Devil's Cia ·is • ·Saw I 1n• Congratulates
ivv1ERICAN BOTANICAL COUNCIL
On the 50th issue of
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4 HERBAlGRAM 50 2000 MISSION: The American Botanical Council is the leading nonprofit educational and research organization disseminating science-based information that promotes the safe and effective use of medicinal plants and phytomedicines. VISION: I'MERIC!'N • To maintain a superior quality herbal education research center BoT!'J\JICAL • To provide excellence in herbal education COUNCIL • To continue as an internationally recognized authority on herbal medicine • To create and meet demand for herbal information • To develop new sources of funding and strategic relationships INITIATIVES AND PROJECTS: Health Professional Continuing Education teaches healthcare providers about medicinal plants while they earn CME credits.
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2000 HE RBALGRAM so 5 ADVISORY BOARDS Ea ch issue of Herba/Gram is peer reviewed by members of our Advisory Boards before publication.
American Botanical Council Herb Research John Thor Arnason, Ph.D., Professor of Biology, Dept. of Gail B. Mahady, Ph.D., Research Assistant Professor, Foundation Biolog y, University of Ottowa, Ontario, Conodo Deportment of Medical Chemistry &Pharmacognosy, College of Pharmacy, University of Illinois, Chicago Dennis V. C. Awang, Ph.D., F. C. I. C., MediPiont Natural Rob McCaleb, President Products Consulhng Se rvices, Vancouver, B.C., Conodo Robin J. Maries, Ph.D., Associate Professor of Botany, Brandon University, Brandon, Manitoba, Conodo Manuel F. Balandrin, R.Ph., Ph.D., Research Scientist, NPS Glenn Appelt, Ph.D., R.Ph., Author and Professor Phormoceuhcols, Salt Lake City, Utah Dennis J. McKenna, Ph.D., Consulting Ethnophormocologist, Emeritus, University of Colo rado, and with Bould er Beach Institute for Natural Products Research; Senior Lecturer, The Consulting Group Marilyn Barrett, Ph.D., Pharmacognosy Consulhng Service, Cen ter for Spirituality and Healing, Academic Health Center ot Son Carl os, California the University of Minnesota, Minneapolis John A. Beutler, Ph.D., Na tural Products Chemist, Bradley C. Bennett, Ph.D., Associate Professor of Biology, Daniel E. Moerman, Ph.D., Will iam E. Stirton Professor of Notional Cancer Institute Florida lnternohonol University, Miam i Anthropology, University of Michigan/ Dearborn Robert A. Bye, Jr., Ph.D., Professor of Ethnobotan y, Joseph M. Betz, Ph.D., Vice President of Scienhfic & William Obermeyer, Ph.D., Vice-President of Research and Notional University of Mex ico Technical Affairs, American Herbal Products Associohon, Technology, ConsumerLob.com, Annapolis, Maryland Silver Spring, MD Ara DerMarderosian, Ph.D., Professor of Samuel W. Page, Ph.D., Director, Division of Natural Products, Pharmacognosy, Philadelphia College of Pharmacy Donald J. Brown, N.D., Director, Natural Products Center for Food Safety and Applied Nutrition, Food and Drug and Science Research Consultants, Seattle, Washington Adm inistra tion, Washington, D.C. Subhuti Dharmananda, Ph.D., Director, In stitu te for Thomas J. Carlson, M.S., M.D., Senior Director, Joseph E. Pizzarno, Jr., N.D., President Emeritus, Tra ditional Medi cine and Preventive Health Core Ethnobiomedicol Field Research, Shaman Botonicols.com, Bastyr University, Seattle, Washington South Son Franc isco, California James A. Duke, Ph.D., Economic Botan ist (U.S.D .A. , Mark J. Plotkin, Ph.D., Author, Execuhve Director, ret. ), author, Herbal Vineyard, Fulton, Maryland Jean Carper, Author and synd icated co lumn ist, Washington, D.C. Ethnobotony ond Conservation Team, Arlington, Virgin ia Norman R. Farnsworth, Ph.D., Research Professor of Jerry (ott, Ph.D., Scientific Director and Chief Science Officer, John Riddle, Ph.D., Deportment of History, North Carolina Scientific Herbal Products, Inc., College Pork, Maryland Pharmacognosy, Program for Collaborative Research in the State University, Raleigh Pharmaceutical Sciences, and Senior Uni ve rsity Scholar, Paul Alan Cox, Ph.D., Director, Nohonol Tropical Botanical Eloy Rodriguez, Ph.D., James Perkins Professor of University of Illinois at Chicago Gorden, Kouoi, Howoi i Environmen tal Studies, School of Agriculture &life Sciences, Richard I. Ford, Ph.D., Professor of Ethn obo tany, Lyle E. Craker, Ph.D., Professor, Deportment of Plant ond Soil Cornell University, Ithaca, New York University of Michigan Sciences, University of Massachusetts, Amherst James E. Simon, Ph.D., Professor of New Use Agriculture, Edward M. Croom, Jr., Ph.D., Scienhfic and Regulatory Director of the Center for New Use Agriculture and Natural Plant David Kroll, Ph.D., Associate Professor of Ph arm aco logy Products, Rutgers University, New Brunswick, New Jersey and To xicolo gy, University of Colorado, School of Affairs Manager, lndena USA East, Inc. , Paramus, NewJersey Pharmacy Wade Davis, Ph.D., Author, ethnoboton ist, Washington, D.C. Beryl Simpson, Ph.D., C. L. Lundell Professor of Botany, Deportment of Botany, University of Texas ot Aushn Harriet Kuhnlein, Ph.D., Professor of Nu trition, Steven Dentali, Ph.D., Senior Director of Botanical Sciences, McGill University Rexoll Sundown, Inc., Boca Rotan, Florida S. H. Sohmer, Ph.D., President and Director, Botanical Research lnshtute of Texas, Fort Worth, Texas Albert Leung, Ph.D., Pharmacognosist, Glen Rock, Hardy Eshbaugh, Ph.D., Professor of Botany &Assistant New Jersey Curator, Willard Sherman Turrell Herbarium, Miami University, Barbara N. Timmermann, Ph.D., Professor of Pharmacology Oxford, Ohio ond Toxicology, College of Pharmacy, University of Arizona, Walter Lewis, Ph.D., Professor of Biol ogy, Washington Tucson University, and Senior Botanist, Missou ri Botanical Christopher Hobbs, LAc., AHG, Herbalist, botanist, licensed Gardens acupuncturist, Santo Cruz, California G. H. Neil Towers, Ph.D., Professor Emeritus, F. R. S. C., Botany Deportment, University of Brihsh Colu mbia, Vancouver, James D. McChesney, Ph.D., Vice President, Natural David Hoffmann, B.Sc., M.N.I.M.H., Medical herbalist, Canada Santo Rosa , California Products Chemistry, NoPro Bio Thera peutics, Boulder, Arthur 0. Tucker, Ph.D., Research Professor of Agriculture and Colorado Maurice M. lwu, Ph.D., Bioresources Development ond Natural Resources, Delaware Stole University, Dover, Delaware Conservohon Program, Senior Research Associate ot the Division C. Dwayne Ogzewalla, Ph.D., Retired Professor of of Experimental Theropeuhcs, Wolter Reed Army lnshtute of Nancy Turner, Ph.D., Professor and Ethnobotonist, Pharmacognosy, University of Cincinnati Research, Washington, D.C. Environmental Studies Program, University of Victoria, British Columbia, Conodo Robert Rountree, M.D., Physician, Boulder, Colorado Steven King, Ph.D., Senior Vice President of Ethnobotany and Conservohon, Shaman Botanicals.com , South Son Francisco, Andrew T. Weil, M.D., Author, Director of the Program in E. John Staba, Ph.D., Professor of Pharmacognosy, California Integrative Medicine and Associate Director of the Division of University of Minnesota Social Perspectives in Medicine of the College of Medicine, Varro E. Tyler, Ph.D., Dean and Distinguished Professor Thomas L. Kurt, M.D., M.P.H., Cli nical Professor, University of Arizona, Tucson Deportment of Internal Medicine, University of Texas of Pharmacognosy Em eritus, School of Pharmacy and Southwestern, Dallas ad hoc advisor: Pharmacal Sciences, Purdue University Tom Mabry, Ph.D., Professor of Plant Biochemistry, David M. Eisenberg, M.D., Director, Center for Alternohve Phil Weber, M.D., Physicia n, Boulder, Colorado Deportment of Botany, University of Texas ot Aushn Medicine Research, Beth Israel HospitoljHorvord Medical School, Boston, Massachusetts Andrew T. Weil, M.D., Author, Directo r of the Program in lntegrohve Medicine and Associate Director of the Division of Social Perspechves in Medicine of the College of Medicine, University of Arizona, Tucson
6 HERBALGRAM 50 2000 Educating the Public on the Use of Herbs and Phytomedicines DEAR READER Our SOlh Issue. We've come a Mork Blumenthal (President), Fou nder and Execu tive Director long way from our fust HerbalGram, Michael J. Bo lick, Ph.D ., Directo r and Phi lecology Curator, an eight-page newsletter in 1983. Our In stitute of Eco nomic Botany, Th e NewYo rk Botani cal Gorden, Bron x, NewYo rk new managing editor, Karen Robin, writes about our history in this issue. James A. Duke (Treasurer), Ph .D., Econom ic Botanist (USDA, ret.) Auth or, Fulton, Maryland Advertising in HerbalGram. Norman R. Farnsworth (Secretory), Ph .D., Research Professor of Beginning with this i sue, we accept Pharmacognosy, Progra mf or Coll aborative Research in th e Board of Pharmaceuti cal Science s, University of Il lin ois at Ch icago ads from manufacturers and market ers of herbal raw materials and fin Trustees Steven Foster, President, Steven Foster Group, Inc., ished products. We believe that new advertising revenue will Faye tte vi ll e, Arkansas enable us to maintain the level of accuracy for which Fredi Kronenberg, Ph .D., Director, Rosenthal Center for Comp le mentary HerbalGram has become well known. The staff and boards of and Alternative Medici ne, Columbia Unive rsity Coll ege of Physicians and ABC remain committed to the same high quality of information Surgeons, NewY ork, NewY ork presented in an accurate, rational, unbia ed, and aesthetically Vorro E. Tyler (Vice President), Ph .D., Sc.D ., Dean and Distingu ished pleasing fashion. To make room for these new ads, we have Professor of Pharmacog nosy Eme ritus, Sc hool of Pharmacy an d Pharmacal Sciences, Purdue Uni ve rsity removed our Herbal Education Catalog from HerbalGram and put it on our redesigned website with secure on-line ordering,
2000 HERB ALGR AM 50 7 Number 50
10 (/) ~ z w 16 Plight of lnternationa Update Avai,lu ..._, '"'""" Presents Audrey TlkliHrn"*' ~ Cornell; HRF Ad,..,nt·wc·ni'ft ..-· ~-.. -- and Regulat.o y ~ t:otted1ra Update: Industry Coalition Asks FDA 19 Grants and Awards National Labeling Guidelines on Tyler Receives Honorary ra ; Offers Cooperative Research w ith ~ University; Two-Year Clinical H; CSPI Files Complaint to FDA on Herbs in Ecninacea for Upper Respiratory lnra.~nnnc Foods; FDA Publishes New Draft Guidance for Children; NIH Funds Two Addition Botanical Drug Products <( Research Centers o_ Market Report 20 Organization News ----"~ntc. r:.al Marketing Institute Measures Consumer USP Establishes ."!!!li;,.,..'.v of erbal roducts UJ Botanicals; T Wort Man
0 21
J, ' SING ~ lh, page 4 page 5 page T5-. page sa page 57 page 75 page 83
8 HERBALGRAM 50 2000 47 DEVIL' S CLAW: FROM AFRICAN TRADITIONAL REMEDY TO MODERN ANALGESIC AND ANTIINFLAMMATORY
by Tankred Wegener
A review of the experimental and clinical literature documenting the analgesic and anti inflammatory actions of this traditional African medicinal plant. Photo © 2000 Steven Foster. AJ m (/) 58 TERRAFORMING IN SOUTHERN BAJA CALIFORNIA: Arid-Tropical Biodiversity, Regeneration, and Preservation
by James E. Williams, OMD
Master herbal gardener Gabriel Howearth recla ims a piece of Ba ja California, turning it into a paradise of herbs, cactii, fruits, and exotic plants. Photo © 2000 J.E. Williams.
32 SAW PALMETIO ORIGINAL RESEARCH 55 ELDERBERRY by Mark Blumen thal by Chris Kilham This native American herb has received some 40 FLOR-ESSENCE® A short view of the traditional use positive publicity recently, supporting its use for and research into the benign prostatic hyperplasia in older men . HERBAL TONIC USE immunostimulating properties of this traditional European herb and its IN NORTH AMERICA potential benefits in colds and flus . by Mary Ann Richardson, DrPH, Tina Sanders, MPH, Carmen Tamayo, MD, Carrie Perez, MPH, J. Lynn Pa lmer, PhD Results of an NIH-funded study on the demographics and use patterns of an herbal combination product used by many to prevent and sometimes treat cancer.
Cover: Saw Palmetto, Serenoa repens. Photo © 2000 Steven Foster.
0 HERB ALGRAM is printed on recycled paper at Wetmore Printing Company, Houston, Texas.
2000 HERBA LG RAM 50 9 ABC NEWS
The magazine you hold in McCaleb said. "We started Herba!Gram with the idea of letting your hands is the fiftieth issue of healthcare professionals, the general public, and the media know He rba!Gram. Started in 1983 , that there was, and is, high-quali ty research on the safety and ben- HerbalGram reflects the growth efits of herbs for all kinds and concerns of the herbal move of health problems and , HEKI' NEW.5 ..... K ...... ,IIUot ~.t ~ ment in those years, as we ll as the ., ...... perhaps more impor Herbalgram·· development of pub li shing technol ~ tantly, for helping to
ogy. 1Uin.o#I"''IS5U11011•!'!!£I maintain and improve n.. ••• tuM • .,.. ,.,,.. ( rul ..._It Ito Lou ••""' ot ...._ ... ,,of'''""" lo ....,.,. "Herba!Gram started as ala ....UU .\O...... J.u f hto .,.• ..ll•o...... ,_
,,au""' loU flo.o ... rt•lllrouoooollolli'A oloo-olu .. lp-,_tuolo oootool,nt .. tq oM dation (HRF) as vice president and ::~ : ~ .·· ::.'1:::::.·:.~.:..: :.:;:~·:.:: . :~h"::: ~:::::'..:;: ;:::-;-:: ~.~· Loren Israelsen, Peter president, respecti vely ; the Ameri olo DC. rto.. u, U-GJ wu n., .._ Joloot cu7 , 111 111'" u•a ut.)Ut. Landes, Varro Tyler, and can Botanical Council was formed Roy Upton, just to name some six years later, in 1988, by a few. Blumenthal. McCaleb continues to "Certainly, HerbalGram is the best all around herbal medi direct HRF. cine publication in the U.S. , if not the world," said Varro Tyler. "I've "Doctors don't generall y read read it almost since its inception. Aside from the evoluti on of the journals like Planta Medica, Jour format, the increase in content has been the biggest change." nal ofEthnopharmacology, Journal For th e first 49 issues, Barbara "BJ" Johnston served as man Top to Bottom: Herba/Gram of Natural Products, or the other aging editor. "I enjoyed most working on articles about people. For issues 18/ 19, 26, 31 , 35. excell ent sources of peer-reviewed example, Richard Evans Schultes (issue no . 38) was a great ethno sc ientific information on herbs," botanist, an astounding man who went into the unexplored jungle. Contributors to ABC's Capital Campaign The following companies and individuals have made and pledged contributions toward the Case Mill Capital Campaign Visionaries - $500,000 and Greater Planners- $10,000 to $49,999 A.M. Todd Botanicals Nature's Bounty Architects- $100,000 to $499,999 AIIHerb.com Nature's Herbs* Global Health Sciences * * Bio Botan ica Nature's Way* * Botanicals International New Hope Communication Builders - $50,000 to $99,999 * Capsugel Pharmaton Natural Health Products En zymatic Therapy lndena USA* Cosmopolitan Trad ing Stryka Botan ies Co. * ExtractsPius Pure World Botan icals Henkel Corp. Traditional Medicinals * GNC, Inc. Connie and Jul ian Whitaker* Martin Bauer /Finzel berg Vicus .com MotherNature.com Whole Foods Market 10 HERBALGRAM50 2000 ABC NEWS He is a true hero of min e. Look at al l the plants he identified and "Herba/Cram is a real too l for brought back fo r further research." the professional," McCaleb sa id. BJ first created Herba/Cram on a glorified typewriter and a "whether in medical prac ti ce or th e daisy wheel printe r. On to nascent desktop publishing software by herbal ind ustry, and for people learn th e tenth issue, BJ said, "It was like taking Conestoga wagons into ing more about herbs from a solid sc i the wilde rness; you had to fi gure it out as you went." entific perspective in an interesting At the twentieth issue, HerbaiCram was printed on a four way." co lor press, and photographic images and artistic des ign fi ll ed the Certain issues continue to war pages with color. Four art di rectors have added fla ir to the appear rant space in these pages: the activi ance of Herba/Cram. Di ane Perwein developed the Herba/Cram ti es of the Food and Drug Adm ini s logo on the cover, fo ll owed by Ira Kenn edy, Ginger Hudson, and tration and other regulatory agenc ies. Natali e Reittinge r. the state of the market as reflected In add ition to the by consumption of herbal products, rigorous sc ientific stan and, of course, scientific research and dards set for arti cles, conference reports. These years of Herba/Cram brought at wo rk and the standard s of qua li ty tention to the beauty of have been noted, forma ll y. by Utn e plants, featuri ng articles Reader. which twice in three years. on medic inal plant stamps nominated HerbaiCram as one of the of Yugoslavia (iss ue no. best magazines in alternative maga 30), an ex hi bit of glass zine publishing. plant spec im ens at " We have att empted to Harva rd Uni ve rsity (no. chroni cle the development of the 28), pl ants in porcel ain herb move ment in the U.S.," sa id (no. 38), botani cal jewelry Blumen th al. "And we are ex tremely (no. 29), dried pl ant sculp grateful for the recog nition and sup tu re (no. 26), African port we have received from our read ethnopharmaco logy art i ers." - Karen Robin, ABC 0 fac ts (no. 47), the flora of Lo ui siana (no. 4 1), tea [Note: Special "50th Issue" (no. 37), med icinal plants of Shakespeare (no. 35), Tibetan med ical celebration rates noH· apply to back paintings (no. 31), and an excerpt from the Nati onal Geographi c issues of HerbalGram. Visit ABC's book, Nature's Medicine (no. 49). website: Other Contributors: American Ingredients LLC, The Beretta Foundati on, Donald J. Brown, N .D., Celesti al Seasonings, Chai-Na-Ta Corp., Chemco Industries, Inc., Flora Manufacturi ng & Distributors, Steven Foster, Supporters - $5,000 to $9,999 Fruitful Yield, Healthnotes Online, Herb Phorm, Herbs AK Equ ipment for Kids, Hilary's Distribution, Indiana Botanical Mr. & Mrs. Alfred Blumenthal Gardens, Interweave Press, Jason Natural Products, Mark Blumenthal* Dr. and Mrs. Steven R. King , Laboratories Mixim, City of Austin M .W . International, Metagenics, Natural Business Euromed * Communications, Nature's Pantry, NOW Foods, Fetzer Fou ndation Phormonex/NuSkin International, Inc., Phormovite, Phormline, Inc., PhytoMed International, Mark Plotkin, Franklin Publicati ons Ph .D., Prince of Peace Enterprises, Procter & Gamble, Haworth Press Inc. Pro Poe Labs, Pure Gar, QBI -Quality Botanical Lichtwer Pharma US Inc. Ingredients, Quaker Oats, Swedish Herbal Institu te, Nutrilite, a division of Amway Triorco, Trout Lake Form, Tsumuro , Wokunogo of White River Hardwoods America, Inc., David Winston, Herbalist & Alchem ist, Janet Zand and Michael M arcus Xylomed Resea rch, Inc. Historic Case Mill Homestead. Photo © 2000 Steven Foster. * Multi-year pledge 2000 HERBAL GRAM50 11 I ABC NEWS ABC's Herbal Medicine Earns 4-Star Rating from ABC and Virgo Publishing Doody Publishing in Agreement for For th e second time in two years, an Herbal Medicine: Expanded Commis Herba/Gram Ad Sales Ameri can Botani cal Council publi cati on has sion E Monographs expanded upon more earned a high rating by Doody Publishing, a than I 00 herbs that are relatively im portant HerbalGram now accepts di splay ad leading reviewer of medi cal publicati ons. to the U.S. marke t. and also th e un approved verti sing fo r herbal products and services. Herbal Medicine: Expanded Commission herb yohimbe ( Pausinystalia yohimbe) and Phoe ni x-based Virgo Publishing wi ll coor Monographs was given a fo ur-star rating (out the unapproved plant parts of haw th orn dinate adve rti sing sales on behalf of ABC. offive) based on a weighted numerical score (Crataegus monogyna or C. laevigata) and "For 17 years HerbalGram has been of95 (o ut of a poss ible IOO). ln 1998,ABC's parts and/or species of echinacea (Echinacea the leading publication dealing with research, The Complete German Commission E Mono spp.). The integrity of the ori gin al mono regul ation, and related issues on herbal medi graphs: Therapeutic Guide to Herbal Medi graphs was maintained, whil e new info rma cine," said Mark Blumenthal, founder and cines wo n a five-star ra ting, based on a tion was cited to enable th e reader to di stin executi ve director of ABC. "During thi s time weighted numeri cal score of I 00, and was gui sh between th e ori ginal monograph and we never accepted advertising for commer one of three fi nali sts for Book of th e Year by added info rmati on. cial herb products. Gi ven the general climate Doody Publishing. The editors also added di scussion on surrounding herbs in the U.S., the ABC board An ex pert panel reviewed approx i geographical di stribution, usage hi story, and decided it is time for a new poli cy on adver mately 4,000 medi cal titles released duri ng available clinical studi es, plus quality con tising." 2000 for Doody. All titles must pass various tro l parameters from official pharmacopeias, Blumenthal, who is also HerbalGram levels of ex pert peer review, including au and rev ised safety and dos ing data. A notable editor/publisher, emphasized th at the edi to thori ty of the author and currency of refer sec ti on is Tabl e 5, "Most Frequently Pre ri al integrity of HerbalGram will not be al ences. The weighted numeri c rating system sc ribed and Researched Phytomedicine tered in any way. The journal has a reputa evaluates 16 elements. Only five percent of Brands in Germany and U. S. Brand Coun tion fo r strong credibility and hi gh journal the pu bli cati ons receive a fi ve-star rating; 25 terparts." isti c ethics. Its commitment to quality con percent receive fo ur stars. With 90 full-co lor photos by noted tent will be enhanced by the increase in rev Herbal Medicine: Expanded Commis botani st and author, Steven Foster, Herbal enue through th e acceptance of advertising. sion E Monographs revised and updated The Medicine: Expanded Commission E Mono Ads may be refused if they do not meet ABC Complete German Commission E Mono graphs is "an informati ve reference guide standards of providing credible info rmation graphs: Therapeutic Guide to Herbal Medi about herbal remedies with informati on pre about herbal products. cines, published in 1998, after feedback from sented in an attracti ve format th at is easy to "The additional revenue will all ow us readers who wanted to know the sources of read and follow," wrote Paul a F. Scharf, to continue our mission of educating the pub the Commi ssion E's research to evaluate the Ph.D., R.N., in her rev iew for Doody Pub li c about the safe and responsible use of bo currency of the data. li shin g. - Jan Veenstra, ABC 0 tani cal medi cines. The public needs and wants us to continue to provide informati on it can trust about herbs. Adverti sing prov ides Financial Planning for ABC'sFuture new opportunities for reputable manufactur To continue its work of educating the Planned giving may offer significant estate, in ers and ourselves," said Way ne Sil verman, public about the safe and responsible use of come, and gift tax savings, an important con PhD, ABC's chief administrati ve offi cer. "As herbal medici nes, ABC needs fin ancial support. sideration in light of the high rate of federal es our emphasis has been on educati on, rather While many ways to support current operati ons tate taxes, which start at 37 percent and rise as than commerce, we are delighted that we and projects already exist, another option is high as 55 percent. Above all , the donor is pro have fo und a knowledgeable partner to guide pl an ned giving, which can provide significant viding long-term support and stability to ABC. us into this new territory. Working with Virgo fun ding for ABC's future stability. Many of these gifts are arranged with Publishing also will help to keep the bound By working with a planned giving spe other estate planning tools to ensure a compre ari es cl ear between our editori al vision and cial ist, provided by ABC or through the donor, hensive and thoughtful arrangement for the di s our commercial obli gati ons." a pl an can be developed to benefit both the position of donors' estates and property. ABC Virgo Publishing, producers of a vari donor and ABC. Vari ous instruments may has the resources to assist ex ploration of op ety of industry magazines and the SupplyS ide achieve the donor's fin ancial goals, including tions that would not only ensure a lasting legacy, trade shows, will contact pas t supporters of outright donations, life insurance, trusts such but also express support of the important edu ABC as well as clients of Virgo Publishing as charitable lead trusts, charitable remainder cational and research efforts of ABC. to build support for the program. Displ ay annui ty trusts, and through will s. ln some cases, For more info rm ati on, pl ease contact adverti sing debuts in thi s issue. For info r these instruments provide income to donors or Wayne Silverman at 51 2/926-4900, ex t. 120, mati on about adverti sing in Herba!Gram, their benefi ciaries during the donor's lifetime; or by email at 12 HERBALGRAM 50 2000 ABC NEWS Join History: Become a Charter Member of ABC Almost every visitor to the American program is a natural step toward ex panding Herbal Education Catalog; first-notice in vi Botanical Council 's Case Mill Homestead our educational activities," says ABC tations and member discounts on et hnobo and herb gardens ends their tour with the Founder and Executive Director Mark tanical tours and special events such as same question : How can I become a mem Blumenthal. "A strong membership base will booksignings and lectures; access to a mem ber of ABC and get more involved in sup improve our ability to attract corporate do bers-only area on our award-winn in g porting your mission? nations and other sources of charitable giv website; access to our research serv ices; and Until recently, the answer has only ing, as we grow closer to our supporters." free fac ility tours. been through subscribing to HerbalGram, Following the traditi on of other lead "To thank our loyal readers, many of making a donation, or by volunteering. ing scientific educational and research orga whom have been with us since the first ABC's by-laws established it as a non-profit nizations best known for their magazi nes, Herba!Gram 17 years ago, current educational research organization and did not such as National Geographic and The Herba!Gram subscribers may become Char permit memberships. Smithsonian, subscriptions to Herba!Gram ter Members of ABC," says ABC's Chief Recognizing the many services and are now a membership benefit. While this Administrative Officer Wayne Silverman, benefits ABC offers, and the tremendous journal will continue to be ava il able at natu PhD. Charter Members will also receive spe opportunity to engage the interest and finan ral food stores and bookstores, subscribers cial gifts . To become a Charter Member, cial support of committed individuals, busi may choose from various categories of mem please complete the form on page 4 of this nesses and organizations, ABC's by-laws bership as they convert from subscribers to issue of Herba!Gram and fax or mail it to now include a membership component. members. ABC. Watch for more exciting news about These new membership options will serve Other membership benefits include ABC's new membership program in the next the needs of its growing constituency. discounts on publications and merchandise issue of Herba!Gram and in the mail. "Developing an ABC membership available through ABC's Internet-based - Gloria Moore, ABC 0 Friends Help ABC Herb Gardens Grow The herb gardens at American Botani The First Aid Garden has plants known "Demonstrati on herb gardens are the most cal Council's Case Mill Homestead expanded to staunch bleeding cuts, soothe burns, or effective teaching tool available to herb en thi s past year with a new Systems Garden, a take the itch out of insect bites and other skin thu siasts. We are delighted to contribute to Phytocosmetic Garden, and a First Aid Gar irritations. "We placed thi s garden just out the maintenance and development of the den. Since ABC moved to the Case Mi ll side the kitchen door, in case these plants are ABC gardens." - Karen Robin, ABC 0 Homestead in 1998, 15 theme gardens have needed in a hurry," says Li sa been installed and more are planned with the LaRousse, ABC's garden coordi intention of becoming one of the nation's nator. premier herbal medicine gardens. Garden Every garden is the result of tours are scheduled on the second and fourth joint effort and expertise. Several Thursdays of each month, and by appointment. outstanding volunteers and interns As a part of ABC's ongoing education worked side by side with staff hor commitment, these demonstration gardens ticulturists LaRousse and Rachel show the beauty of beneficial plants. A list Hagan. Donors to ABC gardens of proposed plants is peer reviewed for ap over the past year include a chip propriateness to each themed garden. per/shredder from J .J. Jennings of The Systems Garden, placed in the Austin, Texas; compost from front yard of ABC's office, contains seven Natural Gardener in Oak Hill , sections for different human body systems: Texas; seeds from Horizon Herbs cardiovascular, excretory, pulmonary, mus of Williams, Oregon ; plants from culoskeletal, digestive, nervous, and the eyes, Misty Hill Farm of Dale, Texas; ears, nose and throat. Each section is planted garden supplies from Colleen with species used historically or currently to Ostlund of Boulder, Colorado, and benefit these systems. support for replacement plants The Phytocosmetic Garden - plants from the Greater Fort Worth Herb hi storically known or clinically prove n to be Society (GFWHS). beneficial to skin and hair care- surrounds As Ann McCormick of the Rachel Hagan, ABC botanist and gardener, plants a chaste tree (Vitex agnus-castus). GFWHS said in making their gift, Lemon Balm, Melissa officina/is, at the Case Mill Homestead. 2000 HERBA LG RAM 50 13 ABC NEWS Presentations and Major Calendar of Upcoming Continuing Education Papers by ABC's Executive Accredited Expeditions and Voyages Director, Mark Blumenthal The number of study trips co-sponsored by the American Botanical Council offering CME and ACPE credits continues to grow. These programs are open not onl y to all healthcare MAY - OCTOBER, 2000: May 18 -Alliance In stitute of Integrative professionals but to all interested individuals. Previous expeditions have been attended by Medicine, Cincinnati, OH. Conference: Practical science teachers, health food store owners and employees, and students of various ages and Applications of Integrative Medicine: Applicable disciplines, as well as doctors, pharmacists, nurses, and herbali sts. Alternative Therapy Solutions, "Efficacy of When req uesting information on these programs, please mention the three-digit num Ph ytomed icine" ber fo ll owing the location so we can provide you wi th the appropriate information . Contact May 19-20 - Canadian Coll ege of ABC at 512/926-4900, ext. I 0 I for further information.- Gayle Engels, ABC 0 Naturopathic Medicine & Dominion Herbal College, Herbal Seminar 2000. North York, Patagonia Voyage/ ...... 461.... 200 I .... Perspectives in Medicine ...... Jan 25-Feb 4 Ontario, Canada. " Herbs For Health" Tierra del Fuego May 22-24 - Columbia Univers ity Conference: Belize ...... 370 .... 200 1 .... Women 's Healthcare Issues ...... March 10-17 Botanical Medicine in Modern Clinical Practice, Brazil 's Pantanal : ...... 462 .... 200 I .. .. Perspectives in Medicine ...... May 5-13 Columbia University, New York , NY. "History of Savannah Safari Botanicals in Medicine" & June 9-11 -Comprehensive Cancer Care Germany Rhine ...... 463 .... 200 I .... Traditions in Medicine Pharmacy .... Sept 1-9 2000, Arlington, VA. "Most Promising Herbal Wine Vall ey Therapies" Amazon ...... 355 .... 200 1 .... Pha1macy from the Rainforest ...... Oct 27-Nov 4 June 29-July 14- International Health Issues Andes ...... 421 .... 2002 .... Spirituality & Healing ...... Jan 26-Feb 3 Safari 2000, South Africa. "Roots Revisited: Tanzania & Kenya- ...... 468 .... 2002 .... International Healthcare Iss ues ...... Feb 8-21 African Medicinal Plants/ lulu Culture" and Africa Safa1i "Evolution of Herbs in Medicine." Co-Leader of Bali & Komodo- ...... 469 .... 2002 .... Perspectives in Healthcare ...... April 6-19 Botanical Bush Walk Sea Safari Voyage July 17-19 - Nutracon 2000, Las Vegas, NV. Nepal & Kathmandu ...... 470 .... 2002 .. .. Traditions in Medicine & Pharmacy .... Sept 27-0ct 6 Panel moderator: "Differentiating Products an Quality: Standards/Effi cacy, 3rd Party Certification Processes, and Quantitive Gene Expression Tec hn ologies." July 25-30 - NNFA Las Vegas " Educa tional Resources & Opportunities in Herbs" Aug. 22-24 - Banner Ph armacaps Symposium, Greensboro, SC. "Herbal Myths and Misconceptions in the Media" Sept. 12 - Food Marketing Institute: FMI Consumer Affairs Conference, New York, NY. "The Science of Supplements " Sept. 14 - O hio Pharmaceutical Seminar, Columbus, O H. "Unraveling Medical Myths & Misperceptions of the Modern Herbal Marketplace: A Di scussion of Market Trends, Consumer Attitudes, Regulations, Quality Control & an Assessment of Safe ty & Efficacy" Sept. 1 5 - Functional Foods, Houston, TX. "Modern Media Myths and Misconceptions about Herbs" Oct 6 - Testimony before the White House Commission on Complementary and Alterna ti ve Medicine Poli cy, Washington, DC , "Stimulating Research on Herbal Products in the Private Sector: Issues and Possible Government Poli cies" Oct. 19 - Great Earth Annual Conference, Las African sce nes : Zebras mowing the lawn Vegas, NV, "Herbal Myths & Misperceptions" and Jim Duke checking arboreal Oct. 28- AdvoCare Success School, Arlington, aromath erapy. Photos © 2000 Mark TX, "Media Myths and Misconceptions of the Blumenthal. Modern Herbal Market" 14 HERBALGRAM50 2000 Ameri(an Botani(al Coundl's English translation of The Complete Gennan Commission E Monographs-Therapeutic Guide to Herbal Medicines • 380 monographs Plus Shipping • 190 herbs and fixed combinations Item #BIB/ approved for therapeutic use • 150 indications $165 • Glossary of anatomical, botanical, medical, pharmaceutical, Mark Blumenthal, Senior Editor. and technical terms Werner R. Busse, Alicia Goldberg, Joerg Gruenwald, Taro Hall, Chance WRiggins, RobertS Rister, Associate Editors. • Common, latin, pharmacopeia!, Sigrid Klein, Ph .D. , Senior Translator; RobertS. Rister, Associate Translator. and German names • Cross referenced • Extensive general index AVAILABLE $ 99 ON CD-ROM Plus Shipping • Extensive 65-page introduction FOR ONLY ltem#C/81 Herbal Medicine Expanded Commission E Monog .. ~~~ .... Mark Blumenthal I Alicia Goldberg I Josef Brinckmann This new and updated reference is based on the oririnal, renowned Commission Etranslation by the American Botanica Council • New in-depth overviewwith clinical research • More on dosage and administration • list of most-researched brands • Extensive references • Expanded sections on chemistry • 90 full -color photos and pharmacology • 520 pages S49?~~, ltem#BI BI E AVAILABLE "The most authoritative, comprehensive, and affordable guide for anybody who ON CD-ROM s4995 . . FOR ONLy Plus Sh1ppmg wants to use herbal remedies wisely and safely." /tem#C/ 81£ -J ean Carper, Best-selling author of Miracle Cures and columnist for USA Weekend Credit card holders, order toll free 800/373·7105, fax 512/926·2345, or email: [email protected] Visit our website: www.herbalgram.org HRF NEWS Plight of Buchu Underscores the Need for International Herb Development Diminished habitat, increased com thi s probl em. As the demand for buchu mercial demand, destructi ve wild harvesting grows, some growers have mixed seed from practi ces, and growing genetic vulnerability different populations indiscriminately, ulti to natural di saster all signal troubl e for bu mately creating hybrids. Because the hybrids chu (Agathosma betulina and A. crenulata), are likely to breed with nati ve buchu pl ants, nati ve South African medicinal plants impor ARC scienti sts are concerned that wild popu tant in traditional healing and, increasingly, lations may become geneti call y homoge for export to the world market. neous. To illustrate the problem, they point Buchu is one of a number of th reat out that oil from A. betulina is more valu ened African plants targeted fo r development able than A. crenulata in the Western market by Agribusiness in Sustainable Natural Af because it contains higher levels of the com ri can Pl ant Products (A-SNAPP), a network pound diosphenol. If the two species hybrid created to foster th e development and imple ize extensively, there will be no source fo r mentati on of sociall y conscious and environ the hi gher-quality oil. mentall y sustai nable Afri can natural products Working with A-SNAPP, African businesses. A-SNAPP, a coll aborative project Buchu, Barasoma betulina. small farmers have planted more than five of the Herb Research Foundati on (HRF), the Photo © 2000 Cobus Coetzee. acres of buchu as a commercial crop, and Agricultural Research Council (ARC) of are planning future test plots. A-SNAPP par South Africa, and Dr. Jim Simon of Rutgers pect of US$250 fo r a ni ght's work difficult ticipants are careful to maintain the geneti c Uni versity, is fun ded by a grant from the to resist. The situation is complicated by im integrity of the wild strains when sourcing United States Agency for Intern ati onal De proper harvesting practi ces, in which collec and pl anting seeds. Successful cultivati on velopment (U SAID). tors uproot and kill entire pl ants in the pro will bring African farmers reli able income, For centuries, South Africans have cess of harvesting leaves. On September I, provide a source of hi gh-quality buchu oil to used buchu leaves to treat conditions such FOX News drew attention to the threats fac the intern ational market, protect wild popu as kidney disease, stomach ailments , and ing buchu and other Afri can medi cinal plants lati ons, and preserve this important tradi rheumatism. Now, essential oil fro m buchu in an online story entitled, "Poachers Plun ti onal medicine for local people. All of these is in demand by Western food manufactur der South Afri ca's Flora l Treasures" goals are in keeping with the mission of ers (who use it as a fl avor enhancer) and per A~ Readers interested afri ca>. The newsletter features profiles of Internet access will receive a print version Afri can herb compani es and specific natural of A-SNAPP Update after local print shops = ·~~!',.