ON THE CovER Licorice Glycyrrhiza glabra L. G. uralensis Fisch. ex DC. and G. inflata Batalin (Chinese licorice ), G. echinata L. (East European licorice), and other species of Glycyrrhiza Family: Fabaceae

INTRODUCTION Most of the natural licorice imported to the United States today is used to flavor tobacco products.1 Licorice root extract is used i cori~e is nativ~ to ~he Mediterranean, central-to-southern Russta, and Asta Mmor to Iran, and it is now widely culti­ in cough drops, syrups, laxatives, and nicotine lozenges, and it is Lvated throughout Europe, the Middle East, and Asia.! It added to foods to sweeten them. The root is added to teas and is a perennial with aggressive laterally spreading roots and loose can be purchased dried, sliced, or powdered} The root is also sold spikes of pale blue to violet pea flowers in summer.2 The roots or in capsules, tablets, tinctures, and other dietary supplements for stolons (underground horizontal stems) are the most commonly traditional uses or as a flavoring.5 Licorice preparations are added used plant parts and can be harvested after 3 to 4 years of to candy, cakes, ice cream, and packaged desserts, but most of the growth. I candy sold in the United States today as licorice is flavored with a synthetic licorice or flavorings made from anise (Pimpinella HISTORY AND CULTURAL SIGNIFICANCE anisum L., Apiaceae).3 Dioscorides, a first-century Greek physician, coined a name MODERN RESEARCH that was later developed into the genus name Glycyrrhiza, which is derived from a combination of the Greek words, glukos (sweet) Licorice is one of the most extensively researched medicinal and 1 and riza (root) .1 One of the main constituents of the root is food planrs. Studies on licorice have demonstrated positive effects glycyrrhizin (also known as glycyrrhizic acid or glycyrrhizinic for treatment of various types of ulcers and chemoprevention.G acid), which is about 50 times sweeter than sucrose (common Other studies indicate the following: (I) dietary consumption sugar).1 The Roman name, gliquiricia, of licorice root extract may help to lower which became liquiritia, evolved over the cholesterol and act as an antioxidant,6,7 years into licorice} (2) compounds in licorice inhibit sero­ Ancient Arabs used licorice to treat tonin re-uprake and may be useful in the coughs and to relieve constipation.! treatment of mild to moderate depres­ Theophrastus, an ancient Greek physi­ sion in women,S and (3) licorice may help cian and botanist (circa 371 - 286 BCE), reduce body far mass.9 One study suggests documented the use of licorice to assist that topical application of licorice extract with coughs and asthma. Since 25 CE, may be effective in treating the itching the Chinese have used the herb exten­ and inflammation associated with derma­ sively to relieve and prevent cough and titis.10 as an expectorant, as well as an adj u­ Persons with cholestatic liver disorders, vant in many herbal formulas. It also liver cirrhosis, hypertension, hypokalemia relieves spasms of the smooth (involun­ (low levels of potassium in blood), severe tary) muscles and exhibits a cortisone­ kidney insufficiency, and possibly diabe­ like action. Licorice has a long history as tes (unconfirmed contraindication) should a common remedy in Ayurvedic medicine consult a healthcare provider before using 6 for its expectorant, ami-inflammatory, licorice. Licorice is not recommended and laxative properties. The German during pregnancy, as heavy exposure to Commission E approved licorice root for glycyrrhizin may double the risk of birth 11 inflammations of the upper respiratory before 38 weeks. tract and stomach ulcers. I No adverse effects have been associ­ Until around 1000 CE, licorice was ated with licorice root preparations when collected mainly in the wild, which is still used appropriately. Prolonged use (longer a common practice in China.1 Cultivation was recorded in Bolo­ than 6 weeks) and higher doses (generally greater than 50 g gna, Italy, in the 13th century, in Bavaria in the 16th century, and per day) may lead to sodium retention, water retention, and in Northern England by the end of the 16th cenrury.4 potassium loss, all of which may be accompanied by hyperten-

Continues on page 4 Photo by Steven Foster. ©2006 stevenfoster.com www.herbalgram.org 2006 HerbaiGram 70 I 1 There's not one reason to join ABC, there are hundreds - front Aloe to Witch Hazel

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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat cure or prevent any disease. LICORICE advisory board Continued from page 1 Each issue of Herba/Gram is peer reviewed by members of our Advisory Board and other qualified experts before publication. sion, edema (swelling), hypokalemia, and in rare cases, myoglobinuria (excretion of Cindy K. Angerhofer, PhD Steven Dentali, PhD the m uscle's oxygen-tra nsporting protein, Director of Botanical Research, Aveda Institute, Vice President of Scientific and Technical Affairs, myoglobin, in the urine) .6 Side effects are less Minneapolis, Minnesota American Herbal Products Association, Silver Spring, likely with aqueous licorice root extract than John Thor Arnason, PhD Maryland with isolated glycyrrh izin d ue to the lower Professor of Biology, Department of Biology, Hardy Eshbaugh, PhD intestinal absorption when consumed as part University of Ottawa, Ontario, Canada Professor of Botany & Assistant Curator, Willard of the total extract.1 2 Dennis V. C. Awang, PhD, FCIC Sherman Turrell Herbarium, Miami University, In 2 separate cases, pulmonary edema and MediPiant Natural Products Consulting Services, Oxford, Ohio life-th reatening ventricular tachycardia (rapid White Rock, B.C., Canada Trish Flaster, MS heart beat) due to hypokalemia occurred as a Bruce Barrett, MD, PhD Executive Director, Botanical Liaisons, LLC, Boulder, CO result of overdoses of black licorice-flavored Assistant Professor of Family Medicine, Joe Graedon, MS candy. Dietary supplements are available that Un iversity of Wisconsin-Madison Medical School Author, syndicated columnist, radio host, contain licorice extracts w ith the glycyrrhizin Marilyn Barrett, PhD Durham, North Carolina removed. T his eliminates some of the poten­ Pha rmacognosy Consulting Service, Charlotte Gyllenhaal, PhD tial adverse effects associated w ith consump­ San Carlos, California Research Assistant Professo r, College of Pharmacy, tio n of relatively large amounts of licorice (as Ezra Bejar, PhD University of Illinois at Chicago; Research Program noted above). Director ofTechnical Sciences, Herbalife International, Manager, Block Center for Integrative Cancer Care, Licorice may potentiate the side effects In c., Los Angeles, CA Evanston, IL of potassium-depleting thiazide diuret­ ics (e.g., chloroth iazide, chlo rthalidone, Bradley C. Bennett, PhD Mary Hardy, MD Associate Professor of Biology, Florida International Director, Cedars-Sinai Integrative Medicine Medical hyd rochlorothiazide, and metolazone). University, Miami Group, Los Angeles, California With potassium loss, sensitivity to digitalis glycosides (heart medications, e.g., digoxin, Josef Brinckmann Christopher Hobbs, LAc, AHG VP of Research and Development, Traditional Herbalist, botanist, licensed acupunctu rist, lanoxin) increases. Licorice should not be Medicinals, Inc., Sebastopol, CA Davis, California combined w ith corticoid treatment.6 HG Francis Brinker, NO David Hoffmann BSc, FNIMH Clinical Assistant Professor, Department of Medicines, Medical Herbalist, Author, and Research Associate -Gayle Engels Traditional Medicinals, Sebastopol, California Program in Integrative Medicine, University of Arizona, REFERENCES Tucson Maurice M. lwu, PhD 1. Blumenthal M, Goldberg A, Brinckmann J, Donald J. Brown, NO Bioresources Development and Conservation ed itors. Herbal Medicine: Expanded Commis­ Director, Natural Products Research Consultants, Program, Senior Research Associate at the Division of sion E Monographs. Austin, TX: American Seattle, Washington Experimental Therapeutics, Walter Reed Army Institute Botanical Council; Newton, MA: Integrative of Research, Washington, D.C. Thomas J.S. Carlson, MS, MD Medicine Communications; 2000. Associate Adjunct Professor, Timothy Johns, PhD 2. Bown D. The Herb Society ofAmerica New Department of Integrative Biology; Director, Center for Professor, School of Dietetics and Human Nutrition; Encyclopedia ofHerbs & Their Uses. New York: OK Publ ishi ng, Inc.; 2001. Health, Ecology, Biodiversity, & Ethnobiology; Centre for Indigenous People's Nutrition and the Curator of Ethnobotany, University and Jepson Herbaria; Environment, McGill University, Montreal, Canada 3. Onstad D. Whole Foods Companion. White University of California, Berkeley Kenneth Jones River Junction, VA: Chelsea Green Publish­ ing Co.; 1996. Jean Carper President and Medical Writer, Armana Research, Inc, Halfmoon Bay, BC, Canada 4. Foster S, Yue C-X. Herbal Emissaries: Bring­ Author and syndicated columnist, Washington, D.C. ing Chinese Herbs to the West. Rochester, VT: Jerry Cott, PhD Edward Kennelly, PhD Healing Arts Press; 1992. Pharmacologist, U.S. Food and Drug Administration, Associate Professor and Chair, Department of Biological 5. Leung AY, FosterS. Encyclopedia of Common Center for Drug Evaluation and Research, Sciences, Lehman College, City University of New York, Natura/Ingredients Used in Foods, Drugs, and Rockville, Maryland Bronx, NY Cosmetics. New Yo rk: John Wiley and Sons; 1996. Paul Alan Cox, PhD lkhlas Khan, PhD Associate Professor of Pharmacognosy, Assistant 6. Blumenthal M, Hall T, Goldberg A, Kunz Executive Director, Institute for Ethnomedicine T, Dinda K, Brin ckmann J, Wollschlaeger Jackson, Wyoming Director, National Center for Natural Products Research, University of Mississippi, Oxford, MS B, editors. The ABC Clinical Guide to Herbs. Lyle E. Craker, PhD Austi n, TX: American Botanical Council; Professor, Department of Plant and Soil Sciences, Steven King, PhD 2003. University of Massachusetts, Amherst Vice President, PS Pharmaceuticals, Inc., 7. Fuh rman B, Volkova N, Ka plan M, et al. South San Francisco, California Antiatherosclerotic effects of licori ce extract Edward M. Croom, Jr., PhD Richard Kingston, PharrnD, CSPI supplementation on hypercholesterolemic Adjunct Associate Professor of Pharmacognosy, patients: Increased res istance of LDL to University of Mississippi, Oxford, Mississippi President, Regulatory and Scientific Affairs, Safety Call"' International Poison Center; Professor, Department of atherogenic modifications, reduced plasma Wade Davis, PhD Experimental and Clinical Pharmacology, College of li pid levels, and decreased systolic blood pres­ Explorer-in-Residence, National Geographic Society, Pharmacy, University of Minnesota, Minneapol is, MN. sure. Nutrition. 2002: 18;268-273. Washington, D.C. 8. Ofir R, Tamir S, Khatib S, Vaya J. Inhibition Thomas L. Kurt, MD, MPH of serotonin re-uptake by licorice constitu­ Clinical Professor, Department of Internal Medicine, ents. journal ofMo lecular Neuroscience. University ofTexas Southwestern, Dallas, Texas 2003:20(2); 135-140.

4 I HerbaiGram 70 2006 www.herbalgram.org 9. Armanini 0 , De Palo C B, Manerello MJ, et al. Effect of licorice on the reduction of body advisory board far mass in heal thy subjects. Journal of Endo­ crinological Investigation. 2003:26(7);646- (continued) 650. I 0. Saeedi M , Morreza-Semnani K, G horeishi M-R. T he treatment of atopic dermatitis Roberta A. Lee, MD Holly Shimizu with li co rice ge l. j ournal of Dermatological Medical Director, Co -Director Integrative Medicine, Executive Director, US Botanic Garden, Washington, DC Treatment. 2003 :1 4; 153 -1 57. Continuum Center for Health and Healing; Director of 11. Strandberg T O, Javenpaa A- L, Van hanen Victor Sierpina, MD Medical Education and Integrative Fellowship, Beth Associate Professor of Family Practice Medicine, H , McKeigue PM. Birth O utcome in Israel Medical Center, New York, NY relati on to li co rice consumption during University ofTexas Medical Branch, Galveston pregnancy. American j ournal ofEpidemiol­ Martha M. Libster, PhD, RN, CNS James E. Simon, PhD ogy. 2001;153(11):1085- 1088. C ited by: Associate Professor of Nursing and History, Purdue Professor of New Use Agriculture, Director of the Center Blumenthal M , H all T, Goldberg A, Kunz University, West lafayette, IN for New Use Ag ri culture and Natural Plant Products, T, Oinda K, Brinckmann J, Wollschlaeger Tieraona low Dog, MD Rutgers University, New Brunswick, New Jersey B, editors. The ABC ClinicaL Guide to Herbs. Clinical Asst. Professor, Director of Botanical Studies, Beryl Simpson, PhD Austin, TX: American Botani cal Council; Program in Integrative Medicine, University of Arizona C. l. Lundell Professor of Botany, Department of Botany, 2003. School of Medicine, Tucson, Arizona University ofTexas at Austin 12. Canrelli-Forti G, Maffei F, Hrel ia P, et Tom Mabry, PhD al. In teraction of li corice on glycyrrhizin S. H. Sohmer, PhD Professor of Plant Biochemistry, Department of Botany, pharmacoki netics. Environ Health Perspec­ President and Director, Botanical Research Institute of University ofTexas at Austin tives. 1994; I 02:65-68. C ited by: Blumenthal Texas, Fort Worth M , Hall T, Gold berg A, Kunz T, Oinda K, Gail B. Mahady, PhD Barbara N. Timmermann, PhD Brinckmann J, Wollschlaeger B, editors. The Research Assistant Professor, Department of Medical Chairperson-Professor of Medicinal Chemistry, Austin, TX: Chemistry & Pharmacognosy, College of Pharmacy, ABC CLinicaL Guide to Herbs. Un iversity of Kansas, lawrence, Kansas American Botanical Council ; 2003. University of Illinois, Chicago Arthur 0. Tucker, PhD Robin J. Maries, PhD Correction Research Professor of Agriculture and Natural Director of the Bureau of Research and Science, Natural Resources, Delaware State University, Dover T he byline fo r an article in HerbalGram 69 Health Products Directorate, Health Products and Food was inadve rtently omirred. O n T he Cover: Branch, Health Canada, Ottawa Nancy Turner, PhD Red C lover should have been credited to Professor and Ethnobotan ist, Environmental Studies Dennis J. McKenna, PhD Program, University of Victoria, British Columbia, Gayle Engels and Mededith Podraza. T he Executive Director, Institute for Natural Products Canada Ameri ca n Botanical C ouncil apologizes for Research; Senior lecturer, Center for Spirituality and this error. Healing, University of Minnesota, Minneapolis Daniel T. Wagner, RPh, MBA, PharmD Owner, Nutri-Farmacy, Wild wood, Pennsylvania Marc S. Micoui, MD, PhD Executive Director for Integrative Medicine, AndrewT. Wei!, MD Thomas Jefferson University Hospital, Philadelphia, PA; Author, Director ofthe Program in Integrative board of trustees Director, Policy Institute for Integrative Medicine, Medicine and Associate Director of the Division of Washington, DC Social Perspectives in Medicine, College of Medicine, Michael J. Balick, PhD Un iversity of Arizona, Tu cson Director and Philecology Cu rator, New York Botanical Daniel E. Moerman, PhD Garden, Bronx, New York William E. Stirton Professor of Anthropology, Bernd Wollschlaeger, MD University of Michigan/Dearborn Family practice physician; Clinical Assistant Professor Neil Blomquist of Medicine and Family Practice, University of Miam i, President, Sustainable Solutions Consulting Services William Obermeyer, PhD School of Medicine, Florida Sebastopol, California Vice President of Research and Technology, Consumerlab.com, Annapolis, Maryland Jacqueline C. Wootton, MEd Peggy Brevoort President, Alternative Medicine Foundation, Inc. President, Brevoort, ll(, Kapa 'au, Hawaii Samuel W. Page, PhD Director, HerbMed• HerbMedPro™, Potomac, MD Scientist, International Programme on Chemical Safety, Norman R. Farnsworth, PhD World Health Organization, Geneva, Switzerland Research Professor of Pharmacognosy, Senior University Scholar, University of Illinois at Chicago Joseph E. Piuorno, Jr., NO ad hoc advisor: President Emeritus, Bastyr University, Seattle, Steven Foster David M. Eisenberg, MD Washington, and Ed itor, Integrative Medicine: A President, Steven Foster Group, Inc., Brixey, Missouri Director, Osher Institute, Oinician'sJournal Di vis ion for Research and Education in Complementary Fredi Kronenberg, PhD Mark J. Plotkin, PhD and Integrative Medical Therapies, Director, Rosenthal Center for Complementary and Author, Executive Director, Amazon Conservation Team, Harvard Medical School, Boston, Massachusetts Alternative Medicine, Columbia University College of Arlington, Virginia Physicians and Surgeons, New York John M. Riddle, PhD Morris Shriftman Professor of History, Department of History, CEO, Mozart, Inc., San Rafael, California North Carolina State University, Raleigh James A. Duke, PhD {emeritus) Eloy Rodriguez, PhD Botanical Consultant, Economic Botanist (USDA, ret.), James Perkins Professor of Environmental Studies, Herbal Vineyard Inc. I Green Farmacy Garden, Fulton, School of Agriculture & life Sciences, Cornell University, Maryland Ithaca, NewY ork Mark Blumenthal {ex officio) Founder and Executive Director

www.herbalgram .o rg 2006 HerbaiGram 70 I 5 dear reader American Botanical Council here's been mounting concern about how the media reports and/or misreports results of clinical trials on herbs and other dietary supplements. This trend received additional Mark Blumenthal T impetus this past summer with the publication of a negative trial on an echinacea Founder and Executive Director preparation in the prestigious New England journal of Medicine. Further evidence of this Wayne Silverman, PhD trend occurred when the same journal recently published a negative trial on the revered pros­ Chief Administrative Officer tate remedy saw palmetto. We received calls from health professionals and (of course) some Sean Barnes industry execs who were concerned and disappointed at the way the media was portraying the Art Director negative results of this saw palmetto trial (see our summary in Research Reviews on page 34 Gayle Engels in this issue). Education Coordinator But perhaps the final straw occurred in February when the Glucosamine Michael Finney Arthritis Intervention Trial (GAIT) was published in the same journal. Herba!Gram Managing Editor Although this trial does not concern a botanically-derived dietary supple­ Lori Glenn ment ingredient, rhe way the media reported the results of this trial HerbCiip Managing Editor has energized people not only in the supplement industry, but numer­ ous health professionals and researchers as well. They are upset because Cassandra Johnson HerbaiEGram Managing Editor though the majority of the 1500+ patients in the trial who suffered from mild to moderate osteoarthritis (OA) did not experience greater Nancy Moon benefits from either glucosamine sulfate, chondroitin, or a glucosamine­ Executive Assistant chondroitin combination (compared to placebo) , a subset of patients Ellyn Polis with moderate to severe OA did experience a significant benefit from the Receptionist/Administrative supplement combination compared to placebo and a leading drug. This last point was all bur Assistant ignored in the media. George Solis And then, to make matters worse, the Associated Press and the Wall Street journal published HerbCiip Production Assistant "review" articles in which the bottom line results of numerous trials on herbs and other Nathanael Sponseller supplements were uncritically lumped together to erroneously suggest that the growing body Gardener of evidence does not support their benefits, and even worse, that some vitamins may actually Cecelia Thompson be harmful. As we have stated previously, members of the media need to be more careful and Finance Coordinator accurate in reporting the results of clinical research on dietary supplements. Aileen Truax In this iss ue we present two guest editorials that deal with an important element related to Development/Marketing this controversy, i.e., at least insofar as how to interpret the results from many recent clini­ Coordinator cal trials on herbs, particularly those with negative outcomes. Professor Edzard Ernst of the Margaret Wright University of Exeter, one of the world's most prolific authors of systematic reviews and meta­ Accounting Coordinator analyses on herbs and complementary and alternative medicine (CAM) therapies, takes a look at the economic implications of herbs and other CAM modalities. After listing numerous significant costly diseases and their potential herbal therapies, Ernst calls for more research in this field, despite some suggestions in op-ed pieces in major medical journals to the contrary. "What we need is not less but more research to define more closely the true value of herbal and other CAM therapies which are supported by encouraging but nor (yet?) conclusive evidence," Ernst writes. "Unless there is dramatic change in the direction of research fund­ ing, the current uncertainty is here to stay for many years. And each year this uncertainty will cost us billions." With respect to recent confusion surrounding the efficacy of various types of echinacea preparations, Dr. Bruce Barrett of the University of Wisconsin-Madison Medical School, an authoritative expert on the clinical literature on echinacea and a member of the ABC Advisory Board, interprets two recent meta-analyses on echinacea trials. After acknowledging some of the contradictory evidence on various recent clinical trials conducted on different echinacea preparations, Dr. Barrett concludes, "it is clear that the majority of evidence still favors some 1\tv\ERICAN treatment effect." Although lamenting that the totality of clinical data were not more compel­ BOTfo.NICAL ling in favor of echinacea, he cautiously acknowledges, "What I can state with reasonable COUNC IL certainty is that effects on the immune system appear real, and that the safety profile appears favorable." The relative safety and benefits of any herb are not going to be established in any single clini­ Mission: Provide education cal trial, especially as it may be misreported to the public by the media. A rational review of the using science-based and traditional totality of the historical, pharmacological, and clinical evidence must be evaluated to deter­ information to promote responsible mine an herb's safety and efficacy, and this too should be properly and fairly reported. HG use of herbal medicine-serving the public, researchers, educators, healrhcare professionals, industry, and media.

6 I HerbaiGram 70 2006 www.herbalgram.org Burgundy Botanical Extracts

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Contributing Writers Dennis V. C. Awang Bruce Barrett features Ezra Bejar Golden Flower of Prosperity: Oregon's Kam Wah Chung Museum Displays Rare Collection Josef Brinckmann of Chinese Herbal Artifacts Donald J. Brown by Courtney Cavaliere William Lee Cowden The Kam Wah Chung museum in John Day, OR, displays a collection of over 500 herbal artifacts that were Edzard Ernst used in the medical practice of Chinese immigrant "Doc" Hay. The museum building was once the home and Ed Fletcher 40 business of Doc Hay, who worked as an herbal healer from the late 1880s to mid-1900s, treating a wide variety Chandra Prakash Kala of patients in Oregon and beyond. This article describes the history, contents, and cultural significance of this national landmark, as well as its future needs and restoration plans. David La Luzerne James McGraw Preserving Ayurvedic Herbal Formulations by Vaidyas: The Traditional Healers of the Michael Mcintyre Uttaranchal Himalaya Region in India Brenda Milot by Chandra Prakash Kala Maryellen Molyneaux One of the world's most enduring medical systems, Ayurveda has been practiced widely and studied HeatherS. Oliff extensively throughout India since antiquity. Its reputation as a holistic approach to healing has generated increased attention in the West. The herbs used in Ayurvedic formulations are particularly interesting because Marissa Oppel 42 of their economic potential within the global herb market. Unfortunately, some traditional Ayurvedic practices Stephanie Pohl appear to be entering a state of decline, in part because of the declining knowledge of how to prepare the complex Eric Yarnell traditional Ayurvedic formulas. This article reports on a study that documents knowledge held by the traditional herbal healers-known as vaidyas- focusing primarily on their understanding of Ayurvedic formulations. Also examined are some Herba/Gram Staff of the challenges currently faced by both vaidyas and Ayurvedic practice in general. Mark Blumenthal Government Increases Restrictions on Wild Editor I Publisher American Ginseng Export: Minimum Harvest Age Extended to 10 Year-old Roots Michael Finney Ma nag ing Editor by Mark Blumenthal The US Fish and Wildlife Service placed new Sean Barnes restrictions on the export of wild American Art Director 52 ginseng roots in August 2005, increasing Steven Foster the minimum age requirements of exported Associate Editor plants from 5 to 10 years. This article examines wild ginseng conservation issues, its harvest and exportation, and the Rakesh Amin reasons cited by regulatory officials for enacting the new Legal & Regulatory Editor restrictions. Further, it presents perspectives from two experts on wild ginseng populations-one an expert on wild medicinal Maureen Jablinske plant production and the other a botanist specializing on Proofreader natural and human-induced stresses on native plants of Nancy Dennis economic importance. Editorial Assistant Tamiflu and Star Anise: Courtney Cavaliere Securing Adequate Supplies of the Oral Editorial Intern Antiviral for Avian Flu Treatment

Cynthia Crimmins by Dennis II. C. Awang, PhD, FC/C, and Mark Blumenthal Editorial Intern Increased concerns over the possible spread of the avian flu virus have led to massive production Lance Lawhon of the prescription drug Tamiflu over the Adverti sing Sales 58 past few years. Tamiflu's manufacturer, Roche 877-832-1881 Pharmaceuticals, announced that it will produce greater [email protected] quantities of the drug, but there are concerns regarding American ginseng Panax quinquefo/ius short supplies of shikimic acid- a key ingredient ofTamiflu. A Photo ©2006 stevenfoster.com popular source of shikimic acid is Chinese star anise, yet this plant is difficult to cultivate, matures slowly, and is relatively scarce. This article describes such difficulties in manufacturing Herba/Gram• is printed Tamiflu and discusses possible alternative sources for shikimic acid. on recycled paper at Branch-Smith Printing, Ft. Worth, Texas departments

10 ABC News 62 Legal & Regulatory ABC Adds New Members to Advisory Board Proposed Quality Control Guidelines for the EU Directive on Traditional Herbal Medicinal Products: Implications for Small­ ABC's Celebration and Botanical Awards Banquet a Huge to Medium-Sized Enterprises Success Recent Magazine Cover Articles Feature ABC's Mark Blumenthal 68 Market Report ABC Employee Profile: Michael Finney Integrated Herbal Supplement Users: Their Pathways to Usage Pharmacy Intern Participates in Upgrading ABC Demonstration Gardens 70 Book Reviews ABC's 2006 Amazon and Machu Picchu Ethnobotanical Tour Natural Standard Herb & Supplement Handbook: The Clinical Bottom Line 18 Organization News Natural Standard Herb & Supplement Reference: Evidence-Based NDI Notifications Database Developed by AHPA and NPicenter Clinical Reviews HerbDay 2006 Off to a Good Start Complementary and Integrative Therapies for Cardiovascular Disease 20 Grants & Awards Understanding Medicinal Plants: Their Chemistry and Therapeutic Action Enzymatic Therapy, Inc. Named "Manufacturer of the Year" by Nutrition Industry Executive Complex Herbs- Complete Medicines: A Merger of Eclectic & Naturopathic Visions of Botanical Medicine. 21 Research & World News New Book Profiles American Ginseng Being Tested for Cancer-Related Fatigue Sativex• Cannabis Oral Spray Accepted in Canada and 76 In Memoriam Approved for US Clinical Trials Enid A. Haupt New Organization to Develop Quality Standards for African Maurice Hanssen Herbs Silena Heron WHO Atlas Provides Global Perspective on Traditional and CAM Trends 78 Calendar

28 Research Reviews 79 Access Kudzu Extract Reduces Alcohol Consumption in Heavy Drinkers in Small Trial 80 Classifieds Review ofTrials Shows Peppermint Oil Capsules to be Effective in Treating IBS Correction The byline for an article in 69 was inadvertently COLD-fX•, Special Patented Extract of American Ginseng Root, HerbaiGram omitted. On The Cover: Red Clover should have been credited Treats Cold Symptoms in Canadian Trial to Gayle Engels and Mededith Podraza. The American Botanical Supercritical C02 Extract of Feverfew Leaf Effective for Migraine Council apologizes for this error. Saw Palmetto Extract Does Not Produce Benefits in Treatment of Moderate to Severe BPH in Clinical Trial

36 Guest Editorials New Review on Echinacea Reinvigorates Debate on Evidence of Popular Herb's Benefits The Unaffordable Cost of Not Funding Research in Herbal Medicine

Subscriptions to Herba/Gram are a benefit of ABC membership at every level. One year memberships: Individual $50; Academic $1 00; Professional $150; Organization $250; Retailer $250; HerbCiip Service $500; Corporate; Sponsor. Add $20 for memberships outside of the U.S. Student and Senior discounts are available. For information about Corporate or Sponsor Memberships, contact Wayne Silverman, PhD, at [email protected] or 512-926-4900. 0 2006 American Botanical Council. ISSN #0899-5648. Printed in the U.SA. The information in Herba/Gram• is intended for educational purposes only and is not a substitution for the advice of a qualified healthcare professional. Although we attempt to ensure that advertising in Herba/Gram is truthful and not misleading, the publication of an ad for a product or company in Herba/Gram does not constitute an endorsement by ABC of the product or the company being advertised. Publication of an ad that makes a health claim or structure-function claim does not necessarily constitute an approval of that claim by ABC. Further, ABC has not reviewed any manufacturer's Good Manufacturing Practices. ------~l~_A_B_CN_e_ws__ J~------

ABC Adds New Members to Advisory Board he American Botanical Council (ABC) has recently added 13 new members to its Advisory Board. The latest advisors include experts from the broad field of sciences and academic disciplines related to herbs and medicinal plants. These include the T areas of botany, ethnobotany, horticulture, analytical chemistry, clinical medicine, integrative medicine, nursing, pharmacol­ ogy, and toxicology, as well as informatics and quality control issues.

"We are deeply grateful that these herbal Medicine: Expanded herbal medicine in medicine experts and clinicians have Commission E Mono­ the Colleges of Medi­ accepted our invitation to join the ABC graphs (IMC, 2000) cine and Pharmacy Advisory Board," said Mark Blumenthal, and The ABC Clini­ at the University of Founder and Executive Director of ABC. cal Guide to Herbs Illinois at Chicago, "In many cases, the appointments simply (ABC, 2003) and co­ and she is a co-inves­ formalize long-term relationships and translator and editor tigator of the Inter­ friendships. Many have already contrib­ of the recent edition national Cooperative uted their time and expertise to assisting of Herbal Drugs and Biodiversity Group ABC staff in the editorial development of Phytopharmaceuticals: Brinckmann project, "Studies on Gyllenhaal numerous articles for ABC's publications, A Handbook for Prac- Biodiversity of Viet- such as HerbalGram, HerbClip, and The tice on a Scientific Basis (Medpharm, 2004) nam and Laos." ABC Clinical Guide to Herbs." and Medicinal Spices: A Handbook of Culi­ In addition to numerous other duties, nary Herbs, Spices, Spice Mixtures and their Ken Jones: President and Medical Writer, the primary role Advisory Board members Essential Oils (Medpharm, 2006). He also Armana Research, Inc., Halfmoon Bay, play at ABC is participating in the peer edits the Medicinal Plants and Extracts B.C., Canada. Mr. Jones is co-author of review of ABC publications. However, newsletter for the Market News Service of Botanical Medicines: The Desk Reference they also assist in an advisory capacity, the International Trade Centre. for Major Herbal Supplements, 2nd Edition helping to determine ABC policy and (Haworth Press, activities. The 13 new members join the Trish Flaster, MS: Executive Director, 2002), a textbook 51 scientists, clinicians, and other experts Botanical Liaisons LLC, Boulder, CO. of extensive mono­ who currently comprise the ABC Advi­ Ms. Flaster worked in both the natu­ graphs on 33 herbs. sory Board. ral products and pharmaceutical indus­ He is also the author tries where she formalized botanical iden- of numerous books, New ABC Advisory Board Members tification systems, including Nutri­ Ezra Bejar, PhD: Director of Techni­ provided sourcing tional and Medicinal cal Sciences, Herbalife International, of unique botani­ Guide to Hemp Seed Los Angeles, CA. A pharmacologist with cals, completed Jones (Rainforest Botanical extensive expertise in the use of bioassays sustainability stud­ Laboratory, 1995), for botanicals and in evaluating the safety ies, and protected the Cat's Claw, Healing and effic acy of intellectual rights of Vine ofPeru (Sylvan Press, 1995), and vari- dietary supplements. native peoples with ous extensive reviews on herbs and related Dr. Bejar is also the whom she collabo­ natural ingredients. rates. She has served co-author of Herbs Flaster of Southern Ecua­ as the editor of the Edward Kennelly, PhD: Associate Profes­ dor: A Field Guide to newsletter for the sor and Chair, Department of Biological the Medicinal Plants Society for Economic Botany for 20 years, Sciences, Lehman College, City Univer­ sity of New York, of Vileabamba (LH and she is currently producing an online Bronx, NY. Dr. Press, 2001). He virtual herbarium to satisfy the new GMP Kennelly, whose work has written chapters requirements for the natural products Bejar for several books on industry. has been published in several scientific dietary supplements Charlotte Gyllenhaal, PhD: Research journals, is currently and currently serves as an editorial board Assistant Professor, Program for Collab­ researching botani­ member of the journals Phytomedicine and orative Research in the Pharmaceutical cals for women's Phytotherapy Research. Sciences, College of Pharmacy, University hea lth and cancer­ Josef Brinckmann: Vice-President of of Illinois at Chicago; Research Program chemopreventive Research and Development, Tradi­ Manager, Block Center for Integrative constituents from Kennelly tional Medicinals, Inc., Sebastopol, CA. Cancer Care, Evanston IL; Associate tropical fruits. Dr. Mr. Brinckmann is an expert on herb Editor, Integrative Cancer Therapies. In Kennelly's phytochemical analysis was the quality control and international herb addition to her research on integrative foundation of a recent HerbalGram arti­ monographs. He is co-editor of Herbal cancer care, Dr. Gyllenhaal lectures on cle entitled "85-Year-Old Black Cohosh

10 I HerbaiGram 70 2006 www.herbalgram.org ------~l__ A_B_CN_e_ws __ J~------

Root Still Contains Active Compounds" NY. Dr. Lee is the co-author/editor of cine, Thomas Jefferson University Hospi­ (HerbaiGram #66; 2005). Integrative Medicine: Principles for Practice tal, Philadelphia, PA; Former Director, (McGraw-Hill, 2004) and was one of rhe National Museum of Health and Medi­ Ikhlas Khan, PhD: Professor of first fe llows in Dr. Andrew Wei! 's Integra­ cine, Washington, DC. Dr. Micozzi has Pharmacognosy; Assistant Director, rive Medicine Program. Dr. Lee also holds authored and edited 16 textbooks, includ­ National Center for Natural Products an honorary fel lowship at The New York ing the textbook Fundamentals of Comple­ Research, University of Mississippi, Botanical Garden where she conducts mentary and Integrative Medicine, 3rd Oxford, MS. The research on the traditional uses of botani­ edition (Elsevier Hea lth Sciences, 2006). multilingual and cals in M icronesia. highly prolific Dr. Holly Shimizu, Executive Director, Khan is the Core United States Botanic Garden (USBG), Leader for research "We are deeply Washington, D.C. Ms. Shimizu is a groups examining former curator of analytical finger­ grateful that these the National Herb printing for stan­ Garden at the US dardiza tion of herbal herbal medicine experts National Arboretum. materials and prod­ She served as Manag­ Khan ucts. In recognition and clinicians have ing Director of the of his many scientific accepted our invitation to Lewis Ginter Botani­ publications on the chemistry of botani­ cal Garden in Rich­ cals, the International Society for Horti­ join the ABC mond, VA, for fo ur cultural Science presented Khan with irs yea rs before return­ 2005 Award for Meritorious Service. Prof. Advisory Board," said ing to rhe USBG in Shimizu Khan also directs an annual conference, Mark Blumenthal, 2000. For the las t 12 cosponsored by the University of Missis­ yea rs, Ms. Shimizu has worked as a special sippi and the US Food and Drug Admin­ Founder and Executive correspondent for The Victory Garden on istration on quality, safety, and efficacy of PBS. botanical dietary supplements. Director of ABC. Jacqueline Wootton, M.Ed., President Richard Kingston, Pharm D, CSPI: Pres­ and Director, Alternative Medicine ident, Regulatory and Scientific Affairs, Martha Libster, PhD, RN, CNS: Asso­ Foundation, Inc; Director, HerbMeds Safety CaW" International Poison Center; ciate Professor of Nursing and History, database and HerbMedProT" (the profes­ Professor, Depart­ Purdue University, West Lafayette, IN. sional ve rsion of rhe ment of Experimen­ Dr. Libster is author of Herbal Diplo­ database) . These tal and Clinical Phar­ mats (Golden Apple unique research tools macology, College of Publications, 2004) are a benefit of ABC Pharmacy, Univer­ and Integrative Herb membership at or sity of Minnesota, Guide for Nurses above the Academic Minneapolis, MN. (Delmar, 2001). The level. Ms. Wootton An acknowledged American Associa­ was the Executive expert on safety iss ues tion for rhe History Editor of the jour­ nal of Alternative & related to dietary King ston of N ursing awarded supplements and her the 2005 Lavinia Complementary Medi­ drugs, Dr. Kingston Dock Award for cine from 1996-2001 , Libster is also the director of the recently-formed Exemplary Historical and she is currently a section editor. She National Center for Dietary Supplement Resea rch and Writ- also se rves as an Associate Editor for Safety at the University of Minnesota. ing. Dr. Libsrer has been a clinical herbal­ Seminars in Complementary Medicine and ist for 15 yea rs and speaks internationally is a member of rhe international edito­ Roberta Lee, MD: on the complementarity of nursing and rial board for Evidence-Based Integrative Medical Director, healing traditions. Medicine. Co-Director Inte­ grative Medicine, Marc S. Micozzi, The names of the new ABC Advisory Continuum Center MD, PhD: Direc­ Board members are listed with rhe current for Health and tor, Policy Insti­ Advisory Board in H erbalGram and on Healing; Director tute for Integrative the ABC Web sire (www.herbalgram. of Medical Educa­ Medicine, Wash­ org). HG tion and Integra­ ington, DC. Former -Nancy Moon tive Fellowship, Executive D irector Lee Beth Israel Medical for Integrative Medi- Center, New York, Micozzi

www.herbalgram.org 2006 HerbaiGram 70 I 11 ABC News ------~l------J~------ABC's Celebration and Botanical Awards Banquet a Huge Success he American Botanical Council recently hosted its first Sponsor Member appreciation and awards banquet, the American Botanical Celebration, during the Nutracon Conference and just prior to Natural Products Expo West (NPEW) conference T and trade show in Anaheim, California. ABC attends NPEW each year. Since it is the largest annual gathering for the natural products and herbal community, Nutracon/NPEW conferences were the ideal setting for ABC's first Celebration.

More than 230 people from across the natural products Mark Blumenthal, ABC Founder and Executive Director, community and the world gathered on March 23, 2006, in the echoed Brevoort's enthusiasm about the event and said, "Consid­ Hilton Hotel in Anaheim to honor key supporters of ABC and ering the important role played by ABC over its 18-year history, botanical excellence. Notable presentations were delivered by often a role that is played behind the scenes, we are pleased to ABC Board of Trustee members Peggy Brevoorr, James A. Duke, honor these many deserving individuals at a venue with such wide PhD, and Norman R. Farnsworth, PhD. exposure as Nutracon, SupplyExpo, and the Natural Products Expo West."

"We have demonstrated to the natural products community that ABC has an historic and future role to play in determining the direction of the health of our world," Blumenthal concluded.

