Botanical Medicines FROM THE AMAzoN AND MACHU PICCHU
OCTOBER 21-31, 2004 Sponsored by: The American Botanical Council, The Texas Pharmacy Association, The ACEER Foundation, and West Chester University of PA Earn CME and CEU credits on mcation in Peru!
On-site seminars will address Sites visited will include: the following topics and more: • Reserva Amazonica Ecolog • Amazonian plants and their ical Reserve health potential • ACEER Education Center • Reliable and unreliable at Inkaterra sources of information • Sandoval Lake on herbs • Cusco and the Sacred • Medicinal foods from Peru Valley of the Incas • Herbal safety issues and • Machu Picchu challenges • Allcamayo Falls • Temperate and tropical plant medicines and the conditions they treat • Update on herb regulation $3598* all inclusi1•e from i'vfiami • Ecology of the flora and • Costs include mternauonal airfare, fauna of Peru meals. lodgi11g. grou nd transponacion. baggage handling, workshops
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Cindy K. Angerhofer, Ph.D. Hardy Eshbaugh, Ph.D Joseph E. Piuorno, Jr., N.D. Director of Botanical Research, Aveda Institute, Professor of Botany & Assistant Curator, Willard Sherman Turrell President Emeritus, Bastyr University, Seattle, Washington, and Minneapolis, Minnesota Herbarium, Miami University, Oxford, Ohio Editor, Integrative Medicine: AClinician's Journal John Thor Amason, Ph.D. Adriane Fugh-Berman, M.D. Mark J. Plotkin, Ph.D. Professor of Biology, Department of Biology, Author, Assistant Clinical Professor, George Washington University Author, Executive Director, Amazon Conservation Team, University of Ottawa, Ontario, Canada School of Medicine, Washington, DC Arlington, Virginia Dennis V. C. Awang, Ph.D., F.CI.C. Joe Graedon, M.S. John M. Riddle, Ph.D. MediPiant Natural Products Consulting Services, Author, syndicated columnist, radio host, Durham, North Carolina Professor of History, Department of History, White Rock, B.C., Canada North Carolina State University, Raleigh Mary Hardy, M.D. Manuel F. Balandrin, R.Ph ., Ph.D. Director, Cedars-Sinai Integrative Medicine Medical Group, Eloy Rodriguez, Ph.D. Research Scientist, NPS Pharmaceuticals, Sa lt Lake City, Utah Los Angeles, California James Perkins Professor of Environmental Studies, School of Agriculture & Life Sciences, Cornell University, Ithaca, New York Bruce Barrett, M.D., Ph.D. Christopher Hobbs, LAc., AHG Assistant Professor of Family Medicine, University of Herba list, botani st, licensed acupuncturist, Davis, California Victor Sierpina, M.D. Wisconsin-Madison Medical School Associate Professor of Family Practice Medicine, David Hoffmann, B.Sc., M.N.I.M.H University ofTexas Medical Branch, Galveston Marilyn Barrett, Ph.D. Medical herbalist, author, Sa nta Rosa, California Pharmacognosy Consulting Service, San Carlos, California James E. Simon, Ph.D. Maurice M.lwu, Ph.D. Professor of New Use Agriculture, Director of theCenter for New Use Bradley C. Bennett, Ph.D. Bioresources Development and Conservation Program, Senior Agriculture and Natural Plant Products, Rutgers University, Associate Professor of Biology, Florida International University, Research Associate at the Division of Experimental Therapeutics, New Brunswick, New Jersey Miami Walter Reed Army Institute of Research, Washington, D.C. Beryl Simpson, Ph .D. Joseph M. Betz, Ph .D. Timothy Johns, Ph.D. C. L. Lundell Professor of Botany, Department of Botany, Director of the Dietary Supplements Methodsand Reference Professor, School of Dietetics and Human Nutrition; Centre for University oflexas at Austin Materials Program, Office of Dietary Supplements, National Indigenous People's Nutrition and the Environment, McGill Institutes of Health, Bethesda, Maryland University, Montreal, Canada S. H. Sohmer, Ph.D. President and Director, Botanical Research Institute oflexas, Francis Brinker, N.D. Steven King, Ph.D. Fort Worth Clinical Assistant Professor, Department of Medicines, Vice President, PS Pharmaceuticals, Inc., Program in Integrative Medicine, University of Arizona, Tucson South San Francisco, California Barbara N. Timmermann, Ph.D. Professor of Pharmacology and Toxicology, College of Pharmacy, Donald J. Brown, N.D. Tieraona Low Dog, M.D. University of Arizona, Tucson Director, Natural Products Research Consultants, Seattle, Washington Chair: United States Pharmacopoeia Dietary Su pplements/Botani cals Expert Panel Clinical Asst. Professor, Dept. of Family and G. H. Neil Towers, Ph .D. Thomas J.S. Carlson, M.S., M.D. Community Medicine, University of New Mexico Professor Emeritus, F. R. S.C., Botany Department, Associate Adjunct Professor, University of British Columbia, Vancouver, Canada Department of Integrative Biology; Director, Center for Health, Tom Mabry, Ph .D. Ecology, Biodiversity, & Ethnobiology; Curator of Ethnobotany, Professor of Plant Biochemistry, Department of Botany, Arthur 0. Tucker, Ph.D. University and Jepson Herbaria; University of California, Berkeley University ofTexas at Austin Research Professor of Agriculture and Natural Resources, Delaware State University, Dover Jean Carper Gail B. Mahady, Ph.D. Author and syndicated columnist, Washington, D.C. Research Assistant Professor, Department of Medical Chemistry & Nancy Turner, Ph.D. Pharmacognosy, College of Pharmacy, University of Illinois, Chicago Professor and Ethnobotanist, Environmental Studies Program, Jerry Cott, Ph.D. University of Victoria, British Columbia, Canada Pharmacologist, U.S. Food and Drug Administration, Robin J. Maries, Ph.D. Center for Drug Evaluation and Research, Rockville, Maryland Director of the Bureau of Research and Science, Natural Health Daniel T. Wagner, R.Ph., MBA, Pharm.D. Products Directorate, Health Products and Food Branch, Owner, Nutri-Farmacy, Wildwood, Pennsylvania Paul Alan Cox, Ph.D. Health Canada, Ottawa Director, National Tropical Botanical Garden, Kauai, Hawaii Andrew T. Weil, M.D. Dennis J. McKenna, Ph.D. Author, Director of the Program in Integrative Medicine and Lyle E. Craker, Ph .D. Executi ve Director, Institute for Natural Products Research; Associate Director of the Division of Social Perspectives in Medicine, Professor, Department of Plant and Soil Sciences, Senior Lecturer, Center for Spirituality and Healing, University of College of Medicine, University of Arizona, Tucson University of Massachusetts, Amherst Minnesota, Minneapolis Bernd Wollschlaeger, M.D. Edward M. Croom, Jr., Ph.D. Daniel E. Moerman, Ph.D. Family practice physician; Clinical Assistant Professor of Medicine Scientificand Regulatory Affairs Manager, lndena USA East, Inc., William E. Stirton Professor of Anthropology, and Family Practice, University of Miam i, School of Medicine, Florida Oxford, Mississippi University of Michigan/Dearborn Wade Davis, Ph.D. William Obermeyer, Ph.D. Explorer-in-Residence, National Geographic Society Vice-President of Research and Technology, ConsumerLab.com, ad hoc advisor: Washington, D.C. Annapolis, Maryla nd David M. Eisenberg, M.D. Steven Dentali, Ph .D. Samuel W. Page, Ph.D. Director, Center for Alternative Vice President of Scientific and Technical Affairs, American Herbal Director, Division of Natural Products, Center for Food Safety Medicine Research, Beth Israel Products Association, Silver Sp ring, Maryland and Applied Nutrition, U.S. Food and Drug Administration, Hospital/Harvard Medical School, Boston, Massachusetts Washington, D.C.
4 I HerbaiGram 61 2004 www.herbalgram.org • dear reader ust before the New Years holiday on Tuesday, the various interviews: December 30, the FDA dropped a bombshell on 1. The proposed ban demonstrates that FDA does have the media, announcing plans to ban the sale of the authoriry and power to remove supplements from the dietary supplements containing ephedra. FDA market that it (actually HHS) deems unsafe, contrary to said they constitute an "unreasonable risk of previous asserrions by FDA officials, some Congressper illness or injury" to the public. That night all sons, and others. OSHEA actually gives the FDA added major TV and radio news outlets covered the authoriry to remove unsafe dietary supplements from the ban. FDA Commissioner Mark McClellan was marker. This new action by FDA supports that interviewed on the PBS News Hour with jim realiry. Lehrer and on Wednesday newspapers ran 2. This might not have major impact on the headlines like "FDA says it wi ll outlaw entire herbal market because: (a) Ephedra is an ephedra" (Austin American-Statesman, running outlier insofar as it is not like most of the popu Marc Kaufman's Washington Post arricle at the lar herbal products, which have shown an top of page 1). impressive record of their safery; ephedra's fairly ABC received calls from USA Today, the dramatic acriviry raises irs potential risks, while Baltimore Sun, Time, the Los Angeles Times, the most other popular herbs are much more Fort Worth Star- Telegram and the News Hour gentler acting, rhus in general have a higher (for background information to prepare for the safety profile. (b) Most companies who interview with Commissioner McClellan). I formerly sold ephedra have discontinued it in also appeared the following Saturday on Joe favor of the so-called "ephedra-free" formula and Terry Graedon's People's Pharmacy on over 100 NPR tions or dropped rhis category altogether due to concerns radio stations and, later, KABC, the anchor station for the about bad PR and/or insurabiliry problems. ABC radio network in Los Angeles. Industry veteran 3. This may nor bode ill for rhe herb industry, as , hope Loren lsraelsen was interviewed on NPR's All Things fully, ir will not become a precedent or gateway for rhe Considered and in the New York Times' arricle. AHPA Pres banning of other popular herbs. In fact, this may have a ident Michael McGuffin was quoted in the Washington benefit for the industry, as it wi ll remove the shadow rhar Post article and many other papers, plus an interview on ephedra has cast over the rest of the herbs and possibly NPR's All Things Considered. lower some of rhe demands by some in Congress for more Aside from Commissioner McClellan and HHS Secre laws requiring rhe stringent (and possibly unreasonable) tary Tommy Thompson, the person who seems to have regulation of the entire herb and supplement industry. It gotten the most coverage was consumer advocate Sidney indicates that current laws are adequate when fully Wolfe, MD, of the non-profit group Public Citizen. Dr. enforced. Wolfe is a long-time opponent of ephedra who has pushed 4. ABC believes that, absent any compelling evidence for its ban for several years. He stated repeatedly that the suggesting significant safery problems, rhe free market FDA ban was a bit late, that 3 states have already banned ava ilabiliry of most herbs should be supporred. In cerrain it (CA, IL, NY) as have many sports organizations, the cases, where serious safery concerns suggest their limita International Olympic Committee, and the military. tion to the general public, these herbs should be available What follows are the main points of my comments in Continues on page 13
board of trustees
Michael j. Balick, Ph.D., Vice President and Chair. Fredi Kronenberg, Ph.D., Director. Rosenthal Center Research and Training Director and Philecology for Complementary and A lternat ive Medicine, Curator. Institute of Economic Botany, The New York Columbia University College of Physicians and Botanical Garden, Bronx, New York S u ~geo n s, N ew York
Peggy Brevoort, President, Brevoort, LLC. Seattle, Thomas L. Kurt, M.D., M.P.H., Clinical Professor of Washington Internal Medicine, University ofTexas Southwestern, Dallas, Texas James A. Duke, Ph. D., Economic Botanist (USDA. ret.) NviERIUN Author. Fulton, Maryland Morris Shriftman, CEO, Mozart, Inc., Ponte Vedra BoT,ANI CAL Beach, Florida COJNCIL Norman R. Farnsworth, Ph .D., Research Professor of Pharmacognosy, Program for Collaborative Research in Mark Blumenthal, Founder and Executive Director Educating the the Pharmaceutical Sciences, University of (ex officio member) Public on the Illinois at Chicago Use of Herbs & Steven Foster, President, Steven Foster Group, Inc., Phytomedidnes Brixey, Missouri
www.herbalgram.org 2004 HerbaiGram 61 I 5
HERBAIGRAM ® The journal of the American Botanical Council
Mark Blumenthal Editor I Publisher Karen Robin Managing Editor Sean Barnes Art Director Steven Foster Associate Editor Maureen Jablinske Proofreader Jon Lucksinger Editorial Intern
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Subscriptions are a benefit of membership at every level. One year memberships: Individual $50; Academic $1 00; Professional $150; Organization $250; Corporate; Sponsor. Add $20 for memberships outside of the U.S. Student, Senior. and Busi ness Memberships also available, see ad in this issue.© 2004 American Botanical Coundl. ISSN #0899-5648. Printed in the U.S A The information in Herba/Grom® is intended for educational purposes only and IS not a substitution for the advice of a qualified healthcare professional. Although we attempt to ensure that aavertiSing 1n Hetba/Grom 1s truthful and not m1slead1ng. the publication of an ad for a product or company in Herba/Grom does not consti - tute an endorsement by ABC of the product or the company be1ng advertised. . . Publication of an ad that makes a health claim or structure-function claim does not ..- necessarily constitute an approval of that claim by ABC. Further, ABC has not .. .. reviewed any manufacturer's Good Manufacturing Practices.
