockscomb or silver cockscomb (qing xiang or qing xiang zi for the seeds), co mprises a separate article of materi a medica valued for its effective ness in lowering blood press ure, among other uses . It is often planted as an ornamental annual in the West. T he first mention of the use of cockscomb seed in China is in the Divine Plow man's classic materia medica Shen Nong Ben Cao j ing (first century C.E.) . T he fl owers were said to be useful to stop bleeding and the seeds to treat eye disease; the same uses are found in India. The flower heads of C. cristata have a history of use for blood diseases, bleeding, hemorrhoids, diarrhea, and dysentery. How it was introduced to the West is unclear.
Above and left: Cockscomb Celosia argen· rea. Photos ©2003 stevenfoster.com
HerbaiGram 58 I 51 Peony
Tree peony (Paeonia suffruticosa Andrews, syn. P. mouton Sims, Paeoniaceae), mu dan; or Chinese peony (P./actiflora Pall., syn. P. albiflora Pall.), shoo yao eonies have been cultivated as ornamentals in C hina since about 900 B. C.E. There are two well-known ornamentals in the gen us PPaeonia. The roots of both species are famous medicines in C hinese tradition. Tree peony produces an official drug of the C hinese pharma copeia, mu dan pi (root bark). Chinese peony is common in American gardens. It produces two distinct herbal drugs bai shao (root without bark} , and chi shao (root with bark). The common garden peony - sporting white, red , or pink flowers - is among the most popular and widely grown of garden perennials throughout the Northern H emi sphere. Peonies are thought to have been introduced to European gardens from Siberia as ea rly as 1558. By 1805 P lactiflora was known in English gardens, introduced by Sir Joseph Banks (1743- 1820). In Western terms bai shao is considered analges ic, spasmolytic, diuretic, antibiotic, promotes circul ation, and has emmenagogue, sedative, and anti-inflam matory properties. It is primarily used to cool the liver while promoting blood circulation, and rhus aids the liver in its detoxify ing function. It is one of the most often used C hinese medicinal plants. Above: Peony Paeonia suffruticosa. Photos ©2003 stevenfoster.com
Steven Foster, president ofSteven Foster Group, Inc., is an author, photographer, and consultant specializing in medicinal and aromatic plants.
Reference: 5. Fortune R. Residence Among the Chinese: Inland, on the Coast, and at I. Bensky D, Gamble A. Chinese Herbal Medicine: Materia Medica. Seat Sea: Being a Narrative ofScenes and Adventures During a Third Visit to tl e, WA: Eastland Press; 1986. China, from 1853 to 1856 Including notices of many natural produc 2. Foster S, Yue CX. Herbal Emissaries: Bringing Chinese Herbs to the tions and works of arts, the culture ofsilk, etc. London: John Murray; West. Rochester, YT: H ea ling Arrs Press; 1992. 1857. 3. Hu SY. An Ea rl y History of Daylil y. American Ho rticultural Magazine 6. Wyman D. The Forsythias. Arnoldia 1950;10(2}:9-1 6. Sp ring 1968;47(2):51-85. 7. Bretschneider E. History ofEuropean Botanical Discoveries in China. 2 4. Fortune R. Tzuo Visits to the Tea Countries ofChina and the British Tea vols. (reprint 198 1) Leipzig: Zenrrai-Anriquariat der Deutsch en Plantations in the Himalaya: With a Narrative ofAdventures and a Full Demokratischen Republik; 1898. Description ofthe Culture ofthe Tea Plant, the Agriculture, Horticulture, 8. Needham J, Lu G O, Huang HT. Science and Civilization in China and Botany of China. London: John Murray; 1853. Vol. 6. Biology and Biological Technology Part 1: Botany. Cambridge: Cambridge University Press; 1986.
52 I HerbaiGram 58 2003 www.herbalgram.org Symposium 2003 American Herbalists Guild
October 17-19, 2003 Preconference intensives will be held on October 16
La Posada de Albuquerque, New Mexico
Keynote Speaker Tieraona LowDog, M.D.
Over 40 workshops by leading herbalists. Teachers include: Mary Bove NEW!!! 2-DAY POST-CONFERENCE Francis Brinker Isla Burgess CLINICAL INTENSIVE. Bevin Clare OCTOBER 20 & 21. Mitch Coven Improve your clinical skills and gain valuable Steven Dentali hands-on experience. Special opportunity Robin Dipasquale for in-depth study with AHG teachers. Margi Flint Daniel Gagnon Continuing education Christopher Hobbs Phyllis Hogan credits for nurses, KP Khalsa pharmacists, Brigitte Mars acupuncturists, Michael Moore Aviva Romm and naturopathic Robert Rountree physicians. Brant Secunda James Snow For information contact: Kevin Spelman AHG Jill Stansbury 1931 Gaddis Rd Shelley Torgove Canton GA 30115 Jonathan Treasure Roy Upton 770.751.6021 fax: 770.751 .7472 David Winston Donald Yance email: [email protected] and many others. www.americanherbalist.com Some Arguments against the Standardization of Herbalists
BY STEPHEN HARROD BUHNER
Editor's note: For years, the herbal community has hotly debated of medieval Europe. Guilds, he remarks, existed for three reasons: the issue of regulating, licensing, certifYing, or "standardizing" money, power, and control. They restricted entry into certain areas its practitioners. An earlier issue ofHerba!Gram presented one of trade, they allowed more money to flow to those working in the side ofthought on this complicated issue; here the author devel restricted areas of trade, and they concentrated power in the hands ops a competing body ofargument to the "accepted wisdom" that of a few. regulation results in positive outcomes for profissions and Friedman is not alone in questioning whether or not the consumers. publicly stated goals of these groups - protecting the consumer and raising quality (of either product or practitioner) - are actu he drive by some segments of rhe herb community to ally mer. Increasingly, studies show that there is little or no relation begin certification for herbalists is a parallel move between licensure or certification, consumer protection, and ment to rhe standardizati on of plant medicines - a higher standards. way of standardizing herbali st practitioners. It is The lack of relationship is possibly due to the reasons why licen accompanied by the same arguments sure or certification is pursued. It is very rare that Tput forward in support of standardizing herbs - consumers themselves initiate licensure or certifica to protect the consumer and raise quality. There is tion processes. T he drive for licensure and certifi evidence rhar such an approach to herbal practice Guest cation is nearly always begun by the to-be-licensed will nor produce rhe outcomes that proponents groups. The underlying reason has been found to assert. Commentary be universal, irrespective of trade - the desire to Milton Friedman comments succinctly in carve out protected territory in which they can Capitalism and Freedom 1 that the overthrow of the practice either uninhibited or without competition European guild system was indispensable to the rise of freedom in - in other words, protecting turf and increasing income. 2·4 And the Western world. Ir allowed everyone to pursue whichever trade restrictive legislation does seem to provide rhis: studies show that they desired; the huge surge in the development of new knowl professional incomes generally double after stare regulation is insri edge, rhe growth of an entrepreneurial society, was completely rured. 5·6 dependent on this freedom to explore, cross boundaries, and blend An essential point about herbal certification is that there is no disparate information and skills. He argues convincingly that demand by consumers - no clarion call - for legislation protect li censure and certification are simply a return to the guild system ing them from inadequately trained practitioners.* The call comes,
*An Herba/Gram reviewer commented on thi s point, I would agree that in The author responded, Canadian activity has no place in this discus many cases the call comes from the practitioners themselves, but th ere is a sion. I co uld just as wel l eire Mexican population desires and concerns in clear public demand for regulation roo. For example, the White House response and it would have as much relevance. The reviewer cites the Commiss ion on Complementary and Alternative Medicine Policy found WHC on CAM, whi ch "found that Am eri ca ns want assurances that CAM that Americans want assurances that CAM practitioners are qualified/ In a practitioners are qualified." This statement actually means nothing. 1997 CTV/Angus Reid Group poll of I ,200 Canadian adults, 67 percent Havi ng lobbied ex tensively for five years on just these kinds of issues, I am agreed with the statement that "The government should regulate altern a we ll awa re that these kinds of statements by committees are highly tive medicines and practices in the same way that they regulate other drugs suspect, espec ially in the United States in this area of practice. How was and practices to make sure they are safe and really do what it is they claimed the question worded? How many people were intervi ewed? What were the they will do."8 Many witnesses before the Canadian Parliamentary Stand biases of the questioners? Who co nducted the survey? Nevertheless, unlike ing Committee on Health "were concerned at the lack of appropriate and other areas of co ncern , such as inappropriate sexual contact between consistent training and education for practitioners using natural health priests or psychotherapists and clients, where a clear clarion call for reform products. Because there is little standardization among provinces in their exists, such a clarion call does not exist here. Other than by competing approaches to registering herbalists, homeopaths, naturopaths, consumers medical professio ns or from within the herbal community itself, there is have no assu rance of common standards of practice."9 In Britain as well, a no organized political activity calling for regulation of herbalists on the parliamentary committee found that "high quality, accredited training of part of co nsumers in order th at they might be better protected from harm. practitioners in the principal CAM disciplines is viral in ensuring that the For the reviewer to be accurate about this concern here, clear evidence of public are protected from incompetent and dangerous practitioners." 10 a co nsumer group (co ntaining, as it always will , harmed members) actively Thus, there is ample evidence that consumers do want legislation protect lobbying for herbalist regulation would need to be provided. ing them from inadequately trained practitioners.
54 I HerbaiGram 58 2003 www.herbalgram .org as it historically seems to do, from rhe practitioners themselves, in There is nor, however, a lor of empirical data that supports this this instance, a particular type of herbal practitioner- the rational ass umption as accurate." 14(pii l The state of Colorado rook a unique phytotherapists or "science-based" clinicians. But does certification approach to solving the problem: it decided to allow anyo ne who or li censure of these kinds of groups actually result in better care, wishes to do so to practice as a psychotherapist. To protect the consumer protection and higher standards of practice? A century public it instituted, instead of licensure or certification, a compre of such laws finds that it does not. hensive process of informed consent backed by a regulatory board Numerous articles and studies have appeared over the past three ro hear complaints of harmt decades commenting on the healthcare crisis in the United States. There are increasing reasons to apply the Colorado findings to Rising costs, poor or no care for certain groups, delays in even the licensing of physicians and other health care practitioners. minimal services for the ill have all illustrated the need for health Studies continue to show that the licensure of medicine has care reforms. A number of studies have resulted in the very same outcomes examined whether or nor regulation of found in other fields - poorer care, healthcare workers has any relationship higher prices, less innovation, and stri to these problems. One Iowa study But does certification or dent protectionism. l.4.JJ.Jo.J7 found that while medical licensure was licensure of these kinds of The extensive education and training originally established for the purported required of physicians does not actually purpose of raising the quality of care for groups actually result in better seem to eliminate patient harm. A land the ill, the actual result was a decreased care, consumer protection and mark study commissioned by the Insti availability of services, especially for the tute of Medicine's Committee on Qual poor. 11 higher standards of practice? ity of Health Care in America found Neither do these types of regulations A century of such laws finds physician error to be rampant. The seem to protect consumers from harm. study estimated that between 44,000 A U.S. Federal Trade Commission that it does not. and 98 ,000 people die each year from study on regulation of the television medical errors. The authors of the report repair industry found that the incidence concluded that their figures are almost of consumer harm was unrelated to regulation; levels of harm certainly conservative. 18 An additional study, reported in the jour remained the same irrespective of comprehensive licensing laws nal of the American Medical Association, showed that some 300 designed to protect consumers. Prices, however, were significantly people are killed every day by properly prescribed and adminis higher. Simil ar studies have shown that levels of real estate fraud tered pharmaceuticals. Nearly 7,000 people per day are hospital and consumer harm are unrelated to the licensure of real estate ized or permanently disa bled by those same drugs. 19 While it agents. 12 A U.S. Bureau of Economics study of seven licensed might be argued rhat physicians have little control over the impact professions noted that "While a few studies indicate that higher of pharmaceuticals on their clients, that it is a U.S. Food and Drug quality levels may result from such licensing restrictions, a major Administration issue, it is in fact the physicians that ac tually ity of the work to date finds quality to be unaffected by licensing prescribe the drugs and death and disability from pharmaceuticals or business practice restrictions associated with li censing. In some is rightly viewed as an iatrogenic, or doctor-caused, disease.* cases quality actually decreases." The study found that restrictions In-depth knowledge of a "science-based Western" approach to the on professional practice - in all cases - were ultimately detri human body and illness does not, in practice, seem to necessarily mental to consumers. 13 produce safer outcomes or competent practice. In part this is C loser to herbalism perhaps, laws regulating psychologists have because many of the areas that physicians must now study have not not been found to protect consumers from harm. The reform legis lation eventually instituted in Colorado occurred not because there 1 A reviewer commented, clearly there are problems with rhe delivery of were no laws in place to protect consumers but because existing conventional health care and the toxicity of conventional drugs. However, licensure laws did not do what legislators were told they would to equate this with a need for deregulation is a non sequitur. What when passed. In revisiting the issue Colorado's Department of evidence shows rhar this would nor make a bad situation much worse? Regulatory Agencies noted that licensure did not effectively The author replied, deregulation is nor the same as nor protecting the prevent harm and further found that there was, in fact, no relation public, which the reviewer here seems to equate with deregulation. I make between training and competence. "Traditional licensing theory," a different point, arguing rhe benefits of deregulation with strong co nsumer protection - stronger protection actually than rhar which is they commented, "assumes that competent practice is derived from currently in place. Significant evidence shows that medical technology has the educational base, the skills development and the supervised little to do with the increase in rhe average life span of Americans rhar experi ence that licensees must demonstrate prior to licensure. mosr studies show - authors generally lay ir at rhe feet of better sanita tion more ofren than nor. There is evidence that rhe leadi ng cause of death in 1900 was medical intervention; I don't think the situation has changed tA reviewer asked what jurisdiction does a regulatory board have if the all th at much: medical errors, deaths from antibiotic resistant bacteria, practitioners are nor regulated? The only recourse would be bad publicity pharmaceutical side effects, and other related factors, when all taken and/or civil litigation. together, could conceivably put medicine as the leading or second leading The author replied that in this approach to protecting the consumer, ca use of death in the United Stares. There is, however, nor a lor of serious the regulatory boards cannot interfere with who practices or what they study in this area. This is nor to say that medicine is nor a crucial compo practice, but can only intervene if there is a complaint of harm. While nent of any healrhcare system. Rather rhar the same rigorous scientific there are problems, as usual political ones from competing groups who inquiry into and evaluation of medical outcomes and impacts rhar are influence board policy and actions, in how the board in Colorado fulfills app lied ro other systems must be applied to conventional medicine; it irs function, it has a great many powers at irs command (e.g., prohibiting makes no scientific sense to judge medicine by irs successes and all other practice or requiring certain courses of study) in order to protect systems by their failures. It, roo , must be judged by irs successes and fail consumers in the event of complaints of harm. The board does nor regu ures. The current drive for medical reform, wh ich does enjoy a strong late practice, bur only acts to protect consumers in event of complaint and consumer base, is an attempt to develop other approaches that can allevi a subsequent finding that harm actually did occur. ate the current levels of medical harm. www.herbalgram.org 2003 HerbaiGram 58 I 55 come our of what they have found they need , but from licensure certification is not intended to be state sanctioned but is merely boards that set standards for physicians and the schools they attend. voluntary. This approach, outlined in Kathy Abascal's and Eri c T his is common in any field where licensure or certification occurs. Yarnell 's article "Certify ing Skill in Medicinal Plant Use" in Once a regul atory law is passed , a board is appointed to oversee Herba!Gram 5220 is, in actuali ty, no better than state li censure, and the implementati on of the law. These boards are generall y indeed, is only a prelude to it. It will, voluntary or not, possess the composed of members of the professional group being regul ated same problems that state certification has been found to have for it - for they are generally more aware of and motivated about the is, in general, being pursued for the sa me reasons. needs of the profession than the general public. There may or may H erbal certification in, as Abascal and Yarnell describe it, a not be one or two consumer members of the board. Over time, the "science-based, Western sys tem of botanical medicine" is being boards set more and more complex educati onal and tes ting promoted as a mea ns to protect the consumer and raise the stan requirements fo r those seeking li censure or certification. 