Norman R. Farnsworth, founding ABC Board ofTrustee member, delivers key remarks prior to the presentation of the first annual Norman R. Farnsworth Botanical Research Award. Photo ©2006 stevenfoster.com

ABC invited and honored its Sponsor Members, who provide vital support to ABC. "We were gratified by the turnout and the enthusiasm expressed by everyone who participated," said Peggy Brevoort, President Joseph M. Betz received the first Norman R. Farnsworth Botanical Research of the ABC Board Award. Photo ©2006 stevenfoster.com of Trustees. The event also honored The Celebration was sponsored by lndena, KGK Synergize, the seven-member New Hope Natural Media, Spectrum Organic Products, and Board of Trust­ Unigen Pharmaceuticals. It provided a venue for ABC's diverse ees (the govern­ leaders to meet, recognize accomplishments, and look toward ing body of ABC) the future. The evening began with welcoming remarks from and the 61-member Brevoort, Blumenthal, and Karen Raterman representing New Advisory Board Hope Natural Media and Nutracon. Raterman surprised Duke who provide edito­ and Farnsworth with Lifetime Achievement awards presented by rial and peer-review New Hope Natural Media. Loren lsraelsen of the LDI Group support. It was the and Presidenr of the Utah Natural Products Alliance provided his first time that many view of the impact of ABC and Blumenrhal. Wayne Silverman, Wayne Silverman, Libby Harvey Fitzgerald, and of ABC's academic, ABC Board of Trustee President Peggy Brevoort. PhD, ABC's Chief Administrative Officer, served as the master research, and edito­ Photo ©2006 stevenfoster.com of ceremonies and presenred a visual overview of the history, rial supporters mixed programs, headquarters, and staff of ABC. with ABC's market and industry supporters at an ABC-sponsored The first annual Botanical Excellence Awards were presented. national event. The James A. Duke Botanical Literature Award was given to

12 I HerbaiGram 70 2006 www.herbalgram.org ABC News -----~l------J~------

Simon M ills and Kerry Bone for the publication of the book The Essential Guide to Herbal Safety (Elsevier, 2005). T he Norman R. Fa rnsworth Botani cal Resea rch Award was presenred to Joseph M . Betz, PhD, for his work in promoting and developing va li­ dated analytical methods and reference standards to help ensure the quality of botanical ingredients and finished pro ducts. A ll in atten­ dance considered the evening a great success. "ABC has now made its pres­ ence known at a major national conference. We are proud of the contribution of our Sponsor Members, Boa rd of Trust­ James A. Duke, founding ABC Board ofTrustee member, looks on as recipi­ ents of the James A. Duke Literature Award deliver their remarks. Photo ©2006 ees, and Adviso ry stevenfoster.com Board, and the ro le that ABC plays in Mark Blumenthal, Josef Brinckmann, and Chris Chappell. Photo ©2006 stevenfoster.com from the artendees in the days foll owing the event demonstrated supporting educa­ significant support for continuing this event and for the work of tion regarding the ABC. "T he event provided a reunion fo r those who pioneered the hea lth benefits that can be ga ined from the rational uses of herbs herbal movement, and it created a clearer view of the many roles and plant-based ingredients," sa id Blumenthal. "We have demon­ played by ABC and the need for this wo rk to continue into the strated to the natural products community that ABC has an future," concluded Silve rman. HG historic and future role to play in determining the direction of the -Aileen Truax health of our world ," Blumenthal concluded.

The 2006 American Botanical Celebration was sponsored by ~NewHoPe NaTuraL MeDia A Division ofP enton Media, Inc.

I fiJl indena·

Simon Mills and Kerry Bone, co-recipients of the first annual James A. Duke Botanical Literature Award, accept their award at the Celebration by video. Photo ©2006

In another surprise presentati on, Rory Mahony, Pres ident of Nature's Way, a company which provided the initial support that launched ABC 18 yea rs ago, requested time at the podium and uniGen presented Blumenthal with a special award for his 30 years of PHARMACEUTICALS, INC. work for the herbal and dietary supplement community. In response to the overwhelmingly positive response to the C elebration, ABC is planning another similar C elebration and Awards dinner for 2007. New Hope has already expressed an interes t in making this an annual event, and positive responses

ww w. herbalgram.org 2006 HerbaiG ram 70 I 13 ------~l__ A _B_CN_e_ws__ j~------Recent Magazine Cover Articles Feature ABC's Mark Blumenthal ABC Employee Profile: by Courtney Cavaliere and Wayne Silverman, PhD Michael Finney he magazine you are holding in your hands is wo publications devoted cover stories to ABC's Founder produced by a team of writers, editors, peer review­ and Executive Director Mark Blumenthal this past T ers, and an art director. In the middle of all the T March. The article "Herbal Advocate: an Interview activity is our Managing Editor, Michael Finney, who is with ABC's Mark Blumenthal," published in Integrative Medi­ now in his third year performing this vital role. cine: a Clinician's journal, featured Blumenthal's comments on Michael came to ABC from the Los Alamos National ABC's role in the herbal community, as well as his opinions on Laboratory in Los Alamos, New Mexico, where he worked the challenges currently faced by the herbal industry. Mean­ as a technical writer and editor for various scientific and while, the article "Mark Blumenthal: Portrait of an Industry technical publications, mostly in the area of physics and computer science. He has also taught Icon," published in Whole Foods Maga­ technical writing at Oklahoma State zine, provided an in-depth account of University and English composition at Blumenthal's work and many insights ~ Austin Community College. This is his into his personal life and family, plus •.:~, first association with the world of herbs .; r.. ... ·P • f comments from long-time friends and .,, and medicinal plants. d~ colleagues in the herb community. As managing editor Michael has a The synchronistic cover stories are part wide range of responsibilities; there are coincidence and part the result of the life- many balls in the air when it comes long efforts of Mark Blumenrhal. Fi nney to producing a publication like this Through his influence within the one. These include being involved with herbal and dietary supplement the inception of each issue through the many stages of community, hi s impact in the the entire editorial process, plus peer review, and finally, media, and the role that ABC now proofreading with the aid of a professional proofreader plays on the world stage, the two and members of the ABC staff. Producing a magazine feature articles are timely and well­ like Herba!Gram is a an almost Herculean task, especially deserved. The staff of ABC would considering that almost every article must undergo a form like to thank both publications for of peer review that requires considerable communication providing this recognition. with numerous reviewers, as well as the collection and The article from Whole Foods evaluation of their comments and edits. (Sometimes more Magazine can be accessed online at than a few of these reviewers need a bit of diplomatic coax­ http: I /www.herbalgram .o rg/files/ ing to respond with their edits in a timely manner.) pdfs/WF_Mark Blum. pdf. The article in Integrative Medicine: a One of Michael's key tasks is the reviewing and editing Clinician's journal is available through the journal's Web si te at of every article (features, research reviews, books reviews, hnp:/ /www.imjournal.com/imj /login/index.jsp. HG etc.) to ensure a smooth style and proper adherence to the style manuals we follow. Many of the articles benefit from his subtle but important rewrites. In addition to his role in the actual management and editing of HerbalGram, Michael also provides another invaluable function here at ABC: He recruits local univer­ sity students in journalism and communications for edito­ rial and ~riting internships at ABC and supervises and trains these interns. They provide a much-needed source of editorial support for our publication. The bottom line for us at ABC, and our thousands of members, is that Michael has performed admirably since his arrival at ABC, ensuring that every issue of Herbal Gram is sent to the printer on or before the deadline. Michael's diligence has enabled ABC to meet irs obligations to its members and distributors by ensuring that every issue of HerbalGram is accurate, and on time! HG -Mark Blumenthal

14 I HerbaiGram 70 2006 www.herbalgram.org Vita Plant

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Pharmacy Intern Participates in Upgrading ABC Demonstration Gardens thin a few weeks of starting my Pharmacy Doctorate internship rotation at the American Botanical Council in Janu­ ary 2006, I began the task of making signs for the ABC gardens. In all the gardens, some of the plants had appropriate W signs, some had signs with outdated information, and some had no signs at all due to breakage and wear from the harsh Texas sun. Starting with the Women's Reproductive Garden, I investigated the traditional uses and evidence-based clinical uses of plants such as lady's mantle (Alchemilla xanthochlora Rothm., Rosaceae), lemon balm (Melissa officina/is L., Lamiaceae), and red clover (Trifolium pratense L., Fabaceae). I also noted the warnings, contraindications, and drug interactions if there were any. To find this information I used the PubMed database at the National Library of Medicine (www.pubmed.gov) and respected, authoritative books, such as those published by ABC and others offered through the ABC online catalog (http://www.herbalgram.org/bookcata­ log/default.asp). Other gardens I worked on included the Men's Reproductive Garden and several Culinary Gardens, such as the Mediterranean, Mexican, Middle Eastern, and Southeast Asian. Meanwhile, Natashaa Brown, a pharmacy intern from Texas South­ ern University, created signs for the Antioxidant, Children's, and Phytocosmetic gardens.

Researching and producing informational signs for the gardens ciation's Herbs of Commerce, 2nd edition.1 T he signs also include was a va luable educational experience for me, bur they serve I genus, species, and family; primary uses supported by clinical a larger purpose as well. Visitors are trials; traditional uses from authorita­ welcome at ABC, and when a formal tive herbal and ethnobotanical texts; tour is not scheduled, visitors can learn The knowledge I have gained and any contraindications or other about the plants in the various ga rdens pertinent safety information. through a self-guided tour. In this way, while interning at ABC will Concurrent with updating the signs the gardens support ABC's mission to definitely benefit my patients for the demonstration gardens, ABC promote the responsi ble use of herbal is developing a brochure, the "ABC medicine by providing science-based and me as a future pharmacist. Garden Guide," which will be given to and traditional information. Each sign visitors who want to take a self-guided includes the plant's standardized common tour of the gardens. This brochure will name, when available, from The American Herbal Products Asso- include a map and descriptions of the theme gardens, examples of the plants that are in each garden, a legend that defines the safety concern abbreviations found on some of the signs, an introduction to ABC and its mission and programs, and a history of the Case Mill Homestead (ABC's 2.5 acre headquarters in Austin). T he knowledge I have gained while interning at ABC will defi­ nitely benefit my patients and me as a future pharmacist. After briefly touching on the topic of herbs and phytomedicine in my courses at pharmacy school, my experiences at ABC have allowed me to learn more in-depth information about the potential herbs have in modern medicine, as well as the significant role they already play in many people's self-care. When a patient inquires www.fhcommunication.com about the responsible uses of herbs and supplements, I now fee l more confident that I will either know the answer or know where to locate the answer from the reliable sources with which I have become acquai nted. For those who would like to explore the possibilities of herbal plants, I suggest a self-guided tour of the ABC gardens. For tour groups offive or more visitors, please call ABC at (5 12) 926-4900 to set up a guided tour. For a preview of what you will see, visit ABC's virtual tour of the gardens (http://www.herbalgram.org/ default.asp?c=virtual_tour). HG

-Stephanie Pohl University of Texas College of Pharmacy PharmD May 2006

Reference 1. McGuffin M, Karresz JT, Leung AY, Tucker AO, eds. The Ameri­ can Herbal Products Association's Herbs of Commerce. 2nd ed. Si lver Spring, MD: American Herbal Products Association; 2000.

16 I HerbaiGram 70 2006 www.herbalgram.org ------~l ABC News J~------ABC's 2006 Amazon and Machu Picchu Ethnobotanical Tour he American Botanical Council and the ACEER Foundation's annual Botanical Medicines from the Amazon and Machu Picchu ethnobotanical tour will be held October 2nd through 9th, 2006. The optional extension to Machu Picchu will be an T additional four days through October 12th. An exciting new developmenr this year is the addition of Steven The optional extension ro the Andes and the spectacular Inca Foster as fac ulry. Foster is the pres idem of the Steven Foster G roup mountain-top citadel of Machu Picchu is wel l worrh the extra (www.stevenfoster.com), a res pected author and photographer, time and investmenr. In addition to ex ploring the arch itec tural and a member of ABC's Board of Trustees. He will be presenr­ remains of one of the true wonders of the world, travelers can ing "History of Herbs in Medicine and Pharmacy" and leading climb Huay na Picchu, the pinnacle so uth of Machu Picchu thar a session with Jim Duke, PhD, on "Herb-Drug Inreracrions." is so prominenr in typical views of rhar ancienr cir y, or hike rhe Fosrer and Dr. Duke will do rwo presenrarions in rhe ACEER's other direction ro Inripunku (Sun Gare) where one can wi rness Jardin de Planras Medicinales and will be accompanied by head rhis spectacular view of Machu Picchu firsthand. Machu Picchu ga rd ener Justo Rengifo. Topics will include "Medicinal Plams of and its environs abound with orchids, bromeliads, begonias, the Amazon" and "Planrs of Economic and Health Value." and mounrain minr among other interesting Andean pl ants. It is Dr. Duke is an inrernarionally known ethnobotanist and the perfect se rring for an ongoing opportunity ro discuss lncan economic boranisr, a prolific aurhor, a long-rime faculty member culture and medicinal practices. on rhe ABC-ACEER erhnoboranical tours, and a member of Anyone wishing ro arrend should send a $500 deposit , along ABC's Board of Trust­ with their registration form ro rhe ACEER Foundation by June ees. Upon arrival in the 13th, 2006. A downloadable registration form and itinerary are Amazon, he will lead a available on ABC's Web site (www.herb algram.org) or by call­ visir to rhe local market, ing Marguerite Gould at ACEER at (610) 738-0477. T he cost which includes medici­ of the Amazon portion of the trip is $3395 all inclusive from nal herb stands where Philadelphia, PA . The optional extension ro Machu Picchu is there will be an oppor­ $1075. HG tunity to ralk with local -Gayle Engels hea lers about tradi­ tional remedies. Duke will presenr additional lectures on "Amazonian Shamanic Traditions" (with Jusro Rengifo), "A mazonian Food Farmacy Diet," and "Medicinal Weeds." New rhis yea r is a labo­ ratory ac tivity led by Dr. Duke in the new field lab at ACEER­ Tambopara Inkaterra (ATI) where arrendees Machu Picchu. Photo ©2006 Mark Blumenthal will study traditional medicines obtained in rhe marker in Puerto Maldonado and botanicals from the medici­ nal ga rdens at ATI. In addition ro rhe lectures, which can provide continuing medi­ cal education for phys icians and conrinuing education for phar­ macists, there will be a visit ro the new Inkaterra Canopy walk­ way, a series of suspended walkways I 00 fe et above the fores t floor that provides an unparalleled opportunity ro view the flora and fa una of the forest canopy. An exploration of ATI with its Nature Interpretation Center, medicinal plants garden, children's rainfor­ est ga rden, and 3.5 km Useful Planrs Trail is also on the itinerary, as is a trip ro the 10,000 hectare (25,000 acre) lnkaterra Ecologi­ cal Reserve. At rhe reserve, there wi ll be opportunities ro view numerous species of small animals, including numerous tropical birds, as well as a wide diversity of Amazonian plants that are the bas is for medicines from the rainforest. www. herbalgram.org 2006 HerbaiGram 70 I 17 ------~~rganization New~~------4? } ( NDI Notifications Database Developed by AHPA and NPicenter he American Herbal Products Association (AHPA) and NPicenter have collaborated to create a database to access all noti­ fications the Food and Drug Administration (FDA) has received for new dietary ingredients (NDis).1 AHPA is the national T trade association of the herbal products industry, and NPicenter is a company offering Internet-based information, services, and resources for natural and nutritional products companies.

The AHPA NDI Database is a resource for industry, regula­ responded to every notification, and the problems, if any, that the tory attorneys, and others who seek a convenient and comprehen­ FDA identified for each. sive way to check the outcome of submissions by industry that "New ingredients are key to the supplement industry's future document the safety of new dietary ingredients. Section 8 of the and the AHPA NDI Database will be a valuable resource for firms Dietary Supplement Health and Education Act (DSHEA) requires that are filing the required notification prior to marketing an manufacturers or distributors of an NDI-a dietary supplement NDI," said Michael McGuffin, pres ident of AHPA. "By access­ ingredient not sold in the United States before DSHEA went into ing and reviewing other relevant NDI notifications, companies effect in October, 1994- to provide information to FDA within will be better prepared to file complete submissions and thereby 75 days prior to the date of the initial introduction of a new ingre­ prevent delays to marker entry." dient to the market. The submission is the basis for a conclusion Since Congress passed DSHEA, manufacturers and marketers by the FDA that the ingredient is reasonably expected to be safe. have submitted almost 300 NDI notifications, which FDA has New dietary ingredients used as food in a form in which the food posted on its dockers Web sire (http://www.fda.gov/ohrms/dock­ has not been chemically altered are exempt from the notification ets/dockers/95s0316/95s0316.hrm). However, the only access to requirement. an individual notification, or multiple notifications on the same The AHPA NDJ Database can be searched by numerous rele­ ingredient, provided on this site is by the FDA-assigned report vant fields: the generic or brand name of every 75-day notice number. This makes individual reports difficult to locate. Even (for both botanical and non-botanical ingredients), the Latin when found, it is impossi ble to know without opening and exam­ binomial of herbs, and the name of the company that made the ining the entire file (which can run to hundreds of pages) whether submission. The database also provides a concise "outcome state­ a filing was successful or whether (a nd why) FDA objected to the ment" for each file that quickly summarizes how the FDA has notification. The AHPA NDI Database was specifically designed to provide faster and more informative access to filed notifications and the FDA's responses. The database will be maintained on an ongoing basis; future NDI filings and FDA responses will be promptly added to the system. Special introductory access fees for AHPA members are $125 per year per sire or $40 per day per site; fees for non­ members are $495 per year per site or $125 per day per site. The AHPA NDJ Database is located at http://ndi.npicenter. com/. For more on the NDI process, see the article on NDis in Herba!Gram 632 or the article by Michael McGuffin and Tony Young in the journal ofthe Food and Drug Law Institute) HG -Mark Blumenthal

References 1. Database for New Dietary Ingredient Notifications Launching D ece mber 5. Searchable AHPA NDI Database Developed by AHPA and NP!cenrer [press release]. Silver Spring, MD: American H erbal Products Assn. ; December 2, 2005. 2. Noonan C, Noonan WP. New Dietary lngredienrs: OSHEA Provides u..-.. 1>--.ct:c.l~-· ..... ,1« ...... uwd· ~ -..-~ Tt• f¥-.t~e.:u."':cwfM~t>otd ~h.l'\t~-··"'tl-01: f-.ecoUdt.-to•,..rqor~~oiA. -.s.•"''•'~ lhtVor.ern--PHM Aa.:t~-1Ul~by .. J.IcN-t~aol""' 0 ·-'~"" oO'(;I'

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18 I HerbaiGram 70 2006 www.herbalgram.org ------~~ rganization NewJ~------

Herb Day 2006 Off to a Good Start by Cynthia Crimmins

lans for the first HerbDay 2006 are moving forward. The HerbDay Coalition launched the official HerbDay Web site, www. herbday.org, in February to organize and disseminate event schedules, planning strategies, activity suggestions, and educa­ Ptional resources to vendors, sponsors, educators, practitioners, and the public. HerbDay 2006, the first recognized day of celebrating herbs and herbalism, will occur across the United States and Canada on Saturday, October 14. The HerbDay Coalition would like to invite everyone in the herbal community to get involved.

"HerbDay is envisioned as a grassroots effort involving thou­ and the United Plant Savers, encourages irs collective members sands of people in North America celebrating herbs," said Wayne to get involved with HerbDay. Opportunities range from host­ Silverman, PhD, Chief Administrative Officer of the American ing events, providing sponsorship, and contributing financial Botanical Council. "We hope this will be rhe starr of an event rhar support, to volunteering time and expertise, and attending events. is enjoyed for years to come." T he excitement is building, and a truly successful HerbDay will The majority of events will require involvement by active participants from the entire herbal likely rake place at retail chains community. and independenrly owned retail "We are extremely pleased to be parr of this group of national stores. In addition to local and organizations working together cooperatively to create such an regional events, the HerbDay important event," said Michael McGuffin, President, American Coalition will be present­ Herbal Products Association. ing national events specifically "We have designed a very dynamic opportunity to bring the designed to draw media atten- public a positive message about herbs in their own communities," tion to the herb movement. A added Silverman. press conference will be held on For more HerbDay information and links to Coalition Web Thursday, October 12, at the sires, please visit www.HerbDay.org. HG United Stares Botanic Garden (USBG) in Washington. Members of Congress have been invited. In addition to this activity, the Coalition and USBG are planning a day of seminars, an Herb Fest on Saturday, October 14, 2006, and a keynote speaker. Information regarding these national, as well as regional and local, HerbDay events can be found on the HerbDay Web site. The site is open to rhe public and provides continuous event and participation updates. Registration is requested to sched­ ule events, view the event ideas menu, and download educa­ tional content. Educational resources include information about common herbs, herb safety guidelines, botanical sanctuaries, and US legal and regulatory issues. Downloads are available to host sites at no charge. The HerbDay Coalition, consisting of the American Botani­ cal Council, the American Herbal Pharmacopoeia, the American Herbal Products Association, the American Herbalists Guild,

Adding value through science to botanicals used in complementary and alternative medicine

www. phytosynergy.com

clo Missouri Innovation Center, Inc. [email protected] University of Missouri-Columbia CELL: (573) 356-7372

www.herbalgram.org 2006 HerbaiGram 70 I 19 ------~l Grants &Awards J~------

Enzymatic Therapy, Inc. Named "Manufacturer of the Year" by Nutrition Industry Executive nzymatic T herapy, Inc., a leading manufacturer and marketer of branded natural medicines and dietary supplements, has been named "2005 Manufacturer of the Year" in the October 2005 issue of Nutrition Industry Executive (NIE) magazine. Enzy­ Ematic Therapy was recognized for its leadership and innovation in product development and education, and for its success­ ful marketing programs that have enhanced its own business as well as that of its retail partners. In the previous year, the company has grown three to four times the rate of the overall industry, according to a press release from the company.1 (Note: According to market data from SPINS, during the 52-week period through June 11, 2005, the supplement industry growth rate was 7%. Enzy­ matic Therapy growth rate for the same time period was 24.2%, or about 3.5 times the growth of the industry. [M. Schueller e-mail to M. Blumenthal, November 29, 2005.])

The editorial staff of NIE chose the company from a group of states that it introduced the concept dietary supplement manufacturers for which nominations were of "standardization" of the chemis­ received by its readers. Criteria included product quality, industry try of herbal extracts to the Ameri­ reputation, financial success, trend-setting abilities, and contribu­ can herbal industry in 1986 and tions to the industry. was first to introduce what it calls "Enzymatic Therapy has a long history of leadership and 'firsts' "pharmaceutical-grade" ginkgo in the nutritional supplement industry," commented Randy Rose, extract to the United States in the president and CEO. "Nutrition Industry Executive's designation same year. The company pioneered is an honor for us, as it recognizes Enzymatic's commitment to the popular joint flexibility supple­ being the highest quality provider of therapeutic dosage natural ment glucosamine sulfate when it medicines and nutritional supplements in the industry."1 first introduced it to the American The company says that it is the first and only dietary supple­ market in 1993. ment manufacturer that is an FDA-registered drug establishment "Enzymatic Therapy has earned and also a certified organic processor. The Enzymatic press release this recognition over a long period of time, with its leadership and excellence in several areas," said Paul Bubny, Editor in Chief of NIE. "The company's successful marketing of the Hot Plants line and the favorable media attention this created in the past year tipped the balance in its favor."1 Hot Plants™ for Him and Hot Plants™ for Her formulas, DANDELIONS co-developed with renowned author and herbalist Chris Kilham, PULL 'E M , THEY ' RE J US T WEEDS . combine 10 libido-enhancing botanicals sourced by Kilham in China, Malaysia, Indonesia, Peru, the Amazon basin, Siberia, and Syria. Upon launch, H ot Plants was featured on ABC's 20/20 and on a CNN newsmagazine, plus stories in Outside magazine, the Washington Post, Boston Herald, and in hundreds of articles and Actually, the dandelion, or Taraxacum officinale, broadcast interviews nationwide. has many health benefi ts. Its leaves carry primary N utrition Industry Executive, a publication of Vitamin Retailer nutrients lihe calcium, magnesium and potassium. Magazine, Inc., is a leading trade publication for nutraceutical industry manufacturers. Initially published in January 1997, NIE Dandelions have also been used medicinally to support says it is the first trade magazine specifically for manufacturers of the liver and hidneys. dietary supplement and nutraceutical products.1 Enzymatic T herapy was initially founded by Terry Lemerond in 1981. T he company was later purchased by North Castle Part­ ners, and other supplement manufacturers (NF Formulas, Tyler Formulas, and Vitaline Formulas) were merged into the existing company in 2000. The company's various divisions sell dietary supplements and natural medicines to health food and health professional channels of trade. HG -Mark Blumenthal

Reference Find out about an Herbal Sciences degree. I. Enzymatic Therapy, Inc. Named "Manufacturer of the Year" by For the best natural health education in the BASTYR Nutrition Industry [press release) . Green Bay, WI: Enzymatic Therapy world. visit herbal3.bastyr.edu. UNIVER S ITY Inc. October 24, 2005. Available at: http://www.enzy.com.

20 I Herba!Gram 70 2006 www.herbalgram.org ------~~esearch &World Ne~~------

American Ginseng Being Tested for Cancer-Related Fatigue andomized, double-blind, placebo-controlled, multi-center clinical trial on the root of American ginseng (Panax quinquefolius L. , Araliaceae) is being conducted to determine whether it can increase energy levels in patients with various types of cancer, A.! ccording to a notice posted on the Web site of the National Cancer Institute (NCI).1 Researchers are enrolling 280 patients aged 18 and over who have been diagnosed with cancer and who are experiencing cancer-related fatigue. The enrollment period will last for 35 months from September 2005 when the notice was initially posted. According to Debra Barton, PhD, a co-investigator of the study, the research team has already recruited 99 of the 280 patients needed for the study, and they are adding over 20 patients per month (D. Barton e-mail to C. Cavalier, February 27, 2006).

The primary objective for the trial is to son M D, PhD, from the North Central borh ginsenosides have the potential to compare the effi cacy of Ameri can ginse ng Cancer Treatment Group (NCCTG), a be effective, we decided ro study Ameri­ (root powder administered at 3 diffe rent nati onal resea rch consortium sponsored can ginse ng as it is 'locally' grown and doses [750 mg/day, 1,000 mg/day, and by NCI. NCCTG is a network of ca ncer harves red." 2,000 mg/day]) versus placebo in patients specialists and institutions rhroughour According to Dr. Brent Bauer, principal with cancer-related fa tigue. T he second­ rhe United States, Canada, and Mexico. invesrigaror of rhis rri al at the NCCTG, ary objectives are (1) to determine the Irs research base is located at the Mayo "Ginse ng has a hi story of use in tradi­ potential toxic effects and tolerability of C linic in Roches ter, MN. A list of the tional medici ne rh ar sugges ts it may lessen American ginseng in these patients and numerous srudy sites (located in 19 srares) the sense of fa ri gue that cancer patients (2) to determine the impact of American and the eli gibility cri teria are ava il able at ex peri ence, and some small studies have ginse ng on quality of life-related variables http:/ /cancer.gov/clinicaltrials/ CCT G­ indicated rhar ginseng may have so me effi­ (e.g., sleep, vitality, and quality of life N03CA. cacy as a remedy for fa tigue. Consequently, domains) in these patients. many ca ncer patients are using ginseng on Patients will be administered Ameri can thei r own to combat fa ti gue. By srudyin g ginseng dried root powder in capsules, Ginseng has a history ginse ng in a contro ll ed se tting, we can which are being supplied by the Ginseng of use in traditional better determine whether ir has a benefi­ Resea rch Institute of Wausau, W I. cial effect for patients experiencing fatigue The patients wi ll be randomized to 1 of medicine that suggests and, if rhere is a negarive effecr, we'll be 4 treatment arms: able ro berrer educate pati ents abour rhe • Arm !-Patients receive oral Ameri­ it may lessen the sense possible danger."1 can ginseng twice daily fo r 8 weeks in of fatigue that cancer There have been only a few cl inical the absence of unacceptable toxiciry. trials conducted on Ameri can ginseng • Arm II-Patients receive oral Ameri­ patients experience. root preparations, mosr of rhem being in can ginseng as in arm I, but ar a rhe pas r decade to res r rhe herb's abil iry ro higher dose. help normali ze blood sugar level in rype- • Arm III-Pati ents receive oral Ameri­ Importance of This Trial 2 diabetic and normal adults. Mosr seri­ can ginse ng as in arm I, but at a According to the NCI notice, "fatigue ous clinical research on ginseng has been higher dose than arm II. is a frequently debilitating symptom of conducted on rhe more widely known and • Arm IV-Parienrs receive oral cancer, as well as a common side effect of distributed As ian ginseng (Panax ginseng placebo twice daily for 8 weeks in the cancer treatment. Many cancer patients C.A. Meyer). absence of unacceptable toxiciry. report ex peri enci ng ex treme tiredness, After 8 weeks of treatment, patients in exhaustion, and weakness, often severe Contact Information arms I-III may continue to receive Ameri ­ enough to negatively affect their quality More informatio n on this trial is avail­ can ginse ng on the optional continuation of life." able at the NCI Web sire (hrrp://cancer. portion of the srudy for an additional 8 Dr. Barton ex plained to Herba!Gram gov/clinicalrrials/NCCT G-N03CA) or weeks. Patients in arm IV (placebo group) rhat the fa tigue caused by cancer is nor via CI's Cancer Info rmatio n Service may begin oral American ginseng twice relieved by sleep: "We do nor have ve ry ar 1-800-4-CANCER (1-800-422-6237) . daily for 8 weeks on rhe optional continu­ effective, es tablished treatments for cancer­ T he ca ll is roll free and completely confi­ ation portion of the study. Quali ty of li fe related fatigue. We decided to pursue dential. HG wi ll be assessed at baseline, every 2 weeks rhis study based on laboratory, animal, -Mark Blumenthal during treatment, and at the end of trea t­ and pilor data fo r the use of ginseng for ment. fa tigue. Though much of the dara are with Reference A lisr of pati ent qualification/disquali­ Asian ginseng, there are dara to suggest I. National Cancer Institute. Randomized fication criteria is available on the N CI that borh ginsenosides Rbl and Rgl study of American ginseng in patients with Web site. [two of the primary ac rive compounds in cancer-related fatigue [Web sire]. Septem­ ber 9, 2005, revised February 17, 2006. The principal inves tigators are Brent ginseng ro or] have ergogenic activiry, and Available at: http:/ /cancer.gov/cl inicalrrials/ Bauer, M D ; Charles Loprinzi, M D ; Teresa one di fference berween Asian and Ameri­ CCTG-N03CA. Rummans, MD; Tait Shanafelt, MD; can ginseng is di ffere ntial amounts of Debra Barton, PhD; and Patricia A. John- these two ginsenosides . T herefore, since www. herbalgram .org 2006 HerbaiGram 70 I 21 ------i~esearch &World Ne~~------

Sativex®Cannabis Oral Spray Accepted in Canada and Approved for US Clinical Trials by Courtney Cavaliere

he cannabis-based medicine Sativex8 is gradually gaining recognition within the international health community. Sativex was made available within Canada in June 20051 and approved for testing in US clinical trials in January 2006.2 Sativex, an T oro-mucosal spray derived from marijuana (Cannabis sativa L., Cannabaceae), is intended for the relief of severe pain associ­ ated with such conditions as multiple sclerosis (MS) and cancer. It is a whole cannabis extract from two chemovars of can nabis-one primarily expressing tetrahydrocannabinol (THC) and the other expressing cannabidiol-that contains the plant's full range of natu­ ral phytocannabinoids and terpenoids (E. Russo, e-mail, January 31, 2006).

Canada became the first country in the Clinical trials of Sativex in the United arthritis pain,6 peripheral neuropathic world to approve Sativex as a prescription States-particularly if successful- could pain with allodynia (severe pain from medication in April 2005 as an adjunctive help open the door to further FDA­ stimuli that are normally painless, caused treatment for symptomatic relief of neuro­ approved US cannabis research, said by damage to the central nervous system), logical pain in adults with MS.1 It was Dennis McKenna, PhD, senior lecturer and brachial plexus injury pain (pain approved under Health Canada's Notice and research associate at the University caused from damage of the nerves that of Compliance with Condition status, of Minnesota's Center for Spirituality and conduct signals from the spine to the requiring that the UK-based company Healing and Adjunct Professo r of Clini­ shoulder, arm, and hand).5 GW Pharmaceuticals, the manufacturers cal and Experimental Pharmacology (o ral of Sativex, pursue further clinical trials communication, January 2006). Further­ regarding efficacy. Sativex is marketed in more, the approval of an IND Applica­ Cannabinoids represent Canada by Bayer HealthCare. tion for Sativex may indicate a signifi- a brave new world The US Food and Drug Admin­ cant shift within the FDA itself, istration (F DA), meanwhile, which has proven a highly politi­ of therapy. accepted GW's Investigational cized agency in the pas t regard­ New Drug (IND) Application for ing controversial issues. "This "The clinical benefits noted with Sativex, allowing GW to launch may signify that the FDA is Sativex have been maintained in long­ Phase III clinical trials in the changing its stance and basing its term safety extension studies (some up United States.2 These trials will decisions on good scientific judg­ to four years)," said Ethan Russo, MD, test the drug's ability to treat ment and medical judgment, as senior medical advisor of the Cannabinoid pain in advanced cancer patients opposed to political motivations," Research Institute of GW. "During that who have not found relief Dr. McKenna sa id. interval, no tolerance has developed to through conventional opioid GW was able to success­ these therapeutic benefits, no significant medications (e.g. , codeine, fully introduce Sativex into withdrawal symptoms have been noted morphine, and/or their Canada and begin the regu- on abrupt withdrawal of Sativex, and in synthetic analogs). GW has latory review process in the regular usage, patient subjective intoxi­ planned 2 extensive clinical United States, due to the cation scores on the medicine have been trials and some smaller-scale posmve results garnered indistinguishable from placebo. All of supporting studies for its from previous clinical trials. these benefits of Sativex have occurred in US clinical program, which Sativex proved significantly patient groups who qualified for clinical is likely to commence in effective at reducing MS pain trials with this new medicine after fail­ late 2006. "Proceeding in a study published in the ure of available conventional treatment. with cancer pain indication journal Neurology3 in 2005 The changes in their conditions were thus seemed to offer the optimal (reviewed in HerbalGram above and beyond those attainable with route for opening discus­ 694) . Further studies with other [conventional) pharmaceuticals." sions with the FDA," said MS patients have also indi­ According to Rogerson, GW purpose­ Mark Rogerson, GW's head cated that Sativex alleviates fully allowed itself time to generate exten­ of press and PR (e-mail, other MS symptoms, includ­ sive data on Sativex in Europe before January 9, 2006). "GW ing spasticity, spasms, blad­ embarking upon discussions with FDA. does not anticipate stopping der symptoms, and sleep "This strategy has now provided the opti­ at cancer pain in the US , but disturbance.5 Likewise, clini­ mum outcome in allowing us to proceed rather will seek to investigate cal trials ofSativex have demon­ directly into US Phase III trials, thus Sativex in other medical indica- strated the drug's efficacy in treat­ compressing the overall potential timelines tions in due course." GW ex pects to file a ing intractable cancer pain, rheumatoid to filing a regulatory submission. We are regulatory submission with the FDA 2 to delighted that the FDA has accepted this 3 years after the trials commence. Photo© GW Pharmaceutica ls pic approach," Rogerson said.