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Reviews and Textbook Adoptions of The ABC Clinical Guide to Herbs
ince its publication last year, The ABC Clinician's journal and co-founder of
Dell Community Volunteers Give Time to ABC
n September 24 and 26, rwo Accordingly, ABC gardener O employee volunteer groups from Dell Nathanael Sponseller had set up some Computer Corporation, which is head much-needed garden projects for quartered in Austin, came ro rhe Case Mill them. The first group helped Spon Homestead ro help ABC with chores in irs seller remove a large accumulation of herbal gardens and various administrative branches and brush from rhe roadside tasks. Each group consisted of 12-15 next ro the Case Mill Homestead, volunteers, all of whom donated a day's eliminating a chronic eyesore and worrh of labor ro ABC. opening a large amount of previously unusable space for ABC. The volun teers then moved the brush ro the compost pile, a task that could have taken Sponseller days to do alone. Two days later, the second group of volunteers arrived ar ABC only ro have rain cancel plans for working in Dell volunteers clearing brush from ABC fenceline. the gardens. Instead, they rook on a Photo ©2004 De ll variery of administrative tasks that ees while at the same time benefiting the might otherwise never get accomplished. communities where Dell is based. The Dell The volunteers gave rheir time and employees choose a nonprofit organization efforr ro ABC as a parr of Dell's Global to which they would be willing to donate Community Involvement Week. The time and efforr. _. program, in its second year, is parr of an -Jon Lucksinger Dell volunteers take a break from working in the internal employee efforr designed to build ABC ga rdens. Photo ©2004 Dell trust and camaraderie among Dell employ-
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Botanical Medicines from the Amazon and Machu Picchu Tour Set for October
he American Botanical Council's Presenters will incl ude Tannual pharmacy from the rainfores t ABC founder and execu tour is starring up again, under the new ti ve director Mark name of Botanical Medicin es fro m the Blumenthal, ACEER Pres i Amazon and Machu Picchu. ABC and the dent Roger Mustalish, Amazon Center for Environmental Educa PhD , and ABC Board of tion and Research (ACEER) will lead trips Trustees Fo unding through the Peruvian Amazo n in late Member Jim Duke, PhD. October 2004, presenting seminars on Tentative se minar topics native botanicals and habitat, and, as a include: Herbs and Heal special treat this year, visiting the Andes ing, Ancient Medicine and and the breathtaking ruins of the "Lost Modern Cures, Cultural C iry of the Incas," Machu Picchu. Competence and Health Sleep with the ge ntle susurrati on of the ca re Outcomes, Rainfores t rainforest in the background and wake up C ultures, N utrition and to the lovely descending notes of the the Tropical "Food oropendula. Dine on good, simple foods Farmacy, " Spirituali ry and in the fres h air to the accompaniment of H ea ling, Psychoactive Mac hu Picchu, the "Lost Ci ty of the Incas." Photo ©2004 AC EE R laughing fro gs . Hear a tropical sto rm pass Plants and their Role in overhead while you stay relatively dry Shamanic H ealin g, the walking the trails surro unded by 20-foot Amphibian Pharmacy, Visit
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ABC Phases Out Commission E CD-ROM: Full Commission E Database Available Online for Members
fter five years of sales, ABC's CD fully cross-referenced volume. Along with by known uses and indications, side A version of The Complete German this, a CD-ROM version allowed for fast effects, contraindications, and pharmaco Commission E Mono- electronic cross logical actions. Unapproved herbs do not graphs: Therap eutic referencing of the have listings for uses and indications; herbs Guide to Herbal Medi - Commission E data are listed as unapproved because they cines will no longer be base. Though the either pose a possible health risk or because available for retail. The CD will no longer Commission E could not obtain adequate information, a compi be sold, the cross information to document efficacy. These lation by the German referenced database unapproved herbs, some of which are used government of more is located at regularly for medicinal purposes in West than 380 different
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Expanded Benefits Provide Increased Value to ABC Memberships
ew member benefits have been fin al • Highlights and links to the latest ABC has reorganized the benefit struc Nized for 2004. Membership in ABC HerbClip™ releases; ture and added new services for Corporate provides the bes t way for individuals, • Breaking news about herbal medicine; and Sponsor level members. In these times healthcare professionals, academics, • Upcoming eve nts and ABC appear of economic challenges and demand for a government institutions, the media, and ances with links to ABC's extensive return on investment, the total value of industry to get the latest and most accurate web calendar; these benefits can likely be greater than the information in the herbal medicine move • Information on The ABC Clinical actual financial support that these compa ment. Since ABC launched irs member Guide to Herbs: lates t adoptions & ni es provi de. These include discounts on ship program three years ago, an increas revtews; many ABC services, such as li censing ingly valuable set of benefits has been • Much more. ABC's vast electronic content of articles offered, and the 2004 addition should be ABC staff is eager to start communicat from Herba/Gram and HerbClip for welcomed by new and prospective ing with its members via this new service. websites, safety labeling, HerbalGram members. Members are encouraged to contact ABC advertising, and numerous other benefits. In response to member requests for to make sure their current emai l address is Of course, all funding through member more frequent communication and up-to on file . ship enables ABC to achieve its mission. date information, ABC has launched an New and renewing Academic, Profes For more than 15 years, the nonprofit electronic newsletter as a key member sional, and Organizational members will educational and research work of ABC has benefit at all levels. This service, launched receive a new booklet co ntai ning the ther contributed to improving selfcare and this winter, will provide valuable updates apeutic monograph on garli c reprinted healthcare through the dissemination of between iss ues of HerbalGram. In the from The ABC Clinical Guide to Herbs. reliable information on the benefits of future, ABC will increase the frequency of This literature wi ll provide comprehensive herbs and phytomedicines. the e- newsletter. Brief updates linked to information on the history, use, safety, More information on ABC membership more comprehensive information on dosage, and clinical trials of ga rli c. New levels and a derailed list of benefit levels are ABC's website will provide an easy way to and renewing Profess ional and Organiza ava il able on page 3 of this issue, our scan and learn. Content will include: tional members will also receive a Black website at
Austin Jewish Academy Students Learn about Herbs in ABC Gardens
Two groups of first- and second-grade (Melissa o.lficinalis), which is calming and Teas were not the only things the yo ung I students from the Austin Jewish Acad relaxi ng. She showed the groups how to visitors were interested in tasting, though. emy at the Dell Jewish Community sweeten the teas using stevia (Stevia rebau- Engels said the naturally curious kids Campus visi ted ABC in October to tour wanted to taste or eat almost every plant in the gardens and learn about medicinal the gardens. Though happy wi th their herbs from ABC education coordinator enthusiasm, Engels stressed that they Gayle Engels. should not eat anything they find in a Each group was made up of 18 students garden without aski ng the appropriate and four adults who learned some uses of adult first. She taught the students which medicinal plants and how to identify plants are proper for consumption and them. The lessons focused specifically on which are not. It gave an opportunity for a herbal teas and aromatherapy, including lesson in garden safety and the proper care essential oils such as rosemary (Rosmarinus of plants as well as oneself through the use officina/is) and lave nder (Lavandula angus of medicinal herbs. tifolia). The students learned about plants T he day was a rewarding experience they knew from their home gardens, but according to Engels, who felt the children Austin Jewish Academy students learn about echi had not known were medicinal, and about nacea. Photo ©2004 ABC truly learned something about herbs and many new herbs they could use for both their appli cations. medicinal and other practical purposes. "I think the kids really had their hori Using plants from the demonstration diana) extract as a non-caloric sugar substi zo ns expanded," she said. "They learned a gardens, Engels made some teas from tute. The students greatly enjoyed the teas, lot and seemed to have a good time doing peppermint (Mentha piperita), a good herb according to Engels, and most of them it." ""' for settling the stomach, and lemon balm tas ted both varieties and asked for seconds. -Jon Lucksinger www.herbalgram.org 2004 HerbaiGram 61 I 11 abc news
ABC Participates in Festival de las Plantas
he American Botanical Council was one were built, while the park master plan cultural ceremonies. In the morning, Tof numerous herb, native plant, and ensures that it will be kept more in its TreeFolks and the City of Austin organized conservation-related organizations partici "natural state," according to Ted Siff, execu a community tree planting along with a pating in the first Festival de las Plantas tive director of the Austin Parks Founda blessing ceremony of the trees. There were celebration to honor rhe varied and vital tion. traditional Aztec dances and ceremonial roles of plants in culture and to inaugurate Austin City Council member Raul performances, along with booths from vari a new riverside park in Austin, Texas last Alvarez originated the idea for the Festival. ous food, farm , art, plant, and environmen Alvarez said that the event's main purpose tal organizations. Several exhibitors featured was "to facilitate learning of our natural indigenous musical instruments made from environment and rake advantage of this plant material such as gourds, and the recreational resource to bring together the Austin Herb Society had tea-making community to promote the park." Other demonstrations along with tea sampling. speakers at the event included U.S. Congressman Lloyd Doggett and other local offi cials. ABC participated in this event to educate consumers on the safe use of herbal medicine and to make connections in the Austin community. Mark ABC offers educational materials at the fest ival. Blumenthal, founder and exec Photo ©2004 Lan Truong. utive director of ABC, spoke about the historical uses of October. The festival occurred at the new herbal medicine and modern Roy G. Guerrero Colorado River Park in lessons in herbal medicine. In east Austin on the banks of the Colorado addition, he discussed the Aztec dancers entertain the crowd at Festiva l de las Plantas. Photo River. The theme of the festival was the return of herbs and their popu- ©2004 Lan Tr uong. celebration of the biological and cultural larity as a result of affordable values of plants in the Austin community. costs, minimal adverse effects, and their The festival was sponsored by four organ The process of acquiring the former river various benefits. Local herbalists Carlos izations: the City of Austin, Austin Parks bottom ranchland for the park took at least Hernandez and Ginger Webb led herb Foundation, People Organized in Defense 30 years. With various acquisitions and walks. of Earth and her Resources (PODER), and donations during that time, the Roy Guer The Festival de las Plantas offered numer the Lady Bird Johnson Wildflower rero Park today consists of 363 acres. ous activities, including tree plantings, Center. A Between 1995 and 1999, baseball fields nature walks, dancing, music, lectures, and -LanTruong
ABC Employee Profile: George Solis eorge Solis has been an employee of ABC since its incep all-trades. Currently, one of his primary responsibilities is to Gtion, even before, having worked with me in various capac photocopy the thousands of pages of HerbClip articles every ities since 1986. We first met when George was a night atten two weeks, collate and insert them into envelopes, and ensure dant at a service station in Austin. George's home was the cab of that they are mailed to hundreds of ABC members who receive his Chevy Luv pickup truck and he used the station's restroom this membership benefit. as his bathroom and the cold water hose for showers. He was George has a host of other vital responsibilities at ABC. He one step from being homeless. makes daily runs to the post office - picking up mail in the I immediately recognized George's outgoing and amicable morning, processing all outgoing mail and taking it to the post nature, and offered him some odd jobs at my house and help office in the afternoon. He also helps with processing orders for ing to complete the closing of my former herb business, Sweet books, monographs and other educational materials. He takes hardt Herbs. George impressed me with his intense desire for the daily deposit to bank. He is responsible for ABC's recycling hard work, his fast pace, and his positive attitude. program and handles much of the physical maintenance of Eventually, when I founded ABC in 1988, George was right ABC's building, including helping in ABC's gardens. Without there, helping in many ways. And ever since, for ABC's entire George's hard work and e._ositive energy, ABC could not be the 15-year history, George has been an integral part of the organi organization it is today. A zation. He has held many positions and has been ABC's jack-of- - Mark Blumenthal
12 I HerbaiGram 61 2004 www.herbalgram.org abc news
D EAR READER 6. Further, I said that FDA was probably Continued from page 5 very confident that it had all the necessary scientific and medical justification that it via qualified health practitioners. Regarding may need to support its case in an adminis retail sale, they should be allowed to be trative hearing as required by DSHEA, ifit marketed so long as they are made accord were challenged in a lawsuit by a manufac ing to proper GMPs, do not contain any turer or industry group. synthetic additives or adulterants, are Reuters carried an article on Wednesday, marketed for appropriate purposes, are December 31, saying that acupuncturists properly labeled with adequate warnings were happy that the ban would exempt and risk disclosure, and there are industry licensed practitioners of traditional Chinese and government-supported education medicine, allowing them to continue using campaigns regarding their potential risks ephedra for appropriate conditions in clini and benefits. cal practice. This, of course, makes sense. The ABC Board ofTrustees came to the Case Mill 5. I also noted that initially the RAND Also on December 31 , less than a day Homestead this past Oc tober for an on-site meeting. report, released in February 2003, did not after the story broke, the AP ran a story on They also enjoyed a moment of fresh air in the give FDA the scientific basis it probably gardens (left to right) Michael Ba lick, Fredi Kronen· an ephedra "run," citing examples of berg, Mark Blu mentha l, Morri s Shrift man, Norman wanted and needed to move forward with a companies who were experiencing a rush of Farn sworth, and Steven Foster. Attending via tele ban. However, in the intervening months orders by phone and the Internet. This was phone were Peggy Brevoort, Ja mes Duke, and with so much activity in Congress support highly predictable. There are thousands or Thom as Ku rt. Photo ©2004 stevenfoste r. com ing and calling for FDA action, and with 3 possibly millions of people whose experi scenario: If challenged and if an administra states having banned the herb, FDA proba ences with ephedra-based products have tive hearing upholds the ban, then ephedra bly assessed that it had growing political been safe and successful. goes. If FDA loses the challenge, then FDA, support for such a ban. It probably deter Where does it go from here? FDA has mined that the fractionated part of the herb intimated that it is considering actions on and its allies in Congress and the medical community, the media, etc. can argue that industry that was still interested in ephedra other problematic herbs but has not the law does not allow FDA to protect the was losing political support, and that some revealed their identity. USA Today listed public from unsafe supplements, thereby leading industry groups probably would not some herbs in a sidebar box along with its giving impetus to those who want to amend challenge a ban (i.e., so long as FDA's final editorial on January 6; it contained much DSHEA, as proposed in some bills now in regulations present a cogent and substanti misleading and erroneous information, Congress. Either way, from the standpoint ated rationale). most of which the editor told me it received of an ephedra seller, it's a lose-lose proposi from the FDA. ABC sent a letter that clari tion. From the perspective of the entire herb fied the misinformation, which was industry, the second scenario, possibly published on January 12 (see ABC's website resulting in additional legislation, may be a for the letter,
he Amazon Center for Environmental the Amazon. The organization, founded in extended up to 120 feet above the forest TEducation and Research (ACEER) 1991, has hosted many workshops on the floor and was more than 400 yards long. Foundation has relocated its base of opera ecology, importance, and conservation of The new walkway will be 1-2 km from the tions to a new location in Southern Peru. the rainforest, as well as operating the rain ATI cente, along the Madre de Dios River, ACEER has maintained numerous educa forest canopy walkway. The new center at and construction will involve new non-tree tional environmental activities in Peru ATI will serve all the functions of the old attached technology. One or more towers although it temporarily suspended opera location at Napa, and also allow the foun housing a classroom and lab space will also tions rwo years ago at the site of its former dation to implement new, original be included with the new walkway. The research center and rainforest canopy walk programs. canopy system is expected to be open in way in Northern Peru. Along with the center, work has begun on October 2004, in time for ABC's tour (see ACEER dedicated its new facilities on the Gardens at ATI, a complex of gardens, page 9). Initial funds to construct the new August 8, demon Rainforest Canopy Access System will come 2003, 1n a stration from a $50,000 challenge grant from West lighthearted plots and Chester University of Pennsylvania. To ceremony. in terpre meet the challenge, a minimum of $50,000 Aura Murri tive trails. in additional funds must be raised by eta, ACEER's Heading ACEER. Additional funding, external to Director of the proj the challenge grant, will be provided by the P e r u ect is National Geographic Society. Programs, distin ACEER has also launched two new used a guished programs. First is the jAMIGOS! Partner machete to cut Peruvian ship for Education program, which replaces a "ribbon" of botanist the former Adopt-a-School program. The eat's claw Rodolfo second is the University Outreach Program, (Un c aria Vasquez. in conjunction with West Chester Univer tomentosa T h e sity, which will provide study tours to ATI, (Willd.) DC., Missouri Reserva Amazonica, and the Tambopata Rubiaceae) to Botanical Research Center, as well as the Andean officially open The newly renovated ACEER-Tambopata at lnkaterra along the Madre de Garden cloud forests and the famous Lost City of the facility. In Dios River. Photo © 2004 ACEER a n d the Incas, Machu Picchu. attendance Wind- ABC members and other interested were ACEER President Roger Mustalish, hover Foundation financed this first phase persons should note that October 21-31, PhD, and ACEER staff Antonio Montero of development. 2004, are the dates for a new ABC/ACEER Pisco, Caterina Cardenas, and Mary workshop, "Botanical Medicines Heaton. Representatives from ACEER part from the Amazon and Machu ners lnkaterra Association and West Chester Picchu" to be held at ATI and University were also in attendance. Machu Picchu. ABC's founder The refurbished rwo-story building, and executive director Mark called ACEER-Tambopata at lnkaterra Blumenthal, ABC Trustee Jim (ATI), is on a 900-acre private reserve along Duke, and ACEER's Roger the Madre de Dios River east of the city of Mustalish, among others, will Puerto Maldonado and directly adjacent to lead the workshops. Academic Tambopata National Park. ATI will house a credit, CEUs and CMEs will be nature interpretation center, classrooms, available. meeting rooms, staff offices, a field labora In other ACEER develop tory, and a distance learning center. Sleep ments, the Foundation is settled ing quarters and a kitchen provide services into its new home in West for overnight and resident researchers. Chester, Pennsylvania. New Other visitors are housed at Reserva Members of the ACE ER's US and Peruvian offices join their partners contact information is: ACEER, Amazonica lodge and its 10,000-hectare from lnkaterra at the ded ication of the new center along the P.O. Box 2549, West Chester, private reserve, 4 km downriver from ATI. Madre de Dios River. Photo © 2004 AC EER PA 19383. Phone: 610/738- The National Geographic Society provided 0477; Fax: 610/436-2860. E- the necessary funds for the new center. Also at ATI, there are plans to construct a mail for Dr. Mustalish: Prior to its 2-year operational hiatus, new version of the famous rainforest canopy
14 I HerbaiGram 61 2004 www.herbalgram.org organization news
Morton and Schultes Awards Given at Annual SEB Meeting
he Society for Economic Botany (SEB) presenred its annual The Morton award is given to the best student poster presenta T Richard Evans Schultes and Julia Morton awards at the society's tion at the annual SEB meeting. The 2003 win ner was Sarah Khan annual meeting in Tuscon, Arizona this past June. Both awards for her presentation, "Madhumeha: Diabetes Mellitus and Classical wenr to young studenrs and researchers for their contributions to Ayurvedic Formulations for Treatment." the field of economic botany. A founding member of SEB, Julia Morton worked for most of The 2003 Schultes award was presenred to Christiane Ehring her life in South Florida where she built a reputation as an expert haus, of Yale University, for her research project, "Post-victory on poisonous planrs. She is well known among botanists for her Challenges: Non-timber Forest Product Use and Marketing in Morton Collectanea, an invaluable compilation of botanical infor Amazonian Extractive Reserves. " The award is open only to mation. students or young professionals (5 years or less post-doctoral expe SEB was established in 1959 with the purpose of encouraging rience) working on research in economic botany. research on the uses of plants. Now the largest professional society The award's namesake, Richard Evans Schultes, was known as a for those interes ted in botanical, phytochemical and ethnological founding father of the field of ethnobotany and made several expe studies, SEB seeks to inform the public of planr-related research ditions to the rainforests of South America to chronicle and study and inrerest students and young professionals in economic botany the various plant species found there and the manner in which they with meetings, publications, and grants and awards. A influenced the native cultures. At the time of his death in 2001 he -Jon lucksinger was Professor Emeritus of Biology at Harvard Unive rsity.