16 Fri ed dards of the profession - things which certification (a nd even man has some succinct comments abour the li ce nsure of barbers as li censure) has ge nerall y been found incapable of doing. It is also an example of this. being pursued, as Aviva Romm, the American H erbalists G uild All potential barbers must attend a school for barbering, then (AHG) president, puts it in a response to a Letter to the Editor in participate in an internship. They must show proficiency in "the Herba!Gram 54,21 so that "those wishing to practice herbali sm in scientific fundamentals of barbering, hygiene, bacteriology, histol increasingly public venues such as hospitals and clinics" can do so. ogy of the hair, skin, nails, muscles and nerves, structure of the It has to do with gaining a legally recognized status so that herbal head, face and neck, elementary chemistry relating to sterilization ists can continue to practice, with getting into and becoming a part and antiseptics, d isease of the skin, hair, glands and nails, haircut of the American healthcare system of hospitals, referrals, and insur ting, shaving, arranging, dressing, coloring, bleaching, and tinting ance. If it were only about protecting the people who need herbs of the hair." 1(P 142l There is little evidence that the majority of these for their medicine and making sure they have access to the bes t areas of study actually produce a better barber or are even rel ated quali ty of health care, there are other options available from which to barbering. T hey do support an increas ingly complex education to choose, options that have acruall y been found to decrease prices, industry that provides both the initial education and continuing protect the public, and enhance health care. education credits (CEUs) aft erward. N o studies confirm the beli ef While a careful reading of the writings by those arguing for certi that CEUs enhance practitioner competence.§ For example, Morri fi cati on reveals an escalating argument for consumer protection, son notes, "Nati onal organizations in pharmacy have also pressed there is, in fact, little harm from herbs, even in the hands of inex for continuing education credits in each state using material peri enced practitioners. Herbalism is a ve ry safe modali ty. In approved by the American Council on Pharmaceutical Educati on, contrast to deaths fro m pharmaceuticals, deaths from appro pri despite criticism that these requirements bear little relationship to atel y taken herbal medicines are es timated to be one per year.22 what pharmacists need to enhance their actual competence in Other herbal deaths, es timated to be approximately 50 per year, are practice. " 16 T hese increasingly complex regulations do increase mostly attributed to the improper use of ephedra (Ephedra sinica prices to the consumer and prevent people who want to approach Stapf., Ephedraceae) as a weight-loss aid or energy booster. 23 (The barbering from a different orientati on from entering the field and popular use of ephedra for weight loss and energy is a separate iss ue creating alternatives. and one that should be dealt with through other, ex isting product Economists such as Milton Friedman make an important point: regul atory channels. It is unrelated to the regulation of herbal prac prices are always lower and consumer protection higher in the titioners.) Again , this can be addressed by much less intrusive presence of the least intrusive government regulation. This is means than certification. because the fi eld remains open to innovative outsiders, to cross In their article, Abascal and Yarnell argue that government regu mixing between disciplines, and to competitive pricing. Just what lators and media opposition to herbs and herbalism will be quieted produces the bes t training and knowledge base (and hence by a voluntary certification program. They cite no srudies or outcomes) is left open to those who feel compelled to work in the his torical circumstances that support these assertions. H owever, field to discover. the actual nature of state government indicates that this assertion T hose arguing for the certification of herbali sts might insist that is quite likely incorrec t. (I ndeed , Richard Morrison, former Exec utive Director of the Virginia board of H ealth Professions and an ex pert on this issue, comments that "the existence of private certi §An Herba/Cram reviewer co mmented, the enh ancement of practitioner fi cati on has not stemmed the growth of li censure or government co mpetence is proportional to rhe amount of rraining they rece ive, so, yes, certificati on programs for allied health occupations.") 1G( p3l if they get only three hours of insrr ucrion in herbal medi cin e, th ey cannot Fo r herbali sts to practice in hospital settings, with doctors, learn very much. At least CEU instruction ca n create an awareness of accorded the same res pect and practi ce rights, to eas il y receive some of rhe issues and help them to learn where to go for further infor referrals, to ge t in to the healthcare sys tem as an equal player mation as rhe need arises. The author rep li ed, rhe statement about practitioner co mpetence bein g usuall y necessitates state recognition. As herbalism gains more visi proportional ro rhe amount of trainin g is speculation and belief, not some bility (much like midwifery or Traditional C hinese Medicine), thi ng supported by study or rrial. In fact, co mprehensive studies in the each state will sooner or later feel compelled to deal with it as a fiel d of psychotherapy have shown that there is no clear relati onship practice category. So me states will keep it strongly ill egal - much between competence and training. In fact, some studies have shown th at as many do now with naturopathic practice. Some will all ow the more training a pract itioner possesses, rhe wo rse their competence. limited practice, some will allow only those licensed in some other T his is why both Colorado and Washington Stare no longer require any category to practice it: acupuncturists, midwives, and so on. Some training to work as a psychotherapist. I would suggest that there may be will legalize it through some form of registration, certification, or factors much more important than amount of training in producing co mpetence in herbalists (and psychotherapists), a calling to the profes licensure. Trade regulati on is a primary area of state control and sion bei ng one. Intelligence another, integri ty anoth er, and empathy oversight and the states control it jealously. Lobbyists in this field another. Zero raised to the nth power is still zero; training in and of itself exist to convince state legislatures to all ow uncontrolled practice by will nor produce co mpetence. specific groups or conversely to pass licensure/certification laws
56 I HerbaiGram 58 2003 www.herbalgram.org enabling certain groups ro practice or receive insurance. The To help prevent this it only makes sense, if all approaches ro assumption that the states will give up this power simply because a herbalism are to be protected, to begin with a certification that is trade group has instituted voluntary not limited in scope. certification is seemingly naive and There are very real problems inherent hisrorically inaccurate. The assumption that in proposals ro restrict certification ro Proponents of voluntary certification the states will give up only a "science-based, Western system want herbalists ro be able ro practice of botanical medicine." There are legally within the existing medical this power simply because a numerous approaches to herbal practice system. Nothin g can allow that ro trade group has instituted in the United States - an obvious happen except state-recognized status, question is why this particular restric for it is only the state that can grant the voluntary certification is tion? Why not choose a wise woman or right of practice- especially since most seemingly naive and even community herbali st approach for existing medical practice statutes restrict certification? Obviously, the reason is exactly this type of work. Voluntary historically inaccurate. that a "science-based, Western system of certification is therefore only a prelude botanical medicine" is somehow to state regulation for herbali sts. Once states begin to accept the considered to possess more value, to more accurately describe and certification of herbalists, only the certification proponents' prepare practitioners for the treatment of disease, or, perhaps, to be approach of a "science-based, Western system of botanical medi more acceptable to those who control access to the existing health cine" is likely to be put forward as a model for herbal training." care system. The Botanical Medical Association (BMA) and the American But a "science-based, Western" model is itself problematic as a Herbalists Guild, by authoring the certification process, put them primary model - is it really the most accurate approach or is it selves in position to approach legislatures with this particular plat only one approach? There is a bias among groups seeking licensure form- indeed Yarnell's and Abascal's article insists that working in favor of awarding a special onrological status or fundamental with government regulators is a primary reason for certification. reality ro the elementary panicles discovered by physicists and an Because the certification system emphasizes Western scientific attempt ro emulate that orientation in other scientific and healing approaches, the state legislatures that adopt it will tend to restrict disciplines. There is an inherent belief that the understanding of practice to herbalists trained in that system; nothing in the the physicality and interrelationship of matter in its tiniest realms proposed certification testing supports the practice, for instance, of somehow connects people more successfully ro reality than other wise woman or community folk practitioners who use alternate approaches. A "science-based, Western sys tem" is generally paradigms. T hose who use other approaches will - based on how assumed to get people closer to the way things "really" are and states have historically responded to this kind of industry certifica therefore to possess more value than other approaches. Underneath tion- most likely be marginalized or denied the right to practice. this belief is another, deeper assumption that the use of such a system will result in sufficient understanding to allow effective control over nature and disease. In consequence, it is given a kind • An HerbaLGram reviewer commented, certification of naturopathy and Traditional Chinese Medicine (TCM) practitioners is already occurring, of first ranking in the hierarchy of approaches to disease descrip 2 261 11 82 1 and orher CAM modalities are becoming more accepted. American , tion and rreatment. + PP · Other approaches, such as wise Canadian, and British researchers and practitioners from many different woman or folk herbalism, appear, from this perspective, more conventional and CAM healthca re sys tems held an "International Work "fuzzy," less accurate, not as valuable or real. But does such physi shop on Research Methods for rhe Investigation of CAM Whole Systems" cali st reductionism really get us closer ro reality? Consistent (Vancouver, BC, October 20-21, 2002) to deal with questions of appro research over the past five decades increasingly indicates that it priate types of research on CAM systems to facil itate greater mutual does not. understanding, cooperation, and co llaboration. The danger in one school of herbalism designating "science The author replied, TCM is becoming more accepted because a based Western botanical medicine" as that most proper for certifi number of irs practitioners went to court ro force legal recognition . Because of a fairly unique and land mark decision in a Texas case, wherein cation is that, through their parallel drive to cerrify educational rhe judge found rhar rhe law in question did nor actually support rhe training programs for herbalists, this one perspective will begin ro health, safety, and welfare of rhe people of rh e stare of Texas (all laws must eclipse other paradigms. There is also a very real danger of finan pass rhis primary test to be enacted by a state legislature) to prohibit the cial conflicts of interest. Historically, those who own the educa practice of acupuncture by a TCM practitioner with decades of training tional institutions or have financial stakes in them are also those and allow it of a physician with a weekend's experience, a legal precedent who design the educational criteria for li censure or certification. was established that, along with other court cases in other states, made it Studies show that the exams des igned for licensure or certification clear that the states co uld not restrict practice in this particular field. That the system in question is highly formalized, from another culture, very testing are often influenced by special interest groups within old, and that it is used by a large As ian immigrant population in this professional organizations, by education committees with financial country also supported its emergence as a unique discipline. However, interests in the types of tests designed, or by industry seeking ro without aggressive litigation on the parr of alternative practitioners TCM promote a specific approach to practice. 16 would not be as legal as it is. In spite of this it is not difficult to find Herbalists at this juncture possess a unique opportunity to not acupuncrure, herbs, chiropractic, and other alternative healing modalities only help heal those who come ro them, but ro also work for a cure identified as quackery or dangerously unproven pseudoscience in medical for the medical system put in place a century ago by conven literature or on medical internet sites. See, for example, 58 I HerbaiGram 58 2003 www.herbalgram.org GUEST COMMENTARY Industry Needs to Re-think DSHEA Leaders Must Address the Realities of a Post-DSHEA World by Looking in the Mirror by Loren D. Israelsen and Thomas D. A arts he Dietary Supplement Health and Education Act of 1994 (DSHEA) became law nearly nine years ago amid high hopes among many in the herb and dietary supplement industries that many ofthe regulatory barriers to growth and the overreaching and restric tive policies of the U.S. Food and Drug Administration (FDA) were things of the past. Prospects for increased consumer access to T supplements and long-term expansion and sustainable markets seemed assured. Fast-forward a decade, and the reali ty is could do more ro change the industry than American Botanical Council (A BC) since far less rosy: OSHEA is under arrack from eve n regulatory change) likely contributed it published the English translations of many fronts and irs future uncertain, as is to this decision, and probably represent risk Germany's Commission E monographs. 