~ ~~;: ~~;e~so ~~ a~~~t~~~~ products, market research and news about downl oad them from the website. Upcom .,,.,,, ,,,,, ,,,,,,, able Natural Afri can Plant regul atory issues, articles on A-SNAPP par ing issues will discuss new markets fo r Afri Products (A-S NAPP) project can find news ti cipants' success with specific plants, and can herbs, the internati onal regulation of bo online in A-SNAPP Update - a biweekly other relevant topics. In the future, Afri can tani cal medicine, and intellectual property newsletter availabl e at 16 HERB ALGRAM 50 2000 HRF NEWS Rob McCaleb Presents Audrey Harkness O'Connor lecture at Cornell In September, HRF President Rob ton , DC, and in 1980 was awarded the Helen herbs, it was fasc in ating to visit a repos itory McCaleb was honored by an in vitati on to deConway Little Medal of Honor by the Herb of so many fine examples of th e importance present thi s year's Audrey Harkn ess Society of America. of herbal medicine in the past." O'Conn or lecture at Cornell University. While at Cornell , McCaleb enj oyed an More than 200 members of the Cornell McCaleb's presentation was the 12' 11 in a se opportunity to ex plore the herb garden and fac ulty and student body attended McCaleb's ri es sponsored annually by Cornell Planta other portions of Cornell Plantati on's 3,000 presentati on, entitl ed "The Role of Herbs in tions, a coalition representing Modern Health Care." the university's arboretum, bo- 11 McCaleb remarked, "There tanical garden, and natural ar- Learn about herbs ... was a hi gh level of interest eas. The botani cal lecture se in the evidence supporting ri es commemorates the life 11 the use of herbs, and good and work of th e late Audrey then follow your own path. comments about th e major Harkness O'Connor, a horti- -Audrey Harkness O'Connor, 1914-1999 debates in th e botani cal culturist, writer, illustrator, and health care wo rld today, es- educator who dedicated her pecially the subject of herb energy and talent to Cornell Plantati ons dur ac res, whi ch encompass the F.R. Newman drug interactions and product quality and ing a career that spanned more than 40 years. Arboretum, num erous specialty gardens, consistency issues." Pas t lecturers in the According to a recent article in Cornell campus trail s, and 18 off-campus areas pre Aud rey Harkness O'Connor seri es have in Plantations Magazine, for which she served served for natural science studi es. McCaleb cluded Steven Fo ter. who presented "Herbal as editor for 22 years, O'Connor" ... was es was equall y impressed with the co ll ecti on of Folk Medicine to Modern Phytomedicine" peciall y well known for her love of herbs and antique herbals, botanical illustrati on, and in 1993 , and Mark Pl otkin. who spoke on her equally strong love for educating people hi stori cal information at the Cornell Univer "Rain Forest Con servation and the Search about them ." O'Connor was instrumental in sity Library. "The library contains a wealth for ew Jungle Medicine" in 1997. the development of Cornell 's Robison York of inform ation on the history of herbals and O'Connor requested that McCaleb be the Herb Garden, which was later recognized by th e major role they played in the develop invited speaker for the fall 2000 lecture Garden Design magazine as one of th e best ment of publi shing," said McCaleb. "Fro m shortl y before her death in 1999. herb gardens in America. She also assisted HRF's perspec ti ve, as the keeper of one of - Evelyn Leigh, HRF 0 with the planning of the National Herb Gar th e world 's most comprehensive coll ec ti ons den at the National Arboretum in Washing- of current sc ienti fic journal literature on HRF Adopts Community Herb Gorden The Herb Research Foundati on is for HRF staff members tunate to be located in beautiful Boulder, make plans to Colorado, where an abundance of parks, foot rehabilitate the paths, and open space make th e city a pleas neglected garden. ant pl ace to live and work. To help preserve Ph oto © 2000 Lyndee Berg . thi s part of Bou lder's unique charac ter, staff members at HRF have adopted a small herb garden on county property near the down town area, just minutes from the HRF of fice. The orphan garden was planted 15 years ago by the local Rocky Mountain Herbalist Coalition, but has received no regul ar care in at least I 0 years. Many of the plants have done such an ad mirable job of hanging on (especially the yarrow and mints!) that HR F staff were inspired to rehabilitate and main about herbs-or just pass a sweetl y scented pl ays. Along with popular med icin al, aro tain the garden. aftern oon. This fa ll , HRF volunteers wi ll fo matic, and culinary herbs, the garden wi ll In addition to beautifying a local green cus on tidying up the garden for wi nter. featu re native plants that are threatened by space, the project will provide the public with Spring plans include the addition of new overharvest, with informational signs high a place to see, touch, taste, smell , and learn plants, identifying signs, and educational dis- li ghting their plight. - Nancy Hoegler, HRF 0 2000 HERBALGRAM 50 17 DEAR READER continued from page 7 Botanicals in Baja. James Williams describes gardener extraordinaire Gabriel How earth Landeros' beautiful sanctu ary at the tip of the Baja Cali forni a. Gabriel is known among the herbal cognoscenti as a master herb gardener. Hi s numerous verdant accom plishments incl udes three of the theme gardens at ABC's Case Mill Homestead. Lauding Elderberry. Peripatetic herb-story hunter Chri s Kilham writes of European experience with elderberry, especiall y its imrnunostimulant ap plicati on for upper respiratory tract infections associ ated with colds and flu . Legal- Regulatory. Lots happening: A coalition of industry associati ons has petiti oned the FDA to ac cept the industry label warning and recommended maximum dose limits fo r ephedra. The Office of Women's Health at NIH held hearings and fi led a re port calling for more research on ephedra to help es ~~~~~·: C02 process is a state tablish appropriate regul atory policy. FDA has pub that optimizes lished proposed guidelines fo r herb compani es that fluid extraction may want to fil e for dru g approval fo r botani cals. And ~~~~~~~~ ·~izes the amount of 1!11 ients removed from the Center for Science in the Public Interest has fil ed and eliminates any complaints to FDA about herbal ingredi ents in snacks, contamination from soft drinks, and ready-to-drink teas. 0 . Our extracts are in the only certified ~~i'lf:i~f:¥ er, super critical ~ North America. formation on 0 , KAVA, GINGER, I-OXIDANTS and ORDER ONliNE BURG • FL 34749 e : 877.SAWPALM Fax: 352.787.6496 .USNUTRA.COM I NSTITUTE '01 NU TIACEUTICA LAOVAIIICEMUT 18 HERBALGRAM 50 2000 GRANTS AND AWARDS Tyler Receives Honorary Doctorate from German University Recalling how a single let Bioc hemi e der Pflanzen in Hall e, fight was lost and no one seemed ter, written 50 years ago, dra East Germany. Tyler's fami ly to care. Then in the late 1980s matica ll y changed hi s life, Yarro fo und housing in West Berlin and and earl y 1990s, the tide began E. Tyler, Ph.D ., Sc.D., accepted he commuted on weekend s. to turn and phytomedicines be an honorary doctoral degree in Although not fully real gan to regain popularity in the September from Martin-Luther ized at the time, Tyler's experi U.S. University in Hall e-Wittenberg, ence in Germany and his many In 1993. Tyler persuaded Germany, the first time such a new ac quaintanc es would th e American Botanical Coun cil degree has been awarded to an change hi s life dramatically. to publish an Eng li sh translation American. There, in the city where the term of the German Commission E In hi s acceptance speech, "alkaloid" originated in 181 9, he monographs that compil es au Dr. Tyler recounted hi s first was startl ed by the rational use thoritative information on the meeting with the eminent Ger of plant drugs by ph ysic ians, safety and efficacy of botanical man academician, Dr. Kurt pharm acists, and consumers, in med ici nes. Excell ent reference Mothes. While still a you ng, in contrast to th e synthetic chemi wo rks, based large ly on German Varro E. Tyler, Ph .D. experienced scienti st, Tyler ca l drugs that dom in ated Ameri sc ience, have appeared and are wrote Mothes a letter inquiring can medi cin e at the time. He increasingly in th e hands of stated Tyler in his speech. about hi s work on ergot alkaloid learn ed th e importance of American physicians, pharma Dr. Tyler views his work biosynthesis. In vited to visit ph ytomed-ic ines and their sig cists, and consumers. "We have as a composite of the work of Mothes' Gatersleben laboratory, nificant hea lthcare role. not yet been able to convince our many and thanked them for Tyler and his wife visited in 1956 Following hi s return home ultraconservati ve Food and Drug ''helping revolutionize medical and began a life-l ong friendship in 1964, Tyler made every effort Administration of th e value of practice in the United States and relationship of scientific co to keep plant medicine ali ve . He such a safety and efficacy review. by demonstrating the im operat ion. In 1963, Tyler was co-authored a pharmacognosy but I am confiden t that the de portance of phytomedicine." in vited to serve as a vis iting pro textbook, but ad mits that it was sire of the American people will - Jan Veenstra. ABC 0 fessor at the ln st itut flir a stru gg le. Many thought the prevail in that arena as welL'' Two-Year Clinical Trial to Evaluate Echinacea for Upper Respiratory Infections in Children Bastyr Uni vers ity and the of Health , will be a doubl e- blind, II years of age. Researchers in ch ild to a provider of comple University of Washington are randomized, pl acebo-controlled tend to determine whether the mentary medicine and that 53.3 co ll aborating to evaluate the ef clini cal tri al (using a liquid non use of echinacea shortens the du percent used complementary and ficacy of echi nacea in treating alc oholic solution expressed ration, or lessens the severity of altern at ive medicines for the upper respiratory infection fr om the above-ground URis in children, co ll ect data on treatment of URi s. (URis) in children. Echinacea purpurea pl ant parts side effects. and de termine James Taylor. M.D .. of the The two-year stud y, with citrus fruit flavoring) in whether the use of echi nacea University of Washington Child funded by the National In stitutes volving 600 children from 2 to helps reduce the rate of second Health In sti tu te, is the principal ary bac terial infections associ investigator. Leanna J. Standish, ated with URi s. Previous stud N.D .. Ph .D.. L.Ac .. and Carlo ies have been perfo rmed with Calabrese. N.D .. M.P. H. are adults; thi s will be one of the first co-investigators at Bastyr Echinacea, trials to study the efficacy of University. - Jan Veenstra, Echinacea ec hin acea in treating URi s in ABC 0 purpurea. children. Photo © 2000 A survey conducted re [Bastyr Universi ty website Karen Robin . centl y by the Puget Sound Pedi 2000 HERBAlGRAM 50 19 GRANTS AND AWARDS NIH Funds Two Additional Botanical Research Centers Purdue University and the Alabama Birmingham (UAB). der the center's associate direc (Zingiber officinale), turmeric University of Arizona at Tucson Weaver, who is a distinguished tor, UAB pharmacology profes (Curcuma tonga), and gum resin received grants in September professor and head of the Purdue sor Stephen Barnes, Ph.D., will of boswellia (Boswellia serrata). from the National Institutes of Department of Foods and Nutri in vestigate the ability of botani ACPRx researchers intend to Health (NIH) Office of Dietary tion, will lead research into cals to inhibit inflammation that identify and study the acti ve in Supplements (ODS) in coll abo plants considered to prevent age is characteristic of many chronic gredients and pharmacology of ration with the National Center related di seases, including os di seases, including cardiovascu these herbs, which will, in turn, for Complementary and Alterna teoporosis, cancer, cardiovascu lar diseases, and the antioxidant lead to clinical studies of arthri ti ve Medicine (NCCAM). They lar di sease, and loss of cognitive activity of polyphenols fo und in tis and other chronic inflamma join the Uni versity of California function. Researchers at Purdue such foods as grapes (Vitis vin tory diseases, including respira at Los Angeles and th e Univer will focus on soy (Glycine max) ifera) and berries. tory diseases such as asthma. sity of Illinois at Chi cago in re products and their constituents' The new Arizona Center - Jan Veenstra, ABC 0 ceiving approximately $8 mil ability to replace estrogen and for Phyto medi cine Research li on each in similar botani cal re protect against bone loss in post (ACPRx), under the direction of [NCCAM website ORGANIZATION NEWS USP Establishes New Expert Committee on Botanicals The United States Phar raw materials and 10 for finished Home Products; Prof. Norman Scientific Director FDA/Joint macopoeia (USP) has estab dosage forms. Farnsworth, University of Illi Institute of Food Safety and Ap lished a new Committee of Ex The committee contains nois at Chi cago; Prof. Dr. Otto plied Nutrition (JIFSAN), Wash perts on Dietary Supplements - several internationally respected Sticher, Swiss Federal Institute ington, D.C.; William Popin, Botani cals. Consistent with herb experts and two technical of Technology, Zurich; Yuan Director, Quality Assurance, US P's commitment since 1995, ex perts from the herb industry. yuan Chiu, Director, Office of Twinlab Utah Division, Ameri the committee will draft stan The chairman is Prof. Paul Schiff New Drug Chemistry, Center for can Fork, Utah; Farouz Ertl, dards monographs for the most Jr. of the University of Pitts Drug Evaluation and Research, D.V.M. , Vice President, Techni popular herbs sold as dietary burgh; vice-chair is Paul Kucera, FDA, Rockville, MD; Dennis cal and Scie ntific Affairs, supplements in the U.S. market. Senior Director of Global An a Gorecki, Dean and Professor, Botanical International/Hauser, To date, USP has published 15 lytical development, Wyeth University of Saskatchewan, Long Beach, CA. standards monographs for herbal Ayerst Division of American Canada; Samuel Page, Ph.D., - Mark Blumenthal, ABC 0 Trade Associations Guide St. John's Wort Manufacturers with labeling Statements Both the American Herbal AHPA's Board of Trustees This suggestion is pro statements are permitted, but the Products Association (AHPA) adopted the following statement: posed as "guidance" rather than statements should be placed on and the Consumer Healthcare "NOTICE: Do not use this prod formal "trade recommendation." product labels by April 2, 200 I. Products Association (CHPA) uct while taking any prescription CHPA's voluntary labeling CHPA members may also opt to have made labeling recommen drug(s) without the advice of program agreed on the fo ll owing combine the new statement with dations fo r St. John 's wort (Hy your prescribing physician. information statement: "If you other voluntary labeling infor pericum perforatum) products. Avoid excessive exposure to UV are taki ng a prescription medi mation, as appropriate. While similar in intent, the irradi ation (e.g., sunlight; tan ci ne, ask a health professional." - Karen Robin, ABC 0 actual verbiage varies somewhat. ning) when using thi s product." Al ternative, but equi valent 20 HERBAlGRAM 50 2000 RESEARCH AND WORLD NEWS Peruvian Plant Extracts Found to Inhibit TB and Other Pathogens New research has identified several in their medical practices. identified active ingredients in extracts that Peruvian botanical extracts that show in vitro Researchers examined approximately show activity again t malaria. activity against several known pathogens and I ,250 extracts from plants utilized by the "It's one of the best examples I know parasites. The project focused on the phar Aguaruna people in their traditional medi of collaboration between America and the macopeia of the Aguaruna people, a tribe of cine. Many in vitro screens showed activity host country universities. Perhaps even more theJivaro of the Upper Amazon Basin, work agai nst Plasmodium Jalciparum (w hich important is the tremendous collaboration ing with the International Cooperative causes malaria), Cryptosporidium parvum, and trust that has developed between our Biodiversity Program - Peru. This program Toxoplasma , Leishmania, and Mycobacte selves and the Aguaruna people," stated Dr. helps to identify new phytopharmaceutical rium tuberculosis (which causes tuberculo Lewis. possibilities while promoting cultural and sis, orTB). Some 46 percent of those samples Lewis presented hi s research at the 14'h economic support to the native people. showed TB inhibition, "an incredibly encour Annual meeting of the Society for Economic In addition to the large information aging result so earl y in the research," Lewi s Botany in June 2000, and analytical results base founded upon the region's rich vegeta said . The extracts inhibited the TB bacteria are to be published in an upcoming tion, the Aguaruna people have "tremendous by 80 to 100 percent, a surpri sing discovery, issue of Pharmaceutical Biology. scientific knowledge of the medicines and Lewis said, as these rates are "extremely hi gh - Ja n Veenstra, ABC 0 great knowledge of plant biology," said lead for medicinal plants in general." [Lewis W. Personal communication. Oct researcher Walter Lewis, Ph.D., biology pro The next step in the project is to iden 16,2000. fessor of Washington University in St. Louis, tify the active compounds in the extracts and Schnall B. Peruvian Plants Hold Promi se Mi ssouri , who, with his team, lived among their bacterial targets. The research team, col for TB Drugs. Washington University the tribe for months, collecting samples and laborating with the Federal Hansen Labora Record, 2000 Aug 10; 24(35): 1-2.] learning about specific plants the people use tory at Louisiana State University, has already New Sweet Potato Variety May Prevent Blindness The leading cause of childhood blind in Lima, Peru is sponsoring a $3.2 million potato is a staple food in the targeted area. ness in some developing countries is a defi project to plant 5,000 hectares with the new The current sweet potato consumed is white ciency of vitamin A, a deficit that affects ap variety of sweet potato by 2004 to help fleshed and does not contain the targeted mi proximately 251 million children in devel people in sub-Saharan east Africa to avoid cronutrients, while just a small serving of I 00 oping countries. Of those 251 million chil vitamin A deficiency. grams of the new variety (6-7 tablespoons) dren, 10 million of them suffer from xe Sweet potato is rich in beta carotene provides the daily requirement of beta caro rophthalmia (dry eye), 500,000 are irrevers (which the body converts into vitamin A) and tene, vitamins B and C, and iron. ibly blinded, and 3 million die from vitamin SPK 004 was selected from approximately - Jan Veenstra, ABC 0 A deficiency illnesses. However, a new va 5,000 varieties stored in the center's gene [Wallerstein C. ew sweet potato could riety of sweet potato, under development by bank. The potato project will act as a backup help combat blindness in Africa. Br Med J the name SPK 004, has the potential to re to other supplement programs and has one Sep 30, 2000;321 :786] duce these losses. element that may strongly favor its succes s: The International Potato Center, based diets will not have to be changed as the sweet Furtive Fungus Among Us A honey mushroom (Armillaria wood decay, stunts, and sometimes kills The huge fungus spreads its fine ostoyae) has been discovered under 2,200 trees. It is estimated to be 2,400 years old. rhizomorphs underground through upper acres (about 3.5 square miles) of the Malheur Catherine Parks, a scientist at the Pa level soil. Dead trees are the primary indica National Forest in eastern Oregon, and is cific Northwest Research Station in La tion of its presence, although during autumn considered the largest living organism ever Grande, Oregon, ferreted out the fungus this rains, light brown mu shrooms come to the found. It seized that title from another honey past summer after hearing of a major tree surface. Otherwise the fungus li ves an un mushroom, which covers a paltry 1,500 acres die-off. Using aerial photos, she estimated eventful but long, by human standards, life. near Washington state's Mt. Adams, found the extent of the fungus and identified col - Karen Robin, ABC 0 in 1992. The massive root-rot fungus causes lected samples through DNA testing. [Associated Press report. Aug 6, 2000] 2000 HERBALGRAM 50 21 RESEARCH AND WORLD NEWS White House Creates Commission on Complementary and Alternative Medicine Policy The White Hou se Commi ssion of The focus of thi s meeting was to I) events. Tow n Hall meetings arou nd the U.S. Compl ementary and Altern ati ve Medi cine learn the most significant opportunities, ob and Commi ssion hearings will elicit testi Poli cy held its first formal meeting in Was h stac les, and barriers to the coordin ati on of mony fro m a variety of ex perts on various ington, D.C. in October, 2000. Establi shed Compl ementary and Alternati ve Medicine aspects of CAM. by Executi ve Order on March 7, 2000, thi s (CAM) research in the public and private The October hearin gs covered such commi ssion is to report, through the Secre sectors, and 2) to di scuss strategies and pos issues as federal support fro m the National tary of the Department of Health and Hu sible solutions to improve and expand th e In stitutes for Health for CAM research, re man Services, on legislati ve and administra current research environment to address search support and co ll aborations, research ti ve reco mmendati ons to ass ure th at publi c CA M research needs. in the regul atory fra mework, and private sec policy max imi zes the benefits of comple Meetings are open to th e public and a tor support fo r CAM research. mentary and alternati ve medicine. Pres ident website Harvard Medi cal Schoo l has created a Medical Center and associate professor of Eisenberg emphas izes th at the use of new Di vision fo r Research and Educati on in medi cine at HMS , has bee n appointed direc complementary and in tegrati ve therapies Complementary and Integrati ve Medica l tor of the new divi sion. He notes th at in spite must be gui ded by scientific in vestigation. Therapies. The di vision 's goals include co of the growing popul arity and acceptance of "Thi s new di vision will permit a scholarl y, ordin ating sc ienti fic research (including compl ementary and integrati ve medicine, evidence-based approach to complementary clinical trials) in complementary and inte "there has been a tendency to marginali ze and integrati ve care. In turn , thi s info rma grati ve medicine, sharing ev idence-based compl ementary and alternati ve medi cine in ti on will serve to create a system of checks resources between Harvard Medical School mainstream medi cal institutions. Despite dra and balances to enable consumers and pro and its teaching affili ates, developing edu mati c increases in federal funding for re viders to navi gate thi s new field with greater cati onal programs and poli cy, and establi sh search as well as in creased pati ent interest, confidence." - Jan Veenstra, ABC 0 ing criteri a to jud ge efficacy and safety of fa r too littl e data currentl y ex ists on safety, [Harvard Med ical School Office of Pub complementary therapi es. efficacy and mechani sms of acti on of com li c Affa irs website To help clarify en'Ofs and mi sconcep Ph ytoChem's pres ident and head of uct based on the clinical data of the ori gin al tio ns about th e herb al mark etplace, sc ience, Robert Barry, PhD, beli eves th at if company when, in fac t, they are not produc Ph ytoChem Technolog ies of Chelm sford , PhytoChem 's edu cational efforts can "help ing an identi cal or equi valent product. Giv Massachusetts now offers what the company clear up misconcepti ons and improve herbal ing exampl es of products made from gi nkgo claims is accurate scientifi c informati on on quality in the market" then "it's worth the (Ginkgo biloba), St. John 's wort (Hypericum botanicals to members of the industry and effort." petjoratum) and kava (Piper methysticum), the medi a. Free of charge, Ph ytoSci ence PhytoChem's first PhytoScience Brief, the brief goes on to discuss how th is type of Briefs will address such issues as accurate "The Hazards of Borrowed Sc ience," was practi ce leaves th e herb market vu lnerabl e testing, standardi zation , tox icity of herbs and released in August 2000. Thi s bri ef discusses to poor quality and possibly ineffective bo herbal products, proper dosage amounts, bio th e current problem of compani es that "bor tanical products, according to PhytoChem. log ical acti vity, and what constitutes "real row" or mimi c a product th at has been suc - Jan Veenstra, ABC 0 sc ience." These reports are not associated cessful , based onl y on a small portion of its [PhytoChem website 22 HERBALGRAM 50 2000 RESEARCH AND WORLD NEWS The Traditional Acupuncture Institute launches New Botanical Healing Master'sProgram The Traditi onal Acupuncture Institute cia! Advisor to th e House of Lords Science will also work in the nea rby medi cinal pl ant (TA l), of Columbi a, Maryland , is laun ching and Technology Committee inquiry into gard en of noted ethnobotani st Jim Duke, two new mas ters degree programs. in botani complementary and altern ati ve medi cine. He PhD. Students will accompli sh 500 hours of ca l hea ling and appli ed healing art s. Cl asses has al so received a personal appointment by cl inica l prac ti ce th at will include ex posure will begin in the fa ll of 200 I at a new cam HRH the Prince of Wales to co-chair th e to a wide range of all opathi c specialties. pus in Columbi a, Mary land . Reg ul atory Working Group for hi s Founda "We will rein state the apoth ecary tra oted herbal medi cine practitioner and tion for Integrated Medi cine in the U. K. dition." Mill s said , "graduates from thi s pro author SimonY. Mill s will direct the botani The two M.S . degree programs have gram will understand what herbs may or may cal healin g program. A co-founder and been approved and end orsed by the Mary not do, and how to ass ure that what th ey pro fo rmer head of Exeter University's Comple land Higher Educati on Commi ss ion . The vid e is rea ll y good for th e ir cli ent. " mentary Medical Center, Mills will coordi Institute is seeking reg ional accreditation - Jan Veenstra, ABC 0 nate curriculum, recruit faculty, and teach. from Middle States Associati on of Colleges [TAl Press Release. World-fa med Herbal M i li s is the Secretary of the Europea n and Universiti es Commi ss ion on Hi gher ist to be Director of New Botanical Healing Sc ienti fic Cooperati ve on Ph ytotherapy Education. The three-year program will in Master's Degree Program in Man·land. Sep (ESCOP), whi ch wo rks to ensure quality, clude a blend of sc ientific and holi sti c meth tember. 2000. STE\'EN FOSTER GROL"P, 1:\C . ea tured in HerbaiGram for over a decade, th e ph otographs of Steven Fo ster are available fo r licensing for editorial or comm ercial projects. Specializing in medicinal and aromatic plants, our stock photo files include more than 70, 000 images, including most major herbs sold as dietary supplements . ....,., .•... Steven Fosler Croup, Inc. Ellen Miller, Vice President, Sales and ,lfarketing P.O. Box 1343 Fayelleville, AR 72702 501- 52 / -5887 fax 50 1-521-6369 e 111 a i 1: emiller@stevenfoster. com www. stevenfoster. com C 0 l\1 E T 0 T H E S 0 l" R C E 2000 HERBALGRAM 50 23 The HERB REsEARCH FOUNDATION provides accurate up-to-date scientific information on the health benefits of herbs. Our members include the public, health professionals, researchers, and herb industry manufacturers. Anyone can access HRF information services - call (303) 449-2265. And tiupport the organization that educateJ the worUJ ahout herhti HRF is internationally recognized as a leading source of current scientific information on botanicals. We advocate worldwide plant conservation and sustainable cultivation, and are instrumental in educating legislators and the media about the health benefits and safety of herbs. HRF D EPENDS ON M EMBER S UPPORT TO MEET JTS G OALS. P LEASE JOIN US IN S UPPORTING THE FUTURE OF BOTANICAL MEDICI E! MemberJbip BenefitJ • Subscription to HerhaLGram or Herh.J for Health (or both) HERB • Herh Ruearch NewJ, our quarterly newsletter RESEARCH • Discounts on all Information Services • Special benefits for higher level supporters FOUNDATION Better world health through the informed /Me of herhtt~ 1007 Pearl Street, Suite 200, Boulder CO 80302 USA RESEARCH REVIEWS The authors of the more recent stud y suggested that the anti Antioxidant Activity of Tea oxidant assay utilized by Serafini and coll eagues (called the Total Radical trapping Abi lity of Plasma, or TRAP assay) might be less Unaffected by Milk reliable th an the FRAP method, as TRAP may be associated with a hi gher degree of variabil ity.- Evelyn Leigh, HRF 0 1. Leenen R, Roodenbu rg AJC, Tijburg LBM , Wi seman SA . A single dose of tea with or without milk increases plasma antioxidant activity in humans. Eur J Clin Nutr 2000;54:87-92. 2. Serafi ni M, Ghi selli A, Ferro-Luzzi A. In vivo an ti ox idant ef fect of green and black tea in man . Eur J Clin Nutr 1996;50:28-32. Willow Bark Extract Reduces low Back Pain In spite of its long and compelling history of traditional use, there is little research-based informati on on willow bark (Salix alba L., Salicaceae) as a pain reli ever, and dosages recommended by of ficial sources are often contradictory. To clarify dosage iss ues, a team Green Tea, Camellia sinensis. Photo © 2000 Steven Foster. of German researchers conducted a four-week clinical tri al designed to compare the effectiveness and safety of two different dosages of wi ll ow bark extract for all ev iating flare- ups of low back pain. 1 Re The antioxidant activity of both green and black tea (Came l sults showed that both the hi gh and low doses of willow bark extract lia sinensis (L.) Kuntze, Theaceae) in the body (in vivo) is welles afforded significan tl y more pain relief than placebo, but the hi gher tablished, but an important question remains: Does the addition of dose of wi ll ow bark (240 mg/day) was significantl y more effective milk to tea inhibit the bioavailability of antioxidant tea polyphe than either th e low-dose treatment (120 mg/day) or the placebo. nols? Not according to the results ofthi s Dutch stud y, which showed The placebo-controlled stud y in volved 2 10 chroni c low-back that a single dose of either black or green tea, with or without milk, pain sufferers currentl y experi encing exacerbati ons of pain (rated 5 caused a significant ri se in plasma antioxidant activity. 1 or higher out of a possible score of I 0 on a visual pain-approxima The crossover study compared the antiox idant effects of green tion scale). The tea, black tea, and non-carbonated mineral water, with or without study participants milk, in 21 healthy volunteers. Each participant received a dose of were randoml y as one of the six test substances on six different days. A single dose of signed to receive tea was defined as 2 g of tea solids in 300 ml of water (Lipton Re wi ll ow bark extract search Blend, Lipton, Englewood Cliffs, NJ). The researchers uti at a low dose (120 lized the ferric reducing ability of plasma (FRAP) assay to mea ure mg/day) or a hig h both plasma antioxidant and catechin levels. Blood samples were dose (240 mg/day), taken before consumption of the test substances and again 30, 60, or placebo. Patients 90, and 120 minutes after consumption. According to the results, were permitted to both green and black tea caused a significant ri se in plasma antioxi supplement their test dant and catechin levels, but the effect of green tea was significantly treatment as needed, greater at all time points. The additi on of milk to either type of tea with up to 400 mg did not significantly alter responses. per day of tramadol, While a limited number of studies support these results, oth a prescription pain ers have shown that milk had a negative impact on the antioxidant reliever. capacity of tea. An earlier study published in the European Journal N inety -one of Clinical Nutrition concluded that while the addition of milk to tea percent of patients had no effect on antioxidant activ ity in vitro , it did appear to inter completed the trial. fere with absorption of tea polyphenols in vivo. The authors of the The main outcome older study offered two possible explanations for thi s effect. First, meas ured was pain because milk proteins can cause complexation (binding) of tea relief, defined as the polyphenols, the researchers proposed th at milk/polyphenol com proporti on of pa plexes resist gastric breakdown, rendering the polyphenols un ava il tients reporting free Willow, Salix spp. Photo © 2000 able for absorption. They also theorized that milk might hinder dom from pain for at Steven Foster. polyphenol absorption by increasing gastric pH .2 least 5 days during 2000 HERBAL GRAM 50 25 RESEARCH REVIEWS I the last week of treatment, without the use of tramadol. Secondary measurements were the proportion of patients who needed to use tramadol during th e study and improvement in sy mptoms from baseline. According to the resu lts, 39 percent of participants in the high-dose wi ll ow group were pain-free during the final week of treat ment, as compared to 21 percent of the low-dose group and onl y six percent of the pl acebo group. For those taking the hi gher dose of willow bark, pain relief was ev ident after on ly one week, and sig nificantly more people in the placebo group req uired tramadol dur ing each week of the study. There was a similar low rate of mild adverse effects among all three groups, some of whi ch were attrib uted to tramadol. One patient in the low-dose willow group experi enced an all ergic reaction (swo ll en eyes and itching) that the in ves tigators believed was treatment-related. The willow bark preparation used in the study was a dry ex tract containing 0. I 53 mg of sa li cin per mg of extract, manufactured by Plantina GmbH of Munich, Germany. According to the research ers, results of this tri al support earli er reports that willow bark ex tract "standardized to yield 240 mg of sa li cin" is an effective pain 23 reliever. - Evelyn Leigh, HRF 0 Vitex, Vitex agnus-castus. Photo © 2000 Steven Foster. I. Chrubas ik S, Eisenberg E, Balan E, Weinberger T, Luzzati R, Conradt C. Treatment of low back pain exacerbati ons with willow cycles. The questionnaires were specificall y designed to determine bark ex trac t: A randomi zed double-blind stud y. Am J Med the effect of vitex on psychological and phys ical sy mptoms, the four 2000; I 09:9- 14. classic DACH complexes, and single groups of characteristic symp 2. Schaffner E. Eidenrinde-Ein Antiarrheumatikum der toms. Improvement was assessed according to the standard Clinical modernen Phytotherapie'l In : Chrubasik S, Wink M, eds. Global Impression Scale, whi ch allo ws patients to rate symptomatic Rheumatherapie mit Phytopharmaka. Stuttgart: Hippokrates change on a scale of one to seven (very much improved to very Yerlag; 1997: 125-7. much worse). 