22 I HerbaiGram 70 2006 www.herbalgram.org ------~ Research &World News t------

Physicians and patients In Canada, cancer pain trials in United States [press meanwhile, have expressed excitement release]. London: GW Pharmaceuticals; about achieving first use of the drug. January 4, 2006. 3. Rog OJ, Nurmikko TJ, Friede T, and All an Gordon, MD, a neurologist and the Young CA. Randomized, controlled trial director of the Wasser Pain Management of cannabis-based medicine in central Centre and rhe Edward Bronfman Fa mily pain in multiple sclerosis. Neurology. Foundation MS Research C lin ic at Mount 2005;65:812-819. Sinai Hospital in Toronto, Ontario, began 4. Blumenthal M. Sativex cannabis-based prescribing Sarivex to some of his patients medicine red uces pain in MS patients. in the Spring of 2005 (A. Gordon, oral Herba/Gram. 2006; No. 69:34-35. communication, November 2005). 5. Russo EB, Guy GW. A tale of two cannabinoids: the therapeutic rationale According to Dr. Gordon, many physi­ for combining tetrahydrocannabinol and cians in Canada have welcomed Sativex as cannabidiol. Medical Hypotheses. 2006;66 a new treatment option for pain manage­ Marijuana Cannabis sa tiva Photo ©2006 (2):234-246. steve nfoster.com ment. He added that MS patients, more­ 6. Blake DR, Robson P, HoM, Jubb RW, over, typically express approval of the currently ava il able to individual patients and McCabe CS. Prel im inary assessment medication's spray format, which gives as an unlicensed medication in the UK of the efficacy, tolerability and safety of a them some degree of control over their and to certain patients in Spain under a cannabis-based medici ne (Sativex) in the treatment of pain caused by rheumatoid treatment. compassionate access program. HG arthritis. Rheumatology. 2006;45(1):50- Many conventional pharmaceutical References 52. treatments for MS pain include anti­ 7. Spotlight: Communicating about Cancer depressants, ami-epileptic medications, I. Sativex-novel ca nnabis derived treat­ Pain. National Cancer Institute Web and opiates. "If it's truly nerve pain, ment for MS pain now available in site. Available at: hrtp://www.cancer.gov/ however, you need some sort of treat­ Canada by prescription [p ress release]. ncicancerbulletin/NCI_Cancer_B ulle­ ment more specific to nerve pain," Dr. Toronto, Ontario: Bayer HealthCare; rin_ll2905/page4. Accessed January 17, June 20, 2005. Gordon explai ned. Sativex, therefore, is 2006. 2. Sativex to enter directly into phase Ill particularly appealing, due to its clini­ cally proven efficacy in treating nerve pain and spasms. Although it currently is used as an adjunctive treatment with other pain medications, Dr. Gordon said it may a eventually serve as a primary pain medi­ Earn Master of Science cation for patients with MS. "Right now, we're just trying to learn how to use it," in Herbal Medicine he said. "Cannabinoids represent a brave new world of therapy. They have not yet ADVANCED STANDI NG CORE & RESIDENTIAL FACULTY been investigated thoroughly and are very NOW AVAILABLE FOR promising. I think 10 years from now EXPERIENCED HERBALI STS Simon Mills, MA, FNIMH, MCPP, we'll have a lor more information." Director of Herbal Medicine Program 800 HOURS OF EXTENSIVE Pain is a common symptom of both CLINICAL TRAINING & PRACTICUM James Snow, Chair-Herbal Division (AHG ) MS and advanced cancer. Central pain, Kevin Spelman, BS, RH (AHG), MCPP which is caused by a primary lesion or Now e11rolling for Fall 2006! Chair-Cl inical Division dysfunction of the central nervous system , Claudia Joy Wingo, BSN, DMH is estimated to occur within 17 to 52% of Acting Chair-Clinical Division people with MS; around 32% of patients Bevin Clare, BS, RH (AHG) classify it among their worst symptoms.3 James Duke, PhD Cancer pain, meanwhile, can be caused Tina Lightner, MS. RH (AHG) by tumors or by cancer treatments, such as radiation or chemotherapy.? Studies VISITING FACULTY indicate that 30 to 50% of patients who undergo active treatment for cancer and 7Song, RH (AHG ) 70% of those with advanced stages of the Mary Bove, NO, CPM disease experience significant pain. Tai Sophia Jerry Cott, PhD GW's goal is to ultimately obtain Institute Steven Dentali, PhD marketing approvals for Sarivex through­ www.tai.edu Jill Stansbury, ND out the world (M. Rogerson, e-mail, Janu­ Roy Upton, RH (AHG ) ary 9, 2006). In addition to its pres­ 800-735-2968 ext. 6647 David Winston, RH (AHG) ence within Canada and its preliminary ad mi [email protected] Eric Yarnell, ND introduction into the US FDA, Sativex is www.herbalgram.org 2006 HerbaiGram 70 I 23 E~ ChromaDex setting THE standard New Organization to Develop Quality Standards NEW ChromaDex for African Herbs 2006/2007 Catalog by Courtney Cavaliere

Available April 2006 n May 2005, herbal experts from 14 countries gathered in South Africa and formed the Association for African Medicinal Plants Standards (AAMPS). The organization's • Hundreds of NEW standards goals include developing and promoting internationally recognized quality control • Many new KITs I standards for African medicinal plants and creating an African Herbal Pharmacopoeia comprised of 53 native medicinal plant species. 1 With over 3500 standards available, we are the most comprehensive Denzil Phillips, founder and director of The founding members of AAMPS will supplier of phytochemical reference Denzil Phillips International Ltd, and a review all of the profiles before the phar­ standards. co-organizer of the South Africa meeting, macopeia is published, which is expected explained that the organization's found­ to take place by the end of 2006. AAMPS our product line includes: ing was a spontaneous act of the dele­ ultimately plans to launch an interac­ • Primary Standards gates (D. Phillips, oral communication, tive database and Web site featuring the • Secondary Standards August 2005). According to Phillips, the 53 profiles, in addition to releasing print 28 experts of African herbal medicine who and CD ROM versions of the pharma­ • Reagent Grade Standards attended the meeting in South Africa orig­ copeia. "We're building what's called a • AHP-Verified'"'Standards-NEW inally gathered for the purpose of review­ living database," Phillips said. "We plan to • Snap-n-Shoot"" Standards-NEW ing the progress of 23 African herbal continue to upgrade [the profiles] ." profiles. These profiles were drafted by the According to Phillips, several of the • Botanical Reference Materials- University of Pretoria in collaboration with plants chosen for the pharmacopeia are • Reference Standard Kits other African Universities, and funded by recognized as medicines in much of Africa • Complete Analytical Kits the African Caribbean Pacific-European bur not sold officially within their native Union (ACP-EU) Centre for Develop­ regions (i.e., they are not recognized as ment of Enterprise and the ACP-EU Tech­ officially approved drugs by government Contact ChromaDex to get your nical Centre for Agricultural and Rural agencies). "We hope to get them integrated 2006/2007 copy now. Co-operation (see Table 1). During the into the African healthcare system," Phil­ tel. 949.419.0288 review process, the members of the meet­ lips said. Among such plants are Toddafia fax. 949.419.0294 ing unanimously agreed that the issue of asiatica, (L.) Lam., Rutaceae; Euphorbia email. [email protected] African herbal quality standards warranted hirta, L., Euphorbiaceae; and Adansonia the establishment of a permanent organi­ digitata, L., Bombacaceae. AAMPS also zation. They signed the Centurion Lake intends to assist the development of busi­ Oeclaration2 pledging their commitment ness and income within Africa, foster to the organization's goals. increased trade between Africa and inter­ T he founding members of AAMPS national markets, and help train African subsequently voted on 30 additional pharmacologists. plants for herbal profiling, resulting in Professor James E. Simon, PhD, direc­ a pharmacopeia of 53 medicinal plant tor of the New Use Agriculture and Natu­ species. All plant species selected for the ral Plant Products Program at Rutgers pharmacopeia are native to Africa, are not University, said AAMPS could also help endangered, and are of regional or inter­ challenge stereotypes of African herbal national importance. products (J. Simon, oral communica­ Phillips said the University of Pretoria tion, August 2005). A common percep­ will likely serve as coordinator of the phar­ tion about African herbal products is that macopeia's development, with a group of they lack quality standards and are not experts and sub-contractors from all over harvested sustainably. AAMPS could Africa preparing the profiles of plants most play a major role in alleviating this nega­ commonly grown in their regions. These tive image by encouraging more formal profiles will contain elements addressing trade procedures, modern and consistent regulatory issues, similar to those featured processing, and quality control measures in the American Herbal Pharmacopoeia similar to those employed in the United (www. herbal-ahp.org) and The ABC Clin­ States and Europe. "Africa has both a chal­ icaL Guide to Herbs, 3 as well as elements lenge and opportunity to show itself not as designed for companies that might import a second or tertiary tier provider of cheap or trade such plants. raw botanicals but as a premier source of

24 I HerbaiGram 70 2006 www.herba lg ra•11 .org ------~ Research &World News ~------

high quality botanicals, whether in rhe raw over conventional western pharmaceuti­ unprocessed form or as parrially or fu lly cal treatments, emphas izes rhe necessity processed natural products," Simon sa id. of quality herbal alternatives within the "Africa is one of those underdevel­ continent. "About 70 ro 80% of Africans oped and underappreciared regions with rely on traditional healers as rheir first •••• • phenomenal porenrial and a virrual rrea­ caregivers," Gbewonyo said. • • sure of generic dive rsity relative ro medici­ Phill ips said AAMPS is parricularly •• •• nal planrs," Simon conrinued. African inreresred in raising awareness of the orga­ herbs and herbal products already contrib­ nization and garnering financial supporr bi c:luminex ute millions of dollars ro rhe international for irs mission. "We want everyone ro Bioluminex~ a revolutionary new herbal industry. According ro Simon, rhe know what we're doing and ro criticize analytical bioassay herb indusrry on rhe African conrinenr is what we're doing and ro contribute," Phil­ poised ro play a more significanr role m lips said. AAMPS offers membership ro Bioluminex~ is a new assay for rhe global arena than it does presendy. others committed ro rhe cause of African biological activity and toxicity Kodzo Gbewonyo, SeD, president of quality standards and rhe development of screening of complex sample mixtures such as foods, beverages, BioResources International Inc. in Somer­ an African Herbal Pharmacopoeia, and dietary supplements and waste water. set, NJ, srressed that the progression of the organization has its office registered in This unique and effective technology rhe African herbal industry is especially Mauririus.1 He added rhar rhe pharmaco­ was invented by Bayer to combine imporranr ro rhe people of Africa (oral peia rhar AAMPS is developing will be rhe Thin Layer Chromatography (TLC) communication, August 2005). 'The costs firs t ro highlight native plants from across with the use of bioluminescent marine bacteria, Vibrio fischeri, as a bioassay of Wes tern medicines are way beyond rhe Africa. Phillips said a previous attempt at detector. Bioluminex~ is a fast, reliable, reach of most Africans," he sa id. Furrher­ an African pharmacopeia, commiss ioned economic tool for quality control, more, rhe poor ratio of trained docrors ro by rhe Organization for African Unity, research and manufacturing of food patients in Africa, as well as rhe preference related products or water. of many Africans for natural medicines Continues on page 27 Key Benefits of Bioluminex':"

Table 1. African Plants Selected for Profiling by AAMPS • Greatly enhances TLC with a Latin Name Family Common Name biological detector Agathosma betulina Rutaceae Buchu • Rapid results Aloe ferox Aloaceae Cape aloe • Easy-to-use Antidesma madagascariensis Euphorbiaceae Bois bigaignon Aphloia theiformis Flacourtiaceae Fandamane • Works with almost any sample type

Aspalathus linearis Fabaceae Rooibos • Wide application base Balanites aegypticus Zygophyllaceae Desert date • Determination of both "active" Bos wel/ia spp. Burseraceae Frankincense and "toxic" compounds Colaspp. Sterculiaceae Kola nut • Cost effective (low cost per assay) Cyclopia genistoides Fabaceae Honeybush Donais fragrans Rubiaceae Liane Griffonia simplicifolia Fabaceae Griffonia Harungana madagascariensis Guttiferae Haronga Harpagophytum procumbens Pedaliaceae Devil's claw Hypoxis hemerocallidea Hypoxidaceae African potato Kigelia africa no Bignoniaceae African sausage tree Moringa oleifera Moringaceae Moringa (aka horseradish tree) To learn more about Biolurninex '" or Pelargonium sidoides Geraniaceae Umckaloabo for a detailed brochure of applications Prunus africa no Rosaceae Pygeum bark (aka African plum) please contact us at: Sceletium tortuosum Aizoaceae Sceletium Siphonochilus aethiopicus Zi ngiberaceae African g in ger E) ChromaDex Sutherlandia frutescens Fabaceae Cancer bush 2952 S. Daimler St. Santa Ana, CA 02705 Warburgia salutaris Canellaceae Warburgia tel. 949.419.0288 Xysma lobium undulatum Asclepiadaceae Uzara fax. 949.419.0294 Source: Centre for Development of Enterprise, University of Pretoria, Phytomedicine Programme, Africa n email. [email protected] Medicinal Plant Standards Project. web. www.chromadex.com

www.herbalgram.org 2006 HerbaiG ram 70 I 25 WHO Atlas Provides Global Perspective on Traditional and CAM Trends by Courtney Cavaliere

n April of2005, the World Health Organization (WHO) released its 2-volume WHO Global Atlas of Traditional, Complementary and I Alternative Medicine (TCAM), which provides visual and textual accounts of natural healthcare issues worldwide. The atlas was commissioned by the amount of rich information uncovered by WHO, it underscores the importance of WHO Centre for Health Development the teams' efforts led the editors to produce the field in global healthcare at the begin­ in Kobe, Japan, in response to an inter­ 2 separate volumes. The first provides ning of the 21st century." national symposium of TCAM experts textual descriptions of TCAM practices The atlas' map depicting "Utilization held in October of 2000 (G. Bodeker, e­ and trends through over­ of Herbal/Traditional Medicine" mail, November 29, 2005). Six teams were views of 6 global regions­ indicates greater data availability assembled to collect data from different the African, Americas, and worldwide presence of herbal global regions, and the information was South-East Asia, Euro­ treatments than any other TCAM ultimately implemented and edited by the pean, Eastern Mediterra­ modality.2 Moreover, according to Global Initiative for Traditional Systems nean, and Western Pacific statistics and tables within (GIFTS) ofHealth Team at Oxford Univer­ regions-and 23 case stud­ the atlas, herbal medicine is sity. "This was a large exercise involving ies of individual countries.1 one of the only TCAM treat­ dozens of experts around the world," said The second is composed ments as likely to be popular Gerard Bodeker, EdD, chair of Oxford's of maps illustrating global in low-income nations as in GIFTS of Health, adjunct professor of TCAM patterns visu­ high-income nations. The epidemiology at Columbia University, and ally, covering such topics vast majority ofTCAM ther­ co-editor of the atlas. "The data on which as national legislation and apies-including acupunc­ each regional tea m drew were from a wide policy, public financing, education, ture, homeopathy, massage, range of sources: government reports and practitioners and their legal recog­ and chiropractic-appear to documents, international agency stud­ nition, and popularity of particu­ be far more popular in high­ ies- including WHO reports and other lar TCAM therapies.2 "This is the income countries than devel- UN data-books, published research first time that approaches outside oping nations. literature, unpublished NGO reports, and the formal medical sector have been the According to Dr. Bodeker, the atlas other so-called 'grey literature."' focus of a public health atlas," Dr. Bodeker could serve as a particularly important According to Dr. Bodeker, the massive explained. "And as this was produced by resource for policymakers and research­ ers. Furthermore, it pinpoints areas Utilization of Herbal/Traditional Medicine where additional data should be collected and clas­ sified. Some maps have significant blank areas, indi­ cating the lack of available informa­ tion within certain parts of the world. • "Clearly this sector • has been margin­ alized for a long • q_ time, and while governments keep data on the extent of private practice in their countries and on the extent and distribution of immunizations, Level of utilization • Low or insufficient data • Medium • High D No data they overlook other forms of Note: Re-drawn from original map "01. Utilization of Herbai!Traditional Medicine;' WHO Global Atlas of Traditional, services such as the Complementary and Alternative Medicine- Map Volume, page 46. Courtesy World Health Organization. TCAM modalities

26 I HerbaiGram 70 2006 www.herbalgram.org used in many cases by most of their citi­ ered for the WHO atlas but not ultimately zens," Dr. Bodeker said. "The atlas is included in the document. Dr. Bodeker AAMPS useful for identifying gaps in information and Ms. Gemma Burford, research asso­ Continued from page 25 and information planning needs for future ciate of GIFTS of Health, assembled and understanding of this sector and its role in co-edited this new book with permission mostly focused on plants of European and national and global healthcare." from WHO. The book features chapters Indian origin, was very limited in circula­ on policy-related issues ofTCAM, profiles tion, and featured profiles very limited in depth and breadth. ofTCAM practices used to manage health Herbal medicine problems in the developing world, and More information about AAMPS can be various TCAM research issues. HG found at its Web site: www.aamps.org. HG is one of the only References TCAM treatments as References 1. Bodeker G, Ong CK, Grundy C, Burford 1. Centurion Lake African Medicinal Plants Standards Meeting Launches New likely to be popular in G, Shein K. WHO Global Atlas of Tradi­ tional, Complementary and Alternative Association ro Prepare African Pharma­ copoeia [press release] . Association for low-income nations as Medicine: Text Volume. Kobe, Japan: WHO Cemre for Health Developmem; African Medicinal Plams Standards Web in high-income nations. 2005. Sire. Available at: http://www.aamps. 2. Bodeker G, Ong CK, Grundy C, Burford org/aampso/o20pressrelease.pdf. Accessed G, Shein K. WHO Global Atlas of Tradi­ August 10, 2005. 2. Association for African Medicinal Plams Two co-editors of the atlas have also tional, Complementary and Alternative Standards. Cemurion Lake Declaration. developed a separate book to supplement Medicine: Map Volume. Kobe, Japan: WHO Cemre for Healrh Development; Available at: http://www. underutilized­ the atlas (G. Bodeker, e-mail, Feb, 21, species.o rg/ docu men rs/ map/ declara rion . 2006). Public Health & Policy Perspectives 2005. 3. Bodeker G, Burford G. Public Health & pdf. Accessed February 8, 2006. on Traditional, Complementary & Alterna­ Policy Perspectives on Traditional, Comple­ 3. Blumemhal M, Hall T, Goldberg A, which is to be published Kunz T, Dinda K, Brinckmann J, tive Medicine,3 mentary & Alternative Medicine. London: in June 2006 by Imperial College Press, Imperial College Press (in press) . Wollschlaeger B, eds. The ABC Clinical is based upon information that was gath- Guide to Herbs. Austin, TX: American Botanical Council; 2003.

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www.herba lgram.org 2006 HerbaiGram 70 I 27 ------~[Research ReviewJ~------

Kudzu Extract Reduces Alcohol Consumption in Heavy Drinkers in Small Trial D eviewed: Lukas S, Penetar D, Berko J, et al. An extract of the Chinese herbal root kudzu reduces alcohol drinking by heavy .ftdrinkers in a naturalistic setting. Alcohol Clin Exp Res. 2005;29(5):756-762.

There are no uniformly effective drugs where its roots are commonly used in food consumed, reduced the average sip size, for treating alcohol abuse or dependence. (a thickener in sauces and soups) and as a and increased the average number of sips Only three drugs have been approved in medicinal herb. per beer (P < 0.0001-0.019). While taking the United States for treating alcohol­ In this study, 14 volumeers residing in kudzu, but not placebo, participants ism. Since 600 CE, herbal preparations Massachusetts with a body mass index reduced their beer consumption from 6 to have been used to treat alcohol-related between 19 and 24 kgfm2 were screened 4 beers per day. Data collected before each diseases in various systems of traditional for alcohol dependence. On the average drinking session indicates that there was medicine. The Chinese herbal medicine each drank 25 alcoholic beverages each no change in the desire for alcohol and XJL (NPI-028) has been used to lessen week, and none had a family history of yet the participants drank less. There were alcohol intoxication. NPI-028 contains alcoholism. The experiment was designed no adverse side effects and the patients several plants, including kudzu (Pueraria to determine whether pretreatment with could not identify when they were taking montana [Lour.) Merr. var. lobata [Willd.) kudzu extract alters alcohol consump- the active treatment or the placebo. There Maesen & S.M . Almeida, Fabaceae) and were no biochemical changes. an extract of Citrus reticulata Blanco, The data suggests that kudzu root prob­ Rutaceae. Kudzu is a legume with large ably does not block alcohol's effect but leaves and thick, long roots. Kudzu was rather prolongs the acute effects of the introduced to the United States in 1876 first drink. This effect may reduce binge to control soil erosion in the Southeastern drinking. The altered sip pattern may states; it spread rapidly, engulfing many indicate that individuals "titrated" their farms. Since it has no natural preda­ alcohol intake to a lower amount. The tors (e.g., herbivores or insects), it spread authors suggest that the first 1 or 2 beers unchecked and the vine has become may have satisfied their desire for beer. common on trees and telephone/power In the pilot study, subjects reported that Kudzu Pueraria montana Photo ©2006 poles throughout the southern United stevenfoster.com kudzu plus alcohol made them feel "tired, States. It has been branded "the vine that floating, or intoxicated." ate the South." tion in a "natural" setting. The natural Although the actual decrease in drink­ Previous research on Syrian golden setting was a house-like environment with ing was modest, any decrease is impor­ hamsters suggested that kudzu root can a kitchen, stocked with the volunteers' tant when the individual is drinking large inhibit cravings for alcohol. 1 To date, there favorite beer and other beverages, and a quantities. The authors conclude that has been only one efficacy study published living room with a television, movies, etc. kudzu may help heavy or binge drinkers on kudzu, especially as it relates to possi­ Volunteers had free access to the beverages reduce their alcohol consumption. The bly reducing cravings . for alcohol; most and could drink at their own pace. lack of adverse side effects indicates that other reports are anecdotal. Although the Volunteers were first given the kudzu higher doses should be tested and may anti-intoxication mechanism of action is preparation or placebo in a double-blind be more effective. This study was of the unclear, the isoflavones found in kudzu are fashion for 7 days and then given the highest quality regarding design, which believed to be responsible for the reduced opportunity to drink beer in the natural is not surprising considering that it was alcohol intake in animals, as documented laboratory. They were assessed 4 times, conducted by researchers from Harvard by several studies. One human clinical each separated by a washout period. One Medical School and supported by the trial reported that a kudzu preparation of assessment was conducted before receiving National Institute on Alcohol Abuse and undocumented analysis had no effect on kudzu and used as the baseline. Partici­ Alcoholism and the National Institute on alcoholism in human subjects (military pants rook 2 capsules (500 mg each) 3 Drug Abuse. HG veterans). 2 Additionally, the authors of the times daily. Each 500 mg capsule of kudzu -Heather S. Oliff, PhD present study discovered negative findings (NPI-031, Natural Pharmacia Int., Inc.; in a preliminary study. In an attempt to Research Triangle Park, NC) contained References increase the potential efficacy, the authors sugar beet-based filler and 19% puerarin, 1. Keung WM, Vallee BL. Daidzin and have increased the concentration of kudzu 4% daidzin, and 2% daidzein. Riboflavin daidzein suppress free-choice ethanol isoflavones from 1o/o to 25%. The discus­ was added to the formulation to measure intake by Syrian golden hamsters. Proc Nat! Acad Sci USA. 1993;90: 10008- sion below is a report of the findings. To compliance. Volunteers served as their 10012. date, other than its original intention to own controls. 2. Shebek J, Rindone JP. A pilot study help stop soil erosion, there is no economic There was a 100% compliance rate. exploring the effect of kudzu root value for kudzu; that is, it is not consid­ One-week treatment with kudzu extract on the drinking habits of patients with ered an economically important plant in significantly reduced the number of chronic alcoholism. J Aft Compl Med. the United States, as comrasted with Asia, beers consumed, reduced volume of beer 2000;6:45-48.

28 I HerbaiGram 70 2006 www.herbalgram.org

------1~esearch ReviewJ~------

Review of Trials Shows Peppermint Oil Capsules to be Effective in Treating IBS Reviewed: Grigoleit HG, Grigoleit P. Peppermint oil in irritable bowel syndrome. Phytomed. 2005;12:601-606.

Irritable bowel syndrome (IBS) is a disorder of the gastroin­ The placebo response was in the range of 10-52% for all stud­ testinal tract that is characterized by constipation, diarrhea, and ies; the average placebo response was 29%. Of the 12 placebo­ abdominal cramps resulting from intestinal spasms. Although IBS controlled trials, 8 showed a statistically significant positive effect is widespread, there are relatively few safe and effective treatments for peppermint oil over the placebo. The 9 double-blind, cross­ for its symptoms. Peppermint (Mentha x piperita L., Lamiaceae) over trials showed oil is used as a treatment for IBS in herbal medicine. peppermint oil effi­ The authors reviewed 15 clinical trials on peppermint oil in cacy in the range the treatment of IBS , emphasizing the safety and cost effective­ of 39-79%, with ness of peppermint oil therapy. They also reviewed an article on an average positive abdominal pain in children. The 15 clinical trials enrolled a total response rate of of 651 patients and lasted from 2 weeks to 6 months. Nine clini­ 58%. The 2 open cal trials were randomized, double-blind, crossover studies; 5 were label studies showed randomized, double-blind, parallel group studies; and 2 were open mixed results: the label studies. In the clinical trials, peppermint oil was compared range of positive to placebo (n=12), psychotherapy (n=1), and anti-cholinergic response to pepper­ smooth muscle relaxants (n=3). Thirteen trials included enteric­ mint oil treatment coated peppermint oil capsules, and 3 trials did not specify the was 18-93%. Three formulation. The authors used "overall success" to compare the double-blind, studies in order to account for study method variations. crossover studies comparing pepper­ mint oil to smooth muscle relax­ ants did not show significant differ­ ences between the 2 types of treatments in terms of effi­ cacy. The authors Peppermint Mentha x piperita Photo ©2006 conclude that stevenfoster.com "[t]here is reasonable evidence that enteric- coated peppermint oil, 180-200 mg t.i.d., given for 2-4 weeks, in IBS is efficacious as compared to placebo and the smooth muscle relaxants investigated." Adverse event reports associated with peppermint oil were generally mild and transient and included heartburn (n= 14) and anal discomfort or burning (n=26). Tolerance in the study on In Canada, we nave regulations that ensure KGK has the unparalleled advantage of having children and abdominal pain was "good." A total of 71 patients our nutraceutical products are based on an in-house cl inic and lab, with a location that sound scientific research. Why is that better gives us access to a patient population of dropped out of the 15 clinical trials, 58 dropouts were unrelated for our U.S. clients? Because we know that more than one million. to the study medications. Six patients dropped out due to worsen­ investing in doing it right the first time gives Contract research services include: you a competitive advantage in the market for ing of symptoms, including nausea, vomiting, peri-anal burning, • in vitro models the long term. We also know our costs are very • in vivo models peppermint taste, and heartburn. competitive and most importantly, we know • human clinical trials The bulk of the clinical evidence shows that peppermint oil • research consultation KGK is owned and operated by internationally enteric-coated capsules are a safe and effective short-term treat­ Call us. We'll clearly demonstrate an renowned scientists in the field of nutraceuticals ment for the symptoms of IBS. The wide response ranges listed advantage to you. and functional foods. Our team of research professionals ensure we deliver results on time above may be partially due to the fact that IBS has multiple and on budget. @ causes. Peppermint oil therapy is more cost effective and is associ­ ated with a lower risk of adverse events than conventional pharma­ KsKsynerg1ze ceutical drug treatments available for IBS. The authors conclude Sc1entific Excellence. Unparalleled Serrice. Quality Results. that peppermint oil " ... may be the drug of choice in IBS patients 2:05 Oue..ros Ave <;u•tl" 1030, London ON Canada N6A SRS with non-serious constipation or diarrhea to alleviate general t 51943893id i 5194388314 wwwkgl-synerg•ze.col"l"' symptoms and improve quality of life." HG - Marissa Oppel, MS

30 I Herba iGram 70 2006 www. herba lgra m.org ------i~esearch ReviewJ~------

COLD-fX®, Special Patented Extract of American Ginseng Root, Treats Cold Symptoms in Canadian Trial viewed: Predy GN, Goel V, Lovlin R, Donner A, Stitt L, Basu TK. Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory tract infections: a randomized controlled R rial. CMA}. 2005;173(9):1043-1048. On average, Americans get 2-6 colds each year. Finding ways ro difference was not statisticall y significam. However, there was a reduce the frequency of the common cold is imporram. Botanicals significam diffe rence in the recurrence of colds, with 10 % in the that stimulate the immune system have been used ro combat the COLD-fX group havi ng more than one cold compared with 23% common cold , but clinical srudies have sometimes been incon­ in the placebo group (P = 0.004), represeming a 56% relative ri sk clusive. reduction. COLD-fX-treated subj ects had less severe symptoms Preparations made from the roots of American ginseng (Panax (P = 0.002) and were sick for fewer days (P < 0.001). Both COLD­ quinquefolius L., Araliaceae) have demonstrated immuno­ fX and placebo were well tolerated with few advers e effects. There modularory effects ; however, only recendy has there been clinical was no significa m difference between the 2 groups with respect research conducted on this traditional herb- most of it being in ro the use of NSAIDs (non-steroidal ami-inflammarory drugs) or the area of comrolling blood sugar levels in type 2 diabetics. amibiotics. Most sciemific literature on both Asian ginseng (Panax ginseng T he authors concluded thar COLD-fX is a safe and effective C.A. Meyer) and American ginseng tends ro focus on the treatment for reducing the absolute risk of recurrem colds and the ginsenosides as the putatively primary active compounds. A mean number of colds per person. They do point out rhat rhe find­ patemed poly-furanosyl-pyranosyl-saccharides-ri ch ex tract of ings apply only ro healthy adults and furrher studies in children American ginseng roots (COLD-fX", also known as C VT-E002, and immuno-compromised adults are needed. This srudy had produced by CV Technologies Inc, Edmomon, Alberta, Canada) excellem methodology and reporting, which provides additional has been shown in vitro to demonstrate immunostimulating credibility to rhe findings. While a 13% absolute reduction in the effects. An increase in immune activity may decrease suscepti­ ri sk of getting a recurrem cold does nor seem particularly clinically bility to colds. The purpose of this clinical trial was to test this impressive, more promisingly, rhe authors report that "the total ex tract as a prophylactic treatmem for upper res piratory tract symptom score was 31.0% lower and the rotal number of days infections. symptoms were reported [was) 34.5% less in the ginseng group Healthy subj ects (n = 323) who had experienced at least 2 rhan in the placebo group over rhe 4-momh imervemion peri od ." colds in the past year participated in this randomized, double­ Also, rhe activity of C OLD-fX seems to compare favorably with blind, placebo-controlled srudy conducted at the University of that of common amivi ral drugs such as rimamadine, amamadine, Alberta, Edmonton, Canada. For 4 momhs the subjects took za namivir, and oseltamivir (Tamiflu"). COLD-fX was reported either placebo or 400 mg per day of the CVT-E002 patemed stan­ in an earlier srudy wirh elderly people ro reduce the relative risk dardized extract (concemrated ro 80% poly-furanosyl-pyranosyl­ of laboratory-confirmed influenza infections by 89% .1 This is a saccharides and 10 % protein). level of effectiveness similar to that of zanamivir and oselramivir. 2 Treatmem bega n just after the onset of influenza season. These amiviral agems have bee n reported to reduce the severity Subjects were instructed not ro take any other cold medication and duration of illness by 1.5 -2.5 days,3 while COLD-fX treat­ unless advised by their phys ician. Every evening the subjects mem reduced rhe duration of a cold by 2.4 days . completed a diary detailing the severity of cold-related symproms. T he authors of this study further assert that, "This North A 2-day total symptom score greater than 14 was considered ro American ginse ng ex tract has a broader range of activity (than indicate a modified Jackson-criteria-verified cold. The Jackson common amivirals) and hence is poremially more effecti ve in score is one of the most accurate and res trictive definitions of a combating diffe rem strains of virus." Due to the unique chemi­ cold because it quantifies cold symptoms. By contrast, other srud­ cal profile of rhe CVT-E002 (COLD-fX) preparation, it is highly ies often use the less precise method of simply noting the absence doubtful whether the res ulrs of rhe clinical research on rhis or presence of a runny nose to define a cold. patemed preparation could be applicable ro resea rch conducted There were no significam differences in baseline character­ with convemional extracts of Ameri can ginseng roots. HG istics between the groups. Compliance was rated high in both -HeatherS. Oliff, PhD, and Mark Blumenthal groups and blinding was maimained. (Seventy-seven percem of the patiems taking placebo thought they were raking COLD-fX, References indicating that the formulation and administration of the placebo I. McElhaney JE, Gravenstein S, ColeS, Davidson E, O'Neill D, was successful. In some clinical trials with other herbs, the prepa­ Peti gea n S et al. A placebo-controlled trial of a proprietary extract ration of placebo and lack of successful blinding has sometimes of Norrh America n ginse ng (CVT - E 002) ro prevent acute respi­ rarory illn ess in institutionalized older adults. jAm Geriatr Soc. been inadequate, thereby producing equivocal res ults.) 2004; 52:13-19. Overall, there was a 13% reduction in the absolute risk of 2. Turner D, Wailoo A, Nicholson K, Cooper N, Sutton A, Abrams K. getting recurrem colds meeting the Jackson criteria. The mean Systematic review and eco nomic decision modeling for the preven­ number of Jackson-verified colds per person was significantly less ti on and treatment of influenza A and B. Health Techno! Assess. in the COLD-fX group than in the placebo group (P < 0.017). 2003; 7:1-1 70. Fewer subjects in the COLD-fX group than in the placebo group 3. Stiver G. The treatment of influenza with antiviral drugs. Can Med reported comracting at leas t 1 cold during the study, but the Assocj. 2003; 168(1):49-57. www.herbalgram.org 2006 HerbaiGram 70 I 31 ------.....jlResearch ReviewJ~------

Supercritical C02 Extract of Feverfew Leaf Effective for Migraine eviewed: Diener HC, Pfaffenrath V, Schnitker J, Friede M, Henneicke-von Zepelin H-H. Efficacy and safety of 6.25 mg t.i.d. feverfew COrextract (MIG-99) in migraine prevention: randomized double-blind, multicentre, placebo-controlled study. RCephalalgia. 2005;25(11): 1031-1041. This is the second randomized, double­ This erial, which used much larger attacks within the baseline period of 4-72 blind, placebo-comrolled erial with active and placebo cohorts than the 2002 hours. The dosage used was 6.25 mg of a successful outcome using a special trial (more than 3 times greater: 107 and the MIG-99 exeract given 3 times daily. supercritical carbon dioxide extract of 108, respectively), is the largest comroll ed T he main outcome measure confirmed feverfew leaf (Tanacetum parthenium [L.] study in migraine prophylaxis with a the earlier observation of a statistically Schultz Bip., Asteraceae) . The prepa­ feverfew preparation to be reponed to significam reduction of the number of ration is known as MIG-99, and it is date. The trial was based on out-patients migraine attacks during feverfew treat­ produced and marketed by Schaper and of both genders (18 to 65 years) who had ment as compared to placebo. Although Brummer GmbH, Salzgitter, Germany. It suffered migraine attacks for at least I the data for the convenrional pharma­ raises some interesting questions regard­ year, with age of onset prior to 50 yea rs of ceutical treatment of choice, propranolol, ing both feverfew ami-migraine prophy­ age, an average of 3-6 attacks per momh showed greater efficacy for the pharmaceu­ lactic efficacy and its adverse event (AE) within the 3 months prior to initiation of tical, the less frequent and less severe side profile. A previous study using MIG-99 the study, 4-6 attacks per 28 days within effects associated with the phytomedicinal was published in 2002.1 the baseline period, and a duration of treatment conferred a comparable ri sk­ benefit ratio to the latter: a meta-analysis of propanolol erials indicated that I of 6 patients (17%) discontinued propranolol ereatmem,2 compared to di scominuation of feverfew by 4.3% of feve rfew users, as revealed in a survey of 164 use rs .3 In the currem study, the discominuation rate due to an adverse event was roughly 3% and idemical in both placebo and feverfew groups: 3 patients in each group withdrew because of gastroimestinal disturbances. Methodologicall y, the best trial conducted thus far on whole feverfew leaf (as opposed to extracts) reponed in 1988 that of 59 test subjects, 10 experienced mouth ulceration on feverfew as compared with 16 on placebo.4 lmerestingly, of the 215 patients involved in this recem success­ ful trial of the MIG-99 C02-extract of feverfew leaf, which is highly enriched in the sesquiterpene lactone parrhenolide (formerly the putative anti-migraine prin­ ciple), no incident of mouth ulceration was reponed. The authors of the publication attributed mouth ulceration to contact of powdered feverfew leaf with oral mucosa. However, it has long been established that aphthous mouth ulceration is a systemic condition that is not obviated by encap­ sulation of leaf material.3 Mouth ulcer­ ation and sore tongue were reported by 6.4% of 270 feverfew patients surveyed,5 but the more widespread inflammation of the mucous membrane of the mouth and surface of the tongue, often with swelling of the lips, is likely a serictly direct contact effect precipitated by chewing of fresh leaves; in its most severe form there can also be loss of taste sensation.3

32 I HerbaiGram 70 2006 www.herbalgram .org ------"""""'lResearch ReviewJ~------

This recent trial of MIG-99 supports of migraine days per 28 days, no significant Friede M, H enneicke-von Zepelin H-H. results of rhe earlier trial wirh 3 dosage difference was noted for rhe mean duration The efficacy and safety of Tanacetum regimens, rhe intermediate dose of 6.25 of migraine attacks per 28 days. parthenium (feverfew) in migraine prophylaxis-a double-blind mulricentre mg 3 rimes daily being most effective in The persistent adherence of some randomized placebo-controlled dose­ researchers and manufacturers to high alleviating migraine attacks in a small response study. Cephalalgia. 2002; subgroup of subjects who experienced at parthenolide content is puzzling given the 22:523-532. least 4 migraine attacks per month. An failure of a 90% ethanol extract, amply 2. Holroyd KA, Penzien DB, Cordingley increased dose of 18.75 mg 3 times daily charged with parthenolide, 6 whereas a GE. Propranolol in rhe management did nor increase effecriveness. 1 whole leaf product with a lower level of of recurrent migraine: a mera-analyric The main prophylactic effect of MIG- parthenolide was successful in countering review. Headache. 1991 ;31 :333-340. 99 was a reduction in the frequency of migraine attacks.? An obvious explanation 3. Johnson S. Feverfew. A traditional remedy migraine attacks. The effect begins after of the failure of the ethanol extract would be for migraine and arthritis. London: Shel­ don Press; 1984:79-83. I month and is maximal after 2 months that the active principle(s) was/were either 4. Murphy JJ , Heptinstall S, Mitchell JRA. and does not abate for at least 4 months. A lost or degraded during the protracted Randomized double-blind placebo­ significantly better efficacy ofMIG-99 over extraction period (19 days) ar ambient controlled trial of feverfew for migraine placebo (P = 0.046) was revealed by statisti­ temperature. Parthenoli de possesses a vari­ prevention. Lancet. 1988;ii: 189-192. cal analysis for the primary endpoint (roral ety of bioactivities including cytotoxicity. 5. Johnson ES . Patients who chew chrysan­ number of migraine attacks within 28 days An understanding of the mechanism of themum leaves. MIMS Magazine. May during the second and third 28-day treat­ feverfew's anti-migraine activity awaits 15 , 1983:32-35. 6. deWeerdt CJ, Bootsma HPR, Hendriks ment period compared wirh baseline); the further study, particularly assessment of H . Herbal medicines in migraine preven­ frequency of attacks decreased in rhe inren­ parrhenolide-free extracts. HG tion. Phytomedicine. 1996;3:225-230. tion-ro-treat group from 4.8 per month - Dennis V. C. Awang, PhD, FCIC 7. Palevirch 0, Earon G, Carasso R. during baseline to 2.9 (-1.9±0.2) in weeks MediPlant Consulting Services, Feverfew (Tanacetum parthenium) as a 5-12 for MIG-99 and to 3.5 (-1.3±0.2) for White Rock, BC, Canada prophylactic rrearment for migraine: a placebo. Additionally, while a significant double-blind placebo-controlled study. difference was noted between active and References Phytotherapy Research. 1997; II :508-571. placebo groups for decrease in the number I. Pfaffenrarh V, Diener HC, Fischer M,

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Saw Palmetto Extract Does Not Produce Benefits in Treatment of Moderate to Severe BPH in Clinical Trial Reviewed: BentS, Kane C, Shinohara K, eta!. Saw palmetto for benign prostatic hyperplasia. N Eng!] Med. 2006;354(6):1-10.