3· 4 the future of the dietary supplement and reduction concerns for numerous other Several industry groups responded appro herb industry. The industry is in crisis, due companies. Unfortunately, merely defend priately, including the American H erbal mainly ro the following factors: lack of ing OSHEA will nor save the supplement Products Association {AHPA) President effective self-regulation, greater ri sks of industry. In the December 19, 2002, issue Michael McGuffin {in a December 3 1, doing business, self-destructive behavior, of rhe New England j ournal ofMedicine, rwo 2002, Ietner), criticizing so me of the and, most importantly, erosion of consumer articles were published with familiar tides errors in the article and noting that confidence. and rel ated themes: "Herbal medicines: OSHEA has adequate authority to deal The crisis is captured in a recent press what's in the borrle?" 1 and "Botani cal medi with most of these iss ues. 5 Nevertheless, release iss ued by a well-known dietary cines: the need for new regularions. "2 an appropriate response must also include supplement company as parr of irs U.S. The latter article, authored by rwo action from responsible members of the Securities and Exchange Commisson M .D .s, called for six changes to the regula herb industry. forward-looking statement disclaimers. In tory system: addition to the standard risks and liabilities 1) mandatory registration of all supple Facing Up to Reality the disclaimer referred ro new risks and ment manufacrurers with the FDA; How did the industry devolve from seem costs illustrative of virtually the entire 2) following Good Manufacturing Prac ingly boundless potential ro being besieged? dietary supplement industry. These new tices {GMPs) and allowing FDA ro More importantly, what can the responsible risks include: inspect records (the editorial erro members of industry do ro secure their • Slow-to-negative growth in the indus neously and outrageously stated that future? try; "the botanical industry has consistently We believe that five key realities must be • Adverse publicity; blocked" the publicati on of GMPs!); addressed: • Adequacy and availability of insurance 3) pre-market approval of evidence show 1) Defending OSHEA will nor save the coverage {parricularly for ephedra ing rhar products "present no substan supplement industry; containing products); tial/unreasonable risk of injury"; 2) Discipline, not regulation, will create a • Exposure to and expense of resolving 4) reporting all adverse events ro the sustainable marketplace; product li ability claims and other liti FDA; 3) Popular political support has eroded; gation; and 5) unambiguous labeling of ingredients 4) Too many companies are competing • Limitations on future fin ancing and interactions; and for roo few customers; (i ncreases in the cost of borrowing and 6) convening U.S. Department of Health 5) Negative media are a symptom, bur unavailability of capital). and Human Services expert panels to not necessarily the problem. Like certain other manufacrurers, the review the safety of all dietary supple company that published these disclaimers ments except essential nutrients and Reality #1: Defending OSHEA Will recently said it would discontinue ephedra single/multivitamins. Not Save the Supplement Industry products. Spiraling insurance costs, plus the This last proposal is similar to the one There is growing discussion that the risk of product liability claims {risks that suggested repeatedly by the nonprofit nex t great challenge will be defending www.herbalgram.org 2003 HerbaiGram 58 I 59 O SH EA in Congress . H owever, defense of name. It is the FDA's selective enforcement, mi ry to the common names of commercial O SH EA should not be a defense of the or failure to enforce, that gives the appear herb products; its Botanical Safety Hand industry's misdeeds, but it should recog ance that the industry is unregul ated. In book, IS its attempt to provide rati onal guid nize its fa ilure to abide by the principles fac t, this is an industry that has been ance of safety information for herb product laid down by OSH EA. T he chall enge is to begging for GMP regul ations for over 8 labels (although the degree of irs members' build on the fou ndation of OSH EA; this yea rs." co mpliance to these guidelines might merit means accepting the need for modifica We believe that the FDA's fa ilure to further study); and numerous other iniria ti o ns to industry's treasured law in the enforce should be addressed by the new ti ves.16 interest of all parties. A zealous, unthink Commiss ioner before he throws too many ing defense will li kely fa il and onl y sharpen stones. H owever, it is also sel f- deception to Reality #3: Popular Political Support cri tics' resolve to force an eve n greater believe that more regul ation alone will Has Eroded overh aul, or possibly a repeal. res tore order and public confidence. W ith Histori call y, th e supplement industry has T he fact is we already li ve in a post the rules already on the books widely been economica lly insignificant but politi D SH EA world. Passage of the Public regarded as adequate, what is urgently cally powerful. T he consumer base upon H ealth, Security and Bi oterrorism needed is the will to self-regul ate. The whi ch it relied as a political buffer was ideo Preparedness and Res ponse Act of 2002 supplement industry does not have the logically driven by a belief in natural self (particul arly T itle 3 - Protecting Safety and time or luxury to beli eve that the publica care and a des ire for self-reliance. T his is Security of Food and Drug Supply) grants ti on of the long-awaited new GMPs alone why consumers shop at health food stores FDA broad new powe rs to stop "suspi will solve quali ty problems. For too long, and why they react to any threat to fre e cious" goods from entering the co untry, the eventual publication of the new dietary choice or access to supplements. The inspection of food facil ities and access to supplement G MPs has bee n heralded by supplement industry of 2003 looks very company facili ty registratio n records. This so me as if they we re a panacea that would di ffe rent. Ownership has shifted fro m law specifica ll y includes the supplement lift the industry out of the morass of the private to public, and management from industry and, when implemented by late- quali ty control problems that are repeat entrepreneur/founders to professional exec 2003, could have profound implications edly reported in the media. While it is clear utives. As a res ult, the industry has replaced fo r products that may have poss ible that more stringe nt G MPs have bee n idealism and acti vism with profit goals and contaminati on iss ues, such as needed - particul arl y in order to increase ri sk ave rsion and some of the fo rmer herbal/botanical ingredients. 6·7 In addition, the minimum standards that are required perso nal and professional relationships are the FDA's Final Regul ations on Struc for those manufac turers who have not yet at least one generation removed from many ture/Functi on C laims iss ued in January vo luntaril y increased their G MPs to a level of the founders of what has evolved into the 2000 stripped away manufact urers' ability consistent with (or higher than) the modern dietary supplement/herb industry. to promote the benefits of key categori es proposed G MPs that have just bee n like all ergy, cold and flu , blood press ure published by FDN - it is still poss ible to Reality #4:Too Many Companies and cholesterol management. In short, produce poor quali ty products in a G MP Compete for Too Few Customers much of the world that the industry approved facili ty. GMPs are onl y parr of OSH EA was the "big bang" for the thought it had created through O SH EA no the answer. T hey do not guarantee high di etary supplements industry. T he sudden longer exists. quality products. confirmati on of the industry's existence OSHEA cannot bring order to the indus (and legitimacy) caused a chai n reaction of Reality #2: Discipline, Not try; it was never intended to do so. The capital investment, distributor and retail er Regulation, Will Sustain the Market purpose of OSHEA was at least twofold: expansion, positive news coverage and, It is truly a myth that the supplement First, it was intended to help assure above all, a supreme sense of self-confi industry is unregul ated - a myth that has consumers' access to dietary supplements dence. In all of this, the industry, like other been extensively debunked in a previous and to increase the informati on on how to industries (e.g., relecom and dot.com), iss ue of Herba/Gram. 8 In fac t, many indus use them responsibly (hence the inclusion fo rgo t the big iss ue: Don't lose yo ur try obse rvers beli eve that there are plenty of of "Educati on" in the ride of the Act). consumer on the way to the bank. T he regul ati ons that have, for one reason or Second, it was designed to correct the industry made its move to the mass market, another, not bee n adequately enforced by former behavi or and excesses of the FDA but did not truly capture the mainstream. the FDA. Congress man Frank Pall one (D (e.g., the Black C urrant O il Case10·12), T here are now fa r fewer committed NJ) pointed this our agai n in a strongly whi ch it did with alacri ty and astonishing consumers than this industry needs, and the worded letter to the new FDA Commis force. Just as the dietary supplements indus industry has fall en into the unfortunate sioner Mark McClell an, M .D ., Ph.D ., on try demanded that FDA be hel d account habit of drivin g away those that remain December 20, 2002, in res ponse to recent abl e, so also it is now being held to account. with public embarrass ments over quali ty statements. Pall one wrote, "T he agency's Self-regulati on is the shorr-rerm answer to and safety of its products, herb/drug inter actions and omiss ions to act (in spite of the barrage of publi c cri ticisms and sin king action concern s, and unsubstantiated industry's repeated requests fo r guidance consumer confidence- and if the industry cl aims. Since the beginning of the year, we and cooperation), contribute to the myth doesn't show a willingness to do it, the FDA have each received hundreds of unsolicited that the industry is unregul ated, add fuel to and others will. email offers to reduce our weight by 20 the recent controversy regarding the use of T his is not to say that self-regul atory percent, reverse the aging process by 50 certai n dietary supplements and do a initiatives have not been attempted. For perce nt, or ex pand the size of our male disse rvice to the American consumer .. .. example, in the domain of herbs AHPA has organs by 100 percent. Fueled by low barri T he industry desires appro priate enforce initiated numerous self-regul atory ers to entry, the industry is quite simply too ment acti on to rid the market of unscrupu programs, including two editions of irs big for its consumer base. Manufac turers lous players that give the industry a bad Herbs of Commerce13·14 that bring unifor- and marketers operate in a maturing indus- 60 I HerbaiGram 58 2003 www.herbalgram.org try knocked off-kilter by consumer confu the Council for Res po nsible N utritio n, and Reference: sion and lack of confidence in product qual legal counsel , which formed a tas k fo rce to I. Straus S. Herbal medicin es: what's in the ity, safety, and efficacy. Until a state of equi address quali ty standards. T his culminated borde' N Eng J Med Decembe r 19, 2002;347(25): 1997-8. librium is regained , the industry must in a voluntary mo nograph fo r labeling and 2. Ma rcus DM, Grollman AP Botanica l attract new customers or contract. quali ty for marine-based Omega-3 prod medi cines: the need fo r new regulations. N As a political, economic, and regulatory ucts. The program went into effect Jan. 1, Eng j Med Dec. I 9, 2002;347(25):2073-6. initiati ve, OSHEA dissipated most of its 2003 (see 62 I HerbaiGram 58 2003 www.herbalgram.org Proposed Regulation Overview incorporate the principles underlying those of DSHEA, FDA attempted to regulate Scope. The proposed GMP regulations terms. It is primarily the documentation various herbal ingredients as "food addi will cover the fo llowing areas related to the element that differentiates these aspects of tives" instead of foods. Food is generally manufacturing, packaging or holding of the proposed regulation from drug GMPs. deemed safe and does not require pre dietary ingredients or dietary supplements: The proposal also avoids the documenta market approval from FDA, but food addi design and construction of manufacturing tion requirements for certain operations tives do; they are considered unsafe until facilities, equipment and utensils, produc that would be required under drug GMPs, their safery is proven. FDA applied this tion and process controls, testing, packag but requests comment on the extent to rationale against black currant seed oil ing and labeling, basic holding for raw which such documentation requirements (from Ribes nigrum L. , Grossulariaceae) in a materials and finished products, the ultimately will be necessary. The omission famous case in which the agency claimed processing of GMP-related consumer of such requirements may leave some holes that the oil was unsafe due to the technical complaints, and manufacture-related record in the qualiry system. icy of its being termed a food additive and keeping, including personnel data. without any evidence to support its 8 1 Who is affected. The GMP regulations Some question contention of toxiciry. - ° FDA lost in both will apply to anyone who manufactures, whether the proposals the District and Circuit Federal courts and packages, or holds (warehousing or trans in another related case. This case was one of porting) a dietary ingredient or dietary are reasonable, feasible, the major issues presented to Congress as an supplement. It includes contractors and and economical example of misregulation and abuse of foreign firms if their products are imported authoriry by FDA during the passage of or offered for import into the U.S. , unless DSHEA. the products are being imported for further Quality control. FDA's proposal requires Although the proposal states that FDA processing and export under Section the addition of a bona fide qualiry control will have "flexible standards that can evolve 80l(d)(3) of the Act. The preamble to the (QC) group in every plant. The QC func with improvements in the state of science, proposed regulation makes clear that there tion can be performed by a single person or such as in validating tests for identiry, is no exemption for "herbalist practitioners" a group, depending upon the size of the puriry, qualiry, strength, and composition who individually manufacture herbal plant. Duties attributed to the qualiry of dietary ingredients," questions regarding dietary supplements for their clients. Such control group are similar to the qualiry the testing burden remain to be resolved. an exemption is made for a dispensing assurance duties found in the drug world. The proposal does not clarify what duties herbalist in Australia's Therapeutic Goods Certificates of analysis. The supplement different companies have in the manufac Act, so long as the herbal materials are industry has a long tradition of relying turing chain. A final regulation must make supplied by vendors who meet GMP speci upon certificates of analysis (COAs) from clear that the testing obligation falls prima fications/ The regulation does not apply to suppliers that "vouch" for dietary ingredi rily upon the manufacturer of the finished persons engaged solely in harvesting, stor ents. This system saves cost, permits compa dosage form and that only one company in age or distribution of raw agricultural nies that underpay for ingredients to claim the chain has to do the appropriate testing. commodities that will be incorporated into that they thought they were getting the Apart from manufacturers that have, to dietary supplements by other persons. correct materials, and also takes a load off date, turned a blind eye to the safery Food or drug model. The proposed manufacturers that do not wish to invest in substantiation and qualiry control analyses regulations are a mix of HACCP (Hazard QC equipment or personnel. This tradition that must be performed, the most heavily Analysis and Critical Control Point), wi ll not continue under the proposed regu impacted group will be foreign manufactur bioterrorism identification principles, and lations. These proposals impose a heavy ers. U.S. purchasers will now require a drug GMPs. FDA appears to have antici assay load on at least one company in the stronger certificate of analysis to back up pated receiving comments from some in the manufacturing chain. As with over-the the safery and qualiry standards that these industry asserting that, contrary to counter (OTC) drugs