Worthen New Editor-In Chief of Pharmaceutical Products Press ennis B. Worthen, PhD, Lloyd Scholar of the D Lloyd Library in Cincinnati, Ohio, was named editor-in-chief of the Haworth Press Pharmaceutical Products Press. Worthen, who was the founding co editor of Haworth's Pharmaceutical Heritage book series, replaces founding editor Mickey C. Smith, PhD, RPh, Barnard Distinguished Professor at the University of Mississippi's School of Pharmacy. Prior to his joining H aworth, Worthen held posi we give you the answers. tions wi th Procter & Gamble Health Care where he he ABC Herbal Information Course is a self-paced, online course was director of Pharmacy Affairs and editor of the Proc t hat presents a range of general topics to familiarize you with the ter & Gamble Pharmacist's Handbook. He has also Tovera ll field of herbal medicine and focuses on the specific use of published more than 50 papers in professional journals many popular herbs. (This course is suitable for retailers and clinical and has served on several editorial boards including practitioners.) It will also provide you with tools needed to appropri that of the journal ofthe American Pharmaceutical Asso ately discuss herbs with customers. Topics include: ciation. • Science-Based Information on 29 Popular Herbs During Smith's tenure, Pharmace utical Products • Herb Safety Press produced specialry ancillary textbooks for under • Legal and Regulatory Status of Herbs and Phytomedicines in the U.S . graduate- and graduate-level pharmaceutical courses, • Interpreting Product Labels provided coverage of medicinal chemistry and clinical • Communicating with Customers pharmacy practi ce, and created practitioner-oriented Those successful ly completing the program will receive: books for pharmaceutical scientists in industry, govern • Herbal Information Specialist Certificate ment, trade agencies, and professional practices. • Window decal An independent publisher of academic and profes • Formatted press release to send to your local media sional books and journals, the Haworth Press has publi cations that span a wide range of subjects with a fo cus For more information on this ground-breaking course, on contemporary issues. Information about the book please visit us online at: and journal titles published by H aworth www. herbtraining. com Pharmaceutical Press is available online at: ~NARIO'N
American Herbal Pharmacopoeia Launches AHP-Verified Botanical and Chemical Reference Standards and Testing Programs by Roy Upton period of rime are fully aware of the many problems that exist in the herbal products industry. Over the years there have been n keeping with the tradition and purpose of all pharmacopeias, numerous occasions where adulterations have occurred, such as the Ithe American Herbal Pharmacopoeia (AHP) has developed a accidental substitution of Grecian foxglove (Digitalis lanata Ehrh., collaboration with several botanical sources, analytical laboratories, Scrophulariaceae) leaf for English plantain (Plantago lanceolata L. , and institutions to provide the botanical industry with authenti Plantaginaceae) leaf; or Periploca sepium Bunge, Asclepiadaceae cated botanical and chemical reference materials to use in the qual (also known as Chinese silk vine) for eleuthero (aka Siberian ity assessment of herbal products. AHP has also developed testing ginseng; Eleutherococcus senticosus (Rupr. & Maxim.) Maxim., services for those wishing to ensure the authenticity of their herbal Araliaceae). Equally important is the variable quality of raw mate raw materials. The reference materials are designated as AHP-Veri rials that exists on the commercial market. fied, showing they have been subjected to independent identity Multiple techniques must be employed to establish the authen and purity tests. ticity and quality of botanical raw materials; this is necessary rather than simply focus ing on individual marker compounds (i.e., AHP Pharmacopeia! Standards chemical constituents of an herb that can be used to help ensure Since 1995, the AHP has been producing some of the most proper identity or levels of quality). AHP's policy is that quality comprehensive and authoritative mono- assessment of herbal products requires graphs for botanicals available in the world. focused attention to all aspects of growing, While lacking the official recognition harvest, handling, drying, and storage condi enjoyed by long-standing organizations such tions. Testing of a raw material or finished as the European Pharmacopoeia (EP) and product after all production processes have United States Pharmacopeia (USP), AHP 1111 been completed can only provide a pass-fail monographs have been widely received by determination based on specific specifica academia, industry, and regulators for their tions. Such resting at the end of the produc completeness and practical utility. As with all pharmacopeia! tion cycle cannot alter the identity, quality, purity, or potency of a monographs, AHP establishes standards of identity, quality, and product. These issues must be considered as part of procuring raw purity and provides validated analytical methods for testing of raw materials and manufacturing. In the herbalist community there is botanical materials, and, when applicable, finished products. In a saying, "garbage in, garbage out. " No amount of testing will addition to these standard quality control parameters, AHP mono improve the quality of a botanical product. graphs contain other fields of information that are critical to the For this reason, the AHP favors the development of fingerprint true quality assessment of herbal products. These include botani methods that look at a wide variety of chemical constituents that cal identification, optimal growing, harvesting, and drying condi are naturally occurring in the plant rather than focusing only on a tions, and the identification of potential adulterants. Each quali ty particular marker compound. Looking at the naturally occurring control monograph is also richly illustrated with full-color botani constituent profile of the plant gives a truer representation of the cal illustrations and photographs, macroscopic and microscopic botanical and how it was applied historically. While characteriza imagery, and representative high performance thin layer chro tion using an individual compound is appropriate for pharmaceu matography (HPTLC) and high performance liquid chromatogra tical development (since most conventional medicines are single phy (HPLC) chromatograms - all of which provide quality chemical entities), it is antithesis to traditional herbal medicine. control personnel with the guidance needed for establishing the This philosophy is consistent with international guidelines such as identity, purity, and quality of their herbal products. those used in Europe and developed by the World Health Organi A Therapeutic Compendium also accompanies each monograph zation (WH0), 1 which considers the whole herbal product as the and provides a comprehensive, up-to-date critical review of the active ingredient, not simply one chemical constituent. The therapeutic and safety data regarding herbal products outlining all combination of the published AHP monograph standards and published clinical and pre-clinical research, drug interactions, side reference materials provides all involved with the production of effects, appropriate dosages, precautions, and toxicology. In addi commercial herbal products the tools necessary for truly assuring tion to the sheer completeness of the monographs themselves, the the authenticity, purity, and quality of herbal products. greatest strength of the AHP is in its peer review process. Each monograph is subjected to a critical review by a multi-disciplinary AHP-Verified Botanical Reference Materials collection of medicinal experts worldwide to ensure the accuracy of Through a network of botanical institutes, farms, and testing the material presented. facilities worldwide, the AHP has archived approximately 100 authentic botanical reference materials to use in the development The Importance of Reference Materials of internal quality control specifications. Each AHP-Verified The development of quality control standards partially depends botanical reference material has been verified as to irs botanical on the availability of authenticated botanical and chemical refer identity regarding both genus and species and is accompanied by ence standards against which authenticity and quality can be an AHP Certificate of Authenticity. The primary purpose of these assessed. All who have been involved in the herb world for any botanical reference materials is to confirm the authenticity of other
16 I HerbaiGram 61 2004 www.herbalgram .org organization news samples through macroscopic, microscopic, HPTLC, or other ava il able for the analys is of ginkgo, soy bean (Glycine max (L.), specific methods of analyses. T hey may also be valuable fo r the Merr. , Fabaceae), red clover (Trifolium pratense L., Fabaceae), black quantitati on of specific compounds. H owever, their primary fu nc cohosh (Actaea racemosa L., Ranuncul aceae, syn. Cimicifuga race ti on is for qualitative purposes. The abili ty to utilize botanical mosa (L.) N un.) , and dang gui (dong quai), among others, and are reference materials for quantification purposes requires ex tensive ava il able through C hromaDex . constituent profiling, stabili ty testing, and strict control of light, temperature, and humidity. Natural products are naturally va riable AHP-Verified Testing Services in their constituent profile, an important considerati on when In addition to developing standards and providing botani cal and an empting to utilize botanical reference materials for quantifica chemical reference materials, AH P, in coll aborati on with a select tion purposes. group of independent analytical laboratories and institutions, has AHP-Verified Botanical Reference Materials currently available developed AH P-Verified Testing Services to assure the authenticity include ginkgo leaves (Ginkgo biloba L. , Ginkgoaceae), dong quai and quali ty of herbal raw materials. AHP can provide complete root (a.k.a. dang gui; Angelica sinensis (Oiiv.) Diels, Apiaceae), cran characterization of botanical materials used in trade. T he level of berry ( Vaccinium macrocarpon Aiton, Ericaceae), goldenseal root the charac terization provided is dependent upon the needs of the (Hydrastis canademis L. , Ranuncul aceae), and saw palmetto berry client. For regulatory purposes, full characterization, which (Serenoa repens (W Bartram) Small , Arecaceae) , among many others. includes phys ical and chemical characteri zation, is recommended. Fo r general quali ty assurance purposes, partial charac terization AHP-Verified Chemical Reference Standards may suffice , depending on the specific character of the material to C hem ical reference standards are pure compounds (e.g., be tested, and may include macroscopic, microscopic, H PTLC, ginkgolide B from gi nkgo, hydrastine from goldenseal) used in the and/or specific chemical characterizatio n. analytical processing of a botanical materi al in a laboratory to For more information about the AHP and its products and serv detect the presence, or absence, of the specifi ed chemical ices contact: Ameri can H erbal Pharmacopoeia at P.O. Box 66809, compound. There are many sources of chemical reference materi Scorrs Vall ey, CA 95 067. Tel : 83 1/46 1-6318, or emai l:
White House Commission on CAM Issues Final Report by Hannah Bradford Recommendation 29: The President, governor of Wisconsin; cranberries are a Secretary of Health and Human Services, major agricultural crop in that state.) In he White House Commission on or Congress should create an office to addition, Thompson called an interagency T Complementary and Alternative Medi coordinate Federal CAM activities and to meeting on September 15 to discuss strate cine Policy (WHCCAMP) delivered its facilitate the integration into the nation's gies to implement the recommendations. final report at a press conference in Wash health care system of those complementary At this meeting, several Commissioners ington, D.C. on Tuesday, October 28, and alternative healthcare practices and were asked to present their comments. 2003. The Commission had been products determined to be safe and effec According to the press office at NCCAM, appointed by President William Clinton in tive. the final report of this meeting is to be March 2000 and had met numerous times made public sometime in the future. between July 2000 and February 2002, Actions Several federal initiatives have already including 14 public meetings in which 29.1 The office should be established begun, including the Institute of Medi testimony had been given by about 700 at the highest possible and most appropri cine's Committee on CAM, which held its groups and individuals. Another 1,000 ate level in the Department of Health and final fact-finding meeting in December; submitted written testimony. The mission Human Services and should be given suffi the publication of final good manufactur of the WHCCAMP was to recommend cient staff and budget to mee t its responsi ing practices (GMPs) for dietary supple policy and legislative changes related to bilities. ments by the FDA (proposed GMPs were CAM research, access and delivery, dissem 29.2 The office should charter an published in March 2003 and final rules ination of information, and licensure, advisory council. Members should include are expected in 2004 after the Food and .education and training of practitioners. CAM and conventional practitioners with Drug Administration has had time to The Commission was chaired by James S. expertise, diverse backgrounds, and neces review the extensive public comments Gordon, MD, the founder and director of sary training, as well as representatives of submitted before the August 2003 dead the Center for Mind-Body Medicine, both the private and public sectors, to line); and a project at the Veterans Admin which has developed pioneering educa guide and advise the office about its activ- istration to develop methods to credential tional programs of MindBodySpirit medi ities. CAM providers. cine and integrative cancer care. 29.3 The office's responsibilities From an herbal perspective, the recom Opening the press conference to deliver should include, but not be limited to, mendations of the WHCCAMP that most the WHCCAMP Final Report, US Sena coordinating Federal CAM activities; serv directly or indirectly affect the botanical tor Tom Harkin (D-Iowa) stated, "What ing as a Federal CAM policy liaison with and dietary supplement communities and was once dismissed is now essential" in conventional health care and CAM profes those practitioners who employ botanical describing the field of complementary and sionals, organizations, institutions, and dietary supplements in clinical practice are alternative medicine (CAM) in general. commercial ventures; planning, faci litat as follows: Sen. Harkin also implied in his opening ing, and convening conferences, work Recommendation 2: Congress and the remarks that it was his position as Chair of shops, and advisory groups; acting as a Administration should consider enacting the Senate Appropriations Committee that centralized Federal point of contact regard legislative and administrative incentives to allowed him to push for the publication of ing CAM for the public, CAM practition stimulate private sector investment in the report in printed form. The report has ers, conventional health care providers, CAM research on products that may not been available electronically since March and the media; facilitating implementation be patentable. (ABC's founder and execu 2002 at 18 I HerbaiGram 61 2004 www.herbalgram.org organization news tiveness. tion, training, and scope of practice. CAM practices and products to determine Recommendation 15 : Provisions of the Recommendati on 2 1: Nationally recog their applicability to programs and services Federal Food, Drug, and Cosmetic Act, as ni zed accrediting bodies should evaluate that help promote wellness and health. modified by the Dietary Supplement how health care organizati ons under their Demonstrati on programs should be Health and Education Act of 1994, should oversight are using CAM practices and funded for those determined to be benefi be fully implemented, funded, enforced, should develop strategies for the safe and cial. and evaluated. appropriate use of qualified CAM practi "The Commiss ion," Dr. Gordon Recommendation 16: Activities to ti oners and safe and effective products in summarized in an interview with Herbal ensure that adve rtising of dietary supple these organizations. Gram, "has li stened to the concerns and ments and other CAM practi ces and prod Recommendati on 26: T he Department needs of the American people. O ur re port ucts is truthful and not misleading should of H ealth and Human Services and other is a road map, a guide to the creati on of a be increased. Federal agencies and public and priva te new medicine, one whi ch encourages the Recommendati on 17: The collection organizations should evaluate CAM prac deepest study and makes the wises t use of and dissemination of information about tices and products that have been shown to all healing traditions. This new medicine adverse events stemming from the use of be safe and effective to determine their with its emphasis on integration and natu dietary supplements should be improved. potential to promote wellness and help ral products on wellness and self-care will Recommendation 20: States should achieve the nati on's health promotion and come into being only if all those who want evaluate and review their regulation of disease prevention goals. Demonstration it insist on it in their private lives, in their CAM practitioners and ensure their programs should be funded for those professional work and in ongoing dialog accountability to the public. States should, determined to have benefit. with elected officials. " A as appropriate, implement provisions for Recommendatio n 27: Federal, State, licensure, registration, and exemption public, and private healthca re delive ry consistent with the practitioners' educa- systems and programs should evaluate Five New Members Added to NCCAM Advisory Council his pas t September saw five new professor in the Department of Psychiatry Larry Walker, PhD, director of the T appointments to the National Advisory and director of the Anxiety and Traumati c Nati onal Center fo r Natural Pro ducts Council for Complementary and Alterna Stress Program at Duke University Research at the School of Pharmacy at the tive Medicine (NACCAM). The Council Medical Center. He is a fe llow of the University of Miss issippi, is the current works as the main supportive and adviso ry American Psyc hiatric Associati on, the editor of the j ournal of Biomolecular body to the National Center for Comple American College of Neuropsychophar Screening and Phytotherapy Research. H is mentary and Alternative Medicine macology, and the Royal College of Psychi research has invo lved bioassay develop (N CCAM), a division of the Nati onal atrists in the United Kingdom where he ment fo r natural products screening and Institutes of Health (NIH), within the has also received professional training in evaluation of herbal and botanical reme Department of Health and Human homeopathic medicine. Davidson also dies. Servi ces. served as the principal investigator in T he newly appointed council will meet The appointments are for a term of four N CCAM's four-year clinical trial on St. in late January of 2004. A years, and the 18-member Council meets John's wort and severe depress ion -Jon lucksinger three times annually to make recommen published in 2002. dations on prioritization, co nduct, and Alan I. Les hner, PhD, MS, is the editor support of complementary and alternative of Science magazine and chief executive New ABC E-Newsletter medicine research. New appointees officer of the American Association fo r the Sunin~ this wimc.:r, AB C members will include scientists, physicians, educators, Advancement of Science. He has bee n rc.:ceivc.: ' the: latest information on ABC and and CAM practitioners. They will aid and commended as one of the top researchers the herbal community ri ght in their e-mail guide the NCCAM in informing the in the nation on the subjects of behavioral in-box. ABC's new HerbaiEGram d ec tronic n ~:wslettc.:r will feawre up-to -date public and healthcare providers on the medicine and drug abuse. information on: lates t CAM research and training available. Tieraona Low Dog, MD, is an ass istant • AB C and 1-krb l"ews Those added in September include: professor in the Department of Family and • l.c·ga l and Rc.:gu latory issues Deborah J. Cotton, MD, MPH, a Community Medicine at the Unive rsity of • Upcoming an ides in HerbaiC:Iil/11; professor at the Boston University School New Mexico. O ne-time president of the • L.n c.:st HerbClip n 1 bin lisr with links of Public H ealth and also at the BU School American Herbal ist's Guild , Dr. Low Dog to sample.: Hc.:rbC lips of Medicine, was one of the first phys icians is an expert in the fi eld of traditional • Upcoming events & ABC appear;~nc~:s in the United States to treat AIDS patients. Native American medicine and focuses her • And much more. She is a leader in the study of the epidemi research on herbal medicine and its appli Contact us today to make sure we have ology of the HIV virus and has edited a cations within modern healthcare. She is your correct email address or to also chair of the US Pharmacopeia's column on the subject in the N ew England become a member, j ournal ofM edicine since 1989. Dietary Supplements and Botanical Ex pert [email protected] or 800-373-7105 Jonathan R.T. Davidson, MD, is a Committee. www.herbalgram .org 2004 HerbaiGram 61 I 19 research reviews Esberitox® Improves Lung Function during Bronchitis eviewed: Hauke W, Kohler G, Henneicke-von Zepelin H-H, controlled, parallel group, multi-center study. Patients received a RFreudenstein J. Esberitox® N as supportive therapy when new generation macrolide antibiotic, such as roxithromycin providing standard antibiotic treatment in subjects with a severe (which may