Extracts of the saw palmeno (Serenoa urinary flow rate. Secondary outcome serious adverse events were reponed (8 repens, [W. Banram] Small, Arecaceae) measures included quality of life ratings in the saw palmetto group and 18 in the berry are often used as an alternative (assessed with the use of2 self-administered placebo group), no significant differences to pharmaceutical agents in the treat­ questionnaires), prostate size (measured were observed between the groups. ment of benign prostatic hyperplasia by transrectal ultrasonography), residual The authors conclude that "saw palmetto (BPH), the noncancerous swelling of the volume after voiding (measured by ultra­ was not superior to placebo for improving prostate gland in middle-age and older sound), and serum prostate-specific anti­ urinary symptoms and objective measures men. BPH usually manifests in numer­ gen, testosterone, and creatinine concen­ of benign prostatic hyperplasia." This ous urinary dys functions. In a United trations. The outcome measures were finding contrasts with the findings of 21 States survey conducted in 2002 cited assessed during 8 visits to the study clinic randomized, placebo-controlled trials of in this paper, 2.5 million (1.1 %) adults over the study period. saw palmeno on over 3000 men that were reponed using saw palmeno. In Germany, many urologists prescribe this plant-based extract in preference to synthetic drugs for BPH. Although most randomized trials of saw palmetto have shown at least small improvements in urinary flow and in symptoms associated with BPH, the authors of this trial write that many of these studies had limitations, including small sample sizes, shon durations, and the lack of standard outcome measures. The objective of the present study was to assess the efficacy of saw palmeno for the treatment of moderate to severe BPH. In this trial 225 men (112 in saw palmeno group; 113 placebo) older than 49 years with moderate-to-severe symp­ toms of BPH were randomly assigned to receive either 160 mg saw palmeno extract (Rexall-Sundown, Boca Raton, Saw palmetto Serenoa repens Photo ©2006 stevenfoster.com FL) or a similar-appearing placebo 2 times daily for 1 year. The material used in the product was a standardized carbon diox­ The baseline characteristics of the 2 sys tematically reviewed in 2001.3 In 9 ide extract of saw palmeno berry that had groups were not significantly different, of these studies, saw palmeno consump­ previously been shown to be effective in except for significantly lower scores (P tion increased the peak urinary flow clinical trials on men with mild to moder­ = 0.02) in the placebo group on 1 of rate 1.86 mL per second more than did ate BPH. 1'2 The BPH severity was defined the 2 questionnaires (Benign Prostatic placebo. In a tenth study reviewed (a by a score on the American Urological Hyperplasia Impact Index, BPHII). Both trial conducted in the United States), saw Association Symptom Index (AUASI) of at study groups showed a small decrease in palmetto improved symptom scores equiv­ least 8 (a nd a top score of 35), plus a peak the AUASI score over the 1-year study alent to the AUASI by 4.4 points while the urinary flow rate of less than 15 mL per period: mean (± SE) decreases of 0.68 ± placebo group improved 2.2 points after second. The 160 mg twice daily dose is the 0.35 and 0.72 ± 0.35 in the saw palmeno randomization of both agents.4 The Bent standard dose used in earlier saw palmetto and placebo groups, respectively. However, et al trial after randomization showed trials performed primarily on men with the mean change in AUASI score over time a reduction of AUASI of only 0.68 in mild to moderate symptoms of BPH. was not significantly different between the the saw palmetto group and 0.72 in the The men were recruited from the groups. Similarly, the peak urinary flow placebo group. In comparison to many San Francisco Veterans Affairs Medical rate, prostate size, residual volume after trials conducted on conventional BPH Center. The patients made 8 study visits voiding, BPHII, overall quality of life drugs and saw palmetto, this is a very low over a one-year period to assess changes in scores, and serum prostate-specific anti­ symptom response for both the active and the AUASI scores. The primary outcome gen, testosterone, and creatinine concen­ the placebo groups. This is a cause for measure was a reduction in the AUASI trations were not significantly different concern since the patients in most clinical score and improvement in the maximal between the study groups. Although some trials should have a much larger placebo

34 I HerbaiGram 70 2006 www.herbalgram.org ------~lResearch ReviewJ~------response than reported in the trial by measures, so they cannot be compared­ conventional drug therapy, or sometimes Benr eta!. so I don't agree with this point and would surgery, is warranted. This is the most There was a potenrial anomaly in this need to do a more extensive literature rational clinical guideline for men in the trial-the significantly higher adverse review to be definitive about it" (S. Bent United States as well who want to try saw effect profile in the placebo group. Saw oral communication to L. Glenn, March palmetto as a first-line mild therapy for palmetto preparations are known to be 6, 2006). mild to moderate stages of BPH. safe and very well tolerated, producing Furure trials on men in the more few adverse effects. In this trial, minor advanced stage of BPH might be advised adverse effects in the saw palmetto and to test saw palmetto preparations at higher placebo groups were nearly equal (saw Although most doses to determine if there might be a palmetto, 39; placebo, 34)-evidence of randomized trials of saw dose-response relationship, i.e., a possible the safety of saw palmetto. However, there positive trend at the higher dose(s). were almost twice as many serious adverse palmetto have shown at This study was funded primarily by the effects in the placebo group (11) as in the least small improvements National lnstirute of Diabetes and Diges­ saw palmetto group (6), suggesting that tive and Kidney Diseases, with additional the patienr population may have had other in urinary flow and in funding from the National Center for serious illnesses, possibly interfering in the Complementary and Alternative Medi­ attempt to treat the moderate-to-severe symptoms associated ci ne. HG BPH symptoms. Even though the serious with BPH, the authors -Brenda Milot, ELS, adverse evenrs in the placebo group were and Mark Blumenthal almost twice as high as the saw palmetto of this trial write that group, according to the principle investi­ many of these studies had References gator, Dr. Bent, this was not considered a I . Braeckman J, Bruhwyler J, Vandekerckhove statistically significanr difference. limitations, including K, Geczy J. Efficacy and safety of the extract One possible explanation for the discrep­ of Serenoa repens in the treatment of benign prostatic hyperplasia: Therapeutic equiva­ anr findings of this trial, according to the small sample sizes, lence between twice and once daily dosage authors, is that blinding may not have short durations, and forms . Phytother Res. 1997; II :558-563. been effective in the prior studies. The 2. Mattei FM, Capone M, Acconcia A. adequacy of blinding was measured in the lack of standard Medikamentose therapie der benignen pros­ the present study and shown to be effec­ outcome measures. tatahyperplasie mit einem extrakt der sage­ tive. The placebo capsules were made of pal me. TW Uro! Nephro!. 1990;2:346-350. polyethylene glycol-400, which the paper 3. Wilt T, lshani A, Mac Donald R. Serenoa describes as "a bitter-tasting liquid with an repens for benign prostatic hyperplasia. The Cochrane Database ofSystematic Reviews oily appearance and no free fatty acids." A Overall, as has been shown previously, 2002, Issue 3. Art. o.: CDOOI423. DO!: brown coloring agent was also added to a comprehensive systematic review of I 0.1 002114651858.CD001423. produce a placebo with the appearance of the totality of the evidence from all the 4. Gerber GS, Kuznetsov D, Johnson BC, saw palmetto extract. published clinical trials3 (plus data from Burstein JD. Randomized, double-blind, It is also possible that the subjects in the clinical experience in Europe), in which placebo-controlled trial of saw palmetto in present study had characteristics (i.e., the saw palmetto preparations were used, leads men with lower urinary rract symptoms. more severe symptoms of BPH) that made to the conclusion that saw palmetto prepa­ Urology. 200 I ;58(6):960-964. them less likely to have a positive response rations are the safest first course of therapy 5. Bach D, Ebeling L. Long-term drug treat­ ment of benign prostatic hyperplasia­ to saw palmetto, particularly at the dosage and that when they are shown to bring results of a prospective 3-year multicenter used. There are at least 2 published open, significant relief, they remain the safest study using Saba! extract IDS 89. Phytomed. uncontrolled trials that show positive and most economical therapy. In clinical 1996;3(2): 105-111. results of saw palmetto extracts on men practice many European urologists use 6. Kondas J, Philipp V, Dioszeghy G. with BPH at stages II and IIJ.5·6 However, saw palmetto extract preparations as the Saba! serru!ata extract (S trogen forre•) these trials employed a differenr method standard first-line therapy for men with in the treatment of symptomatic benign of scoring symptoms than the method urinary symptoms associated with BPH prostatic hyperplasia. Inter Uro! Nephro!. used in the trial by Bent et al. But accord­ and, if they do not respond, then stronger 1996;28(6):767-772. ing to a peer reviewer of this article, many patients in European trials would have been classified as mild in the AUASI scor­ ing system used by Bent et al and, there­ HerbClip™ fore, were not included as patients in the The preceding Research Reviews are drawn from more than 2,800 HerbClip critical reviews, Bent trial. According to Dr. Bent, "my which are available online to members of ABC at the Academic level and above. The full own review of the literature suggests that HerbClip Educational Mailing Service is distributed semimonthly to ABC Sponsor Members our patients had similar severity ofBPH to and includes 12 critical reviews along with many of the original articles drawn from a variety other studies, as measured by peak urine of professional and mainstream sources. To receive the full service, contact Wayne Silverman, flow-older studies did not use AUASI PhD, at 512-926-4900 ext. 120, or via e-mail at [email protected].

www.herbalgram.org 2006 Herba!Gram 70 I 35 ------...... jl Guest Editorials J~------

New Review on Echinacea Reinvigorates Debate on Evidence of Popular Herb's Benefits by Bruce Barren, MD, PhD n Late December 2005 a meta-analysis ofclinical trials on Echinacea preparations was published by the Cochrane CoLLaboration, an inter­ national consortium of researchers and clinicians that evaluate the safety and efficacy of various complementary and alternative medicine I modalities according to evidence-based medicine criteria. The American Botanical Council (ABC) asked Dr. Bruce Barrett to write a perspective on this new meta-analysis. Dr. Barrett is Assistant Professor of Family Medicine at the University of Wisconsin-Madison Medical School and a member ofth e ABC Advisory Board. He has extensive knowledge ofthe published Echinacea scientific and clinical Literature and has published a clinical trial and several reviews, including one in HerbalGram.l

This edirorial seeks ro interpret the paLLida roots, and E. purpurea aerial parts of 7 potentially relevant trials.l i,J6 ,25-29 recently released Cochrane report on and/or roots. Only trials which tested Some Cochrane exclusions were due to echinacea2 within the wider field of echinacea-only formulations for preven­ trials testing preparations that included echinacea-related scientific literature. To tion or treatment of community acquired potentially active non-echinacea compo­ begin, I should disclose my insider status common cold were analyzed. The fact nents. Others followed our decision to as a co-author on that report. Readers that the body of echinacea clinical trials include only community-acquired colds, should also know that I have published is based on a heterogeneity of prepara­ which led us to exclude the three induced an echinacea trial that produced nega­ tions from the various species, plant parts, cold rhinovirus trials,9,28,29 Interestingly, tive results,3 as well as a few cautious­ and methods of preparation has long in the most recent review, Roland Schoop yet-optimistic echinacea reviews.1 ,4-6 I presented a significant challenge for those and co-authors have now combined these am also currently directing an echinacea who would attempt meta-analyses of these 3 rhinovirus-induced cold trials using trial funded by the National Center for trials. formal meta-analys is and have found Complementary and Alternative Medi­ that while each failed to make statistical cine at the National Institutes of Health. significance individually, enhanced power Our outcome data will be blinded for at Echinacea remains a gained by pooling data yields a statistically least the nex t year while the trial is in reasonable choice for significant result in favor of the echinacea progress. preparations used.30 The last Cochrane review led by Dieter prevention or treatment It is unlikely that simple publication Melchart was published in 2000.7 Since of the common cold, as bias (the tendency to publish positive then, several trials have been published, but not negative trials) can account for justifying the need for a new review. The sadly, there are the relatively large number of positively current Cochrane review was ably led by reported RCTs. Klaus Linde and was about as rigorous few if any well-proven Could the positive evidence be attrib­ and carefully done as is possible. Cochrane remedies, conventional utable to the placebo effect through systematic reviews employ exhaustive conscious or unconscious unblinding, as search criteria ro find all published reports or alternative. Caruso and Gwaltney3l suggest? Possi­ of a medical intervention (echinacea) for a bly, but if we were to accept such an given condition (common cold). Multiple explanation for the positively weighted databases are sea rched in several languages. Perhaps the main finding of this echinacea evidence, then we would have In this case, we sought all reports rele­ Cochrane review is that the evidence is to keep open the same possibility for simi­ vant to echinacea's ability to prevent or quite contradictory. Some trials are clearly lar findings from antibiotic trials for otitis to treat common cold (upper respira­ positive, others clearly negative. This media32 and sinusitis,33 and for a whole tory infection, presumed viral.) Cochrane cannot easily be explained by the type of host of other medical interventions that reviews preferentially focus on random­ echinacea used, by the population stud­ are accepted as well-proven. ized controlled trials (RCTs), as these have ied, or by other objective factors. While So, where are we left? Sadly, I have to say greatest internal validity. Non-randomized the trend among the newer, higher quality that I just don't know. While it is true that trials, cohort studies, case-control studies, RCTs3,8- JO is towards negative findings, the majority of published trials suggest case reports, and descriptive reviews are there has been an accumulation of positive both preventive and treatment effects, it is generally discounted, unless RCTs are findings as welJ.ll-16 Taking these find­ also true that the highest quality trials are not available. In this case, 16 RCTs met ings in context with earlier trials and with the most negative. What I can state with inclusion criteria. Of these, 13 tested trials including echinacea combination reasonable certainty is that effects on the echinacea preparations as treatment; 3 preparations containing non-echinacea immune system appear real,34 and that tested echinacea preparations as preven­ components, 17-24 it is clear that the major­ the safety profile appears favorable.l ,35-37 tion. The preparations used were derived ity of evidence still favors some treatment As the only trial in children was negativeS from several of the commercially available effect. (albeit with some evidence of a preventive species of Echinacea and from two parts As for prevention, the Cochrane review effect16) and showed increased rash in the of the plants, i.e., E. angustifolia roots , E. inclusion criteria led to analysis of only 3 echinacea group, I recommend against

36 I Herba!Gram 70 2006 www.herbalgram.org ------4l Guest Editorials J~------use in children. Despite one small case­ nal ofMedicine . 2005;353:34 1-348. 19. Braunig B, Knick E. Therapeurische control study finding no harm among I 0 . Yale SH, Liu K. Echinacea purpurea Erfahrungen mir Echinaceae pallidae pregnant women,38 I also recommend therapy for rhe treatment of rhe common bei grippalen lnfekren. Naturheilpraxis. against use in this group, as developing cold: a randomized, double-blind, 1993;1:72-75. placebo-controlled clinical rrial. Archives 20. Dorn M , Knick E, Lewirh G. Placebo­ embryos and fetuses are especially vulner­ ofInternal Medicine. 2004; 164:1237- controlled double-blind srudy of able, and as even a small rate of harmful 1241. Echinacea pal/ida radix in upper respira­ outcomes would be unacceptable. II. Cohen HA, Varsano I, Kahan E, Sarrell rory rracr infection. Comp Ther Med. In conclusion, I would voice my opin­ EM, Uziel Y. Effectiveness of an herbal 1997;5 :40-42. ion that echinacea is a beautiful perennial preparation containing Echinacea, 2 1. G rimm W, Muller HH. A randomized plant, worthy of gardeners everywhere, Propolis, and Vitamin C in preventing controlled trial of rhe effect of fluid and that if one believes in its therapeutic respiratory rracr infections in children: ex rracr of Echinacea purpurea on inci­ A randomized, double-blind, placebo­ dence and severity of colds and respira­ properties, it is likely to provide substan­ controlled, multicenter srudy. Archives tory infections. American journal ofMedi­ tial benefit, as either a preventive or as ofPediatrics & Adolescent Medicine. cine. 1999; 106:138-144. a treatment for the common cold. For 2004; 158:217-221 . 22. Hoheisel 0, Sandberg M , Berrram S, non-pregnant adults, it remains a reason­ 12. Goel V, Lovlin R, Barron R, Lyon Bulina M, Schafer M. Echinagard treat­ able choice for prevention or treatment MR, Bauer R, Lee TO et al. Efficacy ment shortens rhe course of rhe common of the common cold, as sadly, there are of a standardized echinacea prepara­ cold: A double-blind, placebo-controlled few if any well-proven remedies, conven­ tion (Echinilin) for rhe treatment of rhe clinical trial. European journal of Clinical tional or alternative. As for definitive common cold: a randomized, double­ Research. 1997;9:261-268. evidence from controlled clinical trials, blind, placebo-controlled trial. journal 23. Henneicke-von Zepelin HH, H entschel of Clinical Pharmacy & Therapeutics. C , Schnitker J, Kohnen R, Kohler G, stay tuned, remain patient, and see what 2004;29:75-83. Wiisrenberg P. Efficacy and safety of develops. HG 13. Lindenmuth GF, Lindenmuth EB. The a fixed combination phyromedicine efficacy of Echinacea compound herbal in rhe rrearment of rhe common cold References rea preparation on rhe severity and (Acure viral respirarory rracr infection): I. Barren B. Echinacea: A safety review. duration of upper respiratory and flu Results of a randomized, double blind, HerbalGram. 2003;No. 57:36-39. symptoms: A randomized, double-blind placebo controlled, mulricentre srudy. 2. Linde K, Barren B, Wolkarr K, Bauer placebo-controlled srudy. The journal of Current Medical Research and Opinion. R, Melchart D . Echinacea for prevent­ Alternative and Complementary Medicine. 1999; 15:214-227. ing and treating the common cold . 2000;6:327 -334. 24. Scaglione F, Lund B. Efficacy in rhe treat­ Cochrane Database ofSystematic Reviews. 14. Narimanian M , Badalyan M, Panosyan ment of rhe common cold of a prepara­ 2006;CD000530. V, et al. Randomized trial of a fixed tion containing an Echinacea exrracr. lnt 3. Barren BP, Brown RL, Locken K, combination (KanJang) of herbal exrracrs j Immunotherapy 1995; II: 163-166. Maberry R, Bobula JA, D'Alessio containing Adhatoda vasica, Echinacea 25. Forth H , Beuscher N. Beeinflussing D. Treatment of the common cold purpurea and Eleutherococcus senticosus der Haufigkeir banaler Erkalrungsin­ with unrefined echinacea: A random­ in patients wirh upper respirarory traer fekre durch Esberirox [Effect of rhe ized, double-blind, placebo-controlled infections. Phytomedicine. 2005; 12:539- frequency of cold infections by Esberi­ trial. Annals ofInternal Medicine. 547. rox]. Zeitschrift for Atlgemeinmedizin. 2002; 137:939-946. 15. Schulren B, Bulina M, Ballering-Briihl 1981 ;57:2272-2275. 4. Barren B, Vohmann M, Calabrese C. B, Koster U, Schafer M. Efficacy of 26. Melchart 0 , Walrher E, Linde K, Echinacea for upper respiratory infection: Echinacea purpurea in patients wirh a Brandmaier R, Lersch C. Echinacea roor Evidence-based clinical review. journal of common cold: A placebo-controlled, extracts for rhe prevention of upper respi­ Family Practice. 1999;48:628-635. randomised, double-blind clinical trial. ratory rracr infections: A double-blind, 5. Barren B. Echinacea for upper respiratory Arzneim- Forsch!Drug Res. 2001 ;51 :563- placebo-controlled randomized trial. infection: An assessment of random- 568. Archives ofFamily Medicine. 1998;7:541- ized trials. Health Notes: Review of 16. Weber W, Taylor JA, Sroep AV, Weiss 545. Complementary and Integrative Medicine. NS, Standish LJ , Calabrese C. Echinacea 27. Schoneberger D. EinflulS der immun­ 2000;7:211-218. purpurea for prevention of upper respira­ srimulierenden wirkung von prelSsafr 6. Barren B. Medicinal properties tory traer infections in children. journal a us Echinacea purpurea auf veri auf und of Echinacea: A critical review. ofAlternative & Complementary Medicine. schweregrad von erkalrungskrankheiren Phytomedicine. 2003; 10:66-86. 2005;11:1021-1026. [The influence of rhe immunosrimularing 7. Melcharr 0, Linde K, Fischer P, 17. Brinkeborn RM, Shah DV, Degenring effects of pressed juice from Echinacea Kaesmayr J. Echinacea for preventing FH. Echinaforce• and orher Echinacea purpurea on rhe course and severi ry of and treating the common cold. Update fresh plant preparations in rhe trearmenr cold infections. Translations by Beare V. Software. Cochrane Library, Issue 4. Ref of rhe common cold. Phytomedicine. Foir, Santa Cruz CA and Sigrid M. Klien, Type: Report. 2000:1 -23. 1999;6: 1-6. January 20, 1993]. Forum lmmunologie. 8. Taylor JA, Weber W, Standish L, et al. 18. Braunig B, Dorn M, Limburg E, Knick 1992;8: 18-22. Efficacy and safety of echinacea in treat­ E, Bausendorf. Echinaceae purpureae 28. Sperber SJ, Shah LP, Gilbert RD, Rirchey ing upper respiratory tract infections in radix: zur srarkung der korpereigenen TW, Monro AS. Echinacea purpurea for children: a randomized controlled rrial. abwehr bei grippalen infekren [Strength­ prevention of experimental rhinovirus jAMA. 2003;290:2824-2830. ening of rhe endogenous resistance colds. Clinical Infectious Diseases. 9. Turner RB, Bauer R, Woelkarr K, Hulsey ro influenza! infections. Translation 2004;38: 1367-1371. TC, Gangemi JD. An evaluation of by Ralph McElroy Co., Austin TX]. Echinacea angustifolia in experimental Zeitschrift fur Phytotherapie. 1992; 13:7- rhinovirus infections. New England jour- 13. Continues on page 39 www. herbalgram .org 2006 HerbaiGram 70 I 37 ------i[ Guest Editorials J~------

The Unaffordable Cost of Not Funding Research in Herbal Medicine by Edzard Ernst MD, PhD, FRCP, FRCPEd

'VJe all know that clinical trials on herbal remedies are expensive. However, it may be even more expensive to not fund such stud­ W ies. This may sound paradoxical, but I am convinced it is true.

Frederic CaJon recently reminded us effective treatments, which comes at a criteria, we find maximum weight and that "ignoring the potential efficacy of very high price for all of us. I believe this clearly positive outcome for an impressive nonpatemable or orphan drugs carries argument applies to herbal medicine as number (n = 52) of treatment/indication a social cost that clearly needs recogni­ well as most of the other areas of comple­ combinations. In other words, these are tion."! He used the examples of omega-3 mentary and alternative medicine (CAM, circumstances where, using the tools of fatty acids for the prevention and treat­ e.g., acupuncture, chiropractic) and I can evidence-based medicine, the usefulness ment of Alzheimer's disease and vitamin supply evidence in support of this notion. of CAM therapies is scientifically proven. D plus calcium supplements to prevent We run a center for the evaluation of Examples of this scenario are cancer osteoporotic fractures. Both conditions CAM at the University of Exeter in the prevention: according to sound evidence, are hugely expensive on a public health UK and we have recently updated the cancer risks can be reduced through level. For instance, 1.5 million Ameri­ second edition of our Desktop Guide to rhe following CAM approaches: regular cans suffer an osteoporotic fracture each Complementary Medicine,2 an evidence­ consumption of garlic (Allium sativum L., year, which costs around $14 billion in based summary of the existing knowl­ Alliaceae), green rea ( Camelia sinensis L, healthcare costs alone. 1 Calon's argument edge in this field. In this book, we evalu­ Theaceae), or lycopene-rich tomato prod­ is convincing. Research into unpatentable ate the clinical trial data according to its ucts (from Lycopersicon esculentum, Mill., treatments is woefully under-funded. As "weight," a composite measure describ­ Solanaceae), or exercise. a consequence we only have encouraging ing the level, quality, and quantity of the For many more treatment/condition but not convincing evidence for many information available to date. We also combinations (n = 108), the directions of important areas of healthcare. This means judge the direction of rhe result accord­ rhe evidence turned our to be clearly posi­ we are not profiting from potentially ing to predefined categories. Using these tive but the "weight" of rhe evidence was

38 I HerbaiGram 70 2006 www.herbalgram.org ------~l Guest Editorials J~------insufficient for definitive conclusions. A of Health currently spends well over $ 100 find treasures in herbal and other comple­ few examples might suffice to ex plain: million per year on research in this area. mentary therapies. Therefore, I genu­ Fenugreek (Trigo nella Joenum-graecum Bur what is $100 million? Compared to inely question whether we can afford to L, Fabaceae) seed preparations are the $10 billion which the pharmaceuti­ not invest real money into researching probably effective in the treatment of cal industry spends on funding some 90% herbal medicine seriously, rigorously, and diabetes; of the 40,000-80,000 randomized clini­ comprehensively. HG Andrographis (Andrographis paniculata cal trials on pharmaceutical drugs being [Burm. f.] Nees, Acanthaceae) leaf conducted across rhe world at any given Edzard Ernst is Professor of Comple­ preparations are probably effective time, 1 this amount is truly and wholly mentary Medicine at the Peninsula Medi­ in the treatment of upper respiratory negligible. It certainly is unlikely to fill cal School at the Universities of Exeter & tract infections related to colds; the existing huge gaps of knowledge in the Plymouth in Exeter, England. He is inter­ Garlic preparations might be effective foreseeable future. nationally known for his prolific publica­ in the treatment of colds; tions, most of which systematically review As ian ginseng (Panax ginseng C.A. and/or meta-analyze various complemen­ Meyer, Araliaceae) root preparations What we need is not tary and alternative treatments, particularly might be effective in the prevention less but more research the scientific and clinical Literature on herbs of some cancers; and phytomedicines. (See related article in Konjac gl ucomannan (Amorphophallus to define more closely HerbalGram #63: University of Exeter konjac K. Koch, Araceae) might the true value of herbal Celebrates 10 Years ofR eviewing the Science be effective in lowering cholesterol on Complementary and Alternative Medi­ levels; and and other CAM therapies. cine.) E-mail: [email protected]. Stinging nettle ( Urtica dioica L. , Urticaceae) leaves (fresh) might References be effective in alleviating pain of Unless there is a dramatic change in the I. CaJon F. Nonpatentable drugs and osteoarthritis. direction of research fu nding, the current the cos t of our ignorance. CMAJ. The conditions in this list are all very uncertai nty is here to stay for many years. 2006; 174:483-484. 2. Ernst E, Pirrler MH, Wider B. The desk­ expensive to the economies of Western And each yea r this uncertainty will cost top guide to complementary and alternative nations. Treating or preventing them us billions. "What is needed is knowledge­ medicine. Edinburgh; Mosby; 2006. effectively would save billions of dollars. based medicine, with randomized clini­ 3. Di Paola RS, Morton RA. Proven and Moreover, there are biologically plausible cal trials of treatments with histories that unproven therapy for benign prostatic mechanisms to explain the clinical effects indicate some reasonable change of effi­ hyperplasia. NEJM. 2006;356:632-633. of these treatments. The trial evidence is, cacy."4 Anyone who looks for such treat­ 4. Sampson W. Studying herbal remedies. however, not sufficiently compelling to ments in an unbiased fashion is bound to NEJM. 2006;353:337-339. be acceptable to skeptics who believe it is their duty to warn against the routine use of not-fully-proven treatments: "Until Echinacea pal/ida (Nurr.) Nurr., Echinacea there is adequate research on an herbal or ECHINACEA D EBATE Continued fro m page 37 purpurea (L. ) Moench): a review of their other botanical product, it is the respon­ chemistry, pharmacology and clinical sibility of phys icians to inform their 29. Turner RB , Riker OK, Gangemi JD. properties. journal ofPharmacy & Phar­ patients and protect them from rhe inher­ Ineffectiveness of Echinacea for preven­ macology. 2005;57(8):929-954. ent risks of unproven therapies ."3 Others tion of experimental rhinovirus colds. 35. Ernst E. T he risk-benefit profile of go even one step further and call for halt­ Antimicrobial agents and chemotherapy. commonly used herbal therapies: Ginkgo, ing all research in this area.4 However, 2000;44: 1708- 1709. St. John's Wort, Ginseng, Echinacea, Saw 30. Schoop R, Klein P, Suter A, Johnston SL. to call therapies "implausible" which are Palmetto, and Kava. Annals ofI nternal Echinacea in the prevention of induced Medicine. 2002; 136:42-53. supported by both biological mechanisms rhinovirus colds. Clinical Therapeutics. 36. Hundey AL, T hompson CJ , Ernst E. and uniformly positive (preliminary) clin­ 2006;28: 1-10. The safety of herbal medicinal products ical studies is nor constructive and simply 3 1. Caruso TJ, Gwaltney JM, Jr. Treatment derived from echinacea species : a system­ discloses bias. of the common cold with echinacea: atic review. Drug Safety. 2005;28:387- What we need is not less but more a structured review. Clinical Infectious 400. research to define more closely the true Diseases. 2005;40:807-810. 37. Parnham MJ. Benefi t-risk assessment of value of herbal and other CAM thera­ 32. Glasziou PP, Del Mar CB, Sa nders SL, the squeezed sap of the purple co nefl ower Hayem M. Antibiotics for acute otitis (Echinacea purpurea) for long-term oral pies which are supported by encouraging media in children. Cochrane Database of immunostimulation. Phytomedicine. but not (yet?) conclusive evidence. Such Systematic Reviews. 2003. 1996;3:95-102. research is now emerging, but I argue that 33. Williams JJ , Aguilar C, Cornell J, eta!. 38. Gallo M, Sarkar M, Au W, Pietrzak K, it is nowhere near enough. In this context, Antibiotics for acute maxillary sinusitis. Comas B, Smith M eta!. Pregnancy the United States is seen by many Europe­ Cochrane Database ofSystematic Reviews. outcome following gestational expo­ ans as "the promised land." The National 2006. sure to Echinacea. Arch Intern Med. Center for Complementary and Alterna­ 34. Barnes J, Anderso n LA, Gibbons 2000; 160:3141-3 143. tive Medicine at the National Institutes S, Phillipson JD. Echinacea species (Echinacea angustifolia (DC.) Hell. ,

www. herbalgram.org 2006 HerbaiGram 70 I 39 Golden Flower of Prosperity- ·~ Oregon's Kam Wah Chung Museum Displays Rare Collection' of Chinese Herbal Artifacts

by Courtney Cavaliere

n September 2005, an icon of herbal history was declared a national historic landmark-the Kani Wah Chung ("Golden Flower ofProspe~ity") museum (M. Gerdes, e-mail, January 24, 2006). The museum is I located in the small <;ity ofJohn,Day, Oregon, about i65 miles east ofPortland.lt showcases aq1extensive collection of herbal remedies and products-some pre-dating the year 1900-which were used by an esteemed Chinese healer and imrpigrant ~f the early American frontier.l ' The Kam Wah....Chung building, constructed grant and Euro-American clients, some from outside around 1866 as a 1rading post, s~rved as a general the state of Oregon. A collection of approximately 1 store, clinic, and social center for Chinese immi­ 500 herbal treatments used by Ing Hay were found grants and non-Chinese Euro-American se_ttlers preserved within the building and are now on display from the late 1880s to mid-1900s.2 Two prosperous in the museum. immigrants, Lung On and Ing Hay, took residence "We've had visitors from China who say their· within the Kam Wah Chung. building in 1888 and country has nothing like this in terms of the breadth used i.t as their place of business. While Lung On was of the herbal collection, and it's vintage," said Marti a prolific businessman, Ing Hay worked as a skilled Gerdes, curator of the museum. "Everything in pulsologist· and herbal healer, attracting both immi- the building dates to 1940 and earlier, so it's like a perfectly preserved time-capsule peek into the past." · The museum's collection of herbs, as docum~nted in the book China Doctor ofjohn Day, 2 which has an appendix summarizing 62 of the herbs, includes such familiar ingredients as clove (Syzgium aromaticum [L.] Merr. & L.M. Perry, Myrtaceae), red pepper (Capsicum annuum, L., Solanaceae), and shrubby sophora (Sophora Jlaves~e ns, Aito~, Fabaceae), as well as exotic non-botanical materials like tiger's bone and bear's paw. 2 All of the herbs were imported by Ing Hay from China. "Doc Hay didn't believe American­ grown herbs were as effective," Gerdes explaine_d. Only about 220 of the lierbs have · yet been identi­ fied. The-Oregon Parks and Recr~ation Department (OPRD), which manages the museum, plans to enlist the expertise of an herbal practitioner to identify and Doc Hay (above) became well lj(lown for his h,_erbal catalog the rest, after securing suf£1cient funding. practice in his Kam Wan The museum also features American-made goods Chu~ & CJJ. office. from the building's trade store and much of the occu­ ~ Lung On (rig I'\ ), a skilled pants' original furnishings and belongings, among merchant, assisted many Chinese residents with other artifacts. immigration matters. • ~

-www.herbalgram.org OPRD and the National Parks Service have formed a partnership to carry out major restoration work for the museum, which may be completed by late 2008 or 2009. Oregon's First Lady, Mary Oberst, spearheaded a campaign in 2004 to raise money for the restoration. By January of2006, the campaign team had raised over 90% of its $1.5 million goal, and the team plans to achieve the remaining funds by the end of the year. "The support for this campaign is incredible and a testimony that Oregonians understand the significance of this historic resource," said Oberst (S. Leighty, e-mail, January 30, 2006). Major restorative work will begin during the This is the scene greeting visitors to the Ka.m Wah Chung & winter of 2006-2007 and will be performed intermit­ Co. Museu m. Medicines and other merchandise are behind the barred window. Photo courtesy Kam Wah Chung & Co. tently during the months that the museum is closed to Museum. the public. The Kam Wah Chung museum is open annu­ ally from May 1 through October 31 (M. Gerdes, e-mail, January 24, 2006). . Such restoration efforts stem from OPRD's recently acquired man.agement. of the museum. The Kam Wah Chung building was left vaca.nt and boarded in 1948, following Lung On's death in 1940 and Ing Hay's contraction of a serious illness. Although the building was deeded to the city of John Day shortly after Ing Hay's death in 1952, it was left untouched for decades. It was rediscovered in 1967 and opened as a museum in 1976, under the management of the city of John Day. The museum was eventually deemed too expensive for the city to maintain, leading OPRD to assume control over the building in 2004. "The Kam Wah Chung & Co. building and its The shrine, occupying a space in the general store, which contents are unique and irreplaceable, and they're truly Doc Hay used to perform religious ceremonies for Ch inese resident\ Photo courtesy Kam Wah Chung & Co. Museum. important in telling the neglected story of Chinese in the American West," Oberst explained. Large numbers of Chinese immigrants initially settled in John Day during the 1880s to work in nearby gold mines, but such work was not available for very long. 2 Many immi­ grants within the area took jobs as ranchers and laborers in the 1890s, but by the early 1900s, the area's Chinese community had diminished significantly. The museum is intended to educate visitors about the history and contributions of such immigrant settlers, as well as about the herbal practices and ingredients imported from Chinese culture.l HG References 1. Kam Wah Chung & Co Museum restoration campaign Mortars and pestles used by Doc Hay along with other medi­ [press release]. Bend, OR: Oregon State Parks Trust; cal 'supplies are showcased in the apothecary. Photo courtesy December 2004. Kam Wah Chung & Co. Museum. 2. Barlow J, RicM.rdson C. China Doctor offohn D ay. Hillsbo:o, OR: Binford &Mort Publishing; 1979 .

• www.herbalgram.org 2006 HerbaiGram 70 I 41 Preserving Ayurvedic Herbal Formulations by Vaidyas: The Traditional Healers of the Uttaranchal Himalaya Region in India by Chandra Prakash Kala

lllll!.. • hroughout Asia, the Ayurveda, Unani, and Chinese medical systems have developed and refined treatments based purely on preparations made from available natural resources. Ayurveda was probably developed much earlier than the Unani and Chinese medicine systems. The oldest existing literature on this form of treatment is the Rigveda, the classic Hindu text, which accord­ ing to legend was written in the years 4500-1600 BCE. Other important Ayurvedic medical texts include the Charak Samhita (1000-800 BCE) and Susruta Samhita (800-700 BCE). The Unani system of medical treat­ ment developed much later and attained popularity in India during the medieval period. Likewise, traditional Chinese medicine developed in China and came to India through its association with Buddhism, trade, and migration. In all these historical traditions, the Himalaya region has been repeatedly described as a rich repository of valuable medicinal plants.

During the past few decades, the advent of conventional pharmaceutical drugs has precipitated and hastened the decline of traditional medical systems all over the world, including Ayurveda. In India, one area of concern is the sharp decline in the centuries-old knowledge of preparing medicines from local plant resources. These medicinal plants and the industries that use them represent great commercial opportunities for India in the world market. The global herbal market for medicinal plants has been estimated to be worth $120 billion a year. Medicinal plants used in Ayurveda represent $60 billion (US) of that.l This amount could be increased multiple times if more organized attempts were made to convey the impressive healing properties of Ayurveda. A number of studies by various researchers have Methods documented the use of traditional medicinal plants in Field surveys were undertaken across the various India. 2-11 About 3500 Ayurvedic formulations have districts of Uttaranchal during 2001 and 2002. A been documented, as well as additional formulations semi-structured survey was conducted among tradi­ based on the Siddhal and Unani2 traditions, including tional vaidyas-practitioners of Ayurvedic medicine. details about their combinations.12 However, much The purpose of the survey was to document their of the knowledge held by various traditional herbal knowledge of preparing various herbal formulations. healers regarding their use of medicinal plants has not The survey also gathered information about the local been documented. This article reports on a study that names of medicinal plants, plant parts used in treat­ documented knowledge held by the traditional herbal ment, and the number of ailments being treated by healers of the Uttaranchal Region oflndia (see Figure medicinal plant preparations. 1 on page 45) regarding their preparation and use of herbal formulations.

During the past few decades, the advent of conventional pharmaceutical drugs has precipitated and hastened the decline of traditional medical systems all over the world, including Ayurveda.

Study Area The study was carried out in the State ofUttaranchal, Indian Republic, during 2001 and 2002. Uttaranchal is located in the northern region of India and spans an area of 53,485 km2 (approximately 20,660 square miles).2 The human population of Uttaranchal is approximately 805 million, of which 78% live in rural areas.l3 Uttaranchal is known as the origin of many sacred rivers like the Gori-Ganga, Kali-Ganga, Alaknanda, and the Ganges. The region is also famous for its rich biodiversity, culture, tradition, and mythol­ ogy. The diverse social and economic setting of the region is well documented,14-16 as is its vegetationP- Lord Dhanvantari, who is believed to be an incarnation of Lord Vishnu, brought medicinal herbs for the well ness of humankind. This 21 Uttaranchal's vast altitudinal differences, ranging Batik style contemporary painting shows Dhanvantari seated on a from the Himalayan foothills to the high peaks of the crescent holding a bunch of medicinal herbs in one hand and a pot Himalaya, plus the resulting climatic and topographi­ of holy nectar (Amruth) in the other. The other two hands hold the icons of Lord Vishnu, the all powerful 'Sudarshana Chakra' (wheel) cal changes, produce a variety of forest types (tropical, in the right hand and the 'Panchajanya' (holy conch shell) in the left temperate, and sub-alpine). hand.© Renaissance Herbs, Inc. A total of 56 traditional vaidyas were interviewed to collect such information. These vaidyas resided in Many of the traditional vaidyas 15 sites spread across various parts of the Uttaranchal, enjoy a high level of local such as Rishikesh, Maletha, Rampur, Sumari, Malsayn, Pauri, Khirsu, Karnprayag, Lambgaun, acceptance and respect, and thus D unda, Dhontri, Joshimath, Bhyundar, Nauti, and have considerable influence on Almora. Field visits were made with vaidyas to iden­ health belief and practice. tify medicinal plants. D ata were crosschecked by interviewing 3 or more vaidyas on the use of each nal plants were used in these medicinal formula­ plant and the preparation of each medicinal formula­ tions. Ailments with the largest number of treatment tion. The participant observation method was used to formulations were coughs and colds, followed by skin understand the methods and techniques adopted by diseases, dysentery, and toothache. Of the 56 vaidyas vaidyas in preparation of formulations. A workshop interviewed, 6 were young (16-25 years), 14 were was organized and various groups of indigenous people adult (26 -45 years), and 26 were older (over 46 years). including vaidyas participated in documenting indig­ Since the 1980s, the number of recognized vaidyas has enous knowledge according to the study's parameters. decreased. There are fewer vaidyas in lower age groups Qyalitative information so gathered was verified by and fewer disciples studying with the vaidyas. Fortu­ cross-examination of different vaidyas. nately, in addition to the vaidyas, a number of women Results and men in the villages are familiar with the healing properties of medicinal plants, though they are not as The study documented 104 formulations prepared well-versed in the actual preparation of various medic­ by the vaidyas. These formulations were used in the inal formulations. This loss of knowledge regarding treatment of 50 different ailments. Table 1 on pages the preparation of traditional medicine is directly 46-48 lists some of the indigenous plants that were related to the declining number of vaidyas. used in the preparation of these formulations. Among the various ingredients, which included animal parts, Discussion minerals, and heavy metals, plants were the major The science of herbal formulations is one of Ayurve­ ingredient. The study also showed that 125 medici- da's most significant contributions to healthcare. Many of the traditional vaidyas enjoy a high level oflocal acceptance and respect, and thus have consid­ erable influence on health belief and practice. According to the vaidyas, some Ayurvedic formu­ lations contain about 15 or more secondary plant species that enhance the potency and support the primary plant species. Sometimes secondary plant species are added to the formulation to counteract any possible adverse side effects from the actions of the primary plants. However, many Ayurvedic herbs are prescribed alone to cure ailments. Examples include katuki (Picrorhiza kurrooa Royle ex Benth., Scrophulariaceae), haida (Terminalia chebula Retz., Combretaceae), baida (Terminalia bellerica [Gaertn.] Roxb., Combretaceae), brahmi (Centella asiatica [L.] Urb., Apiaceae), pudina (Mentha longifolia [L.] Hudson, Lamiaceae), haldi (Curcuma domestica L. Zingiberaceae), and ashwagandha (Withania somnifera [L.] Dunal, Himachal Pradesh (TIBET) t N

INDIA

0 350 L___j Km. Utter Pradesh 0 34 L___j Km.