3. Schmid B, Tschirdewahn B, Katter I, et al. Analgesic effects of At the end of the trial , statistically signi ficant decreases were wil low bark extract in osteroarthriti s: results of a clinical double observed in the frequency of all symptoms and DACH complexes. blind trial. Fa ct 1998;3: 186. Forty-two percent of patients reported that they were no longer af fected by PMS, 51 percent had a decrease in sy mptoms, six percent Vitex Improves Symptoms of PMS reported no change, and one percent reported an increase in the num ber of sy mptoms. Eighty-six percent of physicians noted that vitex A large new clinical trial adds to the growing body of ev i treatment had "a pronounced efficacy," and 81 percent of partici dence supporting the use of the small fru its of vitex, also known as pants rated their status after treatment as "very much or much bet chastetree (Vitex agnus-castus L., Yerbenaceae), in the treatment of ter." With regard to tolerability, 94 percent of the women rated the premenstrual syndrome (PMS), a variable complex of symptoms vi tex preparation as good or very good, and no serious side effects 1 affecting up to 40 percent of fertile women. According to results of were reported. Minor side effects reported by the remaining wo men the open-l abel German trial , 93 percent of study participants reported included mild skin reactions and gastrointestinal upset. that their PMS symptoms either decreased or disappeared altogether In an interesting as ide, th e authors suggested that vitex may after treatment with vitex over the course of three menstrual cycles. have had a positive effect on fertility fo r some women who had According to the investigators, PMS has been associated with trouble becoming pregnant before the trial. They noted , "Data from up to 150 different symptoms, most of which fall into four classic this tri al support the occasionally described restoration of fertility "symptom complexes" defined as depression, anxiety, craving, and by Vi tex treatment. No woman was pregnant at the start of Vitex hyperhydration (DACH). Their study was des igned to assess the ef therapy, and 19 of the 23 women who conceived while on Vitex treat ficacy and tolerability of a new solid vitex preparation call ed ment belonged to th e group of 126 women (8 %) who had been to Femicur®, manufactured by Schaper & Brummer GmbH & Co. , date unsuccessful at becoming pregnant." - Evelyn Leigh, HRF 0 Salzgitter, Germany. Each capsul e contains 1.6- 3.0 mg dried ex tract of vitex berry in a ratio of 6.7- 12.5:1 , equ ivalent to 20 mg of I. Loch E-G, Se ll e H, Bob litz N. Treatment of premenstrual sy n dried berry. drome with a phytoph armaceutical formulation containing Vitex The I ,634 stud y participants received treatment with one cap agnus castus. Journal of Women's Health & Gender-Based Medi sule twice daily of Fem icur, and changes from baseline were re cine 2000;9(3):3 15-20. corded on questionnaires completed by ph ysic ians based on inter views conducted before treatment and aga in after three menstrual 26 HER BALG RAM 50 2000 RESEARCH REVIEWS diazepine drugs. which can have serious side effects, including de Kava Extract Relieves Anxiety: pendence, daytime drowsiness. and memory impairment, among oth ers. Kava. on the other hand. has demonstrated a remarkable safety Meta-Analysis profile, with side effects of onl y 1.5 to 2.3 percent reported in stud To pe1fom1 a meta-analysis, researchers select the best of ava il ies of more than 3.000 patients. The adve rse events reported most able clinical trial s, then review and combine the results, allowing often by kava users were gastrointestin al complaints. all ergic skin them to draw conclusions with more confidence than would be pos reactions. headache, and photosensitivity. The researchers noted that sible from isolated studies. For a meta-analysis of trials on kava as patients often prefer natural alternati ves . physicians shou ld con (Piper methysticum G. Forster, Piperaceae), researchers at the Un i sider kava extract as a viabl e treatment opti on for patients experi ve rsity of Exeter. UK, selected three out of 14 double-blind , ran encing anx iety disorders. - Rob McCaleb, HRF 0 domized, placebo-controlled clinical ttials.1 Their results helped con firm the validity of the ind ividual kava studies: Compared with pl a I. Pittler M H, Ernst E. Efficacy of kava ex trac t for treating anxi cebo, kava extract is an efficacious treatment for an xiety. ety: systematic review and meta-analys is. J Cfin Psrchopharmacol The three trial s were selected based on their use of the same 2000;20:84-9. outcome measurement (the standard Hami lton Rating Scale for Anxi 2. Yolz H-P, Kieser M. Kava-kava extract WS 1490 versus pla ety, or HAM-A) and inclusion critetia (a baseline HAM-A score of cebo in anx iety disorders: a randomized placebo-controlled 25-week 19 or higher), as well as the type and dosage of the kava preparation outpati ent tri al. Pharmacopsychiatrr 1997;30: 1-5 . tested (300 mg/day of extract standardized to deliver a total daily dose of 70 percent kavapyrones, i.e., 21 0 mg). All three trials uti li zed the same kava extract, WS 1490 (Laitan®, manufactured by W. St. John 'sWort Relieves Menopause Schwabe, Karlsruhe, Germany). Results of the meta-analysis dem onstrated a significant reduction in anxiety scores as measured by Symptoms the HAM-A. The sc ientists noted that these findings are supported Menopausal symptoms affect approx imately two-thirds of by the results of the largest randomi zed clinical trial in their data women as they transiti on out of their reproductive years. The sc ien base ,2 and that the results were sim ilar to those of kava clinical re tifi c literature on St. John 's wort (Hrpericum perforatum L., search in general. Patients in the three studies took I 00 mg three Clusiaceae) brietly mentions the herb as a possible treatment for times dail y of kava extract for up to 24 weeks, and analysis sug menopausal complaints. 12 but the first clinica l trial to in vestigate gested a "sig thi s use was conducted on ly last year. nificant reduc While depression is one symptom of menopause that St. tion in th e John 's wort (SJW ) mi ght be expected to improve. German research HAM-A total ers designed a trial to assess its effects on other problems more score of ap spec ific to menopause.' Their results suggest that SJW not onl y helps prox imately 10 reli eve psychological and physical sy mptoms. but also helps en points in favor hance sex ual we ll-being for menopausa l women. Specifically. 76 of kava ex percent of stud y participants experienced a stati sti cal ly sign ifican t trac t. " In non e lessening or disappearance of sy mptoms after 12 weeks of treat of the studies ment with SJW. and participating physicians observed improvement did placebo rate in 79 percent. hi gher th an For the open tri al. I 06 women took three Ki d '· tab lets kava in reduc (Lichtwer Pharma, Germany) per day for 12 weeks. Each tablet con ing anxiety. tained 135 to 225 mg SJW ex trac t standardi zed to 300 meg hyperi Based on cin . No ne of the women had received hormone rep lace ment therapy. U.S statistics, Study participants were assessed at baseline and then aga in around 17 per after 5. 8, and 12 weeks of treatment. At each assessment. the par cent of th e ticipants reported the frequency and severity of psycholog ica l. physi population ex ca l. and vasomotor menopausal symptoms she was experienci ng, periences anxi according to the Menopause Rating Scale. (Psychological sym p ety disorders in toms included irritability. poor conc entrati on. tension, anxiety. and any one year. depression. Phys ical sy mptoms included headaches. heart palpita and the lifetime ti ons, and disturbed sleep. Hot tlashes. excessive sweating, and diz prevalence is al ziness were considered vasomotor symptoms.) She also responded most 25 per to a short sex ual health questionn aire desi gned for this stud y. A phy cent. Conven sician scored eac h pat ient according to the Clinical Global Impres tional treatment sion scale to document therapeuti c effi cacy and side effects. Kava, Piper methysticum. involves benzo- Photo © 2000 Steven Foster. 2000 HERBALGRAM 50 27 RESEARCH REVIEWS Herbal Combination Improves Quality of life for Prostate Cancer Patients In an open clinical trial of 16 men with advanced metastatic St. John's prostate cancer, the herbal combination PC-SPES improved quality Wort, of life and caused significant reductions in pain and levels of pros Hypericum tate specific antigen (PSA), with no major side effects. 1 The research perforatum. ers decided to test PC-SPES in patients whose hormone therapy Photo© 2000 had failed and whose disease was progressing after receiving "nu Steven Foster. merous anecdotal reports" of benefit from the supplement. The PC-SPES formula is a dietary supplement composed of eight herbs: Chrysanthemum flowers (Chrysanthemum morifolium Ramat., Asteraceae); reishi mushroom (Ganoderma lucidum [Leyss. ex Fr.,] P. Karst. Ganodermataceae); licorice root ( Glycyrrhiza glabra L. , Fabaceae); dyer's woad (lsatis indigotica L., Brassicaceae); sanchi ginseng (Panax pseudoginseng Wallich, Araliaceae); Rabdosia rubescens (Blume) Hassk., Lamiaceae; baikal skullcap root, or huang gin (Scutellaria baicalensis Georgi., Lamiaceae); and saw palmetto fruit (Serenoa repens [Bartram] Small, Arecaceae). In the study, the supplemental PC-SPES therapy consisted of three capsules three times a day (total2.88 grams daily) of the herbal formula for five months. Hormone therapy was continued through out the trial. Urologists and anesthesiologists at three different clin ics in Germany and the United States evaluated the effects of PC SPES on pain, quality of life, and PSA levels. Clinical testing at all At the start of the study, 80 to 90 percent of all symptoms clinics included physical exams, blood chemistry, and blood cell (except dizziness and heart palpitations) were "moderate" or count, plus assessment of PSA level, pain, quality of life, "marked" in severity. By the end of the study, only 20 to 30 percent and toxicity. of women were still experiencing psychological and physical symp The results toms of "moderate" or "marked" severity. The researchers reported, were positive. Pain "The overwhelming majority were symptom-free, or their symp scores for each cat toms had become merely 'slight' by this time." Scores for intensity egory of pain de of symptoms on the Menopause Rating Scale were also significantly creased signifi different after treatment, dropping from 63.4 (marked) to 23.5 (slight). cantly, and those Apparently, there was no significant change in vasomotor symp who were taking toms. Only four patients reported adverse events during the trial. narcotics or non Responses to the Sexuality Assessment questionnaire showed steroidal anti-in that patients felt more physically attractive, saw sexual intercourse flammatory drugs as more valuable, and were more likely to initiate sex at the end of (NSAIDs) for pain treatment than they had before taking SJW. Of 82 women who said control before the they no longer felt physically attractive at their first interview, 77 study were able to had changed their view by the end of the study. Overall, approxi reduce their pain re mately 80 percent of the patients agreed that their sexuality had been lief medication by "substantially enhanced" by SJW treatment. The investigators noted, around 40 percent "This represents a significant advantage over synthetic antidepres after 20 weeks of sants, especially in these patients."- Nancy Hoegler, HRF 0 treatment with the herbal supplement. I. Roth L. Hypericum-Hypericin. Botanik, Inhaltsstoffe, Quality of life was Wirkung. Landsberg: Ecomed Verlag; 1990. evaluated with a 2. Wagner H, Wiesenauer M. Hyperici perforati herba standard question (Johanniskraut). In: Phytotherapie. Phytopharmaka und pflanzliche naire that assesses Homoopathika. Stuttgart: Gustav Fischer Verlag; 1995. physical, emotional, 3. Grube B, Walper A, Wheatley D. St. John's wort extract: social, and func Chrysanthemum, Chrysanthemum x tional well-being. efficacy for menopausal symptoms of psychological origin. Advances morifolium. Photo© 2000 Steven Foster. in Th erapy 1999;16(4):177-86. PC-SPES was asso- 28 HER BALGRAM 50 2000 RESEARCH REVIEWS ciated with significant improvements in functional, emotional, and physical well-being, although there was no significant change in social well-being. Finally, PSA levels-a marker for prostate cancer ac tivity-dropped dramatically after PC-SPES suppl ementati on. Compared with the control level, the decrease in PSA level was more than 50 percent in 13 of 16 patients, a result that the researchers believe "indicates that PC-SPES is effective." The investigators were also especiall y impressed with "the hi ghl y significant reduction in reported pain." The product itself was tested and found to be free of any non-herbal pain-relieving sub stances. In addition, there was a decrease in the spread of bone le sions in th ree patients, which could indicate that PC-SPES has a direct anti-tumor effect. In terms of side effects, half of the partici pants experi enced breast tenderness, and one pati ent developed mild stomach upset, which , according to the authors, "suggests th at PC SPES has a low side-effect profile." As researchers often do, the authors recommended that more research is needed, especiall y in li ght of the fac t that eight of the ori ginal patients "are still enj oying the benefi cial effects of PC-SPES, Ginger, Zingiber officina/e. Photo © 2000 Steven Foster. long after the 20-week fo ll ow-up ." They concluded, " ... PC-SPES significantly red uces PSA levels and the pain of metastati c di sease, thereby improvi ng patients' quality of li fe without the detrimental and pl acebo or patients taking 0.5 g of ginger and I g of gi nger. The side-effects seen with other drug regimens. With no cure currentl y authors noted , "The di screpancy between thi s negative outcome and available for these patients, maintaining a good quality of life is a the positive results from other RCT (random ized con troll ed trial s) is realistic therapeutic goal that can be achi eved with the dietary supple not readil y explicable." No adverse events were reported in any of ment PC-SPES."- Rob McCaleb, HRF 0 the studies. oting that the body of li terature on ginger may be influenced 1. Pfeifer BL, Pirani JF, Hamann SR, Klippel KF. PC-SPES , a by publi cation bias- i.e., a tendency among researchers not to pub dietary supplement for the treatment of hormone-refractory prostate lish studies with negative outcomes- the authors end on a caution cancer. BJU lnternational2000;85:48 l-3. ary note: "In summary, we found that ginger is a promising ant i emeti c herbal remedy, but the clinical data to date are insufficient to Systematic Review of Ginger Trials Yields draw firm conclusions."- Evelyn Leigh, HRF 0 I. Ernst E, Pittler MH. Efficacy of gi nger for nausea and vom it "Promising" Outcome ing: a systematic review of randomi zed clinical trials. British Jour Throughout centuries of traditional use, treatment of nausea nal of Anaesthesia 2000;84(3):367-7 1. and vomiting has remained one of the primary therapeutic app li ca 2. Gr0ntved A, Brask T, Kambskard J, Hentzer E. Ginger root ti ons of ginger root (Zingiber officinale Roscoe, Zingiberaceae) . In again st seasick ne ss: a controll ed tri al on the open sea. Acta order to "evaluate whether or not gi nger is trul y efficacious for clinical Orolaryngol 1988; I 05: 45-49. nausea and vo miting," investigators Ernst and Pittler of Exeter Uni 3. Fischer-Rasmussen W, Kj aer SK, Dahl C, Asping U. Ginger versity, U. K., reviewed six randomized, controlled clinical tri als that treatment of hyperemesis gravidarum. Eur J Obstet Cynecol Reprod met standard methodological quality criteria. 1 Bioi 1990;38: 19-24. Onl y randomized, double-blind, placebo-controlled tri als 4. Bone ME, Wi lkinson DJ , Young JR , McNeil J, Char lton S. evaluat ing the use of gi nger as a single age nt in the treatment of Ginger root-a new antiemetic: The effect of ginger root on postop nausea and vomiting were eligible for inclusion in the rev iew. (Studies erative nausea and vomiting after major gynaecological surgery. Ana assessing the effects of ginger on experimentall y induced nausea esthesia 1990;45 :669-7 1. and/or vomi ting were excluded.) The six studies chosen investigated 5. Phillips S, Ru ggier R, Hutchinson SE. Zingiber officinale (Gin the use of ginger in four different areas: motion sickness,2 morning ge r)- an antiemeti c for day case surgery. Anaesthesia 1993;48:715- 3 4 6 sickness, postoperative nausea, • and chemotherapy- induced nau 17. sea.7 6. Arfeen Z, Owen H, Plummer JL, Il sley AH, Sorby-Adams RAC, The majority of the tri als reviewed concluded that ginger pow Doecke LJ . A double-blind randomized controll ed trial of gi nger for der taken at a dose of 1 g dail y was significantl y more effective than the prevention of postoperative nausea and vo miting. Anaesth In placebo in alleviating nausea and vomitin g. The one exception was tensive Care 1995 ;23:449-52. a postoperative nausea stud y by Arfeen and co ll eagues, whi ch dem 7. Pace JC. Oral ingesti on of encapsul ated ginger and reported onstrated no significant difference between pati ents taking ginger self-care ac tions for the re li ef of chemoth erapy-associated nausea and vom iting. Dissertations Abstracts In t 1987;47:3297-98. 2000 HERBA LG RAM 50 29 ('The Herh Redearch Fottndation i1 one of the moc1t reLiable JourceJ of accurate botanical inforn~ation atJaiLabfe:' -0. Akerele, MD, former Traditional Medicine Programme Manager, World Health Organization A world of information at yourfingertipr~ Where do you turn for answers on the health benefits of herbs? The Herb Research Foundation offers a full range of information services for the public, manufacturers, and health care professionals - everything from ethnobotany to scientific documentation of medicinal benefits and safety. The Natural Healtbcare Hotline CtMlom botanical literature re.;earcb • Fast answers a bout health benefits, dosage, and • Full online and in-house literature searches on safety on more than 200 herbs thousands of plants • Special subscription service available for manufac • In-depth information for personal or professional turers, pharmacies, and retailers use - or to substantiate claims made in product literature 185 Herb Information Packei:J • All the information needed to safely and correctly Herb abJtractti~ ruource li.ltti~ and more use herbs HRF ME.M.BERS RECEIVE DISCOUNTS ON ALl. INFOR MATION SERVICES. TO JOIN HRF OR TO REQUEST H ERB A COMPLETE CATALOG OF HRF SERVICI::S, R ESEARCH PLEASE CALL (303) 449-2265. FOUNDATION Better worfi) health through the informed Me of herht~ PLANT PATENTS h\' Karen Dean arrecta plant leaves to manage the symptoms of peptic ulcer in hu mans. The extract signiticantly decreased the volume and acidity of basal gastric secretions. and reduced the number and severity of ul cers. in a dose-dependent degree. in animals treated with the extract. The extract alone showed little tendency to induce inflammation but had significant antiinflammatory activity after administration of egg albumin . Clinical trials of/. arrecta leaf extract indicated its effi cacy against peptic ulcer. with no detectable adverse effects on kid ney, liver, and blood chemistry. The inventors have determined that an appropriate daily dosage of the /. arrecta leaf extract is approxi mately 2.5 to 5 mgfkg of body weight. administered orally in two divided doses. 0 Fenugreek and Ginseng for Stimulation of Hair Growth Ginger, Zingiber officina/e. Photo © 2000 Steven Foster. Inventors: Jutta Mai (Farbrikstr. 16, 78224 Singen/Bohlingen. Germany): Heinz Mai (Farbrikstr. 16. 78224 Singen/Bohlingen. Ger many). No assignee. U.S. Patent 5.900.239. issued May 4. 1999. Black Pepper and Ginger for Infections The inventors describe the extraction of the alkaloid trigonel line or trigonellic acid from the seeds of a plant from the genus Inventors: Jeff J. Staggs (Denver. Colorado). No assignee. U.S. Trigone/lei. in particular. fenugreek (T foenum-graecum). and the Patent 6.063,381, issued May 16, 2000 oral administration of the extract as a strengthening agent for the The inventor describes a new class of general antiinfective skin and horny structures. in particular nails. hooves and claws. of agents extracted from black pepper (Piper spp.), ginger (Zingiber animals. and for the stimulation and/or revitalization of the growth officina/e). and other plant species containing vanillyl and piperi of epidermal structures. in particular. hair. The formula contain s the dine ring structures typical of the pungent principal found in pepper trigonellic alkaloids and at least one of the following materials: bi and ginger. The role of these structures, their attached hydrocarbon otin. Asian ginseng (Pana.r ginseng) extract. horse-chestnut (Aesculus groups, and other agents found within the plant extract is demon hippocastanwn) seed extract (HCSE). or tocopherol. According to strated in the topical treatment of superficial manifestations of fun the patent. the ginseng acts as an "accelerator for the action of the gal disease or systemic fungal infections, tissue injuries, and abnor alkaloid trigonelline on the stimulation and revivication of the growth mal proliferations of keratin . The topical compositi ons contain the of hair.'' The patent also claims that the effects of trigone! Ia occur pungent active ingredient in an oleoresin base, formulated into the after three to four months: with the addition of the ginseng. effects form of an infusion, bath, douche, shampoo, lotion, drops, tincture, are noticeable within one month. Similar effects occur with the ad plaster, powder. aerosoL or other carrier. All the topical preparations dition of HCSE. :J are reported as providing outstanding results in the treatment of athlete's foot, jock itch, ringworm. and favus (a severe, chronic ring worm of the scalp and nails), as wel l as other types of dermatomy coses such as candida. The patent claims that these compositions constitute a less expensive, more effective, less toxic form of treat ment for fungal infections in humans and li vestock an imal s th an the widely used prescription antifungal medications. 0 Phytodrug for Peptic Ulcer Management Inventors: Charles O.N. Wambebe (Abuja, Nigeria) , Shingu K. Gamaniel (Abuja, Nigeria). Peter Akah (Nsukka. Nigeria), Dogara S. Fumen (Kaduna State. Nigeria). and Hafsatu Shittu (Abuja, Nigeria). Assignee: National Institute for Pharmaceutical Research and Devel opment (Abuja. Nigeria). U.S. Patents 6,083,509 and 6,086,882, is sued July 4, 2000 and July I I. 2000. Both patents of the same name. invented by the same people and assigned to the same institution. describe preparation, formula- Fenugreek, Trigonella foenum-graecum. Photo© 2000 tion, and administration of a hot water extract of powdered lndigofera Steven Foster. 2000 HERBALGRAM 50 31 USP Publishes Monograph and Consumer Reports Gives Thumbs Up, Recognizing Benefits for BPH by Mark BLumenthaL; photographs by Steven Foster stringent" level of ev idence, although some of the trials may have methodological flaws , compared to the Level I status applied to con ventional drugs.) The SP products tested in these studies were commercial liposterolic extracts of SP, standardized to 70-95 per cent free fatty acids, at a dose of 160 mg twice dail y. The duration of all the studies were from 2 1 days to 26 weeks. The USP monograph includes mention that the German Commission E evaluated SP as safe and effective for urination problems in BPH stages I and 11. 14 However, lacking any formal system for evaluating benefits of herbs in the U.S., other than the formal new drug approval system, it is possible that the new USPDI monograph may be viewed by health professionals as tantamount to offi cial recognition of the efficacy of SP for the first time in the U.S. The USP notes that "These studies Saw Palmetto, Serenoa repens. provide evidence of moderate scientific qual ity th at commercial extracts of saw palmetto at a dose of 160 mg twice a day are more The nati ve American herb saw pal tion of USP24-NFI9 published on July I , effective than a placebo in relieving lower metto has received some positive publicity 1999.3 The USPDI monograph notes that urinary tract symptoms of benign prostatic in the past year. On Apri l 28, 2000, the U.S. manufacturers are not required to meet the hyperplasia including frequency, urgency, Pharmacopeia published a Dispensing Infor USP-NF standard, but if a manufacturer does dysuria, nocturia (nighttime urination), and mation (DI) monograph that supports the so voluntarily and claims a USP-NF status impaired urinary flow. These effects are re clinical benefits of saw palmetto (Se renoa on a product label, then the product must ported to begin within 30 days of treatment repens (Bartram) Small, Arecaceae) (S P) to meet the USP-NF standard of not less than 7 and to continue through at least 6 months, treat symptoms of benign prostatic hyperpla percent lipophilic extract content and the sum the longest period studied to date. There is a sia (BPH) in older men. 1 In September Con of the percentages of all fatty ac ids must be large placebo effect in studies in this field. sumer Reports published a three-page article not less than 9 percent. Saw palmetto extracts do not significantly discussing the benefits of SP and reviewing According to the US P monograph in affect prostate size or reduce PSA (prostate its analysis of 13 brands. 2 the "Modern Medical Use" secti on, the USP specific anti gen) levels in the blood; nor do The USP Di spensing Information located 29 published clinical studies on SP they appear to alter sexual function . Com monograph deals with the therapeutic param for the treatment of lower urinary tract symp mon side effects are mild and not consistently eters of SP. Unlike the prev ious monograph toms (LUTS) secondary to BPH in the inter different from those reported in patients on publi shed by the USP-National Formulary national medi cal literature through August pl acebo. No seri ous adverse events are (NF) dealing with identity and quality con 1999. This search included seven pl acebo kn own to be associated with saw palmetto."2 4 10 trol characteristics of SP, thi s monograph in controlled trials, - one active-controlled tri al The publication of the SP monograph cludes information for heal th care profession vs . the conventional drug finasteride 11 represents a change in direction for USP. In als on appropriate clinical uses and potential (ProscatiD), one acti ve-controll ed study vs. an the future, all USP resources will be applied risks of SP. The USP-NF monograph setting alpha-adrenergic blocking drug (alfuzosin ), 12 to the development of standards for herbs 13 a standard for SP (extract) and powdered SP and one meta-analysis - all meeting th e and other dietary supplements, not informa fruit became official on January I, 2000. USP quality standard for clinical trials at tion monographs. USP had almost completed These two monographs are in the new edi- Level II or higher. (Level II refers to a "fai rl y information monographs on cranberry 32 HERBALGRAM 50 2000 (Vaccinium macrocarpon) and covered by health insurance) ginkgo (Ginkgo biloba), but compared to about $85 for work on these monographs finasteride.2 was terminated in July. CR concluded its assess According to V. ment of SP's efficacy wi th a Srinivasan, Ph.D., Director of somewhat modest approval: Dietary Supplements at USP: "Although the long-term safety "USP has completed develop and efficacy of saw palmetto ment work on the standards for remain unclear, Consumers raw plant materials fo r 18 bo Union's medical consultants tanicals and has already pro say th ere's enough ev idence to posed standards for as many as conclude that supplements 15 plant extracts and about I 0 containing at least 320 milli botanical dosage forms. The grams per day of saw-palmetto USP Committee of experts will extract, the a mount that continue to develop and estab worked in clinical trials, mi ght li sh public standards for the 20 be worth trying fo r some men botanicals identified earlier wi th mild symptoms; they and may add three or four more should discuss thi s option with important botanicals which are their doctor." 2 in wide use among the public." CR tested 13 products, To date USP has pub concluding that e ight con lished five information mono tain ed adequate levels (320 mg graphs on herbs -- ginger per day of the standardized ex (Zingiber officina/e), valerian tract, presumabl y calculated at (Vale riana officina/is), com 85-95 percent of the free fatty frey (Symphytum officina/e), ac ids) that were deemed nec feverfew (Tanacetum essary to provide efficacy for parthenium) and St. John's sy mptoms of BPH, as deter wort (Hypericum perforatum) mined in clinical studies. This -- however, using the same Saw Palmetto, Serenoa repens. is also the dosage recommen- criteria as used for conven- dation of the German Commis tional drugs, all these mono- sion E monograph. 14 The table graphs resulted in negative assessments of months, compared to those on conventional of test results also shows the daily cost of the potential efficacy (comfrey was rated drugs fo r BPH which last up to six years. each brand required to consume thi s effec negati ve for safety reasons). 15 More at CR says the American Urological Associa tive level varied from $.44 to $ 1.44. continues on page 37 2000 HERBALGRAM 50 33 WE BUY Palmetto Berries URGE QUANTITIES - FROM LAND OWNERS Call AL CURRY (941) 860-4046 PLANTATION MEDICINALS. INC. Roadside billboard in central Florida advertising purchase of saw palmetto berries. Saw palmetto gets its name from the blades of the plant that look like miniature saws . A day's intake of fresh saw palmetto berries at Plantation Medicinals, Inc. , Felda, Florida, to be Laborer harvesting saw palmetto berries in the sweltering Florida sun. transferred to driers before day's end. 34 HERB ALGRAM 50 2000 A worker stirs saw palmetto berries in dryer, prior to being transferred to a cleaning facility. Andrian Herrera, picking crew leader and broker with freshly picked berries, before drying. Full buckets of berries sit in the sun . Independent saw palmetto berry pickers unloading a day's harvest to a loading dock. 2000 HERBAlGRAM 50 35 Top Left and Right, Bottom Right: Ripe saw palmetto berries. Bottom Left: Saw palmetto in bloom. 36 HERBALGRAM 50 2000 SAW PALMETTO LABEL GUIDELINES continued fro m page 33 FOR SAW PALMETTO biloba), St. John 's wort, gin seng (Panax 7. Mattei FM , Capone M. Acconcia A et al. Ser spp.), garlic (A llium sativum) etc. - were enoa repens ex tract in the medical treatment The American Herbal Products Association down in the same period. SP ranked sixth in of benign prostati c hype rtroph y. TW Urol recently endorsed the following (or significantly total mainstream sales for all herbs in 1999, Nephrol 1990:2(5):346-50. simi lar) language on the labels of dietary supple 8. Cukier J. Ducassou J. Le Guill ou M et al. with sales of $45,063,652, refl ecting an in ments containing saw palmetto (SP) intended fo r Permi xo n® versus placebo. Res ults of a use in dealing with symptoms associated with be crease of 34 percent from th e 1998 sales of multicenter study. CR Th er Pharmacal C/in 16 nign prostatic hyperplasia (BPH ): $33,748,984. 1985:4(25): 15-2 1. The herb received strong public rec " Notice: The National Institute on 9. Lobelenz J. Extractum saba! fru ctu s in the Aging recommends that men get regular ogni tion for its benefits in treating symptoms th erapy of beni gn prostati c hyperplas ia medical checkups with a thorough pros of BPH in a meta-analys is of 18 European (BPH ). Tpk therapeutikon 1992:6:34-7. tate exam. You should inform your health clinical studies published in the Journal of I 0. Descotes JL. Rambeaud JJ , Deschasea ux P care practitioner that you are using this 13 th e American Medical Association, which eta!. Pl acebo-contro ll ed evaluati on of the ef product." 1 concluded that SP was significantly more ef ficacy and tolerab ility of permi xon in benign According to the German Commission E, fective than placebo. It is quite probable that prostatic hyperplasia after exc lu sion of pl a the following notice is required with the labeling cebo responders. Clin Drug In vest the new USP monograph will have a posi of all saw palmetto products marketed as non 1995;9(5):29 1-7. tive impact on health profession als and thi s, prescription drugs in Germany: " This medica II . Carrara JC. Ray naud JP. Koc h G et al. Co m tion relieves only the symptoms associated coupled with the increasing market demand parison of ph ytotherapy (Permi xon®) with for prostate medicati ons by ag in g baby with an enlarged prostate without reduc finasteride in the treatment of beni gn pros ing the enlargement. Please consult a phy boomers, will continue to stimulate SP's in tate hyperpl as ia: a randomi zed international sician at regular intervals.m creased growth in sales in the U.S. 0 stud y of 1.098 patients. Prostate 1996. The Commission E approves use of SP for 29 :23 1-40. "uri nation problems in BPH stages I and II. Stage REFERENCES 12. Grasso M, Montesano A. Buonaguidi A. et I is characterized by increase in frequency of uri I. US PDI. Saw Palmetto. Rockville, MD: United al. Comparative effects of alfuzosin ve rsus nation, pollakiuria (abnormally frequent urination), States Pharmacopoeial Convention, Inc., April Serenoa repens in the treatment of sy mptom nocturia (urination at night, usually disrupting 28, 2000. www.usp.org. ati c benign prostat ic hyperpl as ia. Arch Esp sleep), delayed onset of urination, and weak uri 2. Anon. Herbal Rx for prostate problems. Con Uro1 1995:48 :97-103. nary stream. Stage II is characterized by the be stuner Reports 2000; Sept:60-2. 13. Wilt TJ et al. Saw pa lmetto ex trac ts fo r treat ginning of the decomposition of the bladder fu nc 3. US P24-NF 19 (2000). Saw Palmetto. Rockvi ll e, ment of beni gn prostati c hyperpl asia: a sys tion accompanied by formation of residual uri ne MD: United States Pharmacopoeial Conven tematic revi ew. l AMA 1998;280( 18): 1604- and urge to urinate. 2 ti on, Inc., Jul I, 1999:2510. 1609 . 14. Blumenthal M, Busse WR, Goldberg A et al. 4. Braekman J, Deni s L, de Laval J et al. A double REFERENCES Th e Complete German Commission E Mono blind, placebo-controlled study of the plant I. American Herbal Products Assn. Saw Palmetto graphs: Th erapeutic Guide to Herbal Medi ex tract Serenoa repens in the treatment of be Label Guidel ines. Bethesda, MD. Ju ly 25, 2000. cines. Boston: Integrative Medicine Commu nign hyperplas ia of the prostate. Eu J Clin Res 2. Blumenthal M, WR Busse, A Goldberg, J nications, 1998. 1997;9 :247-59. Gruenwald,T Hall , CW Riggins , RS Rister (eds.). 15. Blumenthal M. US P Publishes Information 5. Boccafosc hi C, Annoscia S, Confomto fra (S Klein and RS Rister, trans.) The Complete Ger Monographs on Ginger and Valerian. estratto di Serenoa repens e placebo mediate man Commission E Monographs - Therapeutic HerbalGram 1998:43:30,57.7 1. prova clini ca co ntroll ata in pazie nti con Guide to Herbal Medicines. Austin,TX:American 16. Blumenthal M. Herb Sales Dow n 3% in Mass adenom ato si pros tati ca. Urolog ia Botanical Council; Boston: Integrative Medicine Market Retail Stores- Sales in atural Food 1983;50: 1257-68. Communications, 1998. 6. Reece Smith HR, Memon A, Smart CJ et al. Stores Still Growing, but at Lower Rate. The value of Permi xon in beni gn prostatic hy HerbalGram 2000;49:68. pertroph y. Br J Uro l 1986;58:36-40. ABC's Saw Palmetto Education Project The Saw Palmetto Education Project (S PEP) was created by ABC to prov ide information about thi s increasingly important nati ve American herb. The main body of information to come out of the SPEP will be an eight-page booklet, which wi ll become part of our Botanical Booklet Series, and a comprehensive literature review to be published in a future issue of Herba/Gram. Recentl y, ABC has engaged in some preliminary activities related to SPEP. The first are these articles on the new US P DI monograph, a description of the September 2000 Consumer Reports articl e, AHPA's new label recommendati on. and the accompany ing photographic essay. In October ABC also di stributed a press release on the benefits of saw palmetto to print and electronic media. The SPEP is underwritten by Botanicals International, lndena, Pl ant ation Medi cin als, Trans Atlantic Services and U.S. Nutraceuticals. "The importance of this herb is increasing significantly as the number of men in older age groups increases. and as its benefits become more widely known," said Wayne Silverman, ABC's chief administrative officer. "We thank our underwriters who make it possible for ABC to di sseminate information on saw palmetto.'' 2000 HERBALGRAM 50 37 New Items in ABC's Online Herbal Education Catalog All items on this page are now available through our online catalog at www.herbalgram.org H. D. Ntuwln_ger African H·ERBA·l Traditional Medl 1 PRESCRIPTIONS A Dlctlon ory of Pltu,r u,~ ond App/~ o ~! Medical SIXIY MEDICINAL PLANTS FROM THE ~ HEALTH AROMAfflfRAP' PERUVIAN AMAZON: ECOLOGY, HLallt~gwith HEA! IN ~ .., Esuntla/ Oils ETIINOMEDICINE AND BIOACTIVI1Y by C. YOUR EVERYDAY GUIO[ TO USIN( Desmarchelier and F. W. Schaus. 2000. In English ltfRDS SAFELY AND EFFECT!V[L and Spanish side by side, this book includes -- scientific name, common names, fan1ily, - description, ecology, ethnomedicine, bioactivity, and references on 60 plants. Softcover, 270 pp. $2 1. 90. #B465 PLANTING THE FUTURE: SAVING OUR MEDICINAL HERBS ed. by R. Gladstar and P. Hirsch. 2000. How to grow and use 33 native American herbs that are at risk due to over-harvesting and loss of habitat. Includes botanical features, historical background, medicinal uses, preparation and dosage, propagation and cultivation, harvesting, and references. Softcover, 310 pp. $22.95 #B466 HERBAL PRESCRIPTIONS FOR HEALTII AND HEALING: YOUR EVERYDAY GUIDE TO USING HERBS SAFELY AND EFFECTIVELY by Donald]. Brown, .D. 2000. Addresses how to choose the best herbal supplement, categories of herbal medicines, comprehensive discussion of 20 commonly prescribed herbal medicines, herbal prescriptions for 62 common health condi tions, resources, and references. Softcover, 442 pp. $24.95. #B467 MEDICAL AROMATHERAPY: HEALING WITII ESSENTIAL OILS by Kurt Schnaubelt. 1999 Explores the molecular make-up of major essential oils, their composi tion , biosynthesis, and effects in healing, including their actions. Reviews aromatherapy's standing wi thin science, government, and industry. Softcover, 296 pp. $16.95. #B468 AFRICAN TRADITIONAL MEDICINE: A DICTIONARY OF PLANT USE AND APPLICATIONS by Hans Neuwinger. 2000. Intended for scientists searching for medicinally active plants for further research, this book references more than 5,400 plants and over 16,300 medicinal applications documented in traditional African medicine. Hardcover, 589 pp. $95. #B469 BEYOND ASPIRIN: NATURE'S ANSWER TO ARTIIRITIS , CANCER AND ALZHEIMER'S DISEASE by T. Newnmk and P. Schulick. 2000. COX-2 inflammation lies at the root of many diseases. This book presents a comprehensive review and interpretation of published research supporting the COX-2 inhibiting properties of many popular herbs. Softcover, 316 pp. $14.95. #B470 THE NATURAL HISTORY OF MEDICINAL PLANTS by Judith Sumner. 2000. Describes botanical compounds' biological and ecological importance as toxins and deterrents in protecting plants. Provides interesting examples of birds, primates, and elephants that seemingly recognize and use plants as medicines. Concludes with an analysis of the issues of using medicinal plants without destroying the earth's diversity. Hardcover, 235 pp. $24.95. #B47l PHYTOCHEMICALS: A NEW PARADIGM ed. by W. Bidlack, S. Omaye, M. Meskin and D. Jahner. 1998 Presents current research on isolating and characterizing chemical components, structures, and phys iologic function of foods , and explores the role of food constituents as not only essential nutrients for sustaini ng life and growth, but of preventing or delayi ng premature onset of chronic diseases later in life. Hardcovet; 179 pp. $99.9 5. #B472 AYAHUASCA READER: ENCOUNTERS WITII THE AMAZON'S SACRED VINE ed. by Luis E. Luna and Steven White. 2000. Texts translated from nearly a dozen languages on the ayalmasca experience. Includes indigenous mythic narratives and testimonies, religious hymns, as well as narratives related by western travelers, scientists, and writers who have experienced ayalmasca in different contexts. Softcover, 254 pp. $29.95 #B473 PDR FOR HERBAL MEDICINES 2"d edition. 