be sold as Rulid'M , Alben-Roussel Pharma GmbH, bacterial infection (acute exacerbation of chronic bronchitis). Wiesbaden, Germany), clarithromycin (Biaxin®, Abbott Laborato Chemotherapy 2002; 48:250-266. ries, Abbott Park, Illinois), or azithrimycin (Zithromax®, Pfizer, Chronic bronchitis is defined as excessive cough and abnormal New York) , together with either Esberitox N (50 drops 3 times a production of sputum (fluid coughed up) with at least three day, corresponding to 8.8 mL/day) or placebo for 28 days. One episodes per winter season. Its advanced stage often leads to milliliter ofEsberitox N contains 4 mg thuja (Thuja occidentalis L., chronic obstructive pulmonary disease, a progressive disease char acterized by reduced airflow. Severe bacterial infections exacerbate the disease. The increasing cough and purulent sputum (pus in the fluid coughed up) associated with the disease reduces the patient's quality of life. Antibiotics are the recommended treatment, but their benefits are temporary. Accordingly, cyclical treatments with antibiotics interspersed with short periods off are most beneficial. These issues have led researchers to the alternative of combining antibiotic treatment with the phyto-immunomodularor Esberirox® N (Schaper and Brummer GmbH & Co., Salzgitrer, Germany). Esberitox N is registered in Germany for the supportive therapy of severe bacterial infections treated with antibiotics. This pilot study investigates whether the immunomodulating effect ofEsberitox N is beneficial for patients suffering from acute exacerbation of chronic bronchitis. Adult patients (N = 53) with acute exacerbation of chronic bronchitis participated in this randomized, double-blind, placebo- Thuja Thuja occidentafis Photo © 2004 stevenfoste r.com Cupressaceae), 15 mg echinacea root (Echinaceae purpurea L., E. pallida (Nutt.) Nutt., Asteraceae), and 20 mg wild indigo root (Baptisia tinctoria (L). R. Br., Fabaceae). Improvement in forced expiratory volume of the first second (FEY1) was examined. FEY1 is a well-accepted measure of lung function. Other parameters of lung function were also examined. Both groups had an improvement in FEV1; however, the Esber itox N group improved more quickly. At day 10, significantly more Esberitox N-treated patients had an improvement in FEY1 (P = 0.03). Other lung parameters did not differ between treatment groups. Patients with a diagnosis of chronic bronchitis of less than 48 months seemed to benefit more from Esberitox N treatment. No serious adverse events occurred. Esberitox N appears to act additively with antibiotics. The Distribution partners and acrion is thought to be due to activation of macrophage function. business contacts sought. .. These promising results show that Esberitox N helps patients recover sooner from reduced lung function caused by infectious for high-quality pharmaceuticals in the exacerbation. tradition of the German Homceopathic One weakness of the study is that patients were assessed only on Pharmacopoeia. days 1, 10, and 28. Additional time points are needed to assess the true effect of the treatment combination. T his would allow Hommopathic original tinctures (0) researchers to eva!uate the events that happened between day 10 Dilutions, potencies, injection ampoules, globuli and triturations and day 28 and to determine if it actually takes 18 days for the Spagyric essences placebo group to experience the same level of improvement as the Esberitox N group. Long-term events also need to be considered. Contract manufacturing! A study with more time points, a larger number of participants, and an extended follow-up period might answer some of these As a contract manufacturer we can make small, medium-sized and questions. _...- large batches. -HeatherS. Oliff, PhD 20 J HerbaiGram 61 2004 www.herbalgram.org research reviews Psyllium Improves Glycemic Control, Dyslipidemia in Type 2 Diabetes eviewed: Sierra M , Garcia J, Fernandez N , Diez M, Calle A, the curve, or AUC, for serum glucose over rime) was signi fica ntly RFarmaflbra Group. Therapeutic effects of psyllium in rype 2 reduced by approximately 12% during phase 2, when the patients diabetic patients. European journal of Clinical Nutrition consumed psyllium 4 times/day, compared with phases I and 3, 2002;56:830-42. which we re si milar to each other. "The ex tent of glucose absorp High-fiber diets appear to be beneficial for people with diabetes. ti on decreased in the presence of psyllium when mean valu es we re Dietary fiber, particul arly soluble fiber, has been found to lower considered . . . differences in mean co nce ntrations at different blood glucose and lipid levels and to promote we ight reducti on in sampling times were significa nt," the authors report. T he Cm ax diabeti cs . The specific rypes of fiber that are most effecti ve with (max imum glucose co ncentration) was almost 10% lower in phase regard to carbohydrate metabolism include guar gum, psyllium, 2 than in phases 1 and 3. However, the reduction in glucose and pectin; these fibrous substances are water-soluble and they absorption was not associated with a significant change in insulin form gels when combined with liquids. concentrati ons, which decreased by a mean of 5%. Psyllium, also called ispaghula husk, is the seed husk from T here were large interindividual variations in glucose concentra Indian plantain (Plantago ovata Forssk., Plantaginaceae) . For many tions, with coeffi cients of variati on ranging from 18.7% to 31.9%. years psyllium, alone or in mixtures, has been used to treat consti Thus, rhe authors note rhar it was important to examine rhe pation. Recent studies have shown that psyllium may have other glucose curves for individual pati ents, in addition to the mean uses as well. Specifically, co nsumption of psyllium was found 111 curves. "In 10 patients, glucose concentrations and AUC values previous studies to reduce blood were clea rly lower at the end of concentrations of glucose, phase 2 than at the end of phases I insulin, and cholesterol. and 3, with AUC decreases up to In this study, the authors eval 34%," the authors state. In 5 uated the therapeutic effec t of pati ents, the glucose curves fo r psyllium on glycemic control phases 1, 2, and 3 were ve ry similar, (blood glucose control) and other and in another 5 pati ents, values biochemical parameters in 8 were higher in phase 1 than in women and 12 men with rype 2 phases 2 and 3. (late onset) diabetes. The mean During phase 2 (psyllium supple ages were 66.0 and 67.4 yea rs for mentation), there were insignificant the women and men, respectively reductions in hemoglobin A1 C, C (range: 50- 80 years) . The dura peptide, and 24-hour urinary tion of diabetes in the study glucose exc reti on (reducti ons of patients ranged from 2 to 30 3.8%, 14.9%, and 22.5%, respec years , and all patients were being tively). Psyllium supplementati on treated with the oral hypo was also associated with significant glycemia drug glibenclamide (a decreases in total choles terol, LDL sulphonylurea medication) and choles terol , and uric ac id (7. 7%, conventional dietary restrictions. Psyllium seeds Plantago ovara Photo© 2004 stevenfoster.com 9 .2%, and 1O o/o, res pectively) . The This outpatient study included psyllium was well tolerated, without 3 phases, and each subject served any significant side effects; this find as his or her own control. Phase 1 was a 1-week period when the ing was consistent with other previous studies . patients followed their usual regimen of dietary res trictions and Finall y, the authors report that the psyllium did not have adve rse sulphonylurea medication. Phase 2 was a 6-week treatment peri od effects on postprandial blood concentrations (aft er the test break during which patients took 3.5 g psyllium four times/day (total of fas t) of the vitamins or minerals tested, whi ch included calcium, 14 g/day) and continued their usual diet and sulphonylurea. T he phos phorus, potassi um, magnesi um, iron, and vitamins A and E. psyllium product was Plantaben® (Madaus, S. A. , Spain), an T he one exceptio n was the sodium co nce ntrati on, which was orange- fl avored, sugar-free fiber that the patients mi xed with water significantly hi gher after phase 2 than after phases 1 and 3. and consumed before each meal. Phase 3 was a 4-week period simi In summary, psyllium supplementati on ca used significant mean lar to phase 1; patients followed their usual regimen of dietary reducti ons in pos tprandial blood glucose concentrati ons in res trictions and sulphonylurea medica ti on. Berween phases 2 and patients with rype 2 diabetes. T his same benefi cial effect was fo und 3, there was a 2-week washout period. At the end of each phase, in several previous studies of rype 1 and 2 diabetics and heal thy the pati ents underwent a clinical examination after fas ting volunteers; different preparati ons and dosages of psyllium husk overnight and eating a standard tes t breakfas t at the study clinic. we re used in the different studies. After the standard breakfast, blood samples were drawn at frequent T he authors conclude that "the results obtained indicate a bene intervals for meas urement of glucose and insulin. Additional fi cial therapeutic effect of psyllium (Plantaben) in the metabolic biochemical parameters were meas ured in blood samples obtained control of rype 2 diabetics as well as in lowering the risk of coro at time 0, and a 24-hour urine sample was collected and analyzed nary heart disease." A for glucose and C-peptide. -Christina Chase, MS, RD The res ults showed that mean glucose absorption (area under www.herbalgram .org 2004 HerbaiGram 61 I 21 research reviews Review of Adulteration of Chinese Patent Medicines with Synthetic Drugs eviewed: Ernst E. Adulteration of Chinese herbal medicines each from Belgium, New Zealand, and China. While many reports Rwith synthetic drugs: A systematic review. journal of Internal do nor mention the source of the adulterated medication, 5 came Medicine 2002;252:107-113. from "Chinese herbalists" (including 1 in Kuala Lumpur and 1 in There has been much concern over the past several decades France), 2 were obtained by "mail order," and one case series regarding Chinese "herbal" medicines rhar are found ro be adulter reports 13 patients who obtained medications via "mail order from ated with prescription pharmaceutical drugs. Actually, these occur Hong Kong." The case reports involved medications sold in rences usually involve "patent medicines" - prepared formulations Germany {said to have originated in Macau), from a "Chinese usually sold in China and Southeast Asia, and frequently imported health centre," from a Vietnamese grocery in Australia, and from into the United States - not with true herbal medicines. These Malaysia. patent medicines have been sold primarily in Chinese herb shops Many medications are unnamed and others are identified and other retail outlets in ethnic Asian centers in large cities on the vaguely. The latter include "Black balls from China" {9 patients), West coast and New York, although their range of availability has "non-prescription cream" (3 patients), "Herbal creams" {11 spread across the United States with the increased popularity of samples), "non-prescription tablets" (1 patient), and herbal acupuncturists and other practitioners of traditional Chinese medi massage oils (6 samples) . There are 17 reports of one medication cine, who may dispense these patent remedies as part of a clinical vari ously spelled "Chuifong Toukuwan" and "Chuei-Fong Tou practice. However, the presence of Western pharmaceutical drugs Geu-Wan." Chuifong was formerly illegally marketed in the has nor been detected in Chinese herbal formulations made in the United States as "black pearls" {extensively reported in an earlier United States or those imported into rhe United States by reputable issue of Herba!Gram. 1). manufacturers of traditional Chinese medicines. A wide variety of prescription drugs have been found in these Professor Edzard Ernst, a prolific author and researcher of alter medications: aminopyrine, phenylbutazone, phenytoin, gliben native medicine and the evidence basis of herbs at the University clamide, indomerhacrin, and various corticosteroids. Analytical of Exeter in England, has compiled evidence of adulteration of investigations, employing thin-layer chromatography, mass spec Chinese patent medicines with pharmaceutical drugs. He searched trometry, and high resolution gas chromatography, among other medical databases for articles containing original data about adul methods, have revealed adulterants such as caffeine, acetamino terations. Reports of adulterations may appear as articles or in phen, chlorzoxazone, erhoxybenzamide, and sildenafil. "letters" columns in medical journals - both of which can be Many people have also suffered serious side effects, including retrieved by using computerized literature databases such as one death, attributed to the use of the offending patent medicines MedLine. While no language restrictions were placed on the arti containing these drugs but without labeling showing their presence cles themselves, only English-language databases were searched. or the appropriate warnings usually required by regulatory agen The omission of other language databases may have eliminated a cies. Agranulocytosis {an acute febrile condition marked by severe number of additional case reports. Further, the author did nor depression of the granulocyte-produci ng bone marrow and by search the Internet for press releases; most governmental regulatory prostration, chills, swollen neck, and sore throat sometimes with agencies, such as the U.S. Food and Drug Administration, would local ulceration), septic shock, coma, hypoglycemia, intestinal usually nor publish an article on an adulterated product, bur bleeding, skin lesions, hypertension, and arrhythmia were reported would alert the public with press releases and public warnings. in the cases listed in Prof. Ernst's article. Also reported were cases However, if such an adulterated product were to appear in the of Cushing's syndrome, a condition usually resulting from hyper United States- as has happened on numerous occasions, prima secretion of glucocorticoids from the adrenal cortex characterized rily in the 1970s and through the early 1980s - case reports were by protein loss, adiposity, fatigue and weakness, osteoporosis, submitted by the medical/health professionals making the origi nal amenorrhea, impotence, capillary fragility, edema, excessive hair discovery, sometimes associated with a case report of an adverse growth, diabetes mellitus, skin discoloration and turgidity event, ro medical journals and/or to the U.S. Centers for Disease (plethora), and purplish streaks in the skin. These cases of Cush Control's Morbidity and Mortality Weekly Report. ing's syndrome were caused by ingestion of excess corticosteroids Results of Prof. Ernst's search were analyzed and set into three and added steroids in adulterated Chinese patent medicines. The tables: Table 1 lists case reports ( 15 articles reporting 19 cases of largest of the analytical studies reported on 2,609 samples of contamination); Table 2 lists case series (2 reports including 21 medications collected from patients at hospitals in Taiwan; 23.7% patients); and Table 3 contains analytical studies {6 articles (618) were adulterated, with 52.8% of these containing more than concerning an indeterminate number of samples). While this may one adulterant. (In the text, a possible typographical error has this seem a sparse rerum, Ernst points our that many cases of adulter as 27% adulteration.) Of II Chinese "herbal creams" analyzed in ation may be unreported or even unrecognized. The first two tables a U.K. srudy, 8 contained dexamethasone. Ernst also refers to a include information on the type of Chinese patent medication U.S. analysis, nor included in the table, in which 7% of samples implicated, irs source, adulterants found, information on individ tested were adulterated. uals affected, including symptoms and case outcome, and Prof. Ernst's summary does not include derails of dosages comments. Table 3 substitutes information on the method oflabo consumed and only a few mentions of amounts of adulterants and rarory analysis, where known, for patient information and lengths of rime medications were used. Ernst recommends that to comments. reduce risks associated with these products, consumers should be The case reports and case studies concerned patients in the informed of potential adverse effects of adulterated Chinese patent United States (26), Australia (6), U.K. (4), Holland {1), and one medications. Patients and physicians should be encouraged to 22 I HerbaiGram 61 2004 www.herbalgram.org research reviews discuss use of such medications as well as all alternative and Taiwan or Hong Kong. Fratkin's recent book is a clinician's guide to complementary treatments. Finally, he warns that "regulators must 1,150 Chinese herbal products , made in mainland C hina, that are consider effective measures to prevent adulteration of [Chinese available in the United States. Of the 1,150 products, 460 of them patent medicines] in the future." meet TGA GMPs and are devoid of adulterants, including pesticide There have been few reports on these kinds of products in the res idues. He notes that of the 505 herbal product sa mples analyzed United States in recent years, particularly since the mid-1990s by the California Department of Food, only 10 contained any when California-based Chinese importers cooperated with the conventional pharmaceutical drugs, and these were usually aceta California state health authorities to cease importation of specific minophen or other antifebrile drugs.2 _A brands of patent medicines that previously had been found to be -Mariann Garner-Wizard and Mark Blumenthal adulterated with prescription drugs. References: According to acupuncturist and author Jake Fratkin, many I. McCaleb R, Blumenrhal M. Black pearls lose luster: prescription Chinese patent medicines are reliably manufactured according to drugs masq uerade as Chinese herbal arthritis formula. Herba!Gram 1990;22:4-5, 38-9. the good manufacturing practices (GMPs) required by the Thera 2. Fratkin JP. Chinese Herbal Patent Medicines: The Clinical Desk Refer peutic Goods Administration (TGA) of Australia as a prerequisite ence. Boulder (CO): Shya Publications; 200 I. (Available online at 2 for import into that country from China. Further, he states that www.shyapublications.com). most of the patent medicines that have been analyzed to contai n prescription drugs and other contaminants (e.g., heavy metals) have been produced outside mainland China in factories located in Vitexina Extract Shows Radioprotective Effect in Breast Cancer Therapy eviewed: Van Hien T, Boi Huong N , Manh Hung P, Ba Due co urse of treatment. Side effects frequently found in patients RN. Radioprotective effects of Vitexina for breast cancer exposed to radiati on are headache, restlessness, fatigue, poor sleep, patients undergoing radiotherapy with cobalt-60. Integrative and poor appetite. Al l patients in the Vitexina group reported that Cancer Therapies 2002;1(1):38-43. side effects were not noticeable, that they had good appetite, and It is well known that exposure to high-energy radiation can that they slept well during the course of their treatment. damage biological systems. Radiation damage is the result of a Radiation treatments typically lower the number of peripheral burst of free radicals that leads to oxidative stress in cells and blood cells. A significantly smaller number of pati ents in the Vitex tissues. Radiation exposure makes it an effective treatment for ina group experienced lower platelet count compared to those cancer. However, in the process of damaging cancer cells, healthy using the placebo: among those in the Vitexina group, 67% expe tissue is damaged as well. Researchers have continued to search for rienced a reduction in platelet counts of under 20%, whereas only radioprotectors that will allow radiation to kill cancer cells while 17% of placebo patients experienced that small a reduction. Blood leaving healthy cells intact. counts, including erythrocytes, leukocytes, platelets, and hemoglo The product used in this study, Vitexina (Vietnam Institute of bin, were significantly higher in the Vitexina group than in the Traditional Medicine and the Pharmaceutical Factory No. 4, Ho placebo group. The authors sugges t that this lessened effect on Chi Minh City; it is not commercially available in Vietnam), is blood counts from radiation was due to Vitexina's inhibition of derived from the mung bean (Vigna radiata L. Wilczek [Fabaceae]) free radical induced lipid peroxidation. which has been traditionally used in Vietnam for detoxi fi cation. In Vietnamese traditional medicine, as it has evolved alongside The product consists primarily of the flavonoids vitexin and isovi modern Western conventional medicine in the past century, radia texin. The remedy is also used to treat the symptoms of conditions tion is typically found to aggravate "hot" symptoms such as classified as "hot" in traditional medicine, such as dysentery. Vitex fatigue, restlessness, poor sleep, constipation, and to change the ina has shown promise as an antioxidant radioprotective agent in a appearance of the tongue. The clinical results of these hot symp series of experimental studies conducted by the research team of toms did not worsen in the Vi texina group during radiation ther the Vietnam Institute of Traditional Medicine. Mung bean is a apy, whereas symptoms ranging fro m hot to extreme hot were common foodstuff in Vietnam and has a large margin of safety. found in almost all patients in the placebo group after 6 weeks of T he study examines the effects of the use of Vitexina as a radiation therapy. supportive therapy for breast cancer patients undergoing radiati on T he authors conclude that the radioprotective effects ofVitexina therapy after initial surgery. Parameters assessed included the observed from the trial suggest that cancer, oxidative stress, and the general health status of patients during radiation therapy, the deficiency-hot syndrome of cancer patients may be related. A