that are not the regulations impose. In addition, FDA will DSHEA, the proposed regulation is more subject of a new drug approval, the permis undoubtedly extend its existing drug like drug GMPs than food GMPs. FDA's sible degree of reliance upon COA is not inspection treaties with certain countries to preemptive response on this issue is that the spelled out in a clear fash ion. The proposed permit foreign inspections of dietary plain, dictionary meaning of "model after," regulation also makes clear that "inactive" supplement manufacturing plants by the as stated in DSHEA, suggests that FDA was ingredients or non-dietary ingredients in host country. merely required to "preliminarily pattern" dietary supplements must be identified Public comment. FDA left a number of these GMPs after food GMPs, and that, due and/or tested. The proposal reminds the issues open in the proposed regulation, to their "hybrid" nature, dietary supple industry that these ingredients can be seeking public comment on such issues as: ments have some drug-like characteristics considered unsafe food additives unless they • Recordkeeping: Although FDA did which justify a hybrid-rype GMP regula are approved as food additives or generally not propose documentation require tion. As suggested above, some of these recognized as safe (GRAS). This language ments for certain operations, it proposals are certain to generate consider causes some concern that FDA might, in required extensive documentation in able critical comments. the future, revert to its prior food additive other portions of the proposed regula The proposed regulation avoids using theories in dealing with dietary supple tions. This inconsistency appears to terms such as "validation" and "change ments. exist because of FDA's need to write control," but emphasizes concepts that Additives vs. food. Prior to the passage GMPs that did not appear "drug like." www.herbalgram.org 2003 HerbaiGram 58 I 63 FDA consistently requested comment March, Annette Dickinson, Ph.D., presi industry believes it is at significant on the extent to which it should dent of C RN, stated "FDA's release of the odds with the original intent of require recordkeeping and documenta proposed rule for GMPs signifies an impor OSHEA. tion that certain GMP requirements tant step forward in the implementation of 2. FDA staff at the meeting knew very are performed. OSHEA. We are studying the proposal and little about botanicals or non-nutrient • Expiration Dating: The proposed regu will provide meaningful comments. The products, and were unable to answer lation did not require expiration GMP rule must provide industry with a basic questions on common manufac dating, noting that stability testing financially feasible framework that results in turing issues for the OS industry. would be impossible for many ingredi high quality standards across the board for 3. FDA's economic analysis is considereed ents, including many herbs and botan the entire industry. If properly executed and by some experts to be highly inaccu icals. No requirements have been prof enforced, GMPs can go a long way towards rate. FDA has calculated that the total fered for dissolution, disintegration, or bolstering consumer confidence in our economic cost to industry is approxi biodegradability. FDA requested products." She added, "Our member mately $87 million. However, Israelsen industry comments on these iss ues. companies have great expertise in the prac says that some industry insiders esti • Distinctions based upon the type of tical aspects of producing quality dietary mate that this number could be well dietary ingredient: FDA did not make supplements. We shared this expertise with over $500 million. He wrote, "FDA distinctions based upon the type of admits this proposed rule could put as dietary ingredient. For example, it does many as several hundred companies not propose different testing require Public comment period is out of business." ments for animal-derived dietary ingre 4. FDA also said it does not believe that dients or herbs. extended to August 11 there is a basis to permit or authorize • Identity Testing: The type of identity by this GMP regulation expiration or testing required for "inactive" ingredi shelf dating for botanical and other ents needs to be clarified. Analytical FDA when we drafted the initial GMP non-nutrient supplements, because testing is not necessary for all ingredi proposed rule in 1995, and the Agency's they "have no active ingredients" and ents. Some ingredients may be tested current proposal draws heavily on that therefore it is not known how a shelf by other means. work. There are some omissions and addi life would be determined! "What When the final rules are released, they tions that require careful consideration, and makes this particularly bizarre," wrote will become effective one year from the date we will be offering constructive alternative Israelsen, "is FDA's insistence that of release for "large companies" (companies suggestions in so me areas. When all is said supplements are 'drug-like' and 'phar with more than 500 employees), two years and done, we share the mutual goal with macologically active,' which is the very for "small companies" (companies with FDA of ensuring that consumers have reason for proposing GMPs that in between 20 and 500 employees), and three access to a wide range of high quality, safe many respects are equivalent to Rx years for "very small companies" (compa and beneficial products." [prescription] drug GMPs." nies with fewer than 20 employees). It is Representatives from AHPA, the leading David Seckman, president ofNNFA, the worth noting that many responsible manu trade organization that represents solely trade group representing health food retail facturers in the herb and OS industry have herbal interests, attended one of the four ers and many supplement and natural food not waited for FDA's publication of GMPs scheduled FDA-sponsored meetings on the manufacturers and distributors, wrote to and have voluntarily increased their GMPs GMPs on April 29 at the main office of the Blumenthal on May 20, "This rule is to meet or exceed the proposed regulation. FDA's Center for Food Safety and Applied crucial to building - and, in some cases, Also, some manufacturers, because they Nutrition in College Park, Maryland. After restoring - consumer confidence in produce OTC drug products, already oper wards, AHPA president Michael McGuffin dietary supplements. However, in several ate under GMPs that exceed those required expressed concern about the process of areas we believe the approach is inappropri for conventional foods, including OS. communication with FDA over GMPs ate or excessive. For instance, the rule relies issues, noting the lack of "meaningful heavily on costly and often poorly suited Industry Response exchange" at the six-hour meeting, since testing throughout the manufacturing Industry groups unanimously greeted the most of FDA's comments were based on an process. This requirement, and several publication of the GMPs with a sense of explanation of the proposed rules, even others, would place a heavy burden on relief, although many leaders reserved final though most people attending had already small businesses. We also believe the costs of evaluation until they could wade through familiarized themselves with the proposal. 11 complying with this rule have been seri the massive document and receive Loren Israelsen, director of UNPA, a ously underestimated. In addition, we are comments from member companies. trade group representing Utah-based also very concerned about FDA's previous After review and meetings with FDA, supplement manufacturers, wrote on May 9 misguided food additive theory being some industry leaders expressed concerns about the same meeting to his members, applied here under a new guise. that the GMPs represent a drug model, and raised four major areas of concern: with more expensive, possibly excessive, 1. FDA believes that supplements are What's Next:The Final Regulations testing requirements than was intended by "drug-like" and so drug GMPs are FDA invitied comments from the general Congress in OSHEA. warranted. This is a fundamental inter public, industry, and other interested stake- When the GMPs were proposed in nal decision FDA has taken, and the Continues on page 65 64 I HerbaiGram 58 2003 www.herbalgram.org The Bioterrorism Act: Overview and Implications for Industry by Paul D. Rubin interpretation of these legal requiremem s. requires FDA to iss ue regul ati ons, but does FDA has summari zed some of these provi not specify a deadli ne. n the aft:ermath of the evems of Septem sions as foll ows: As of the writing of this article (March Iber I 1, 2001 , C ongress recognized the I. Debarment -T his authorizes FDA to 2003), FDA has already iss ued the proposed need ro enhance the security of the U .S . debar (prohibit fro m importing food) rules fo r the registration and prior notice food supply. On June 12, 2002, Presidem persons who have been convicted of a provisions of the Bioterrorism Act. Bush signed inro law the Public H eahh fel ony relating to the importation of Comments in res ponse to these proposed Security and Bioterrorism Preparedness and any food or who have engaged in a rules had to be submitted ro the Agency by Response Act of 2002 (Bioterrorism Act)1 pattern of importing adulterated food April 4, 2003. By October 12, 2003, the which provides the U .S. Food and Drug that prese nts a threa t of se ri ous adve rse Agency expects to iss ue fi nal regul ations Adminisnation (FD A or Agency) with health co nsequences o r death to and have its info rmation technology substamial new powers ro regul ate and humans or animals. systems operati onal in anticipati on of the revi ew foods and dierary supplemem s 2. M arking - The Secretary of the December 12, 2003, implementati on date. imponed imo the United States. In addi Department of Health and Human Pro posed rules for the recordkeeping and rion, as pan of Operati on Liberty Shield, Services may require marki ng (label administrati on detention authority provi FDA has hired 800 new inspecrors and ing) of foods refused admiss ion into sions we re p rovid ed to the Office of increased the moniroring of impon ed foods the United States at the owner's or Management and Budget on Feb ruary 14, in order ro protect the U.S. food supply. consignee's expense. 2003; and FDA ex pected the proposed rules Among the new powers authorized in the 3. Port Shopping - Food that has bee n ro be rel eased ro the public by March 3 1, Bioterrorism Act are the following: refused admiss ion into the United 2003. I. Registration of fo od facilities, includ States will be co nsidered adulterated if Except for specified exem ptio ns, FDA's ing fo reign facilities; it is offered agai n fo r import, unless the new regul ati ons will apply to all facili ties for 2. Prior notice of food and dietary perso n importin g the food or offering all foods and animal feed products regu supplements imported inro the United it for import demonstrates that the lated by FDA, including herbs and other States; food is now in compliance with FDA dietary supplements, infa nt fo rm ul a, bever 3. Recordkee ping requiremems that will standards. ages (incl uding alcoholi c beverages), and enable FDA ro idemify the previous In order to ex pedite implememation of food additives. As ex plained below, the so urces and the subsequem recipients the Bioterrori sm Act, Congress established prior notice requi remem for imported of food; and strict deadlines fo r FDA to iss ue and foods is ex pected ro be most problematic for 4. FDA administrative detemion author enforce new regul ati ons. Specifi call y, the the Agency and regul ated industry. Accord ity over food and dietary supplemem s Bioterrorism Act requires the Agency to ingly, this article focuses primarily on the that prese m a threat of se rious adve rse ensure that fin al regul ati ons are iss ued and prior noti ce proposed requirements. health consequences o r death ro in effect by D ecember 12, 2003, for the humans or animals. registration and prior notice provisions of Prior Notice Requirements In addition ro the above major rules, the the Act. In addition, fin al regulations must Beginning December 12, 2003, FDA Bioterrorism Act also contains other be issued by December 12, 2003, fo r the must receive adva nce noti ce of each ship substamive provis ions for which FDA is recordkeeping requirements associated with ment of food (including herbs and dietary currently considering iss uance of guidance the new provisions. W ith regard to FDA documems ro funher ex plain and clari fy its detention authori ty, the Bioterorrism Act Continues on page 66 GMPs the proposal , AHPA, NNFA, and UNPA vo ice public comment, ask fo r clarifica Continued from page 64 persuaded the FDA to ex tend the deadline tions, or otherwise provide input: May 4 in for an additional 60 days, to August 11. J2 .I3 Secaucus, NJ, May 6 in Oakl and, CA, and holders on, in the FDA's words, "How this Comments may be addressed ro Dockets M ay 9 via satelli te b roadcast (see proposed regul ation can best achieve the Management Branch (HFA-305), Food and Analysis and Areas of Concern FDA's prior notice proposal raises numer ous issues of concern, including the funda mental question as to whether the proposed regulatory scheme is commercially feasible. Some of the many areas of concern are iden tified below. First, in part because of the breadth of information to be required in a prior notice, FDA provided for "amendments" and "updates." However, neither the proposed amendment or update process appear broad enough to accommodate the range of largely unavoidable changes that may occur 66 I HerbaiGram 58 2003 www.herbalgram .org between the time a shipment is arranged for FDA is not currently accepting registra ties to ensure that current procedures and the rime of arrival. FDA's proposal will tion forms, and has indicated that any are in compliance with FDA and undoubtedly create the need for multiple forms provided to the Agency prior to Customs expectations. Companies notices involving the same article of food in October 12, 2003 will not be accepted and should remember nor to release food order to make changes to the information will nor be entered into FDA's computer products into commercial distribution initially submitted. system. FDA is expecting most companies until FDA issues a "may proceed" Second, FDA acknowledges that several to register electronically via the Internet. notice, regardless of whether Customs common commercial practices will need to Failure to register is prohibited under the has already issued a "conditional be altered in order to comply with the FFDCA and imported food from an unreg release. " proposal. For example, FDA notes that the istered foreign facility will be held at the • Parries should review contractual rela practice of "topping off" a truckload will port of entry until the facility is registered, tionships with foreign suppliers to present problems because the articles of unless FDA directs the removal of the ensure that they are aware of the food added at the last minute would not imported food to a secure facility. FDA has Bioterrorism Law, and to ensure that have been subject to a prior notice. More indicated that if a firm does nor register by contracts contain appropriate provi over, for shipments that combine food with the deadline, the Agency will have the sions that address the division of non-food items, delivery difficulties will be authority to recommend a civil action in responsibility and indemnification raised if the food items are refused admis federal court. The Agency also will have the issues. Based upon the significant sion because of a notice problem. The ship authority to recommend initiation of a changes that are occurring with regard ment will need to be separated so that the criminal action in federal court. to food imports, companies should non-food items can proceed to their desti Registration will consist of providing revisit existing contractual relation nation. basic information, including firm name, ships and ensure that adequate protec Third, FDA acknowledges that ship address, etc., to the FDA. Farms, restau tion is included for import-related ments of fresh produce and seafood from rants, retail food establishments, nonprofit problems, including costs associated Canada and Mexico will be most affected establishments that prepare or serve food, with potential delays. under its proposal. Given the short fishing vessels not engaged in processing as • Parries should contact their customs distances to the U.S. border and the fact defined in federal regulations, and facilities broker and ensure the broker is imple that in many instances shipments traveling that are regulated exclusively by the U.S. menting processes and procedures to by truck are loaded only several hours Department of Agriculture are exempt from comply with the new law and ensure before departure, it seems probable that this requirement. In addition, foreign facil that food imports are not delayed. either frequent amendments will