2000. Updated to include the latest scientific findings , clinical trials (including abstracts), case reports, and meta-analysis results. More detailed monograph sections on herb/drug interaction side effects , contraindications, precautions, adverse reactions, and dosage. Hardcover, 858 pp. $59 95. #B474 To order call toll free 800/J7J-7105, fax 512/926-2J45, email: [email protected] or order online at www.herbalgram.org Consumer Use of Herbal Products to Prevent or Treat Cancer by Mark Blumenthal The following ar1icle by Dr. Mary Ann some form of cancer is not known. ever anticholeretic actions 6 They also recognize Ri chardson and her colleagues describes the theless, this su rvey, if it is accurate and re that there are no data on the ··possible syner use of an herbal tonic used by many people flective of the popu lation as a whole, might gistic effects of individual herbs in the final in North America as a possible "cancer rem be considered alarmi ng by conven ti onall y product and research on the individual herbs edy." The product, called Flor-Essence®, is trained healthcare practitioners. on the one may not be applicable to the whole prepara sold with no direct claims that are related to hand, and yet predictable by natural health tion." They write that th is formula is an "ex cancer, yet it has been tied to the somewhat advocates, on the other. There are many who ce ll ent candidate for furt her evaluation ." famous Essiac"' herbal formula promoted by prefer natural treatments, even if they have The pub! ica ti on of this articl e does not various marketers, based on the work of Ca not been scienti fically tested or confirmed constitute an endorseme nt or recommenda nadi an nurse Rene Caisse (Essiac is Caisse for efficacy. tion of Flor-Essence by Herba!Gram, ABC, spell ed backwards). Now, for the first time. a survey is be or HRF. Further, ABC has received no finan We understand that the publication of ing published describing be li efs and uses of cial support from Flora Inc., the product's this paper may be considered controversial. a product th at its users believe will either manufacturer, in relation to the publication Some readers mi ght think that we may be prevent or help treat some types of cancers. of thi s article. (Flora has been a supporter of promoting untested cancer cures. Such is not This paper provides demographic profiles of ABC for the HerbClip mailing service since the case. more than 5,000 of these consumers and dis 1995; however, this is support does not re Dr. Ri chardson told us in June that she cusses their expectations and experiences late to Herba!Gram.) considered Herba!Gram was an appropriate related to the product. Like so many other Herba!Gram remains committed to journal to publish thi s paper, sin ce our read herb users in North America, many of the supporti ng scientific research on herbs and ership covers such a wide range, from aca respondents to this survey are we ll educated. medicinal plants and the accurate and respon demic researchers, health professionals, gov Is Essiac an effective formu la to help sible reporting of such research. We are also ernment officials, members of both the herb heal some types of cancer? Is the Flor-Es committed to measures that will help stimu and pharmaceutical industries, to herb con sence variation of the basic Essiac formu la a late more research in all areas of herbal medi sumers, and more. A few of our reviewers useful product'l We do not have scientific cine. We agree with the authors that more and editorial staff expressed concern about data to answer this question. However, the research in thi s area is warranted. 0 the timing of thi s publication, on the heels data provided by this survey suggest that the of the chapter! on the herbs in the infamous users find some value with the product (50.3 REFERENCES Hoxsey cancer formula, excerpted from the percent). It also suggests relative safety of I. Ausubel K. Tempest in a Tonic Bottle : A Bunch book about Hoxsey in our last issue. 2 The the product; on ly 5.1 percent of the users re of Weeds? Herba/Gram 2000a;49:32-43. timjng of these two publications in back-to ported adverse side effects (mostly minor). ~ 2. Ausubel. K. When Healing Becomes A Crime. back issues of Herba!Gram is purely coinci However, Richardson et al. note th at Rochester. YT: Hea lin g Ans Press, 2000b. 3. Johnston BA. Prevention Magazine Assesses dental; some might say synchronistic, in the there have been no randomized double-blind, Use of Dietary Supplements. Herba/Gram placebo-controll ed clinical trial s on thi s for Jungian sense. The chapter on Hoxsey coin 2000:48:65. cided with the publication of Ausubel's book. mulation, or the Essiac formula, although 4. Richardson MA. T Sanders. C Tamayo et a!. As noted in our editors' remarks at the be Essiac was tested experimental ly fo r its an 2000. Flor-Essencen1 Herbal Tonic Use in ginning of that arti cle, we publi shed it for its titumor activity (in vivo), without appare nt Nonh America: A Profi le of General Consum historical importance and to stimul ate dis activity. 5 ers & Cancer Patients. Herba/Gram cussion on this important subject. In contrast, Despite the lack of clini cal sc ientific 2000:50:40-46. the Richardson paper provides a window into trials, there are some chemical and pharma 5. Office of Technology Assessment (OTA ). contemporary use. A survey of 2,000 ad ult co logical data that suggests some potential Essiac. In : UnCO ill'en tional Cancer Treat di etary supplement users polled by Preven activity of the herbs in the fo rmul a. ments. Washington . D.C.: US Gove rnment tion magazine in the spring of 1999 deter Ri chardson et al. ci te a st ud y conducted on Printing Office; 1990. 6. Tamayo C, MA Richardson, S Diamond. I mined that 29 percent of those surveyed use Flor-Essence demonstrating numerous ac Skoda. The Chemistry and Biological Activ herbal products to prevent or treat serious tivities of some of the herbs in the formul a, ity of Herbs Used in Flor-Essence'" Herbal 3 illnesses. How many of them were using or including ant ioxidant, antiestrogenic, Tonic and Essiac '" . Phrtotherapy Research would use herbs to attempt to prevent or treat immunostimulant, antitumor, and 2000; 14:1 - 14. 2000 HERBAL GRAM 50 39 ORIGINAL RESEARCH Flor-Essence® Herbal Tonic Use in North America: AProfile of General Consumers and Cancer Patients by Mary Ann Richardson, DrPH*, Tina Sanders, MPH*, Carmen Tamayo, MD+, Carrie Perez, MPH*, J. Lynn Palmer, PhD** ABSTRACT Canada and the United States each month. Objectives: Flor-Essence® and EssiacTM are widely used A review of the li terature on these toni cs and the four princi herbal toni cs. After three decades, little is known about consumers pal herbs resulted in 107 references. Of th ose, 68% (n=73) were using them. This pattern-of-use survey was conducted to I) profile related to cancer. 5 Although 24 pre-clinical evaluations of individual consumers, 2) characterize cancer patients, and 3) determine rea herbs were reported, no pre-clinical or clinical trials of the tonic sons for use, benefits, and adverse events. were identi fied.5 One clinical study with Essiac was di scontinued Methods: A populati on-based study assessed Flor-Essence by the Health Protecti on Branch of Health Canada in 1978 because consumers in North America between June 1998 and August 1999. of limited physician participati on. Data from 87 participants was Data are presented in frequencies and proportions. considered inadequate to determine any impact on survival.2 How Results: Of 5,051 consumers (response 6.4% ), most were ever, no toxicity was reported, but quality of life or pain control 3 6 Caucasian, educated, Ameri can, long-term users (mean 15.8 months, were not evaluated. · Subsequentl y, cl aims for clinical benefit were SD=17.4), and cancer pati ents. Of 1,577 cancer pati ents (response discontinued by the manufactu rers who th en began marketing th e 42.4%), 85.3% were treated previously and 36.8 % currentl y with product as a dietary supplement with general health claims (i .e., pre conventi onal medi cine for breast, prostate, or lung cancer. Overall , vent di sease, reli eve pain, and improve quality of life). 64.5% discussed using the tonic with physicians; few ( 11.4%) ex Claims as a cancer cure persist, however, with anecdotal re ceeded the recommended dose. Most patients (50.6%) reported im ports of reduced tumor growth, improved quality of li fe, and pro provement in symptoms, but 6.6% experi enced adverse events. longed survival. 7 Although these toni cs remain untested for antican Conclusions: The toni c is widely distributed. Many cancer cer activity, antioxidant activity has been confirmed for th e Flor pati ents combine conventional treatment with the toni c and attribute Essence product. 8 benefits to the toni c. The use of herbal fo rmulas is a public health Moreover, qualitative thin layer chromatography (TLC) has issue; thus, assessment of clinical benefit and potential interaction confirmed seven herbs that contain trace elements, minerals, and with cancer treatment is warranted. HerbalGram 2000; 50:40-46. BACKGROUND Flor-Essence and Essiac are two of the most widely used herbal toni cs by cancer patients. An estimated 35 % of cancer pati ents in Canada 1 use these toni cs, whose long and contro versial hi story spans three decades. 2.3 In a recent survey at a large comprehensive cancer center in the Uni ted States, 38% of patients reported using herbs and overall , 4.9% used the Flor-Essence or Essiac toni c.4 Both fo rmulas contain four prin cipal herbs: burdock root (Arctium lappa L. ), Turkis h rhubarb root (Rheum palmatum L.), sheep sorrel (Rumex acetosella L.), and slippery elm bark (Ulmus rubra Muhl. ). However, Flor-Essence contains four additional herbs that are beli eved to potentiate the fo rmula: watercress (Nastu rtium officina/e R. Br.), blessed thi stle ( Cnicus benedictus L.), red clover (Tri folium pratense L. ) and kelp (Laminaria digitata Lmx.). Flor Essence tonic is manufactured in Canada where approximately Sheep Sorrell, Rumex acetosel/a. Ph oto © 2000 Steven Foster. forty th ousand units of to ni c and dried herbs are distributed to * Centers for Al ternative Medicine Research and Health Promotion Research and Development, The University of Texa s-Houston Sc hool of Publi c Health + Foresight Link Corporation, Ontario, Canada * * Department of Biostati stics, The University of Texas M.D. Anderson Cancer Center 40 HERB ALGRAM 50 2000 phytoestrogensY Levels of fl avonoids, phenylcarboxylic acids, and emodin are monitored regularly in each batch. Pre-clinical and clinical evaluations of Flor-Essence, in collaboration with the Russian Min is try of Health, have assessed acute an d chronic toxicity. Acute toxicity studies were unable to determine a lethal dose in albino mice and rats. Furthermore, chronic toxicity tests found no renal or hepatic toxicity doses that were 10-fold the therapeutic dose ( 15 mlfkg) in albino mi ce and rats and 5-fold (7 .5 milk g) in dogs. 10 Sponsor initiated in vivo studies report reduced number and size of chemical medi ated gastric ulcerations, protection of capi ll aries against xylene mediated leakage, and prevention of chemically induced anti inflammation.9 Red Clover, Trifolium pratense. Photo © 2000 Steven Foster. Given the hi storical and widespread use of these tonic, limited preclinical data by manufacturers only, and the anecdotal reports of efficacy from cancer patients, a pattern of use survey coded survey. Callers who declined to participate or who were ineli of Flor-Essence consumers and cancer patients was conducted to I) oible were encouraged to complete and return the postcard. Flora profile the general consumers, 2) characterize cancer patients, and 0 . Manufacturing and Di stributing Ltd. provided one complimentary 3) determine their reasons for use, perceived benefits, and adverse product to individuals who completed the cancer-specific survey. events. Ultimately, this information will infonn the medical com The cancer-specific survey was adapted from an mstrument munity and cancer patients, stimulate manufacturers to prepare the that assessed complementary and alternative medicine (CAM) use tonics for clinical investigation with an Investigational Drug Appli in a comprehensive cancer center. 11 Cancer patients who were using cation (IND), and guide the development of clinical trials with in the tonic provided information on their cancer status (i .e., date of fonnation about which cancer patients are more likely to use the diagnosis, stage and site of disease, current status), conventional treat product. ment (i.e., chemotherapy, radiati on, surgery. hormonal), and use of other CAM therapies. We also asked about their reasons and expec METHODS tations for using Flor-Essence as well as information on dose, fre Individuals who purchased Flor-Essence in the United States quency, adverse events, positive effects. changes in symptoms (i.e., or Canada between June 1998 and August 1999 were invi ted to par nausea, vomiting, loss of appetite, fatigue, pain). For patients who ticipate, regardless of age, gender, or disease status. The Committee di scussed use with their physicians, we asked how the physicians for the Protection of Human Subjects at the University of Texas responded; otherwise, patients ex plained their reasons for nondis Houston approved the study at two levels; participation was volun closure about the herbal use. tary. The manufacturers shipped 20,000 units of product in Canada ELIGIBILITY AND CONSENT RATE and 65,245 in the United States over a three month period, begin Of the 85,245 units distributed, 5,435 (response rate= 6.4%) ning in June, 1998. Each product contained an invitation from the postcards were received for Phase I. A total of 384 general consum owner of Flora Manufacturing and Di stributing Ltd. (Burnaby, B.C.) ers were excluded because they were treating pets (n = 38) or re to participate so that the company could learn more about who is sponded after the study closed (n = 346) in September, 1999: Of the using the product and why. Each product contained a self-addressed, 5,051 eligible general consumers, 3,749 (74.21k) were elig1ble for stamped postcard with the brief pattern of use survey. To ensure Phase II . Of these, 54.9% (n = 2,060) cancer patients consented to confidentiality, each postcard contained a unique identification num participate, and I ,588 (42.4%) completed the survey; however, II ber. individuals were excluded because they responded after the study For Phase I, the pattern of use survey of general consumers closed. collected information on demographics (i.e., age, gender, ethnicity, country of residence, marital status, education level, and household income), medical condition (i.e., arthritis, cancer, multiple sclero Phase I: Profile of General Consumers sis, or other), reasons for use (i.e., prevention, control symptoms, The majority ofFlor-Essence consumers were educated above treat a medical condition, or other), duration of use, and perceived the high school level (63 .6%), Caucasian (92.0%), ma.Tied (68.8%), benefits using a 5-point rating scale from excellent to poor. livino in the United States (80.0%), 61.6 years of age (S O= 13.9), Current or former cancer patients were invited to call the Uni and ;pproximately equall y di stributed by gender (Table 1.). The versity of Texas Center for Complementary and Alternative Medi averaoe duration of use was 15 .79 months (SO= 17. 35 , range 0-130 cine (UT-CAM) about the details of a second survey, specifically months), and primarily (62.4%) to treat a medical condition rather about their experience with the tonic. For Phase II, interested indi than prevent di sease (35.3%) or control symptoms (2 1. 3%). Cancer viduals who telephoned UT-CAM and were cun·ent or former can was the most commonly reported medical condition (75. 1% ), but cer patients were invited to participate. After obtaining verbal con general consumers' other health conditions were ~rthritis( 14.5 % ), sent, research assistants collected contact information to mail the multiple sclerosis ( 1.0% ), and other ( 14.7 %) conditions (1.e., aller- 2000 HERBAL GRAM 50 41 ORIGINAL RESEARCH gies/asthma, chronic fatigue, cysts, diabetes, high blood pressure/ heart di sease, hepatitis/liver disease, osteoporosis, or bladder, pros tate, skin, or stomach problems). Most consumers rated the benefits of the tonic as very good/excell ent (72.2% ), but 24.4% rated the tonic as okay, and 3.4% as not very good/poor. Phase II: Profile of Current and Former Cancer Patients Blessed DEMOGRAPHICS OF CANCER PATIENTS Thistle, Surveys and postcards were matched for 76.8% (n= I ,2 1 I) of Cnicus respondents in Phase I and II ; thus, data on demographics were un benedictus. available for 366 cancer patients. Flor-Essence was used equally by Photo © men and women, but most individuals were educated above the high 2000 school level (63.9%), Caucasian (94. 1% ), married (71.9%), living Steven Foster. in the Un ited States (79.9%), and 62.4 years of age (SD = 13. 1) (Table 1). DISEASE STATUS AND TREATMENT PROFILE OF CANCER PATIENTS Overall, 63.9% of cancer patients had been diagnosed over a 3-year period (i.e., 30.0% in 1998,20.9% in 1997, 13.0% in 1996) for breast (22.0% ), prostate (I 5.1 % ), or lung (I 0.6%) cancer. At the time of diagnosis, patients were equally distributed across stage I to IV disease; 33.7% reported metastatic di sease. Of the 274 ( 19.0%) who reported "other" stage of disease at diagnosis, 49.8% did not know the stage. At the time of the survey, however, 38.9% of the respondents reported having no evidence of disease. Of the 365 cancer treatment, including surgery (5 1.4%), chemotherapy (46.6%), (26.5 %) who reported "other" stage of disease at the time of the radiation therapy (36.7%), hormonal ( 15. I%), or other ( 11.3%) ap survey, 58.6% did not know the stage (Table 2). proaches. Of the 175 individuals who reported "other" approaches, At the time of their last check-up, 40.6% of participants stated 70.3% were CAM treatments. Therefore, 85.3 % actually had received they were told they had no evidence of disease. The remainder of conventional treatment. At the time of the survey, most patients participants stated their di sease was regressing ( 14.6% ), stable (60.9%) were currentl y being treated with the following: surgery (13.9%), or progressing (15.5 %); however, 9.9% did not know their (2.5 % ), chemotherapy ( 18.6% ), radiation (3.4% ), hormonal ap disease status. proaches ( 14.2%), or other therapies (29.9%) . Of the 460 (29.9%) Most (88.7%) patients had received previous conventional who reported receiving "other" therapies, 3.7% cited immune thera pies while 90.2% were using CAM treatments. Therefore, only 36.8% actually were receiving conventional treatment at the time of the Figure 1: Frequency and Proportion of Accrual by Phase survey. DURATION OF USE AND DOSE INFORMATION 85,245 Postcards Distributed At the time of the survey, almost all (98 .3%) respondents were '----a using Flor-Essence, and most (61.2%) had used the tonic for at least I 5,435 (6 .4%) I Postcards Received 6 months. Specifically, 44.7% had used the tonic for more than 12 '----a months, 16.5 % for 6 to 12 months, 32 .7% for 1 month to less than 6 5,051 Phase I Participants months, and 6.1 % for less than one month . '----a Most patients (85.0%) reported that the instructions were ad eq uate, but 15 .0% stated that information was inadequate in general 13,7 49 (7 4.2%) 1 Phase II: Eligible (n = 49) and specifically, inadequate regarding dose instructions (n '----a = 39), duration of treatment (n = 31), and supporting research (n = 12,060 (54.9%)1 Consented 22). Overall, 30.4% (n = 475/1 ,551) reported following the recom '----a mended dose (i.e., 4 ounces or less daily). For the I ,079 patients j1 ,577(76.6%!1 Completed who provided information on dose, 19.6% (n = 212) stated that they followed the instructions, but 12 individuals exceeded the recom- 42 HERBALGRAM 50 2000 ORIGINAL RESEARCH mended daily dose by using 4.5 to I0 ounces daily. Of the 867 pa ( 11.61k ), vo miting (4. 1%), and other symptoms ( 12.49'c ). However, ti ents (80.3%) who reported not following instructions, the majority 6.6% (n = I 03/1560) reported ill effects with Flor-Essence. Overall, (n = 756) actually followed the recommended guidelines, but Ill the most frequently reported adverse events were diarrhea (I. 9%), individuals exceeded th e recommended dose by using 4.5 to 32 constipation ( 1.2%), nausea ( 1.1%), and fatigue (0.9%). ounces daily. Thus, 11.4% (n = 123/ I ,079) of current or former can cer patients exceeded the recommended dose, but most (88.6%) fol OTHER THERAPIES AND DISCLOSURE TO PROVIDERS lowed the dose instructions (Table 3). Most participants used CAM approaches simu ltaneously with the tonic including high dose vitam ins and antioxidants (6 1.5 9'c ), other REASONS FOR USE, EXPECTATIONS, AND PERCEIVED herbs and herbal mixtures (4 1.6%), special diets (41.4 9'c ), spiritual BENEFITS AND ADVERSE EVENTS practices (35.0%). movement and physical therapies (21.5 %) . mind/ Most cancer patients (84.9%) used the tonic because they be body therapies (20.4%), and other CAM therapies ( 19.5 9'c ). lieved it cou ld help, and 23.7 % because they were told that their Most patients learned about this tonic from family and friends cancer was incurable. Other reasons included the following: the tonic (65.1 %), but other sources of information included books and maga is nontoxic (56.4%), provides hope (50.4% ), all ows control over zines (35.1 %), other cancer patients ( 18.4% ), CAM practitioners medical care decisions (39.8%) , and other reasons ( 18.7 %). Of the (15.0%), doctors (4.3 %), nurses (2.0%), social workers (0.29'c), and 294 who reported other reasons, the most common reasons were the recommendation by family Table 1. Demographic Profile of Consumers & Cancer Patients or friends (34.6%) or belief in Consumers (n = S,OS 1) Cancer Patients (n = 1,211)* possible disease control ( 17.5 %). Most patients (76.5 %) ex Variable n % n % pected the tonic to improve their Gender immune system, and others ex Women 2693 54.3 625 52.2 pected the tonic to improve sur Men 2262 45.7 572 47.8 vival (59.4%) or quality of life {Missing) (96) - ( 14) - (53.2%), cure th eir cancer (48.9%), or relieve symptoms Ethnicity (28.6%). Of the 8.5 % (n = 133) Caucasian 4511 92.0 1118 94.1 who cited other reasons, 63 ex African-American 119 2.4 22 1.9 pected Flor-Essence to control or Asian 111 2.3 27 2.3 prevent disease. The perceived Hispanic 104 2.1 12 1.0 Other 59 9 benefits of the tonic reported by 1.2 .8 {Missing) (147) - (23) - cancer patients were comparable to those of consumers si nce Marital status 75.5% of consumers were ca n Married 3455 68.8 867 71.9 cer patients. Cancer patients Widowed 554 11.0 120 10.0 rated the benefits from very Divorced 438 8.7 99 8.2 good/excell ent (71.0%) and Single/never married 310 6.2 67 5.6 okay (27 .I %) to not very good/ Living with partner 190 3.8 37 3.1 poor (2.8 %). Most patients Separated 72 1.4 14 1.2 (86.7%) reported positive ef Other 2 0.0 2 0.2 fects, including the following: {Missing) (30) - (5) - fe lt better (53.2%), no cancer Education progression (40.6 %), able to High school or less 1790 36.4 427 36.1 carry out daily activities Some college 1371 27.9 309 26.1 (34.0% ), more energy (3 1.5 %), College graduate 995 20.3 268 22.6 coped better with the disease Postgraduate study 756 15.4 180 15.2 (26.3 %), improved cancer symp {Missing) (139) - (27) - toms (22.3 %), and cured their Country of Residence cancer (16.2%). United States 3895 80.0 941 79.9 Overall, 50.3 % (n = 584/ Canada 976 20.0 237 20.1 1162) reported an improvement {Missing) (180) - (33) - in a symptom while using the tonic, including improvements *Surveys and postcards could not be matched to obtain demographic data for 366 cancer patients. in fatigue (29.8%), appetite loss n =number (15.0%), nausea (8.4%), pain 2000 HERBALGRAM 50 43 ORIGINAL RESEARCH 6 other sources (14.6%). Of with age and CAM use. l3.2 28 these 229 pa tients who Most participants had been di learned of Flor-Essence from agnosed with breast, prostate, other sources, 55.9% were ad or lung cancer, but approxi vised by health store person mately one-quarter were un nel or nutritioni sts and 14. 1% aware of their disease stage at from the Internet. the time of di agnosis or the Most pati ents (64.5%) survey. di scussed CAM use with their Although thi s conve health care provider, and of ni e nce sample represents a those, 49.6% talked wi th their self-selected group of cancer oncologists. Patients also dis pati ents, over 60% had used cussed CAM use with their the herbal mixture for greater primary care physician than 6 months. The reasons for (28.6% ), nurse ( 13. 1% ), and using the tonic were consistent social worker or psychiatrist Burdock, Arctium lappa. Photo © 2000 Steven Foster. with other surveys of cancer (3 .7% ). During these discus patients. Most patients use sions, patients perceived the CAM approaches to gai n hope 29 providers to be ei ther neutral (54.4%) or encouraging (40.5 % ). Few and improve quality of li fe; however, one-quarter turned to thi s 2 30 stated they were warned of risks (8.4%) or advised to discontinue CAM approach after learning their cancer was not curable. .1· We th e tonic (4.0% ). Of the other responses ci ted ( 18.4% ), participants also fo und th at many cancer patients combined the toni c with con reported that providers responded with "I don 't believe in CAM" ventional treatment. The find in-g is consistent with the literature that (n = 44) or "It probably won't hurt" (n = 36). indicates that few patients abandon conventi onal cancer care for 14 For the 559 pati ents who did not di scuss CAM use with pro CAM whereas 60-80% combine CAM and conventional treat 12 13 18 19 24 27 29 3 1 35 viders, the most common reasons were related to physicians: doc ment. · · · · · · · - The literature also suggests that physicians 36 37 tors never asked (62.3% ), wou ld discourage/disapprove (28.9% ), or are interested · and willing to discuss CAM therapies with their would not understand (26.7% ). Others felt it was not important for patients, but want scientific evidence of efficacy and safety.38 We physicians to be informed (25.0%) or were un sure if CAM was ben found that most cancer patients discussed using the to ni c with their eficial ( 11.9% ). Only 5.9% believed that disclosure of CAM use physician; however, the majority who did not talk with physicians resulted in the physician di scontinuing the relationship. cited attitude of the physician as the primary reason for their nondis closure. DISCUSSION Although several herbs have demonstrated anticancer, cyto 9 This cross-sectional study is the first in North America to sys toxic, and immunomodul atory activity, clinical evidence to support tematically assess the general pattern of use for Flor-Essence herbal the use of this agent is lacking as is data on possible interactions of tonic and specifically, to document the experience of cancer pati ents. Flor-Essence with conventional treatment. The majority of cancer This study found th at consumers were predominately cancer patients, patients reported following instructions; however, 11.4% were ex had used the toni c long term to treat a medical condition, and per ceeding the recommended daily dose. In fact, 6.6% reported adverse ceived the tonic as hi ghl y beneficial. Overall, they were predomi events, including nausea, vomiting, and diarrhea. Of those who re nately Caucasian, educated beyond hi gh school and thus, character ported side effects, however, 11. 8% reported that they exceeded the 12 14 isti c of cancer pati ents who use CAM. - These pati ents in thi s sur recommended daily dose. Despite the absence of scientific evidence, vey were older and thus, not typi cal of cancer pati ents in general cancer patients expected the toni c to increase or improve the activ 15 25 who use CAM, - although several studies report no association ity of their immune system, and many expected the tonic to improve survival and quality of life . The major sources of information were fam il y, fri ends, and anecdotal reports. Table 2. Stages of Disease at Diagnosis and Time of Survey Time of Staging Table 3. Stage of Disease Diagnosis (%) Survey(%) Compliance with Dose Instructions for Flor-Essence (n =1 ,079) I 24.3 8.9 Reported Following Dose Instructions II 18.8 6.1 Used Correct Dose Ill 19.0 6.4 (< 4 ounces/day) Yes No Total IV 18 .8 13 .2 Yes 200 756 956 Other 19.0 26.5 No 12 111 123 No evidence of disease N/ A 38.9 Total 212 867 1,079 44 HERBALGRAM 50 2000 ORIGINAL RESEARCH Assessment of efficacy and safety by carefull y controlled pro Slippery Elm, spective clinical trials is critical. As a result of this pattern of use Ulmus rubra. survey, a pilot study is planned to determine the feasibility of accru Photo © 2000 ing patients who are presenting for palliative chemotherapy for Stage Steven Foster. IV colon cancer to receive the herbal tonic or placebo. The pilot will provide experience in the context of integrated care to assess CAM. If successful , the preliminary data on quality of life, general health outcomes (i.e., pain, weight, and performance status), safety, and tolerability will provide the basis for a larger, more definitive trial. herbs, and some $27 billion Such a study, however, would need sufficient power and long-term was spent in the U.S . on follow-up to determine efficacy using a full range of outcomes, in CAM therapies in general, cluding disease progression. with two-thirds of that money paid out-of-pocket.19 LIMITATIONS Regu latory require As with all self-selected populations, this sample may be rep ments for the approval of pre resentative of more enthusiasti c and committed consumers and thus, scription drugs req uire a re may be biased and not representative of the Flor-Essence consumer view and analysis of clinical in general. However, these interesting re ults suggest the need fo r data for drug development, more representative samples. The response rate among eligible can but botanicals differ from cer patients was 42.4% and lower than rates for mailed surveys of chemically produced drugs. CAM use among cancer patients in_ltaly (51.2%) and the United These products are sold as di 15 23 Kingdom (69%). · No study that we are aware of has attempted to etary supplements rather than conduct a pattern of use survey of CAM users by targeting consum therapeutic agent s. The e ers of an herbal product. Thus, we are unable to compare our re herbal tonics consist of mul sponse rate with those from similar studies. tiple herbs, each containing multiple constituents with CONCLUSION known compounds, both ac- This study confirmed that the widespread use of CAM is a tive and inactive, as well as unknown compounds and elements. reality and may reflect unmet pati ent needs within the current model which may be active or inactive. The mechanism of action is usuall y of health care. These patients were clearly seeking hope and an op unknown and variabi lity within the same plant material usually high. portunity to enhance their clinical outcome by expanding their treat thus challenging the ability for standardi zation and stability.-'0 Re ment options. This behavior was reflected among general consum gardless, the Flor-Essence tonic has a long history of sustained use ers as well. Since 1990, the prevalence of CAM use in the United over the past decades. Consumers believe they benefit from this prod States has increased to 42%, visits to CAM practitioners have risen uct. Given the widespread use by cancer patients, regardless of clini to 629 million, and out-of-pocket expenditures climbed to $34.4 bil cal benefit, rigorous assessment by the conventional medical com lion.39 In 1997, sales in the U.S. jumped 70% to $3.24 billion for munity is the next logical step to better inform patients and their physicians. 0 Correspondence and Reprillf Requests to: Mwy Ann Richardson, D1:P.H. , National Center for Complemenwn! Alternative Medicine, National Institutes of Health. 6707 Democracy BIFd, #106, Bethesda, Maryland 20892-5475; Phone: 3011402- 12 72; Fax: 3011480-3621: email: Acknowledgement to Thomas Creithe1; President of Flora Manufacturing Compamfor his collaboration and J. Fred Annegers, Ph.D. , Th e Un i1 •ersitY of Texas - Houston School of Public Health for assisting with the studr concept and design. This studr 11·as supported bra grant from the National Institutes of Health ( 5 U24 CA66826-03) through the National Center for Complementar\!Aitematire Medi cine and the National Cancer Institute and approred br the Watercress, Nasturtium officina/e. Photo © 2000 Steven Foster. institutional rel'iew board at the Unirersitr of Texas- Hous- ton Health Science CenteJ: 2000 HE RBALGRAM 50 45 ORIGINAL RESEARCH REFERENCES 23. Downer SM, Cody MM, McCluskey P, et a!. Pursuit and practice of I. Gray RE, Fitch M, Greenberg M, eta!. Perspectives of cancer survivors complementary therapies by cancer patients receiving conventional treat interested in unconventional therapies. Journal of Psychosocial Oncol ment. British Medical Journal. 1994;309:86-89. ogy. 1997; 15:149-171. 24. Weis J, Bartsch H, Hennies F, eta!. Complementary medicine in cancer 2. Kaegi E. Unconventional therapies for cancer: I. Essiac. Canadian Medi patients: demand, patients' attitude, and psychological belief. Onkologie. cal Association Journal. 1998; 158(7):897-902. 1998;21: 144-1 49. 3. Office of Technology Assessment (OTA). Essiac. Washington, D.C.: US 25 . Risberg T, LundE, Wist E, eta!. The use of non-proven therapy among Government Printing Office; 1990. patients treated in Norwegian oncological departments: a cross-sectional 4. Richardson MA, Ramirez T, Palmer JL, Greisinger A, Singletary SE. national multicenter study. European Journal ofCan cer. 1995;31 A: 1785- Complementary/alternative medicine use in a comprehensive cancer center 1789. and the implications for oncology. J Clin Oneal. 2000; 18:2505-2514. 26. So liner W, Zi ngg-SchirM, Rumpold G, Fritsch P. Attitude toward alter 5. The University of Texas Houston Center for Alternati ve Medicine Re native therapy, compliance with standard treatment, and need for emo search in Cancer. Essiac summary. http://www.sph.uth.tmc.edu/www/ tional support in patients with melanoma. Archives of Dermatology. u tsph/utcam /agents/essiac/summ .htm. 1997; 133:3 16-321. 6. Canadian Breast Cancer Research Initiative. 1999. Web Page. Avail able 27. Grothey A, Duppe J, Hasenburg A, Yoigtmann R. Use of alternative at: http://www.breast.cancer.ca. medicine in oncology. Deutsche Medizinische Wo chenschrift. 7. National Research Council. Food Chemicals Codex. Food and Nutri 1998; 123(3 1-32):923-929. rion Board, Division (~f Biological Sciences, Assembly of" Life Sciences. 28. Obrist R, von Meiss M, Obrecht JP. [The use of paramedical treatment Washington. DC: National Academy Press; 198 1. methods by cancer patients. An inquiry on 101 ambul atory patients]. 8. Flora Manufacturing and Distributing Ltd. Flora company literature. [German]. Deutsche Medizinische Wochenschrift. 1986; Ill :283-287. Unpublished Dara. 1996. 29. Liu JM, Chu HC, Chin YH , eta!. Cross-sectional study of use of alter 9. Tamayo C, Richardson MA, Diamond S, Skoda I. The chemistry and native medicines in Chinese cancer patients. Japanese Journal of Clini biological activity of herbs used in Flor-EssenceTM herbal tonic and cal Oncology. 1997;27:37-41. EssiacT.\1. PhYtotherapy Research. 1999; 13: 1- 14. 30. Hoey J. The arrogance of science and the pitfalls of hope. Canadian I0. Flora Manufacturing and Distributing Files. Academy of Agricultural Medical Association Journal. 1998; 159:803-804. Sciences of the Russian Federation Research & Manufacturing Associa 3 1. Ji rill o A, Lacava J, Leone BA, Lonardi F, Bonciarell i G. Survey on the tion. Research & Development Institute of Medical & Aromatic Plants. use of questionable methods of cancer treatment. Tumori. 1996;82:2 15- Unpublished Reporr. 1997. 217. II. Ri chardson MA, Ram irez T, Nanney K, Singletary SE. Alternative/ 32. Arkko PJ, Arkko BL, Kari-Kosinen 0, Taskinen PJ. A survey of un complementary medicine: implications for patient-provider communica proven cancer remedies and thei r users in an outpatient clinic for cancer tion. Proceedings of American Societv of Clinical Oncology. therapy in Finland. Social Science & Medicine-Medical Psychology & 1999; 18:590A (abstr 2279). Medical Sociology. 1980; 14A:5 1 1-514. 12. Lerner IJ , Kennedy BJ. The prevalence of questionable methods of 33. Neogi T, Oza AM. Use of alternative medi cine: are we fai ling in our cancer treatment in the United States. CA A Cancer Journal for Clini communication with patients? A study assessing psychosocial impact of cians. 1992;42: 18 1-1 9 1. alternative medicine on cancer patients. Proceedings ofAm erican Soci 13. Cassileth BR, Lusk EF, Strouse TB, Bodenheimer BJ. Contemporary ety of Clinical Oncology. 1998; 17:416A. unorthodox treatments in cancer medicine: a study of patients, treatments, 34. Fernandez CY, Stutzer CA, MacWilliam L, Fryer C. Alternative and and practitioners. Annals of Internal Medicine. 1984; lO I: I 05-112. complementary therapy use in pedi atric oncology patients in British Co 14. McGinnis LS. Alternative therapies, 1990. An overview. Cancer. lumbia: prevalence and reasons for use and nonuse. Journal of Clinical 199 1; 67 : 1788-93. Oncology. 1998; 16: 1279-1286. 15. Crocetti E. Crotti N, Feltrin A, Ponton P, Geddes M. Buiatti E. The use 35. Sawyer MG, Gannoni AF, Toogood IR, Antoniou G, Rice M. The use of of complementary therapies by breast cancer patients attending conven alternative therapies by children with cancer. Medical Journal ofAustra tional treatment. European Journal of Cancer. 1999;34(3):324-328. lia. 1994; 160:320-322. 16. Munstedt K, Kirsch K, Milch W, Sachsse S, Yahrson H. Unconven 36. Berman B, Singh B, Hartnoll S, Singh B, Rei lly D. Primary care physi tional cancer therapy-survey of patients with gynecological malignancy. cians and complementary alternative medicine: training, attitudes, and Archives of Gvnecology and Obstetrics. 1996;258:81-8. practice patterns. Journal of the American Board of Family Practice. 