Legend: 1-Uttarkashi, 2-Tehri, 3-Dehradun, 4-Rudraprayag, 5-Haridwar, 6-Pauri, 7-Chamoli, 8-Pithoragarh, 9-Bageshwar, 10-Aimora , 11-Champawat, 12-Nainital, 13-Udham Singh Nagar.

Figure 1. Uttaranchal Reg ion of India

Solanaceae). Vaidyas use the whole herb or plant part ing to one survey, over 600 scientific studies are in the preparation of medicine, whereas the pharma­ being conducted in 27 countries at 220 institutions.1 ceutical industry extracts the active ingredient to make Ayurveda has a record of curing some chronic disor­ plant-derived drugs. For example, the pharmaceutical ders that do not respond well to western medicine, industry developed the formerly popular hypotensive such as eczema, cystitis, and migraines.l2 drug reserpine, which is derived from the tradi­ tional Ayurvedic plant Rauvolfia serpentina (L.) Benth. ex Kurz, Apocynaceae. The notion of using the whole herb or plant part rather than an isolated chemical constituent may also contribute to a balanced formula that is less t likely to have adverse side effects. In addition to prescribing herbal medicine, the traditional Ayurvedic system gives an appropriate level of importance to lifestyle, diet, sleep, daily and seasonal routines, and internal cleansing (i.e., of the gastrointestinal tract). The values of disease eradication from its root cause and the treatment of chronic problems are some of the main forces lead­ ing to the increased interest in and acceptance of Ayurvedic treatments in many industrial­ ized and developing countries. During the last few years, about $18 million has been spent on research in Ayurvedic medicine. Accord- Table 1. Indigenous Plants Used in Vaidyas Formulations to Treat Various Ailments (page 1 of 3) Ailment Indian Vernacular Name of Herb Latin Scientific Name of Herb Acidity and gastric disorders Neebu Citrus x limon (L.) Osbeck, Rutaceae Anemia Doob Cynodon dacty/on (L.) Pers., Poaceae Backache,Bodyache Badam (almond) Prunus dulcis (Mill.) D.A. Webb, Rosaceae Bad Breath Sarson (mustard) Brassica campestris L., Brassicaceae Haldi (turmeric) Curcuma domestica Valeton, Zingiberaceae Black spots around eyes Kheera (melon) Cucumis melo L., Cucurbitaceae Blisters in mouth Kela Musa balbisiana Colla, Musaceae Blood purification Neem Azadirachta indica A. Juss., Meliaceae Anar (pomegranate) Punica granatum L., Punicaceae Kali-mircha Piper nigrum L., Piperaceae Boil Seesam Dalbergia sissoo Roxb. ex DC., Fabaceae Bel Aegle marmelos (L.) Correa, Rutaceae Brain tonic Saunf Foeniculum vulgare Mill., Apiaceae Badam (almond) Prunus dulcis (Mill.) D.A. Webb, Rosaceae Gajar Daucus carota L., Apiaceae Child dysentery Am rood Psidium guajava L., Myrtaceae Kali-mircha Piper nigrum L., Piperaceae Cough, cold, and choking on food Adrak (ginger) Zingiber officinale Roscoe, Zingiberaceae Tulsi Ocimum sanctum L., Labiatae Choru Angelica glauco Edgew., Apiaceae Gahath Macro tyloma uniflorum (Lam.) Verd., Fabaceae Basinga Adhatoda vasica Nees, Acanthaceae Haldi (turmeric) Curcuma domestica Valeton, Zingiberaceae Zeera Cuminum cyminum L., Apiaceae Cuts and wounds Pudina Mentha longifolia (L.) Huds., Lamiaceae Diabetes Muli Raphanus sativus L., Brassicaceae Dysentery Doob Cynodon dactylon (L.) Pers., Poaceae Adrak (ginger) Zingiber officinale Roscoe, Zingiberaceae Saunf Foen iculum vulgare Mill., Apiaceae Bel Aegle marmelos (L.) Correa, Rutaceae Anar Punica granatum L., Punicaceae Aam (mango) Mangifera indica L., Anacardiaceae Earache and secretion from ears Tulsi Ocimum sanctum L., Labiatae Bel Aegle marmelos (L.) Correa, Rutaceae Sarson (mustard) Brassica campestris L., Brassicaceae Aam (mango) Mangifera indica L., Anacardiaceae Sullu Euphorbia royleana Boiss., Euphorbiaceae Pyaz (onion) Allium cepa L., Alliaceae Haldi (turmeric) Curcuma domestica Valeton, Zingiberaceae Table 1. Indigenous Plants Used in Vaidyas Formulations to Treat Various Ailments (page 2 of 3) Ailment Indian Vernacular Name of Herb Latin Scientific Name of Herb Epilepsy Bichu Martynia annua l., Pedaliaceae Pyaz (onion) Allium cepa l., Alliaceae Excess heat (heat stroke) Aam (mango) Mangifera indica L., Anacardiaceae Eye disorders Santra Citrus reticu/ata Blanco, Rutaceae Eye pain Aak Calotropis procera (Aiton) W.T. Aiton, Asclepia- daceae Eyesight Muli Raphanus sativus l., Brassicaceae Saunf Foeniculum vulgare Mill., Apiaceae Badam (almond) Prunus dulcis (Mill.) D.A. Webb, Rosaceae Kali-mircha Piper nigrum l., Piperaceae Fat reduction Methi (fenugreek) Trigonella foenum-graecum l., Fabaceae Muli Raphanus sativus l., Brassicaceae Neebu Citrus x limon (l.) Osbeck, Rutaceae Fever, cold Bel Aeg/e marmelos (L.) Correa, Rutaceae Mehandi or henna Lawsonia inermis L., Lythraceae Food poisoning Ritha Sapindus mukorosii Gaertner, Sapindaceae Headache Long (clove) Syzygium aromaticum (L.) Merr. & L.M. Perry, Myrtaceae Surajmukhi Helianthus annuus l., Asteraceae Karel a Momordica charantia L., Cucurbitaceae Pyaz (onion) Allium cepa l., Alliaceae High blood pressure Pyaz (onion) Allium cepa L., Alliaceae Muli Raphanus sativus L., Brassicaceae Indigestion Methi (fenugreek) Trigonella foenum-graecum L., Fabaceae Adrak (ginger) Zingiber officinale Roscoe, Zingiberaceae Am rood Psidium guajava L., Myrtaceae Internal injuries Haldi (turmeric) Curcuma domestica Valeton, Zingiberaceae Arch a Rheum moorcroftianum Royle, Polygonaceae Jaundice Muli Raphanus sativus l., Brassicaceae Anar Punica granatum L., Punicaceae Joint pains Methi (fenugreek) Trigonella foenum-graecum L., Fabaceae Kidney stones Muli Raphanus sativus L., Brassicaceae Palak (spinach) Spinacea oleracea L., Chenopodiaceae Madness Am rood Psidium guajava L., Myrtaceae Nose bleeding Doob Cynodon dactylon (L.) Pers., Poaceae Paralysis Akhrot Juglans regia L., Juglandaceae Piles (hemorrhoids) Bod Ficus benghalensis l., Moraceae Kali-mircha Piper nigrum L., Piperaceae Zeera Cuminum cyminum L., Apiaceae Table 1. Indigenous Plants Used in Vaidyas Formulations to Treat Various Ailments (page 3 of 3) Ailment Indian Vernacular Name of Herb Latin Scientific Name of Herb Piles (hemorrhoids) (cont.) Muli Raphanus sativus L., Brassicaceae Pimples Muli Raphanus sativus L., Brassicaceae Anar Punica granatum L., Punicaceae Pyrrhoea (Infection in mouth) Neem Azadirachta indica A. Juss., Meliaceae Akhrot Jug/ans regia L., Juglandaceae Kali-mircha Piper nigrum L., Piperaceae Long (clove) Syzygium aromaticum (L.) Merr. & L.M. Perry, Myrtaceae Removing foreign object from flesh Ajwian Trachyspermum ammi (L.) Sprague, Apiaceae Reproductive disorder Bod Ficus benghalensis L., Moraceae Semal Bombax ceiba L., Bombacaceae Sciatica Singoli Vitex neg undo L., Verbenaceae Sarson (mustard) Brassica campestris L., Brassicaceae Scorpion bite Ritha Sapindus mukorosii Gaertner, Sapindaceae

Unfortunately, there has been a rapid decline in ability and acceptance of conventional Western medi­ the traditional practice of individual healers identi­ cine, many of those who are familiar with the tenets fying plants and preparing various formulations for and benefits of Ayurveda are concerned that this direct distribution to patients. Because of rapid socio­ traditional healing system is not receiving the respect economic changes and widespread urbanization, most it deserves. These advocates are found in the govern­ of the vaidyas have grown increasingly dependent on ment, among medical practitioners, and consumers. the products supplied by the Ayurvedic pharmaceuti­ By documenting the herbal formulations prepared by cal preparations industry. With the increased avail- traditional vaidyas, it may be possible to prevent unfor­ tunate scenarios like the recent attempt by commercial interests in the United States to patent the traditional Ayurvedic medicinal plant and culinary spice turmeric (Curcuma domestica Valeton, Zingiberaceae). [Note: A US use patent was granted for a turmeric preparation for inflammation, but later overturned/rescinded after strong protest by the Indian government based on turmeric's traditional use in Ayurveda.22] Fortunately, the increasing popularity of Ayurveda in the West should advance the spread of Ayurveda on a global scale. Another factor contributing to the market value of Ayurveda is the growing concern about the escalating costs and safety of conventional Western Medicine. Exporters of herbal products could leverage these issues to their advantage and thereby increase sales. Highly effective formulations can be A boy selling garlands of Origanum vulgare (a medicinal, aromatic developed if steps are taken to sufficiently organize the and religious plant) in Badrinath of Uttaranchal. Photo ©2006 Chan­ traditional vaidyas. dra Prakash Kala, PhD. Before the 1980s, the reputation of the respective herbal formulations, additional studies are needed to vaidya and the formulations developed by him were complete the work. Moreover, the documented prop­ sufficient criteria for people to believe in its value. erties of the medicinal plants utilized by various tradi­ Today, the reduced number of knowledgeable and tional vaidyas should be clinically evaluated to further recognized vaidyas clearly reveals a major disruption in strengthen their validity and to encourage the prepa­ the ancient custom of carrying forward this traditional ration of new formulations. The various formulations knowledge. Although the study on which this article provided by traditional vaidyas must be preserved to reports succeeded in capturing substantial informa­ ensure the integrity of this time-honored knowledge tion about the vaidyas and their use and preparation of of traditional healing. HG

India Digitizes Age-Old Wisdom Effort Seeks to Keep Westerners from Poaching Folk Remedies by Nancy Dennis

he Indian government has embarked upon an ambitious four-year, $2 million project called the Traditional Knowledge Digital Library. The project employs an interdisciplinary team of about 150 T Traditional Medicine experts (Ayurveda, Unani, Siddha, and Yoga), patent examiners, Information Technology experts, scientists, and technicians) The project aims to protect India's traditional remedies from expropriation in the form of patents by various commercial interests, e.g., multinational drug companies. The process of patenting the uses of plants gained from traditional knowledge is frequently referred to as bio­ piracy. The need for such a database became apparent in 1995 when two Indian-born scientists in Mississippi were granted a US patent on the use of turmeric (Curcuma longa L., Zingiberaceae), a common spice in India and other areas of Asia, to heal wounds. After protests from the Indian government, which cited ancient Sanskrit texts describing the use of turmeric for this purpose, the patent was revoked. Although Indian officials can point to only a few such intellectual-property cases, they predict that the threat will inevitably grow as drug companies seek to cut soaring research-and-development costs by finding new prod­ ucts among natural remedies that have been used for millennia in developing countries such as India and China. The new database project also reflects a nationalistic pride in India's ancient scientific heritage and the continu­ ing use in modern times of remedies that are often viewed with skepticism in the West. Indian officials say the data-collection effort will promote the commercialization of traditional Indian remedies, help validate their scientific underpinnings, and encourage collaboration between Indian and foreign pharmaceutical companies. However, according to an article in the Washington Post, the pharmaceutical industry is opposing India's efforts to amend the World Trade Organization rules to protect ancient remedies.2 The database will eventually contain over 100,000 traditional remedies from the collective wisdom of the ancient healing arts known as ayurveda, unani, and siddha. The most popular of these is ayurveda, which remains the dominant form of treatment in many parts of rural India despite the growing influence of Western medicine. Since 2001 the project team has been poring over ancient texts in Sanskrit, Urdu, Persian, and Arabic in search of traditional formulas to create the database. The specialists enter the formulas in alphanumeric code, which are then translated automatically into English, Japanese, French, German, and Spanish. Sometime this year, the complete library will be made available to foreign patent offices on a secure Web site. Indian officials hope the patent offices will use the database in evaluating whether to grant patents on natural remedies. HG References 1. Traditional Knowledge Digital Library Web site. Available at: http://203.200.90.6/tk.dlllangdefault!common/Abouttkdl. asp?GL=. Accessed March 9, 2006. 2. Lancaster J. India Digitizes Age-Old Wisdom. Washington Post. January 8, 2006:A22. Chandra Prakash Kala is a Medicinal Plants Consul­ 3. CSIR. The wealth ofIndi a: Raw Materials. Vol11. New tant at National Medicinal Plants Board, Government Delhi: Publications &Information Directorate, Coun­ cil of Scientific and Industrial Research; 1989. India, New Delhi. He completed his PhD in Forestry of 4. Jain SK Dictionary ofIndian folk medicine and from the Forest Research Institute, Uttaranchal. Dr. Kala ethnobotany. New Delhi: Deep Publications; 1991. has 15 years of research experience on the various aspects of 5. Ramakrishnan PS, Purohit AN, Saxena KG, Rao KS, Himalayan biodiversity and conservation, which includes Maikhuri RK, eds. Conservation and management of biological resources in Himalaya. New Delhi, India: the sustainable utilization of medicinal plants. He has 95 Oxford and IBH; 1996. publications on the various aspects of conservation biology, 6. Pandey G. Medicinal Plants ofHimalaya. Vol1-2. Ethnobotany, and Himalayan ecology. Address for corre­ Delhi, India: Sri Satguru Publications; 1995. spondence: National Medicinal Plants Board, Chandralok 7. Dhar U. Himalayan Biodiversity-Action Plan. Nainital, India: Gyanodaya Prakashan; 1997. Building, 36'-janpath, New Delhi 110001, India. E­ 8. Gaur RD. Flora ofdistrict Garhwal North west Hima­ mail· cpkala@yahoo. co. uk. laya with ethnobotanical notes. Srinagar Garhwal, India: TransMedia; 1999. 9. Maikhuri RK, Nautiyal S, Rao KS, Saxena KG. Medicinal plants cultivation and biosphere reserve management: a case study from Nanda Devi Biosphere Reserve, Himalaya. Current Science. 1998;74:157-163. 10. Maikhuri RK, Semwal RL, Rao KS, Saxena KG. Agroforestry for rehabilitation of degraded community lands: a case study in Garhwal Himalaya. International Tree Crops journal. 1997;9:89-99. 11. Nautiyal S, Rao KS, Maikhuri RK, Semwal RL, Saxena KG. Traditional knowledge related to medicinal and aromatic plants in tribal societies in a part of Hima­ laya. journal ofMedicinal and Aromatic Plant Sciences. 2000;22/4A and 23/1A:528-441. 12. Banerjee M. Public policy and Ayurveda. Economic and Political weekly. 2002;37:1136-1146. 13. Rao KS, Nandy SN. Land use pattern and population pressure in Uttaranchal. Envis Bulletin: Himalayan Ecology and Development. 2001;9(1):17-23. 14. Pant SD. The Social Economy ofthe Himalaya. London: A commercial Vaidya in his herbal shop. Photo ©2006 Chandra Prakash Kala, PhD. George Allen and Unwin; 1935. 15. Raipa RS. Shauka Simavarti]anjati [in Hindi]. Dharchlu, India: R.A. Brothers; 1974. Acknowledgements 16. Hoon V. Living on the move: Bhotiyas ofKumaon Hima­ laya. New Delhi, India: Sage Publications; 1996. For their encouragement, the author would like to 17. Naithani BD. Flora ofChamoli. Howrah, India: Botani­ thank Shri B.S. Sajwan, IFS & Chief Executive Offi­ cal Survey oflndia; 1984. 18. Kala SP, Gaur A contribution to the flora of cer, National Medicinal Plants Board, New Delhi; Dr. RD. Gopeshwar (Chamoli Garhwal). In: Paliwal G .S. ed. U. Dhar, Director, G.B. Pant Institute of Himalayan The vegetational wealth ofHimalayas. 1982;34 7-413. Environment and Development, Almora, UA; Dr. 19. Kala CP. Ethnobotanical survey and propagation ofrare S.C.R. Vishvakarma, Senior Scientist, G.B. Pant Insti­ medicinal herbs for smallformers in the buffer zone ofthe tute of Himalayan Environment and Development; Valley ofFlowers National Park, Garhwal Himalaya. Kathmandu, Nepal: ICIMOD; 1998a. and Dr. N . A. Farooquee, Scientist, G.B. Pant Insti­ 20. Kala CP. E cology and conservation ofalpine meadows in tute of Himalayan Environment and Development. the Valley ofFlowers National Park, Garhwal Himalaya. All 56 traditional vaidyas are greatly acknowledged for [PhD Thesis]. Dehradun, India: Forest Research Insti­ tute; 1998b. their cooperation and help during field work. 21. Kala CP. Medicinal Plants ofIndian Trans-Himalaya. References Dehradun, India: Bishen Singh Mahendra Pal Singh; 2002. 1. Stock J. Ayurveda goes global. The week. 22. Johnston BA, Webb G. Turmeric Patent Overturned in 2002;20(34):16-21. Legal Victory. Herba1Gram.1997;No. 41:11. 2. Dey AC. Indian medicinal plants used in Ayurvedic prep­ arations. Dehradun, India: B.S. Mahandra pal Singh; 1988. Every Herbal Library Starts with the ABCs

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• The ABC Clinical Guide to Herbs edited by Mark Blumenthal et al, American Botanical Council; 2003. How does the healthcare professional effectively respond to patient inquiries on the use of herbal supplements? What clinical research has been conducted? How is safety evaluated? This science-based educational course answers these and other questions for healthcare professionals, pharmaceutical companies, health management companies, policy makers, the dietary supplement industry, and consumers. Hardcover, 512 pp. $69.95. #905 hviERIGAN 13oTflNICAL To order, call toll free 800-373-7105, fax 512-926-2345, COUNCIL e-mail: [email protected] or order online at www.herbalgram.org American ginseng Panax quinquefolius Photo ©2006 stevenfoster.com Government Increases Restrictions on Wild American Ginseng Export

Minimum Harvest Age Extended to 10 Year-old Roots by Mark Blumenthal

n August 3, 2005, the US Fish and Wildlife Service (FWS) announced new restrictions on the export of wild American ginseng roots (Panax quinquefolius L., Araliaceae).l The new require­ ment is part of the FWS finding for issuance of export permits for ginseng harvested in 2005, as required under the Convention on International Trade in Endangered Species ofWild Fauna and Flora (CITES). FWS has now increased the minimum age for legal export to 10 years, doubling the previ­ ously required minimum of 5 years.

In its initial communication of this increased age require­ Representatives of the American wild ginseng industry were ment, FWS referred to the numbers of leaves, or "prongs" as they taken by surprise by the announcement, as no previous notifica­ are called by harvesters, as synonymous with 10-year old plants. tion had been made and they had not been consulted during the FWS suggested a guideline that plants should contain 4 prongs, development of the age increase. Industry members subsequently but the 4-prong proposal was only meant to be a guideline and provided information to counter the FWS erroneous notion that not an absolute rule, according to Pat Ford, a wildlife biologist at all (or even most) 10-year old plants bear 4 leaves. In response, FW S. She wrote that "the increase to 10 years of age is a condi­ the FWS deleted the stipulation regarding the number of leaves tion on export permits. In order to find non-detriment and allow from the findings. Ford emphasized that the 4-prong stipulation the export of ginseng roots, we increased the minimum age from had been "only a guideline not a rule as the FWS does not regu­ 5 years to 10 years" (P. Ford e-mail toM. Blumenthal, December late the harvest of ginseng, only the export" (P. Ford e-mail to M. 15, 2005). Blumenthal, December 15, 2005).

52 I HerbaiGram 70 2006 www.herbalgram.org The actual assessment for the age of roots will be done by count­ Because they deal with plants for export, CITES regulations ing bud-scale scars on the rhizome, the generally accepted method do not apply to wild plants harvested for domestic consumption. for decades, in spite of the fact that most experts do not believe However, in the case of wild American ginseng, virtually the entire there is a good association between the number of scars and the age crop is collected for export to Asia where there has been a robust of a plant (see sidebar). Instead of looking for 5 bud-scale scars, as market for wild American ginseng since it was first exported from has been the case since the rule was last changed in 1999, inspec­ the American colonies around 1720.3 Although American ginseng tors will now require exports of wild American ginseng to possess is a relatively popular ingredient in some natural soft drinks and a minimum of 9 bud-scale scars. 1 dietary supplements, it is cultivated on special After several meetings with herb and ginseng farms in North America (usually ginseng industry representatives-primarily Representatives of the Wisconsin or British Columbia); it is not wild the American Herbal Products Association American wild ginseng ginseng. (AHPA)-and some inquiries from the Amer­ According to export data collected by the ican Botanical Council and others over the industry were taken FWS Division of Management Authority, potential confusion regarding the 3-prong/4- 496,416 pounds of cultivated ginseng roots prong issue and the number of bud-scars, by surprise by the were exported from the United States in FWS issued a letter of clarification on August announcement, as no 2004. Also, approximately 60,190 pounds of 31, 2005. The letter was sent to ginseng coor­ wild roots were exported that year. As previ­ dinators in those states where wild ginseng previous notification ously stated, almost all cultivated and wild­ grows and is approved for export by the FWS had been made and harvested ginseng from the United States is (some states have wild ginseng growing in exported, primarily to Asia; that is, People's them but are not approved for export). The they had not been Republic of China, Hong Kong, Malaysia, letter explained that the number of prongs was Singapore, and Taiwan (P. Ford e-mail toM. meant only as a guide and not a requirement. 2 consulted during the Blumenthal, September 26, 2005). Roddy R. Gabel, Chief for the Division of development of the age Many herb industry members were surprised Scientific Authority at the FWS wrote the at the announcement of the change to 10 years following: "We wish to clarify that the Fish tncrease. of age for the export market, which was devel- and Wildlife Service does not regulate the oped without comment from the public. For harvest of ginseng [this is done by the individual states], and the the purpose of making a CITES non-detriment finding for the information relating numbers of leaves to age was only meant to issuance of export permits, the FWS is not required under Federal serve as a guide to diggers to be able to age plants in the field before regulations to seek public comment. Nevertheless, the newly issued digging. We did not intend to impose a Federal requirement for a age requirement might be seen as predictable in light of concerns minimum number of leaves on ginseng at the point of harvest. We expressed recently by conservation biologists and other scientists note, however, that a number of states do have such requirements about what they consider to be a continual decline in American as a result of our previous minimum-age requirement of 5 years, imposed in 1999-2004. We are aware that the number of leaves may vary, even for plants of the same age. For export purposes, Table 1. Wild Ginseng Harvest Seasons per State roots are aged at the time of export based on the number of bud­ State Harvest season scale scars, not leaves.''2 Alabama Sept 1 - Dec 13 Mr. Gabel continued, "Regarding aging of ginseng roots, in Arkansas Sept 1- Dec 1 our finding we advised that roots from 10-year-old plants should possess 10 bud-scale scars, just as we had previously advised that Georgia Aug 15- Dec 31 roots from 5-year-old plants should have 5 scars. After a further Illinois First Saturday in Sept. - Nov 1 review of the literature, coupled with information provided by Indiana Sept 1 -Dec 31 ginseng experts, we are revising this guidance, so that wild roots (10 years old or older) must possess a minimum of9 bud-scale scars, Iowa Sept 1- Oct 31 and woods-grown and wild-simulated roots must have at least 4 Kentucky Aug 15 - Nov 30 bud-scale scars. This allows for the fact that, during their first year Maryland Aug 20 - Dec 1 of growth, ginseng plants do not form a bud-scale scar."2 Minnesota Sept 1 - Dec 31 CITES and Concern for WUd American Ginseng Missouri Sept 1 -Dec 31 Populations New York Sept 1 - Nov 30 CITES requirements dealing with plant species pertain only to those species that are harvested for export. Not all CITES­ North Carolina Sept 1 - April1 listed plants are considered threatened or endangered. In some Ohio Sept 1 - Dec 31 cases, such as with wild ginseng, where the plant is traded in rela­ Pennsylvania Aug 1- Nov 30 tively high volumes, the government's regulation under CITES is also conducted for the purpose of ensuring that trade is based on Tennessee Aug 15 - Dec 31 sustainable harvest levels to prevent the plant from reaching the Vermont Aug 20- Oct 10 point of being threatened or endangered. Based on recent popula­ Virginia Aug 15 - Dec 31 tion studies, FWS has been concerned that wild ginseng may be West Virginia Sept 1 - Nov 30 approaching that level. Thus the increase in the minimum age required for harvest was intended to keep ginseng populations Wisconsin Sept 1- Nov 1 within such a sustainable level. Source: US Fish & Wildlife Service 1 www.herbalgram.org 2006 HerbaiGram 70 I 53 wild ginseng populations in recent years. Canada. According to a press release from AHPA, "Ironically, one In 1975 American wild ginseng was listed on Appendix II of of the factors cited in [the FWS] decision was that harvests have CITES, thus requiring that its harvest be monitored by state agen­ increased over the past six years."6 However, alrhough the total cies for it to qualify for export.4 FWS began approving export of size of the harvests has increased, biologists have been concerned ginseng on a state-by-state basis in 1978. about the relatively smaller size and low age of the individual roots In the past few years there has also been increased concern in these harvests. expressed about declining populations due to browsing by deer. A recent article states that harvest in Kentucky, a state with Further, there are issues about ginseng management in some an active ginseng monitoring and conservation program, yields states; for example, of the 19 states that have wild ginseng harvest­ about $10 million worth of ginseng a year in legal harvests.? It ing regulations, current rules allow collectors to begin harvesting is not known how much is poached; that is, taken illegally either in August in 7 states (see Table 1 on page 53). 1 Biologists have without a permit or even with a permit, harvested on private or demonstrated that in mid-August, most fruits of ginseng are still federal lands without permission, and/or harvested out of season. green, and seeds from these green fruits germinate at much lower The reported economic value of wild ginseng dug in Kentucky rates than those from ripe fruits. Therefore, harvest seasons are has remained level since 2000, according to state figures.? not optimized to match the reproductive biology of the species (J. According to Patricia Ford at FWS, "We are implementing these McGraw e-mail toM. Finney, March 8, 2006). changes to ensure that wild ginseng remains viable throughout its The previous 5-year-old minimum age for export was established range in the United States. Based on recent information, we have by FWS in 1999.5 At that time FWS expressed concern about the concluded that our previous export requirement-that wild plants continual declines in harvests throughout much of American be at least 5 years of age-is not adequate to allow plants to mature ginseng's range in Eastern North America and up into Eastern and produce a sufficient number of fruits (seeds) to sustain future

Ginseng Ruling: How It Will Affect the Wild Ginseng Industry by Ed Fletcher

he implications of the US Fish & Wildlife Service (FWS) ruling on the American wild ginseng trade will be played out in T the years to come, but the immediate effect will be known this season.

Since wild American ginseng (Panax quinquifolius) is listed to see due to their becoming almost overgrown by the enlarge­ on CITES (Convention on International Trade in Endangered ment of the current season's stem growth. Plus, there is the Species) Appendix II, its trade is also regulated and monitored generally known fact that in some seasons a ginseng plant may wherever it crosses a national border around the world. As such, not grow (it goes dormant) and thus does not produce an herba­ the recent rulings will have a global impact even though they ceous plant part-which I have personally witnessed. Neither were made by an agency of government of the United States. does this take into account disruptions in nature; that is, deer The unfortunate issue is that the rulings most adversely eating tops, late frost, dry seasons, wet seasons, etc. Neverthe­ affect the "wildcrafter," who might depend on the supple­ less, this method of age determination is more accurate than the mental income derived from digging "sang" each year to buy consideration of a "3 prong" plant, referring to the number of winter shoes for the family. For the "ethical" wildcrafter, one branches that support the whorled, palmately compound leaves who understands that to have ginseng plants to harvest and atop the scape, or leafless stem, in the seasonal aerial growth. sell in the future, planting the mature seeds back in the wild is Consequently, for the person who is cultivating ginseng essential to procreate more plants. There are also rulings with and has records to prove it, this new ruling could increase the established dates regarding when annual harvest season begins demand for his or her roots. This is especially true for the plants for ginseng on a state-by-state basis, which is an attempt to being grown in an agroforestry or "wild simulated" ("woods allow the plants in each state to reach seasonally mature growth grown") setting, because they are more likely to take on the and to develop viable seeds. This is a good attempt to allow characteristics of wild ginseng roots, which are obviously the seed maturation, but due to the variety of conditions within most economically valuable per dry weight. the native range of each state, such as climates, altitudes, and I applaud the Fish & Wildlife Service for meeting with repre­ habitats, these dates are sometimes inapplicable. Again, for the sentatives from the herb industry on several occasions to discuss wildcrafters who understand their stewardship with ginseng, it the recent rulings, but I also believe it would have been more is an unwritten code not to dig until the seeds are mature. beneficial to ask for industry's input before the rulings were The ruling pertaining to the age of the plant is a generaliza­ finalized. I think that more collaborative efforts berween the tion, somewhat like the established harvest dates per state, made industry and regulatory bodies will produce better informa­ with good intentions. This "10-year-old" ruling is based on the tion, allowing informed and educated decisions to be made that assumption that following the abscission (the process by which protect both the species and commerce. As the CITES conven­ plant parts are shed) of the herbaceous aerial shoot a "bud scale tion states, "Recognizing that peoples and States are and should scar" remains on the root collar or "neck." The first year, and be the best protectors of their own wild fauna and flora." I The sometimes the second, this bud scale scar does not form but burden is on all of us to assure that these botanical treasures are instead the root is marked by a dormant bud at the cotyledon­ here for generations to come. HG ary node, where the rhizome and the root collar join; thus there 1. Convention on International Trade in Endangered Species of can be at least a rwo-year mistake in determining the age of a Wild Fauna and Flora (CITES). Signed at Washington, DC, on specific root. Also, aerial shoot abscission scars may be difficult March 3, 1973.

54 I HerbaiGram 70 2006 www.herbalgram.org generations of ginseng. We have determined that current harvest have low germination rates. Additionally, several states still do not levels of wild ginseng are not sustainable and are detrimental to require harvesters to plant seeds of harvested gi nseng plants at the the survival of the species. This is compounded by the fact that point of harvest" (P. Ford e-mail to M. Blumenthal, August 10, some states allow the harvest of ginseng before the seeds have had 2005). sufficient time to ripen-usually after August-and consequently

Threats to Wild Ginseng by James McGraw, PhD

very year science is communicating more about the nature of threats to natural populations of American ginseng. The act of harvesting kills the plant, so on the surface it might seem logical to consider harvest as the primary threat to Eginseng. Indeed, early demographic work suggested that only light harvest could be sustained.! Recent work involving more sophisticated models suggests that the quality of harvest (timing, disposition of seeds) may be more important than the quantity. Martha VanderVoort showed that harvester behavior characterized by "stewardship" (waiting until fruits are ripe before harvesting, planting all seeds 1 inch deep on site, and limiting harvest intensity) can yield population growth rates that match or exceed that of natural unharvested populations.2 However, harvesters who merely "comply" with regulations, or worse, those who overtly flaunt harvest regulations, can rapidly ratc!tet population sizes downward, causing local extinction. Due to the secretive nature of harvester activity, very little is known about what percentage of harvesters fall into the steward­ ship, compliant, and noncompliant categories. Without this knowledge, it is difficult to judge the overall effect of harvest on wild ginseng populations.

Most ginseng plants that are observed to "skip years" actu­ In the face of such strong negative forces, it is tempting to ally come up every year, but their aboveground parts have become gloomy about the future of ginseng and other wild been removed by herbivory or accidental breakage, a fact that herbs of this kind. However, ginseng has several factors in its becomes obvious only by observing plants regularly from early favor that mitigate this negative view. First, several aspects of spring through the end of the growing season. Mary Ann Fure­ its life history make ginseng relatively resilient- a fairly broad di's careful field studies showed that deer browsing appears to niche, capability of producing seeds by selfing (a sort of insur­ be the most common source of herbivory, and recent research ance policy), seed dormancy that lasts up to several years, and shows that 11-IOOo/o (mean 45%) of all adult plants may be deer a tendency to become more difficult to find as plants become browsed in a given year.3 Deer lower ginseng population growth more scarce. Second, ginseng is highly valued, both economi­ rates by reducing seed production, shrinking the size of plants cally and culturally by Appalachian people. Therefore, conser­ produced in the year following browsing, and with repeated vation of this resource is an easy sell. Finally, while both state browse, cause plant death. The proliferation of deer populations and federal agencies struggle with the "unfunded mandate" to over much of ginseng's range in the past few decades may help conserve ginseng, a regulatory structure does exist-one which explain both the shrinkage in size of plants found in herbarium is lacking for most understory plants. The challenge to the regu­ specimens4 and the overall impression that ginseng is becoming latory agencies is to blend the best of what science has to offer, scarcer in natural populations. Based on present deer browsing in terms of understanding controls over ginseng population rates in central Appalachia, the prognosis for ginseng's survival viability, with the input from harvesters, to produce a rational in natural populations is poor. policy that will ensure that one hundred years from now, there In addition to harvest and browse, several other factors may will be plenty of wild ginseng in the woods. HG impact natural populations of ginseng. Among them are forces affecting numerous understory species throughout the eastern Dr. james McGraw received his BS from Stanford University in deciduous forest, including expected increase of timbering, 1918 and his PhD from Duke University in 1982. He has studied urban and suburban sprawl into forested areas, invasive species, the effects ofnatural and human-induced stresses on plant popula­ and climate change. Very little is known about the specific tions from Alaska to Africa to Antarctica. In the past decade, his effects of any of these factors on the distribution and abundance research has focused on experimental demographic studies of valu­ of ginseng. able herbal plants native to the eastern deciduous forest of North Another possible threat to ginseng may stem from the actions America. of well-intentioned harvesters-namely, the widespread broad­ casting of seeds from cultivated plants into the forest. The References possible threat is twofold. First, spread of seed-borne disease 1. Name! P, Gagnon D, Nault A. Population viabilicy analysis of from cultivation to the wild is possible. Second, introduction American ginseng and wild leek harvested in stochastic environ­ of genes from cultivated plants may result in reduced fitness ments. Consm~ation Biology. 1996; 10:608-621. 2. Van der Voort M E, McGraw JB. Effects of harvester behavior of progeny of matings with wild genotypes. The evidence for on population growth rate affects sustainabilicy of ginseng trade. large molecular genetic differences among natural "wild" popu­ Biological Conservation. In press. lations is strong. If these genetic variations are important for 3. McGraw JB, Furedi MA. Deer browsing and population viabilicy population viability, then introduction of outside "maladapted" of a forest understory plant. Science. 2005;307:920-922. genes could significantly reduce fitness. We do not yet know 4. McGraw JB. Evidence for decline in stature of American ginseng for certain whether broadcasting cultivated seeds is detrimen­ plants from herbarium specimens. Biological Conservation 98; tal, but the precautionary principle would suggest the practice 2001:25-32. should not be encouraged. www.herbalgram.org 2006 HerbaiGram 70 I 55 Ginseng Experts and Industry Question the Government's Programs for the conservation of wild American ginseng have Rationale been established since 1978 after the herb was listed on Appendix Members of the wild ginseng industry were predictably less than II of CITES in 1975. As stated in an AHPA press release, "species enthusiastic about the new regulations, particularly because of what listed on Appendix II are not necessarily considered to be threat­ ened with extinction but may become so unless trade is subject to they viewed as a closed-door process on the determination of the rules. AHPA's president Michael McGuffin echoed these concerns. appropriate regulation. In order for Appendix 11-listed species to enter into international trade, a determination must be made by "I know that many AHPA members empathize with the biologists the 'scientific authority' in the country of origin that any harvest at FWS and want to be sure that wild ginseng is harvested in a sustainable manner," he said.6 "But it must be acknowledged that is both legally obtained and is not detrimental to the surviva l of the species. The Division of Scientific Authority at FWS serves in the current system does not allow our input in the decision-making this role for the United States."6 ' process, which makes it very difficult to make good business plans Botanist, author, and noted herbal photographer Steven Foster, if wild ginseng is important to your company." who has 30 years experience in studying and writing about Native The new change does not apply to "woodsgrown" ("wild-simu­ lated") ginseng; that is, roots that are cultivated in the woods in American medicinal plants, expressed reservations about the effec­ natural shade under relatively natural conditions. These plants tiveness of the new restrictions: "Limiting exports to American ginseng plants 10 years or older seems curious from a conser­ still must be at least 5 years of age to export, according to Ford. FWS says that it has been contacting all ginseng exporters of vation standpoint. In the fores try industry, the harves t of the oldest, healthiest trees is known as 'high-grading.' In sustainable record to advise them of procedures for export of wild-simulated forestry operations, the healthiest trees are preserved as the best and woodsgrown ginseng. The process that has been developed requires that diggers, dealers, and exporters all keep this type of genetic material, while crowded or weaker trees are harvested. ginseng separated from truly wild ginseng. This is an attempt by Basically, the concern is that when you remove your healthiest, FWS to obviate the sale of wild-harvested roots that may be fraud­ oldest genetic stock, over time, trees of less vigorous genetic stock ulently misrepresented as woodsgrown. Canadian CITES officials dominate and are more susceptible to disease. It seems to me that do not allow the export of woodsgrown (wild-simulated) ginseng ginseng plants that have survived for 10 or more yea rs are the root, treating it as essentially the same as wild-harvested ginseng cream of the genetic crop, so to speak, so why would you encour­ (P. Ford oral communication to M . Blumenthal, December 14, age the taking of the strongest, healthiest survivors as a conserva­ 2005). tion measure? And of course, a digger is not goi ng to be able to Ginseng roots certified by a state as "artificially propagated" determine the age of the root until he digs it anyway (no matter (farm cultivated) may still be exported at any age when accom­ how many prongs or leaflets the plant has). Might the regulation, panied by a va lid CITES export certificate. Further, in the event instead, encourage the harvest of a greater number of larger plants that a seller or ex porter has been holding wi ld roots from a previ­ in an effort to find roots that are 10 years old or more? Increasing ous year's harvest and previously certified by a state, those roots the age of roots allowed for export will certainly slow exports, but ultimately, I fail to see how this regulatory edict benefits the long­ may still be exported under the previous 5-year minimum age requirement. term sustainability of American ginseng. Nevertheless, the ginseng

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56 I HerbaiGram 70 2006 www.herbal gra m.org trade should realize rhar this action is one step away from what li s, IN. For more informatio n regarding the export of American might ultimately be rhe only option left to FWS in the future-an ginseng, contact the FWS D ivision of Scientific Authority (e-mail: outright ban on wild ginseng exports for a few yea rs" (S. Foster e­ [email protected]) or rhe FWS D ivision of Management mail toM. Blumenthal, August 29, 2005). Authority, Branch of Perm its (pho ne: 1-800-358-2104 or 703-358- "A counter argument to Foster is that population biologists 2104; e-m ail : [email protected]). HG w ho have studied ginseng (e.g., D . Gagnon and P. ante!) have all said rhar only 5% of the harvestable plants in a population, o r References sub-population, or parch of ginseng should be harvested per yea r. I. USFWS. Conve ntion permit application for American wild ginseng Foster implies that all mature adults would be harvested at o ne harvested in 2005. Wash ington, DC: US Fi sh & Wildlife Service. time. A ll knowledgeable, well -trained w il d crafters know nor to August 3, 2005. Available ar: http://www.fws.gov/. Accessed March 13, 2006. harvest all plants in rhe setting ar once. It is well documented rhar 2. Gabel RR. Letter to Srare Ginseng Coordinators. Washington, as ginseng plants grow, they reproduce more abundantly. Plants DC: US Fish & Wildlife Service. August 31, 2005. Available ar: usuall y begin by 5 years of age and are reproducing more by 8 to 9 http://www. fWs .gov/in rernarional/pdf/FWS-DSA_ginse ng_clari fy _ years of age. By increasing the expo rt to 10 years of age we [FWS] letter2005.pdf. Accessed March 13 , 2006. anticipate higher reproduction and regeneration to occur" (P. Ford 3. FosterS. American ginseng (Panax quinquefo!ius). Botanica l Booklet e-mail to M. Bl umenthal, January 11 , 2006) . Series No. 308. Austin, TX: American Botanical Council; 1996. Additional concerns and reservations have been expressed by 4. Robbins CS . American Ginseng: The roar of orrh America's veteran wild medicinal plant experts. Ed Fletcher of Strategic Medicinal Herb Trade. TRAFFIC North America; 1998. 5. FWS. Convention Permit Applications for Ginseng. Washington, Sourcing, Inc. (Banner Elk, NC) ra ised concerns about the biol­ DC: US Fi sh and Wild life Service; 1999. ogy of ginseng roots (see sidebar). C huck Wanzer of Bota nies 6. FWS Ex rends Harvest Age on Wild American Ginseng to I 0 Years. Trading, LLC (Blowing Rock, NC) predicts that the probable AHPA Update. Silver Spring, MD: American Herbal Products Asso­ d rop-off in activity by wild ginseng harves ters will have a d irect dation.Augun 5,2005. impact on the collection of other w ild medicinal plants of the same 7. Maimon A. Poachers endanger Kentucky's ginseng. Dye, tracking geographical regions, such as goldensea l root (Hydrastis canadensis used ro protect roar. Louisvi lle, KY: Courier-journal. June 6, L., Ranunculaceae), resulting in sma ller quantities ha rves ted and 2005 . Ava il able at: hrrp://www.couri er-journal. com/apps/pbcs.dll/ a corresponding increase in price (C. W anzer oral communication arricle?AlD=/20050606/NEWSO I 04/506060393. Accessed March 13, 2006. toM. Blumenthal, September 17, 2005). 8. Ford P. Annex I American Ginse ng (Panax quinquefolius L.): Species T he FWS recently provided an A merican Ginseng Species Review. Wash ington, DC: US Fish & Wildlife Service. Available at: Review.S T he FWS has also hosted public meetings regarding the http://www. fWs.gov/i n rernational/ pdf/ Annex I G insengSpec iesRevi ew. ginseng iss ue, including meetings held January 31 in Pirrsburgh, pdf. Accessed March 13, 2006. PA; February 10 in Asheville, N C; and February 15 in India napo-

www.herba lgram.org 2006 HerbaiGram 70 I 57 Tamiflu and Star Anise: Securing Adequate Supplies of the Oral Antiviral for Avian Flu Treattnent

by Dennis V.C. Awang, PhD, FCIC, and Mark Blumenthal

he incipient concern over an impending bird flu pandemic has fueled an almost desperate effort to secure supplies of the most promising oral antiviral against avian flu to date-Tamiflu* {oseltamivir). During last year's influenza season, approximately 1.7 million prescriptions were written for oseltamivir in the United States, and according to the manufacturer, nearly twice as much of the drug was produced for this year's season.!