be needed ities are exempt if the food from the facility • All parties affected by this law should or a substantial portion of the truck traffic undergoes further significant processing or be proactive in addressing potential will be at risk of being held at the border packaging by another facility outside of the problems with the FDA. If problems while notice issues are resolved. United States. develop, it is often preferable to engage Finally, in order to comply with the in proactive informal discussions with proposal, the flow of information between Global Recommendations the Agency rather than subsequently importers, purchasers, and shippers will The Biorerrorism Act is expected to being subject to an Import Alert or a have to be efficient, timely, and seamless. dramatically impact the importation of potential enforcement action. It is far Importers, owners, and consignees will be at foods and dietary supplements into the preferable to avoid issuance of an risk for the consequences of untimely or United States. Based upon the changes that Import Alert in the first instance than inadequate notice as products are delayed at will take place later this year, regulated to prove to the Agency that your ports of entry and, if FDA requires the industry should consider raking a number company and/or products deserve to product to be moved to a secure facility, as of proactive steps: be removed from such an alert. transportation and storage expenses mount. • Companies should not rely on "just in rime" inventory practices while the Finally, due to the complexity of these Proposed Registration new import program is being imple issues, counsel should be consulted prior to Requirements mented. They should be prepared for establishing an appropriate corporate Domestic or foreign facilities that manu potential problems at the border, implementation plan. A facture, process, pack, distribute, receive, or resulting in delays. To the extent possi hold food for consumption by humans or ble, plan for potential disruptions in Paul D. Rubin is a partner in the Food and animals in the United States must register the riming of food imports in Decem Drug Practice Group of Patton Boggs LLP, with the FDA no later than December 12, ber 2003. Washington D. C. He may be reached via e 2003. Registration is a one-rime process • Companies should be prepared for mail at 68 I HerbaiGram 58 2003 www.herbalgram.org consumers, and whether further regulatory signals to toxicity). pl ausible time frame, and elimination of requirements are necessary. "4 Congress A se ntinel event is an "earl y warning to other ca uses) we re labeled "se ntinel further noted, "The number of Ameri cans suggest that certain populati ons may be events."-1 taking dietary supplements containing susceptible to specifi c adve rse effects," RAND makes the fo ll owing concl usions: ephedra has ri sen dramati cally. T he confer according ro Richard Kingsron, Pharm.D., "Ephedrine, ephedrine plus caffeine, and ees encourage [ODS] to enhance clinical of Prosar Internati onal Poiso n Center in ephedra-containing dietary supplements research on the safety and effi cacy of these Minneapolis, a leading expert in product with or without herbs co ntaining caffeine products. "s safety and post-market surve illance. "Hope all promote modes t amounts of weight loss According to a May 29, 2003, email to fully, this will all ow closer sc rutiny of these over the short term. T here are no data rh e aurhor from Paul Coares, Ph.D., ODS types of events ro search for any cause-effecr regarding long-rerm effects on weighr loss. director, "Our goal was ro ger a fa ir reckon rel ationships," he added. 8 Single-dose ephedrine plus caffeine has a ing of the current science as a bas is for furure T he FDA press release summari zes, "The modes t effect on athletic performance. T he research in the area. There is no doubt, RAND study has concluded that ephedra is ava il able trials do not provide any ev idence however, that this approach could be used associated with higher risks of mild to about ephedrine or ephedra-co ntaining by regulatory agencies to fairly and inde moderate side effects such as heart palpita dietary supplements, as they are used by the pendently determine whether a safety tions, psychiatric and upper gastrointes tinal general population, to enhance athletic conce rn exists for a particular ingredient." effects, and symptoms of autonomic hyper performance. Use of ephedra or ephedrine If rh e evidence-based review from RAND activity such as tremor and insomnia, espe plus caffein e is associated with an increased had co ncluded thar ephedra was a public ciall y when it is taken wirh orh er sti mu ri sk of gastrointes tinal, psychiatric, and health danger, it would have sa tisfi ed the lants. Moreove r, its review of some 16,000 autonomic symptoms. T he adve rse event legal requirements to justifY FDA in remov adve rse event reports revealed two dearhs, reports contain a suffi cient number of cases ing ephedra from the market, as most indus four heart attacks, nine strokes, one seizure, of death, myocardi al infarction, cerebrovas try insiders have spec ul ated FDA has wanted and fi ve psychiatric cases involving ephedra cul ar accident, seizure, or se ri ous psychiatric to do for many years. W ithout objecti ve data in which the records appeared thorough ill ness in yo ung athletes to wa rrant a from clinical trials or some other definiti ve and no other contributing facto rs we re hypothes is- tes ting study, such as a case proof of causali ty, and with data supporting identified. RAN D call ed such cases 'sentinel control study, to support or refute the short-term weight loss, under the terms of events,' because they may indicate a safety hypothes is that consumption of ephedra or the Dietary Supplement Health and Educa problem but do not prove that ephedra ephedrine may be causa lly related to these ti on Act of 1994 (OSHEA) or other ex isting caused the adve rse event. The study recog se ri ous adve rse events. "3 standards for safety, FDA would find irself ni zed that such case studies are a weak fo rm hard-pressed to justi fY removal of ephedra of scientific evidence. Other unmeasured Adequate Authority to Protect from the marker. 6 factors may have contributed, and such se ri T he public controversy about the safety FDA also invited public comment as ro ous adve rse events are likely to happen of ephedra has long bee n a concern among "what additional legislative authorities, if (albeit at very low rates) among the millions many people in the herb and OS industry, any, would be necessary or appropriate to of use rs of ephedra anyway. T he study also who see the ephedra iss ue as an Ac hilles' enable FDA ro address [the regul ation of identified other such events potentially heel for the industry, possibly "bringing ephedra] most effectively."2 On March 26, associated with ephedra, in which other down the hea t" on all other herbs and Sen. Richard J. Durbin, O-IL, introduced factors may have contributed to the adverse supplements. The logic holds that the Senate Bill 722, "A bill ro amend the events or in which records were inade mounting concerns about ephedra may Federal Food, Drug, and Cosmetic Act quate. "1 endanger the regulatory sratus of many rela [FDCA] to require that manufacturers of The RAND Report evaluated 52 ti vely benign herbs and other supplements. dietary supplements submit to the Food controll ed clinical trials on ephedra and O thers, particul arl y represe ntati ves of and Drug Administration repo rts on ephedrine for ev idence o f effi cacy fo r ephedra manufacturers, argue that FDA adverse ex peri ences with dietary supple weight loss or athleti c performance (46 fo r caused the bad publicity on ephedra by ments, and for other purposes" (also known weight loss), including ephedrine-caffeine mishandling the science from the start, and by its short ride, "Dierary Supplement combinati ons. T he authors also reviewed that industry should not permit any ingre Safety Act of 2003"), which would require adve rse event reports from a variety of dient ro be removed from the market based pre-market safety approva l for all supple sources including the FDA Medwatch, on bad press and bad science, as that would ments intended fo r use for stimulant published literature, and the fil es of a large serve as a precedent with which industry purposes/ manufacturer. They documented parame could not li ve, which eventuall y would be H owever, the RAND Report, while ters: dose of ephedra reported, timi ng of the counter to publi c interes t. T his position is acknowl edging safety concerns about dose of ephedra (last dose within 24 hours rooted in part in the FD A's p roposed ephedra supplements, does not go so fa r as for acute events), pro duct taken, the adverse ephedra regul ations iss ued in June 199 7; to conclude a causal connection between event, other medical information, and any the agency proposed small doses of ephedra ephedra and seri ous adverse effects (e.g., subsequent inves tigation of the adve rse alkaloids (8 mg per se rving; 24 mg per day heart attack, stroke, seizure, death). In its event. They also "so ught evidence that an limit) and other proposals9 that were later literature review, RAND could only term adequate inves tigati on had assessed and deemed by the U.S. General Accounting these seri ous adve rse effects as "sentinel excluded other potential causes. " Cases thar Office as being scientifically unfo unded.10 events" (i.e. , they could be seen as potential met these criteria (well-documented eve nt, As nored above, in its proposed regul a- www.herbalgram.org 2003 HerbaiGram 58 I 69 tions FDA requested comments as to what system of regulation of dietary supplements M, Mojica WA, Suttorp MJ et al . Ephedra additional legislative authority, if any, might and recognition that much more rigorous and Ep hed rine for Weight Loss and be appropriate to enable it to deal with oversight of these biologically active agents Athletic Performance Enhancement: Clini cal Efficacy and Side Effects. Evidence ephedra most effectively. This request is is necessary to protect the health and safety Report/Technology Assess ment No. 76 consistent with the views of some in the of the public."12 (Prepared by Southern California medical community, who have commented In comments to FDA, ABC noted that Evidence-based Practice Center, RAND , that dietary supplements are not sufficiently previous FDA officials stated that FDA does under Contract No 290-97-0001 , Task regulated. have the authority and power to protect the Order No. 9). AHRQ Publication No. 03- An editorial in the journal of the Ameri public against unsafe dietary supplements. 13 E022. Rockville, MD: Agency for Health can Medical Association (jAMA), accompa ABC cited testimony to the U.S. Congress care Research and Quality; February 2003 nying the publication of a meta-analysis of by former FDA commissioner Jane Henney, 4. House Report 106-645, accompanying ephedra clinical trials by the authors of the M .D .: "FDA has tools at its disposal to take H.R. 4577, Departments of Labor, HHS, 11 and Education and Related Agencies RAND report, calls for "major changes" in enforcement actions against dietary supple Appropriation Bill, 2001, p. 93. 12 the regulation of DS. It states that dietary ments found to have safety, labeling or 5. Conference Report (H Report 106-1033) supplements are readily available to the other violations of the [FOCAl], as accompanying H.R. 4577, Departments of American public often with unsubstanti amended by OSHEA ... I also believe that Labor, HHS, and Education and Related ated claims of benefit and rarely with any OSHEA provides FDA with the necessary Agencies Appropriations Act, 2001 , p. 142. mention of potential hazards. [The new legal authority to protect the public 6. Dietary Supplement Health and Education American Botanical Council (ABC) Safety health."14 Act of 1994 (OSHEA), Public Law 103- Labeling Program attempts to remedy some ABC also cited Stephen H . McNamara, a 417, 21 usc §3419. 7. Dietary Supplement Safety Act of 2003. S of this situation. -Ed.] leading food and drug law attorney and 722. 108th Congress, 2003. Current status Curiously, the editors may have mischar former Associate Chief Counsel for Food at of the bill is online at the Library of acterized one of the conclusions of the FDA, who wrote that FDA does possess Congress website, 70 I HerbaiGram 58 2003 www.herbalgram.org Herbs Continue Slide in Mainstream Market: Sales Down 14 Percent by Mark Blumenthal Of particular interest is the decline of The negative outcome of this trial was ginkgo from the top-selling position it held highly publicized by JAMA, including video erb sales fell 13 .9 percent in food, at least since HerbalGram began to report news releases carried on hundreds of local Hdrug, and mass market retail stores in these statistics in 1995. Ginkgo fell to the television stations and all major cable and 2002, continuing a four-year trend in this second spot, dropping 28.9 percent in network news stations. The bottom line sales channel, according to data from Infor dollar sales. This is most likely due to the message that consumers received was , mation Resources, Inc., a leading provider considerable adverse publicity generated in "Ginkgo doesn't work," despite strong of market statistics and trends. The news August 2002 when the journal ofthe Amer evidence that it is safe and effective for comes as no surprise to industry members ican Medical Association UAMA) published cognitively impaired adults. and product retailers who have witnessed a clinical trial on normal, healthy adults 60 Predictably, the most precipitous decline the erosion of much of the gains made by years and older in which a leading ginkgo occurred with kava (52.9 percent) as it was herbs in the mainstream market during the extract did not produce any significant implicated in cases of liver toxicity and halcyon days of the mid-1990s. improvement in memory or concentration.1 banned in numerous industrialized coun tries (e.g., Australia, Canada, England, France, and Germany). The 2002 Top-Selling Herbal Supplements in Food, Drug, and Ginseng experienced a fall of 30.6 percent. Sr. John's wort dropped 38.4 (52 Weeks Ending January 2003) Mass Market Retail Outlets* percent, probably due in pan to the heavy Herb Retail Sales ($) %change Unit Sales %change 2002 rank reponing related to the negative outcome of I. Garlic 34,509,288 -1.5 5,152,012 -4.2 3 the U.S. National Institutes of Health funded three-year trial, in which the popu 2. Gin kgo 32,998,528 -28.9 3,763 ,780 -28.5 lar prescription antidepressant se nraline 3. Echinacea 32,448,966 - 18.9 4,332,648 - 18.9 2 (Zoloft®) also failed to show effect. Sales of 4. Soy 28,252,518 1.6 2,213 ,997 5.4 5 Pycnogenol®, the patented French maritime pine bark extract, fell 36 percent, while 5. Saw pal metto 23 ,0S3 ,036 -7.1 2,379,683 -6.4 6 grape seed extract, a product containing 6. Ginseng 21 ,686 ,1 92 -30.6 2,728,431 -3 1.6 4 large amounts of highly antioxidant 7. St. John's wort 14,969,575 -38.4 1,837,622 -36.9 7 oligomeric proanthocyanidins and used for similar purposes, fell 24.1 percent, probably 8. Black cohosh 12,333 ,1 88 27.4 1,046,913 15 .7 10 due to the fall-off in the market "hype" that 9. Cranberry 11,857,782 13 .0 1,714,453 10.8 9 characterized the meteoric rise of these two I 0. Vale rian 8,1 20,329 -31.4 1,224,342 -24.1 8 product categories a few years ago. Some good news: Sales of black cohosh I I. Milk th istle 7,762,350 9.2 917,410 7.9 12 surged 27.4 percent. This may have been 12. Even ing pri mrose 6,024,896 2.1 791 ,205 5.9 13 the beneficial result following reports in 13 . Kava kava 4,423,427 -52.9 554,810 -5 1.2 II July 2002 that a major government study found that long-term use of conventional 14. Bi lberry 3,38 1,35 I -4.9 507,167 -2.0 IS hormone replacement therapy may actually I 5. Grape seed 3,054,8 16 -24.1 411,492 - 14.3 14 increase risk of heart disease and cancer in 16. Yoh imbe 2,403 ,010 12.3 210,903 6.7 16 women. And cranberry, which received little to no media attention, saw a 13 17. Green tea 1,752,844 1.0 327,461 7.9 17 percent increase in sales, followed by milk 18. Ginge r 1,094,596 -9.8 225 ,800 -9.2 19 thistle, which enjoyed a 9 percent increase. 19. Pycnogenol® 932,49 1 -36.0 71 ,515 -38.0 18 Another trend that might be surfacing is the general settling out and, perhaps, 20. Aloe vera 524,855 1.1 84,617 11 .7 gradual slowing of the alarming drops the Multi-herbst 8,547,477 27.1 678,460 27.3 n/a herb market experienced over the past few A/0 herbs:j: 33,721 ,286 -5.9 2,879,752 - 12.4 n/a years. A Total Herbs $293,397,664 -13.9 34,054,224 -15. 1 Reference: Source: Information Resources, Inc., Chicago, IL. Used with permission. 