17. Burstein HJ , Gelber S, Guadagnoli E, Weeks JC. Use of alternati ve 1998; II :272-281 . medicine by women with early-stage breast cancer. lAMA. 37. Boucher T, Lenz S. An organizational survey of physicians' attitudes 1999;340: 1773- 1739. about and practice of complementary and alternative medicine. Alterna 18. Verhoef MJ, Hagen N, Pelletier G, Forsyth P. Alternative therapy use in tive Therapies in Health and Medicine. 1998;4(6):59-65. neurologic diseases. Neurology. 1999;52:61 7-622. 38. Crock R, Jarjou ra D, Polen A, Rutecki G. Confronting the communica 19. Mottonen M, Uhari M. Use of micronutrients and alternative drugs by tion gap between conventional and alternative medicine: a survey of children with acute lymphoblastic leukemia. Medical and Pediatric On physici ans' attitudes. Alternative Therapies in Health & Medicine. cology. 1997;28:205-208. 1999;5(2):61-66. 20. Adler SR, Foskett JR. Disclosing complementary and alternative medi 39. Eisenberg DM, Davis RB , Ettner SL, eta!. Trends in alternative medi cine use in the medical encou nter: A qualitative study in women with cine use in the United States, 1990-1997: results of a follow-up national breast cancer. Journal of Family Practice. 1999;48:453-458. survey. lAMA. 1998;280: 1569-1575. 2 1. Begbie SD, Kerestes ZL, Bell DR. Patterns of alternati ve medicine use 40. Lazarowych N, Pekos P. Use of fingerprinting and marker compounds by cancer patients. Medical Journal ofAu stralia. 1996; 165:545-548. for identification and standardization of botanical drugs: strategies for 22. Fisher P, Ward A. Complementary medici ne in Europe. British Medical applying pharmaceutical HPLC analysis to herbal products. Drug Infor Journal. 1994;309:107-l ll. mation Journal. 1998;32:497 -512. 46 HERBALGRAM 50 2000 LITERATURE REVIEW Devil' sClaw: From African Traditional Remedy to Modern Analgesic and Antiinflammatory by Tankred Wegener San women gathering roots of devil's claw in the Kalahari Desert in central Botswana . Photo © 2000 Prof. Ben-Erik van Wyk. branch off horizontally from the primary taproot. It produces large. hook-like frui t wi th rows of curved arms bearing recurved spines. Fruits may be up to 15 em in diameter. ~.~ Th e com mon name de ri ves from the translation of th e Namibian farmers' German name, Teufelskralle, mean ing devil's 3 claw. ..1 Other names are grappl e plant and wool spider. The Harpago in th e genus name translates to hook, a grap pling hook or a drag. obvi ously based on the fearsome-looking fruits that can cripple a larger animal by becoming jammed in the foot or the hoof. In an animal's mouth, it may firmly hook itself to the jaw. In thi s case, the INTRODUCTION animals cannot get rid of the obstruction and some have been known Interest is growing in Germany about preparations made from to starve to death. The hooked fru it may also become entangled in the secondary tubers of the traditional African herb, devil 's claw wool, mane. tail , or hair. where it remains with great tenacity. 5 (Harpagophytum procumbens), based on several recent clinical stud ies showing reduction of pain sensation and improved mobility within HARVESTING a few weeks of treatment. Also, in these studies patients were able to The medicinal material consists of the cut and dried second reduce dosages of standard antirheumatic drugs. Pharmacological ary root tubers of the plant. The primary ve rti cal root contains the studies on devil's claw support analgesic and antiinflammatory ac same constituents but at lowe r leve ls than the secondary roots. These tions. Extracts and drugs of the secondary tubers of devil's claw are tubers are obtained by wild co ll ecti on and by harvesting culti va ted approved in monographs published by the German Commission E as wel l as by the European Scientific Cooperative on Phytotherapy (ESCOP). They appear to be safe and effective herbal remedies for the treatment of degenerative painful rheu mati sm, arthrosis (osteoarthritis) and tendonitis, often as an ad juvant therapy with conventional pharmaceutical drugs. BOTANY AND NOMENCLATURE Oevil 's claw (Harpagophytum procumbens DC , Pedaliaceae) is found only in southern Africa. 1 The natural habi tats are Kal ahari savannas and deciduous forests in Namibia and pai1s of the adjacent Republic of South Africa, Botswana, Angol a, and Zimbabwe. The plant belongs to the same botanical famil y (Pedaliaceae) as sesame (Sesamum indicum ). Devil's claw is a perennial herb. It has several prostrate annual stems from a succulent taproot, with additional tubers on lateral roots. At the beginning of the rainy season, the larger nodular roots produce flat- lying shoots. To survive the dry pe Large devil's claw flower, Harpagophytum procumbens, in the Kalahari riod, the plant forms water-storing secondary root tubers that Desert. Photo © 2000 Nigel Gericke. 2000 HERBALGRAM 50 47 LITERATURE REVIEW logicall y acti ve. The fraction of iridoid glycos ides con sists of harpagos ide, procumbide, harpag id, and 8-para coumaroy l-harpag id . Harpagoside is the primary iridoid 612 15 glycos ides. . Iridoids were not considered previously as a parti cul arl y important pharmacologically active class of compounds. More recentl y, extensive investi gati ons into thei r bi ological ac tivity in general and their potential phar macological activity in particular have revealed that iridoids exhibit a wide range of bi oactivity. They are now known to be present in a number of folk medicines used as bitter toni cs, sedatives, febrifuges, cough medicines, remedies for wounds and ski n disorders, and as hypotensives. 16 Additional constituents with probable acti vity are glycosides of the flavonoids, kaempferol and luteolin, chlo rogenic acid and cinnami c acid, the phenyleth anoid The claw-like fruit of devil's claw has given the plant its scientific name acteoside, quinone, harpagoquinone, triterpenes like ursolic 4 9 Harpogophytum- derived from harpago (a hook) and phylum (plant). and oleani c acid and deri vatives. · Some papers reported Photo © 2000 Nigel Gericke. on a direct inhibition of cyclooxygenase-2 (COX-2) cata- lyzed prostaglandin bi osynthesis or COX-2 acti vity by the 17 19 plant material on farms planted for continuous production for th e fl avonoid kaempferol as well as ursolic and oleanic acid. · 6 7 medicinal market. · Devil's claw is grown and co ll ected onl y in natu ral habitats in Southern Afri ca. Cultivation in other environments PHARMACOLOGY seems impossible. 6·s The first scienti st to study the pharmacological effects of devil's To harvest, the soil is shoveled, by hand, away from the stem claw was Zorn at the Uni ve rsity of Jena, Germany, more than 40 to reveal the primary roots. From these, thin side roots branch off, at years ago. 20 Based on hi s positive findings, further experimental and the end of which secondary storage roots (the tubers) might be found. These are collected, was hed, sli ced, and dried in the sun. To ensure continuous harvest in the next growing cycle, the holes are refilled with so il 7 HISTORY A German soldier, Mehnert, introduced devil's claw 8 9 in Europe as an herbal tea in the mid-1900s. · He discov ered this herb by an intensive study of the local native medi cine of the Bushman, Hottentot, and Bantu in Namibia. The natives prized the tuber of devil's claw as a bit ter-tasting medicine, especiall y for stomach complaints (dyspepsia). Further, an infusion was recommended forthe relief of all fevers, for blood diseases, and as an anti inflammatory and analgesic agent. It was ad ministered to pregnant women to relieve postpartum pain. Ointments are app li ed to sprains, sores, ulcers, and boi ls. 25 In general, Africans have used devil's claw tubers for centuri es, if not millennia. Modern studies document th e effects of devil's claw and are sti ll ongoing. The German Commision E and ESCOP monographs all ow the use of devi l's claw in ar throsis (osteoarthritis) and tendoniti s. 10 11 The recommended Secondary use in dyspepsia is va lid only when admi ni stered in bitter roots of devil's claw show the tasting preparations. natural variation in PHYTOCHEMISTRY size and The cut and dried secondary root tubers of devil's shape. Ph oto claw yield a variety of compounds, mainly iridoid glyco © 2000 sides (up to 3 percent), which are considered pharmaco- Prof. Ben-Erik van Wyk. 48 HERBALGRAM 50 2000 LITERATURE REVIEW clinical studies foll owed , contributing to th e th erapeutic profil e of thi s ph ytomedicine. The most important of th e Commi ss ion E recom mended uses are its antiinflammatory and anal gesic effects. Research also suggests antiarrh ythmic and hypotensive ef fec ts; however, th ese acti ons have not stimul ated clinical interest in dev il 's cl aw. In all th ese studies. the dosages of the extrac ts were about 20- 1,200 mg drug materi al per ki logram of body weight. Some reports of antiinflammatory acti vity of dev il 's claw in animal ex periments conflict. Some studi es show a strong effect, while others fail to show positive effects. An tiinflammatory effects have been demonstrated more con vincingly in recun·ent conditions, ratherthan in ac ute.8 This is consistent with the recommended use in chronic rheu mati c di seases. In conclusion , the experimental findings may ex plain the underl ying analges ic and antiinflamma An example of one of the earliest brand names of devil's claw, a tory effects for both the whole extrac ts and isolated con product from Namibia. Photo © 2000 Prof. Ben-Erik van Wyk. stituents of dev il 's claw. Conflicting results mi ght be ex pl ained by different extrac t qualiti es and by different meth odological des igns. In general, most pos iti ve results were achieved CLINICAL DATA AND MODERN USE fo ll owing oral administration of aqueous extrac ts compared to alco In Euro pe the clinical use of dev il 's claw is restricted to appli holi c extrac ts or isolated constituents or parental application. (For cati ons in rheumatism and dyspepsia. However, its use as a dys pep summari es of the pharmacolog ical and pharm acokinetic literature, ti c aid was limited to in fusions (herbal teas), available in the first see the related story, on page 52 .) decades of marketing of devil's cl aw teas in Europe. The dys peptic ac ti on may be due to the strong and intensive stimul a tory bitterness of th e dried tuber. It is not known whether drug materi al in th e processed state (e.g., extrac ts) ex erts a comparable antidyspepti c effect. In clinical stud ies testing for effects of solid preparati ons (e .g. , cap sul es or tablets) of dev il 's cl aw fo r rh eumati c com plaints, neither physicians nor patients made comments to support an antid ys peptic effect. Many studies have assessed the efficacy of dev il 's claw in the reli ef of arthrosic (osteoporotic) and arthritic 8 9 11 conditions. · The studies support the approved indi cations in the positi ve monographs produced by ESCOP and the German Commi ss ion E: painful arth rosis and tendoniti s10 and fo r supporti ve or adju vant treatment of degenerati ve rheumati sm ("degenerati ve di so rders of the loco motor system").11 The use of dev il 's claw fo r degenerati ve rheumati sm today may be due to the pos i ti ve data fo r thi s indi ca ti on from clinical and pharma cological studies. The pharmacological data support an adju vant effect on arthriti s; however, there are onl y ve ry limited data ava il able. Dev il 's claw is used primarily to improve pain , mobility and motility of pati ents with arthrosic and ar San women thritic conditi ons. In addition, new studies show ing suc display their cessful use of dev il 's claw have been publi shed in the collection of devil's cl aw las t few years (see Tab le I). tubers in the In one study, an insignificant improvement of gri p Kalahari stre ngth and Ritchi e-index (an index for the fl ex ibility Desert. Photo of the trunk) were reported in 13 pati ents, suffe ring © 2000 mainly fro m seropositi ve arthriti s, after a six- week treat- Nigel Gericke. 2000 HERBALGRAM 50 49 LITERATURE REVIEW iridoid glycosides) at a daily dosage of 3 to 9 g. 23 Improve ment of pain sensation and other complaints was demon strated in 42 percent to 85 percent of the patients, according to localization of arthrosis. No side effects other than mild gastrointestinal di sturbances were reported, even at th e hi gh est dosage le ve l. In a double-blind study, 50 patients with arthrosis re ceived three doses totalling 2,400 mg per day of devil 's claw (each dose was two caps ules of 400 mg cryoground dried root material, standardized to 1.5 percent iridoid glycosides) up to three times per week for a three-week period. 24 Sever ity of pain was assessed I 0 days after treatment completion. Compared with placebo, the extract significantly decreased the severity of the patients' pain. 5 Devil's claw product - the sliced and dried secondary roots of In a double-blind study2 of 89 patients with rheumatic Harpogophytum procumbens. Photo© 2000 Prof. Ben-Erik van Wyk. articulation joint pain, the efficacy and tolerance of a daily dose of2,000 mg of powdered devil's claw (three times daily, ment of I ,230 mg per day of devil 's claw extract (unspecified con 2 capsules, each 335 mg of powdered cryoground drug materi al, centration of aqueous dry extract, Salus, Germany) Y standard ized to 3.0 percent of iridoid glycosides; Arkopharma, In a large uncontrolled study, 630 pati ents suffering from ar France) for two months was assessed. The clinical parameters mea throsis of hip, knee, fingers, and spine were treated for six months sured on days 0, 30, and 60, severity of Visual Analog Scale (VAS ) with devi l 's claw aqueous dry extract (standardized to 2.5 percent of pain and joint mobility determined by finger-floor distance, revealed Table 1: Efficacy of various devil's dow products in patients with rheumatic complaints. Review of the most important clinical studies. Design of study Number of patients Treatment period Daily dose Main results Reference Arthrosic conditions uc >630 <6 months 3-9 g Improvement of Belaiche aq extract pain and 198223 complaints PC 50 3 weeks 2.4 g Reduction of pain Guyader dried tuber 198424 PC 100 30 days 2.46 g ha Reduction of pain Schmelz extract 2:1 199730 RC 122 4 months 2.6 g Improveme nt of Cha ntre et al. dried tuber pain and of 20003 1 Leauesne index Low bock poin/ lumbolgio PC 109 4 weeks 2.4 g 2.5 :1 Improvement ot Chrubasik et al. aq extract pain; motility 199626 unchanged uc 102 6 weeks 1.8 g aq Improvement of Chrubasik et al. extract 2.5:1 pain; motility 199728 unchanged PC 197 4 weeks 600 and Dose-dependent Chrubasik et al. 1,200 mg pain improvement 199827 extract Various rheumatic complaints uc 13 2 months 1.23 g Improvement of Grahame and aq extract grip strength Robinson 1981 22 and Ritchie-Index PC 89 2 months 2g Improvement of Lecomte and dried tuber pain and motility Costa 199225 uc 43 30 days 750 mg Improvement of Pingel and dried tuber complaints Lecomte 1997 29 UC = uncontrol led study, PC = placebo-contro ll ed study, RC = reference-controlled study, aq = aqueous, ha = hydroalcoholic 50 HERBALG RAM 50 2000 LITERATURE REVIEW a significant drop in the intensity of pain and a significant increase were reported in the devil's claw group, not necessitating discon in mobility in the treatment group. Neither side effects nor changes tinuation of treatment. in laboratory parameters were observed during the two-month study. Forty-three patients with osteoarthritis and rh eumatoid arthri A four-week placebo-controlled double-blind study with a tis were enrolled in an uncontrolled study with a daily dosage of 750 daily dosage of 2,400 mg of dev il's claw extract (three times, two mg powdered secondary tubers of devil"s claw (Arkogelule tablets, 400 mg each 2.5: I aq ueous dry extract, Dol oteffin®, d' Harpagophytum, Arkopharma, France) for a course of 30 days. 29 Ardeypharm, Germany) tested patients with acute exacerbations of At the end of treatment patients reported significant improvement chronic low back pain. The outcome was measured by a validated of symptoms, mobility, and morning stiffness. Adverse events were low back pain index, and scales to measure pain sensation, back not reported. mobility, and overall patient mobility. Of the 11 8 ori gi nal patients, In a double-blind, placebo-controlled study, th e analgesic ef I 05 completed the study ; nine in the treatment group and one in the fec t of a devil 's claw ex tract (2,460 mg of hydroalcoholic dry ex placebo group were pain tract daily, 2: I, 40 per free at the end of treat cent ethanol; Pagosid®, ment. There was a median Dr. Duenner, Switzer improvement of the low land ) was inves ti gated back pain index of20 per in I 00 patients with os cent compared to the ini teoarthritis, chronic tial value in the devil 's low back pain and my claw group compared to 8 algia. 10 Following 30 percent of placebo. This days of treatment, only trend was related to a sig six patients reported a nificant decrease in the strong, and one patient, pain index . Only minor a medium pain sensa nonspecific adverse ef tion, compared to 32 fects were reported. 26 and nine in the placebo In a placebo-con group , respectively. trolled double-blind study, Only one patient of the 197 patients suffering treatment group re from chronic local , as well ported diarrhea as an as radiating, low back pain adverse event. for at least six months In a recent were treated with 600 or The characteristic lobed leaves and pink tubular flowers of devil's claw, double-blind, random I ,200 mg of devil's claw Harpagophytum procumbens. Photo © 2000 Prof. Ben-Erik van Wyk. ized, multicenter clini extract (three tablets of ca l st ud y, the action of 200 or 400 mg each, WS 1532, Schwabe, Germany; dosages corre powdered cryoground devil's claw tuber, about 2,600 mg daily sponding to 50 or I 00 mg harpagoside per day) for four weeks Y (Harpadol®, Arkopharma. France), was stud ied for four months in The outcome was measured by the low back pain index as in the 122 patients suffering from osteoarthiitis of knees and hips.31 The prev ious study by the same research team. 26 Of the 182 patients who action was compared wi th that of I 00 mg daily diacerhein, an an completed the study, the number of pain-free patients increased dose thraquinone derivative producing rhein (th e actual active compo dependently: 3, 6 and 10 patients of placebo, 200 and 400 mg nent); diacerhein is approved as a conventional osteoarthritis treat harpagoside, respectively. Adverse events were not reported. ment in France and Italy. Spontaneous pain as evaluated by visual In a controll ed study, 102 patients suffering from acute local analog scale showed a sign ifi cant improvement during the course of low back pain for more than six months were treated with I ,800 mg the stud y: about 50 percent in the devil's claw group and about 58 devil's claw extract (2.5: I aqueous dry extract, Jucurba®, Strathmann, percent in the control group. Similarly, there was a progressive and Germany) or with conventional treatment (a non steroidal anti significant reduction in the Lequesne functional index (an interna inflammatory dru g, NSAID) for six weeks. 28 Again, the outcome tional index for the evaluation of severity of osteoarthriti s) . Patients was measured by the low back pain index. The percentage of pain tak ing devil's claw used significantl y fewer SAIDs and analgesic free patients after four and six weeks of treatment was si mil ar in drugs and the frequency of adverse events was signi ficant ly lower both groups (dev il 's claw, 32 percent and 29 percent; NSAID group, in the devil 's claw group. 23 percent and 45 percent, respectively). Six weeks after initiation No significant effects on the mediators of acute infl ammation of treatment, the low back pain index improved in both groups about , , (prostaglandin E2 thromboxane B2 6-ketoprostaglandin F1a, and 20 percent. The relative change of the single components measured leukotriene B) was measured in 25 hea lth y volunteers after a three pain, mobility, and physical impairment- did not differ between week daily intake of 2 g of powdered devil 's claw containi ng 3 per the groups. However, in both groups, the pain index decreased sig cent iridoid glycosides .-' 2 The subjects served as their own control nificantly from week 4 to 6 of treatment. Only minor adverse events and were also compared wi th a separate control group. However. 2000 HERBALGRAM 50 51 ' LITERATURE REVIEW this study was not consistent with dosage and durati on recommen no reports of serious or major adverse effects. Use of devil's claw dations as noted in monographs published by ESCOP (l-3 g of root wi th patients who have gastri c and duodenal ulcers is contraindi in decoction three times daily or l- 3 g dried root or equi valent prepa cated because bitter-tasting preparations are beli eved to stimulate rati ons dail y for 2-3 months) 10 and the German Commission E, i.e., gastric acid secretion. There are no reports of negative interactions 4,500 mg dail y (no durati on noted).11 That is, the study's negative wi th conventional drugs usuall y prescribed for rheumatic or arthrosic outcome mi ght be attributed to the fact that the dosage was about 33 conditions. to 60 percent lower than the upper range noted by ESCOP and Com mission E, respectively, and the duration was significantly shorter CONCLUSIONS than that recommended by ESCOP. Dri ed tuber and extracts of second ary root of devi l 's claw are interesting therapeutic remedi es for the adj uvant treatment of pain THERAPEUTIC SAFETY ful arthrosis (osteoarth ritis) and tendonitis. As has been shown in Devil's claw preparations from dried tu bers, drug, or extract, numerous clinical studi es in patients wi th rheumatoid arthritis, os appear to be well tolerated in all the studies described above. In only teoarthritis, and lower back pain, devil's claw preparations reduce a few cases, mild gastrointestinal compl aints occurred. There were pai n sensation and improve mobility and motility of patients, and Summary of Pharmacological, Pharmacokinetic, Pharmacodynamic, and Toxicological Studies on Devil's Claw Extracts of devil 's claw have shown activity in various experi solution in rats. Also, there was a comparable effect in high dos mental models.33·H In the croton oil-induced granuloma pouch ages to that of aspirin. test and formaldehyde-induced arthritis test in rats, the reduction In vitro, an extract of devil's claw and, to a lesser extent, pure in inflammation produced by I 0 to 12 days of intraperitoneal ad harpagoside exerted a significant, dose-dependent, protective ac ministration of extract, isolated harpagoside, or its aglycone tion against arrhythmias induced by reperfusion on isolated rat harpagogenine33 and by oral administration of devil 's claw extract33 hearts.42 In vivo oral and intraperitoneal treatment with extract was similar to that of the conventional drug phenylbutazone. How of devil's claw in rats protected against arrhythmias induced by 22 35 ever, other studies have not confirmed these results. • calcium chloride or epinephrine-chloroform. Pure harpagoside gave In the carrageenan induced rat paw edema test, extracts of much weaker protection than doses of tuber extract containing devil's claw administered intraperitoneally before paw injection equivalent amounts of harpagoside:B inh ibited edema provocation significantly and dose-dependently.36 Again, the inhibition at maximal dosages was similar to that of Pharmacokinetics. Pharmacokinetic data (information on phenylbutazone. metabolism, excretion, etc. of compounds in the human body) for A reduction of adriamycin-induced edema in rats was ob the total extract are very rare. Few contributions investigated tained after oral administration of powdered tuber.37 Significant, the major constituent, harpagoside. Following oral administrations dose-dependent antiinflammatory effects in the carrageenan of devil 's claw extracts to pigs and humans, some minor amounts induced edema test have been demonstrated in rats following of harpagoside had been detected in plasma .+~-<6 However, it is intraperitoneal pre-treatment with devil 's claw extract.38 The high unknown whether harpagoside is the most important and meta est dose tested was even more effective than pre-treatment with bolically active constituent of the whole extract. Recent contri the conventional drug indomethacin. Pure harpagoside was inef butions showed an intensive in vitro metabolism by the flora of fective in these experiments. the intestine, metabolizing iridoid glycosides to aucubinine BY A recent study assessed the antiinflammatory properties of devil 's claw when administered by different routes in the carrag Pharmacodynamics. There are limited data on the phar eenan-induced rat paw edema test.39 Aqueous extracts adminis macodynamics (actions of substances on body organs or systems) tered intraperitoneally and intraduodenally significantly reduced of devil's claw extract in humans. Various extracts, as well as iso edema. Administered orally, the extracts were inefficient. This is lated harpagoside, were investigated in vitro to determine the consistent with results obtained in another study,38 showing the action of eicosanoid-production in stimulated human blood.48 absence of extract activity after it was treated with hydrochloric There was measureable dose-dependent inhibition of leukotriene acid, simulating acid conditions in the stomach. Since these results and thromboxane-biosynthesis, which was much stronger for the support the inference that gastric degradation of the active prin whole devil's claw extracts than for isolated harpagoside. A stron ciples may occur, the use of appropriate oral preparations pro ger effect was seen for extract with a higher content of 38 39 tected against stomach acid degradation has been suggested. • harpagoside, however. The results of this study propose some A devil's claw aqueous dry extract exhibited dose-depen further constituents of devil's claw total extract may contribute dent peripheral analgesic effects in the writhing test after intra to the pharmacological action especially related to its anti-inflam peritoneal administration in mice.38 The protection at higher dos matory and analgesic action. ages was fai rly similar to the results obtained with acetylsalicylic acid (aspirin). Even pure harpagoside induced protection. Toxicology. Toxicity of devil's claw extracts observed in the 35 49 An oral pretreatment with an aqueous extract of devil's claw animal experiments is very low.H· · Toxic effects have been ob showed a strong antiinflammatory action in the carrageenan-in served only at higher dosages, which exceed by far effective con duced rat paw edema test.o40·41 A dose-dependency was observed, centrations calculated by body weight ratios. No hematological with a maximal effect three to four hours after administration. A or pathological findings were evident following a subchronic oral single pretreatment with this extract also significantly reduced treatment with 7.5 grams per kilogram of body weight with devil's the number of writhings and stretchings induced by an acetic acid claw in rats.35 52 HERBAlGRAM 50 2000 LITERATURE REVIEW therefore increase quality of life within the first weeks of treatment. Mitteilung: Phytochemische Standardisierung von Tubera Harpagophyti. Further, the dosage of conventional antirheumatic drugs mi ght be Dtsch Apoth Ztg 1977:117:1431-4. reduced. 13. Eich J, Schmidt M. Betti G. HPLC analysis of iridoid compounds of The ESCOP and Commission E monographs recommend a Harpagophytum taxa: Quality control of pharmaceutical drug material. daily oral dose of 1,000-4,500 mg of devil's claw crude drug (dried Pharm Phannacol Lell 1998;4:75-8. tuber) or corresponding extracts. However, based on the results of 14. Guillerault L, Ollivier E, Elias R. Balansard G. Determination of recent studies, dosage should be as much as 4,500 mg of dried tuber harpagide, 8-para-coumaroyl harpagide. and harpagoside by high perfor mance liquid chromatography in Harpagophwum procwnbens drugs and or equivalent extracts for a noticeable effect in about four weeks of in a commercial extract. J Liquid Chrom 1994:17:2951-60. treatment. 0 15. Sticher 0. Meier B. Quantitative Bestimmung von Harpagosid in Wurzeln von Harpagophytum procumbens mit Tankred Wegener is a consultant Hochleistungstliissigkeitschromatographie to the phytomedicine industry in Rheda (HPLC ). Dtsch Apoth Ztg Wi edenbrueck, Germany, email: 1980: 120: 1592-4. 2000 HERBALGRAM 50 53 LITERATURE REVIEW I 27. Chrubas ik S, Junek H, Conradt C, Zappe H, Chrubas ik J. Effec ti veness 39. Soulimani R, Younos C, Mortier F, Derri eu C. The role of stomachial of oral Harpagophytum extract WS 153 1 in treating low bac k pain . Arthr di ges ti on on the pharmaco logical activity of plant extracts, using as an Rheum 1998;41 (suppl. 9):S261. exampl e extracts of Harpagophytum procumbens. Can. J Physiol 28. Chrubas ik S, Schmidt A, Junek H, Pfi sterer M. Wirksamkeit und Pharmacal 1994;72: 15 32-6. Wirtschaftlichkeit von Teufelskrall enwurzelextrakt bei Ri.i ckenschmerzen: 40. Baghdikian B, Guiraud-Dauriac H, Ollivier E, N 'Gu yeb A, Dumenil G, Erste Ergebni sse ein er th erapeuti sc hen Kohort enstudie. Fo rsch. Balansard G. Formation of nitrogen-containing metabolites from the main Komplementiirmed l997c;4:332-6. iridoids of Harpagophytum procumbens and H. zeyheri by human intes 29. Pingel M, Lecomte A. Die Wirkung der "Harpago phytum Arkocaps" tinal bacteri a. Plan/a Med 1999;65: 164-5. bei degenerativem Rheuma. Naturheilpraxis 1997 ;50:267-9. 41. Fl eurentin J, Morti er F. Entzuendungs hemmende und analgetische 30. Schmel z H, Haemm erle HD, Springorum HW. An algeti sche Wirksa mkeit Wirkunge n von Harpagophytum procumbens und H. zeyheri . In: eines Teufels-krallenwurze l-Ex traktes bei verschi edenen chroni sch-degen Chrubas ik S, Wink M (eds.): Rheumatherapie mit Phytopharmaka. erati ve n Gelenkerkrankun gen. In: Stuttgart: Hippokrates: 1997:68-76. Chrubas ik S, Wink M (eds.) : 42. Cos ta de Pasquale R, Busa G, Rheumatherapie mit Phytopharmaka. Circosta C, Lauk L, Ragusa S, Ficarra P, Stuttgart: Hippokrates; 1997:86-9 . Occhiuto F. A drug used in traditional 31. Chantre P, Cappelaere A, Lebl an D, medi cine: Harpagophytum procumbens Guedon D, Yanderm ander J, Fourni e. DC. J Ethnopharmacol1985;1 3: 193-9. Efficacy and tolerance of 43. Circosta C, Occhiuto F, Ragusa S, Harpagophytum procumbens versus Trovato A, Tumino G, Briguglio F, de diacerhein in treatment of osteoarthri Pasquale A. A drug used in traditional ti s. Phytomedicine 2000;7 : 177-83. medicine: Harpagophytum procumbens 32. Moussard C, Alber D, Toubin MM , DC- II. Cardiova sc ul ar activity. J Thevenon N, Henry JC. A dru g used in Ethnophannaco/ 1984; I I :259-274. traditional medi cine, Harpagophy!Um 44. Chrubas ik S. Biopharmaze uti sche procumbens: No evidence for NS AID Qualitat und klini sche Wirksamkeit von like effec t on whole blood eicosanoid Zubereitungen au s Harpago producti on in human. Prostaglandins phytumextrakt. In : Chrubasik S, Wink M Leukotriens and Essential Fatty Acids (eds.). Rheumatherapie mit 1992 ;46:283-6. Phytopharmaka. Stuttgart: Hippokrates; 33. Eichler 0 , Koc h C. Uber die 1997:77-85. antiphlogisti sche, analgeti sc he und 45. Chrubasik S. Teufelskral spasmolyti sche Wirksa mke it vo n lenwurzelextrakt. Klini sc h gepri.ifte Harpagophy tum procumbens . Wirksa mkei t bei akuten A rzneim ittel-Fo rsch/ Drug Res Ri.ickenschm erzen. Der Allgemeinarzt 1970;20: I07-9 . 1997; 19:564-8. 34. Erdoes A, Fontaine R, Friehe H, 46. Loew D, Schuster 0 , Moellerfeld J. Durand R, Poeppinghaus T. Beitrag zur Stabilitat und biopharmazeutische Ph arm akolog ie und Tox ik ologie Qualitat. Voraussetzung fi.ir ve rsc hi edener Ex trakte, sow ie des Bioverfi.igbarkeit und Wirksa mkeit von Harp agosid s aus Ha rpagophy tum Harpagophytum procumbens. In : Loew procumbens DC. Planta Med D, Rietbrock N (eds.). Phytophannaka 11: 1978;34:97- 10 8. Forschung und klinische Anwendung. 35. Whitehouse LW, Znamirowska M, Darmstadt: Steinkopff; 1996:83-94. Paul CP. Dev il 's Claw (Ha rpago 47. Baghdikian 8 , Lanhers MC, phytum procumbens): no ev idence for Devil's Claw, Harpag ophytum procumbens. Fl eurentin J, Olli vier E, Maillard C, anti-inflammatory activity in the treat Photo © 2000 Steven Foster. Balansard G, Mortier F. An analytical ment of arthritic di sease. Can Med stud y, anti -inflamm atory and analgesic AssocJ 1983; 129:249-51. effec ts of Harpagophytum procumbens 36. Manez S, Al caraz MJ , Paya M, Ri os JL, Hancke JL: Selected ex trac ts and Harpagophytum zeyheri. Planta Med 1997 ;63: 171-6. fr om medi cin al pl ants as anti -infl amm atory agents. Pla111a Med 48. Tippler B, Syrovets T, Loew D, Simrnet T. Harpagophytum procumbens: 1990;56:656. Wirkung vo n Extrakten au f die Ei cosanoidbi osynthese in Ionophor 37. Jadot G, Lecomte A. Acti vite anti-inflamm atoire d'Harpagophytum A23 187-stimuliertem menschlichem Yollblut. In: Loew D, Rietbrock N procumbens DC ; Lyon Mediterra111fe Medical Medicin du Sud-Est (eds.). Phytopharmaka II. Forschung und klinische Anwendung. 1992;28 :833-5. Darmstadt: Steinkopff; 1996:95-100. 38. Lanhers MC, Fl eurentin J, Mortier F, Yinche A, Younos C. Anti-In 49. Yanhaelen M. La bi ochimie et I 'activite de Harpagophytumprocwnbens fl amm atory and Analges ic Effects of an Aqu eous Ex trac t of et de Glycorrhiza glabra. Toxicite de Symphytum consolida. J ?harm Harpagophytum procumbens. Planta Med 1992;58: 11 7-23. Belg 1986:4 1: 172-82. 54 HERBALGRAM 50 2000 Health Benefits Boost Elderberry by Chris Kilham An old Austrian saying, "Tip your hat to the elder," expresses a boon to Austrian growers. At 8,000 tons of harvested elderberry in the respect with which Europeans have long regarded the elder tree 2000, Austria's commercial production has doubled since 1995. (Sambucus nigra L., Caprifoliaceae) and its dark purple berries. El derberries have been employed in European folk medicine since ELDER'S STATESMAN antiquity for a plethora of maladies, from arthritis and asthma to In Karlstein, Austria at the Paracelsus House nature cure cen colds and constipation. In 400 B.C.E. Hippocrates referred to the ter, Father Hermann Josef Weidinger and 37 assistants prepare and elder tree as his "medicine chest." Other distinguished classical heal prescribe herbal remedies for dozens of health conditions. The 82- ers including Theophrastus, Dioscorides and Galen, also considered year-old Austrian Catholic priest and herbal healer regards elder the elder and its berries one of nature's greatest healing plants. 1 In berry with the same reverence as Hi ppocrates. Before he discusses southern Italy, a decoction made by boiling fresh elderberries in water their healing powers, he serves tall glasses of imponderably dark is a folk remedy for stimulating bowel function. 2 In southeastern purple elder juice. "This is the very best thing for your heal th," he France a decoction of the berries has been used to promote healthy comments with a kind and knowing sm ile. stomach function. 3 And Father Wei- in Jordan, decoctions of dinger ha publi shed elderberries have been more than a dozen employed for diuretic books on natural thera and anti-rheum atic pies, and is especially purposes 4 impassioned about el derberry. "Elderberry INCREASED cleanses the digestive GROWTH AND system and promotes PRODUCTION healthy eliminati on. Austria is the This is most essential world's primary elder to good health." Father berry producing country, Weidinger beli eves and their Haschberg va that elderberry protects riety of elder produces a the body from serious high yield of sweet, diseases, and enhances richly purple berries. both the body and The epicenter of the mind. "Eiderben·y re booming Austrian elder duces inflammation berry industry, and the and relieves the body sponsor of my research Elderberry, Sambucus nigra. Photo© 2000 Steven Foster. of impurities. In thi s in Europe, is the manner it also bal- Beerenfrost Co-op in ances the emoti ons." Thalhammerstrasse, di- Weidinger empl oys rected by Kurt Kaufmann. A virtually tireless elderberry proponent, concentrated elderbeiTY juice as a mainstay in his herbal cleansing Kaufman has organized I ,000 Austrian growers into an efficient co and healing programs, and claims that the juice has helped thou op, with rigid schedules for harvesting, trucking and cool ing ber sands. ''l am convinced that elderberry juice helps to prevent many ries. Kaufmann also designed and built the immense non-profit serious diseases," he says. In conversations, both Kurt Kafmann and Beerenfrost berry freezing facility, where elderberries are cooled Austria's largest elderberry grower Josef Holler credit Father immediately after harvest. In conversation while touring the fac il Weidinger as a key force in popularizing elderberry for im proved ity, Kaufmann described the tricky timing of harvesting and cool health. ing. "In September at harvest, the elderberries must be cooled im mediately, or they spoil. Here at Beerenfrost elderberries are chilled POTENT PURPLE PIGMENTS to -20 degrees Celsius in less than 24 hours." He adds, "We can Folk healers like Father Weidinger aren't the only advocates handle about 600 tons per day, but in once 1998 we took in I ,600 of elderberry. Analytical research conducted in Europe shows that tons in 24 hours." elderberries are concentrated sources of anthocyanins, potent purple Products on displ ay at Beerenfrost fac ilities show that pigments that appear to benefit health in several ways. Ongoing re Haschberg elderbenies are used in juices, jams, fruit yogurts, wines search in Eu rope is focusing on these anthocyanins to determine and nutraceutical supplements. According to Kaufmann, increased what other health-imbuing powers they may possess, and how they demand for elderberry in the food and nutraceutical sectors has been work. 2000 HERBALGRAM 50 55 Antioxidant activity. In Karlsruhe at Germany's berry and its extracts may be used for cardioprotective purposes in Bundesforschungsanstalt research center for food, scientists conduct the future. Additional research conducted at Tufts University shows studies on dietary agents that can reduce oxidation and protect cells. that elderberry anthocyan ins protect vascular epithelial cells against According to research led by the center's director Dr. Gerhard oxidative insult, thereby helping to prevent changes in these cells Rechkemmer, anthocyanins found in elderberries possess apprecia which are associated with vascular disease.10 bly more antioxidant capacity than eitherTrolox (antioxidant, Aldrich Anti-viral activity. An oft-cited Israeli study on the anti-viral Chemical Co., Milwaukee, WI) or vitamin C.5 The work conducted activity of elderberry extract found that in vitro elderberry extract at Bundesforschungsanstalt sup reduced hemagglutination of red ports previous research con blood cells and inhibited replication ducted in Graz, Austria showing of a number of strains of influenza A that anthocyanins possess sig and B in cell cultures.11 In the same nificant free radical scavenging paper, administration of elderberry capacity.6 extract to 27 patients with influenza, Immune enhancement. shortened the duration of flu symp Rechkemmer's investi gations toms. In a Swiss study, elderberry also show that elderberry antho extract inhibited replication of avian cyanins enhance immune func influenza virus in a human breast tion by boosting the production cancer cell line. 12 And in vitro stud of cytokines.7 These unique pro ies conducted by the Southern Re teins act as messengers in the search Institute using elderberry ex immune system to help regulate tracts from Artemis International immune response, thus helping showed inhibition of herpes virus in to defend the body against dis cell cultures.13 ease. When asked if further re Stress Reduction. Of all dis search will reveal additional coveries related to elderberry, the health benefits, Rechkemmer re most surprising is the apparent ca sponded, "I believe so. But the pacity of elderbery and its anthocya anthocyan ins are extremely hard nin-rich extract to reduce stress. This to track in blood plasma, so we effect was discovered by Austrian en do not know exactly what they docrinologist Dr. Sepp Porta, who are doing in the body. We must conducted stress studies using elder discover their mode of action and berry concentrate on a group of vol go beyond belief to certain unteers. 