radioprotective effects ofVitexina for selected peripheral blood cell potential solution could be to use medici nal plants of the tradi classes in breast cancer patients, and the effects on the "cold-hot" tional "clearing heat and detoxification" classification, which are status of patients (i n reference to the energetics diagnostic commonly rich in flavonoid compounds with antioxidant activity. approach to traditional Vietnamese medicine). At the time the paper was written, the authors were beginning a Patients were divided into rwo groups of 36; the Vitexina group study of breas t cancer patients treated wi th surgery, radiation ther received 4 capsules (400 mg active compounds) daily during 6 apy, and Vitexina to monitor recurrence, survival, and immune weeks of radiation therapy; those in the placebo group received 4 responsiveness following treatment. _A placebo capsules a day. Six weeks of treatment with Vitexina -Densie Web b, PhD appeared to improve the general health of patients during the www.herbalgram.org 2004 HerbaiGram 61 I 23 research reviews Effects of Flaxseed on Lipids and Bone Metabolism in Postmenopause eviewed: Lucas E, Wild R, Hammond L, et al. Flaxseed changes in measures of bone metabolism. Neither flaxseed nor Rimproves lipid profile without altering biomarkers of bone wheat-based regimen produced estrogenic effects. metabolism in postmenopausal women. journal of Clinical In this study, LDL-cholesterol was lowered by 4.7%, whereas in Endocrinology & Metabolism 2002;87(4):1527-1532. a previous study by the same authors, it was reduced by 14.7%.1 This three-month study examined the effects of flaxseed supple The authors believe that feeding subjects whole ground flaxseed , mentation on lipids and bone metabolism in post-menopausal rather than incorporating it into baked goods as was done in the women. Flaxseed (Linum usitatissimum L., Linaceae) is the richest previous trial, may have contributed to the difference. It is not known food source of lignans, a type of phytoestrogen, and is clear whether all constituents of flaxseed that influence lipid being incorporated into human diets because of irs health benefits. metabolism are bioavailable when flaxseed is consumed in the raw It has been reported that phyroestrogens reduce serum cholesterol. form. However, this requires further investigation. Lignans may also have estrogenic and/or anti-estrogenic and The authors conclude that the findings of this study suggest that antioxidant properties. Due to the structural simi larities berween flaxseed consumption by postmenopausal women is effective in lignans and estrogen, the authors postulate that flaxseed may play reducing known risk factors of coronary heart disease. Flaxseed did a role in maintaining skeletal health. Estrogen is efficacious at not exert any estrogenic properties and had no role in maintaining preventing bone loss. skeletal health. This randomized, controlled, double-blind, parallel trial is based However, an HerbalGram reviewer noted that the high dropout on 36 postmenopausal women (less than 65 years old), who were rate in this trial may invalidate the author's conclusions. The trial not taking conventional hormone replacement therapy or any started with 58 women with a greater number of fl ax subjects than prescription medications known to influence lipid or bone metab wheat subjects (20 vs. 16, respectively) completing the study. olism. Subjects consumed 40 g of either ground whole flaxseed or Thus, with 22 women (38% of the initial group) not completing wheat-based control regimen daily for 3 months. All subjects were the study, there is more than a 33% dropout rate. Usually, in the provided with 1,000 mg elemental calcium plus 400 IU vitamin D evaluation of clinical trials, a dropout rate of over one-third inval for daily consumption. Food questionnaires and physical and idates the outcomes. gynecological examinations were conducted at the beginning and For more on the actions and potential benefits of flaxseed, see upon completion of the study. Serum total cholesterol and triglyc the extensive monograph in The ABC Clinical Guide to Herbs.l _... eride concentrations, levels of sex hormones, and markers of bone -HeatherS. Oliff, PhD metabolism were assessed. References: Both groups had similar dietary intakes before and after the I. Arjmandi BH, Khan DA, Juma S, Drum ML, Venkatesh S, Sohn E, study. Consumption of flaxseed, but not wheat-based regimen, for Wei L, Derman R. Whole flaxseed consumption lowers serum LDL cholesterol and lipoprotein(a) concenrrations in postmenopausal 3 months resulted in a significant decrease (6%) in both serum women. Nutr Res 1998; 18:1203-14. total and non-HDL cholesterol concentrations. Flaxseed, but not 2. Blumenrhal M, Hall T, Goldberg A, Kunz T, Dinda K, Brinckmann wheat-based regimen, reduced serum levels of apolipoprotein A-1 J, et al., editors. The ABC Clinical Guide to Herbs. Austin, TX: Amer and apolipoprotein B - markers of heart disease risk. This find ican Botanical Council; 2003:143-52. ing suggests a cardioprotective effect. There were no significant CAM Therapies for Menopausal Symptoms Reviewed eviewed: Kronenberg F, Pugh-Berman A. Complementary and Database (AMED) of the British Library for studies published Ralternative medicine for menopausal symptoms: A review of from January 1985 to December 2000, and the authors' own files. randomized, controll ed trials. Annals of Internal Medicine 2002; Multiple search terms related to menopause and CAM were 137(1 0):805-814. employed, and 29 randomized, controlled trials meeting the search As evidence continues to mount showing that conventional criteria were identified. Of these, 10 trials studied herbs, 11 exam hormone replacement therapy (HRT) can cause an increased risk ined soy or isoflavone supplementation, and the remainder of cardiovascular disease and cancer, complementary and alterna concerned vitamin E, acupuncture, behavioral therapies, wi ld yam, tive medicine (CAM) therapies are gaining popularity among and progesterone cream. many perimenopausal women. Information from clinical trials on Black cohosh (Acteae racemosa L., Ranunculaceae, syn. Cimi the safety and efficacy of many of CAM treatments is relatively cifoga racemosa L.) is the most studied herb for treatment of limited; nevertheless, the use of therapies such as herbs and dietary menopausal symptoms, and almost all trials have used the stan supplements rich in phytoestrogens is on the rise. This article dardized rhizome extract product Remifemin® (GlaxoSmirhK!ine, reviews randomized, controlled clinical trials of various CAM ther Pittsburgh, PA; manufactured by Schaper and BrUmmer, Salzgit apies for menopausal symptoms to provide information for clini ter, Germany). Three of the four trials reviewed showed a benefi cians facing this challenge. cial effect for the treatment of menopausal symptoms. The active The authors performed a literature review using the following compounds and mechanisms of action in black cohosh are sources: MEDLINE covering literature published from January unknown (new data being developed at the University of Illinois 1966 to December 2002, the Alternative and Complementary may help provide insights into this area), and no trials as yet 24 I HerbaiGram 61 2004 www.herbalgram.org research reviews completed have lasted longer than 6 months. According to the Eve ning primrose oil ( Oenothera biennis L., Onagraceae) simil arly authors, for these reasons, based on the availability of the currently showed no effect on hot flash es when compared to placebo. published clinical trial literature, the long-term use of this herb Ginseng (Panax spp., Araliaceae), long used as a general tonic, also cannot be considered safe until more data on long-term effects, failed to relieve menopausal symptoms when compared to placebo, particularly on endometrial and breast tissue, is presented. (Editor's although it showed positive effecrs on mood. note: To clarify this situation, the recent monograph published by Vitamin E has shown no clinically significant improvement in the American Botanical Council in The ABC Clinical Guide to hot flashes. A small, inadequately controlled study of acupuncture Herbs 1 points out that the showed benefit in both the German government's treatment and conrrol Commiss ion E recom groups, each of which mended a 6-month dura received a different form of tion of use, not because of acupuncture. Behavioral any projected safety prob therapies, including paced lems with use of black respiration and relaxation cohosh for longer periods, response, showed so me but because it is common in improvement in symptoms German gynecological prac and appear to be safe, but tice for women on HRT to an explanation for their have a checkup with their effects should be pursued. physician at 6-month inter Wild yam (Dioscorea villosa vals. Long-term use of black L., Dioscoreaceae) cream cohosh in German clinical has been studied for hot medicine has not resulted in fl ashes, with no evidence of cases of significant adverse improvement over placebo. effects.) A micronized progesterone Red clover (Trifolium topical cream showed pratense L. , Fabaceae) improvement in a random contains several phytoestro ized, double-blind, gens. Two small short-term placebo-controlled rrial, studies reported no relief of but its use must be weighed hot flashes using an extract against other outcomes standardized to phytoestro such as vaginal bleeding. Of gen content, but the authors the 29 studies of CAM point out that several larger Red Clover Trifolium pro tense. Photo © 2004 stevenfoster.com therapies reviewed in this trials were still underway. (A article, black cohosh is the recent study on a red clover only herb tested for relief of extract published after this review showed some biological activity hot flashes that showed significant beneficial effect (albei t in only for red clover but did not produce a clinically important effect on a few studies). Foods containing phytoestrogens also show prom hot flashes or other symptoms of menopause. 2) ise. Paced respiration and rel axation therapies may improve symp As with black cohosh, the authors note the lack of published toms, while progesterone creams can be problematic, and the data regarding long-term effects on the breas t or endometrium, authors discourage their use. although there is data suggesting that red clover is unsafe. The study's authors are recognized experts in CAM and women's Dietary phytoesrrogens from soy (Glycine max L., Fabaceae) and health. Dr. Kronenberg, a physiologist, is the Director of the other beans, clover, and alfalfa, as well as from lignan precursors Ri chard and Hinda Rosenthal Center for Complementary and found in whole grains, seeds (particularly fl axseed [Linum usitatis Alternative Medicine at Columbia University and is a Trustee of simum L., Linaceae]), fruits, vegetables, rye, millet, and legumes ABC. Dr. Fugh-Berman is a phys ician and associate professor in have been studied for their effects on menopausal symptoms. the physiology department of Georgetown University School of Epidemiological studies support the use of dietary soy, but few Medicine, and director of the Complementary Medicine Project at clinical studies support its use, showing only modest effecrs on the Reproductive Toxicology Center; she is also on the ABC Advi symptoms. Comparisons berween such studies are complicated so ry Board. A due to short treatment duration, variations in products used and -Diane 5. Graves, MPH, RD symptom scoring systems, and the placebo effect. Soy foods are considered safe, but, according to these authors, isoflavone supple References: ments appear to be less effective and cannot be pres umed safe for I. Blumenthal M, Hall T, Goldberg A, Kunz T, Dinda K, Brinckmann J, eta!. , eds. The ABC Clinical Guide to Herbs. Austin (TX): Ameri long-term use until longer studies have been conducted (even can Botanical Council; 2003:13-22. though there is currently no evidence of toxicity associated with 2. Tice JA, Ettinger B, Ensrud K, Wallace R, Blackwell T, Cummings the use of isoflavone supplements). SR. Phyroestrogen supplements for the treatment of hot fl ashes: the The Chinese herb dong quai (Angelica sinensis, Apiaceae) was Iso fl avo ne Clover Extract (ICE) Stud y: a randomized controlled trial. found to have no therapeutic benefit for hot flashes in one trial. JAMA 2003 Jul 9;290(2):207-14. www.herbalgram.org 2004 HerbalGram 61 I 25 research reviews Licorice and Its Potential Risk of Preterm Births eviewed: Strandberg TE, Andersson S, Jarvenpaa AL, Carbenoxolone, a synthetic analog of glycyrrhizin, inhibits RMcKeigue PM. Preterm birth and licorice consumption prostaglandin-metabolizing enzymes and, in the stomach, during pregnancy. American journal of Epidemiology increases prostaglandin levels. If glycyrrhizin has the same effect, 2002; 156:803-805. these authors believe that consumption during pregnancy could Candy made with licorice ( Glycyrrhiza glabra L. , Fabaceae) is lead to increased prostaglandins in the uterus and thus to contrac popular among women of childbearing age in Finland, other parts tions. Traditionally, licorice has been used as an emmenagogue (an of northwestern Europe, and New Zealand. The consumption of agent that induces or increases menstrual flow). this candy is socially acceptable, unrelated to socioeconomic or lifesryle factors. A previous study by these authors revealed a statis tically significant inverse association of heavy licorice consumption with length of gestation. 1 That is, long-term use of relatively high levels of licorice by pregnant women resulted in shorter periods of gestation. Because both glycyrrhizic acid (also known as glycyrrhizin), a principal pharmacologically active component of licorice, and the physical processes of childbirth are associated with glucocorticoid and prostaglandin metabolism, the authors were motivated to investigate licorice consumption in order to shed light on its effects on the mechanisms of preterm birth (i.e., less than 37 weeks gestation). Postnatal questionnaires were distributed in materniry wards of the Department of Obstetrics and Gynecology of the Universiry of Helsinki to all women who had given birth to full-term and preterm babies. Preterm births of twins, elective cesarean sections, and induced deliveries were excluded, as were cases of chorioam nionitis (inflammation of the fetal membranes) - situations and conditions that are not directly related to licorice use. The questionnaire included items such as gestational age (also obtained from patients' charts), whether or not the subject smoked, and detailed questions about licorice consumption during pregnancy. There was no significant difference in response rate among mothers delivering at full-term and preterm. The resulting sample included 107 subjects in the full-term, or control, group (mean gestational age 39.8 weeks) and 95 subjects in the preterm Licorice Glycyrrh iza glabra Photo © 2004 stevenfoster.com group (mean gestational age 33.3 weeks). Of all respondents, 51.5% were first-time mothers and 11.4% were smokers, with no significant differences between groups. Mothers' ages were fairly Interestingly, this study revealed a stronger association oflicorice similar, although those with preterm deliveries were statistically consumption with preterm birth than that of smoking, often asso slightly yo unger (mean age 30.2 years vs. 32.3 years in the control ciated with early delivery. Licorice is known to have mineralocor group). ticoid effects at relatively high doses over prolonged periods; it can Glycyrrhizin intake was grouped into three levels: low (less than produce a condition called pseudoaldosteronism (a buildup of 250 mg/week), moderate (250-499 mg/week), and high (equal to cortisol, which is recognized by the body as aldosterone, the adre or greater than 500 mg/week). In analyzing results, because of a nal hormone that tells the kidney to retain water and sodium, threshold effect, low and moderate levels were combined and which lead to increased blood volume, and as a result, increased compared with heavy consumption levels. The authors discuss blood pressure and lowered potassium levels). While licorice candy their methods of statistical analysis and present results in a table. is the primary avenue of consumption in Finland, licorice is also In brief, the heavy glycyrrhizin intake group included 20% (19 of found in teas and other herbal products, especially many Chinese 95) of the preterm delivery group and 10.3% (11 of 107) of the medicinal preparations. Most so-called "licorice" candy sold in the control group. When preterm births in 40 women were limited to United Stares is artificially flavored with the natural oil of anise those considered early preterm (less than 34 weeks), a significant (Pimpinella anisum L., Apiaceae) seed and contains no real association with heavy licorice consumption was found. The paper li corice. -" does not give the number of early preterm deliveries associated - Mariann Garner-Wizard with heavy licorice intake. The authors conclude that "heavy References: consumption is ... associated with a twofold-to-threefold increase 1. Strandberg TE, Jarvenpaa AL, Vanhanen H, et a!. Birth outcome in in the risk of preterm [less than 37 weeks] birth." relation to licorice consumption during pregnancy. Am j Epidemiol 2001; 153: 1085-8. The authors discuss the biological plausibiliry of such an effect. Glycyrrhizin inhibits the breakdown of cortisol in the placenta, leading to increased cortisol levels that may affect prostaglandins. 26 I HerbaiGram 61 2004 www.herbalgram.org research reviews Trial Studies Effects of St. John's Wort and Sertraline on Depression eviewed: van Gurp G, Meterissian G, Haiek L, McCusker J, declined to about half the mean baseline score. Nine patients in RBellavance F. St. John's wort or sertraline? Randomized each group increased their daily dose to 6 capsules. At 2 and 4 controlled trial in primary care. Canadian Family Physician weeks, the mean number of side effects was significantly higher in 2002;48:905-912. Clinical studies examining the effects of St. John's wort (Hyper icum perforatum L. , Clusiaceae) as a treatment for depression have had many criticisms, including using low doses of a comparison drug (i.e., a conventional pharmaceutical antidepressant drug used as an active control for comparison purposes), relatively short durations (some trials treat patients for less than 4 weeks, while most are from 4-6 weeks), and imprecisely classifying psychiatric disorders. The goal of this paper was to avoid some of these poten tial shortcomings by evaluating the severity of depressive symp toms in patients with major depression (as defi ned by the Diag nostic and Statistical Manual of Mental Disorders, 4th edition [DSM-IV]) for a longer period of time. Patients were treated for 12 weeks with St. John's wort (SJW) or senraline, a commonly used antidepressant, in a primary care setting. A primary care setting was chosen because depressive disorders are among the most common illnesses seen by primary care phys icians. Sertraline, commonly known as Zoloft® (Pfizer, Inc.), was used for compari son because it is currently the most prescribed antidepressant drug. The prospective, randomized, double-blind clinical trial included patients with major depression who had a Hamilton St. John's wort Hypericum perforatum. Photo © 2004 stevenfoster.com Rating Scale for Depression (Ham-D) score of greater than or equal to 16 using DSM-IV criteria. (The severi ty of depression in the semaline group (P < 0.05). Both groups had similar numbers patients in the 2 previously published trials on SJW co nducted in of patients reporting sleep disturbances - the most common side the U.S. was 16.7 according to the Ham-D scores.) The Ham-Dis effect. There was one se ri ous side effect: a patient taking 1,800 mg a 17 -item scale that evaluates depressed mood, vegetative and SJW required hospitalization after developing an acute manic reac cognitive symptoms of depression, and co-morbid anxiety symp tion. Five other cases of manic episodes associated with the use of toms. (Vegetative symptoms refer to sleeping and eating patterns, SJW have been reported in the medical literature. sexual arousal and activity, ere.) The Hamilton scale is the standard Overall, the data shows that the severity of symptoms in patients depress ion outcome measure used in clinical trials prese nted to the with mild-to-moderate depression was similar whether they were U .S. Food and Drug Administration by pharmaceutical companies treated with SJW or serrraline. The authors conclude that the for approval of new drug applications for antidepressants. Patients favorable side effect profi le and similar efficacy to serrraline indi in this trial took one capsule 3 times daily of either semaline (50 cates that SJW can be a first treatment option for mild-to-moder mg total dose) or SJW (extract imported from Germany, supplied ate depression in primary care settings. as 300 mg capsul es by Swiss Herbal Remedies Company, Ri ch However, the weaknesses of the trial design and the data mond Hill, Ontario, presumably standardized to 0.3% hyperi ci n, produced do not permit the authors to conclude that the rwo although the paper states "Hyp ericum content of 0.3%"). Total treatments had equivalent effectiveness. A much larger sa mple size daily dose was 150 mg semaline, 900 mg SJW. The dose for either would be needed to make that claim. It should be noted that the treatment was allowed to be increased to 2 capsules 3 times daily use of "positive controls" (i.e., the semaline/Zoloft gro up) is (300 mg sertraline total dose or 1,800 mg SJW total dose per day), considered the more ethical standard in current clinical trial if the treatment was clinically insufficient at 4 weeks. For blinding design rather than using a placebo that would usually produce a purposes, all opaque capsules looked identical. Patients were eval negative outcome, and which is used in most FDA clinical trials. uated at the beginning of the trial and at 2, 4, 8, and 12 weeks. In this way none of the subjects is denied treatment and the exper Physicians administered the Ham-D, and the patients rated them imental treatment (in this case the SJW) is tested for its equiva selves with the Beck Depress ion Inventory (BDI) . The BDI is a lency to the established positive control. Other weaknesses of this self-administered 21-item ques tionnaire used to ass ist the clinician trial are that some subjects were recruited through adverrising, so to assess the intensity of depression in clinical and normal patients. the study may not be representative of depressed patients in The study started with 87 patients; however, only 29 SJW and primary care settings, and H am-D ratings were not confirmed by 28 sertraline patients completed the trial, showing a high a mental health speciali st. _..