1. Solomon PR, Adams F, Silver A, Zimmer J, * Supermarkets, drug stores, mass merchandisers (except Wai-Mart which no lo nger provides sales DeVeaux R. Ginkgo for memory enhance data to market research companies). Statistics do not include health and natural foo d stores, ment: a randomized controlled trial. JAMA mu lti-level marketing companies, mail order an d Internet sales, or sales via health care profes 2002;288(7):835-40. sionals. t Multi-herb = herb combinations contai ning more than one herb. Based on total sal es in this channel of trade, this li sting wou ld be IOt h, but si ngle herbs are listed first. t A/0 herbs = all other herbs not listed above. www.herbalgram .org 2003 HerbaiGram 58 I 71 where an interest in essential fatty acids, ProstagLandins, Leukotrienes, and EssentiaL prostaglandins and the endocrine sys tem Fatty Acids. He was a prolific writer himself developed. In 1975 he rook up the position who wrote and edited numerous books on a of Professo r of Medicine at the University of wide range of subjects, as well as contribut Montreal, which he held for four years. He ing to more than 800 scientific publica became increasingly interested in the devel tions. One of his main interes ts was in opment of novel therapeutic agents based schizophrenia and he was medical adviser on lipid biochemistry, and in the applica and then president for the Schizophrenia tion of this field to human diseases. Association of Great Britain. Much of his In 1979 Dav id left the university to se t research was devoted to finding a treatment up a small pharmaceutica l company, for this condition. Efamol, which changed its name to Scotia David inspired a multitude of people Pharmaceuticals Ltd. several years later. whose lives he touched. He had a unique David F. Horrobin Scoria Pharmaceuticals Ltd. became one of combination of enthusiasm and tenacity, 1939- 2003 the first biotech companies to be listed on humility and friendliness, open minded the London Srock Exchange. Over the creativity, huge breadth and depth of course of 18 years, his innovative approach knowledge and outstanding analytical avid Horrobin was one of the most to research led to the discovery and eventual power. He was a mentor and regarded as an D original scientific minds of his genera commercialization of products within two inspiration to many people. David was an tion. His study of human phys iology and technologies, namely lipids and photody outstanding communicator and his peers the basis of disease lead him to investigate namic therapy, in the fields of cancer, have said that his ability to express his ideas the role of fatty acids and their derivatives dermatology and diabetes. Scotia Pharma with such clarity and conviction led them to in human disease. David applied his knowl ceuticals Ltd. was built up to a company change the way they thought. There is no edge and understanding of lipids to inves ti with 450 employees and a market capital greater lasting legacy to him than that. H e ga te their possible role as therapeuti cs in ization of over £400 million (US$645 treated eve ryo ne with kindness and respect many fields of medicine. million) at the rime of Dr. Horrobin's and his optimistic outlook on life neve r left Born in Bolton, Lancashire, England, he departure at the end of 1997. him. was a scholar of Balliol College, Oxford, Dr. Horrobin and Scotia were pioneers in Some two years ago he fell ill with mantle where he obtained a First Class Honours researching the health and medical applica cell lymphoma, and recently wrote medical degree. To this, he added a clinical tions of essential fatty acids (EFAs), partic movingly an account of his illness in an arti medical degree and a doctorate in neuro ularly gamma linolenic acid (GLA), from cle in the Lancet, arguing pass ionately that science. H e was a fellow of Magdalen various sources, particularl y evening prim cancer drug development as presently prac College, where he taught medicine to rose oil (EPO) from the seeds of evening ticed with large scale clinical trials is nor students alongside Dr. Hugh Sinclair, one primrose (Oenothera biennis). The wide ethical. of the pioneers in the field of esse ntial fatty popularity today of dietary supplements David Horrobin could trace his family acids. Hugh Sinclair was someone who and medicines made from EFAs from EPO, origins to a small Yorkshire village called heavily influenced the future of David's black currant seed oil (Ribes nigrum) and Horrobin, which was wiped out except for a research . borage seed oil (Borago officinaLis) owes irs few families in the plague of 1348. He is While a medical student, he worked for origin to Dr. Horrobin's vision, genius, and survived by his wife Sherri, his mother the Flying Doctor Service in East Africa. determination. Berry, his brother Peter, his children Cathra This led to an interest in Kenya and an In order to concentrate on research in and Steven, and his grandchildren Jake, appointment in 1969 as Professo r of psychiatry David, along with his wife Oscar, and Luke. Medical Physiology at its new medical Sherri, set up a new company, Laxdale Ltd., David's final resting place is on the Island school. David traveled widely in Eastern at the end of 1997. Based in Stirling, Scot of H arris where, for many years, he spent Africa culminating in his publication of an land, Laxdale is developing novel pharma time fishing, thinking, walking and reading. illustrated guide entitled A Guide to Kenya ceuticals for psychiatric and neurodegenera He will be greatly missed. _...- and Northern Tanzania, in 197 1. This tive disorders. Laxdale is wo rking on prod Mehar Manku, became a classic volume that has played a ucts for diseases such as Huntington's lain Glen, large part in developing the tourist industry disease, depress ion, and schizophrenia. Susan McGoldrick, of the area. Throughout these travels, he David instilled in his team a pass ion for the Fiona Duffy, developed the kernel of thoughts about science, an open-minded approach to David Boa!, fatty acids, schizophrenia and its role in research, and a positive and enthusiastic Harald Murck, evolution which he elaborated on later in attitude to clinical research and develop Amanda Green : the publication of his book in 2001 entitled ment. Laxdale's work will continue and David 's colleagues and co-workers The Madness of Adam and Eve. This was aims to provide a lasting tribute to his short-listed in 2002 for the Aventis Science memory. Book of the Year. David was the founder and editor of In 1972 David returned to the UK to the MedicaL Hypotheses, a forum for the dissem position of Reader in Medical Physiology at ination of new ideas in medicine. He was the University of Newcastle Medical School also the founder and editor of the journal 72 I HerbaiGram 58 2003 www.herbalgram.org ajor Herbs of Ayurveda, edited by cance (or lack thereof) of va nous state the individual), bur the report is from 1956, M Eli zabeth M. Williamson. Compiled ments. with onl y this statement appea ring in the by the Dabur Research Foundation and A challenge in producing any such book book: "the essential oi l exh ibited mild estro Dabur Ayurvet Limited. Churchill Living is accurately presenting a brief summary of genic activity." W ith only mild activity, and stone. London. 2002. 361 pp., hardcover what is found in the usual 15-30 (o r more) less than I perce nt content of essential oil , with color photographs, index, glossary, references used to write the monographs; and no follow-up reports in nearl y 50 years, therapeutic guide. $49.95 ISBN 0-443- each monograph includes about rwo pages one suspects that rh e es trogenic acti vity is a 07203-5 of tex t (not including the reference list). To non-iss ue. Another area of interes t is weight There is a paucity of books on Ayurvedic illustrate the situation, I have selected an loss: this report comes from a 1992 herbs in English, so that all new contribu herb monograph that I think is typical: randomized double-blind placebo tions are of special interest. The las t signifi cyperus or nut grass ( Cyperus rotundus L., controll ed pilot study (which could not cant effort along these lines was the CRC Cyperaceae), which is call ed mustak in have appeared in Kapoor's 1990 book). It Handbook of Sanskrit, and will discuss the main sections was claimed, in the brief prese ntation, that Ayurvedic involvi ng research and the problems that 30 pati ents receiving the powdered herb Medici nal are encountered. experienced weight loss, along with a drop Plants, by Well-studied herbs wi ll often be subject in choles terol and tri gy lcerides (no specifi Ayurveda L.D. Kapoor to several investi gations revealing chemical cation of herb dosage, or amount of change (CRC Press, constituents. Such studies are nor always detected). Apparently, there were no follow 1 9 8 9 ) . aimed at determining the identity and up studies - I checked PubMed to make U nfortu- quantity of major ac ti ve constituents, but, sure the author hadn't missed something nately, the rather, at finding novel chemical suggesti ng that the effect was minor and not 4 00 - pag e co mpounds that might eventually be found worth pursuing during the past decade; the text COSt to have unique properries. Some of these book didn't mention whether the effects $400 and did co mpounds may be prese nt in trace observed we re statisticall y significant. One not find its amounts. As a res ul t of these efforrs, one wonders if the pharmacology studies and way into many libraries as a result; a few will end up with a long li st of isolated clinical appli cations described here have years later, a lower cost reprint under the chemical constituents, but little idea of anything to do with traditional Ayurveda, name Handbook of Ayurvedic Medicinal what contribution, if any, they make to the as opposed to just sc reening by modern Plants: Herbal Reference Library (CRC Press, traditional or modern uses of the herb. In research techniques for va rious potential 2000) came out with a price of $150, which the case of C. rotundus, a I 967 reporr is new uses. made it somewhat more avail able. That tex t cited which states the essential oil of the Under dosage, the specifi cation in Major includes monographs on 251 plants, giving rhizo me constitutes about 0.5-0.9 percent Ayurvedic Herbs is, "Powder: 1-3 grams; different names, their habitat, distribution, of the material, and is co mprised of broad Decoction 56-11 2 mls. " One is left uncer chemical constituents, pharmacology, ther groups of aromatic chemicals (e.g., tain as to whether these doses were the same apeutic uses, and dosage. sesquiterpenes, epoxides, ketones, monoter as those used in clinical studies (s uch as the Like this prior book, Major Herbs of penes, and aliphatic alcohols). Then, based above-mentioned obesity study) , whether Ayurveda is a collection of monographs with on a study published in 2000, a li sting of these are one-rime doses or cumulative dail y essentially the same categories of informa about 20 specific chemical compounds is doses, and what amounts of herb and water tion, focused in on fewer herbs: there are 70 provided. It would have been helpful to are used to make up 56 ml of decoction. At monographs. The new text, which becomes know if any of these constituents had been the beginning of the book, I don't find an affordable to many more potential readers suggested to be an active compound explanation. Under preparation of medi (at $50) and is 13 years newer than explaining traditional or modern uses, yet ci nes, for decoction it only states: "T he herb Kapoor's, should be judged on the bas is of such commentary does not appear. The is boiled in water and the volume reduced." its utility for people who wish to study and, study from 2000, though it may list trace In sum, compared to other monographs perhaps, make use of Ayurvedic herbs. ingredients, was obviously not even avai l on Ayurvedic medicine, this book is Major Ayurvedic Herbs, like other herb able for inclusion in Kapoor's text. updated to include considerable amounts of books comprised of monographs reviewing The review of pharmaco logy experiments new in fo rmation. The reader should be herbal research, presents as many reports as for C. rotundus prese nted in Major aware that there are problems with this possible, and does not provide commentary Ayurvedic Herbs indicates that it is anti monograph approach, problems similarl y on the individual research reports. Thus, emetic, anti-inflammatory, antipyretic, found in other books of herb monographs, old research (from 40 years ago) and new anti-malarial, anti-obesity, anti-bacterial, of li sting information without filtering, research (from las t year) are treated as equal; cyroprotective, estrogenic, tranquilizing, commenting, or elaborating sufficiently. well-controlled carefully designed studies hypotensive, muscle rel ax ing, and has an As a result, practical use of the informa and poorly controlled weak studies are also effect on pigmentati on. This is a compre tion is quite difficult. This deficiency is treated with equali ty. The only advantage of hensive report of what has appeared in the unforrunate, as the author, a senior lecturer this approach is that when seeking back literature, but it ca n be misinterpreted in pharmacognosy and phytotherapy at the ground information on an herb, virtuall y easil y. Thinking in terms of hot-button School of Pharmacy, University of London, everything that has been done is there for subjects today, estrogenic activity of an herb has the background and insight to add some handy access; the disadvantage is that most is one area of interest (a n as pect deemed professional commentaries that would readers cannot get any sense of the signifi- desirable or to be avoided, depending on enlighten the reader. www.herbalgram.org 2003 HerbaiGram 58 I 73 Despite the drawbacks mentioned above, trained in conventional medicine, have writ who prefer to self-medicate these condi I'm very pleased to add this book to my ten Herbs for the Mind. They provide practi tions. For almost every salient point made library of texts on herbs and traditional cal guidance from our current knowledge of in the book, there is an example given from medicine, including Ayurvedic herbs. It four popular herbal remedies: St. John's wort the authors' own practice that helps to illus helps define which herbs have been for depression, kava for stress or anxiety, trate the point being made, greatly facilitat subjected to considerable research and what ginkgo for memory loss, and valerian for ing the comprehension of the shadowy areas research has been undertaken to date (in insomnia. They also provide plain language of the mind that are otherwise difficult to very brief outline form) in terms of chem overviews of the symptoms, causes, and convey to consumers. istry, pharmacology, and clinical studies. I traditional treatments for these ailments. This book is not a scientific treatise; it is do not find the relatively small number of Herbs for the Mind is a valuable resource clearly targeted to the general public. herbs presented in the book as a deficiency, if yo u're a person with symptoms of anxiety However, it is sufficiently scholarly for because this work is not an effort to be or depression and considering using natural physicians and other healthcare profess ion comprehensive in terms of plants used in remedies to treat the symptoms. It offers als to find it useful, particularly for showing the tradition. A feature I like having in this guidance to decide whether you are or are how these agents might be rationally incor book is the listing of Ayurvedic properties not a candidate for self-treatment, where porated into their practice. I highly recom in English, usually not translated in other herbs fit into an overall treatment plan, and mend it to all mental health professionals books. Hence, for C. rotundus, the herb is how and when to enlist a doctor's help. and consumers who are interested in this classified as bitter and astringent, light and Getting your own physician on board can subject. --"' dry, cold, pungent, and having the proper be important not only for those who have -Jerry Cott, Ph.D. ties of pacifying kapha and pitta (very significant disorders, but also very useful for Pharmacologist, U.S. Food and Drug Administration roughly, phlegm and fire). Also, the short helping to determine if an herb is working, Rockville, Maryland paragraph introducing each herb in Major when to increase or decrease the dosage or Ayurvedic Herbs often has useful informa switch brands, and when to give up and try he Killers Within: The Deadly Rise of tion about its dominant use in Ayurvedic another route. The book points out the TDrug-Resistant Bacteria, by Michael practice, the origin of its name, and any pitfalls of both drug and herbal use and Shnayerson and Mark Plotkin, Ph.D . Little, problems with confusing other species with what potential problems might result from Brown and Company: Boston; 2002. 