14 He described this discov knowledge." He added that dis ery, "We gave these people the el coveries at the center help to derberry for only 10 days. We put fashion national food policy in them through typical stress tests, all Germany. If elderberry studies the usual physical challenges, and the continue to be positive, results were so remarkable, I checked Rechkemmer says that he will them over and over." In the study, recommend increased intake of various bio-markers of stress, includ the berries and their juice. Elder flower, Sambucus nigra. Photo © 2000 Steven Foster. ing glucose, magnesium and other Cardiovascular protec plasma chemical levels, were ana- tion. At the scientific heart of the lyzed. "What we found," he said, elderberry boom, Doctors Werner Pfannhauser and Michael "was that elderberry has this extraordinary effect for reducing stress." Murkovic at Austria's University of Graz research the biological Most notably, oral ingestion of elderberry extract resulted in increased activity of elderberry anthocyanins. Their studies show that elder glucose uptake, a pointed fall in ionized magnesium, and a signifi berry anthocyanins are absorbed into plasma and possess in vitro cant increase in basal granulocytes. Porta also found that daily in antioxidant activity.8 These findings corroborate the work of Cao take of elderberry extract significantly shortened recovery time from and Prior at Tufts University, who have tracked anthocyanins in hu physical exertion. man plasma after ingestion. 9 Pfannhauser and Murkovic have fur Dr. Porta's research into the stress-reducing effects of elder ther found that elderberry extract reduces oxidation of LDL choles berry has attracted strong interest on the part of the U.S. Air Force. terol.6 While cholesterol is an essential component manufactured in In a novel collaboration, cadets on loan now work with Dr. Porta to the liver, oxidation of LDL cholesterol is implicated in atherogen conduct follow-up tests, process data, and advance his findings. Dr. esis, thus contributing to cardiovascular disease, especially heart David Westmoreland of the U.S. Air Force Academy, commented attacks and strokes. Both researchers express optimism that elder- that if elderberry is as potent a stress buster as it appears, it could be 56 HERBALGRAM 50 2000 valua ble to jet pilo ts w hose stress load is daunting. ti vities of Elderberry (Sambucus nigra) in Low-Density Lipoprotein Oxi As wo rd of positive research findings spreads into the trade dation. J ofA g Food Chem 1998; 46:4091-96. and po pular media, the status o f elderberry continues to rise. Kurt 7. Watzl B, Roller M, Barth SW, Rechkemmer G. Anthocyanines Stimulate K aufma nn of Beerenfrost said that health findings have fueled sig Cytokine Production (TNF-Aipha, IL-2) in Human Mononuclear Cells. nificant interest in e lderberry fro m the food and beverage sector. Paper presented at: International Workshop on Immunonutrition; June 24-25, 2000; at Schloss Rauischholzhausen, Austria. "C o mpanies wa nt to sell healthy products, especially if they taste 8. Murkovic M, Adam U. Pfannhauser W. Analysis of anthocyane gluco good. It's a good thing for everybod y." 0 sides in human serum. Fresenius J ofA nal Chem 2000; 366:379-8 1. 9. Cao G., Prior RL. Anthocyani ns are detected in human plasma after oral Chris Kilham is a consultant and author of several books, administration of an elderberry extract. Clin Chern 1999; 45(4):574-6. including Tales F rom The Medicine Trail, published by Rodale Press. 10. Youdim K, Martin A, Joseph J. Incorporati on of The Elderberry Antho cyani ns By Endothelial Cells Increases Protection Against Oxidative REFERENCES Stress. Free Radical Biology & Medicine 2000: 29( I ):5 1-60. I. Pfannhauser W, Peters S. Das Vunder von Hoiund er. Sweden: Arcturus II . Zakay-Rones Z, Varsano , Zlotnik M, Manor 0. Regev L, Schlesinger Verlag, 1999. M, Mumcuoglu M. Inhibition of several strains of influenza vi rus in vitro 2. DeFeo V, Aquino R, Menghini A, Ramundo E, Senatore F. Tradi tional and reduction of symptoms by an elderberry extract (Sambucus nigra L.) phytotherapy in the Penensula Sorrentina, Campania, Southern Italy. J during an outbreak of influenza B Panama. J Air Comp Med 1995: Erhnopharmacol 1992; 36: 11 3-25. I (4):36 1-9. 3. Novaretti , R, Lemordant D. Plants in the traditional medicine of the 12. Sauter C, Wolfensberger C. Anticancer Activities as well as Antiviral Ubaye valley. J Erhnopharmacol 1990; 30: 1-34. and Virus-enhancing Properties of Aqueous Fruit Extracts from Fi fty-six 4. AI-Khalil S. A survey of pl ants used in tradi tional Jordanian medicine. European Plant Species. Eur J C/in Oncology 1989; 25(6):987-90. lnt J of Pharmacognosy 1995; 33(4):3 17-23. 13. Turpin, J. et al. Antiviral evaluation of elderberry extracts and standard 5. Pool-Zobel BL, Bub A, Schroder N, Rechkemmer G. Anthocyanins are ized powder. Southern Research lnst. Frederick. MD. Unpublished 2000. potent antioxidants in model systems but do not reduce endogenous oxi 14. Porta S. Impact of Rubini treatment upon workload induced selected dati ve DNA damage in human colon cell s. Eur J Nutr 1999; 38:227-34. stress effects in hu man probands. Abstract of the pi lot study. Unpublished 6. Abuja P, Murkovic M, Pfannhauser W. Antioxidant and Prooxidant Ac- 1999. The Journal of the American Botanical Council and the Herb Research Foundation • Conferences • Legal Issues • Books • Research • Market Reports • Features At all levels of membership, you will receive a new issue of HerbaiGram four times each year along with a collection of historic past HerbaiGrams. 0 Student - $30 0 Academic - S1 00 0 Corporate - SSOO 0 Individual- SSO 0 Health Professional- S1 SO 0 Sponsor - S1 ,000+ Add $20 for memberships outside the U.S. for Student through Health Professional levels. Complete application on page 4 of this issue or ioin online at www.herbalgram.org 8 0 N @ .2 0 _r::; "- Terraforming in Southern Baja California: Arid-Tropical Biodiversity, Regeneration, and Preservation by James E. Williams, OMD Creating an oasis of biodiversity in the imposing desert of west, and the Sea of Cortez (also called the Gulf of California) in the Southern Baja California, Mexico may we ll be the ultimate chal east. Within minutes from San Jose del Cabo or La Paz, the scenery lenge for any gardener. It may also be the key to survi val. Biodiversity, becomes a su rreali stic Castafiedian landscape of giant card6n a term that has become a bit trendy lately, implies more than tallying (Pachycereus pringlei) - a cactus similar in appearance to saguaro species. It also suggests multiplicity. Identifying endangered of the American southwest. White-faced caracaras (Caracara hotspots 1 and preserving the environment in its native state are the plancus), large carrion eating hawk-like birds, are common and are best-know n aspects of biodiversity. However, the practi ce of often seen surveying the bush from atop the card6ns. Lone, metallic biodiversity encompasses other features of equal or, perhaps, more blac k crows sit atop eeril y shaped wind-smoothed tree trunks of critical importance in light of humanity's apparent inability to slow Torote blanco or white elephant tree (Pachycormus discolor) with the rapid loss of wilderness, to stop global warming, or reverse the surface roots reaching over the gravel soil into crevices and basins greenhouse effect. This practice includes heritage seed collection in granite boulders, like fingers searching for a precious lost object. and seed banking to ensure futu re diversity, the creation of urban The land and sea seem timeless and magical. and suburban ecological zones, establishing new and more exten Tourism has scattered small North American colonies along sive botanical gardens, and planting oases of human-made the coast, such as Buena Vista and Los Barri les on the Sea of Cortez, biodiversity. and the artist pueblo of Todos Santos on the Pacific side. However, The botanical gardens of Gabriel Howearth Landeros are a other than the two main paved roads and numerous dirt roads, not case study in the creation of biodiversity. Located in the desert of much has changed. The main tourist centers have overwhelmed the Southern Baja California, Howearth tends more than 3,000 different beach and coastal property at the tip of the cape, from San Jose del native and introduced plant species that co-exist on four hectares (a Cabo to Cabo San Lucas, and destroyed most of the natural habitat hectare is equi valent to 2.47 acres). Compare those numbers with in the name of progress and economic advancement. Still, most of these: 155 plant species in a 400-hectare suburban Boston park. The Baja Sur is free from major industrial zones, the horizon is clear of entire Baja peni nsul a itself has only about 2,700 plant species.2 The smoke stacks, and the air is not tainted with pollution. Most strik 3,000-plus species under Howearth 's care make an astounding vi ingly, no jet trai ls cut across the sky; the views are as they were sion that steadily expands as he adds more species. hundreds of years ago. Thanks to its remoteness, the intense summer heat, and ab THE MAGIC AND BIODIVERSITY OF BAJA CALIFORNIA sence of extensive exploitable natural resources, Baja California re In southern Baja California, the color blue sun·ounds every mai ned inaccessible until recent times. Historically, semi-nomadic thing: from the vault of sky overhead, to the Pacific Ocean in the hunter-fisher societies thrived in the palm canyons and cooler high- 58 HER BALG RAM 50 2000 lands, with the densest indigenous population centered around th e GARDENING IN THE DESERT Cabo region, at the southern tip of the peninsula. These people, mem My first visit to Howearth 's garden s was on a full moon in bers of the Pericu "nation" (as the early mi ss ions classified th e April, late in the eveni ng. After driving through arid and isolated Califomias), are now extinct.) The Spanish Jesuit missionary, Juan country, I saw a patch of greenery in th e distance. Palms, bananas, Maria de Salvatierra, arrived in Baja California in the middle of the and avocado trees were clearly visible from the narrow hi ghway. As 17' 11 century, to establish the first mi ssion in Baja at Loreto in 1697 I drove into the botanical gardens, passing through a narrow gate of and begin the cycle of indigenous slavery, genoc ide, natural resource nati ve wood and over a homemade cattle guard, I entered the patch exploitation, and environmental degradation . Pea rl s, silver, timber, of green and emerged to supercharged oxygen-rich air. the smell s of and fish- originall y rich in parts of Baja - are now extinct or so fruits ripening on the tree, and the perfumes of a profusion of flow reduced that by the early 1900s they were of no commerci al value. ers. The ground- seething with groping seedlings, roots wending Only a few small cattle ranches and isolated fishing vi ll ages remained. their way in the dark underground, insects and worms- felt warm Tourism and sport fi shing are today 's main economic interest, which and ali ve under my feet , and I had the immedi ate impression of step have left the interior of the Baja peninsula and even large sections of ping onto a brave new organic world, futuristic and timeless at the the coast largely untouched for more than a century. same time. Though the peninsula, descending like an octopus' tentacle In the morning, I awoke to a symphony of bird song, includ from San Diego southward for I ,220 kilometers (760 miles), is of ing beautiful zapotera (Icterus zapotera) , Bullock's orioles (lscterus ten called simply Baja, Mexican people consider it part of three dis bullochii), and crimson crested Pyrrhul ox ia finches (Pyrrhuloxia tinct regions, originall y cal led the las Californias. Alta California, sinuata).6 Over breakfast of fresh papaya, avocado, and herbal tea, once Mexican so il , is now the state of California. Baja Norte forms aggressive Xantus' hummingbirds (Hylocharis xantusii), a species the northern half of the peninsula, and Baja Sur, whose capital is La endemic to Baja Sur, fought for air space and defended branches Paz, forms the southern half. Baja Sur is home to numerous species overhead, while beautiful Costas (Calypte costae) gathered nectar of birds, animals, plants, and sea life, including majestic migrating from huge yellow chrysanthemum flowers orn amenting the rustic gray whales which deliver their calves during the sprin g in protected tiled tabl e. Later that day. dinner included freshly picked beets, salad bays and lagoons along the Pac ific composed of several varieties of let- coast. •..- tuce, ye ll ow and red tomatoes, and Geographically, the state of Baja celery - all temperate climate veg Sur is unique, as it is the southern ex etables th at Howearth grows in the tension of North America, specifically, shade of the many native trees that the Southwest desert, while it also en he left when originally clearing the ters the tropical zone of Mexico and land . Many of th e native trees Central America. In a relatively short bloom in spring and will be covered distance (averagin g less th an 125 with thousands of honeybees. mi les wide), several distinct terrains Howearth's Jardin Botanico occur- from saltwater marshes and Co-Evolucionario Buena Fortuna lagoons, to desert, to coniferous for (Good Fortune Co-Evo lutionary ests. Rainfall averages 15.3 em (6-8.5 Botanical Garden) is located near inches) per year. However, plant and the small vi ll age of La Rivera on animal life are not scarce; the sur the Tropic of Cancer. The sound of rounding seas are some of the most waves from the Sea of Cortez carry species-rich in the world (Table l). At through the clear night. To the west a geographi cal crossroad, and a unique rise the Laguna Mountains. Many island desert, Baja Sur is home to a small commercial organic farms variety of natural life, including more nearby grow mostl y tomatoes and than 180 species of land birds, of bas il for the U.S. organic market. wh ich approximately half are North The entire Cape region of Baja Sur American mi gratory species, and 32 is being established as :ana species of marine birds. Among the organica, Howearth says, and local 2,700 species and 4,000 kinds of plants ranchers and farmers understand are more than II 0 species of cacti i of and respect the need for organic which 80 are endemic to the penin practices to protect not only the land sula.4 Approximately 170 species of and its inhabitants but to prevent reptiles and amphibi ans include 18 future toxic run-off into the sea. types of snakes, two of which are On a few acres of desert land, rattlesnakes.5 Howearth has created a botanical Howearth harvests super-sweet Hawaiian/ Mexican cross papayas. Star apple in front and giant black timber bamboo in the background. Photo © 2000 J.E . Williams . 2000 HERBALGRAM 50 59 garden of amazing A lan M. vari ety. Temperate Kapuler, PhD, and zone vegetables hi s associates, in (such as cele ry, cluding Howearth, beets, c hard, rad developed thi s ap ishes, spinach, and proach through broccoli) grow well m a ny years of in the winter and study a nd work, spring, provided the and laying out gar plants are shaded den models. during the day, es Howearth's horti pecially as spring cultural back leads to s ummer ground includes a heat. Tropical fruits, degree in land such as bananas (in scape architecture cluding several rare from the Univer ancestral types) and An example of the extensive diversity of organic annual crops. This living geneology seed si ty of Californi a papayas, grow year source for the local community seed bank includes less common varieties of sunflowers, (UC). He appren round and thrive in corn, amaranth, and basil. Photo © 2000 J.E . Williams. ticed with A lan the summer heat. Chadwick, the leg Tomatoes (more than 350 varieties), sunflowers, and melons grow endary British biodynami c master horticulturist, and with Peter well in full sun but cannot survive the severe heat of mid-summer. Dukish, a Yu goslav biodynamic farmer and spiritual teacher. Dukish Cactii (more than 300 species), agaves, and succulents prefer direct encouraged him to study indigenous farmers, and Howearth trav sun and tolerate the hot dry summers, and therefore a large porti on eled the world to learn traditional farming practices in such coun of the garden is dedicated to these and rare and endangered arid tries as Mexico, Guatemala, Peru, Boli via, Chile, Madagascar, Ethio tropical species. He has planted II species of Pachypodium and two pia, Nepal and India. He also co-founded the first all-organic seed species of Rauvolfia (famil y Apocynaceae), three cinnamon species company in the U.S., Seeds of Change, (Lauraceae), more than 200 Aloe species (Aioeceae), I 5 medicinal Seven years ago, Howearth moved to the Laguna Mountains, bamboo species (Poaceae), I 2 species of wi ld yams (Dioscoreceae), in th e Cape region of Baja Sur, where fo r two years he studied and 25 species of passionflower (Pass ifloraceae), and six species of collected native pl ants, especially endangered species. While there, baobab (Bombacaceae) (Table 2). he established a small nursery and botanical garden, and with other Over th e past four years, Howearth 's focus has been prepar Mexican botanists identified dozens of previously unknown endemic ing the land and designing, planting, and culti vating the co-evolu species. Hi s message of conservation spread to local fa rmers and ti onary gard ens. The plants in a co-evolutionary botanical garden ranchers who now value th eir environmental diversity enough to are positi oned ac have esta blished cording to the nurseries of their "conservatory kin own. ship gardening sys Hi s vision, as tem." Species are he described it to me grouped according one morning in hi s to relationships de gardens, is that fined by new ordi small pockets of pri nal phylogeny (i.e., vately held land can based on the not only be success p la nts ' genetic full y organicall y code) from super farmed and gar order to species. dened, butthatsuch This garden design places can be strategy - show refuges from agri ing the kinship be business and can tween plants - is serve as conservato an important tool ries for seed cultiva to guide research tion, pl ant protec and preservation of tion, and underutilized me Howearth and his wife, Kitzia, in the Asterales branch of the Tree of Life kinship garden. biodivers ity. His dicinal and nutri Ph oto © 2000 JE Williams. goal is "to preserve tional crops. the biodiversity of 60 HERBALGRAM 50 2000 dry tropical regions world-wide, both native, edible, and medicinal" thers his interest in ethnobotanv and biodiversit\' with regular trips and to create a "li vi ng genealogy" of seeds. His wish is th at these to Mexico and th e Peru vian Amazon. Email gardens will show what can be attained. He also educates farmers, 2000 HERBAL GRAM 50 61 Table 1: Selected Native Medicinal Plants of Baja California Sur Common Name Species Part Used Selected Traditional Uses Preparation Cardon Pachycereus pringlei seeds, flower, vaginal hemorrhage, boiled decoction, pulp, root diabetes, tumors, direct application ulcers, digestive problems Choya Opuntia cholla root fever, flu , hepatitis, boiled decoction diabetes, diarrhea Cola de Zorro Haplopappus spinulosus dry plant urinary difficulty tea Copal Blanco Bursera epinnata bark flu , bronchitis, sore throat boiled decoction Epazote Chenopodium ambrosiodes complete plant parasites, gastritis, dysentery, tea menstrual cra mps Guayac6 n, Guaiacum coulteri bark arthritis, flu tea combi ned Palo Santo w ith eucalyptus Hierba de Acalypha camonduano leaves, root, cancer, fistulas , ulcers topical Cancer branches application Hierba Anemopsis californica root fistulas, ulcers, swellings topical application of del Manzo fresh root Hierba Paraph yllum gracile branches diarrhea, indigestion, cough boiled decoction del Venado, Massa Kula Jojoba Simmondsia chinensis seed ulcers topical application of oil Maguey amole, Agave schotii tequila low blood pressu re oral Mezcal Mezquite Prosopis iulif!ora bark, branches indigestion, angina , boiled decoction diarrhea, vomiting Nopal Silvestre Opuntia acanthocarpa root, leaf, fruit diabetes, muscle pain boiled or raw leaf blended w ith water The information from th is table is from : { 1) Carino, MM, Alameda, A de Ia Torre, JAM , eta/. Diagn6stico Ambiental de Baja California Sur . La Paz, B.C. Sur, Mexico: Sociedad de Historica Natural Niparai6, A. C. , Universidad Autonomia de Baia California Sur; 1998 {in Spanish); {2) Roberts NC. Baja California Plant Field Guide. La Jolla, CA: Natural His tory Publishing Co.; 1989. Where.,s the Herbal Education Catalog? ONLINE. AMERICAN M ter yea rs of having the ABC Herbal Education Catalog in each iss ue of HerbalGram, our catalog has gone BoTf'NICAL entirely digi tal. The Herbal Education Catalog can now be found on our website, complete with online ordering, at COUNCIL www.he rbalgram.org. 62 HERBAL GRAM 50 2000 Table 2: A Few Selected Introduced Medicinal Plants Grown at Jardin Botanico (o-Evoludonario Buena Fortuna Common Name Latin Nome, fum, ord. Selected Uses Main Constituents Pharmacology Amalaki or Phyllanthus emblica hepatitis-b, alkaloids, lignans antiviral Ami a fam . Euphorbiaceae gallstones flavonoids hepatoprotective ord. Malpighiales major ingredient triterpenes, phyllantin in Ayurvedic tonics Ashwaganda Withania somn ifera impotence, somniferin alkaloid sedative, tonic, fam . Solanaceae infertility, astringent ord. Solanales insomnia, general weakness Betel Nut Areca catechu constipation, alkaloids, catechi n, antiparasitic fa m. Arecaceae intestinal tannin, glycerides of ard. Arecales parasites lauric acid Bitter Orange Citrus aurantium dyspepsia, volatile oils, antispasmodic, fam. Rutaceae loss of appetite flavonoids, sti mulates gastric ord. Sapindales glycosides, secretions furocoumari ns Hibiscus Hibiscus sabdariffa refreshing plant acids, anthocyans, diuretic, fam. Malvaceae health dri nk flavonoid derivatives cholagogue, ord . Malvales mild laxative Indian Snakeroot Rauvol fia serpentina hypertension, reserpi ne, raulwolfine hypotensive, fam. Apocynaceae psychiatric deserpine, sedative, ord . Gentianales conditions, rescinnamine depressant fever, dysentery Jujube Date Ziziphus mauritiana poor appetite, triterpenoid s, plant acids, nutritive tonic fam . Rhamnaceae general debility zizyphus saponins I, II , ord. Rosales Ill, nucleotides, pectin Myrrh Commiphora myrrha digestive complaints, methyl i sopropenyl antifungal, antiviral, fam . Burseraceae obsteti cal issues, furane, sesquiterpenes antibacterial, nervous ord. Sapindales bronchitis, skin and elemene, copaene, & reproductive sedative, mouth ulcers curzerene mucosal stimulant Neem Azadirachta indica intestinal parasites nimbin, quercitin, purgative, antifungal, fam. M eliaceae maintain healthy skin meliantriol antiinflammatory, ord . Sapindales malaria azadirachtin hepatoprotective, immunogenic N ight Blooming Selenicereus grandiflorus cardiovascular cactine alkaloid, heart trophorestorative, Cereus fam . Cactaceae disorders, menstrual cardioactive flavonoids, tonic, antidepressant, ord . Caryophyllales disorders, edema, rutin , resinoid glucoside nervous restorative/stimulant uri nary/ prostate neurocardiac restorative irritation, depression relaxant, sexual stimulant Passion Flower Passi flora incarnata nervousness , flavonoids, volatile oils, sedative, fam . Passifloraceae insomnia cyanogenic glycosides hypnotic, ord. M alpig hiales anodyne, antispasmodic Wild Yam Dioscorea opposita diabetes, allantoin, phytic acid, antidiarrheal, fam. Dioscoreaceae ch ronic diarrhea, sapon in s, antitussive, ord . Dioscoreales asthma dioscorea-mucilage-B astringent The information from this table is from : ( 1J Carino MM , Alameda A, de Ia Torre JAM , eta/. Diagn6stico Ambiental de Baja Californ ia Sur . La Paz, B.C. Sur, Mexico: Sociedad de Historica Natural Niparai6, A. C. , Universidad Autonomia de Baia Calfornia Sur; 1998 {in Spanish); (2) Roberts NC. Baja California Pla nt Field Guide. La Jolla, CA: Natural History Publishing Co.; 1989; (3) Conversations with Gabriel Howearth , La Rivera, Baia Sur, Mexico, Ma y 2000; (4) Holmes P. Th e En ergetics of Western Herbs 2nd Ed. Berkeley, Californ ia: NatTrop Publish ing; 1993; (5) Murra y M. Th e Healing Power of Herbs 2nd Ed . Rocklin, California; Prima Publishing: 1995. 2000 HERB ALGRAM 50 63 LEGAL AND REGULATORY Ephedra Update: Industry Coalition Asks FDA to Adopt National Labeling Guidelines on Ephedra; Offers Cooperative Research with NIH by Mark Blumenthal An industry coalition of fo ur leading dietary supplement trade • Con sumption data showing that sales of ephedra products assoc iations has formally petitioned the Food and Drug Administra have increased exponentially over the last five years while tion (FDA) to adopt a national standard for the labeling of dietary the number of reports of possible adverse events has de supplements containing the herb ephedra, aka rna huang (Ephedra creased; sinica Stapf., Ephedraceae). 1 The petition was filed on October 25, • Comparisons of estimates of the incidence of strokes, heart attacks and seizures in the general population to the inci 2000 by the American Herbal Products Association (AHPA), Con dence of the sa me events in ephedra consumers, showing sumer Healthcare Products Association (CHPA), National Nutritional that there is no increase in risk from the consumption of ephe Foods Association (NNFA) and the Utah Natural Products Alliance dra; (UNPA)- organizations whose members compri se the maj ority of • Comprehensive analyses of all adverse event reports submit the manufacturers and distributors of dietary supplements contain ted to FDA showing that there is no association between the ing ephedra. 2 reported se rious adverse events and the consumption of ephe The petition comes on the heels of a report from the NIH 's dra products according to the current national standards (i.e. , Office of Women's Health (OWH) whi ch held hearings on ephedra current voluntary industry labeling practices) ; and in August (see below). The OWH report reflected testimony from • Thorough reviews of the published literature, including all various experts on the safety and potential risks of ephedra, plus its published case reports, showing that the published literature supports the safety of ephedra products when consumed ac potential benefits in weight loss. In 1997 FDA had published pro cording to the current national standard 5 posed ru les for ephedra products (see below), 3 but after strong criti cism from the General Accounting Office (GAO) in August 1999,4 The fou r groups plus the Coun cil fo r Responsible Nutrition FDA retracted its proposed rules and put ephedra back on the tab le (C RN) also sent a letter to Joe Levitt, director of FDA's Center for for considerati on (see below). The industry initi ative proposes that Food Safety and Applied Nutrition (CFSAN), requesting more FDA adopt what has been, until now, vo luntary labeling of potential prompt access to adverse event reports (AERs) from the FDA's Spe risks of ephedra by members of the herb and dietary supplement cial Nutritionals Adverse Event Monitoring System (SN/AEMS ). industries. The industry also recommended limits of 25 mg total The letter as ks that FDA share such information within 20 days with ephedra alkaloids per dose, and a maximum of 100 mg tota l alka an indu stry representative designated to receive the reports. 6 loids per day. In addition, the fo ur associati ons sent a letter to Paul M. Coates, The current industry label waming of ephedra, being suggested Ph.D., director of th e Offi ce of Dietary Supplements (ODS), offer as an official national standard in the petition, is as follows: ing to share research data with NIH, in anticipation of possible fund ing NIH may receive to conduct a literature review of the "safety WARNING: Not in tended for use by anyone under the age of and benefits of ephedra as a fo undation for determining NIH 's pos 18. Do not use th is product if you are pregnant or nursing . Con 7 sul t a health care professional before using this product if you sible research agenda" on ephedra . have heart disease, thyroid disease, diabetes, high blood pres sure, depression or other psychiatric condition, glaucoma, diffi FDA WITHDRAWS PROPOSED EPHEDRA RULES; RE · culty in urinating, prostate enlargement, or seizure disorder, if EVALUATES EPHEDRA POLICY you are using a monoamine oxidase inhibitor (MAOI), or any The recent activity surrounding the safety of ephedra was other prescription drug, or you are using an over-the-counter drug stimul ated in part by the FDA's change in its proposed policy. Due containing ephedrine, pseudoephedrine or phenylpropanolam ine to the Congressional, professional, and industry concern over th e (ingredients found in certain allergy, asthma, cough/cold and scientific acc uracy of the safety data supporting FDA's position in weight control products) . calling for stricter controls over ephedra di etary supplements, FDA Exceeding recommended serving will not improve results and withdrew its regulations proposed in June 1997. 3 The primary fac tor may cause serious adverse health effects. Discontinue use and ca ll a health care professional immediately was the GAO report critical of the manner in which FDA's policy if you experience rapid heartbeat, dizziness, severe headache, short was developed, especially the adverse reaction reports all egedly as 4 ness of breath, or other similar symptoms. soc iated with ephedra. In a letter dated February 25 , 2000, sent to members of Co n In support of the petition, the associati ons li sted the following gress concerned with drug and dietary supplement regulation, FDA information: associate commi ssioner for legislation, Melinda K. Pl aisier, said the agency planned another attempt to evaluate the "the potential health • The long hi story of sa fe use of ephedra products, as well as ri sks assoc iated with th ose products." CFSAN's Levitt described the isolated alkaloids ephedrine and pseudoephedrine in ove r the withdrawal as a "mid-course correction" and not a surrender or the-counter (OTC) drugs; capitul ati on. Levitt noted that the agency had new informati on to • Clinical data on ephedrine/caffeine combination products, review, that it would hold a public hearing, and "foll ow that data, and on ephedra alone and combined with caffeine, showing wherever it leads us."8 the safety and benefits of these products for weight loss; 64 HERBALGRAM 50 2000 LEGAL AND REGULATORY OFFICE OF WOMEN'S HEALTH Alternative Medicine of th e National In stitutes of Health already is HOLDS PUBLIC HEARING ON EPHEDRA req uesting proposals to study herb-drug interactions. As noted above, on August 8-9, 2000 the OWH sponsored a The entire report is available at 2000 HERBALGRAM 50 65 LEGAL AND REGULATORY CSPI Files Complaint to FDA on Herbsin Foods by Mark Blumenthal On July 18, 2000 the Center for Science in the Public Interest is the second area of CSPI's concern: the use of these products in (CSPI) held a news conference in Washington, D.C. in whi ch it ex foods and beverages presents the consumer with the impression that pressed its concerns about the presence of herbal ingredients in con these products contai n sufficient quantity of the herb to provide some ventional foods. 1 The organization used as examples ginkgo (G inkgo health benefit. To CSPI, this is hype. biloba) in breakfast cereals (e.g., GinkgOs®), plus St. John's wort However, thi s issue is not as clear cut when one turns the at (Hypericum perforatum) and kava (Piper methysticum) in snack tention to beverages, which constitute a significant porti on of the 73 chips. products CSPI published on its website 66 HERBALGRAM 50 2000 LEGAL AND REGULATORY extracts, e.g., tinctures and related products). The inherent ventional food, suddenly it has to go through the food additive/GRAS absurdity of this policy was patently obvious to most observers of obstacle course, and does thi s make sense? The answer, in many the scene during that time and appears to be irrational in cases, is 'no.' If they are safe as supplements, they should be safe in retrospect 20 years hence. There were few, if any, substantiated foods. However, there is the issue of indi scriminate use among chil reports of adverse reactions to ginseng products at that time to justify this policy. dren and others who would be consuming something either they However, despite this probability of de facto GRAS status based don't know or understand much about and possibly could do some on FDA documents and correspondence to industry, according to harm to themselves." a recent version of the list by the Fla vor and Extract In September the Herb Research Foundation (HRF) issued a Manufacturer's As soc iation, the originators of th e GRAS list in the statement raising objections to CSPI's position. Regarding the issue 1950s before it was recognized by FDA as official policy, of safety, HRF President Rob McCaleb wrote, "HRF believes that "ginseng " (of any type) is not shown 5 herbal extracts whi ch are legally and The bottom line: CSPI has safely sold in tablets or capsul es or as legitimate concerns that creative ... we see some fooling around liquid dietary supplements are not sud marketers may be promoting me denly dangerous when added to foods dicinal herbal ingredients in food going on where mitrostopit like fr uit smoothi es."6 HRF states that products with claims that are not amounts of valuable herbs are functional foods can be an effective ve substantiated, based on the level hicle to educate the consumer about the of the herb in the product. How tossed in lor what appear to be health benefits of certain ingredients, ever, in attemptin g to remove when based on so li d science. but "HRF herbs fro m conventional food purely marketing purposes. agrees [with CSPI ] that fa lse or poorly products, CSPI may be overlook- documented claims should not be used ing the fact that there may be some exceptions to their concerns to market func ti onal foods. However, according to HRF, " It seems about traditional medicinal herbs used as foods: many herbs were that the true issue is not herb safety or deceptive advertising. These (and still are) consumed in soups, teas, and oth er traditi onal food complaints have arisen because it is unclear whether fu nctional foods dosage forms. Also, since most herbs were formerly used as bever are to be regulated as conventional foods or dietary supplements in ages in traditional medicine systems, attempts to remove them a food form." priori from teas and other beverages may create an untenable legal In the fin al analysis, CSPI has articulated a legitimate con and regulatory position for both CSPI and, eventu all y, the FDA. This cern about the additi on of various herbal ingredients in conventi onal may eventuall y become a regulatory concern in various Asian and foods. While some might suggest concern over the potential safety other ethni c communities. of these products, to date, there is little evidence of actual safety In the words of herb industry veteran Loren Israelsen, direc problems from adverse event reports. The more pressing issue is tor of the Utah atural Products Alliance and the LDI Group in Salt one of marketing and ethi cs: to what extent is it reasonable to add Lake City, "Herbs have been used as foods and medici nes for mil what some herbal veterans consider an infinitesimal amount of herbs lennia in all cultures. The so-called "functi onal foods" represent the or herbal extracts to conventional foods, thereby creating the mis most current and curious manifestation of that long tradition. How guided consumer expectation of some benefit of the product due to ever, unlike more mature cultural uses of botanicals, we see some the presumed presence of its herbal ingredient(s). In this matter, fooling around going on where microscopic amounts of valuable CS PI 's action reflects the concerns expressed privately by numer herbs are tossed in for what appear to be purely marketing purposes. ous herb industry in siders: that these products may not bring any This not onl y is di srespectful of th e seri ous tradition of herbal medi noti ceable benefit to the consumer and may, in fact, turn consumers cin e, it also cheats consumers." off from using quality herbal products in fo rms that are more appro Israelsen continues, "The second bi g issue is whether botani priate for obtaining th e herbs' benefits (e.g., capsules, tablets, ex cals should be required to establish GRAS status if included in con tracts, teas, etc.). 