Tamiflu is part of a new class of medicines called stated that it would cooperate with a group of compa­ neuraminidase inhibitors. The surface of an influ­ nies to produce higher quantities of the drug to meet enza virus contains neuraminidase proteins that increasing world demand.3 enable new virus particles to bud on the surface Currently the most satis­ of the host cell. The neuraminidase factory commercial route to enzyme breaks the bonds that the production of Tamiflu is hold these new virus particles based on extraction of shikimic to the outside of an infected acid from the fruits of Chinese cell, setting them free to infect star anise (Illicium verum Hook other cells and spread infection. f., lliciaceae; bajiao in Mandarin). Neuraminidase inhibitors block However, this plant, a the enzyme's activity and prevent small tree up to new virus particles from being 10 meters tall, is released, thereby limiting the notoriously diffi­ spread of infection. 2 cult to cultivate The current sole manufac­ and also matures at turer of Tamiflu, the Swiss-based a very slow rate, flowering only Roche Pharmaceuticals, had previously after 6 years.4 Roche so far has suspended public sales of the drug in the commanded roughly 90% of the wake of a widespread assault on pharmacy world's supply of Chinese star supplies. The company's action is claimed anise, which is grown only in 4 justified on the basis of preserving supplies Chinese provinces. Alarm­ of the drug for governmental agencies and ingly, almost all of this year's institutions caring for the most vulnerable star anise crop has been reportedly destroyed by a series patients. In the meantime, efforts are increas- of mudslides produced by unseasonably severe tropical ing to develop more efficient, cost-effective synthetic storms.5 approaches to the drug. Because the star anise connection as a starting mate­ In addition to announcing that it would increase rial for the production of Tamiflu has some potential its own production of Tamiflu, in December Roche media value-i.e., the drug is based on a chemical

Above: Star anise Illicium verum Photo ©2006 stevenfoster.com

58 I HerbaiGram 70 2006 www.herbalgram.org Alarmingly, almost all of this derived from a traditional spice and medicinal 4, 2005). However, neither such extracts nor plant-numerous articles have appeared in the year's star anise crop shikimic acid itself and its metabolites have been mainstream media focusing on star anise and its has been reportedly demonstrated to have such efficacy. Expressing relative scarcity in relation to the mushrooming concerns about the misuse of star anise as an demand for Tamiflu_3,6 A report in the China destroyed by a series herbal preventive or treatment for avian flu, a Daily states that the price of star anise had coalition of herb and dietary supplement indus­ almost doubled in one week in November. In of mudslides produced try trade associations have stated categorically Guangxi province, the price rose from 5 yuan that such activity is not only nor recommended (US $0.60) per kilogram to 8.2 yuan (US $1.00) by unseasonably severe but is strongly discouraged.12 per kilo, according to a wholesaler in W uzhou, tropical storms. D ue to the initially high cost ($50 per gram) who reportedly had taken stock of 60 tons of the of research quantities of shikimic acid, Roche fruit, even before Roche had purchased available contracted with Michigan State University stocks.? The New York Times reported in November that the cost (MSU) scientist J. W. Frost to develop a fermentation process of shikimic acid in China rose from $40 to over $400 per kilo.3 for production of (-)-shikimic acid. Frost discovered a strain of Shikimic acid is also a constituent of the toxic fruit of Japa­ E. coli that overproduces the acid when fed glucose, which even­ nese, or bastard, star anise, also called sacred anise (I anisatum tually led to bacterial growth on a commercial scale. Roche now L.). T his species, termed shikimi-no-ki in Japanese, is cultivated obtains large quantities (measured in tons) of shikimic acid both near Buddhist temples and used in religious ceremonies, such by fermentation and star anise fruit extraction, but isolation and as branches for decorating graves.4,8 The relative abundance of purification are time-consuming.l3 shikimic acid in the fruits of I anisatum and I verum, and any The current semi-synthetic significant differences in ease of extraction, are not evident in manufacture of Tamiflu from the available literature. However, concern has been expressed shikimic acid is a complex, ri me­ regarding the adulteration of Chinese star anise with Japanese consuming, 10-step process, star anise, due to the documented neurologic and gastrointesti­ involving potentially explosive nal toxicities of purported Chinese star anise rea administered to azide chemistry. Roche claims infants.9,10 A rapid and efficient method for detecting I anisatum that from raw material sourcing in I verum powder has been recently published. II T he proce­ to production of Tamiflu capsules dure involves a combination of microscopy (fluorescence and takes a complete year. Shikimic acid scanning electron) and gas chromatography, which easily detects is first converted to a diethyl ketal the presence of eugenol, methoxyeugenol, and 2,6-dimethoxy- intermediate, which is then 4-allyphenol, compounds not present in I verum. However, the reduced in 2 steps distinction between these two species of Illicium is of concern to an epoxide primarily for the purpose of ensuring the purity of Chinese that is finally star anise for food use (e.g., herbal teas). For the production of transformed shikimic acid suitable for synthetic production of oseltamivir, to Tamiflu in this distinction does not appear to be of significance as only the 5 subsequent shikimic acid is isolated and purified for further chemical elabo­ steps, 3 of which ration into oseltamivir. involve highly toxic explo- Considerable interest has been expressed by reporters in sive azide intermediates.l3 Despite this the mistaken and dangerous belief that drinking star anise apparent complexity, it was reported extracts can be an effective treatment for the avian flu (N.R. in the November 3rd edition of Farnsworth oral communication to D.V.C. Awang, November the Wall Street journal Asial4

Star anise Illicium verum Photo ©2006 stevenfoster.com

The Fermented Cabbage Connection cent Korean research has found that a culture filtrate of the bacterium Leuconostoc kimchi (prepared from the Korean piced fermented cabbage dish kimchi), when administered to chickens infected with the bird flu virus, led to recovery f 11 of 13 birds. However, while surging sales of kimchi across Asia suggest that consumers believe that it may protect them against bird flu, the bacterial preparation has not yet been tested on bird flu in humans, even though it has shown a "very potent effect" against human flu in vitro.! Europeans claim that the Korean process for kimchi production is exactly the same as that for the popular European fermented cabbage dish sauerkraut, but the Korean researchers have stated that their research cannot be used to demonstrate similar benefits for sauerkraut, stressing that the antiviral effect of the bacterial product is "strain-specific."! HG Reference 1. Patton D. Cabbage dish gaining popularity as flu-fighter. November 16, 2005. Available at: http://www. nutraingredienrs.com/news/ ng.asp?n=63932-kimchi-sauerkraut-bird-£lu.

www.herbalgram.org 2006 HerbaiGram 70 I 59 that Roche's claim as to the difficulty of producing Tamiflu is greatly exaggerated. Rather than the claimed full year required for synthesis from shikimic acid, Taiwan's National Health Research Institutes claims to have produced a small quantity of the antiviral in 18 days! Also, Cipla Ltd., an Indian generic drug manufacturer, claims to have been successful in a pilot phase production of the drug.l4 However, these relatively small-scale productions can be expected to be much less time-consuming than large-scale manu­ facture under good manufacturing practices (GMPs). Roche and MSU scientist Frost have explored chemical and microbial means to obviate azide intermediates: an azide-free allylamine route from epoxide to Tamiflu and microbial produc­ tion of aminoshikimic acid as a starting material were developed. Also, two other routes that do not involve shikimic acid have been explored. However, so far, no alternative has been found to surpass the shikimic acid-azide commercial route in terms of cost and efficiency.l3 Perhaps future chemical synthetic innovation and/or a lower­ Chemical Stru cture of (-)-shikimic acid. ©2006 Chromadex. cost, more productive source of shikimic acid will satisfy the urgent demand for increased supplies of Tamiflu. In the mean­ References time, doctors have discovered that teaming Tamiflu with a low­ 1. Hayden FG. Antiviral resistance in influenza viruses- Implica­ cost generic drug used in World War II to extend scarce supplies tions for management and pandemic response. New Eng! J Med. of penicillin, doubles the antiviral's effectiveness: the "helper" February 23, 2006;354:785-788. drug probenecid reduces Tamiflu excretion in urine, thereby 2. Woods JM, Bethell RC, Coates JA, et al. 4-guanidino-2, 4-dideoxy- elevating blood levels roughly twofold. IS 2, 3-dehydro-N-acerylneuraminic acid is a highly effective inhibitor Recently, the Canadian generic drug manufacturer Biolyse both of the sialidase (neuraminidase) and of growth of a wide range Pharma Corp., which specializes in extracting chemicals from of influenza A and B viruses in vitro. Antimicrob Agents Chemother. plants at its plant in St. Catharines, Om., revealed plans to extract 1993;37(7): 1473-1479. 3. Pollack A. Is bird flu drug really so vexing? Debating the difficulry shikimic acid from Christmas trees.16 Extractable shikimic acid, ofTamiflu. New York Times, November 5, 2005. Available at: reportedly constitutes 2 to 3% of the biomass from various pine http:/ /www.nytimes.com/2005/ 11 /0 5/business/05tamiflu.html?ei= 5 spruce, and fir trees. The shikimic acid from this source will be 070&en=e0d5349d5f7 dd5ae&ex= 1136350800&pagewanted=all. considerably cheaper than its current price, which has soared to 4. Small E. Confusion of common names for toxic and edible "star more than $500 (US) a kilogram from $45 over the past year due anise" (Illicium) species. Econ Bot. 1996;50(3):337-339. to shortages ofTamiflu and skyrocketing demand. 5. Slow-growing star anise wiped out by mudslides. Vtmcouver Sun. The question then arises as to how much Tamiflu can be October 27, 2005. produced from the scarce shikimic acid supplies. The New York 6. Goodman PS. Star Rises in Fight Against Bird Flu. Washington Post. November 18, 2005. article cites an unnamed Roche chemist who said that Times 13 7. Wang ZQ. Star anise soars to surprise fame. China Daily. Novem­ grams of star anise could produce 1.3 grams of shikimic acid, ber 2, 2005. which then could be used to make 10 Tamiflu capsules, the 8. Hocking GM. A Dictionary ofNatural Products. Medford, NJ: amount required to treat one person. Thus, one ton of shikimic Plexus Publishing, Inc.; 1997:391. acid could treat 770,000 people. However, the Times article also 9. Ize-Ludlow D, Ragone S, Bernstein JN, Bruck IS, Duchowny cites another expert, Y.K. Hamied, PhD, a chemist and Chair­ M, Garcia Pena BM. Chemical composition of Chinese star man of Cipla, who says that the figure was more realistically about anise (Illicium verum) and neurotoxiciry in infants. JAMA. 300,000 as newcomers to the Tamiflu production business would 2004;291 (5);562-563. 10. Ize-Ludlow D, Ragone S, Bruck I, Bernstein J, Duchowny M, probably not be able to enjoy the production efficiencies currently Garcia Peii.a B. Neurotoxicities in Infants Seen With the Consump­ attained by Roche. Other potential sources of shikimic acid report­ tion of Star Anise Tea. Pediatrics. October 18, 2004; 114;653-656. edly considered by Gilead Sciences Inc. of Foster City, California, Available at: http://www.pediatrics.org/cgi/content/full/114/5/e653. are cinchona bark (Cinchona spp., Rubiaceae, source of quinic 11 . Jashi VC, Srinivas PV. Khan lA. Rapid and easy identification of acid, a precursor of shikimic acid), ginkgo trees (Ginkgo biloba L., Illicum verum Hook. f. and its adulterant Illicium anisatum Linn. Ginkgoaceae), and the needles of giant sequoias (Sequoiadendron by fluorescent microscopy and gas chromatography. J AOAC Int. giganteum [Lind!.]]. Buchholz, Cupressaceae).3 HG 2005;88(3):703-706. 12. Industry Coalition Advises Against Use of Dietary Supplements as Remedy for Avian Flu [press release]. American Herbal Products V. FCIC, Dennis C. Awang, PhD, is president of MediPlant Association, Consumer Healthcare Products Association, Council Consulting, Inc., White Rock, BC, Canada, a natural products for Responsible Nutrition, National Nutritional Foods Association, consulting group. Before retiring after 24 years at Health Canada, November 18, 2005. he was the Head of the Natural Products Section in the Bureau of 13. Yarnell A. Complexiry ofTamiflu manufacturing may hamper on Drug Research at the Canadian Health Protection Branch. He is demand production. Chem & Eng News. 2005; 83(35): 22-23. currently revising the classic Herbs of Choice: The Therapeutic Use 14. Zamiska N, Dean]. Generics Challenge Roche's Tamiflu Claims. of Phytomedicinals (Haworth Press), initially authored by the late Wall Street journal. November 3, 2005. Professor Varro E. Tyler. 15. Spears T. Generic 'helper drug' can stretch Tamiflu ingredient. National Post (Canada), November 2, 2005. 16. Zehr L. Christmas trees to provide key Tamiflu ingredient. The Mark Blumenthal is founder and executive Director ofthe Ameri­ Globe and Mail (Toronto); December 2005:B3, 23. can Botanical Council and Editor ofHerbalGram.

60 I HerbaiGra m 70 2006 www. herbalgram.org Give yourself a good spring cleaning.

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Proposed Quality Control Guidelines for the EU Directive on Traditional Herbal Medicinal Products: Implications for Small- to Medium-Sized Enterprises by Josef Brinckmann and Michael Mcintyre, MA, DUniv, FNIMH, MBAcC, FRCHM he European Union recently published draft quality-control guidelines applying to a new European Directive called the Tradi­ tional Herbal Medicinal Products Directive (THMPD) . This Directive allows the licensing and over-the-counter sale ofherbs T that have a history ofuse anywhere in the world for at least 30 years, 15 ofwhich must be in an EU Member State. Implement­ ing these quality control guidelines is likely to see companies incur significantly higher costs due to the additional requirements and complexities ofproduct registration, labeling, and adverse-event reporting. This raises concerns that the costs for registration ofproducts (especially those with mixtures ofherbs) may be unattainable and uneconomic, resulting in reduction ofboth traditional herbal prepara­ tions and viable small- to medium-sized herbal companies. This is likely to mean fewer choices for consumers throughout the EU.

On June 20, 2005, the European Medi­ ucts Regulatory Agency (MHRA), the herbal producrs.lO In July 2005 the Secre­ cines Agency (EMEA) published an United Kingdom's medicines regulator, tary of the UK Chinese Medicine Asso­ updated draft guidance document enti­ issued two consultation letters to industry ciation of Suppliers (CMAS) wrote to the tled Guideline on Specifications: Test Proce­ for comment: Chair of the Herbal Medicinal Products dures and Acceptance Criteria for Herbal • Consultation Letter: MLX 324: License Committee within the EMEA expressing Substances, Herbal Preparations and Herbal Fees for Medicinal Products for Human concern that the EMEA-proposed new Medicinal Products I Traditional Herbal Use Only - Proposals for October quality guidelines would effectively bar Medicinal Products. 1 The deadline for 2005 [comment deadline August 29, traditional Chinese herbal formulas from public comment was September 15, 2005. 2005]; 7 the marker. This updated draft guidance aims to make • Consultation Letter: MLX 325: Imple­ clarifications and corrections to the earlier mentation ofthe Directive on Tradi­ Scope and General Concepts of the Note for Guidance on Specifications, which tional Herbal Medicinal Products: EMEA Guidelines went into effect January 2002.2 The stated Directive 20041241EC [comment The scope of the EMEA guideline is objective of the new guideline is to provide deadline September 8, 2005]. 8 specifications, i.e., those tests, procedures, general principles on the setting and justi­ and acceptance criteria used to assure fication of uniform specifications for Costs and Complexities of Product the quality of the herbal preparations herbal medicines in order to support the Licensing for SMEs and herbal medicinal products. In this process of applying for marketing autho­ While initially proponents of the Tradi­ model, product quality is determined by rization or registration according to EU tional Herbal Medicinal Products Direc­ the quality of the starting plant material, Directives 2001/82/EO and 2001/83/ tive (THMPD), up through irs passage into development, in-process controls, good EC,4 respectively. law in April 2004, the authors of this arti­ manufacturing practice (GMP) controls, While a simplified registration proce­ cle have subsequently become concerned, and process controls, and by specifications dure was es tablished for Traditional based on meetings with regulators as well applied to them throughout development Herbal Medicinal Products (THMPs) as with regulatory affairs consultants, and and manufacture. The EMEA document under EU Directive 2004/24/EC,S the on briefing papers issued from the EMEA, provides details on concepts followed by guiding principles for quality, specifica­ that the costs and complexities of product the guidelines. General concepts consid­ tions, and documentation are no different registration may be unattainable for small­ ered to be important in the development for a THMP than for any other medici­ to medium-sized enterprises (SMEs).9 The and setting of specifications include: nal product (i.e., a drug). Therefore, the authors are involved with enterprises pres­ • Characterization. EMEA proposes updated draft guidance is intended to ently in rhe process of applying for regis­ that to assure consistent product be read and understood in conjunction trations for THMPs through the MHRA, quality, comprehensive and relevant with the Guideline on Quality of Herbal and are also submitting comments to specifications for the botanical and Medicinal Products I Traditional Herbal rhe EMEA for irs draft guidelines and/ phytochemical aspects of the starting Medicinal Products,6 another draft guid­ or to the MHRA for irs proposals for plant material, manufacture, and the ance document, published in July 2005, implementation. Serious concerns have finished product, should be estab­ the public comment deadline for which also been expressed recently by non-EU lished. was September 30, 2005. national governments with a stake in the • Macroscopical/microscopical charac­ issue. For example, the Government of terization. To distinguish rhe active MHRA Implementation of the EU India Commerce and Industries Minis­ herb from adulterants. Directive on Traditional Herbal ter Kamal Nath is urging the EU Trade • Phytochemical characterization. Medicinal Products (THMPD) Commissioner Peter Mandelson to resolve Analysis of active and marker Also in June 2005, directly correspond­ rhe non-tariff market access barriers rhar compounds including use of chro­ ing to these various EMEA draft guide­ the EU THMPD may likely cause for most matographic fingerprinting. lines, the Medicines and Healthcare prod- traditional Indian Ayurvedic medicinal • Potential impurities/Contaminants/

62 I HerbaiGram 70 2006 www.herbalgram.org ------~~egal & RegulatorJ~------

Degradation products. Specifica­ EU Member Stare Pharmacopeia active substances and related finished tions fo r heavy metals, pes ticide (e.g., British Pharmacopoeia [B P] or products.13 residues, microbial contam ination, German Pharmacopoeia [Deutsches • Universal tes ts/criteria. For imple­ mycotoxins. Arzneibuch, DAB]), an herbarium mentation of this section of the guid­ • Biological variation. Evaluation of sa mple of the herb must be avail able. ance, EMEA suggests that the appli­ histori cal batch data. • Statistical concepts. Methods of cant should rake into account yet rwo • D esign and development consider­ analys is should be described fully to other sets of guidelines, Valid.ztion ations. EMEA proposes that it may allow independent calcul ation of the ofanalytical methods: definitions and be necessary only to tes t the product res ults. terminology, 14 and Note for guid.znce for qual ity attributes uniquely associ­ on validation ofanalytical procedures: ated with the particular dosage form Implementing these methodology. 15 and/or the specific herbal substance. • H erbal substances. The PhEur For example, a certified organic quality control guidelines general monograph, H erbal D rugs, 16 T H M P could have reduced testing is likely to see companies should be consulted for interpreta­ requirements for pes ticide resi dues. tion of the tes ts (e.g., foreign matter, In certain extracts, depending on the incur significantly higher ash, water solu ble extractive, water ethanol content or manufac turing content, microbial, mycotoxins, process, resting fo r microbial limits costs due to the additional pesticides , etc.) and acceptance crite­ might be excluded or reduced. requirements and ria (e.g., identification by three or • Pharmacopeia! tests and acceptance more of the fo llowing: macroscopical, criteria. Wherever appropriate, complexities of product microscopical, chromatographic, pharmacopeia! methods should be registration, labeling, and chemical reactions, and organoleptic utilized for tes ting medicinal herbal characteristics) for botanical raw products. adverse-event reporting. materials. • Periodic/skip testing. EM EA • H erbal preparations. The PhEur proposes that performing certain res ts general monograph, Herbal Drug on pre-selected batches and/or at Sum mary of the P roposed G u id elines Preparations,ll should be consulted intervals, rather than on every batch, for interpretation of the tests (e.g., may be justifiable, e.g., dissolution, Specifications: D efinition and justifica­ resid ual solvents, water content, solvent res idues, and microbiological tion microbial limits, mycotoxins, pesti­ testing fo r solid oral dosage fo rms. • Definition of specifications. EMEA cides) and acceptance criteria (e.g., • Release versus shelf-life acceptance proposes that it may be possible that, identification by a combination of criteria. EMEA proposes that it in addition to QC release rests , the chromatOgraphic tests, e.g., high­ may be acceptable to establish more speci fi cation may incl ude in-process performance liquid chromatography restri ctive criteria for the quality res ts or periodic (s ki p) rests that (HPLC) and thin-layer chroma­ control (QC) release of a fi nished are not conducted on every batch. rography (TLC)-densirometry, and herbal product than for shelf- life In such cases, the appli cant should organoleptic characteristics) for specifica tions. For example, specifica­ speci fY which tests are routine and preparations (e.g., tinctures, extracts, tions fo r degradati on product levels. which are not, with a justification for essential oil s, expressed juices, • In-process tests. Such res ts are used the testing frequency. processed exudates). for the purpose of adjusting process • Justification of specifications. Due to • Vitamins and minerals in THMPs parameters in-process, if necessary the inherent complexity of medicinal for human use. Vitamins and miner­ (e.g., pH of a solution). herbal products, there may not be als may occur as ancillary substances • Alternative procedures. EMEA a single stability-indicating assay or in THMPs. EMEA proposes that proposes that it may be permissible parameter that profiles the stabil- validated assays are required for their to use a spectrophotometric proce­ ity characteristics. EMEA suggests identification, quantification, and dure for Q C release rather than a that applicants shoul d propose a determination of impurities. chromatographic method. H owever, series of product-specific, stability • H erbal medicinal products. Tests and for shelf- life specifications, the chro­ indicating rests that would enable acceptance criteria considered ro be matographic procedure should still be the detection of changes in qual- generally applicable ro all medicinal used to demonstrate compliance. ity during the product shelf- li fe. In herbal finis hed products include a • Evolving technologies. New analyti­ this regard, EMEA refers applicants qualitative description of the dosage cal technologies should be used if to three additional sets of guidance: form, identification as determined by they offer additional qual ity assur­ Note for guidance on stability testing a combination of chromarographic ance. of new drug substances and products, II tests (e.g., HPLC and TLC-densi­ • Reference standard. If the botanical the Guideline on stability testing of rometry) or, in the case of powders, raw materi al does not have a mono­ new veterinary drug substances and microscopical and macroscopical graph published in the European medicinal products, l 2 an d rhe Note for characterization in combination with Pharmacopoeia (PhEur) or in another guidance on stability testing ofexisting other methods, validated quanrira- www.herbalgram.org 2006 HerbaiGram 70 I 63 ------i~egal & RegulatorJ~------

rive assays for active constituents or ex rracrables, alcohol content, disso­ matographic means is easier sa id than marker substances (when actives are lution, particle size distribution, done. T hese quality control measures are not known). A non-specific assay redispersibility, rheological properties, relatively easy to carry our for an ortho­ could be justified, as long as other specific gravity, reconstitution rime, dox drug which contains a single chemical supporting analytical procedures water content. entity bur difficult to demonstrate when are also used to achieve overall • Herbal teas. Loss on drying, total evalu ating a complex herbal mixture of specificity. For example, a combina- ash I ash insoluble in hydrochloric several herbs, each one containing a multi­ rion of ultraviolet visible (UV/VlS) acid, identification (e.g., chromato­ plicity of chemical signatures. The bulk of spectrophotometric assay fo r deter- graphic methods, with microscopical the UK products that are planning to seek ruinati on of anthraquinone glycosides and macroscopical characteriza tion if registration under the THMPD are nor with fi ngerprint chromatography justified), purity, uniformity of mass single ingredient products. Instead, they could be acceptable under this guide- I average mass of rhe sachet, assay are likely to be complex herb mixtures, line. Additionally, finished products (where possible, a specific, stabil­ often with 3 to 5 herbal ingredients and are to be res ted, with a justifiable ity-indicating quantitative assay, bur in the case of Ayurvedic and C hinese frequency, for organic and inorga nic non-specific assays can be justified, herbal medicines, there may be 10 or impurities and res idual solvents, as e.g., UV/VlS spectrophotometric even 20 individual herbal ingredients. T he well as microbial limits. Microbial assay in combination with T LC proposed quality standards will be d iffi­ limi ts should comply with the PhEur fingerprint), particle size, and micro­ cult, if nor impossible in many cases, to G uidel ines. bial quali ty as per PhEur general apply to these complex herbals. • Specific tests/criteria. In addition to text on the Microbiological Quality of In practice, when using the relatively the aforementioned universal rests. Pharmaceutical Preparations, Category inexpensive T LC, the chromatographic • Herbal medicinal products. This 4a. Fo r multi-herb products, where fingerprint of one herb often obscures that guidance co ncerns dosage form- an assay of each herbal substance of other herbs with which it is combined specifi c tes ts: is not poss ible, the applica nt can in a product so that no determination of • Tablets and capsules. Dissolution I instead justi fY how reproducibility the individual marker compounds of all disintegration, hardness I fri ability, of the finished product is guaranteed rhe herbs can be made. Ir appears rhar uniformity of dosage units, water and res ted. rhe only way that these data might be content, microbial limits. provided for combinations of several herbs • Oral liquids. Uniformity of dosage European Herbal Practitioners is by rhe use of HPLC. Bur even with such units , pH , microbial limits, anti- Association (EHPA) · View on the equipment the task of identify ing mark­ microbial preservative co ntent, Costs of the Proposed Quality ers of several herbs blended together in antioxidant preservative content, Standards IS one formulation might well prove impos­ T he relatively rigid quality standards sible. T he cost of a basic HPLC machine is Table 1. Acronyms and Abbreviations being implemented under the THMPD about £50,000 (US $92,000), bur the true CPMP Committee for Proprietary are proving to be technically difficult, cost of these procedures has to include Medicinal Products expensive, and in many cases unwork­ the development of techniques to demon­ able in practice. The EM EA G uidance strate rhe chemical markers of each herb in EHPA European Herbal Practitioners Note on the Quality of H erbal Medicinal combination. This is likely to be expensive Association Producrs19 call s for res ts to demonstrate in terms of time and personnel involved EMEA European Medicines that the known constituents of any herbal and beyond the financial resources of rhe Evaluation Agency medicines in the product are present in many micro, small, and medium compa­ GMP Good Manufacturing Practice the fi nished product. T his G uidance Note nies in the UK herbal sector. stares that if an herbal medical product In response to concerns ex pressed by HPLC High -performance liquid contains a combination of several herbs, the H erbal Forumt about these techni­ chromatography "the determ ination may be carried jointly cal diffi culties with regard to the qual­ MHRA Medicines and Healthcare for several acti ve substances." The Note ity guidelines, the MHRA has recently products Regulatory Agency advises that such identification tests have res ponded: (UK) to be carried our "by different appropriate On the general iss ue of how to use chromatographic methods." The problem PhEur European Pharmacopoeia quality guidelines, we have picked here is rhar demonstrating exactly what is up one point of difficulty fro m time QC Quality Control present in the finished product by chro- to rime in our discuss ions with the SME small- to medium-sized enterprises * The European Herbal Practi tioners Associati on, fo unded in 1993, represe nts the interests of THMP Traditional Herbal Medicinal profess ional herbal practi tioners of all traditions and their patients across th e EU. The EHPA was a stakeholder in the Herbal Medici ne Regul ato ry Wo rkin g Parry (2 002-3) set up by the UK Product Gove rnment to advise on the regulati on of herbal practice and herbal medicines in the UK. THMPD Traditional Herbal Medicinal t The Herbal Forum (launched in 2000) is a co nso rtium of representatives of UK herbal suppli­ Product Directive ers, manufacrurers, and practitioners wo rking together to ensure that changes to UK and EU herbal legislation are appropriate and proporti onate and in the bes t interests of consumers and TLC Thin-layer chromatography the herbal secto r.

64 i HerbaiGram 70 2006 www.herbalgram.org ------~~ega I & RegulatorJ~------

H erbal Forum and with some indi­ (US $20,200) per irem while a four­ such as herbal teas, oil s, syrups, and vidual companies . This relates ro rhe herb combination tablet per packaging tinctures, among others. It may also be concept rhar rhe guidelines are rhere format would be in the region of £31,000 considered more logical rh an rhe current ro be followed bur sometimes in rela­ (US $57,000). These are large sums of regul arory fr amework in rhe USA, where tion ro an applicant's specific prod­ money that will be difficult for many herb the sa me medicinal herbal products are uct, it may be reasonable for rhe companies ro find.* regul ated in stead as food /dietary supple­ company ro seek ro demonstrate rhar ment products. H owever, rhe accumu­ a parricular element of rhe guidelines lated costs of rhe proposed requirements is nor fully applicable ro their situ­ The relatively rigid fo r rhe development of va lidated, product­ arion and rhar a modified approach specific, quantitati ve assays for complex would be acceprable.20 quality standards being herbal mixtures , along with the product T he point here is rhar for herbal prod­ implemented under registration fees imposed by rhe national uct complexes containing more rhan rwo government and subsequent costs to or rhree herbs, rhe technical diffi culries the THMPD are proving obtain mutual recognition from orher of meeting rhe EMEA Guidance Note EU national authorities, plus other costs requirements is likely ro be a frequent to be technically difficult, related to pharmacovigilance, labelling in experience. Ir is nor really reasonable or expensive, and in many Braille, and use r testing for rhe develop­ practical ro consider rhar rhe majority of ment of Patient Advice Leafl ets, may, in these multi-herb fo rmulations can some­ cases unworkable the end, permit only the bes t- funded large how negotiate the difficulties of the Q C in practice. companies ro ex ist in rhe marker. Many guidelines by labelling some of their herbs traditio nal herbal medicinal products may as excipients. T hus, these exceptions are disa ppear as a res ul t. The rota! costs to likely ro be the rule, thereby proving the bring a single herbal product into the EU G uidelines more or less unworkable for Some Possible Solutions market, as undersrood by the current draft small or medium herb companies with Recommended by the EHPA proposa ls, appea r out of reach for micro-, limited resources. The current guidelines on quality and small -, and medium-sized companies. The G uidance Note mentioned above, stability for herbs must be adapted ro make One of rhe main objectives of rhe EU rogerher with that on stability tes ting,2 1 them appropriate for multi-component Directive was ro es tablish a harmonized also states that by using the required traditional herbal products. T he product­ legislati ve framework for THMPs within "appropriate fingerprint chromarograms," release specification of compound herbals the Eu ro pea n Community in order to herb companies prove that herbal constit­ (where the acti ves are often undefined) remove ex isting trade obstacles wi thin uents within their products are stable. A should be based on T LC aga inst ' finger­ the Community while ensuring rhe full typical tes t procedure is likely ro occur at print' standards. Similarl y, the stability of protection of publi c health and maintain­ three-month and then six-month inter­ the product should be assessed by poten­ ing consumer choice.22 An initial aim vals over a minimum of three years. tial changes in the TLC pro file over time of rhe Directive was to encourage cross­ Again this tes ting is likely ro require as actives are often nor quantifiable and border trade in THMPs, which is pres­ expensive HPLC machinery, and multi­ rhe stability of "markers" is not necessarily ently quire limited due to significantly ple tes ts may be required ro identify indicative of the stability of rhe actives . different national rules for rhe marketing all the active constituents in a complex In order ro build rhe "quality picture" authori zation of THMPs from country herbal formula. For a product with other of a finished herbal medicine, other asso­ to counrry.23 If the current proposals are actives, such as vitamins, this would again ciated quality measures, as described adopted in their present form, it appears require a further identification and assay by current C PMP guidelines on herbal that just the opposite of rhe ori gin al intent for each one. Stability cabinets used ro medicinal products, should be employed of rhe Directi ve may rake place. HG conduct these tests are not inex pensive. To as appropriate. T his would include res ts purchase cabinets capable of holding 20- on the herbal acti ve materi al, aiming ar j osef Brinckmann is the Vice President 30 products sa mples for up ro three years "up front" quality control as well as appro­ of Research & Development at Traditional is likely to cost from £9,000-£12,000 (US priate and detailed batch documentation, Medicinals, Inc. in Sebastopol, California; $16,500-22,000). The UK Herbal Forum including in-process records. Solutions a Consultant on Market Intelligence for has recently calculated that the cost of a must be sought ro ensure that rhe signifi­ Medicinal Plants & Extracts for the Inter­ single herb stability study per packaging cant costs ro small - and medium-sized national Trade Centre (fTC) of the United format would be in the region of £ 11 ,000 businesses of implementing the Directive Nations in Geneva, Switzerland; editor of are minimized and introduced gradually f TC 's quarterly Market News Service for • A wel l-known German Laborarory recently over the transitional peri od which runs Medicinal Plants & Extracts, and a member gave a wri tte n cost estimate to an Ameri­ until 2011. of the Advisory Board of the American ca n appli ca nt, Traditional Medicinals", Botanical Council. for qual ity assurance and srabil iry resti ng Conclusion Michael M cintyre is a former President sufficient ro quali fY an herbal rea wirh rwo The EU Directive on T HMPs poten­ and an elected Fellow of the National Insti­ acti ve ingredients for THMPD li censing ar tially provides a much needed regula­ tute of M edical Herbalists, a Fellow of the approximately a minimum of 100,000 Euros tory framework for traditional medicines Register of Chinese M edicine, Chairman of per product (US D $125,380).