328 the intended one. When such information long-term use . A glossary defines pp. , hardcover, includes index. $24.95 is offered (it is not in the case of C. rotun commonly used terms, and a resource ISBN 0-316-71331-7. dus, however), I find it a useful summary as section provides a list of recommended One of the is the £_aragraph on traditional and modern herbal and mental health textbooks, jour oldest concerns of use. A nals, and organizations for additional infor humans is to iden - Subhuti Dharmananda, Ph .D. mation. tify why so me Director, Institute for Traditional Medicine The fact that pharmaceutical companies people get sick and Portland, Oregon don't put research funds into products they others do not, can't patent means that results from large especially when erbs for the Mind: What Science scale clinical trials are not available to direct they have similar HTells Us about Nature's Remedies for decisions about herbals. While substantial lifestyles, expo Depression, Stress, Memory Loss and clinical trials are available for the herbs sures, and diets. Insomnia, by Jonathan R.T. Davidson, covered in this book (with the exception of Only a little more Kathryn M. Connor. Guilford Press: New valerian), results are often inconclusive due than a century ago York; 2000. 278 pages paperback $14.95 to small sample size and sometimes contra doctors and scien ISBN 1-57230-476-6. Hardcover $33.00 dictory findings. Here, the authors' experi tists discovered that perhaps microscopic ISBN 1-57230-572-X [out of print] . ence is most valuable. Two psychiatrists, things, called germs, can cause disease. Despite large they are able to make use of all of the Medical science in the twentieth century WHAt SC IIN( f gaps in our knowl nus us u ou t current information by combining evidence made Herculean strides in identifying edge, interest in NATUII ' S from controlled clinical studies, herbal liter bacteria, viruses, fungi, and a litany of other herb use is still iiM I Dt U • Oo ature, and from their own practices. The microbes related to various illnesses. Then strong as people result is a very useful guide, containing no came the wonder drugs during the middle grow increasingly her b Sford hyperbole, yet making use of the rich anec and latter part of the century. Antibiotics, dissatisfi ed with theffilll dotal and folkloric information available for sulfa, and other drugs on the cutting edge of conventional main OIPU UION , these herbs. Davidson and Connor explain technology have healed millions, saved PUU, ,_IM OitT stream medicine. lOU , AND what the herbs do, how they may work, countless lives, and helped immensely in This is particularly I N S OMN I A how to take them, and what to expect from the longevity of the human species. Or have true for indications them. While the herbs don't always work for they? I'·~·· \I' generally consid ".uhn n \1 1 ::Onn. \11 everyone, neither do their pharmaceutical As many phys icians and microbiologists ered to be within counterparts. When they do work, experi of the 21st century fear that the golden age the realm of mental health and psychiatry, ence has shown that the herbs were gener of antibiotics and similar drugs is coming to namely anxiety and depression. To help so rt ally as effective as drugs, while having far an end, and as resistant bacteria become an out the rational from the irrational, two fewer unpleasant side effects. This informa urgent global issue, the stark reality of The respected Duke University psychiatrists, tion will be welcomed by the many people Killers Within: The DeadLy Rise of Drug- 74 I HerbaiGram 58 2003 www.herbalgram.org Resistant Bacteria emerges. The implications (the medical community) must defeat the about the rev1 ew of the first edition the are horrifying. Today's hospitals face bad guys (the bacteria) with the right editors expected it "to steadily improve and increased antibiotic-resistant staphylococ weapons (new miracle drugs) before the expand," such a large expansion does not cus, frequently known as methicillin-resist world is in real jeopardy. Unforrunately, the seem to be warranted given the rate of ant Staphylococcus aureus (MRSA) and authors cannot predict how the saga will development of new medicinal plant treat vancomycin-resistant Staphylococcus aureus end. _..- ments. They have not eliminated any of the (VRSA). Methicillin and vancomycin are -Daniel T. Wagner, Pharm.D., R.Ph ., M.B.A. monographs dealing with very toxic and powerful antibiotics and are considered Nutri-farmacy clinically insignificant plants, and only one drugs of last resort. If they cannot kill a Wildwood, Pennsylvania of Tyler's noted omissions (eat's claw) has particular bacterial strain, there are no other been included ( Unicaria [sic] tomentosa) in options for the patient. DR for Herbal Medicines, 2nd the Alphabetical Index which precedes the Shnayerson and Plotkin convincingly Pedition, edited by Joerg Gruenwald, main body of the text. Soybean is still repre point out that the principal cause is overuse Ph.D., Thomas Brendler, Christof Jaenicke, sented as the wi ld species Glycine soja - and misuse - of antibiotics. In 1954, M.D. Medical Economics Co.: Montvale, instead of the commercial cultigen G. max. two million pounds of antibiotics were NJ; 2000. 858 pp. hardcover $59.95 ISBN It would be interesting to review the res t of produced in the United States. By the end 1-56363-361-2 the hundred or so new entries, roughly of the century, the annual figure had risen When the equal in number to the herbs of major by some estimates to more than 50 million late Prof. Varro significance in North America. pounds. E. (Tip) Tyler, Nevertheless, the second edition is The authors' timing could not have been reviewed the considerably improved over the first, more perfect. In December 2002, newspa first edition of including recent literature references and pers were printing front page stories about this work in information on herb-drug interacti ons such the overuse of antibiotics. They addressed HerbalGram 46, as those involving St. John's wort (SJW). the continuing campaigns to educate the he made a However, eve n wi th these additions there is public not to ask for antibiotics every time number of criti a lack of critical attention to published they get a cold, and urged doctors not to cisms of it, as research results, as in perpetuating the erro write these prescriptions due to patient well as sugges neous notion that SJW has potential for pressure. tions for its reproductive toxicity, and promoting the The book takes the reader on a global improvement. The German editors, g1ven long-discredited theory that hyperi cin is the "sleuth" to track the invisible killers that the opportunity to co mment on Prof. SJW principle responsible for its anti seem to be winning the battle. Hospitals in Tyler's review, promised to implement his depressant activity: "In general a range of the United States and Western Europe are suggestions in a timely fas hion "wherever 200 to 1000 micrograms/day of hypericin is in trouble, trying to deal with antibiotic possible and appropriate." Salient among recommended for treatment of depression resistant strains of bacteria, and are losing Tyler's criticisms of the volume was the (Anon, 1996). " more patients than they did years ago. Cases uncritical character of its monographs, While much prominence is given to the are cropping up in Russia and many Third omission of significant botanicals, and judgments of the German Commission E, World countries. inclusion of a number of toxic and clinically these bulleted lists of abbreviated indica Moreover, problems surmount as time "insignificant" herbs. This from a book ti ons neglect the Commission's findings goes on, and even modern medicine cannot touted as "The Information Standard for that some 600 plants did not have sufficient seem to keep up with bacterial resistance. Complementary Medicine" and aimed at research to support safe ty or efficacy recom For example, the two newest drugs that physicians. He further advised that "The mendations. Occasional inaccuracies have cured vancomycin-resistant infections clinical utility of the PDR for Herbal Medi appear, such as in the case of rosemary and have provoked resistant strains within a year cines could have been greatly improved by yarrow: the PDR erroneously states that the of their release. Streptococcus pneumoniae judicious editing." Commission E approved rosemary's use for: tops the list of diseases to worry about, and The second edition is similarly in need of blood press ure problems, loss of appetite, are perhaps the most common cause of expert scientific editing - as well as proof rheumatism. However, the Commission lobar pneumonia as well as being common reading. The careless ness evident in both cites rosemary leaf use only for dyspeptic causative agents of meningitis, sinusitis, and areas is prevalent enough to enervate complaints, at least insofar as the mono other infections. And although it is still knowledgeable herbal scientists. A number graph published in ABC's The Complete susceptible to several antibiotics, it is a of egregious examples will be provided later Commission E Monographs, for which Dr. widespread killer in countries with meager in this review, but the shoddiness of editing Gruenwald was an associate edi tor. Interest medical care. is nowhere more evident than in the kava ingly, Tyler wrote in Tyler's Honest Herbal The Killers Within is already a highly kava entry, where, under the contraindica (H aworth Herbal Press, 1999) that it is praised book. The research is timely and tions heading, two virtually identical used to treat low blood press ure, while the meticulous. I believe that doctors, pharma sentences caution against its use in patients British Herbal Pharmacopoeia lists as indica cists, nurses, epidemiologists, and other with endogenous depression because of an tion: "headaches migrainous or hyperten healthcare practitioners will find this book increased risk of suicide. sive." Also inexplicably, the PDR adds to the as scientifically useful as the public will find The number of entries in the seco nd Commission E ap provals for ya rrow: "Liver it provocative. The book reads quickly, like edition increased from 600 or so in the first and gallbladder co mplaints," which are not a suspense novel in which the good guys to more than 700. While in their comments listed in the ABC publication. www.herbalgram .org 2003 HerbaiGram 58 I 75 Regarding format, the second edition, se nsibly, has altered the release from blood platelets, the sciemific fo cus of the subject vas t majori ty of monograph headings to give priori ty to common bioassay - and there is no indication in the wormwood mono names, inferi orly listing Latin binomials in their accustomed ital graph of any relation to such fun ction. In rhe case of feverfew, ics. However, the binomials are not italicized in the main tex t, as there are rwo references ro "Groenewegen, 1986" in the mono they ought to be. It also seems unnecessary to retain the ori gin al graph text but the literature listing notes two publications anrib heading entries in the main body of tex t since the Latin binomials uted to Groenewegen in 1986, both without tides. are available in the Alphabeti cal Index for those unfa miliar with In addition to annoying misspellings - notably "panholide" the respective common names. A fin al note regarding Latin bino repeatedly for parthenolide, which is particul arl y co nfusing to mials: No naming authorities are given, nor are any synonyms. those unfamiliar with feverfew chemistry, since secotanapanholide W hile this neglect is often inconsequemial, there are instances A is regard ed as one of the plant's significa nt actives- more se ri where confusion could occur with inexpert readers. For exa mple, ous is the anriburion of dominam activi ty to parthenolide, espe in much of the European literature saw palmen o is referred to as cially regarding feverfew's anti-migrain e effect. It is stared that "rhe Saba/ serrulata rather than the des ignation Serenoa repens common usual standardiza ti on level is 0. 2 percem parthenolide content," in North Ameri ca. Also, while German chamomile is curre ndy but since 1996 it has been apparent that parthenolide is not a widely represemed as Matricaria recutita, the earlier binomials M. signi ficant contributor to feve rfew's migraine prophylactic effect. chamomilla and Chamomilla recutita are still occasionally encoun In fact, the 0. 2 percem parthenolide minimum was mea m as an tered today. identity cri teri on, es tablished by rhe Canadian regulatory agency in T here is a disconcerting situati on res pecting the literature li st an an empr to ensure similari ty to rhe clinically res ted feverfew ings and textual references, when they occur. T here are so me chemotype: at least rwo other feve rfew sesquiterpene lactone monographs with numerous literature listings that have no corre chemotypes contain no parthenolide. Finally, regarding feverfew lation with the monograph tex t (e.g. , 34 unreferenced literature drug imeractions, the statement that "there is a strong poss ibility li stings under wormwood). The situation is further confounded by that Feverfew may interact with thrombolyri cs, anticoagul ams and the fac t that a number of literature citations do nor include the platelet aggregati on" is simply not supported by record ed ex peri ride of rh e publicati on, and some are incorrecr: in both the ginger ence: no case of a bleeding problem has ever been associated with and wormwood monographs, a paper by Mari es et a/. is cited as feverfew use. Such specul ation is based entirely on in vitro labora being "In: JN P 55: 1044-1056, 1992". However, the JN P paper tory obse rvation of an anti-platelet aggregati on effect. included me as an author and has a differem author list than that T he heading Ginse ng, Panax ginseng, (Asian G inse ng) is cited. In any evem , ginger was found nor to inhibit se rotonin followed by a list of Trade Names, which include "Siberian G inse ng ... American G in seng Root. . . Standardized Siberian G inseng Root. .. . Siberi an G inse ng Power H erb .. . Eleuthero Ginse ng Root, Siberi an G inse ng Root." A later listing is Siberi an Ginse ng, Eleutherococcus senticosus. The Ameri can H erbal Products Association wisely recognizes eleuthero as the preferred common name for E. senticosus, acknowl edging, as the U .S. Congress has recently, that only Panax species may legitimately be claimed to be gmse ng. Under Acti ons and Pharmacology are listed protopanaxadiol ginse nosides, "protopanaxyrri ol" [s ic] ginsenosides, and oleanolic acid ginsenos ides. No mention is made of the significant panaxa rriol ginsenoside '\z• and mentioned as oleanolic acid deri vatives , are ginsenos ide R0 chikusetsusaponin- V and Rbl> Rb2, Rc, Rd, Re and R 1: Rb1 , Rb2, Rc and Rd are protopanaxadiol glycosides, while Re anJ Rgl are protopanaxatriol derivati ves. G insenoside R0 is the only oleanolic acid derivative present in Asian and American Distribution partners and ginse ngs; it is identical with chikusetsusaponin-V, first identified in business contacts sought... Japanese ginseng (P. japonicus). In summary, while this ve ry substantial volume contains much for high-quality pharmaceuticals in the useful fac tual information on a vas t array of medicinal plants, its tradition of the German Homreopathic striking deficiencies and extensive errors of both commiss ion and Pharmacopoeia . omiss ion seriously limit irs usefulness while promoting an inaccu rate appreciation of many of the more important and commer Homc:eopathic original tinctures (0) cially p ro minent herbal preparati ons. -"' Dil utions , potencies, inj ecti on ampoules, globul i and triturations -Dennis V.C. Awang , Ph.D. MediPiant Consulting Inc. Spagyric essences White Rock, BC, Canada Contract manufacturing! As a contract manufacturer we can make sma ll , medium-sized and large batches. 76 I Herbal Gram 58 2003 www.herbalgram .org New Book Profiles ue to economic considerations and the natural evolution of book marketing and sales, the American Botanical Council is adding Dto its catalog very few of the good new books that are being published. However, we do intend to keep our readers informed of books of particular interest that have arrived in our offices. In this issue we launch a new feature, New Book Profiles. Here, we only describe these new books; we have not yet had them reviewed. If you wish to purchase any of these books or those that have been reviewed fully, please go to the book review on our website Healing Planu: Medicine of the Florida Semi Originally written in German by Pennsylvanian mentary and alternative medicine into clinical nole Indians, by Alice Micco Snow, and Susan apothecary Christopher Sauer, this was the first care. Enns Srans. Unive.rsiry P.ress of Florida: American herbal. Now translated by interna The Clinical Practice of Complementary, Gainesville, FL; 2001. 134 pp., hardcover, tionally known food historian William Woys Alternative, and Western Medicine, by W phorog.raphs, illustrated. $24.95 ISBN 0-8130- Weaver, this book contains descriptions of 266 John Diamond, MD. CRC Press: Boca Raton, 2062-x. plants, period woodcuts, and cultural informa FL; 2001. 