0 ventional foods." It should be noted that the laws dealing with di etary supplements under OSHEA and th ose dealing wi th safety of REFERENCES foods under general food Jaw are different: As dietary supplements, 1. Cen ter for Science in the Public Interest. Press Conference, July 18, 2000. herbs are not required to be proven safe to be sold on the market, so 2. Blumenthal M and LD lsraelsen . The History of Herbs in th e United States : Legal and Regulatory Perspectives . In: Miller LG and WJ Murray. Herbal long as they were already sold in the U.S . prior to passage or OSHEA Medicinals : A Clinician 's Guide. New York : Pharmaceutical Products Press, in October, 1994. Any new herbs introduced after that time are con 1998. sidered "new dietary ingredients" and can be allowed onto the mar 3. U.S. Food and Drug Administration. 1980. Import Alert No. 66-02 (May ket onl y after notification to FDA of their intended use and substan 5). tiation for their safety, as submitted by the party wishing to market 4 . Leger, E.R. nd . Personal communication from E.R. Leger, Assistant to the Director, Division of Regulatory Guidance, Bureau of Foods, FDA to Jay H. the new ingredient. Conventional foods, by th eir nature, are usually Geller. considered GRAS. 5 . Flavor and Extracts Manufacturers Assn. List of GRAS Substances (GRAS 3- Says Israelsen, "Something that is an old di etary ingredient 18), May 5, 2000. doesn't have to be GRAS in order to be sold as a di etary supple 6 . Herb Research Foundation. Herb Research Foundation separates functional ment. However, when that same herbal ingredient is put into a con- food facts from frenzy (press release). Sept. 27, 2000. 2000 HERBALGRAM 50 67 LEGAL AND REGULATORY FDA Publishes New Draft Guidance for Botanical Drug Products by Holly M. Bayne, Esq. The U. S. Food and Drug Administrati on (FDA) recentl y pub carcinogeni city of the finished botanical drug product. The docu li shed draft guidance for industry clarifying certain regulatory re ment outlines the specific points to consider in preparing a preclini quirements for botanicals marketed as drug products in the U.S.1 cal pharamacology/toxicology development plan for a botanical drug The guidance was prepared by working groups within FDA's Center product that is intended to be used in large-scale human trials or to fo r Drug Evaluati on and Research (CDER) and addresses the com support an NDA. It appears that FDA will exercise discretion and plex legal and scientific issues- many of which have remained in evaluate the specific requirements concerning toxicology and relative obscurity- associated with obtaining drug status fo r a bo pharamacologic data, as well as the CMC info rmation that might be tani cal product. Considering the complexity of the issues involved, needed to support expanded clinical trials or an NDA, on a case-by it is understandable that even generally reli able news sources inside case basis. The agency encourages applicants to di scuss these issues Washington, D.C. have mi sreported both the contents and signifi with the appropriate review di vision within CDER prior to the prepa cance of this new document. ration and submission of an NDA. In short, the guidance can be seen as a significant step for Additionall y, FDA's new guidance provides useful definitions ward in FDA's nascent regul atory policy concerning the drug devel relevant to the botanical drug development and approval process. opment and approval process for botani cals, particularly in light of For example, according to the draft guidance, a "botanical drug sub the agency's long-standing hostility to botani cal products and resis stance" is deri ved from "one or more plants, algae, or macroscopic tance to "opening" the over-the-counter (OTC) Drug Rev iew to bo fungi" that is prepared by one or more of the foll owing processes: tani cals with well-estab- "pulveri zation, decoction, lished marketing hi stories in expression, aqueous ex Western European and oth er ... a signififant step forward in traction, ethanoli c extrac countries with soph isti cated ••• ti on, or other similar pro drug regul atory systems. In the drug development and cess." 1 A botani cal drug the guidance, FDA briefl y s ubstance may be a expl ains when a botani cal approval pro1ess for botani1als "single-herb" or "multi product may be marketed as ••• herb" substance, depend- a dru g pursuant to an OTC ing on whether it is de drug monograph and when FDA approval of a new drug applicati on rived from one or more than one "botanical raw materi al," which is (NDA) submitted under section 505(b) of the Federal Food, Drug, defined to include the fresh or processed part of a single species of and Cosmetic Act (FDC Act) would be required. However, FDA plant. A botanical drug substance does not include a hi ghl y purified offers little "new" guidance concerning th e eligibility of botanicals or chemi cally modified substance derived from natural sources; that with no prior U. S. marketing hi story as drugs fo r inclusion in the would be a conventional drug. OTC Drug Review. Significantly, the document appears to provide Further, FDA acknowledges that, in some cases, the active meaningful informati on to companies regarding the data require constituent in a botanical drug is not identified, nor is its bi ological ments for submitting in vesti gati onal drug applications (INDs) to acti vity well characteri zed. FDA states that the agency recognizes conduct initial clinical studies on botani cals, including those th at that the CMC documentation that should be provided for botanical are currently marketed in the U. S. as foods and di etary supplements drugs will be different from that required for synthetic or highly plus those with no U. S. marketing hi story. purified drugs and indicates a willingness to rely on a combination FDA indicates that, to support initial clinical (i.e. , phase I and of tests and procedures to ensure the identity, purity, quality, strength , phase II) studies under an IND for botani cals that have been legall y potency, and consistency of a botanical drug. Such tests and proce marketed as di etary supplements in the U. S. without any safety con dures might include: spectroscopic or chromatographic fin gerprints, cern s, an applicant may submit reduced preclinical safety data as chemical assays of characteri stic markers and biological assays, strict well as documentati on concern ing chemi stry, manufacturing and quality controls of the raw starting materi als, adequate in-process controls (CMC), compared to that required for syntheti c or hi ghl y controls, and process validati on. purified new drugs. According to FDA, fo r botani cals legall y mar In the guidance document, FDA reiterates th e agency's long keted under the Dietary Supplement Health and Educati on Act of standing poli cy that, in order to be eligible fo r inclusion in the OTC 1994 (DSHEA), "there will often be very little new CMC or toxico Drug Review and "bypass" the more costl y and time-consuming logical data needed to initiate such trials," provided that the product NDA process, a botanical product must have been marketed in the is used at approximately the same doses as those currently or tradi United States for a specific OTC drug indication (not as a dietary ti onall y used or recommended.1 supplement) for a material extent and materi al time. At the same However, to support expanded (i.e., phase III) clinical studies time, FDA acknowledges its pending proposed regul ati on to estab of safety and effecti veness, or to support an NDA for a botani cal li sh criteri a by whi ch the agency would consider foreign marketing product, additional preclinical toxicity data may be required, includ data to qualify a botanical drug for inclusion in an OTC drug mono ing systemati c tox icological evaluations to supplement the avail graph.2 FDA indicates that statements made in the botani cal drug able knowledge concerning toxicity, teratogeni city, mutagenicity, and guidance are subject to changes implemented thro ugh that 68 HERBALGRAM 50 2000 LEGAL AND REGULATORY rulemaking. According to FDA , a fin al regulation is "hopefully" other new drug product in this regard. expected to be published by the end of the year. Although FDA's new botanical guidance provides useful in Under the proposed regulation, a company would be permjt formation to companies interested in botanical drug development, ted to submit to FDA foreign marketing data concerning a botanical significant chall enges and un settled issues remain, whether a com drug substance with no prior U.S. marketing experience as a drug to pany seeks to obtain approval fo r a botanical product as a new drug demonstrate the product's or as an ac ti ve ingredi safety and effectiveness for ent included in an ore a specific use and qualify ... in some tases, the attive drug monograp h. Until the botanical for inclusion FDA beg ins to apply the in an OTC drug mono tonstituent in a botanital drug is regulatory pol icy out graph. (In 1992, the Euro lined in th e draft guid pean-American Phyto not identified, nor is its biologital ance, it is not certain medicines Coalition whether th e age ncy's (EAPC) fi led a Citizen Pe apparent wi llingness to tition requesting FDA to attivity welltharatterized. consider botanical drugs permit the filing of data in a manner that is not and information concerning certain botanjcal drug products with well inherentl y biased against such products wi ll translate into greater establi shed marketing hi stories in Western Europe for considerati on avai lability of botanical drug products in the U.S. market. The an in the OTC Drug Review. 3 The petition languished at FDA for many ticipated final regulation regarding FDA's con ideration of botani years, until the proposed rulemaking late last year.) FDA's new guid cals with no prior U.S. drug marketing experience for inclusion in ance does not sub stantively address the iss ues related to th at an ore drug monograph might provide increa ed access to the non rulemaking. Furthermore, the agency cautions that the definitions prescription drug market for certain phytomed icines with foreign included in the new draft guidance apply only to the present doc u marketing experience for particular ore drug indi cations. 0 ment. However, these definitions are likely relevant to FDA's pend ing proposed rule and the procedures and criteri a by which botani Holly Bayne is an attorney with th e Washington, D.C. la w firm cals might be included in an ore drug monograph based on foreign of Hyman, Phelps & McNamara, PC, specializing in reg ulator.• is marketing data. sues concerning food, dietary supplements and botanical products. In addition, FDA clarifies that once a final OTC drug mono REFERENCES graph is published authorizing the conditions of use for a botanical 1. FDA, Center for Drug Evaluation and Research (C OER), Guidance for dru g, any company can market a product containing the same sub Industry Botanical Drug Products (Draft Guidance) (A ug. 3. 2000) . stance according to the specifications of the monograph. Under the 2. 64 FedReg. 71062 . Dec 20. 1999. Additional Criteria and Procedures FDC Act, however, an "innovator" company that gains approval of for Classifying Over- the-Counter Dru gs as Generally Recognized as a botanical drug pursuant to an NDA, using clinical data deemed Safe and Effective and ot Misbranded . [Docket No. 96N-0277] essential to the approval, can expect five years of marketing excl u 3. Pineo RG , Israel se n LD . European-American Phytomedicines Coali sivity from the time of the approval, regardless of the existence of a tion Citizen Petition to Amend FDA's OTC Drug Rev iew Policy Re patent. FDA indicates that botanical drugs will be treated like any garding Foreign Ingredients. Jul y 24. 1992. HerbaiGram Now Accepts DISPLAY ADVERTISING hviERI~ BoTI'NICAL c o uNCIL For Information, Contact Jon Benninger at 4801990·11 01 ext. 1108 2000 HERBAlGRAM 50 69 MARKET REPORT Natural Marketing Institute Measures Consumer Use of Herbal Products by Mark Blumenthal The Natural M arketing Institute herb als fo r over three years. (NMI), a company in Telford, Pennsylvania 4. Frequency of Us e: 57 percent of that measures trends in the natural food and herb al supplement users take herb als once dietary supplement marketplace, has com per day, and 25 percent of those users use pleted its annual survey of consumer uses and th em more than once per day. (82 percent of preferences for natural products. users ingest herbs at least once per day.) The NMI survey reveals the foll ow 5. Duration of Benefits: According to ing conclusions: th e survey, 45 percent of users desire dail y 1. Satisfaction: Only 53 percent of benefits, i.e., benefits that they can observe KNOWLEDGE • 1!\SIGHT • SOLl i" IIONS herbal supplement users are satisfi ed with or measure on a dail y basis; 35 percent use herbal supplements. Consumer satisfacti on herbals for long-term benefits, and onl y 6 etary supplements, the questi onn aire was was tested within 37 specific vitamin/min percent use them for short-term benefits very specific about the differences between eral/herbal product categori es. In each case, (short-term was not defined in the survey). herbs, vitamins, and minerals. It mentions sati sfaction is rated on a five-point scale, 6. Type of Benefits: 59 percent of us specific herbs by name, e.g., ginkgo, ginseng, from "extremely sati sfi ed" to "not at all sat ers seek general health benefits of herbs, and St. John 's wort. According to Joseph J. isfied." Reasons fo r dissatisfacti on were not compared to 40 percent who seek to prevent Marra, Esq., Director of Marketing at NMI, measured. or treat specific conditions. "It is clear from the structure of the ques 2. Increased Use: The survey tested 7. Priorities: A signi ficant 88-90 per ti onnaire that these are all different things. whether use of herbal supplements was in cent of herb users agree that research, effi Nonetheless, this is a survey of consumers, creasing or staying steady. The survey pro cacy, and safety are most important in a prod and their kn owledge and ability to differen duced stati sti cs th at attempt to measure the uct choice, according to NMJ. This was de ti ate is out of our control, as this is aJJ self basis fo r the recent downturn in sales of herbs termined by their answering questi ons that reported. We make every effort to cross-tabu in the past year: 46 percent of herbal users indicated th eir level of agreement to a seri es late the data in several ways such that we have increased their use of herbs, while only of statements dealing with safety and effi beli eve that we are seeing an accurate ren 10 percent of the general populati on has in cacy. dering of the various categories." However, creased usage. Al so, 48 percent of herbal The 2000 Natural Marketplace Trends there may be some ambiguity regarding some users have remained at the same level as the Report was based on 2,002 randoml y cho of the terms used in this field: 95 percent of previous year, while onl y 24 percent of all sen U. S. households that responded to a 12- all shoppers reported that they understand the shoppers have remained at same levels. Put page mail-home questionnaire and was con term 'di etary supplements,' but onl y 20 per another way, 94 percent of herbal users have ducted in Jul y-August 2000. These respon cent report that they understand the term stayed the same or increased usage, while dents are considered representati ve of the 'nutraceuticals,' said Marra. 0 onl y 34 percent of general population has general U.S. popul ati on of 600,000 house For more information, contact done so. A total of 8 percent of all shoppers holds, balanced to U.S. census data. The mar The Natural Marketing Institute at (including those in natural food stores plus gin of error was plus or minus 2 percent. (215) 72 1- 1258, or o n the we b at the mass market), reported reducti ons in herb Approximately 30 percent of the survey 70 HERBA LG RAM 50 2000 Cutting-edge Phytomedicinal Research from the Zurich Conferences by Ernest B. Hawkins, RPh, MS The International Congress and 48 'h Parkinson's di sease and dementi a of the (inhibiting or retarding the growth of bacte Annual Meeting of the Society for Medici Alzhe imer's type. ria) and bactericidal (actuall y destroying the nal Pl ant Research , entitled "Natural Prod Several toxic effects of diazepam bacteria) acti vit y in vitro. Thi s oil mixture ucts Research in the New Millennium" and (Valium®), an oft-prescribed anti-anxiety may be effecti ve as an over-th e-counter the 6'h International Congress on pharmaceutical medication among the class (OTC) topical antibacterial ointment or other Ethnopharmacology of the International So known as benzodiazepines, have been re phytopharmaceutical antibacterial prepara 3 ciety for Ethnopharmacology (IS E) , entitled ported in laboratory studies. .4 These toxic ti on for minor wounds, cuts, and/or ab ra "Ethnopharmacology 2000: Challenges for effects include increased oxidative stress to sions. the New Millennium" were held concur neutrophils and a general decrease in immune A licorice preparation (G ircy rrhi~a rently at the University of Zurich on Sep function while taking the medication . Sev glabra) - a popul ar herb used commonl y tember 3-7, 2000. This meeting consisted of eral isolated pol yphenols from medicinal as a tonic in adrenal stress, as an expecto plenary lectures, workshop s, short lectures, plants, including caffeic acid, chlorogenic rant, and also as a standardized preparation and poster presentations regarding plants as acid, and cynarin - all three ph ytochemicals in the treatment of gastrointestinal ul ceration medicines in the future. Most attendees were found in globe arti choke (Cynara scolymus) -was recently reported to protect li ver dam pharmacognosists - scientists involved in - have exhibited a concentration-dependent age induced by acetaminophen (Tylenol®) fundamental phytomedicine research. Their inhibitory effect on ox idative stress and stress poi so ning 9 The co nst ituent glycy rrhizin, research helps validate why and how herbs protein synthesis induced by diazepam.5 The extracted from li cori ce roots, exhibited vari from around the world can be used as medi conclusion was that these natural pol yphe ous anti-gastric ulcer and anti-inflammatory ci nes, and their work spawns most of the nol s potentially could reduce the toxicologi properties in laboratory animals. The aut hors phytomedicinal products on the worldwide cal properties of di azepam. concluded that the anti ox idant ac ti vity of market. Antitumor effects of an extract from glycyrrhizin and its derivatives, as well as The Egon-Stahl award, presented an the leaves of gotu kola ( Cen tella asiatica) their ab ility to interact with intracellular cal nually by the Society of Medicinal Plant were reported. 6 In vitro tests showed that cium in hepatic cells, are possible mecha Research to an outstanding sc ienti st, was phytochemicals fro m go tu kola (including ni sms of their protective effects on acetam i awarded to Thomas Schmidt, professor at the saponins and steroid alkaloids) had antican nophen-induced hepatotoxic ity. Gl ycy rrhizin University of Dusseldorf, Germany, for his cer, antiinflammatory and immuno has been reported to increase the ri sk of a work involving the phytochemical class ses modulatory effects. Other therapeutic quali co ndition known as pse ud ohyper quiterpene lactones. ties of the long-term use of gotu ko la extracts aldosteronism, which leads to increased The opening remarks presented by include wound healing, analgesic, anti-ulcer, blood pressure, potassium loss, weakness , 10 11 former Nobel Prize winning scientist R.R. and hepatoprotective effects. and edema in susceptible individuals. · Ernst, Ph.D., professor emeritus in physical An extract of neem (Azadirachta in Phytochemicals compounded into chemistry in Winterthur, Switzerland, ad dica), a commonly used herbal medicine in cosmetic products are very popular in Eu dressed sc ience in the new millennium. th e Ayurvedic medi cal system of Indi a for a rope, and increasingly popular in th e U.S. In The conference sessions included cut variety of conditions, was reported to have Europe, some cosmetic products can be sold ting-edge phytomedicine research. Below are ac tivity against head lice. 7 Aqueous prepa onl y in pharmacies, depending on the phy brief synopses of a few of the hundreds of rations of neem leaf in 5 and I 0 percent con tochemical ingredi ents used. A rece nt unpub clinicall y applicable presentations that are centrations (in a shampoo base) were used li shed stud y reported that the topical appli relevant for the herbal movement in the U.S. on individuals presenting with head lice. Use cati on of biflavones from ginkgo (Ginkgo The sessions consisted of unpublished stud of the 10 percent extrac t shampoo for 10 biloba) leaves (diluted in I percent DMSO ies presented either as lectures or poster pre minutes provided the optimal effect in de to increase absorpti on) had an inhibitory ef sentations. lousing the head. fect on cyclic AMP (cA MP) phosphodi Ashwagandha (Withania somnifera ) A mixture of the essential oils of tea esterase in rat adipose (fat) tissue, which can is a noted adaptogen (a plant that exhibits tree (Melaleuca alternifolia) and the polar increase the breakdown of fat ti ssue. 12 The protective biological effects when given fraction of manuka (Leptospermum topical ginkgo product was also reported to orall y in response to various "stressors" - scoparium, another common tree from Aus have antiinflammatory and vasoki netic (the either physiological, emotional, or environ trali a) was reported effective against gram altering of blood vessels) properties. mental ).1 The root may exhibit cholinest positive bacteri a. ~ The mixture (marketed as Marketed in the U.S. mainl y as a erase-inhibiting ab ility in laboratory ani Lema oi l) inhibited the bacteria Staphylococ component in male "libido" formulas, muira mal s.2 This pharmacological activity may cus aureus, and was more effective th an ei puama root (Ptychopetalum olacoides) has lead to as hwagandha supplements used to ther oiI used alone against the pathogens. The been recommended for centuri es as a nerve treat neurodegenerati ve di seases of the cen combination had sy nergistic effects on S. tonic in the Braz ilian Amazon, generall y used tral nervous system (CNS) such as aureus inhibition, causing both bacteriostatic by elders and convalescents to treat diseases 2000 HE RBAlGRAM 50 71 affecting the central nervous system (such a ll y increased dopamine levels in laboratory Stress, Poster Presentation, 48th Annual Meet as strokes and age-related memory deficits). experiments. 16 ing of the Internati onal Congress of the Soci Recent research reported th at an alcoholic As a note, the first reports of the use ety of Medicinal Pl ant Research, P2N 15, Sept. extract of muira puama root had both cogni of an extract from ayahuasca, bani sterine, 5, 2000. 6. Chakraborty A, et al. Anticarcinogenic Pro ti ve and physical performance-enhancing was used to treat postencephalitic parkin moting Activities of Herbal Extracts Used in effects, making this a potential adjunctive soni sm in 1929 and created a stir in the popu Tropi cal Ethnomedicine, Poster Presentation, lar press as it was hail ed as the " magic drug" phytomedicine for use in senile dementia and 48th Annual Meeting of the International Con 13 Alzheimer's disease. Also, the root extract for this untreatable disease. Despite contin gress of the Society of Medicin al Pl ant Re had a high anti oxidant potential, partially ued research on the use of harmine alkaloids search, P2A/ 17, Sept. 5, 2000. explaining the increase in brain function due in Parkinson's, interest in the therapeutic 7. Chakraborty A, et al. Antilice Activity of to the scavenging of free oxygen radials. value of these compounds vanished during Azadirachta indica leaf extracts, Poster Presen Impotence treatment and manage the 1930s. Maybe now, with the focus on tation, 48th Annual Meeting of the International ment is of great interest for individuals suf natural products, research on products such Congress of the Society of Medicinal Plant fering from this problem and also for the as these alkaloids may be funded with the Research, P2A/ l8, Sept. 5, 2000. many supplement and pharmaceutical com potential of discovering a much anticipated 8. Chri stoph F, et al. Death Kinetics of Staphy lococcus aureus Exposed to Commercial Tea panies trying to devise a safe, effective, and "cure" for many diseases such as Parkinson's tree Oils, Poster Presentation, 48th Annual " natural" alternative to the drug Viagra®. disease and others. Meeting of the Intern ational Congress of the In summary, there are thousands of Recent literature on in vitro animal studies Society of Medicinal Plant Research, P2N20, suggests that several plants have relaxant hard-working scientists around the globe Sept. 5, 2000. effects on the smooth muscle of the corpus doing basic research every day on plants from 9. Dehpour AR, et al. Liquori ce Components cavernosum (erectile tissue of the male pe all over the world. They study countless num Protect Li ver Damage Induced by Acetami nis) which would indirectly cause erection bers of herbs to find the one that may give nophen, Poster Presentati on, 48th Annual Meet of the male penis. 14 Two plants determined society relief from problems ranging from ing of the International Congress of the Soci to have this activity were dami ana (Turnera stiff joints, minor wounds and baldness, to ety of Medicinal Pl ant Research, P2N23, Sept. diffusa, commonly used in aphrodisiac for life-threatening illnesses such as heart dis 5, 2000. 10 . Takeda R, et al. Prolonged Pseudo mulas from traditional healers) and Huperzia ease, cancer and AIDS. Working coopera aldosteronism Induced by Gl ycyrrhi zin , Endo saururu (in the same genus with H. serrata, tively, the scientific community may be able crinology Japan 1979;26(5):541-47. to move forward in the fight for global health. 0 isolated as the dietary supplement Huperzine 1 I. Farese RV, et al. Li corice-induced A used to enhance memory and learning and Hyperminera1ocorticoidism, New England J effects associated with Alzheimer's disease). Ernest B. Hawkins has more than 10 Med 1991;325: 1223-7. Further research needs to be performed on years of experience in hospital and retail 12. Dell ' Ag1i M, et at. Stimulation of Lipolys is these herbal supplements to ensure clinical pharmacy, as well as pharmaceutical re in 3T3-Ll Adipocytes by Biflavones of Gingko efficacy. search. He has worked extensively in the biloba L. , Poster Presentation, 48th Annual Parkinson's disease is once again in herbal supplement industry, focusing on the Meeting of the International Congress of the the medical and media spotlight, thanks to manufacturing and quality control of herbal Society of Medicinal Plant Research, P2N26, efforts of celebrities with the disease. The ingredients. A consultant, author, and edu Sept. 5, 2000. 13. Elisabetsky E, eta!. Antioxidant and Memory causes of Parkinson's di sease are unknown, cator in the dietary supplement arena, Enhancing Properties of Ptychopetalum but it is associated with low levels of dopam Hawkins is also Director of Herb Research olacoides, Poster Presentation, 48th Annual for lntramedicine, In c. ine (a neurochemical) in parts of the brain Meeting of the International Congress of the and central nervous system. Drugs for the Society of Medicinal Plant Research, P2N28, treatment of Parkinson's disease are usually I. Grandhi A, et al. Comparative Ph armacologi Sept. 5, 2000. developed to elevate dopamine levels. This callnvestigation of Ashwagandha and Ginseng, 14. Hnatyszyn 0 , et a!. Extracts of American is accomplished allopathicall y by the admin J Ethnopharmaco 1994 Dec;44(3): 131-5. Plants With Rel axant Effects on Smooth 2. Houghton PJ. Leads to Treatment of CNS istration of !-dopa (a dopamine precursor in Muscle of the Corpus Cavernosum, Poster Pre Disorders with Plant Extracts and Constituents the body) or by inhibition of the monoamine sentation, 48th Annual Meeting of the Interna Poster Presentati on, 48th Annual Meeting of oxidases (MAOs) - enzymes that break tional Congress of the Society of Medicinal the International Congress of the Society of Plant Research, P2N39, Sept. 5, 2000. down dopamine, thereby decreasing its level. Medicinal Pl ant Research, PL1 2, Sept. 5, 2000. 15 . Sanchez-Ramos JR. Bani sterine and Ayahuasca (Banisteriopsis caapi), a 3. Lee HY, et al. Diazepam Inhibits eurul ation Parkinson's di sease, Clin Neuropharmacol vi ne traditionally used in Brazil , contains the Through Its Ac ti on on Myosin-containing Mi 199 1 Oct;l4(5):39 1-402. alkaloids harmine and harmaline, which have crofilaments in Earl y Chick Embryos, Camp 16. Schwarz MJ, et a!. Activity of Extract and 15 been reported to be MAO inhibitors. Biochem Physiol C 1984;77(2):33 1-4. Alkaloids from Banisteriopsis caapi Stem with Recent research reports that a freeze 4. Gavish M, et al. Eni gma of the Peripheral Relevance to Its Use as a Treat ment for dried aqueous extract from the vine (contain Benzodiazepine Receptor, Pharmacal Rev Parkinson's Disease, Poster Presentation, 48th 1999 Dec;51 (4):629-50. ing 1.92% harmine) had MAO inhibiting Annual Meeting of the Intern at ional Congress 5. Perez-Garcia F, et al. Effect of atural properties (specificall y MAO-A) and actu- of the Society of Medicinal Pl ant Research, Polyphenols on Diazepam Induced Neutrophi l P2A/42, Sept. 5, 2000. 72 HERBALGRAM 50 2000 IN MEMORIAM lured throughout the country and published Army captain during World War II , he was many articles in the field of food and drug in charge of an experimental cinchona (Cin law. chona ledgeriana) fa rm in Costa Ri ca- an He was a constant defender of the attempt to provide an American supply of ri ghts of both retail ers and manufacturers, as quinine for the treatment of malaria for sol well as consumers' access to health choices. di ers fighting in the Pacific. He returned to Bass' contributions are immeasurable and he Costa Ri ca in 1945 and establi shed penna will be greatl y mi ssed. nent residency. A memori al fund fo r Mr. Bass has been In 1946 Hope, along with co-founders established with the New York Metropolitan Charlie Weddle and W. D. Holl ey, fou nded Opera Association, Linco ln Center; New PanAmerican Seed Co. to increase the ava il York. - Jan Veenstra, ABC 0 ability of double petuni as and utilize Costa Ri ca as a production environment for an in tensive labor crop. PanAmerican Seed, head Milton A. Bass quartered in Paonia, Colorado was closely allied with Hope in Costa Rica. 1921-2000 Linda Vista, S.A., was the dream of Milton A. Bass, pioneering attorney in Claude Hope - a flower seed company he natural food and di etary supplement indus fo unded while also working with try law, lost his life in an automobile acci PanAmerican Seed. In its early years, Linda dent on Oct. 9, 2000. He was 79 years old. Vi sta was a flower garden exporting flowers Well-known for hi s dedicati on to the field of and ornamental plants. Sold in 1981 to Ball food and drug law over the last 50 years, he Horticultural Company, today Linda Vista is has a distinguished record. He was a staunch a leading producti on site for F I hybrid im advocate for the rights of the consumer and pati ens seed. Hope continued as president of members of the dietary supplement industry Linda Vista until hi s retirement in 1989 and to buy and se ll products, and to receive and Claude Hope acted in an advisory capacity until his death. provide information about those products. Hope was honored with many distin He is perhaps best known for hi s in 1907-2000 guished floriculture awards throughout hi s volve ment with the ProxmireAmendmen t to career, including induction into the Ameri Claude Hope, the noted horticulturi st the Food, Drug and Cosmetic Act in 1976, can Society of Horticultural Sciences, an who developed impatien from an unknown which was created to blunt the FDA's at Elected Fellow to the American Society for "weed" to the Number 1 selling bedding plant tempts to impose limits on the potencies of Horticultural Science, the Liberty Hyde in the U.S. , died at hi s home in Cartago, vi tamins and other dietary supplements. Bail ey American Horticultural Society Costa Rica on Jul y 14, 2000 at the age of 93 Resulting from 10 years of lobbying, labor Award, and many others. years. He inspired horti culturists fo r years negoti ations, and grassroots activism, the In add ition to hi s work as a floricul and is considered largely responsible for de Proxmire bill was a major milestone and tu ris t, Hope was honored for hi s social and veloping the bedding pl ant industry. Work helped ensure consumer access to dietary economic contributions to the people of from hi s Linda Vista Ranch commercial supplements. Costa Rica. Committed to improv ing the breeding program was instrumental in pro Mr. Bass also successfull y fought the welfare of his employees through education ducing the ftrs t hybrid petuni a, "Comanche," FDA on issues such as the Vitamin A and D and other opportuniti es, Hope establi shed an as well as the first ye ll ow multiflora petu Case (an attempt to bestow by-prescription employee pension fund, the highest level of only status upon hi gh doses of vitamin A ni a. Other varieties produced by this program healthcare benefits in Costa Ri ca, and assis included coleus (Rai nbow and Carefree va and D), the Omnibus Vitamin regulations (a tance to purchase homes and finance educa rieties), impatiens (Ripples and Grande), restrictive array of prohibitory regulations on tion. torenias, kalanchoes, and li sianthus. dietary supplements' ingredients, claims and When awarded an honorary doctorate Born in Sweetwater, Texas on May 10, forms) , and the FDA's attempt to prevent of Agriculture from Michigan State Univer 1907, Hope began his work wi th plant ge health food retailers from selling books about sity, Hope was cited for hi s humanitarian netics at Texas Tech University. He was a dietary supplements. busi ness prac tices that showed an uncommon horticulturist with the U.S . Department of Providing counsel to members of Con concern for social and economic needs of hi s Agriculture for six years before he earned gress, Bass litigated before the U.S . Supreme employees, and established standard s for hi s Master of Science degree from the Uni Court on many significant food and drug U. S.-owned companies operating throughout versity of Michigan. He worked at the Divi cases, and served as Chairman of the World Central America. sion of Plant Research and Introduction in Bar Association Committee on Food and Hope felt that a successful pl ant Maryland where, at the time, all new plant Drug Law, among others. In addition, he lee- breeder needed to be a good observer, take materi al was introduced to the U.S. As an 2000 HERBALGRAM 50 73 I IN MEMORIAM risks, use their imagination to dream up pass ing, I asked her if she was afraid. There something "new," and work their tail off try was a long, labored pause before she answered, William D. Hamilton ing to make it a reality. Hope never married "No. I just feel like I'm climbing a big moun and has no immediate survivors. His legacy tain." She reached the top and soared. 