- "dropout" rare, which usually reduces the va lidi ty of the trial's -Heather 5. Oliff, PhD outcome. (Normally, a one-third dropout rate would invalidate a trial; in this study, a total of 57 or 65% completed the study, mean ing that over one-third dropped out). Mean Ham-D and BDI scores declined similarly by 12 weeks in both study groups. Scores www.herbalgram.org 2004 HerbaiGram 61 I 27 research reviews Echinacea Unsuccessful in the Treatment of Common Cold eviewed: Barrett BP, Brown RL, Locken K, Maberry R, Babula R]A, D'Alessio D. Treatment of the common cold with unre fined echinacea. Annals of Internal Medicine 2002; 137(12):939- 945. The common cold is one of the world's most prevalent illnesses and can have substantial effects on productivity and well-being. Common colds are caused by several different categories of viruses, including rhinoviruses, adenoviruses, and coronaviruses. Effective medical treatments for the common cold have not been identified; antibiotics are only useful if bacterial infections, such as sinusitis or pneumonia, develop as complications after the onset of a cold. Products made from echinacea are widely used around the world to prevent or treat the common cold. Three species of genus Echi nacea (E. purpurea (L.) Moench, E. angustifolia DC, and E. pallida (Nutt.) Nutt., Asteraceae) are used in various types of herbal prepa rations intended to increase immune sys tem function in associa tion with symptoms of the common cold and flu. These products may be made from any combination of the flowers, stems, roots, leaves, and whole plant of any of these 3 species; some preparations are extracts or fresh-pressed juice of the aerial parts, whereas others consist of dried plant material (either root or aerial parts). Numerous studies have been done on the effectiveness of echi nacea for either preventing or treating the common cold. However, all of the previous studies have had important methodological limitations, according to the authors. In general, studies have Echinacea E. pal/ida Photo © 2004 stevenfoster.com found little evidence that echinacea preparations can prevent the common cold. Data on echinacea's ability to treat the common cold by reducing its symptoms and duration have been somewhat more promising, but sti ll inconclusive. "The 11 published treat You are cordi'a!fy i'1wi'teJ to ment trials are somewhat more positive, and systematic reviews have been cautiously optimistic," the authors report. FOLLOW YOUR HEART In the current study, the authors compared an encapsulated, whole-plant echinacea preparation with a placebo for treating the common cold. A total of 148 college students with early cold WH EN: symptoms were randomly assigned to either placebo or active treat Now. ment in this double-blind trial. The echinacea product was an unrefined, dried mixture that WHERE: consisted of 50% E. angustifolia root, 25% E. purpurea root, and Ba.~tyr U niver.Jity, Seattle. 25% E. purpurea herb (Shaklee Tecnica; Pleasanton, CA). Each WH Y: dose consisted of 4 capsules, totaling 1 gram of echinacea. Subjects took 6 grams of echinacea on the first day of the treatment proto Don't .Jettle. Be true. col and 3 doses (3 grams) on each subsequent day for a maximum Live green, work green. of 10 days. The echinacea capsules also contained thyme (Thymus Malee your pa.1.1ion your life'c! work. vulgaris L., Lamiaceae) and peppermint (Mentha x piperita L. , With a degree in Herbal Science.J. Lamiacea) to disguise the taste. The placebo capsules contained alfalfa (Medicago sativa L. , Fabaceae). The use of alfalfa as a placebo is a potential weakness of this trial, as the herb is potentially active RL\STYR and thus may be inappropriate for an "inert" control. UNIVERSITY Subjects began treatment as soon as possible after noticing new cold symptoms. Potential participants were asked to call a research assistant at the first sign of cold or flu symptoms. The mean time lag from the subject's first symptom to study enrollment was 27 RSVP: To geu.be best natural health hours. education in the world, please visit The study outcome variables were the duration of the cold and Herbs.Bastyr.edu. Call 425-602-3330. the severity of 15 specific symptoms. The duration of the cold was Or email [email protected]. defined as the number of days between study enrollment and the 28 I HerbaiGram 61 2004 www.herbalgram.org research reviews last day before the subject answered "no" to the question "Do yo u in terms of side effects. The specific side effects noted by subjects think rhar you are still sick today?" Symptom severity was self raking echinacea were heartburn, nausea, stomachache, upset stom reported on a 9-point Likert scale. ach, and sleeplessness (each reported by 1 subject). A total of 142 subjects completed the study (73 in the placebo The authors conclude rh ar their results "do nor support a benefit group and 69 in the echinacea group). The mea n age was approxi of echinacea in the treatment of common cold sy mptoms." mately 21 years, and about 70% of the subjects in both groups were However, they believe that further research needs to be done women. Approximately 40% of the subjects in both groups had because their study had limitations, and irs resu lts co ntradict prev i taken echinacea before. Exit interviews showed that the blinding ous studies that did find a benefit. Several studies that were similar was successful; subjects were nor able to determine whether they in quality to the current study found rhar echinacea reduced symp received the placebo or the active treatment. A total of 853 person toms when taken early in the course of the common cold, the days of illness were captured by the study data-collection methods. authors note. The data showed that there were no significant differences The limitations of the current study, according to the authors, between the placebo and echinacea groups for any of the outcome included the possibility that healthy, young persons may benefit less variables. The mean duration of the subjects' colds was 5.75 days in from echinacea than would older or immuno-compromised the placebo group and 6.27 days in rhe echinacea group; this differ persons, and only rhe former were included in rhe study. Also, rh e ence was nor significant. No significant treatment effect was found dried, unrefi ned mixture of the herb that was used had nor been after controlling for subject sex, dare of enrollment, use of non rested previously and may have been ineffective due to poor protocol medications, and duration and severity of symptoms bioavailabiliry or rh e specifi c mixture of phytochemical before enrollment. constituents that it contained. Further, self-reported data were used, Symptom severity also did nor differ significantly over rime which can introduce certain types of bias. In addition, other weak between the two groups based on multivari ate regress ion models. nesses may include rhe rime lag from rhe subjects' first noticing The symptoms assessed in this study were muscle aches, fever, sym ptoms to rime of treatment (average 27 hours); herbalists gener hoarseness, feeling run down, loss of appetite, swears, and ally recommend that echinacea treatment be initiated at the first headache. Subjects also rated the global severity of their colds by onset of symptoms. Finally, rhe use of a potentially active placebo answering the question "How sick do yo u feel today?" (alfalfa) might nor have shown as much difference as a known inac Adverse effects we re reported by some subjects in each group, bur tive placebo.---- there was no significant difference overall between the two groups -Christina Chase, MS, RD S T E V E N F 0 S T E R G R 0 l 1 P , I l'\ C . ' ...... ·~·.:.• ~ eatured in HerbaiGram for over a decade, the photographs of ' : i Steven Fo ster are available for licensing for editorial or , J commercial 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 Foster Group, Inc. Steven Foster, President PO. Box 57, Brixey, MO 65618 4 171261-2663 fax 4 171841-4843 email: [email protected] www.stevenfoster.com C 0 l\I E T 0 T H E S 0 C R C E www.herbalgram.org 2004 HerbaiGram 61 I 29 Clinical Update by Donald J. Brown, N.D. No Interaction between Hawthorn and Digoxin Suggested in Human Study D eviewed: Tankanow R, Tamer H, Streetman D , eta!. lnter in Germany and other parts of Europe to treat Class I and II of ~ction study between digoxin and a preparation of hawthorn congestive heart failure as defined by the New York Heart Associ ( Crataegus oxyacantha). The journal of Clinical Pharmacology ation (NYHA) Classification of Congestive Heart Failure (CHF); 2003 June;43(6):637-42. such preparations are approved by the German Commission E for Summary: To determine the potential interactions and effects this indication.1 In HerbalGram 57, I reviewed a clinical trial of hawthorn ( Crataegus monogyna Jacq. or C. laevigata [Poir] DC, demonstrating the efficacy of the hawthorn extract WS 1442 in syn: C. oxyacantha auct., Rosaceae) on the conventional patients with Class III congestive heart failure.2 The review cardiotonic drug digoxin's pharmacokinetic* parameters, an concluded with the statement, ''According to the literature, there open-label, randomized, crossover trial with 8 healthy volunteers are no known interactions with prescription cardiac drugs. (19-43 years old) was performed. The trial evaluated 0.25 mg Although the potential for hawthorn extracts to potentiate (i.e., digoxin (D) per day for 10 days or 0.25 mgD per day taken with to make more powerful, especially a drug) the effect of digoxin 450 mg hawthorn special extract WS 1442t (hawthorn leaves and has been suggested, this has not been documented in any clinical flowers ; Dr. Wilmar Schwabe Pharmaceuticals, Karlsruhe, trials to date nor has it been cited as a concern by either the Germany) (D + H) taken 2 times per day for 21 days. After each German Commission E or American Herbal Pharmacopoeia treatment period there was a 2-day washout period after which monographs on hawthorn."3 These two compendia evaluated subjects received crossover treatment (i.e., the D patients received most of the published literature available at the time of their D + H, and the D + H patients received D only). Pharmacoki respective publications, 1994 for Commission E, and 1999 for netic data were collected during the AHP monograph.4 12-hour clinic stays starting on The statement prompted a day I 0 (for D subjects) and day letter to HerbalGram 59 from 21 (D + H subjects). Blood Daniel Mowrey, PhD, suggesting samples were drawn from that this statement may not be subjects immediately before completely accurate.s Based on administration of study medica old and somewhat obscure case tions (time 0) and then at 0.25, reports from Germany and a 0.5, 1, 1.5, 2, 4, 6, 8 and 12 pharmacological study with an hours after administration of isolated frog heart preparation study medication. Subjects (please see Dr. Mowrey's letter for returned to the clinic for blood references), Dr. Mowrey suggests draws at 24, 48, and 72 hours that hawthorn may potentiate the after the initial blood draw. effect of digoxin. In response, Dr. Twenty-four hour urine was also Egon Koch of the Dr. Willmar collected at the time of baseline Schwabe Pharmaceutical blood collection for determina Company provided information tion of digoxin renal clearance. to suggest that these studies are Pharmacodynamic+ measure insufficient to suggest a potential ments included blood pressure, interaction between hawthorn and digoxin. He ends his letter by and electrocardiogram (ECG), Hawthorn Crataegus monogyna Photo © 2004 stevenfoster.com which was obtained prior to and citing the recently completed after each treatment phase. There were no statistically significant pharmacological study summarized above. differences between the two groups for the area under the serum While the study does not look at concomitant use of hawthorn concentration-time curve (AUC) to 24 hours (AUC0_24) and the leaf and flower extract with digoxin in patients with diagnosed last measured time point (AUC0_72) or the elimination half-life heart disease, it suggests that hawthorn has no effect on the (t 1, 2) minimal serum concentration (Cma,), maximum serum normal pharmacokinetic parameters of digoxin. In short, it does concentration (Cma,) , time to Cmax (tmax) or renal clearance not appear to either decrease or increase serum levels of digoxin (CLR) . In addition, there were no differences between the two when co-administered. The hawthorn dosage of 900 rug/day is groups for the pharmacodynamic parameters. based on the current daily dose used for patients with mild to Comments: Hawthorn leaf and flower extract are widely used moderate congestive heart fai lure (Classes I and II according to * Pharmacokinetics refers to the study of rhe absorption, elimination, and excretion of a substance in rhe body. t WS 1442 is a standardized erhanolic extract (4-6.6:1) of hawthorn leaves with flowers produced by the Dr. Wilmar Schwabe Pharmaceuticals, of Karlsruhe, Germany. The extract is standardized to contain 18.75% oligomeric procyanidins. Sold under the registered trade name Crataegutt® in Europe, the extract is sold in the United Stares by Nature's Way Products, Inc. as HearrCare® and by their professional subsidiary MMS Pro as Cardi Planr™ Pro. + Pharmacodynamics refers to the study of the physiological effects of a substance on tissues, organs and/or physiological systems. 30 I HerbaiGram 61 2004 www. herbalgram.org NYHA CHF Classification). It is interesting to note that the opposite side of the scale was observed on the reverse side. Parents authors of the study (from the University of Michigan) suggest were instructed to measure the pain just prior to administration of that the two agents may be co-administered safely. A the medication in the morning and 15 and 30 minutes after References: administration of the medication on day 2, and before instillation I. Blumenrhal M, Busse WR, Goldberg A, Gruenwald J, Hall T, of the ear drops in the morning and 15 minutes after this instilla Riggins CW, Rister RS , editors. Klein S, Rister RS , translators. The tion on day 3. Complete German Commission E Monographs: Therapeutic Guide to Treatment was considered successful in the NHED groups Herbal Medicines. Austin (TX): American Botanical Council; 1998. (groups A and B) with the average total level of ear pain reduced 2. Tauchert M. Efficacy and safety of Crataegus extract WS 1442 in from 8.53 at baseline to 0.56 at 30 minutes after instillation of comparison with placebo in patienrs with chronic stable New York drops on day 2 (93.4% pain reduction). Corresponding values for Heart Association class-III heart failure. Am Heart J 2002;143:910-5. patients given anesthetic ear drops (groups B and C) were 8.44 and 3. Brown D . High dose hawthorn extract for advanced congestive heart 1.6 1, for a pain reduction of 80.9%. By subgroup, the rates of pain failure. HerbalGram 2003;57:24-25, 28. reduction at day 3 compared to baseline were 95.9% for Group A, 4. Upton R, editor. Hawthorn leaf with Jlower-Crataegus spp.: Analyt 90.9% for Group B, 84% for Group C, and 77.8% for Group D. ical, quality control, and therapeutic monograph. Sanra Cruz, CA: On analysis by rime, the NHED groups had less pain than the American Herbal Pharmacopoeia; 1999. American Herbal Pharma anesthetic groups on both day 2 and day 3. According to the inves copoeia and Therapeutic Compendium (series). tigators, statistically greater pain relief was noted for both days 2 5. Mowrey D. Hawthorn inreraction potenrial [letter and reply]. HerbalGram 2003;59:70-71. and 3 of treatment for patients in Group A compared ro patients in Group B (P facror not given). Nevertheless, all of the variables considered explained only 22% of the reduction in pain and Herbal Ear Drops for Pain suggested that the remaining relief may be accounted for by the passage of time alone. On repeated measurements analysis, time (3 Associated with Otitis Media: days) proved ro be the most effective treatment variable. Do Antibiotics Help? Comments/Opinions: This trial is the second published by a research group at Tel-Aviv University and the Edith Wolfson D eviewed: Sarrell EM, Cohen HA, Kahan E. Naturopathic Medical Center in Holon, Israel studying the efficacy of "naturo ~rearment for ear pain in children. Pediatrics May 2003; 111 (5 pathic" herbal ear drops for AOM in children. The first trial 1 Pt 1):e574-79. found that a similar herbal ear drop product (the previous product Summary: In a randomized, double-blind clinical trial, 171 apparently lacking lavender oil) reduced pain as effectively as the children (ages 5 to 18 years) with a diagnosis of acute otitis media anesthetic ear drop combination used in the current trial. A review (AOM) were randomized for 3 days to 1 of 4 treatment groups. of the earlier trial appears in Herba/Gram 54 .2 Group A received "naturopathic" herbal extract drops (M. Pharm The current trial builds nicely on the findings of the earlier trial Co., Petach-Tikva, Israel) - 5 drops, 3 times per day to the exter by adding the antibiotic amoxicillin into the mix. With the focus nal ear canal of the affected ear. The naturopathic herbal ear drops solely on pain management during the first 3 days of AOM, the (NHED) contained a combination of extracts of calendula (a.k.a. investigators actually find no added benefit from the addition of marigold, Calendula officina/is L., Asteraceae) flowers (28%), St. antibiotics to either the herbal or the anesthetic eardrops. As John's wort (Hypericum perforatum L., Clusiaceae) herb (30%), opposed ro the earlier trial, this trial actually finds greater pain mullein (Verbascum thapsus L., Scrophulariaceae) flowers (25%), essential oils of garlic (Allium sativum L., Liliaceae [in 0.05% olive oil]) bulb and lavender (Lavandula angustifolia Mill., Lamiaceae) flowers (1 Oo/o and 5%, respectively), and vitamin E oil (2%) in a base of olive oil. (It is nor clear whether this preparation is avail able in the United States.) Group B received the herbal eardrops together with oral amoxicillin (80 mg/kg/d divided into 3 doses). Group C received an anesthetic eardrop (amethocaine and phenazone in glycerin) - 5 drops, 3 rimes per day to the affected ear. Group D received the anesthetic eardrops together with oral amoxicillin (same dose as above). The presence or absence of ear pain was subjectively assessed over a three-day period with a specially devised instrument called the Pain-0-Meter. One side of the instrument consisted of a numbered scale from 1 (no pain) to 10 (worst possible pain). The reverse side contained a scale of 5 facial expressions, ranging from a broad smile (no pain) to a sad and crying face (worst possible pain) and a corresponding color scale ranging from blue to dark red. The child was instructed to point to the appropriate face and color on the scale, and then the corresponding number on the www.herbalgram.org 2004 HerbalGram 61 I 31 Clinical Update by Donald J. Brown, N.D. relief for those children using the herbal eardrops compared to Practice Implications: The results of this trial support the those taking the anesthetic ear drops. notion that the wait-and-see approach to AOM in older children Criticisms of this trial include the lack of an antibiotic-only may be the most prudent. It also suggests that, although modest, group as well as the lack of clear reporting on follow-up otoscopic the use of traditional herbal eardrops is a therapeutic option for examinations by the attending physician. As noted in the previ pain during this waiting period. Herbal eardrops containing a ous review of the earlier triaJ,2 any practitioner would expect combination of mullein, marigold (calendula), Sr. John's wort, successful outcomes to be based at least partially on follow-up lavender, and garlic in an olive oil base reduce ear pain associated evaluation of the child's affected ear and not based solely on with AOM as effectively as standard anesthetic eardrops. subjective feedback of patients or parents. In addition to evalua However, recommendation of these drops should only be made tion at 3 days, follow-up evaluation of the tympanic membrane following otoscopic examination of the tympanic membrane and to rule out fluid build-up in the middle ear (otitis media with the absence of any rupture that would allow the drops to enter the effusion) would be critical to determining success with or without middle ear. Persistence of sr mptoms beyo nd 3 days would suggest antibiotic therapy. the need for antibiotics. A Finally, as was the case with the earlier trial, the children References: included in the current study are older (5 years and over) and I. Sarrell EM, Mandelberg A, Cohen HA. Efficacy of naturopathic more likely to spontaneously recover from AOM without antibi extracts in the management of ear pain associated with acute otitis media. Arch Pediatr AdoLesc Med 200 I; 155:796-9. otics. Hopefully, the investigators will extend their findings to 2. Brown D . Herbal ear drops effectively trea t ear pain associated with yo unger children in future trials to see if the NHED work as acute otitis media. HerbaLGram 2002;54:23-4. effectively in managing pain in that patient population - a 3. Daly KA. Epidemiology of otitis media. OtoLaryngoL CLin North Am group that makes up the majority of AOM cases.3 1991 ;24:775-86. The herbs used in the Israeli product and similar products in 4. Leung A, Foster S. EncycLopedia of Common NaturaL Ingredients the U.S. are based on traditional use. Marigold flowers have been Used in Food, Drugs and Cosmetics, 2nd ed. New York: John Wiley traditionally used topically as an anti-inflammatory and for & Sons, 1996, 113-4. wound healing.4 Mullein flowers and leaves, because of high 5. Hoffmann D. The HerbaL Handbook: A User's Guide to MedicaL HerbaLism. Rochester, VT: Healing Arts Press, 1998, 67. mucilage content, act as a demulcent to soothe irritated mucous 6. Hobbs C. St. John's wort (Hypericum perforatum L.): A review. membranes internally and as an emollient topically to treat skin HerbaLGram 1988/ 1989; 18/ 19:24-33. 