www.herbalgram.org 2006 HerbaiGram 70 I 65 ~egal & RegulatorJ the European H erbal Practitioners Associa- Guideline on Quality of Herbal pdf. tion and was a member of the UK Depart- Medicinal Products I Traditional 14. European Medicines Agency (EMEA). ment ofH ealth H erbal Medicine Regulatory Herbal Medicinal Products. London, Note for Guidance on Validation of UK: EMEA Committee for Medicinal Analytical Procedures: Definitions and Working Group. H e is visiting Professor at Products for Human Use (CHMP) Terminology. London, UK: EMEA. June Middlesex University and a Doctor of the Committee for Medicinal Products I, 1995;CPMP/ICH/381195. Available University. for Veterinary Use (CVMP). July 21 ar: http:/ /www.emea.eu.int/ pdfs/human/ 2005;CPMP/QWP/2819/00 Rev ich/038195en. pdf. References I;EMEA/CVMP/814/00 Rev 1. Available 15. European Medicines Agency (EMEA). 1. European Medicines Agency (EMEA). at: http:! /www.emea.eu. in t/Inspections/ Note for Guidance on Validation of Guideline on Specifications: Test docs/281900en.pdf. Analytical Procedures: Methodology. Procedures and Acceptance Criteria 7. Medicines and Healthcare products London, UK: EMEA. November 6, for Herbal Substances, Herbal Prepara- Regulatory Agency (MHRA). Consulta- 1996;CPMP/ICH/281195. Available at: rions and Herbal Medicinal Products I tion Letter: MLX 324: License Fees for http:/ /www.emea.eu.int/ pdfs/human/ Traditional Herbal Medicinal Products. Medicinal Products for Human Use ich/028195en.pdf. London, UK: EMEA Committee for Only- Proposals for October 2005. 16. European Pharmacopoeia Commission. Medici nal Products for Human Use London, UK: MHRA. June 7, 2005. Herbal Drugs (Plantae medicinales) . In: (CHMP) Committee for Medicinal Prod- Available at: http://medicines. mhra.gov. European Pharmacopoeia. 5th ed. Srras- ucts for Veterinary Use (CVMP). June uklinforesources/ publications/mlx324. bourg, France: Council of Europe; 2005. 20, 2005;CPMP/QWP/2820/00 Rev pdf. 17. European Pharmacopoeia Commis- 1;EMEA/CVMP/815/00 Rev 1. Available 8. Medicines and Healrhcare products Regu- sion. Herbal Drug Preparations (Plantae at: http:/ /www.emea.eu.int/pdfs/human/ latory Agen cy (MHRA). Consul tation medici nales praeparatore). In: European qwp/282000en.pdf. Letter: MLX 325. Implementation of the Pharmacopoeia. 5th ed. Srrasbourg, 2. European Medicines Agency (EMEA). Directive on Traditional Herbal Medici- France: Council of Europe; 2005. Note for Guidance on Specifications: nal Products : Directive 2004/24/EC. 18. European Herbal Practitioners Associa- Test Procedures and Acceptance Criteria London, UK: MHRA. June 16, 2005. ti on (EHPA). European Herbal Practi- for Herbal Substances, Herbal Prepara- Available at: http://medicines.mhra.gov. tioners Association Response to MLX tions and Herbal Medicinal Products. uklinforesources/publications/MLX325. 325 Implementation of the Directive on London, UK: EMEA Committee for pdf. Traditional Herbal Medicinal Products: Proprietary Medicinal Products (CPMP) 9. Implementation of the Directive on Directive 2004/24/EC. London, UK: Committee for Veterinary Medicinal Traditional Herbal Medicinal Prod- EHPA. 2005. Products (CVMP). July 26, 200l ;CPMP/ ucts (THMPD). Frankincense Euro- 19. European Medicines Agency (EMEA). QWP/2820/00;EMEA/CVMP/815/00. pean Herbal Practitioners Association's Note for Guidance on the Quali ty of 3. T he European Parliament an d the Coun- Newsletter. June 2005;2. Available at: Herbal Medicinal Products. London, cil of the European Union. Directive http://www. users.globalner.co. ukl -ehpa/ UK: EMEA. July 26, 200l;CPMP/ 200 1/82/EC of the European Parliament Frankincense%20Jun e05 . pdf. QWP/2819/00; EMEA/CVMP/814/00. and of the Council of 6 November 200 I 10. DH News Service Delhi. EU asked 20. Written response from MHRA to the on the Community code relating to veter- to resolve Ayurvedic products import Herbal Forum (page 2), January 27, inary medicinal products. Official j ournal issue. Deccan Herald. August 25, 2005. 2005. ofthe European Communities. November Available at: http://www.deccanher- 21. European Medicines Agency (EMEA). 28, 2001; 1-66. Available at: http:// ald.com/deccanherald/aug252005/ Note for Guidance on Stability Test- europa.eu.int/eur-lex/ pri/ en/ oj/dat/200 1I national1428182005824.asp. ing: Stability Testing of Existing Active 1_3 1111_3 1120011128en00010066.pdf. 11. European Medicines Agency (EMEA). Substances and Related Finished Prod- 4. T he European Parliament and the Note for Guidance on Stability Testing: ucts. London, UK: EMEA Commit- Council of rhe European Union. Direc- Stability Test of New Drug Substances tee for Proprietary Medicinal Products rive 200 l/83/EC of the European and Products (Rev 2). Lo ndon, UK: (CPMP). December 17, 2003;CPMP/ Parliament and of the Counci l of 6 EMEA. February 20, 2003;CPMP/ QWPI122/02. Available at: http://www. November 2001 on the Community ICH/2736/99. Available at: http://www. emea.eu.int/pdfs/human/ qwp/0 12202en. code relating to medicinal products emea.eu.inr/pdfs/human/ich/273699en. pdf. for human use. Official journal of the pdf. 22. Commission of the European Commu- European Communities. November 28, 12. European Medicines Agency (EMEA). nities. Amended proposal for a Direc- 200 I ;67 -128. Available ar: http:// europa. Guideline on Stability Testing of New rive of the European Parliament and eu.int/eur-lex/pri /en/oj/dar/200 I 11_31!1 Veterinary Drug Substances and Medici- of the Council amending the Directive 1_3 11 200111 28en00670128.pdf. nal Products. London, UK: EMEA. May 200 I /83/EC as regards traditional herbal 5. T he European Parliament and the Coun- 25, 2000;CVMP/VICH/899/99. Avail- medicinal products. Brussels, Belgi um: cil of the European Union. Directive able at: http:/ /www.emea.eu.int/pdfs/vet/ Commission of the European Commu- 2004/24/EC of the European Parliament vich/089999en.pdf. nities. January 17, 2002;COM(2002) and of rhe Council of 31 March 2004 13. European Medicines Agency (EMEA). I final. Available at: http://www.use rs. amending, as regards traditional herbal Note for Guidance on Stabili ty Test- globalner.co. ukJ -ehpa/Commission%20 medicinal products, Directive 200 1/83/ ing: Stability Testing of Existing Active proposedo/o20Direcriveo/o20Jano/o20200 I. EC on rhe Community code relating to Substances and Related Finished Prod- pdf. medicinal products for human use. Offi- ucts. London, UK: EMEA Commit- 23. Brinckmann ] . MHRA Publishes Guid- cia! journal of the European Union. Ap ril tee for Proprietary Medicinal Products ance on Acceptable Sources of Evidence 30, 2004. Available at: http:// europa. (CPMP). December 17, 2003;CPMP/ for Traditional Use Under the Future EU eu.int/eur-lex/pri/en/ oj/ dat/200411_ 136/ QWP/122/02. Available at: http://www. Directive on Traditional Herbal Medicinal 1_1 3620040430en00850090.pdf. emea.eu.int/pdfs/human/ qwp/0 12202en. Products. Herba!Gram. 2004;64:54-55. 6. European Medicines Agency (EMEA).

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Integrated Herbal Supplement Users: Their Pathways to Usage by Maryellen Molyneaux

ore consumers are taking a proactive approach to their health by making healthier lifes tyle choices and adding preventive measures such as using vitamins/minerals/herbal supplements. Many factors are instrumental in motivating consumers to M purchase vitamins/minerals/herbal supplements, and it is crucial to understand the dynamics behind the beliefs, behav­ iors, concerns and barriers that are driving the marketplace.

Usage ofVitamins/M inerals/ Herbal sending and are overcoming any precon­ tions consumers report suffe ring fro m Supplem en ts: An O verview ceived barriers to usage. T hat doesn't mea n most frequently is empowering consu m­ According to recent consumer stud­ that concerns don't exist. T he supplement ers to take control of their health, which ies conducted by T he Natural Marketing industry needs to be aware of the unique provides a growth category for the supple­ Insti tute (NM I), the usage of vitamins concerns of consumers, including the ment industry. growing concern of potential interactions and minerals has re mained fa irly stable Integrated Herbal Supplem ent Users: over the past 6 years. However, after between supplements and conventional prescription drug products, dissatisfaction Beliefs, En try D rivers, and Barriers sli ght declines in 2002 and 2003, the to Usage use of herbal supplements appears to be with the quantity of pills taken (consum­ on an upswing with just over half (5 1o/o) ers may need to take multiple supplements N MI defines Integrated H erbal Supple­ of the 2,000 general population/primary to address all their requirements), difficul­ ment Users as consumers who use herbal grocery shoppers surveyed indicating use ties swallowing pills or capsules, as well as supplements once a day or more. O f the (up from a high of 42% in 1999). Condi­ a conflict over government certi fication entire vitamins/minerals/herbal supple­ tion-specific supplements are also on the and clinical claims (which will be covered ment (VMH S) consumer category, this ri se and represent an increase in usage of in more detail below). group is the most knowledgeable about 11 9% from 1999. T his dynamic increase in the usage of the supplements they are using and are Bel ievability in the effective ness of condition-s pecific supplements is likely more likely to state cross-category usage herbal supplements is growing fas ter than due to consumers' switching from indi­ of vitamins, minerals, herbal and condi­ that of vitamins and minerals. From 2003 vidual vitamins and minerals to treat and tion-specific supplements. Given this high to 2005 there was a compound annual prevent health iss ues to the variety and cross-category usage, it is not surprising growth of +14% for prevention and +1 6% specific nutrients that ca n be conve niently that Integrated Herbal Supplement users for treatment within the general popu­ obtained in one combination formula. spend more per month than any other lation/primary grocery shoppers. T hese It is also indicative of consumers' desire consumer segment on VMHS and dietary gai ns would seem to va lidate the percep­ to take a proactive stance in the preven­ supplements and are highly brand loyal. tion that certain segments of consumers tion and sel f- treatment of specific medical C onsumers initiate usage of supple­ understand the messages that members of conditions. T he development of supple­ ments for a myriad of reasons, includ­ the herbal supplement industry have been ment formulas targe ted towards condi- ing prevention of specific health iss ues, performance/energy issues, and for trea t­

Fi gure 1. Percentage of General Population/ Primary Grocery Shoppers who, when thinking about Vita­ ment of specific health issues. T he initial min-Mineral-Herbal Supplements and other nutritional supplements, completely/ somew hat agree w ith use of herba l supplements fo r preven­ the following statements: tion has shown stability over the past 5 years despite the inability to adequately -+- I prefer to buy supplements with proven clini ca l effectiveness measure their effectiveness as a preventa­ --- Proven clinica l resea rch has considerable impact on the believability of a supplement hea lth cla im tive. However, the use of herbal supple­ ments for both treatment and perfor­ 80% mance/energy is declining. With regard to energy, the disappointing res ults from products touted as energy enhancers, such 79% • •• -··········· • 69% as gingko (Ginkgo biloba L. , Ginkgoaceae) • • -·· 68% • and Asian ginseng (Panax ginseng C.A . • • Meyer, Araliaceae), may have led consum­ • • I ...... • ers to turn to alternative pro ducts such .. as energy drinks and bars which appear 62% .... 61 % -· -...... to provide more tangible res ul ts. The ...... --- 58·-%-- • •• declining usage of herbal supplements for • 54% •• ••• performance/energy and treatment iss ues may also be attributed to increased use 2000 2001 2002 2003 2004 2005 of condition-specific formulas to targe t those needs. Source: The NMI Health & Well ness Trends Database © The Natural Marketi ng Institute, 2006

68 I Herba iGram 70 2006 www.herbalgram.org ------l\_r Market Report Jl'------

The Impact of Government advantage of patent protection will have stand the pathways necessary to reach this Regulation/Certification and Clinical insulation in the marketplace. marker. Knowing what consumers want Research and which messages wou ld be most rele­ Health-Related Claims and vant is crucial in succeed in g in a marker­ As more and more consumers rake Condition-Specific Supplements control of their health and turn to supple­ place crowded with look-a-like products ments, they are still looking for authorita­ Nearly three-quarters (73%) of Inte­ and claims. Such due diligence by manu­ tive verification and guidance from both grated Herbal Supplement users indicate facturers can lead to a new generation of the government and from clinical claims that they prefer to purchase VMHS that successful VHMS products and enhance to validate their decisions. have a specific health-related claim as the image of herbal supplements overall. Over the past 5 years, consumers' faith compared to slightly more than half (5 1%) The data sources in this article are from in the value of certification has declined, of the general population/primary grocery NMI's Health & Wellness Trends Data­ and they are no longer as desirous of shoppers. As educated consumers, they baseT" , an annual research study of 2,000+ government regulations. These findings are more selective about the attributes of US general population consumers. The are most likely due to the numerous corpo­ the products they choose. They are look­ HWTD contains 7 years of trends and rate scandals and government failings that ing for manufacturers to provide prod­ is based on a nationally projectable study have plagued industry over the past few ucts with an inherent va lue that they are with a margin of error of +1- 2%. HG years. From 2001 to 2003, consumers' willing to "guarantee" via labeling with a desire for increased government regula­ specific health claim. Maryellen Molyneaux is President! tion of supplements declined 18 %, from As such, Integrated Herbal Supplement Managing Partner at The Natural Market­ 58% to 48%. Users are very high users of condition­ ing Institute. Her range of experience Over the past 2 years, however, consumer specific supplements with 82% indicating includes retail and corporate management, confidence in government regulation usage of specific-condition supplements new business development, consumer pack­ and certification appears to have leveled during the past year (as compared to only aged goods marketing, market research off. Half of all consumers are amenable 48.6% of the general population/primary management, and international consult­ to increased regulation and believe in grocery shoppers). ing. Ms. Molyneaux is a frequent speaker the value of a good manufacturing seal. Companies looking to attract and retain Figure 2. Percentage of Integrated Herbal Supplement Users who have used condition specific supple­ supplement users need to actively pursue ments in the past year and types used measures to raise consumer confidence in Used Condition-Specific Supplements in Past Year 82% their products and corroborate consumers' choices and build loyalty back among an Acne . 4% Arthritis 29% apprehensive group of consumers. Blood sugar 13% As shown in Figure 1, 4 out of 5 (80%) Cholesterol 30% Diabetes - 9% consumers in 2000 preferred to purchase Digestion 23% supplements that were clinically proven Energy 25% to be effective. That number dropped to Heart health 39% Immune support 36% 68% in 2005. Four our of 5 consumers Joint health 40% also agreed in 2000 that proven clinical Menopause 26% Osteoporosis 32% research had a considerable impact on PMS - 5% the believability of a supplement's hea lth Prostate Issues 43% claim. Only 64% of consumers agreed to Sleeplessness 23% Vision 15% that statement in 2005. While consumer confidence appears to be rebounding since 2003, the supple­ Source: The NMI Health & Well ness Trends Database© The Natural Marketing Institute, 2006 ment industry needs to be more aggressive in breaking down the barriers that would impede consumer usage. As the industry As shown in Figure 2, the top condi­ at industry events and has published several approaches a consumer that is familiar tion-specific supplements used by this written reports and articles. More informa­ with over-the-counter drug-type claims, group include supplements for prostate tion on this subject can be found in NMI's supplement manufacturers should strive issues, joint health, heart health, immune 2006 Health & Wellness Trends Report, to provide their own clinical research to support, and osteoporosis. 2005 Dietary Supplement Consumer Insight back up the claims that they are making In summary, Integrated Herbal Supple­ Report and 2005 Condition-Specific Supple­ and to further differentiate their prod­ ment Users are an opportunistic target for ment Report. The NMI Web site is www. ucts. Indeed, consumers are interested manufacturers and retailers in the supple­ NMisolutions.com. in clinical research; in fact, two-thirds ment marketplace. In addition to provid­ desire it and qualitative research also indi­ ing the clinical research to back adver­ cates high interest in the specifics of the tising/marketing claims, manufacturers research methodologies. Any manufac­ must also be willing to invest time and turer that can prove its claims and take money in consumer research to under- www.herbalgram.org 2006 HerbaiGram 70 I 69 ------~l · Book Reviews ]~------

atural Standard Herb dr Supplement in alternative medicine for the past 20 scale to be somewhat arbitrary in some N Handbook: The Clinical Bottom years, I was immediately drawn to the places and have concerns that it may deter Line by Ethan M. Basch, MD, MPhil, primary textbook. Each monograph is a clinician from trying a potentially useful and Catherine E. Ulbricht, PharmD, eds. prepared based on an electronic search therapy in some instances. St. Louis, MO: Elsevier Mosby; 2005. 963 of 10 databases, including AMED, The breadth and depth of informa­ pages. ISBN 0-323-02993-0. $39.95 CANCERLIT, CINAHL, CISCOM, the tion included in each monograph is very atural Standard Herb dr Supple­ Cochrane Library, EMBASE, HerbMed, impressive. Following a section entitled N ment Reference: Evidence-Based International Pharmaceutical Abstracts, "Clinical Bottom Line" that includes the Clinical Reviews by Catherine E. Medline, and NAPRALERT. Researchers grading scale, each monograph exhaus­ Ulbricht, PharmD, and Ethan M . Basch, in the CAM field were also consulted for tively covers dosing/toxicology, adverse MD, MPhil, eds. St. Louis, MO: Elsevier access to additional references or ongo­ effects/precautions/ contraindications, Mosby; 2005. 1012 pages. ISBN 0-323- ing literature. Interestingly, no mention is mechanism of action, history, and review 02994-9. $129.00 made of any inter­ of the clinical evidence. Each monograph Created in 1999, the Natural Standard action with herbal! ends with a section entitled "Formulary: Research Collaboration is an international phytomedicine or Brands Used in Clinical Trials" that lists effort aimed at becoming a source of scien­ nutritional supple­ the names (when available) of commercial tifically based information on complemen­ ment manufac­ brands that have been used in statistically tary and alternative medicine (CAM). The turers. Following significant clinical trials-both European organization maintains an online database selection of refer­ brands and their US equivalents. I was of evidence-based CAM reviews, includ- ences, data analy­ surprised to discover that this last section ing coverage of herbs, nutri­ sis is performed by is omitted from the The Clinical Bottom tional supplements, treat­ healrhcare profes­ Line companion textbook. Both books ment modalities, continu­ sionals conducting also have Conditions Tables at the end ing education, and condi­ clinical work and that list specific conditions (as well as tions-based cross-referenc­ research at academic centers using related conditions) and list herbal or nutri­ ing. Perhaps most impres­ standardized methods for defining tional treatments by grade using the grad­ sive is the input of over 300 the validated measures of study qual­ ing scale mentioned above. Prior to this contributors from various ity. Following creation of each mono- is another section listing potential inter­ fields including conven­ graph, blinded review of each mono­ actions based on mechanism of action(s) tional medicine, pharmacy, graph is conducted by a multidis­ including cytochrome P450 isoenzyme(s) osteopathic medicine, ciplinary research-clinical faculty at induction or inhibition. chiropractic, naturopathic major academic centers with expertise For persons such as myself who love medicine, Ayurvedic medi- in epidemiology and biostatistics phar- as much detail as possible, I highly cine, and traditional Chinese medicine. macology, toxicology, CAM research, and recommend the Natural Standard Herb The Natural Standard Herb dr Supple­ clinical practice. In cases of the predict­ dr Supplement Reference: Evidence-Based ment Reference: Evidence-Based Clinical able editorial disagreement, members of Clinical Reviews as an excellent reference Reviews is designed to be a comprehensive the editorial board were convened in an for your library. I was most impressed systematic review of selected herbs and attempt to reach a decision, either with or with the detail shown in the adverse facts/ nutritional supplements. According to the without the help of outside experts. precautions/contradictions as well as the introduction, the textbook is designed for Perhaps the most difficult and poten­ interactions section. While it is important use by clinicians and researchers. With the tially controversial part of each monograph to keep many of these listings in perspec­ dizzying array of choices available for a is an "evidence-based validated grading tive, the comprehensive review of the liter­ first-time text of this sort, the editors have scale" that is used to evaluate the level of ature in these areas is extremely impres­ based their choice of herbs and nutritional evidence for an herb or nutritional supple­ sive. The interactions section also includes supplements "on utilization data, sales ment for treating a specific disease/condi­ potential interactions with other supple­ trends, frequency of information requests tion. The level of evidence grade ranges ments as well as foods. A safety summary by institutional/individual users of the from "/\' (strong scientific evidence) to is offered in the Clinical Bottom Line Natural Standard database, and safety "F" (strong negative scientific evidence). section of each monograph. The review of concerns." The Natural Standard Herb According to the authors, the objective evidence section requires a bit of reading dr Supplement Handbook: The Clinical criteria are derived from validated instru­ and the tables listing the studies for herbal Bottom Line is a smaller, soft-bound book ments from evaluating studies, includ­ medicines pales in comparison to the ABC designed to serve as a companion text that ing the 5-point scale used in some recent Clinical Guide to Herbs and The Handbook gives the busy clinician more abbreviated meta-analysis of common herbs. 1 Some of Clinically Tested Herbal Remedies. versions of the content of the larger text­ examples from the book include: an "/\' While herbs dominate the monograph book. Apparently, the information in this for saw palmetto for benign prostatic entries in the first editions of both books, "bottom line" reference can be accessed hyperplasia; a "B" for valerian for insom­ there are monographs on nutritional on-line as well. nia; and a "C" for ginger for motion sick­ supplements such as coenzyme QlO, Being someone who has been in the ness/seasickness. Being more of a pass/fail niacin, and fish oil. Controversial supple­ thick of the "evidence-based" movement kind of a guy, I found the A to F grading ments such as creatine, DHEA, the now-

70 I HerbaiGram 70 2006 www.herbalgram.org ------~l Book Reviews J~------discredited and unavailable PC-SPES•, Reference are approved by the Food and Drug and shark cartilage are also included. I I . Jahad AR, Moore RA, Carroll D, ec Administration as authorized by the was disappointed in the monograph enti­ al . Assessing the quality of reports of Nutrition Labeling and Education Act tled "Acidophilus (Lactobacillus)." With randomized clinical trials: is blinding of 1990 (NLEA). What the authors are the explosion of research on probiotics necessary? Controlled Clinical Trials. obviously referring w are "statements of over the past decade and the use of propri­ 1996; 17(1): 1- 12. nutritional support" and so-called "struc­ etary strains that have been researched, a ture/function" claims as authorized by the 3-page monograph feels like an oversight omplementary and Integrative Ther­ Dietary Supplement Health and Educa­ compared to the detail shown in many of Capies for Cardiovascular Disease tion Act of 1994 (OSHEA), which do the herbal monographs as well as the fish by William H . Frishman, Michael I. not require FDA pre-approval but which oil and coenzyme Q10 monographs. Hope­ Weintraub, and Marc S. Micozzi. Sr. Louis, marketers and manufacturers of "dietary fully, future editions will either MO: Mosby Elsevier; 2005. supplemenrs"-not "nutritional prod­ dedicate a longer section to 456 pp. ISBN 0323030025. ucts"-must notify FDA within 30 days probiotics or break this section $51.95. after such products are initially intro­ into individual strains that This is a fairly well-refer­ duced into the marker. Unfortunately, have sufficient research and enced book on the impact of such misnomers and confusion are rela­ safety information to warrant various alternative and inte­ tively commonplace when physicians their own monograph. grative therapies on cardiovas­ and other conventionally trained health So, here's my bottom line. cular disease. The book has professionals attempt to write about regu­ I think the primary text­ 27 chapters, 9 of which were latory issues about which they are often book, Natural Standard co-authored by Dr. Frishman inadequately knowledgeable.] Unfortu­ Herb & Supplement Refer­ and one of which was co­ nately, some companies producing dietary ence: Evidence-Based Clinical authored by Or. Weintraub. supplement products have come under Reviews, is a must for any medical library The 27 chapters are divided attack from the FDA, or even worse, the and for those researchers or practitio­ into 6 parts. Part I covers The Placebo Federal Trade Commission, presumably ners interested in ex haustive reviews of Effect in Cardiovascular Diseases and because of governmental concerns about the clinical safety and efficacy of herbal Legal Issues (Chapters I and 2), both well the way some manufacturers of dietary and nutritional supplements. It stands written and important chapters, especially supplements are using structure/function shoulder-to-shoulder with other impor­ for alternative/integrative health practi­ claims of potentially dubious substantial­ tant clinical herbal references such as the tioners. ity on dietary supplement product labels. ABC Clinical Guide to Herbs, The Hand­ Part II covers nutritional and herbal The presumed rationale of the FDA and book of Clinically Tested Herbal Remedies, therapies (Chapters 3 and 4), both FTC is that such labels tend to confuse or and the ESCOP monographs. While subjects being well treated. Some of my deceive the na·ive American public; unfor­ some practitioners may find the compan­ own favorite herbs were discussed, includ­ tunately, current label restrictions make ion guide useful, I think many who are ing hawthorn leaf and flower extract it more difficult for the general public to looking for a real quick reference will (Crataegus spp., Rosaceae) for angina and know which herb or dietary supplement find it a bit cumbersome. congestive heart failure (CHF), garlic might be reasonable to try for a particular References such as the Natural Standard (Allium sativum, Alliaceae) for atheroscle­ health condition. Herb & Supplement Reference: Evidence­ rosis and moderate cholesterol problems, On page 72 under adverse reactions of Based Clinical Reviews are critical to not Ligusticum wallichii (Apiaceae) for high L-arginine, it should have been noted that only the understanding of the safety and blood pressure, tienchi or sanchi ginseng outbreaks of previously indolent oral or efficacy of herbal and nutritional supple­ (Panax notoginseng, Araliaceae) for angina, genital herpes can be caused by L-arginine ments but also to the expanded use of ginkgo (Ginkgo biloba, Ginkgoaceae) stan­ unless simultaneously supplemented with these therapies by healthcare professionals dardized extract for cerebral and periph­ a comparable amount of L-lysine. in the United States. Some of the herbal eral arterial disease, and horse chestnut Part III of the book (Chapters 5-8) and nutritional supplements covered in seed extract (Aesculus hippocastanum, covers different Mind-Body Approaches this book are best used based on sound Hippocastanaceae) and butcher's broom and overall is quite good, the weakest medical diagnosis and knowledge of other (Ruscus aculeatus, Liliaceae) for chronic chapter being Chapter 6 on Hypnosis. medications that a patient may be taking. venous disease, as well as many others. Parr IV of the book (Chapters 9-14) covers It's my hope that books like this are the On page 58 the authors state that various "Alternative Medicine Practices" first step toward a true CAM textbook "health claims can be made on the label" and most of these chapters are excellent. that covers the best of both worlds­ of nutritional products "if they are accom­ The chapter on Native American Healing conventional pharmaceutical and herbal! panied with a disclaimer saying that the is quite interesting but does not reference phytomedicine/nutritional supplements­ product is not intended to diagnose, treat, any scientific peer-reviewed literature to to offer patients a greater spectrum of cure or prevent any disease." [Editor's support its use; that is, if such literature choices in treating disease and maintain­ Note: Actually, the authors are mistaken: exists. (This reviewer has not searched the ing wellness. HG "Health claims" are risk reduction claims peer-reviewed literature for the effects of -Donald J. Brown, ND that are allowed for conventional foods Native American healing on cardiovascu­ and dietary supplements only after they lar diseases.) www.herbalgram.org 2006 HerbaiGram 70 I 71 ------~l Book Reviews J~------

Overall Part Von "Specific Approaches" T his book is an excell enr so urce of 21st cenrury and the challenges of reach­ (Chapters 15-26) is also quite good. Even information for any college student who ing biomedica l sciences. Dr. H anso n, a though Chapter 20 on "Refl exology" is has a strong inreres r in rhe scientific professor of chemistry at DePauw Unive r­ ve ry prac ti cal and likely useful for health knowledge required to understand rhe sity in Greencastle, Indiana, inrro­ practitioners as well as rhe lay public, it is effects of herbs, as well as for those who duces basic chemical and pharmacologi­ nor wel l referenced from rhe peer-reviewed are not so attracted to lea rning chemis­ cal concepts clea rly and seamlessly, so scienti fic literature; rhar is, if such litera­ try from traditional so urces . lr is also an rhar students ca n learn about chemical ture exists. T his reviewer has nor sea rched exceptional fo undati on for lay people who bonds, secondary metabolism in plants, rhe li terature on this bur has seen benefit want to expand their herbal chem is try and neuropharmacology, and DNA replica­ from refl exology in his own patients with pharmacology knowledge beyond what tion, all from just one source. I have nor hypertension, hea rt disease, and many they find in other magazines and publi­ been in Dr. H anson's classro om, bur I am other chronic health conditions. cations. pretty sure his students don't think these Chapter 25 on "Magnetic Bios rimula­ H aving taught physiology and phar­ topics are boring. rion" lacks sufficient discussion about rhe macology in several unive rsities, I have T he book includes, among other things, diffe rence between north pole magnetic personally witnessed many first-year rhe symbolism of chemical structures, rhe therapy and south pole magnetic therapy, undergraduate students who ro ok an intro­ origins of bonding and molecular proper­ and the risks ass ociated wirh their use. ductory course in chemistry or biology ties, and a structural lexicon of medici­ Parr V of the book would have been and then changed their academic goals nally important chemical families fo und an appro priate section to include chap­ to non-science. Perhaps these students in plants. It reviews the chemica l behavior ters on the effects of color therapy, focal would have chosen organic chemistry or of medici nal molecules (often extracted infrared li ght . therapy, pulsed magnetic pharmacology in their ca reer paths if they and purified as drugs), as well their appli­ therapies, micro-current and other electro­ had found a compass ionate mentor, bur ca ti ons. T he las t two chapters are my magnetic therapies, dental therapies (root instead they opted to discard the favo rites-and yes, I am show­ ca nals, osriris cavitations and heavy metal hard sciences from their curricu­ ing a personal bias as a pharma­ tox icity) , neural therapy, enhanced ex ter­ lum altoge ther. cologist. Dr. H anson explores nal counterpulsa ti on therapy, and vari ous For us botanica l scienrisrs the pharmacologica l acti on of detoxification therapies other than sa una. at heart, who religiously read plant molecules by touching on Parr VI has just one chapter, "Integra­ HerbalGram, we lea rned chem­ drug delivery and action, intro­ rive Medicine in Cardiorhorac ic Surge ry," istry and biology ea rly in li fe. If ducing the concept of receptors which is wel l written. we did nor like a bas ic chemis­ and molecular targets, as well Overall this book is very useful, espe­ try or biology to pic, we would as providing a clea r explanation cially for alrernarive/integrarive health still swallow it as a bad prescrip­ about levels of acti on. A very practitioners, all of whom should read rhe tion. We thought many of these fascinating group of case stud­ first two chapters very carefully. Hope­ concepts were absolutely neces­ ies of selected planr drugs is fully this book will spur such practitioners sary to understand rhe more included, which I expect to be into becoming involved in more clinical complex and fascinating topics such as particularly appealing to students. research projects in their practices so rhar NMRspectroscopy, secondary metabolism T he las t section addresses an all-time rhe alternative therapeutic tools which in plants, toxicology, pharmacokinetics, favorite-the traditional South Ameri ­ rhey have seen working well anecdotally and drug metabolism. If we were bored can ritual concoction ayahuasca and irs ca n be va lidated in the peer-reviewed liter­ by the way they were presented, we ro ok effects on the central nervous system. It ature and bro ught into mainstrea m medi­ a deep breath and rhoughr: "''m sure touches on rhe complex chemistry and cine fo r the benefit of more people suffe r­ this will expand my knowledge and hori­ effects of B-carb oline alkaloids, harmine, ing from cardiovascular disease. HG zons." We made ourselves believe that rhe harmaline, and rerrahydroharmine, as -William Lee Cowden, MD, FACC concepts were empoweri ng tools to explore well as the structural similarity of key more complex and intricate subjects as we ayahuasca molecules with lysergic acid nderstanding M edicinal Plants: advanced into higher level classes. (LSD) and serotonin. It also deals with the U Their Chemistry and Therapeutic However, let's face it. Fo r the bulk of complexity of serotonin recepto rs and how Action by Brya n H anson. New York, N Y: college students, accustomed to quick va rious compounds in this complex plant T he Haworth Herbal Press; 2005. 307 pp. visual streams of informati on and nor as mixture create rhe "therapeutic" effect, ISBN: 978-0-7890-1552-5. $44.95. interes ted in science textbooks as many of which is still far from being completely Are yo u passionate about lea rning rhe us, diges ting these basic concepts ca n be understood. bas ic chemistry and pharmacology of a source of frustration. Perhaps we have In an unass uming tone, rhe book also medicinal plants? Were you frustra ted by been taught to believe the hard sciences ex plains the co mplex chemistry of ginkgo yo ur college professor and then turned are just for a privileged group of geeks or (Ginkgo biloba, G inkgoaceae) ex tract and off fo r the res t of your li fe when dealing those brave enough to pile stacks of infor­ irs antioxidant and pharmacological effects with chemistry and biomedical topics? mation in their brain. on cerebral circulation, poss ibly conrrib­ If you say yes to one of these ques tions, Fortunately, we now have an excel­ uri ng to rhe medicinal effects. Ir also then Understanding M edicinal Plants is rhe lent book and a great reacher who under­ describes a number of cancer treatments book fo r yo u. stands college classroom realities in the from plants and natural sources, including

72 I HerbaiGram 70 2006 www.herbalgram.org ------.....o~L~ook Reviews J~------an ex planation of cell cycle and DNA repli­ omplex Herbs-Complete Medicines: where in rhar milieu ir became apparent cation. T hus we learn about the effects of CA Merger of Eclectic & Naturopathic to me rhar isolated chemica ls used to treat colchi cine from autumn crocus (Co lchicum Visions of Botanical Medicine. Francis symptoms did nor really address illness in autumnale, Liliaceae), pacliraxel from Brinker, N.D. Sa ndy, OR: Eclectic Medi­ a way that was effective and safe. Plants the Pacific yew tree (Taxus brevifolia, cal Publicati ons; 2004. 428 pp, paper­ in all their complex ity seemed to be better Taxaceae), vinca alkaloids from the Mada­ back. ISBN 1-888483-12-1. $24.95. suited for dealing with the complex ity of gascar periwinkle ( Catharanthus roseus, So many years ago that it feels like the human body, helping to restore the Apocynaceae), and camptothecin from rhe another lifetime, I rook courses in balance known as health. Chinese happy tree (Camp to theca pharmacology and It was through rhe disciplines of acuminata, Nyssaceae). fll.ANCIS llJNK.Il. N.D. pharmacognosy while pharmacognosy and pharmacology rhar I Any undergraduate student can CoMPLEX HERBs­ attending the Unive rsity found my calling to herbs. T hese sciences greatly benefit from this book. CoMPLETE MEorCINES of Wisconsin pharmacy take the complexity of plants and reduce Not just the biology, chemistry, sc hool. My class, which them to isolated chemicals. Ahh! - reduc­ and pre-med or pre-pharmacy graduated in 1972, was tionism! My instincts brought me full majors, bur also the students study­ the las t of an era, as the circle back to the benefits of the whole ing general education, anthropol­ pharmacognosy require­ plant complex. ogy, or psychology. Professional ment was dropped for Now Fra ncis Brinker, a formall y trained students already enrolled in phar­ the incoming first year naturopathic physician who focuses on macy and medicine programs will class. herbal research, has written a book that also find inva luable details on the I was fascinated by nearly establishes a scientifica lly unsci­ chemistry and pharmacology of the idea that drugs entific reconstruction of the value of medicinal plants, which can se rve could be derived from "Complex Herbs-Complete Medicines" as an important source of reference In plants. T he science of pharmacognosy (which happens to be the title of the their careers. looked ar rhe natural origins of drugs. book). I don't mean ro imply that this I encourage any university program T he science of pharmacology looked at treatise is unscie ntific. Rather, I believe interes ted in attracting culturally diverse how those isolated constituents we called that Dr. Brinker has made the science students to acquire the book. It is a useful drugs interacted with the body. Some- of plant medicines understandable for reference for learning basic topics in chem­ is try and phys iology, and it would be an asset ro any college library that wants to offer more cultural and historical context about the science of medici nal plants. An example of how the author engages people to lea rn is demonstrated by the way he describes how ginkgo fossils have been Best Botanical Book of 2005 found that are 200 million years old and how this plant was rescued from becom­ he Essential Guide to Herbal Safety by Simon ing extinct by Buddhist monasteries in T Mills and Kerry Bone. 2005. Presents an extensive China. T his is followed by a brief discus­ discussion of principles of and current major issues sion of irs historical use in C hina and its in herbal medicine safety. Contains comprehensive more current use as a concentrated and reviews of the published safety data for 125 herbs. chemically standardized extract in Europe Covers issues of quality, interactions, adverse reactions, toxicity, allergy, and the United States, where it has been contact sensitivity and idiosyncratic reactions. Hardcover, 704 pp. B535. adapted to treat aging conditions and the $64.95 ABC Member Price 10% off: $58.46 ea rly stages of Alzheimer's disease. The historical and cultural references are an • Provides the most current information on safety issues in herbal excell ent way to motivate students to learn medicine. more about the chemistry and the phar­ • Presents authoritative and credible safety information macology, which are presented later using from two experienced herbal practitioners. a very readable format. Congratul ations ro the author in • Combines theoretical chapters with 125 well-researched accomplishing a powerful goal-bring­ monographs, making it the most thorough and ing a simple message to students and lay comprehensive text on the market for herbal safety in people. Chemistry and pharmacology of practice. medicinal plants really can be interesting and fun to learn! HG To order, call 1-800-373-7107 -Ezra Bejar, PhD or email to [email protected] Director of Technical Sciences Herbalife International, Inc. or order online at www.herbalgram.org www. herbalgram .o rg 2006 HerbaiGram 70 I 73 ------~l Book Reviews J~------anyone caring to learn. Many lively discus­ tiona! and modern, and their compara­ mum of laboratory standards. Brinker's sions these days pit science against nature tive benefits, drawbacks, and differences, use of a quote by Steven Demali, PhD, a as if they were exact opposites. Gratefully, which allow the reader to better under­ pharmacognosist and currently Vice-presi­ Dr. Brinker realizes that the nature of stand how the method of preparation can dent of Scientific and Technical Affairs at science is complex and that the frequently affect the outcome of treatment. He also the American Herbal Products Associa­ reductionist nature of scientists is not gives an excellent explanation of standard­ tion, is appropriate: "There is no biological natural. ization, its rationale, and its shortcomings. reason why a standardized extract would Most scientists and the vast majority of make a better herb. If it was necessary, the public at large don't understand herbal we wouldn't be using these herbs already. products. Brinker knows that "Botani­ This book is .. . It is foolish to think that one group of cals are now perceived more as drugs a step forward in explaining compounds will entirely account for an than foods, and many believe that they herb 's activity. Even inactive compounds should be manufactured and regulated as to herbalists and herbal play a role in an herb by affecting the such. The status of herbal products now is enthusiasts the differences distribution and absorption of the active comparable to Frankenstein being estab­ components. When you place an herb in a lished as the standard of what constitutes among different dosage different medium, you change its effects." a legitimate human." forms and the comparative Standardization is pharmacologic, not This book is a step forward in explain­ therapeutic. ing to herbalists and herbal enthusiasts values and shortcomings It's interesting to note Brinker's exten­ the differences among different dosage of the myriad of products sive use of the writings of the great eclectic forms and the comparative values and pharmacist John Uri Lloyd, who embod­ shortcomings of the myriad of products in the herbal marketplace ies the bridge between the reductionist in the herbal marketplace today. This in today. science of plant chemistry and the natu­ turn can help them to better educate the ral complexity of whole plant prepara­ health-seeking public in its quest for the tions. Lloyd believed that the best medi­ potion that will cure their ailments. Unfortunately, many health consumers cines-"specific medicines" as defined In Parr One of the book, Brinker assume that standardized potency also for the Eclectics by John Scudder-were discusses how to choose the most appro­ means standardized outcome. However, made from fresh, whole, medicinal plants priate herb product. He looks at issues since most herbal products are "stan­ and were prepared as liquid extracts to of complexity and synergy, as well as dardized" to chemical markers and not preserve "an energetic matrix, constantly considerations affecting quality of prod­ necessarily to herbal activity, all stan­ transforming itself according to the vital ucts. He also gives a good explanation of dardization achieves is a surety of batch­ demands of the cells and their functions." the many different dosage forms, rradi- to-batch conformity that meets a mini- This concept of "an energetic matrix,"

New Book Profiles Traditional Medicines for Modern antioxidants, and polyphenols. Medicinal Plants in Tropical Coun­ Times: Antidiabetic Plants. Amala Intoxication: The Universal Drive for tries: Traditional Use-Experience-Facts. Soumyanath, PhD, ed. Boca Raton, FL: Mind-Altering Substances. Ronald Markus S. Mueller, MD, and Ernst CRC Press, Taylor & Francis Group; K. Siegel, PhD. Rochester, VT: Park Mechler, PhD. Stuttgart, Germany: 2006. 314 pages, softcover, contents, Street Press; 2005. 372 pages, softcover, Georg Thieme Verlag; 2005. 176 pages, tables, b&w charts, drawings & photo­ contents, bibliography, index. $18.95. hardcover, contents, 28 illustrations, graphs, references, index. $139.95. ISBN ISBN 1-59477-069-7. 22 tables, references, index. $109.95. 0-415-33464-0. This book is a reprint of the 1989 ISBN 1-58890-253-6 (US), ISBN 3-13- Detailed scientific discussion of plants edition. Intriguing discussion about the 138341-0 (outside US). that may help treat and prevent diabetes desire for intoxication, not only in humans Primarily fact-filled monographs of and its complications. Includes an exten­ but throughout the animal kingdom. many plants used in traditional medi­ sive list of antidiabetic plants and their The author, a psychopharmacologist, cine in Mrica and other tropical coun­ actions, followed by a systematic analy­ describes the pursuit of intoxication as tries. Each monograph gives information sis of plants used globally in traditional the "fourth drive" after food, sleep, and on the part used, chemical constituents, medicine paradigms including Chinese, sex. Filled with fascinating stories of traditional uses, experimental and clinical Kampo (Japan), Native American, Afri­ animals and humans seeking out altered studies, cautions and unwanted effects, can, and Ayurvedic. Describes various states, the book attempts to explain the drug interactions, use, dosage, and a final models and methods of scientific study psychological and social forces behind evaluation. Includes a brief introduction used to evaluate antidiabetic activity. intoxication and addiction, with many on the widespread use of plants in tradi­ Also provides the antidiabetic actions of examples of intoxicating substances from tional medicine and the potential for inte­ plant compounds including saponins, plants. gration into Western practices.