1936-2000 grows in gardens around the world. William Donald Hamilton, considered - Jan Veenstra, ABC 0 Here in the Wild Fields as one of the towering figures of modern bi by Gail Ulrich, 7-30-80 ology and the man who helped unify Darwin's principles, died March 7, 2000, in Here in this wild field devic spirits surround me. The very being and essence of sunflowers, Oxford, England of malaria contracted on a Black-eyed Susan, Wild bergamot and recent expedition to the Congo, where he was Blazing Star seeking evidence to bol ster a radical hypoth Soothe me esis that the AIDS epidemic can be traced to Here contaminated polio vaccines. Hamilton 's In this quiet kingdom , zealous pursuit of this theory was character The sweet cacophony of birds istic of his unquenchable intellectual curios And drone of bees I am at peace ity and interest in ideas others mi ght consider My medicine is here half-baked. I need no doctors, no shamans, "He believed that if you have a weird I am bathed in color and sound idea that sounds wrong at first, you should Violet heals my spirit Golden yellow heals my mind give it a chance before you throw it out," said Sun and earth glorify these devas Nancy Moran, a biologist at the University Gail Ulrich I need no shaman of Arizona who studied with Dr. Hamilton. My medicine is here Recently he suggested that autumn 1951-2000 In this wilderness leaves turn brilliant colors not just because Gail Ulrich, beloved New England Is my medicine of loss of chlorophyll, but, since red and or herbalist, author, friend, and mentor to many, ange are common warning colors in nature, passed away Jul y 23,2000, SUITounded by her Gailiives on in the hundreds of people this coloration would warn off insect pests family and close friends at her home in whose hearts she touched through her kind that might lay eggs on the tree, thus preserv Shelburn Falls, Massachusetts. Diagnosed ness and her teachings will continue to thrive in g the species. with an aggressive form of colon/liver cancer through the lives of the hundreds of people He was a professor at Oxford Univer in May, Gail ardently followed a succession she taught. The Women 's Herbal Conference sity since 1984 and forcefully entered the of treatments that encompassed a wide spec a gathering she dreamt of and seeded man; field of evolution as a graduate student at trum of healing arts, but, tragically, the cancer seasons ago, will continue as a living monu Cambridge University. He published two ment to her. had already seriously progressed. papers based on hi s doctoral work that were A few weeks before Gail was diagnosed Gail was widely known in the herbal so seminal to evolutionary biology that al with cancer, she had asked me - had asked community not only for her many contribu most every contemporary study in that disci several times, in fact- to send her a poem I tions to herbalism, but for her warm, vibrant pline will contain his name and the term, "in had read to her months earlier; personality. She was the founder of Blazing clusive fitness," also known as kin selection. "For years I never knew whether the Star Herb School, a founding member and Hamilton was best known for a theory twilight was the ending of the day or the be president of the North East Herbal Associa offering a genetic bas is for altruism, popu ginning of the night. And then suddenly one tion, and was the founder and co-director of larized in two books, The Selfish Gene by day I understood that this did not matter at The New England Women 's Herbal Confer Richard Dawkins and Sociobiology by E.O. all. For time is but a circle and there can be ence and of the Healing With Flowers Con Williams. ference. She authored Herbs to Boost Immu no beginning and no ending. And this is how I came to know that birth and death are one. He was born in 1936 in Cairo, but nity, and owned New England Botanicals. She moved to England as a small child, being edu was known internationally as a popular teacher And it is neither the coming or going that is of consequence. What is of consequence is the cated at Ton bridge School and St. John's Col and herbal educator. lege, Cambridge. He was shy and reclusive, Death brings to those of us still on thi s beauty that one gathers in this interlude called but a risk-taker, physicall y as well as intel journey an ever deepening awareness of the life." - W.O. Abbott lectually ; in a teen-age experiment with ex gift of life and those who are closest to us bring There are few people I know who plosive chemicals he blew off two fingers. us many gifts in their passing. The stories of walked the beauty way more than Gail did . He was a member of the Royal Soci how she touched our lives continue to circu May her journey be in beauty, beauty before ety of London and the winner of man y prizes, late and help to keep her flame alive. They her, beauty behind, beauty above and below. including the Darwin Medal, the Linnean will be forever part of the landscape of our Beauty all around. May she know beauty al Medal and the Drafoord Pri ze, awarded by hearts. She was one of my dearest friends, a ways in her heart and continue to spread beauty th e Swedish Academy of Sciences. sister in spirit, and co-worker in the green. On on her journey into the spirit world. In the spirit - Barbara A. Johnston, ABC 0 my last visit with her, a few days before her of the green.- Rosemary G/adstar 0 74 HERBALGRAM 50 2000 BOOK REVIEWS When Healing Becomes people. From there the story takes on all the many of th ose who wo rked to bring him a Crime trappings of a Dav id and Goliath battle that down . Much of thi s material made it into his The AmuJng StOf)' of the in volved Senators, Congressmen , th e FBI, award-winning film of th e same title. ow Ho.uey Cancer Clinks and the llleturn of FDA , AMA , the National Cancer Institute, Aus ubel has provided the defi niti ve in-depth Altem•ttve TMrapu report on Hoxsey in th e best trad ition of in "'' \'\\ H ~ t nu lawyers, th e press, tapped phones, secret sur veill ance, and all the power of the govern ves ti gati ve reporting. ment brought to bear on one man who had The book is organized into three sec the temerity to suggest th at cancer could be ti ons: the first on Hoxsey's story and hi s fam cured by common roadside weeds. It is, in il y hi story, the second on Hoxsey's herb al short, a great and compelling story. treatment itself and the nature of conven When Healing Becomes a Crime: Ausubel documents the amaz ing story tional cancer remedies, and the third recount The Amazing Story of the Hoxsey of Hoxsey's ri se to prominence: hi s early ing the suppression (and the grow ing return ) Cancer Clinics and the Return of beginnings in 1924 when he first began treat of alternati ve cancer therapies in the U.S. The Alternative Therapies. Kenny in g patients, to his powerful chain of cancer book reveals the growing body of ev idence Ausubel. 2000. 461 pp. , illustrated clini cs that operated in numerous states by that supports the potential anti cancer act ivi softcover. ISBN 0-89281-925-1. $19.95. 1955, and the eventual destruction of hi s ties of many of the Hoxsey herbs and does a ABC Catalog #B462. businesses in this country by the AMA and great job of ex ploring many of the powerful Legend has it that Harry Hox sey's FDA . The most amazi ng part of the book alternative cancer treatments th at have been great-grandfather saw a cancerous, dying (a nd its most significant contribution to th e suppressed since Hoxsey's time. In true in horse recover by eating a combination of hi story of herbalism in th e United States) is vesti gati ve reporting style, Ausubel traces the common weeds from the fi eld into which it the phenomenal amount of research Ausubel money behind many of the groups and people had been released to die. The knowledge of conducted to bring Hoxsey's story to li ght. who ha ve been influenti al in suppressing al those herbs, passed down from fa th er to son, He interviewed many of the last survivors ternati ve cancer meth odolog ies. came at last to Harry Hoxsey who was ini who knew Hoxsey or had benefited from hi s In spite of its brilliance, the book is tiall y reluctant to treat cancer in animals or work- both those who believed in him and not without flaw s. Most troublin g is that onl y The American Botanical Council's HERBCLIP™ on CD-ROM '96-'99 • 1000 critical reviews of seminal articles from 300 publications • Instant access with new search and sort functions • Library of top references at your fingertips • Multi-user license available He rbCiip is a moiling ser vi ce containing art icles drownfrom the ma instream media and a wide variety of newsletters, scientific journals, government Item documents, and special reports, along with on executive summa ryof the #HC04 article. For mo re informati on on rece iv ing He rbC ii p, call Wayne Silverman, WHILE SUPPLIES LAST 512/ 926-4900 ext. 120, or email wsilvermon@herbolg rom.org. 2000 HERBALGRAM 50 75 BOOK REVIEWS the alternative cancer proponents are pre nate in the human sphere. But at the risk of a edition, and an emphasis is placed on the sented in human dimension. Their opponents bad pun, there is much to be said for the no regulatory status of herbal remedies, based possess the basest of human motives and no tion that the ecological devastation we now on the German Commission E and European where in the book is the reader invited to see face (both medical and environmental) Scientific Cooperative on Phytotherapy them as human beings- to understand the comes to a great extent from putting (ESCOP). This is not surprising, given that human motivations behind their assault on Descartes before the horse. the second author, Fintelmann, has the im herbal medicines and alternative cancer treat -Stephen Buhner 0 portant role of chairman of the Commission ments. The result, for many readers, is help E. The new edition includes more realistic less rage. flJ ' Herbal Medicine discussions about some of the unproven Hav ing lobbied for many years to pro ~ "' <;,'<'untl l dillon 1\\l'f'd.md•~ l '·mdt'fl herbal remedies, like borage (Baraga tect the ri ght of access to alternative medi afficinalis), nutmeg (Myristicafragrans), and cine, I understand from experience that it is Egyptian water lily (Nymphaea lotus) as psy all too easy to see opponents as evil and ill chotropic herbs, included in previous editions meaning, intent only on the accumulation of that have no place in modern clinical thera money and power, especially when they en peutics. gage in abuse of power to achieve their ends The language itself is more precise, but and especially when innocent people suffer sounds like a translation from the German, from that abuse of power. For some, this at whereas the previous English editi on was tribution of evil can justify any means to stop often a more enjoyable read. such abuses. While granting these improvements in Growing up in a family of powerful the new edition, I find myself wishing for a medical physicians, which included a U.S. Herbal Medicine: Second edition, blend of the new and old English editions in Surgeon General (who, to my shame, could revised and expanded, Rudolph F. Weiss, one book. What I miss most is Weiss' per have prevented Hoxsey's destruction if he Volker Fintelmann. 2000. 438 pp., sonal clinical experience, anecdotes, and, had decided to), places me in a difficult po illustrated hardcover. ISBN 0-86577-970- especially, his clear grasp of how herbal sition. Having worked the majority of my life 8. $59.00. ABC Catalog #B006. medicine is different from modern drug to undo what they spent their lives doing, Dr. Rudolph Weiss's Herbal Medicine therapy (its safety and gentleness) which still I cannot fail to remember them as hu has been a standard text for western herbal pops up in some of the best places in the first man beings, seeing both their strengths and ists since its first English edition in 1988. It English edition. These features are the main weaknesses. If in the end we do not want to has been one of the only, if not the only, west reasons why Weiss' work was so popular become what we have fought against, it is ern herbal texts based on extensive clinical among herbalists everywhere. He brought an essential to see the human faces of our op experience by a medical professional, rather exceptional clinical experience and reper ponents and to understand that the means are than a compilation of past writings of the toire, as well as a surprisingly holistic view the end. older herbalists, a rehash of works from early of healing, to the work. Some of this feeling Despite this, Ausubel's book is essen 20th century physicians like the Eclectics, is retained in the new edition, but precious tial for anyone interested in the history of and quite a bit of other second- and even little. These aspects could be emphasized in medicine or the hi story of herbalism. third-hand writings. the next edition, and would likely increase Hoxsey's story stands as compelling testi It is a pleasure to see the work brought circulation of the book. Many scientific com mony to Milton Friedman's warning that if up to date and published in a more quality pilations have been written on herbs of late, any group achieves complete control over binding with better paper quality and added but few textbooks summarize a highly healing, the result is poorer care for patients, color photographs. Here are some improve skilled clinician's experiences and observa loss of innovation, and higher costs to soci ments over the first English edition: tions, especially from the German perspec ety. In addition (with indigenous herbalism The new edition has better overall or tive, unique in that Germany is a country and zoopharmacology in mind), there is ganization and indexing, with an added pre where herbal medicines are freely-prescribed something mythic in a tale wherein a horse scribing index. I especially appreciate the by doctors and herbalists alike, and paid for discovers a cure for cancer and passes it on added clinical utility of organizing herbal by the national healthcare system. to a person intelligent enough to examine the remedies for a given ailment group by ac If we do accept the new edition as a natural world with fre sh eyes and to act on tion types. For instance, herbs under "Acute more modern, science-based work for clini what is received without prejudgment (never and Chronic Respiratory Tract Inflamma cians, founded less on Rudolf Weiss' years mind that some of the herbs in Hoxsey's for tion" are organized under Demulcents, Ex of clinical work, then it is useful in itself. mula do not grow wild in Kentucky where pectorants, and Antispasmodic Cough Rem Perhaps, in this light, it shouldn't be strictly Hoxsey's great-grandfather's horse grazed). edies. compared with the first edition. In its own Following in Descartes' footsteps, most of The color pictures and hard-binding right, this edition is clinically useful, espe us have been trained to discount such old make the book enjoyable to use. More mod cially because it contains more clinical ex wives' tales for complex theories that origi- ern scientific studies are woven into the text perience than most other current texts. How to support clinical and empirical uses in this ever, one would hope for some refinements 76 HERBALGRAM 50 2000 BOOK REVIEWS in a further edition, such as clearer color pho di git alpha or alphanumeri c abbreviations, PH2: all ergy, A OREXIA , art hritis. tographs with better compositions, and es KOM , BGB , PHR, and PH2. cholestocystosis, cystosis, degenerati ve cen pecially, since thi s work leans much more KOM = Blumenthal M, et al. (Eds.) tral nervous system disorders, DYSPEPSIA, heavil y on the current sc ientific literature, The Complete Ge1man Commission E Mono feve r, hepatosis. metabolic di sorders, neph more up-to-date citations. For the most part, graphs: Therapeutic Guide to Herbal Medi rosis. pain , pregnancy, RHE UMAT IS M, the new edition is already several years out cines. Austin, Texas: American Botanical sk in , wo und . of date. Over th e last I 0 years many Council, Newton , Massachusetts: and Inte KOM : approved devil's claw root for phytomedicines have seen a profound in grati ve Medicine Communications; 1998. "Loss of appetite, dyspepsia, supporti ve crease in the number and quality of random (ABC Catalog #B 181 ) therapy of degenerative disorders of the lo ized, controlled clinical studies. The next BGB = Blumenthal M, et al. (eds.). comotor system." PH 2 trans lates this to ap edition, if the publishers want to continue Herbal Medicine: Expanded Commission E proval for "dyspeptic complaints, loss of with thi s orientati on, should include a criti Monographs. Austin, Texas: American Bo appetite, and rheumatism." cal look at thi s literature, including meta tanical Council, Newton, Massachusetts: and BGB provides more chem ical data analyses, and more emphasis on "evidence Integrative Medicine Communications; than PH2 for devil 's claw, including three based" herbal medicine. 2000. (ABC Catalog #B 181E) COX-2 inhibitor compounds (kae mpferol, Meanwhile, thi s current edition can be PHR = Gruenwald , J. et al. PDR for oleanoli c ac id, and urso li c acid) th at might recommended for any clinical herbalist, or Herbal Medicine. I st ed. Montvale, New contribute to fu rthering the sy nergistic ac student of herbalism, especially in England Jersey: Medical Economics Co. ; 1998. ti vities. The whole extract has been shown or Europe. For the North American or Aus PH2 = Gruenwald, J. et al. ?DR for to be more active than is olated tralian markets, the book remains quite fo Herbal Medicines. 2d ed. Montvale, New phytochemicals studied to date. cussed on herbal practice in Germany, and Jersey: Medical Economics Co.; 2000. (ABC Secondly, let's look at similarities (and misses much of the Eclectic and international Catalog #B474) differences) between KOM and PD2 on el influence that makes herbalism so exciting If you want a lot of acc urate informa derberry. Both approve I 0-15 g elder flow and vivacious. Still , the book is worth stud y tion about some hundred of the most impor ers (Sambucus nigra, not American elderber ing, and will surely add some gems to the tant herbs on the American market, then BGB ries , S. canadensis) in teas, sipped through clinical repertoire. is the best buy for the money. If you want out the day, for colds. In th e Herbal PDRs Bottom line: Still one of the best manu more superficial coverage on some 600 more (PHR and PH2), Commission E approval is als on clinical western herbal medicine, de herbs, many not sold here in America, PH2 indicated by a square black bullet. PH2 indi spite its mo stly European focus. is the best buy for the money. These are just cates "A pproved by Commiss ion E - -Christopher Hobbs L.A c., A. H.G. 0 four of more than a dozen Engli sh books in cough/bronchiti s - fevers and cold s. The cluding information on Germany's Commis drug is used for colds and coughs. It is a sweat sion E. The good news is that all these pub producing remedy for the treatment of fever Commission Eversus lications bring to us anglophones the delib ish colds." Then fo ll ows thi s almost contra erations of the distingui shed panel of Com dictory sentence, "Unproven uses : In fo lk Herbal PDR mission E, the German Commission that has medicine, Elder flowers are used internally "They represent the most acc urate in been likened by some to our FDA. The bad as a sudorific tea and for colds and other fe form ation available in the whole world on news is that th ere are confusing variations in verish cond itions." Then PH2 li sts several the safety and efficacy of herbs and the various translations, many tri vial but a other folk indications, not ap proved (or di s phytomedicines ... Ignorance of Commis few serious. The following comparisons approved) by Commission E: flu , head co ld, sion E monographs is ignorance of a sub hi ghli ght a few variatio ns. laryngiti s, short breath, antiedemic, antiin stantial segment of modern medicine ... Devil's claw, di scussed elsewhere in flammatory, and lactagogue. Without question , their ready availability will this HerbalGram, the differences are not sig One big problem here is that the in benefit all of us, consumers and health care nificant; BGB seems to have done a better tended target audience, American physicians, practitioners alike." (Varro Tyler, writing of job than PH2 overall. Here are summaries will not know whether these indications ac the foreword of The Complete German Com of the indications in these two books, with crue to the bark, air-dried flowers, fresh or mission E Monographs: Therapeutic Guide Commission E approval indicated in capital dried leaves, fres h or dried ripe fruits, dried to Herbal Medicines). letters, unproven uses in lower case. roots, or a mix of fresh leaves and inflores I join Prof. Tyler in assigning a score BGB : allergy, A OREXIA, arrhyth cences whi ch PH2 li sts as the Medicinal of E for Excellence to Blumenthal et al., and mi a, arthrosis, backache, blood disease, "DE Parts. Gruenwald et al. for giving us English trans GENERATIVE DISORDERS OF THE LO KOM is much more specific in th is lations of Germany's Commission E. In this COMOTOR SYSTEM," DYSPEPSIA, regard, suggesting, correctly I presume, that review I will cursorily compare and contrast edema, fever, gout, headac he, hi gh blood Commission E approved onl y the flowers. four English interpretations of the commis pressure, inflammation , les ion , lumbago, Both KOM and PH2 note that the elder has sion , focusing upon two herbs. Since these neuralgia, pai n, rheum atism, ski n lesions, diaphoretic acti vity and increases bronchi al texts are multi-authored, I assign them three- sore, tendoniti s, ulcer, wound . secretions. 2000 HERBAL GRAM 50 77 BOOK REVIEWS Here are summaries of the indications Commission E approved a few poison terpreted in many different ways, some con in the later books BGB and PH2, with Com ou plants, including belladonna (Atropa tradictory. There are at least II more books mission E approval indicated by all upper belladonna), autumn crocus (Colchicum on herbs in English that include some infor case Ietters. autumnale), broom (Cytisus scoparius), hen mation attributed to the Commission E. I've BGB: catarrh, COLD; fever, inflam bane (Hyoscyamus niger), Scopolia failed to be as specific as I should in the past, mation, virus, water retention. carniocola, and Solanum dulcamara - all as have most of the authors of these other, PH2: alactea, BRONCHITIS, COLD, wisely dropped by BGB but still included in unnamed books. As with the game Simon COUGH, FEVER, flu, head cold, inflamma PHR and PH2. These powerfully active me Says, without a source author's name, we tion, laryngitis, short breath, swelling, water dicinal plants have a place, comparable to should necessarily believe what we read retention. powerful prescription pharmaceuticals, but when encountering in English, "Commission Regarding elder flowers, KOM notes their place belongs in a practitioner-medi E says ...."Before authors and lecturers pass " none known" for its section, ated setting, not in over-the-counter type di on this gravely ambivalent citation to their "Contraindications, Side Effects and Inter etary supplements. readers and listeners, they must specify actions with Other Drugs." PH2 reads, "No Both of PH2 and BGB books are great which version of translation and interpreta health hazards or side effects are known in buys for the money, BGB better for Ameri tion they draw from. As with the Bible - conjunction with the proper administration cans interested in the major herbs on the and there are those who wish to make Com of designated therapeutic dosages." American market, PH2 better for Europeans mission E into the Bible of the To their credit, both BGB and PH2 interested in major and minor herbs of the Phytomedicinal World - which author, added chemical data and are generous with world, whether on the American market or not. which edition, which testament, which trans references, but, unfortunately, other th an by The unhappy conclusion to this story lation, which version makes all the comparing the dates of the original mono is that no one, including myself, should cite dogmatic d ifference in the world. graphs with research citations, we'll never Commission E without being very specific. - James A. Duke, Ph.D. 0 know which the Commission E consulted. Commission E has been translated and in- SAW PALMETTO MECHANISM ceived discrepancy to our attention. First, like tute scientific confirmation of the claims I wonder if you can address an appar most phytomedicines, saw palmetto (SP) made by the patent applicants. ent discrepancy between two articles in the (Serenoa repens) preparations are chemically -Mark Blumenthal last issue of HerbalGram (No. 49) regard complex. There is a significant likelihood of ing the mechanism of saw palmetto. On page multiple mechanisms of action occurring si 24, under Research Reviews, you discuss the mu ltaneously. Second, the putative 5-alpha fact that saw palmetto does not effect reductase (5-AR) inhibition activity is docu COMMON NAME CONFUSION dihydrotestosterone levels. However, on mented mainly in vitro; there are no reliable In issue #49 of HerbalGram, the plant page 31, the report of a patent for a saw pal data from human or animal (in vivo) studies Adonis vernalis is referred to by the com metto based product is discussed as having a to confirm this. The summary of the Marks mon name False Hell ebore. I am concerned mechanism based on its ability to inhibit 5- et al. study on the SP-nettle root (Urtica about the fact that species of the genus Ver alpha-reductase (and thereby reduce dioica) preparation (page 24) focused on the atrum- quite common in the West and ex dihydrotestosterone). The two formulas dis new finding of contracted and atrophied pros tremely poisonous -are much more com cussed are slightly different, but both discus tate cells, suggesting that the herb combina monly (and in most field guides) referred to sions of DHT revolve around the actions of tion slowed the growth of prostate tissue. as False Hellebore. I hope thi s does not lead saw palmetto. However, the effect on hormonal levels was to any dangerous confusion on the part of I would appreciate any clarification on minimal, thereby raising questions regard someone inclined to seek herbal benefits this point. I ask not just to point out a dis ing SP's ability to inhibit 5-AR. The patent from wild plants and disinclined to go by crepancy, but as a clinician who has been summary (page 31) discusses the 5-AR scientific names. wondering about this very issue for some mechanism in male pattern baldness and vari Daniel Athearn time. ous herbs with (presumed) 5-AR inhibiting Eugene, Oregon Thank you for your reply- as well activity, thereby purportedly making the as for your terrific journal! herbs useful in preventing baldness. Read Your letter points out the need to en Elaine Stern, L.Ac., M.S. ers should keep in mind that a patent approval sure that people always use the Latin names New York, NY is not a formal recognition of the efficacy of of herbs, especially those that are lesser a substance, just its novel use. Thus, the known. This is why we always employ Latin We appreciate Ms. Stern's diligence in patent summary describes the language of binomial as part of our style requirements reading HerbalGram and calling thi s per- the patent application, but does not consti- in HerbalGram. In our book translating the 78 HERBAlGRAM 50 2000 German Commission E monographs, Ado The tables and the literature review are YOUNGKEN HERBARIUM nis is li sted as the common name "Pheasant's excellent and I would encourage you to con I read the article about your getting the Eye." (Neither Adonis nor Veratrum are used tinue the publication of such articles. Youngken herbarium collection and have much in the U.S.) There are, generally, few Unfortunately, too few phys icians use mixed feelings about it. It is very sad that hard rules about the use of common names, HerbalGram as their resource for concise and my alma mater, once the bastion for phar compared to the standards for binomials. The detailed description of the clinical applica macognosy, has eliminated all traces of thi s American Herbal Products Association 's sec tions of herbal medici nals. di scipline. The number of pharmacognosists ond edition of the Herbs of Commerce, due I can imagine, and hope, that trained by Youngken and Quimby was as out early next year, should help to standard Blumenthal's article will contribute to the tonishing, considering the small number of ize common names for those herbs that are wider distribution of your magazine among students. sold in commerce.- Mark Blumenthal healthcare professional s. l remember couple of stories about Bernd Wollschlaege r; M.D. Heber Youngken. By the time I was a gradu Clinical Assistant Professor of ate student, he had retired but would come Medicine and Family Medicine into th e lab a few times each week. When HERB-DRUG INTERACTIONS University of Miami School ever he drove into th e parking lot, he re I am a board certified family physi of Medicin e minded us of Ichabod Crane - he was so cian in private practice, trained and educated North Miami Beach, FL short one could not see him sitting behind in Germany. I integrate herbal remedies into the wheel. And, when he came into the lab, the clinical practice and consider those as he would always ask, "Where is that Greek pharmacologically active substances and as lady?" He could read and understand Greek, such can potentially interact with prescrip READER'S KUDO and wanted to talk to me about it because I tion drugs and/or OTCs. Thank you for providing such a won am bilingual. Hi s great passion was reading Physicians are often not aware of such derful resource. As a home herbal ist, I am the ew Testament in Greek. I always ap effects and, generall y, neither record or re always trying to stay abreast of recent stud preciated hi s comments. port herb-drug interactions, even though sev ies pertaining to the medicinal use of herbs. Georgia J. Persinos, PhD eral review articles have been published in Your magazine is the best that I have found. Editor medical literature regarding this matter. Ironi Michael D. Ingram Washington Insight cally, such reported interactions are being Salida, Colorado No rth Beth esda, Maryland used to discredit the applicati on of medici nal herbs. Meanwhile, the often serious com plications or even fatal outcomes associated with drug-drug interactions have discouraged HERB REGULATION PHARMACIST' S CONVERSION few people so far to continue their use in the Well , it 's about time' I was delighted I have always admired your work; it daily management of medical conditions. to read Bill Soll er's article on how herbs are was HerbaiGram th at got me out of phar It is important to promote among regul ated, "Regulation in th e Herb Market: macy and into the herbal world. It really is healthcare professionals the rational appli The Myth of the 'Unregulated Industry."' I an inspiration. Also, the herbal education cations of herbal remedies as possible first urge you to get as much exposure for thi s as books that ABC brings to our attenti on are line treatment options (saw palmetto for be possibl e. I am so tired of dealing with re invaluable. ni gn prostate hyperplasia, St. John 's wort for porters who have bought the FDA party line Take care and keep up the great work! minor depression etc. ) as currently applied about OSHEA preventing them from regu Ernie Hawkins, MS, RPh in Germany. lating supplements. It seems to me that the Director of Herb Research Therefore, Mark Blumenthal 's article agency has spent a ton of effort to undermine lntramedicine "Interactions Between Herbs and Conven OSHEA. I'm thrilled that someone with ex Asheville, No rth Carolina tional Drugs: Introductory Considerations" pertise has finally answered them. Please published in HerbalGram No. 49 is an ex send me a copy of the original, and I will do cellent source of inf01mation. It lends itself everything I can to di sseminate the informa as an introduction into the unknown territory tion. At a minimum, I wi ll provide it to re of herbal medicinals and their interactions porters I speak with about these issues. either with prescription drugs, OTCs or even Thanks for a great job. with other herbal remedies. It should be fol Candace Campbell lowed by a more detailed review, either em Executive Director phasizing drug categories and how herbs af American Preventive Medical fect the pharmacology of such medications Association, Great Falls, Virginia or disease entities in which herbal remedies are used as treatment alternatives. This article is also on our website 2000 HERBALGRAM 50 79 ACCESS In thi s department of Herba/Gram , we list resources such as publications, organizations, seminars, and networking for our readers. A listing in this section does not constitute any endorsement or approval by Herba/Gram, ABC, HRF, or their Advisory Boards. National Aromatherapy Registration Examination, Sustainabi I i ty. CALENDAR 2000 6 10/647-8565. Emai l: 80 HERBALGRAM 50 2000 CALENDAR May 28-June 3: Society for Economic Botany Annual Manager, Plant Biotechnology, VTT Biotechnology, P.O. included in a special issue of the lmemariona/ Journal Meeting " Crops and Cultures in the Pacific" in Box 1500, 02044 VTT Finland. Ph: 358 9 456 4459. of Medicinal Mushroom s. Contact: Dr. Elvira F. association with "Building Bridges with Traditional Fax: 358 9 455 2 10. Email CLASSIFIED A listing in this classi fied section does not constitute any endorsement or approval by Herba/Grom , the American Botanical Council the Herb Research Foundation, or their Advisory Boards. Herba/Grom Classified ad rates : $2 per word; $45 minimum . Contact Debbie Jones, P.O. Box 144345, Austin , TX 78714-4345. 512/926-4900 ext. 106. Fo x 512/ 926-2345. BOOKS, TAPES & VIDEOS call 800/372-8255 or write to The School of Natural sons. wi ldcrafti ng diagrams. and recipes for body and Spagyric & Alchemical Healing: Paracelsian Ener Healing, P.O. Box 412, Springville, UT 84663 or mind. 2000 HERBAL GRAM 50 81 CLASSIFIED Medical Herbalism - Subtitled "A Clinical Newslet P.O. Box 19254, Boulder, CO 80308-2254. ter for the Herbal Practitioner." Edited by Paul Bergner. Ph one 303/442-686 1. Northeast School of Botanical Medicine - Three Substantial British company manufacturing and mar programs emphasizing hands-on, community-based, keting Health food suppl ements and Herbs to European clini cal herbali sm. A six-month 360+ hour residency G. M. P. is see king a joint venture with a USA market program, a one weekend-per-month course, and an Ad ing company, to take advantage of e-commerce and di For Information, vanced Western Clinical Herbali sm program . Classes rect marketing in the USA. Interested parties shou ld e include clinical evaluation, botanical identification, mail Tom Chapman- 82 HERBA LGRAM50 2000 Top Ten Sellers In ABC's Online Herbal Education Catalog june 2000 through October 2000 PREVIOUS STAN DI NG SHOWN IN ( ) 1. HERBAL MEDI CINE: EXPAN DED COMMISSION E MO NOGRAPHS (1) Ed. B1 \1. Blumenthal. A. Goldberg. and). Brinckmann. 2000. Expanded content in the Commission E herb monographs of the most widely used herbs in the L.S. to include updated , detailed information on their botanv, historv, composition, safetY, effi cacy, and therapeutic use. Extens ive list of published references. Hardcover, 519pp. $49.95. #BISIE 2. THE COMPLETE GERMAN COMMISSION E MONOGRAPHs-THERAPEUTI C GUIDE TO HERBAL MEDI CINE (2) Ed. Bv M. Blumenthal , W. Busse, A. Go ldberg,). Gruenwald. T. Hal l. C. Riggins. and R. Rister. 1998 The official English translation of the monographs resul ting from the German Federal Heal th Agenc1··s expert commi ttee. Accordin g to Prof. l·arro E. 1)'1er, "the most accu rate information available in the entire world on the safetY and efficacY of herbs and phrtomedicines ... Hardcover, 685 pp. $165. #Bl81 3. HERB CONTRAINDICATIONS AN D DRUG INTERACTIONS (3) bY Francis Brinker. \.D. 1998. 2nd Ed. Infom1ation on 181 traditional therapeutic herbs exp laining documented contraindications and drug interactions. Appendices identifYeven more herbs as thev affec t certain conditions and medicines. Softcove r, 148 pp. S19.95. #B282 4. ITLER'S HERBS OF CHOICE: THE THERAPEUTIC USE OF PHYfOMEDICI NALS (first time for this edition) byjames Robbers and l'arro Tyler. 1999. 2nd edition . Up-to-date legal data about herb use in the L.S., clinical studies and advances in determining mechanism of acti on. infom1 ation essenti al for understanding anY medicinal agent and its rational use in therapeuti cs, easy-to-follow breakdown of how herbal remedies are used to treat various conditions and systems. and an expanded introduction to ph)1omedicines and their respective app li cations. 287 pp. HardcoYer. 549.95. #B079H. Softcover. 519.95 . #B079S 5. BOTAN ICAL SAFElY HANDBOOK: GUIDELI NES FOR SAFE USE AN D LABELING FOR HERBS IN COMMERCE (5) Ed. by M. McGuffin , C. Hobbs, R. Cp ton, and A. Goldberg. 1997. Provides safetl' data on more th an 550 herbs as guidelines for product labels, including contraindications. side effects, and special warnings. Each herb is classed as can be safelY consumed when used appropriatelv. herbs wi th the following restrictions, for external use on lr. or not to be used du ring pregnancy. Hardco1·er. 256 pp. $39.9 5. #B275 6. HERBS FOR YO UR HEALTH ( 4) b1· Steven Foster. 1996 Designed as a quick reference guide to the 50 most common l1 used herbs available in the U.S. as dietary supplements. Profiles include common and botanical names, brief histor~ · of tradi ti onal uses. summary of credible scientific reports, brief descriptions of condi tions and SYmptoms the herb treats. forms in which it is available in the U.S ., acti ons, dosage, cautions or contraindications, and photograph. Softcover, 121 pp. 59.95. #B232 7. BRITISH HERBAL PHARMACOPOEIA (7) bY the British Herbal ~!edicine Assoc iation 1996 :-;ow with 169 monographs on definition. description, identificati on and standards for plant materials common !I- used in herbal products on the market toda1·. Hardcove r, 212 pp. 590 #BOIS 8. ENCYCLOPEDIA OF HERBAL MEDI CINE (back after an absence) b1· Thomas Bartram. 1995. Includes over 900 entri es of general disease conditions with appropriate herbal treatment. 550 monographs of medicinal plants. therapeutic action and properties of herbs, preparations (tinctures. liquid extracts. poultices. essential oils. etc.), and British legal requirements. Hardcover. 474 pp. $43 #B213 9. DRUGS OF NATURAL ORIGIN: A TEXTBOOK OF PHARMACOGNOSY (new listing) bY Gunnar Samuelsson . 1999 ·Hh edition. Extensi ve lv revised and ex tended. Arranged according to biosyntheti c principles. wh ich places the substances in a natural context and fac ilitates the understanding of the often complicated chemical structures. Knowledge of the biosYnthesis of pharmaco logically active compounds has increased tremendouslv in the last few vears and is reflected in a substantial increase in the informat ion presented in th is book. Hardcover, 550 pp. $64 #B093 10. WOME N'S ENCYCLOPEDIA OF NATURAL MEDICI NE: ALTERNATIVE THERAPIES AN D INTEGRATIVE MEDICI E (new listing) by Tori Hudson. 1999. Provides sel f- care treatments for 18 common female disorders as well as guidelines about when self-care is not app ropriate. Each chapter begins with an oYe fl•iew of the condition. followed b1· in-depth discussion of appropriate therapies, sample treatments. dosages where herbal treatments are recommended, and conYentional therapies when suggested. Softcover. 358 pp. $24 95. #8430 To order, call toll free 800/J7J-7105, fax 512/926-2J45, email: custserv@ herbalgram.org or order online at www.herbalgram.org eaicine Expanded Commission E Monographs Mark Blumenthal I Alicia Goldberg I Josef Brinckmann This new and updated reference is based on the original, renowned Commission Etranslation by the American Botanical Council • New in-depth overview with clinical research • List of most-researched brands • Expanded sections on chemistry and pharmacology • More on dosage and administration • Extensive references • 90 full-color photos • 519 pages EACH Plus Shipping Book: Item #Bl81E • CD: Item #Cl81E F======! P.O. Box 144345 Non-Profit Org. Austin, TX 78714-4345 U.S. Postage 512/926-4900 Paid www.herbalgram. o rg Houston, TX Permit no. 10968 CHANGE SERVICE REQUESTED POSTMASTER: TIME SENSITIVE MATERIAL. PLEASE EXPEDITE DELIVERY.