5 irritations and minor burns. .Although more commonly associ 7. Hughes BG, Lawson LD. Antimicrobial effects of ALLium sativum ated with its use as an antidepressant, St. John's wort flowering L. (ga rlic), ALLium ampeLoprasum L. (elephant ga rlic) and ALLium tops have been used topically to reduce "nerve pain" and inflam cepa L. (onion), garlic compounds and commercial garlic supple mation.6 Garlic bulbs are thought to have topical antimicrobial ment products. Phytother Res 1991 ;5: 154-8. effects - an action that has been shown in vitro.? Cardiovascular Benefits of a Theaflavin-Enriched Green Tea Extract D eviewed: Maron D , Lu Ping G, Sheng CaiN, et al. Choles After 12 weeks, there was a statistically significant decrease in ~ero l-lowering effect of a theaflavin-enriched green tea TC of 11.3% (P < 0.01) and LDL-C of 16.4% (P < 0.01) in the extract. Archives ofInternal Medicine 2003; 163:1448-53. green tea group. No significant changes were seen in TC or LDL Summary: This double-blind, placebo-controlled trial C in the placebo group at any point during the study. After 12 included 240 men and women (18 years or older) with mild to weeks, HDL-C and triglycerides increased by 2.3% and 2.6%, moderate hypercholesterolemia (high cholesterol characterized in respectively in the green tea group, while HDL-C fell by 0.7% this trial by subjects with low density lipoprotein cholesterol and triglycerides increased by 5.6% in the placebo group. The [LDL-C] in the range of 130-190 mg/dL). The subjects were mean TC to HDL-C ratio fell from 4.61 to 4.05 (P < 0.00 1) from consuming a low-fat diet (less than 32% of total calories from fat) baseline to week 12 in the green tea group, bur did not change and were randomized to receive a daily dose of either 375 mg of significantly in the placebo group (from 4.55 to 4.57, P = 0.85). theaflavin-enriched green tea (Camellia sinensis [L.] Kuntze, There were no significant differences in adverse events between Theaceae) extract (Nashai Biotech, LLC, Nashville, Tennessee) or the two groups (specific adverse events are not listed). placebo for 12 weeks. Subjects were recruited from 6 urban Comments/Opinions: Already the second most popular hospitals in China. They were administered one green tea extract beverage in the world next to water, tea is enjoying a resurgence capsule per day, which contained 75 mg theaflavins, 150 mg of based on population studies linking it to decreased risk of cardio green tea catechins, and 150 mg of other tea polyphenols. The vascular disease and cancer. 1·3 Interestingly, these data have main outcome measure was the change from baseline for total included both green tea and black tea consumption and have cholesterol (TC), LDL-C, high density lipoprotein cholesterol been based on tea consumption in populations as diverse as the (HDL-C) and triglycerides. Lipid and lipoprotein concentrations Japanese and the Dutch. Additionally, tea drinking has been asso were measured after a 12-hour fast at weeks -2 (2 weeks prior to ciated with an improved lipid profile in some4 but not ailS obser treatment), week 0 (beginning of treatment), week 4, and week vational studies. These data have led to not only a large increase 12. in tea consumption in the North America but also a preponder- 32 I HerbaiGram 61 2004 www.herba lgram .org ance of encapsulated green tea supplements.* of consumption of green and black tea on plasma lipid and antioxi The choice of the green tea extract for this trial was based upon dant levels and on LDL oxidation in smokers. Arterioscler Thromb Vase Bioi what is assumed to be beneficial in both green and black teas. As 1998; 18:833-41. 8. va n her Hof KH , de Boer HS, Wiseman SA, et al. Consumption of is widely known, catechins (e.g., (-)-epigallocarechin gallate green or black rea does not increase resistance oflow-density lipopro [EGCG]) are the predominant flavonoids in green tea and are tein to oxidation in humans. Am] Clin Nutr 1997;66: 1125-32. associated with increased antioxidant activity in the body.6 After 9. Mcanlis GT, McEneny J, Pearce J, Young IS. Black rea consumption fermentation from green tea to black tea, about 15% of carechins does not protect low density lipoprotein from ox idative modifica remain unchanged and the rest are converted to rheaflavins tion. Eur J Clin Nutr 1998;52:202-6. (polyphenol pigments) and thearubins.3 I 0. Third report of the National Cholesterol Education Program Despite favorable epidemiological evidence for both green and (NCEP) Expert Panel on Detection, Evaluation, and Treatment of black teas, this is the first trial to actually demonstrate that a tea High Blood Cholesterol in Adults (Adult Treatment Panel III ): final report. Circulation 2002; I 06:3143-421 . extract lowers LDL-C. According to the authors, the rationale to II . Maron D, Lu Ping G, Sheng Cai N, er al . Cholesterol-lowering effect enhance the level of theaflavin is based on a previous trial of daily of a theaflavin-entiched green rea extract. Arch Intern Med consumption of 3.6 g of encapsulated green tea polyphenols in 2003; 163: 1448-53. which no effect on lipids was found.? It should be noted that this earlier trial was with smokers. Also notable is the fact that human tea-drinking trials have tested exposure to 0-35 mg of theaflavins Is Black Cohosh a Selective and 50-850 mg of catechins per day, again with no significant effect on lipidsJ·9 As noted by the authors, more research is needed Estrogen Receptor Modulator? on this new proprietary rheaflavin-enriched green tea extract to eviewed: Wuttke W, Seidlova-Wuttke D, Gorkow C. The better understand its potential for reducing risk of cardiovascular RCimicifuga preparation BNO 1055 vs. conjugated estrogens in disease. At the time of writing, the extract was rapidly making its a double-blind placebo-controlled study: effects on menopause way into products in the U.S. market. However, more clinical trials symptoms and bone markers. Maturitas are needed to support the positive effects of theaflavins. 2003;44(Suppl.l):S67-S77. Practice Implications: The T hird Report of the National Summary: In a double-blind, placebo-controlled trial, 97 peri Cholesterol Education Program Adult Treatment panel stares that and postmenopausal women (40-60 years), who were experienc diet therapy is the initial recommendation for lowering LDL-C. 10 ing at least three hot flashes per day, were randomized to receive These guidelines have included increasing fiber and plant stanols either one tablet of 20 mg of black cohosh (Actaea racemosa L. , and sterols to assist in lowering LDL-C. According to data from Ranunculaceae; syn. Cimicifuga racemosa [L.] Nutt.) extract corre previous observational studies as well as trials conducted on sponding to 20 mg of the rhizome, 0.3 mg of conjugated estrogens conventional statin drugs, it is estimated that each 1% reduction (CE), or placebo 2 times per day for 3 months. (The final analysis in LDL-C results in approximately a 1.0% to 1.5% reduction in contained 62 postmenopausal women; 33 perimenopausal patients the relative risk of major cardiovascular events. 11 Extrapolating the were excluded from the statistical analysis as well as 2 dropouts.) resu lts above suggests a decreased risk of 16% to 24% with regular The black cohosh (BC) extract used in the trial (B 0 I 055, sold consumption of the theaflavin-enriched green tea extract in as Klimadynon® and Menofem®, manufactured by Bionorica AG, persons with mild to moderate hypercholesterolemia. _...- Neumarkt, Germany) is a dried aqueous/ethanolic extract (58%, v/v) of the rhizome (standardization specifics are not provided in References: the paper). The change from baseline in the Menopause Rating I. Pereres U, Poole C, Arab L. Does rea affect cardiovascular disease? A Scale (MRS) was the primary efficacy endpoint. Subjects meta-analysis. Am J Epidemiol September 15 , 2001; 154(6):495-503. completed the MRS at baseline and at weeks 4, 8 and 12. The 2. Sasazuki S, Kodama H, Yosh imasu K, er al. Relation between green rea consumption and rhe severity of coronary atherosclerosis among MRS covers I 0 climacteric (menopausal) symptoms - hot flashes Japanese men and women. Ann Epidemio! August 2000; I 0(6):40 1-8. and sweating, heart palpitations, sleep disturbances, mood swings, 3. Blumenthal M, Hall T, Goldberg A, er al., ed itors. The ABC Clini tension and nervousness, mental fatigue and memory loss, loss of cal Guide to Herbs. Austin , TX: American Botanical Counci l; sexual drive, urinary incontinence, vagi nal dryness, and joint pain. 2003:335-49. Patients were instructed to report the intensity of each symptom 4. Imai K, Nakachi K. Cross sectional study of effects of drinking green on a I 0-poinr scale (0 = no symptoms, to I 0 = severe symptoms). rea on cardiovascular and li ver di seases. BMJ March 18, Patients were also instructed to complete a diary of symptoms each 1995;310(6981):693-6. 5. Tsubonon Y, Tsugane S. Green rea intake in relation to serum lipid day, which included information on the number of hot flashes, the levels in middle-aged Japanese men and women. Ann Epidemiol occurrence (intensity, duration) of vaginal bleeding episodes, and 1997;7:280-4. sleep disturbances. Blood samples were collected at baseline and at 6. Benzie IFF, Szeto YT, Strain JJ, Tomlison B. Consumption of green weeks 4, 8, and 12, and used to measure luteinizing hormone tea causes rapid increase in plasma antioxidant power in humans. (LH ), follicle-stimulating hormone (FSH), estradiol , and proges Nutr Cancer 1999;34:83-7. terone. Additionally, the levels of CrossLaps (a marker of bone 7. Princen HM, van Duyvenvoorde W, Buyrhenhek R, er al. No effecr degradation) and bone-specific alkaline phosphatase (a marker for bone formation) were measured by immunoassays and enzymatic • Note: For an excellent overview of cli nical trials on green and black teas, please see the chapter on rea in The ABC Clinical Guide to Herbs. 3 assay, respectively. At baseline and at week 12, all subjects had complete gynecological examinations, including transvaginal ultra- www.herbalgra m.org 2004 HerbalGram 61 I 33 Clinical Update by Donald J. Brown, N.D. sound for determination of endometrial thickness and a vaginal ter, Germany, licensed to GlaxoSmithKiein for U.S. sales).3 smear to determine the maturity index of the vaginal epithelium. The clinical trial summarized above is one of several papers on Compared with placebo, both CE and BC were both equally BC presented at a conference sponsored by Bionorica AG entitled effective in reducing menopausal symptoms as measured by all 10 "Modern Phytotherapy in Menopause: Cimicifuga racemosa MRS items (P = 0.05 for both). For specific vasomotoric MRS (Kiimadynon, Menofem) Pharmacological and Clinical Data symptoms of hot flashes and sweating, heart palpitations and Oune 10, 2002, Berlin). The proceedings are published in a sleep disturbances, CE showed a statistically significant difference supplemental issue of Maturitas, the official journal of the Euro compared to placebo (P = 0.05), while BC showed a marked pean Menopause and Andropause Society 34 I HerbaiGram 61 2004 www.herbalgram.org ity of the products tested. The scale used for measuring the efficacy with the reported decrease (albeit not statistically significant) in was MRS I: this scale was created and validated as a tool for MRS symptoms (e.g., depression, impaired memory, vaginal doctors, not patients. However, in the study this scale has been dryness, urinary symptoms), lead the investigators to conclude that rated by the patient. Regarding the change from baseline, the MRS BC contains substances with SERM activity that exert desired I score was equal in all 3 groups, indicating no benefits forCE and effects in the hypothalamus, the mesolimbic brain regions, and BNO 1055 in comparison to placebo. bones, without estrogenic actions in the uterus and vaginal cytol While BC shows improvement of the overall symptom complex ogy. Future trials with larger populations of postmenopausal comparable to CE, one of the potential shortcomings of BC in the women and longer duration are needed to co nfirm their conclu clinical trial reviewed above (i.e. , Wuttke et al .) is in the relief of sions. A recendy published 6-month trial demonstrated no vasomotor symptoms such as hot flashes. As women continue to sys temic estrogenic effects even for a high dose of 127 mg daily of seek alternatives to HRT, it is imperative that companies sponsor a crude BC rhizome in which hormone levels and vaginal cytology 1 ing BC research sponsor more trials to demonstrate efficacy and were analyzed on a daily basis. --" tolerability in this arena. On the other hand, BC shows marked References: improvements in a wider area of symptoms than CE that warrants I . Liske E, Hanggi W, Henneicke-vo n Zepelin HH, et al. Phys iological BC its own position independent from CE as treatment option. A investigation of a unique extract of bl ack cohosh ( Cimicifugae race mosae rhizoma): a 6-month clinical study demonstrates no sys temic recent paper has been published documenting the general safety of estrogenic effect. J Women Health Gender-Based Med 2002; II: 163- 3 11 BC. Monographs from the German Commission £, World 74. Health Organization, 12 and the recent one from the European 2. Jacobson JS, Troxel AB, Evans J, er al. Randomized trial of black Scientific Cooperative on Phytotherapy,13 state the primary indica cohosh for the treatment of hot flashes among wo men with a history tion for BC as a treatment for climacteric/menopausal symptoms. of cancer. j Clin Oncol200 I; 19:2739-45. While concerns about postmenopausal bone and cardiovascular 3. Lowdog T, Powell KL, Weismena SM. Critical evaluation of the health are now extended to alternative therapies such as soy bean safety of Cimicifuga racemosa in menopause symptom relief. (Glycine max (L.) Merr., Fabaceae) 14 and red clover (Trifolium Menopause 2003; 10:299-3 13. 4. Nesselhur T, Liske E. Pharmacological measures in postmenopausal women with an isopropanolic aqueous extract of Cimicifugae race mosae rhizoma. Menopause 1999;6(4):331. 5. Gaj dos C, Jordan VC. Selective estrogen receptor modulators as a new therapeutic drug group: concept to reality in a decade. Clin Breast Cancer 2002;2:272-81. 6. Anderson PW, Cox DA, Sashesgyi A, et al. Effects of raloxifene and hormone replacement therapy on markers of serum arherogenicity in heal thy postmenopausal women. Maturitas 2001;25:71-7. 7. Einer-Jensen N, Zhao J, Andersen KP, K.ristoffersen K. Cimicifuga and melbrosia lack estrogenic effects in mice and rats. Maturitas 1996;25: 149- 153. 8. Seidlova-Wurrke D, Jarry H, BeckerT, er al. Pharmacology of Cimi cifuga racemosa extract BNO 1055 in rats: bone, far, uterus. Maturi tas 2003;44(Suppl.1):S39-S50. 9. Nisslein T, Freudenstein J. Effects of an isopropanolic extraCt of Cimicifuga racemosa on urinary crosslinks and other parameters of Black cohosh Actaea racemosa Photo © 2004 stevenfoster.com bone quali ty in an ovariectomized rat model of osteoporosis. J Bone Min Metab 2003 (2 1);370-6. pratense L., Fabaceae) isoflavones as well as BC, inconsistency in 10. Bodiner C. Freudentsrein J. Influence of Cimicifuga racemosa on rhe managing vasomotor symptoms will severely affect patients' proliferation of es trogen receptor-positive human breast cancer cells. compliance with these products. Hopefully, future clinical trials Breast Cancer Res Treatment 2002;76: 1-10. will also seek dosages of BC that are likely to improve bone and 11. Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, cardiovascular health in postmenopausal women. Riggins CW, Rister RS, eds. Klein S, Rister RS , trans. The Complete Practice Implications: Questions continue as to whether BC is German Commission E Monographs: Therapeutic Guide to Herbal a phytoes trogen with mild estrogenic actions or is devoid of any Medicines. Austin, Tx: America n Botanical Coun ci l; 1998:90. estrogenic activity. While earlier studies from Germany and the 12. World Health Organization. WHO Monographs on Selected Medici nal Plants. Vol., 2. Geneva: World Health Organization; 2002:55-65. United States failed to find an effect ofBC on se rum estradiol, LH, 13. European Scientific Cooperative on Phytorherapy. ESCOP Mono or FSH levels, and no effect on endometrial thickness as well as graphs: The Scientific Foundation for Herbal Medicinal Products. 2nd vaginal cytology was observed, they did not look at markers of ed. Exeter, UK: ESCOP, rhe European Scientific Cooperative on bone resorption (the process of bone formation) nor at superficial Phytorh erapy; and Stuttgart and New Yo rk: Thieme Scientific cells in the vagina. The results of this trial suggest that BC might Publishers; 2003:79-91. have a mild effect on increasing vaginal superficial cells, however, 14. Serchell KDR. Soy isoflavones: benefits and risks from nature's selec not statistically significant to placebo. Also noteworthy were the tive estrogen receptor mod ulato rs (S ERMs). J Amer Coli Nutr increased levels of serum alkaline phosphatase - an indicator of 2001 ;20:3 54S-362S. increased osteoblast activity. The experimental pharmacological results as well as the above-mentioned clinical actions, together www.herbalgram .org 2004 HerbaiGram 61 I 35 plant patents Gum Guggul Extract as an Anti-Wrinkle Agent by Anthony L. Almada, MSc T he inventors assert that the ability of the novel constituents to increase lipid synthesis in mouse fibroblasts can translate into U.S. Patent Number: 66301 77 increased volume of the cell s and closer contact with the surround Dare of issuance: 7 October 2003 ing proteins in the skin, res ulting in the dermis (the elas tin- and Assignee: Parfums C hristian Oior (Paris, France) coll agen-ri ch layer just below the epidermis) becoming more Priori ty date (France): 13 September 1995 "consolidated." Two different anti-wrinkle compositions incorpo Products extracted fro m a plant of the genus Commiphora, partic rating the inventions are described, containing either 0.1 o/o ularl y the C. mukul plant, extracts containing same and applica (specific co nstituent molecule Ila) or 0.5% of a supercritical fluid ti ons thereof, fo r example in cosmetics extract containing both Ila and lib in amounts 6-8 rimes greater Background than that fo und in the native guggul res in. The all owed claims incl ude: 1) the method of using at least one extract from any T he wides pread practi ce of incorporating plant extracts in to member of the genus Commiphora to promote the synthesis of widely distributed cosmeti c products has recently encompassed triglycerides in skin cells, and thus "reducing depth of large and plants and their constituents from India, such as extracts oflndian small wrinkles" and smoothening the skin's appearance; 2) the frankincense (Boswellia serrata Roxb., Burseraceae). International methods of extraction to produce such an extract, including super cos meti c and fragrance brand C hristi an Oior discloses novel critical fluid extracti on with carbon dioxide; and 3) an anti-wrin constituents discovered in Commiphora species, especially guggul kl e product enriched in one of the elucidated molecules, or their (Commiphora wightii (Arn) Bhandari, syn. C. mukul (H ook. ex salts or esters, or their derivatives . Stocks) Engl. , Burseraceae). T he oleo-gum-res in of this plant is also known as gum guggul (obtained fro m d rying the milky white Notes sap of the tree) and harbors a number of constituent triterpenes . In Constituents of guggul have achieved commercial attention in the current patent the inventors subj ected guggul to a se ries of the past decade through their potential as blood choles terol/lipid ex tractions: the first step involved extracti on of guggul (preferen- and body composition-modifying agents. ' Notably, one of the most rigorous studies to dare examining the impact oflow or high doses of a standardized, commercially available guggul ex tract fa iled to show favo rable changes in blood lipid profil es in a study wi th 103 men and women with elevated LDL choles terol, with the two guggul groups showing signifi cant increases in LD L choles tero J.2 [Editor's note: T here was a statistically significant, al beit small increase in LDL (5 % in rhe low dose and 7% in the high dose), but because the LDL levels in the placebo group went down 5%, the between-group differences achieved significance.] The Dior patent describes a guggul constituent almost identical to a compound found both in C. wightii and C. myrrha (Nees) Engl. 3 T he compound, named myrrhanone A, diffe rs fro m Ila in the Dior patent only in the spati al (3-0) orientati on of one of rhe atoms in this large triterpene. It is likely that a cosmeti c company of Dior's stature would have undertaken some inves ti- Franki ncense Boswellia serrata Photo© 2004 stevenfoster.com gati onal human studies bur none were disclosed in this parent. _...