74 I HerbaiGram 70 2006 www.herbalgram.org ------~l Book Reviews J~------or herbal energetics, is perhaps the area intended use, documented evidence, and inflammatory, toning an enlarged uterus, where natural arguments and scientific preferred form. This limited number of improving digestion, and relieving irrita­ arguments come closest to being one. herbs is used simply as an illustration of tion of mucous membranes, rhus making Brinker says it well in the section of rhe immense differences in applications it useful for asthma, colds, and bronchitis. the book entitled "Modern Roads to the for any single herb and how rhe percep­ (Note: None of these historical and empir­ Future": tions of irs use have changed, and in some ical uses have been confirmed by scientific The truism of the vis medicina cases remained the same, over rime." research.) naturae, the healing power of The nine herbs included are as follows: Dr. Brinker notes the relative lack of nature, is rhar right relationships are Classic Native American Herbs­ adverse effects such as erectile dysfunction hardwired into living systems in ways goldenseal (Hydrastis canadensis), in 1.1% (vs. 0.7% for placebo) and gastro­ and by means that we must appreciate Echinacea angustifolia, and cranberry intestinal effects in 1.3% of extract users and acknowledge even when we don't (Vaccinium macrocarpon); American Herbs (vs. 0.9% for placebo) in a 1996 review of understand the full mechanisms or Acclaimed Across rhe Atlantic-black 18 clinical trials. That is, the side effects implications. In spite of many scien­ cohosh (Actacea racemosa syn. Cimicifuga observed are comparable to those rhar tific advances, we still lack the means racemosa), Echinacea purpurea, and saw occurred in the placebo group. He also to adequately assess and effectively palmetto (Serenoa repens); and Immi­ notes a potential drug interaction: in hibi­ explain rhe inherent significance of grant Herbs Transplanted to America­ tion of binding of alpha-1-adrenoceprors many components residing in plants kava (Piper methysticum), Sr. John's wort by antagonists ramsulosin and prazosi n that impact health. Life, after all, is (Hypericum perforatum), and milk thistle (in rest tube studies done by Goepel and a mystery to be lived, not merely a (Silybum marianum). others in 1999) , which could theoretically problem to be solved. To achieve full Saw palmetto is an herb I rake myself reduce the effects of these and related health we must be guided by more for prostate health. Most of us are familiar drugs, bur for which no documented than limited scientific knowledge. with the liposterolic extract standardized evidence exists. Dr. Brinker does an admirable job to 70-95% free fatty acids and taken at a The book is easy to read and under­ of helping the reader understand this dose of 160 mg twice dai ly. Brinker gives stand, strivi ng nor to be roo pedantic. I mystery. us "the rest of the story." The whole fruit highly recommend it as a good teaching Parr Two of the book, "Changing has been the primary historical dosage tool for beginning herbalists and enthusi­ Perceptions and Preferences-Popular form and dosages in the range of 200 mg asts as well as a good refresher and resource Herbs in American Traditions," looks at to 4 grams of the whole fruit and up to 12 for veterans of the herbal world. HG nine herbs that are widely used in America. ml daily of various extracts. Ir was widely -David La Luzerne, RPh Brinker notes that "the nine herbs covered used for prostatitis and prostate enlarge­ Green Earth Natural Medicine here demonstrate the diversity of potential ment, but it had many other applications, Madison, WI choices for each herb depending on rhe including immune enhancement, anti- [email protected]

Opium Culture: The Art & Ritual of ISBN: 0-7434-8052-X (softcover), ISBN: areas of wastes and pollution, filter water, the Chinese Tradition. Peter Lee. Roch­ 0-7434-7402-3 (hardcover). control ants and other insect pests, and ester, VT: Park Street Press; 2006. 232 Explores the principles and design improve the environment overall. Offers pages, softcover, contents, 16 pages color of a healthy diet with brief descrip­ an array of colorful photographs that photos, b&w photos, appendix. $16.95. tions of several popular modern diets. help illustrate the ecological function ISBN 1-59477-075-1. Gives a history and culinary analysis and beauty of fungi. Offers exceptional insight into opium's of many specific foods from all of the Sacred Vine of Spirits: Ayahuasca. role in Chinese culture and history. food groups, including fruits, vegeta­ Ralph Metzner, ed. Rochester, VT: Park Discusses the global history, traditional bles, grains, legumes, herbs and spices, Street Press; 2006. 264 pages, softcover, uses, detailed pharmacology, and produc­ meats, and dairy. Concludes with "food contents, b&w photos, figures, refer­ tion of opium. Interesting discussion of prescriptions" for various diseases and ences. $16.95. ISBN 1-59477-053-0. the psychological and social implications conditions from acne to varicose veins. Familiarizes readers with Ayahuasca of the substance. Includes commentary Mycelium Running: How Mushrooms (Banisteriopsis caapi [Spruce ex Griseb.] from interviews with modern-day opium Can Help Save the World. Paul Stamets. Morton, Malphigiaceae), a vine used smokers as well as a description of the Berkeley, CA: Ten Speed Press; 2005. traditionally by Amazonian tribes to practices and rituals surrounding opium 339 pages, softcover, contents, color induce spiritual hallucinations and expe­ smoking. photos, glossary, bibliography, index. riences. Using history, chemistry, phar­ The Encyclopedia of Healing Foods. $35.00. ISBN: 1-58008-579-2. macology, and psychology, the book Michael Murray, NO, Joseph Pizzorno, Fascinating explanation of how attempts to fully explain the nature NO, and Lara Pizzorno, MA, LMT. mushrooms can help rescue and regu­ of this plant and its derivatives. Also New York: Atria Books; 2005. 895 pages, late the earth's ecosystems through included is a collection of essays and softcover and hardcover, contents, tables, "mycorestoration." Describes the science personal experiences with the mind­ references, appendices, index. $24.95. behind using fungal mycelium to rid altering hallucinogen. HG

www.herbalgram.org 2006 HerbaiGram 70 I 75 ------~l in Memoriam J~------

unique facility. Following its restoration, of 74. As a leader and member of multiple she would take great joy in visiting, often trade associations, an international consul­ sitting in one of the Conservatory's galler­ tant, and a dedicated industry spokesman, ies, watching the reactions of the visitors. Mr. Hanssen contributed greatly to the Her legacy can be found throughout the presence and credibility of the health food United States at many prominent institu­ sector and its products. tions, where she will continue to intro­ Throughout his career, Mr. Hanssen duce the wonder and beauty of nature to contributed to the creation and develop­ future generations" (written communica­ ment of several industry trade associa­ tion, December 2005). tions. He became founding chairman of Enid A. Haupt was born in 1906 to Sadie the Health Food Manufacturer's Asso­ and Moses L. Annenberg. Mr. Annenberg ciation in 1965, and he later served as Enid A. Haupt was a prominent publisher who founded its president. In 1975, he helped form 1906-2005 Triangle Publications, which included TV the European Federation of Associations Guide and various newspapers, as well of Health Product Manufacturers, again nid A. Haupt, a distinguished as television and radio stations. She was serving as president at one point, then life magazine publisher and editor, the fourth of the Annen bergs' 8 children, president. Further, Mr. Hanssen assisted Eskilled horticulturist, and renowned all of whom later participated in philan­ in the development of both the UK Coun­ philanthropist whose generosity benefited thropic activities. 1 cil for Responsible Nutrition and the UK numerous botanical programs and insti­ Mrs. Haupt's journalistic career began Vitamin Forum. In 1997, he encouraged tutions, died on October 25, 2005, at at The Philadelphia Inquirer, one of her widespread industry participation in the her home in Greenwich, CT. She was 99 father's newspapers. During World War II, inaugural meeting of the International years old.1 she wrote and broadcast for the Office of Alliance of Dietary/Food Supplement Mrs. Haupt's devotion to the impor­ War Information and in 1954 was named Associations (IADSA). tance of nature, beauty, and life led her to publisher of Seventeen, another family "Maurice was everything you could support horticultural institutions, muse­ holding. She served as the magazine's desire in a colleague on or off a commit­ ums, and hospitals. A major recipient of publisher and later as editor for 17 years. tee," said Michael Mcintyre, chairman of Mrs. Haupt's generosity was The New She also wrote 4 books for girls, offering the European Herbal Practitioners Associ­ York Botanical Garden. According to an advice on young living and etiquette. ation (e-mail, January 30, 2006). "He was obituary in the New York Times, Mrs. She was married to Ira Haupt, the warm-hearted with a wonderful sense of Haupt donated more than $34 million founder and senior partner in a Wall humor, infectious laugh and mischievous to the Botanical Garden over the years, Street security concern, from 1936 until twinkle in his eye. He was larger than helping to restore the landmark glass­ his death in 1963. She was similarly the life and filled the meeting rooms with his domed Victorian Conservatory, which was last of her siblings to survive. HG jovial presence." renamed the "Enid A. Haupt Conserva­ -Courtney Cavaliere Simon Penman, executive director of tory" in her honor. Reference IADSA, likewise remembered Hanssen The many gifts given by Mrs. Haupt 1. Nemy E. Enid A. Haupt, philanrhropist, for his light-hearted and friendly manner. during her lifetime included a $1 million dies at 99. New York Times. Ocrober 27, "I, of course, knew Maurice well and had piece of property to the American Horti­ 2005:A:29. worked with him on numerous initia­ cultural Society for use as its national tives over the past 18 years. What made headquarters. Other beneficiaries of Mrs. Maurice special was his exceptional abil­ Haupt's charitable donations include ity to connect with so many key people the Wildlife Conservation Society, the whether in business or in government. I Horticultural Society of New York, the never ceased to be amazed how Maurice National Wildflower Research Center in was able to go into a meeting with, for Austin, TX, and the National Gallery of example, an official vehemently opposed Art and Smithsonian Institution in Wash­ to supplementation, and come out of the ington, DC. room as friends. It was a special ability but Michael J. Balick, PhD, director and one which was based on Maurice's perma­ philecology curator of The New York nent curiosity and love of life" (e-mail, Botanical Garden Institute of Economic January 29, 2006). Botany and American Botanical Coun­ In addition to his consulting and cil Board of Trustee, noted that, "Mrs. Maurice Hanssen committee work, Mr. Hanssen was a Haupt was an important member of The celebrated author. His bestselling book E New York Botanical Garden family. She 1931- 2005 for Additives, published in 1986, alerted had the vision to rescue the great Conser­ consumers to the increasing and poten­ aurice Hanssen, a leading figure vatory from demolition in the mid-1970s tially dangerous inclusion into foods of of the European health and through her generous support for the reno­ synthetic chemicals. It further led food natural food industry, passed vation and ultimate endowment of this M companies and governments to reevalu- away on November 21, 2005, at the age

76 I HerbaiGram 70 2006 www.herbalgram.org In Memoriam

ate the future direction of food manufac­ an electrician, who helped build the World rice. She was one of the few clinicians turing. Trade Center. Instead of going to college, who actively combined botanica l medi­ "Even when he was struggling with his she attended nursing sc hool. By age 19 she cine and constitutional homeopathy, and health, he continued to attend meetings was a registered nurse working in inten­ wrote two articles about the rationale and and campaign tirelessly for the ri ghts of sive care and then psychi atric medicine in her successful experiences doing so in rhe the consumer to access healthy food, natu­ New York C ity. She attended the famous journal of Naturopathic Medicine. She was ral medicines and CAM [complementary Woodstock rock concert in 1969 and later co-recipient of the NF Formulas In-Office and alternative] treatments," Mcintyre moved to Bolinas, CA, in 1972, where she Research Award in 2000 for a study on said. "We all owe him a great debt of grati­ was known as Nancy Denmark. There the safety of bitters containing Artemisia tude. Now he is no longer in our meetings. she studied weaving and helped create a absinthium (wormwood). He will be greatly missed for his wisdom, macrame playground in 1974. In the late 1990s, Dr. H eron successfully se nse of fun, and ever generous encour­ Tending the ga rden for the weav ing championed the drive to start the Botani­ agement." collective, she eventually developed such cal Medicine Academy, recognized by the Mr. Hanssen is survived by his wife, an interes t and love for the pl ants that she American Association of Naturopathic son, and 5 grandchildren. HG incorporated them into her weaving prac­ Physicians as a specialty society in botani­ -Courtney Cavaliere tice by using and reaching natural dyes. cal medicine. The Academy has since In 1975 she traveled to Central America worked to develop continuing education Sources to connect with native weavers and began and credentialing for experts in botanical I. Health Food Manufacturer's Associa­ studying herbal medicine. By 1976 she was medicine, a lengthy and difficult process. tion. Maurice H anssen obituary. Health back in West Marin County, CA, practic­ In 2000, Dr. Heron was diagnosed with Matters. December 2005:25. ing as an herbalist and reaching classes on stage III ova ri an cancer. Within a year 2. Va n Doorn P. Industry mourns passing herbal medicine. She particularl y favored she was roo debilitated to keep practicing of pioneer Maurice H anssen. Functional Foods & Nutraceuticals. January 2006. giving herb wa lks so people could learn and she experienced fi nancial difficulties . Ava ilabl e at: http://www.ffnmag.com/ the local flora and use these plants as In 2001, the American Herbalists Guild ASP/articleDisplay.asp)strArticleld=872& foods and medicines. She was part of established the Herbalist Health Trust, a strSite=FFNSITE&Scree n=CURRENTIS California's herbal renaissance, studying fund in which tax-deductible contribu­ SUE. Accessed February 9, 2006. with the late herbalist William LeSassier tions can be specified for recipients in among other notable herbal teachers. need of medica l care-people who may Through her many travels she was not be eligible for insurance reimburse­ exposed to a wide range of herbs in ment. Dr. Heron was the first recipient numerous habitats and developed an ency­ and was the motivating fo rce behind the clopedic knowledge of hundreds of herbal Trusts' creati on. After five years of various medicines. Dr. Heron became involved treatments, she ultimately succumbed to a with the Native American Church, spend­ recurrence of the cancer. ing rime with Soloho, a Hopi bone setter, Dr. Heron's commitment to healing and working with the late, great, medi­ others was unequaled, and she was a cine woman Keewaydinoquay Pakawakuk friend of the truest kind. She was a strong Pesc hel on the island off Traverse City, woman, uncompromising, dogged, and MI. Her experiences with Soloho resulted persistent. My own love of herbs started in her name change: Silena is a Hopi word. when Si lena led an herb walk at the It means the female part, the stigma, of a University of Washington herb garden. squas h blossom when used by females; She seemed to know everything about Silena Heron when used by males, it means the male every herb, no matter how obscure. One part. of her last acts was to work on a book 1947-2005 By the early 1980s, Soloho told Dr. about formulating herbal medicines with ne of the stars of naturopathic Heron that she should use her gifts and me, which I intend to complete. Hope­ and herbal medicine died the bridge the worlds of traditional and scien­ fully, it will serve as a small reminder of 0 morning of October 15 , 2005. tific medicine, urging her to ge t further her wisdom about medicinal herbs. Dr. Silena Heron influenced a genera­ scientific training and to spread the knowl­ Dr. H eron is survived by her 19-yea r­ tion of herbalists and naturopathic physi­ edge of herbal medicine. She became old son Paige. Donations can be made to cians through her reaching, clinical work, a naturopathic physician, enrolling first the Conscious Alliance, attention: Justin medicine making, writing, and speak­ at the Pacific College of Naturopathic Levy 903 Summit St., Barrington, IL ing. She practiced as an herbalist and Medicine, and after this sc hool closed in 60010. HG then naturopathic phys ician for over 20 1983, transferring to what is now Bastyr -Eric Yarnell, NO, RH (AHG) years and was the first chair of botanical University. The author would like to thank Noel Berg­ medicine at Bastyr University and faculty Dr. H eron graduated from Bastyr in man-Benson, Sherry Hirsch, Jim Kravets member from 1985-1991. 1988 and by 1990 moved to Sedona, AZ. and the Point Reyes Light, Paul Bergman, Dr. Heron was born Nancy Feldman in There she wrote and lectured extensively and Roy Upton for providing some of the 1947 in Queens, New York. Her father was while maintaining a busy family prac- details in this tribute. www.herbalgram .org 2006 HerbaiGram 70 I 77 May 6-9 (exhibits May 7-9): Organic Trade May 24-27: North American Research 2006 Association (OTA) All Things Organic. Conference on Complementary and Inte­ Chicago, IL. Promoted as North America's grative Medicine. Edmonton, Canada. T hi s May 1-3: SupplySide East. Secaucus, NJ. on ly all organic conference and trade show, conference, sponsored by the Consortium This event features presentations on the latest this event features various speakers and exhi­ of Academic Health Centers for Integrative science and research for natural products bitions regarding natural products and ingre­ Medicine (CAH CIM), is intended to foste r and ingredients, information on marketing dients. Over 33,000 buyers are expected to the development of new collaborations and procedures and trends for new products, and attend the show. Phone: 412-774-7511. Web to strengthen ex isting partnerships. Areas opportunities for networking with industry sire: http://www.organicexpo.com/. of CAM research prese nted and discussed professionals. Phone: 480-990-1101. Web sire: May 13: The New England Unit of the Herb will include research in basic science, clini­ http: //www.supplysideshow.com/ east/. Society of America: 26th Annual Herb cal resea rch, methodological research, hea lth May 1-3: Nutrition and Health: State of Plant Sale. Welles ley, MA. More than 200 services research, and education research. For Science & Clinical Applications. New York, va rieties of cu linary, medicinal, and fragrant more information on the conference, contact NY. This conference will provide an overview herbs wi ll be ava il able, including unusual Robb Scholten at: robert_scholren@hms. and practical summary of the latest informa­ herbs donated from members' gardens. H erb harvard.edu. Web site: http://www.imconsor­ tion on nutrition and health. It brings together of the Year 2006 is Scented Geranium- many tium-conference2006.com/. leaders in scientific research in nutrition and va rieties will be available. Rain or Sh ine. Free June 3-5: Medicines from the Earth Herb health, clinicians skilled in nutritional medi­ Parking and Free Admission. Phone: 617-484- Symposium. Black Mountain, NC. Annual ci ne, expertS on food and agricultural policy, 4841. Web site: www.neuhsa.org. symposium on herbal medicine at Blue Ridge and innovative chefs. Phone: 212-305-3334. May 18: Texas and Global Ethnobotany: Assembly near Asheville, NC. Over 40 presen­ E-mail : [email protected]. Web site: http:// The Shape of Things to Come. Lady Bird tations wi ll be delivered by such excellent ColumbiaCME.org. Johnson Wildflower Center, Austin, TX. Join speakers as David Winston, Mark Blumenthal, May 3-4: The 1st IFOAM Conference Mark Blu menthal, Founder and Executive Richo Cech, James Duke, PhD, Doug Elliott, on Organic Wild Production. Bosnia and Director of the American Botanical Coun­ Cascade Anderson Geller, Bi ll Mitchell, ND, Herzegovin a. This conference will focus on cil , for a fascinating look at both Texas and Jill Stansbury, ND, Jonathan Treasure, Roy the harvesting of wi ld vegetable products from Global Ethnobotany. Mark, a world-fa mous Upton and Donald Yance. The symposium forest, "natural" lands, pastures, and uncul­ expert on herbs and herbal medicine, wi ll will feature a pre-conference intensive that tivated land in the agriculture landscape. It discuss plants in Texas and around the world; examines unique case-studies from the 30- wi ll concentrate on current production that both plants that are currently in the news and yea r career of Bill Mitchell, ND. The event enters the organic marker stream, bur will also ones that have potential economic uses for will also include panel discussions and 7 work­ extend to other concepts, such as fair trade, the future. As our world expands, we have shops. CE credits for hea lth profess ionals . sustainable fores t management certification access to plants that have been used in other Phone: 800-252-0688. Web sire: http://www. and Good Manufacturing Practices. Web site: cultures for hundreds, if not thousands of botanicalmedicine.org/. http://www. i foam.org/even rs/ifoam_con fer­ years. Blumenthal wi ll address how we can June 5-8: 48th Annual Meeting of the ences/IFOAM_Wild_ Confere nce.hrml. use these natural resources in a sustainable Society for Economic Botany. C hiang Mai, May 5: Well-Sweep Herb Farm. Port Murray, way while preserving the intellectual prop­ Thail and. T he Society for Economic Botany NJ. Join David Winston for a unique even ing erty rights of the indigenous peoples who have is calling for submiss ion of oral presentation herb wa lk followed by Cherokee stories around husbanded them over the yea rs. or poster abstracts for the 48th annual meet­ a fire. Contact: Louise Hyde, Well Sweep http://www.wildflower.org. Phone: 512-292- ing of the society. Abstracts of presentations Herb Farm. Phone: 908-852-5390. Web sire: 4100. and posters will be published in the confer­ www.wel lsweep.com. May 18: Herbs for Chronic Back and Neck ence program distributed to all registered attendees. For primary consideration, submit May 5-6: Spring Vegetable and Herb Pain. Washington, NJ. C hronic back and neck abstracts as soon as possible. The deadline Symposium: Producing and Market­ pain are very common and the leading cause of for submission is April I, 2006. All abstracts ing Fresh Herbs and Vegetables. Moun­ missed work in the United States. Orthodox should be subm itted via the online Call for rain State University in Beckley, WV. The medicine often does nor offer significant relief Papers submission. For submission derails symposium provides two days of intensive and, while chiropractic and massage therapy and registration information visit http://www. educational activities, which include lecture can offer rea l benefits, the use of herbs in addi­ seb2006.com/. sessions, workshops, tours, herb walks, and tion to these body centered therapies can offer an exhibitor/trade session. For more informa­ greater pain relief as well as correcting the June 10-16: Food As Medicine. The Trem­ tion, please visit www.mountainstate.edu/usda underlying causes of muscle and spinal pain. ont Plaza H otel, Baltimore, Maryland. The or contact Dean Myles at 304-929-1630 or Contact: Cathy Garland, Herbalist & Alche­ most comprehensive professional nutrition [email protected]. mist, Inc. Phone: 908-689-9020, ex t. 101. training program in the United States, provid­ in g the equivalent of a semester's worth of May 6: 4th Annual, 2006 Herb Fest: Herbal E-mail: carhy@herbali st-alchemisr.com. Web nutrition curriculum in one week. Jointly Thymes. Boulder, CO. Browse rhe "herb site: www.herbalist-alchemisr.com. sponsored by Georgetown University School marketplace"-35+ booths displaying hand­ May 18-19 &July 6-7: Biochemical Separa­ of Medicine and the University of Minnesota. crafted herbal products, herbal soaps, skin tions: An Introduction to Laboratory Tech­ Partial scholarships and CME credits ava il­ care items & therapies, herbalists & hea ling niques in Biotechnology and Proteomics. able. Visit the Web sire for course schedule practitioners, aromatherapy, herbal books & New Brunswick, NJ. This is an introduc­ and complete derails: www.cmbm.org/fam. videos, food, and more. Free admission with tory-level course designed to acquaint partici­ Contact: Jo Cooper, [email protected]. canned goods to be donated to Silver Key, pants with rhe wide range of modern tech­ Senior Pantry. Please note New Location: 420 niques available for separatin g and purify­ June 21-24: VIII World Congress of Inter­ N. Nevada at St. Vrain, in the Hospitality ing biomolecules. Web site: http://www.rci. national Society for Adaptive Medicine. Center at the north entrance of First United rutgers.edu/-crebb/biosep. html. Moscow, Russia. International organiza­ Methodist Church. For more information, May 24: Natural Health Products in Clini­ tion representatives, scientists, clinicians, and contact Sharon Schulman, BSc., CNHP 719- cal Practice. Edmonton, Alberta, Canada. academics are invited to !SAM's annual World 533-0707. E-mail: Herbalist@my nsp.com. The Natural Health Product Research Society Congress to present research fi ndings and discuss issues of adaptive medicine in an May 6-7: Healthy Products Expo Retailer of Canada (NHPRS) has invited rhe world's atmosphere of open communication, coopera­ Show. Secaucus, NJ. Healthy Product Expo leading experts to share their resea rch results tion, and friendship. This year's main topic is ideal for retail decision-makers across all that cover rhe spectrum of healing modalities is: Molecular and Cellular Adaptation and categories, including independent retailers, germane to clinical practice. The roster of Biomedical Technologies. For more informa­ chain health retailers, natural food retail­ distinguished presenters includes: Drs. Mary tion, please visit www.isam-russia.ru. ers, herb/botanical retailers, independent H ardy (Chair), Steven Aung, Joseph Betz, and chain pharmacies, supermarkets, grocery Betsy Singh, M ichael Smith, Vlad Vuksan, July 29-30: A Weekend in Wales with David stores, wholesa lers, and distributors. Phone: and other internationally recognized speakers. Winston. Conwy, North Wa les . Lectures 480-990-1101. Web sire: http://www.healthy­ Web sire: www.NHPresearch.bcit.ca. E-mail: will include Talking Leaves, An Indigenous productexpo.com/. nhprs@bcir. ca. Language of Plants, Remaking Yourself, and

HerbaiGram 70 2006 www. herbalgram.org The Parh ro Becoming Human. Conracr: August 10: Countercurrent Chromatogra­ August 21-24: Quality and Safety and Pip Whersrone, Haforry Gelynen, Maerd y, phy of Natural Products. Bethesda, MD. Processing Conference. O xfo rd , MS. The Corwen, Conwy LL21 9PA (North Wales}, The symposium will be the first of its kind purpose of this conference is ro review, disc uss, 01490 460493. E-mail: www.thedreaming­ in providing an inrroduction of what is stare­ and explore methods for determining the iden­ butterfly.com. of-the-art and what are future developments tity, purity, quality, and processing of the August 5-6 : Rutland Biodynamics Confer­ in countercurrenr and partition methodol­ material. Topic areas will include such issues ence. Oakham, UK. Dav id Winsron wi ll be ogy in natural products resea rch. The eve nt as authenricarion, cultivation, collection; post­ the keynote speaker ar this wonderful event will feature spea kers who are ex perts in vari­ harvest prac tices for producing quality planr in rural Oakham. He will reach classes on ous fields of basic and/or applied CCC with material; and chemical, roxicologica l methods rhe Duyukta-A Cherokee Look ar Health, particular relevance ro natural products. Please for quality/safety assessment. Phone: (662) Spirit, and Life; The Differential Treatment of register by May 15, 2006. Registration is free, 915-7821. E- mail: ikhan@olemiss .edu. Depression and Anxiety; and T he Alchemy of bur required. Web site: hrrp: //www.coun­ August 28: Materia Medica of the American Herbs. Contact: Rutland Biodynamics, Ltd., tercurrent.org/ or hrrp: //ti gger.uic.edu/ ~gfp/ West. Laurel, MD. Michael Moore, founder Town Park Farm, Brooke, Oakham, Rutland ccc2006/contenr/06narprodsy mpos ium.htm. of the Southwest Sc hool of Botanical Medi­ LE15 8DG, Phone: 44(0}- 1572-757440. Web August 19: Sage Mountain Herbal Retreat cine, will co nduct this one-week workshop ar sire : www.rutlandbio.com. Center. East Barre, VT. Rosemary Gladstar rhe Tai Sophi a Institute. Materia Medica of August 5-9: Natural Products on Target: joined by Pam Monrgomery, Deb Soule, Bob the American West will cover Moore's mosr The 47th Annual Meeting of the Ameri­ Beyfuss, Marrhias & Andrea Reise n, Kate favored plants and clinical applica ti ons. He can Society of Pharmacognosy. Washing­ Gilday & Don Babineau, Nancy & Michael will disc uss their habitat, environmental risks, ron, DC. Please join us at the meeting for Phillips and many others. Classes are held and avai lability. To register or for more infor­ an exciting series of presenrations covering from 9am-5pm and will focus on sustainable mati on, ca ll the Tai Sophia Institute at 410- conremporary developmenrs in natural prod­ practice of herbal medicine, "ar risk" pl anr 888-9048, Ext. 6611. Web sire: www.rai.edu. ucts chemistry, biosynrhesis, drug discovery, cultivation, plant identification wa lks, and drug developmenr, and NIH Road Map initia­ related ropics. For more information and regis­ tives. Phone: 301 -846-1943. Web site: www. tration forms, vi sit www.uniredplanrsavers. More calendar listings at phcog.org/AnnualMtg/Washingron.html. org. Phone: 802-476-6467. www.HerbalGram.org

In this department of Herba/Gram, we list resources such as publications, organizations, seminars, and networking for our readers. A li sting in this section does nor constitute any endorsement or approval by Herba!Gram, ABC, or irs Advisory Board.

International Hemp Association (IHA) first accredited sc hool of Tibetan medicine in interest ro users in rhe industry, academia, extends an open invitation ro studenrs, indi­ rhe West and graduates of the program wi ll be and government. Please visit www.phcog.net/ viduals, businesses, institutions, libraries, among rhe first certified practitioners trained phcogmag for more information, including and age ncies ro join rhe IHA, a member­ in the United Scares. Seasonal inrensives are subscription, on line access, and manuscript based, nonprofit organization dedicated ro provided and ca n be applied rowa rd ce rtifica­ submission instructions. rhe advancement of Cannabis through the tion. Work-study opportunities are also avail­ Post-Graduate Diploma in Medici­ dissemination of information. Members are able, though limited. For additional informa­ nal Botany is now available through a new further encouraged ro subscribe ro the IHA's ti on, pl ease visit www.ShangShung.org. d istance-learning program of the University of official, bi-annual publication, the journal of Trees for Life Journal is a new, free, public Hyderabad in India. The program is divided Industrial Hemp (JIH), and receive a 15-35% hea lth journal launched by Trees for Life into 2 terms, eac h co nsisting of 3 courses. subsc ription discount. The JIH, published by (TFL), a nonprofit organization chat helps ro Courses wi ll feature such ropics as rhe hisrory rhe IHA in Amsterdam and Haworth Press pl ant fruit trees in developing countries. The and id enrifica rion of medicinal planrs, meth­ in New York, provides educational mare­ goal of rhe online journal, whose ediror-in­ ods for ex traction of natural materials, and rial related ro the legal uses of Cannabis and chief is Jed W. Fahey, SeD, faculty resea rch developmenr and marketing of new products, features peer-reviewed scienrific and popular associate at Johns Hopkins University, is among other ropics. The program is designed articles from various disciplines including expanding global knowledge about the med ic­ for agricultural sc ientists, extension specialists agronomy, chemistry, ecology, economics and inal and nutritional va lue of pl ants, in order and agents, new crop researchers, pharma­ markers, ethnology, genetics, phyropathology, to educate citizens of third world counrries. ceutical represe ntatives, governmenr officers, technology, history, and geography. Addition­ To accomplish this goal, rhe TFL Journal private produce rs and marketers, and graduate ally, rhe JIH conrains conference announce­ see ks ro share scienrific studies, in a clear and studenrs. Any person wirh a bachelor's degree menrs and reviews, current events, product inreracrive manner, wirh communities who may seek admission. Derails are avai lable ar developmenr, book reviews, museum reports, stand ro benefit from the findings; serve as an rhe Web sires hrrp://pgdmb.info/ and hrrp:// regional reporrs, and hemp collectables. For inrernarional link bridging the gap between www.uohyd.ernet.in/cdenew3/. more information on how ro join rhe Inter­ grassroots knowledge and scientific research; NNFA FDA Handbook for Retailers, origi­ national Hemp Association or ro subscribe provide a forum for global contriburors to nally published in 2000, is now ava il able ro the journal of Industrial Hemp, please report resea rch progress; and invo ke a tradi­ in a revised 2005 ve rsion. This handbook, contacr David Warson and Janet Erisman ar tional Western peer-review system for scien­ developed by rhe National Nutritional Foods [email protected]. tists wishing ro have their findings published. Association (NNFA), outlines the rights and Traditional Tibetan Medicine Program. For more information, please visit www. responsibilities of retail supplemenr and natu­ The Shang Shung Institute of America is tfljournal.org. ral food s sellers in the eve nr of an inspection accepting Fall 2006 enrollment applications Pharmacognosy Magazine is a quar­ from the Food and Drug Administration for its Traditional Tibetan Medicine Program. terly publication dedicated ro the field of (FDA). The handbook provides information Founded in 1994 by Chogya l Namkhai phyrorherapy through rhe di ssemination of on what nutritional information retailers can Norbu, rhe mission of rhe Shang Shung Insti­ medicinal planr research and development provide to their cusromers regarding rhe prod­ tute of America is ro preserve Tibetan cu ltural data. Published by Phcog. er, chi s maga­ ucts for sa le in their srores, as well as rhe knowledge and ro foster interest in Tibetan zine seeks ro bring new ideas ro the quest for prac tices that FDA inspecrors are allowed ro arrs, culture, hisrory, philosophy, and religion. unraveling the mys tery of plants and covers perform during inspections. The handbook The Institute's 4-year, full-time program is the a variety of ropics related ro natural prod­ also conrains new information rel ated ro the only one of irs kind in rhe United States and uct drug discovery. Manusc ripts appea ring in Biorerrorism Act of 2002. NNFA members derives irs traditional Tibetan curriculum from the magazine are peer-reviewed and describe ca n download a PDF version of the hand­ the Gyud Zhi, rhe fundamental text ofTiberan inves tigations, clinical reports, methods, tech­ book at the following lin k: www.nnfa.org/ medicine, al so known in English as The Four niques, and applications of all forms of medic­ site/DocServer/FDA_ Handbook_Retail.pdf. Tantras. T he Institute seeks ro become the inal plant research which are of immediate www.herbalgram .org 2006 HerbalGram 70 I herbalists, MDs, nurses, NOs, veterinarians, as an HerbClip Service Member. Or access Publications nutritionists, etc. in the an and science of more than 2800 reviews through HerbClip'" clinical herbal medicine. For more informa­ Online, a searchable database updated twice American Herb Association Quarterly tion, please visit www.herbalstudies.org, www. monthly. Available when you join at desig­ Newsletter: $20/yr. AHA, P.O. Box 1673, herbaltherapeurics.net, or contact us at 908- nated Membership levels. To receive the full Nevada City, CA 95959. 835-0822, or [email protected]. service, contact Wayne Silverman, PhD, Australian Journal of Medical Herbalism: Herbal Seminar in the Greek Islands with at 512/926-4900 ex t. 120, or via e-mail at quarterly publication of the National Herbal­ Cascade Anderson Geller: October 2-17, [email protected]. ists Association ofAustralia (founded in 1920). 2006. Smal l group tour explores the beauty Get Certified with ABC's Herbal Informa­ Deals with all aspects of Medical Herbalism, and cu lture of Greece. For information and tion Course. This self-paced online course is including latest medicinal plant research find­ day- by-day itinerary contact: Traditional designed to help retail employees and multi­ ings. Regular features include Australian Tours, (541)895-2957. level disrributors communicate knowledg­ medicinal plants, conferences, conference ably with customers abour herbs and dietary reports, book reviews, rare books, case studies, Lehigh Valley Healing Arts Academy offers supplements. After successfully completing and medicinal plant reviews. AUD/$95 plus a Clinical Herbalist Diploma Program. the course, you' ll receive an Herbal Informa­ AUD/$15 if required by airmail. National This 600-hour, classroom-based program is tion Specialist Certificate and a window decal Herbalists Association of Ausrralia, 33 Reserve certified by the Pennsylvania Department announcing "Herbal Information Speciali st Srreet, Annandale, NSW 2038, Ausrralia. of Education and is designed to provide the student with a so und foundation in both the On Staff." Renewable annuall y. $69.95 Bulk HerbalGram: Quarterly journal published theory and practice of botanica l medicine, pricing available. www.herbtraining.com. by the American Botanical Council. A benefit including materia medica, botany, and clini­ Interns, Get hands-on experience before at all levels of membership in ABC. See page cal uses of herbal remedies. LVHAA, 5412 you graduate! If you're a furure ph arma­ 2 for membership information or join online Shimerville Road, Emmaus PA 18049; (610)- cist or dietitian, you can choose a rota­ at www.herbalgram.org. P.O. Box 144345, 965-6165; email [email protected] tion through ABC's internship program. Austin, TX 78714. 800-373-7105 or fax 512- You ' ll get a comprehensive introduction to 926-2345. E-mail [email protected]. NW Herb Fest: 25 lectures, July 22-23, 2006, at Wise Acres Farm, near Eugene, Oregon. phytomedicines - researching the medici­ Medical Herbalism: Subtirled "A Clini­ Cost is $145 prior to May lsr. More informa­ nal, culinary and cosmetic uses of herbs, cal Newslerrer for the Herbal Practitioner." tion at www.herbaltransitions.com or 541- answering ABC members' questions, work­ Edited by Paul Bergner. $36/yr, $60/2 yrs. 736-0164. ing with medicinal plants in ABC's 2.5 Canada $39/yr. O verseas $45/yr. Sample/$6. acres of herbal gardens, and preparing herbal Medical Herbalism, P. 0. Box 20512, Boulder, sa lves, tinctures or meals. For more informa­ 80308. co Other tion, call Gayle at 512-926-4900 or email [email protected]. Schools Not enough time to read all of the latest Stock Photography that doesn't look like journal articles? ABC makes it easier for Stock: Steven Foster Group, Inc. Photog­ yo u to stay up-to-date. Twice monthly, ABC raphy, Consulting, Publications. Speciali z­ David Winston's Center For Herbal Studies publishes 13 summaries and critical reviews ing in medicinal and aromatic plants, along To Offer On-line Course! 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