356 pp., hardcover, illustrated. This book provides the first published record of tion that puts Sauer's advice in irs historical $99.95 ISBN 0-8493-1399-6. Florida Seminole herbal medicine and healing context. Although outdated even when first Integrates homeopathy, acupuncture, Chinese practices, history, and the life of Alice Snow, a published in a series from 1762 to 1778, this herbology, Western herbology, and clinical Seminole herbalist. Charts with plant names in book is a fascinating mix of history, recipes, nutrition, then combines them with conven Greek, Mikasuki, and English and lists of plant horne cures, botanical advice, and even a bit of tional medicine. It also provides a disease properties with their common and botanical magic ro delight gardeners, cooks, historians, oriented treaunent section, explains Western names offer easy reference. Herbal treatments and herbalists. scientific conceptualization of alternative medi include those intended for babies, for people Clinical Manual of Chinese Herbal Medicine cine modalities, and documents the effects of who have had a hysterectomy, stroke, blackouts and Acupuncture, by Zhou Zhong Ymg, and alternative therapies on medication. or shortness of breath, who have chronic pain, Jin Hui De. Churchill Livingstone: New York; Alternative Medicine: The Definitive Guide, sleep disturbance, or are pregnant, and more. 1997. 585 pp., hardcover. $121.00 ISBN 0-443- edited by Larry Trivieri Jr. and John W. Ander The Fever Trail: In Search of the Cure for 05128-3. son. Celestial Arts: Berkeley, CA; 2002. 1233 Malaria, by Mark Honigsbaum. Farrar, Straus Describes the treatment of 185 disease and 18 pp., softcover. $34.95 ISBN 1-58761-141-4. and Giroux: New York; 2001. 307 pp., hard common symptoms with Chinese herbal medi An educational tool to acquaint the reader with cover. $25.00 ISBN 0-374-15469-4. cine and acupuncture. These diseases span such alternative methods to maintain good health and This book is about the search for a cure for specialist areas as internal medicine, surgery, treat illnesses. It offers more than 400 leading malaria. British journalist Honigsbaurn gynecology, pediatrics, dermarology and otorhi physicians' explanations of their treatments, how combines a fascinating historical narrative of the nolaryngology. The etiology and pathogenesis of ro reverse over 200 health problems, 50 alterna discovery of the first possible cure for malaria disease are dis~ussed briefly, bur the main tive therapies, and hundreds of self-help tips. quinine with a critical assessment of the current emphasis is on key points in diagnosis, differen Lavender: The Genus Lwt~ndula , edited by prospects for vaccine. It follows the adventures tiation of syndromes, and treatment, particularly Maria Lis-Balchin. Taylor & Francis: New York; of 19th century English naturalists Robert with herbal medicine. 2002. 268 pp., hardcover, photographs. $128.00 Spruce, Charles Ledger, and Sir Clements Misdetoe: The Genus Vucum, edited by Arndt ISBN 0-415-28486-4. Markham, and their Indian guides who braved Biissing. Harwood Academic Publishers: A comprehensive volume covering all aspects of Andean peaks and fever-ridden jungles to obtain Amsterdam, The Netherlands; 2000. 265 pp., our current knowledge of lavender including: quinine, a malaria cure derived from the bark of hardcover, photography. $110.00 ISBN 90- taxonomy, and history of usage and nomencla the rare cinchona tree. 5823-092-9. ture; cultivation; phytochemistry of the genus; Dutch Transatlantic Medicine Trade in the Provides a comprehensive overview of current chemistry of Lavandula oils; pharmacology and Eighteenth Century under the Cover of the knowledge in rniscletoe use from well-recognized therapeutic properties; use of lavender oil in West India Company, 2nd edition, edited by researchers from Argentina, England, Greece, aromatherapy, cosmetics, perfume, and food Alphons M.G. Rutten. Erasmus Publishing: Korea, Switzerland, Germany and the United processing; theory and practice of distillation Rotterdam; 2000. 198 pp., softcove.r. EUR27 Stares. It contains a series of expert dissertations and standardization of lavender oils. (±US$30) 78 I HerbalGram 58 2003 www.herbalgram .org Alternative Therapies for Human Welfare" confer ian Hotel and Sands exhibition center. Contact: Website: In this department of HerbalGram , we list resources such as publi cations, organizations, seminars, and networking for our readers. A listing in this section does nor constitute any endorsement or approval by HerbalGram, ABC, or its Advisory Board. Integrative Medicine: A Clinician's journal. extensive evaluation of safery of this popular botan Salvia divinorum, a new magazine focusing on the Formerly rhe International journal of Integrative ical to date. Website: GMPs Manufacturing, Packing, o r Holding Association; Apr 30, 2003. Dietary Supplemenrs: Proposed Rule. 12. Letter to FDA proposing 60-day extension Continued from page 65 Federal Register Volume 62, No. 25, Docket of public commenr period for proposed No. 5700-9. Washington, DC: Food and GMP rules. Docker No. 96N-0417. Amer and is publisher and editor ofHerbaiGram. Drug Administration. February 6, I 997. ican Herbal Products Association, National Daron Wtztts is a partner in the Los Angeles 7. Therapeutic Goods Act, Schedule 5: Ther N utritional Foods Association, Utah office of Sidley Austin Brown & Wood LLP, apeutic goods exempt from the operation of Natural Products Alliance. April 21, 2003. where he practices in the food and drug law Parr 3-2 of the Act, Subregularion 12(1). 13. C urrent Good Manufacturing Practice in and litigation groups. Canberra, Australia: Therapeutic Goods Manufacruring, Packing or Holding Administration; I990. Dietary lngredienrs and Dietary Supple 8. United States of America vs. Two Plastic menrs: Proposed Rule; Esrension of Reference: Drums, More or Less of An Article of Food, Comment Period. Federal Register Vol. 68, I. Currenr Good Manufacturing Practice in Labeled in Parr: Viponte Ltd. Bl ack No. 96, Docket No. 96N-0417. Washing Manufacturing, Packing or Holding C urranr Oil Barch Number BOOSF 039, ron, DC: Food and Drug Administration. Dietary lngredienrs and Dietary Supple etc., and Traco Labs Inc. United States May 19, 2003. menrs: Proposed Rule. Federal Register Vol. District Court, Central District of Illinois, 14. Blumenthal M. FDA accepts supplement 68, No. 49, Docket No. 96N-04 I 7. Wash Number 88-2398. industry GMP proposal: new good manu ington, DC: Food and Drug Administra 9. United States of America vs. Two Pl astic facturing practices required under OSHEA tion. March 13, 2003. Drums, More or Less of An Article of Food, ro be published for public comment. 2. FDA Proposes Labeling and Manufactur Labeled in Parr: Viponre Ltd. Black Herbal Gram 1996;38:27-8. ing Standards for All Dietary Supplements C urrant Oil Barch Number BOOSF 039, 15. McCaleb R. FDA publishes proposed regu [p ress release]. Washington, D.C.: Food etc., and Traco Labs Inc. United States lations for good manufacturing practices and Drug Administration, March 7, 2003. Court of Appeals, Seventh Circuit, for dietary supplements. Herba!Gram 3. Anon. New rules from FDA offer little Number 92- I 172. 1997:40:24-6. supplemenr safety aid. Wall Street journal I 0. Blumenthal M. Firm wins appeal in black 16. Soll er RW. Regulation in the herb market: Online March II , 2003. currant oil case: court chides FDA's "Alice the myth of the "unregulated industry." 4. McNeil DG, DayS. FDA to put new rules in-Wonderland" approach. Herba!Gram Herba!Gram 2000;49:64-7. on dietary supplemenrs. The New York 1993;29:38-9. Times March 8, 2003. II. AHPA attends FDA meeting on proposed 5. Marcus OM , Grollman AP. Botanical cGMP; regional AHPA-sponsored meet medicines: the need for new regulations. N ings proposed [AHPA Update]. Silver Eng! j Med 2002;347(25):2073-6. Spring, MD: American Herbal Products 6. C urrent Good Manufacturing Practice in 80 I Herba!Gram 58 2003 www.herbalgram.org Natural Medicine Comprehensive Database 2nd Cancer Research edition. Compiled by the editors of Pharmacist~ Legai/Regulatol:l' Natural Compounds In Cancer Therapy: Letter and Prescriber ~ Letter. 2000. Contains a listing Herbs of Commerce 2nd edition. ed. by M. McGuffin, Promising Nontoxic Antitumor Agents from for almost every natural medicine sold in the U.S. J. Kartesz, A. Leung, and A. Tucker. 2000. Destined to Plants and Other Natural Sources by John Boik. and Canada and a li sting for every product be the "de facto standard by which all plant common 2001. Presents a solid scientific basis for the use of discussed in any reputable reference. Information and scientific names will be determined on all natural compounds in cancer treatment. Includes covered includes name of product, also known as, products containing herbs" (Christopher Hobbs), this in-depth discussions of cancer at the cellular level scientific names, uses, safety, effectiveness, possible edition lists Latin binomials, Standardized Common and the level of the organism, as well as clinical mechanisms of action and active ingredients, Names, Ayurvedic, Chinese (pinyin), and other considerations covering trace metals, vitamin C and adverse reactions including known allergies, common names for 2048 species, including 25 fungi antioxidants, polysaccharides, lipids, amino acids possible interactions, typical dosages and common and 23 seaweeds. A must-have for anyone who and related compounds, flavonoids, nonflavonoid modes of administration, and other comments. writes about or manufactures herbal products. phenolic compounds, terpenes, lipid-soluble Softcover, 1,3 10 pp. $92. #B463 Access to web Hardcover, 421 pp. $95. #B475 vitamins, and the effects of natural compounds on version for 1 year, updated daily. $92. #D008 Both chemotherapy and radiation therapy. Softcover, book and web access. S132 . #B463C Sc~le(l ·!Toxicolor;{y 521 pp. $32. #B494 PDR for Nutritional Supplements 1st edition. 2001. Provides detailed Botanical Safety Handbook: Guide for Safe Clinical/Therapeutic information on each nutritional Use and Labeling for Herbs in supplement including clinical Commerce ed. by M. McGuffin, C. The Clinician's Handbook of Natural Medicine by research summary; scientific .ABc Members Hobbs, R. Upton, and A. Goldberg. Joseph Pizzorno Jr., Michael Murray, and Herb and common names; 1997. Provides safety data on more Joiner-Bey. 2002. Provides an easily accessed set of now receive a chemica l and physical than 550 herbs as guidelines for decision-making flowcharts and summary attributes; indications and product labels, including information based on the best available evidence 1 0% discount usage; pharmacology and contraindications, side effects, and on natural medicine options, including herbs, on all orders! pharmacokinetics; precautions, special warnings. Each herb is classed supplements and dietary advice. Covers 74 adverse reactions and as can be safely consumed when used common diseases and includes scientifically verified contraindications; potential interactions with appropriately, herbs with the following therapies. Softcover, 522 pp. $39.95 . #B506 drugs, food, alcohol, and herbs; and dosage and restrictions, for external use only, or not to be used The Desktop Guide to Complementary and administration. Hardcover, 575 pp. $59.95. #B 500 during pregnancy. Hardcover, 256 pp. $44.95. #B275 Alternative Medicine: an Evidence-Based PDR for Herbal Medicines 2nd edition. 2000. Essential Oil Safety by Robert Tisserand and Tony Approach ed. by Edzard Ernst, Max Pittler, Clare Updated to include the latest scientific findings, Balacs. 1995. Up-to-date research findings. Practical, Stevinson, and Adrian White. 2001 . Offers concise clinical trials (including abstracts), case reports, and comprehensive guide. Detailed profiles of 95 information on 64 popular CAM diagnostic meta-analysis results. More detailed monograph essential oils, including constituents, hazard s, methods and treatments; summarizes clinical trial sections on herb/drug interaction side effects, dosage, toxicity data and contraindications; brief data on the effectiveness of CAM for 38 specific contraindications, precautions, adverse reactions, safety profiles of 311 essential oils and 135 essential conditions; weighs the benefits and risks of each and dosage. Hardcover, 858 pp. $59.95 . #B474 oil components; sa fety guidelines, details of CAM treatment; and includes a CD-ROM of the book essential oil absorption, metabolism and excretion; that links to Medline. Softcover, 444 pp. $36.95. Principles and Practice of Phytotherapy by Simon oils which may react adversely with certain drugs; #B501 Mills and Kerry Bone. 2000. Detailed, practical, and and extensive references. Hardcover, 279 pp. $55. research-based approach to the use of herbal Evidence-Based Herbal Medicine by Michael #B169 treatments in a wide variety of clinical conditions Rot blatt, MD, and Irwin Ziment, MD. 2002. Analyzes and problems. Includes a clear description of the Herb Contraindications and Drug Interactions 3rd a large quantity of the primary literature on principles and foundations for the practice of edition. by Francis Brinker, N.D.2001.1nformation on controlled clinical trials and provides reliable and phytotherapy; in-depth and detailed profiles of 240 traditional therapeutic herbs explaining practical information on the uses, pharmacology, over 45 herbs, reviewing pharmacology, research, documented contraindications and drug efficacy, and adverse effects of approximately 65 and traditional use; therapeutics for actual disease interactions. Appendices identify even more herbs herbal medicines and a few non-herbal dietary states, supported by case histories; and coverage of as they affect certain conditions and medicines. supplements. Softcover, 464 pp. $29. #B516 challenging issues such as dosage, safety, and drug Softcover, 432 pp. $25.95 #B282 Herbal Medicine 2nd edition. by Rudolf Fritz Weiss, herb interactions. Fully referenced with more than The Toxicology of Botanical Medicines 3rd edition. M.D. 2000. The now classic text used by M.D.s in 4,000 citations. Hardcover, 643 pp. $82.95. #B441 by Francis Brinker. 2000. Provides essential Germany. An indispensable modern text in medical information for a basic knowledge of human herbal ism. Many herbs are illustrated. Plant drugs General Herbals reactions to certain plant toxins. A concise are arranged by clinical diagnoses relating to compilation of traditional knowledge and up-to particular systems. Softcover, 362 pp. $59. #B006 New Encyclopedia of Herbs and Their Uses 2nd date information on the toxic effects of plants and edition. by Deni Bown. 2001. The Royal plant extracts that may be used medicinally. Reviews Herbal Medicine - Classic Edition by Rudolf Fritz Horticultural Society's new edition of the most the toxicology of medicinal plants as noted in Weiss, M.D. 2000. This is a key text in the field of comprehensive illustrated encyclopedia of herbs. American pharmacology, pharmacognosy and phytotherapy, used by both herbalists and medical More than 1000 species, varieties, hybrids, and botanical medicine texts and is updated with recent professionals. Arranged by clinical diagnoses cultivars listed alphabetically by genus. Addresses publication and articles from medical journals. related to organ systems, with guidelines for culinary, medicinal, and economic properties of Softcover, 296 pp. $35. #B491 prescribing herbal remedies, sections on dosage, each herb along with cultivation information. More application and precautionary measures. than 1500 color photographs by the author. Proprietary formulations, full references, and a Hardcover, 456 pp. $40. #B 156 comprehensive subject index of almost 2,000 entries round out the coverage. Softcover, 362 pp. $49.#B006A To order, call toll free 800/373-7105, fax 512/926-2345, email: [email protected] or order online at www.herbalgrarn.org to see the complete Herbal Education Catalog and AMERICAN BoTfoNICAL to see special offers, visit us onlne at: COUNCIL www.herbalgram.org/bookcatalog - --1·--- n.. "-ricao -.! CC>UOCil Get the Facts with T Ht A BC CLINICAL GU IDE T O The ABC Clinical Guide to Herbs HERBS or healthcare professionals, researchers, consumers and retailers, it Fclarifies the evidence concerning the safe and effective use of herbs for prevention and treatment of conditions and diseases. This reference work delivers information about 29 commonly used herbs and 13 proprietary products: l~ Answer Complex Patient Questions t~ Review the Latest Clinical Research l~ Access Information in a Clinical Setting "This volume deserves l~ Give Patients Accurate Information to Take Home to stand alongside t~ Utilize a Reference Reviewed by Health Professionals Gray's Anatomy as one of the defining texts l~ Identify Brand-named Products Backed by Clinical Research of medicine." t~ Obtain Continuing Education Credits - Larry Dossey, MD l~ Understand safety and regulatory issues Executive editor, Alurnative Therapies in t~ ABC Members receive 1 0% discount Health and Medicine Author, Reinventing Medicin e, Healing Beyond the Body, and Healing WOrd Order now for $49.95 (plus shipping and handling) Exclusive Worldwide Trade Distributor To order, please call 800-373-7105, ext.118 or Thieme Medical Publishers ~1\MERICAN 800-782-3488, 212-760-0888 visit www.herbalgram.org 8oT,A.NICAL Fax.212-947-1112 · COUNCIL Thieme or visit www.thieme.com F=====l P.O. 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