- tially) with ethanol at obtaining a yield of T hey 95% 45°C, >26%. References: then applied biological assays of fracti ons derived fro m chromato I . Urizar NL, Moore, DM. Guguli pid: A natural cholesterol-lowerin g graphic separation. The bioassays indirec tly determined the ability age nt. Annu Rev Nutr 2003;23:303-13. of each fracti on to increase the synthes is of lipids in cultured 2. Sza papry PO, Wo lfe ML, Bloedon LT, Cucchiara AJ, mouse fib roblas t cells. Interes tingly, a fractio n rich in guggul s DerMarderosian AH, Cirigliano MD, Rader DJ. Guggul ipid in the terones, which are co nsidered the active constituents of guggul treatm ent of hypercholestero lemia. JAMA 2003;290:765-72. related to lipid, choles terol, and thyro id metabolism, was ineffec 3. Kimura I, Yoshi kawa M, Kobayashi S, Sugihara Y, Suzuki M, Oomi nami H, et al. New triterpenes, myrrhanol a and myrrhanone a, fro m tive in this assay and discarded. A fi nal fracti on was obtained that guggul-gu m resins, and their potent anti-inflammato ry effect on displayed the highes t activity in the bioassay and was subjected to adj uvant-induced air-pouch granuloma of mi ce. Bioorg Med Chern purifi cation. T his was then subjected to mass spectrometry and Lett 200 I; II :985-9. carbon nuclear magneti c resonance, to fully elucidate the chemical structures of the two active principles, named Ila and lib. 36 I HerbaiGram 61 2004 www. herbalgram.org plant patents Ginsenosides to Stimulate the Skin Elastin Synthesis by Anthony L. Almada, MSc the increases seen in a skin sample from each of the two donor women). The Rb -rich ex tracts from either Panax species displayed EU Patent Number: 1001 740 1 increases in elastin synthes is (compared to a vitamin C control) of Date of issuance: 15 October 2003 5.5-25%. The described examples of skincare formulations incor Ass ignee: LVMH Recherche porated from 0.2-0.5% of ei ther a sa ponins- ri ch extract or pure Priority dare (France) : 8 August 1997 Rb . Use of the Rb ginse noside for stimulating elas tin synthes is (in 1 1 The claims allowed in the patent relate to the cosmetic use of French) Rb 1, or plant extracts containing the same, to augment elastin Background synthes is and speci fi c concentration ranges of individual sa ponins; Ginsenosides are saponins derived from a variety of ginseng species. Two species of ginseng, Sanchi ginseng, also known as Tienchi ginseng (Panax pseudoginseng Wall. var. notoginseng, Araliaceae) and American ginseng (P quinquefolius L.) contain notably higher concentrations of ginsenoside Rb 1 than other ginse ng species. Numerous patents have described uses of ginseng extracts and specific ginsenosides for enhancement of skin and hair texture and appearance. In this patent, the inventors fo cus upon ginsenoside Rb 1 and its ability to increase the synthesis of the protein elastin in human skin cells in culture. They prepared various so lvent extracts of Sanchi and American ginseng roots to isolate the saponins, Rb 1-rich fractions, and then the chromatographically pure compound Rb 1. To rest the biological activity of the fractions, they used facial skin samples obtained surgically, from two women aged 50 and 47 years. Fibroblasts (connective ti ss ue cells that secrete coll agen and elastin proteins) were cultured fro m the skin samples. The cells were then exposed to diffe rent concentrations of the saponin-rich extract or pure American ginseng Panax quinquefolius Photo © 2004 stevenfoster.com Rb 1 and allowed to incubate for 48 hours. Then the culture fluid was analyzed for elastin, which would have been the inclusion of vitamin C, an extract of goru kola ( Centella asiat secreted by the fibroblasts into the culture medium. In comparison ica (L.) Urb., Apiaceae) and an extract of "ginseng" particularly to a culture to which vitamin C had been added (a known cofac ginsenoside Ro; an extract of "Filicium decipiens" and an ex tract tor in elastin sy nthesis), the combination of vitamin C plus pure (presumably of the leaves) of loquat (Eriobotrya japonica (Thunb.) Rb led to 10-21% greater elastin synthesis (the range pertains to 1 Lindley, Rosaceae) and platelet-derived growth factor; or vita min A, or vitamin E. Notes LVMH Recherche has undertaken a number of investiga tions of plant-derived bioacrive compounds for perso nal care applications. This novel finding, confirmed in cultured human donor ski n fibroblasts, offers a greater degree of confi dence that a cosmeti c product exploiting the in vention would indeed have a measurable effect on elastin synthes is as evidenced by visible changes in skin appearance. It is commonplace for cosmetic ingredients that are sold in commerce to rest upon an evidence base that is limited to such in vitro investigations. Nevertheless, give n the enduring quest for natural products, especiall y those derived from plant biomass, as being ac tive agents within cosmetic products, and the widespread fa miliarity with "ginse ng," this application may prove successful. ,... Tienchi ginseng Panax pseudoginseng Photo © 2004 stevenfoster.com www.herbalgram.org 2004 HerbaiGram 61 I 37 {The following article is based on a presentation given by the late Marlin Huffman at tire American Herbal Product Association's St. fohn's wort conference in Anaheim, California in March 1998. At the time of his death in November 2002, Mr. Huffman was a highly respected producer of saw palmetto and other herbal materials through his business, Plantation Medicinals in Felda, Florida. While his speech focused on the commercial cultivation of and the market for St. John's wort, many of the business and market principles related to the growing of this formerly much more popular herbal medicinal crop apply to the cultivation of most other medicinal herbs. At unities a time when the herb industry is increasingly concerned about conservation of wildcrafted herbs and developing a sustainable supply of these plants through ethical harvesting of wild medicinals as well as their commercial cultivation, Mr. Huffman's experience and sage advice are as relevant today as they were five years ago. We have slightly edited this presentation for publication, while for Herb Farmers attempting to preserve Mr. Huffman's personal $peaking style. For a view of Mr. Huffman's life, please see Steven Foster's memorial in HerbalGrarn 57. -Editor} have been asked to discuss today St. John's wort from a farmer's viewpoint. I think I can do this as we are dirt the ase of · farmers growing and collecting the crops we market. We have cultivated small acreage of St. John's wort [here I inafter called SJW] for several years at our South Dakota and Kansas farms, and we have tried cultivation also at our Texas farm. We have some substantial acreage of one-year-old t. John's cultivation. Cultivators of the soil, farmers view the world about them, the product they cultivate, and the way they do business from a somewhat different viewpoint than the buyers, dealers, manu ort facturers, users, and scientists of the same product. I will discuss SJW from the farmer's perspective. We must remember in dealing with a farmer, as is the case with all other folks, that his or her perception, regardless of whether it is right or wrong, tends to be his or her reality. Prices of the dry SJW herb have risen from $2.50 per kilo gram (kg) or $1.13 per pound (lb) in 1995 to $8.00 per kg or $3.91 per lb at present [1998]. We can expect high prices for the next two or three years, and then, I promise you, the price will fall out the door and down into the cellar. [This was a prescient prediction; SJW prices are now (November 2003) around $0.90-1 .35 per lb., with prices being less a function of availability by Marlin Huffman (there are ample supplies available), but more dependent on qual devoted to the plant have, ironically, been focused on how to ity and the presence of certain of desired marker compounds. eradicate it fro m rangeland. Despite its value as a medicinal -Editor] plant, eradication programs have been developed in Canada, At the worst, if the herb does not live up to its newfound repu California, Oregon, Washington State, Idaho, and Montana, and tation, or if the results of the forthcoming clinical trial funded by Australia to eliminate this invasive foreigner. A natural enemy of the National Institutes of Health (NIH) are negative, the prices the plant, the Chrysolina beetle, has been used in California, will go as low as $3.00 per kg and demand could go to about Oregon, Washington State, and Australia, and introduced in zero. [Another interesting prediction; the NIH trial on SJW funded Canada as a natural biological control to kill the plant. However, by the National Center for Complementary and Alter- this beetle has been marginally successful. [This native Medicine published in April20021 resulted marginal success in the wild has been tempered by in a failed study. Neither SJW nor sertralin e We can expect the beetles' devastation of some commercial (Zoloft"') showed any efficacy in the trial, cultivation plots. - Editor] which was conducted on patients with hieh prices for Establishing a crop of SJW by severe major depression. -Editor] the next two or direct seeding in the fields has been If the herb does live up to its three xears, and then, one of our biggest challenges in my reputation, or if the NIH trial 40 years of farming and we still produces positive results, we can I promtse lou, the price have not succeeded well. Costly greenhouse plants can be used to still expect high prices for the next will 3 to 4 years, but after this, prices will fall ou the door secure a good crop fairly easily with go down from current levels. I say this and down into the cellar. the usual agricultural practices. because most every person in the U.S., However, the cost of greenhouse plugs Chile, Australia, and China - who has will become cost-prohibitive in the next heard of SJW, and owns a shovel and a hoe, and a few years. [Of course, this is all relative to th e few dollars to buy seed - is planning on trying to grow a price of the product, the yield per acre (or square foot in little or a lot of acres of SJW. Those few farmers who are truly greenhouses), and timeframe required to produce a harvestable good farmers and horticulturists will succeed. A large percentage crop. -Editor) will fail. Growing St. John's Wort While SJW is native to Europe, it has naturalized in waste omeone will ask, why report that SJW is a hard plant to places and along roadsides in Asia, North and South America, establish when it is considered a noxious weed in a number and Australia. It is one of those native European plants that has of areas over the world? followed European settlers wherever they have traveled in the S world. Early settlers introduced the plant to North America, and I will answer that question by saying that if you have a bare by 1793 the first recorded herbarium specimen was collected in piece of alkaline acreage that you want to grow SJW on and have Pennsylvania. z 10 years of time, it is an "EASY GO." Especially vigorous populations in western North America Just throw out 2 pounds of expensive seed per acre for each of and Australia have made it a serious weed problem. [SJW is about 4 or 5 yea rs, spray the grass twice a year with a grass kno wn as Klamath weed or goat weed in the Pacific Northwest. killing herbicide, mow the remaining weeds 2 or 3 times a year, - Edito r] It is particularly aggressive in poorly managed and and wait until your 9th or lOth year, and "presto"- yo u have a overgrazed rangeland with dry summers. Historically, the great good solid crop cover. However, your cost of land, seed, herbi est economic importance of the herb focuses on SJW as a seri cide to kill the grass, and interest on your investment by this ous weed of rangeland in Europe, Asia, North and South Africa, method will make your cost far more than the coming market Australia, and eastern and western North America. [Hypericum will bear. perforatum is listed as a Noxious Weed in the states of North Most of us don't have the 10 years of time, or want to support Caro lina, South Dakota, Montana, Colorado, Washington, the cost of 2 pounds of seed a yea r for 4 or 5 years, and the cost Oregon, Californ ia, and Nevada. -Editor] of herbicides and mowing for 8 or 10 years. Wild SJW in rangeland is a major problem because in seasons Geographical location of cultivation is important. Successful when foliage is limited in pastures, livestock will consume SJW cultiva tion must be somewhere close to or between the 42 nd and and their skin then becomes sun sensitive, even to the point of the 47th parallel North or South to grow a good crop of medic death in many cases. [From an ecological perspective SJW presents inal St. John's wort. The most vigorous SJW plant colonies in the a problem as it chokes out some native grasses, thereby reducing wild only grow naturally from the coast inland to about 200 potential natural forage for grazing animals and increasing their miles from the sea coast, and not in the interior of the conti reliance on SJW as a food source. -Editor] nents. SJW grows wild in the northwest area of North America Most of the North American scientific studies that have been to about 200 miles inland in northern California, Oregon, Wash- www.herbalgram.org 2004 Herba!Gram 61 I 39 ington, Idaho, and British Columbia. On the East coast of the strongest 2 will crowd out the others within a couple of months. North American continent, wild SJW grows well inland to about If only one comes up, you still have a plant. 200 miles in such areas as Maine, Massachusetts, Connecticut, Greenhouse plants sowed in January wi ll be large enough to New Hampshire, Vermont, eastern New York, and eastern set out in the field in mid-May. Germinate cool, at around 45° to Canada. It grows well in southeastern Australia and northwest 50° F, then grow at 60° F. Keep moist and be sure you have well ern Europe (Poland, Germany) both fitting between 42nd and drained alkaline soil. Having wet feet [not letting the roots dry 47th parallels. out between watering] kills SJW seedlings quickly. Also, make Yes, I know, someone will say it grows wild in my area of Texas, sure soil is at least 6.8 pH- 7.2 pH would be even better. Georgia, Minnesota, or eastern Kansas. But, I ask, does it become For outside direct field seeding, sow in late autumn or even in a noxious weed of concern in these areas and does one of the the early winter. The timing should be late enough so the seed biologically active ingredients and common marker compound, will not germinate. Let the seed lie all winter. It will germinate in hypericin, average 0.2%? If the answer is no to either one of the spring. Direct seeding has not been very successful for us. these questions, then I rest my case, as SJW culture becomes even The reason for failure is that even when we put in enough seed more risky. to ensure germination of 300,000 to 400,000 seedlings per acre, So, our rules regarding optimum growing location for SJW are the seedlings are so small, they do not compete well with the as follows: weeds and grasses. These small seedlings must have constant SJW must have slightly alkaline to highly moisture for the first 60 days and this requires some alkaline soil. type of nursecrop [such as an annual grass] to SJW should be grown Those few farmers hold in the moisture, limit weed growth, between the 42nd truly good .f.armers give shade to the small seedlings, and 47th parallel who are I' and provide wind protection. At N 0 h or h • l • d the same time, the small SJW So ~:h , and and OftlCU tunsts will SUCCee . seedlings require a very moist within 200 A large percentage will fail. micro eco-level at the soil miles of the seacoast. line. To do this requires good drainage and perfect irrigation control. High levels of hypericin are most easy to obtain at altitudes of 1,800 feet or more. [At the The constant moisture necessary to provide the described time of this speech, most S]W extracts were standardized to micro-conditions brings rapid and rampant weed growth, hypericin content, primarily as a marker compound for qual which, in turn, out-competes with the small seedlings. ity control purposes. Although biologically active in various Three- to five-month-old plants from the greenhouse set in ways, hypericin has little demonstrated activity for the most the field at the rate of 30,000 to 40,000 per acre in rows can be commonly used benefit of SJW (i. e., in affecting mild to cultivated and hoed, or treated with a pre-emergence herbicide. moderate cases of depression ). -Editor] This method has proven successful for us, but again this method • Land should be workable with machinery as hand-harvest is very costly and in future will become cost prohibitive. ing and weed-control costs will never compete well in world Let's discuss varieties. The highest hypericin content seems to markets when the prices fall due to oversupply. come from the narrow-leaf variety, which is native to the south Now, let's talk about seeds and plants and how cultivated SJW ern part of SJW's range in Europe. This narrow-leaf variety can be established. normally has a much higher percentage of hypericin than the more broad-leaf variety from the northern part of the European There are around 2.5 million SJW seeds per pound. About natural growing range. 30,000 to 40,000 SJW plants can be grown per acre. The seed contains a naturally occurring germination inhibitor on it at The SJW growing in Chile, Argentina, Australia, northwestern seed maturity. This inhibitor evolved to prohibit the seed from US, and western Canada appears to be the narrow-leaf type. germinating when it falls to the ground in late autumn as the However, there are some genotype differences among the South small seedling might not survive the winter. American versus Australia versus western US types. All are high producers of hypericin, but have some various differences in the We find washing the seed with running water, or treating it biomass growth. with nitrogen oxide, or freezing in a freezer for 30 days all help to deactivate the inhibitor. But, at this point, we still have prob There have been some selections of SJW made by European lems getting good germination results. seed companies and the best known is Topas. There is also a To pas II and several other selections. From our point of view, we We compensate for germination problems by sowing an over still find the northwestern US type the best. abundance of seed in order to get the plants we want. If you need I or 2 plants to a plant cell for greenhouse production, then put Plants set in May from the greenhouse need constant good 8 or 10 seeds in each cell. If, per chance, all 8 or 10 come up, the moisture in the first growing season. We are afraid to try grow- 40 I HerbaiGram 61 2004 www.herbalgram.org ing without irrigation. This means cutting One fertilization of 50 only the top 6 to 8 pounds of potash and inches of the flower 50 pounds of nitrogen ing tops. If some of per acre will suffice for the flowers have been the first year. pollinated and seed The young plants pods are appearing, lay flat on the ground you have missed the and are very insignifi window of opportu cant the first year and nity for the highest very subject to compe quality. American tition from (other) manufacturers of weeds. If they are 5- capsules may month-old plants purchase older mate from the greenhouse, rial, but the extrac you can expect that tors who buy the big 10% or 15% of the volumes and stan plants will throw off dardize extracts to small flower stalks in hypericin levels will late July and August of avoid the over-aged their first year. These product because of St. John's wort Hypericum perforatum Photo © 2004 stevenfoster.com flower stalks, in our its low hypericin experience, are not content. enough to warrant economical harvesting and their active ingre We harvest our crop with a self-propelled forage harvester dient is very low. We let them go to seed and hope the seed will with an electric eye control on the header, so we are always fall to the ground and germinate the next spring and increase cutting the product at the correct height. We dry the product in plant population. a chain dryer [a continuous belt flow dryer] with heat profiles Contrary to some literature and several US promoters who not above 130° F and in total darkness. Sunlight or artificial light indicate one can expect a crop the first year, one cannot get a good in only a few hours quickly destroys the hypericin and the prod first-year harvest from direct seeding or from plants. In our expe uct is then no good for extractors. rience, it is totally unrealistic to expect a good crop the first year. For this reason field sun drying will not work, contrary to In the second growing season, the still small, flat plants appear what some wildcrafters and collectors and promoters are doing. early in spring. In the first 30 days of the second growing season, One must dry in the dark and this generally calls for using these small insignificant plants will send out root rhizomes and commercial crop dryers. each plant should become 3 to 4 plant centers. The mother plant We package the dry material by baling and putting the bales in (a second-year plant) will produce second-year flowering tops. burlap bags, which are sewed shut. The rhizomes will produce next year's flowering tops. An acre of second year SJW, well-watered and fertilized, can By late June or early July in the second year, the small plants yield a second cutting 4 weeks after the first. Two cuttings can be suddenly explode. The appearance of the foliage changes. The expected to yield between 1,000 and 2,000 pounds per acre the plant begins growing upward. In the space of 3 weeks, the origi second year and for the third and fourth year. After 4 years, we nal small, flat plants, not the new rhizome plants, will put out find yields decrease and new plantings are more efficient, cost leafy flower stalks from 20 to 30 inches tall. Each plant wi.ll have wise. from 1 to 20 flower stalks. Buds will form and flowers begin to At present, high prices of $8.00/kg and more a pound, this is a open. fair profit. The prices we expect in 3 to 4 years from now will At this stage, harvest must be made if you are to only be marginally profitable for the grower. However, have a high level of hypericin. Hypericin is the farmers who use 100% machine culture and presently considered a species marker; In our experience, harvesting, and use chemical weed many scientists are now speculating control and rapid dehydration and looking for the true active it is totally unrealistic equipment, may be able to secure compound(s). Only the buds and reasonable profits if they engineer flowering tops, including top leaves, can to expect a good crop an agricultural method to direct field be harvested if you expect 0.1-0.2% seed or if they develop a source of very, hypericin content. the first year. very cheap greenhouse plants. www.herbalgram .org 2004 HerbaiGram 61 I 41 I want to discuss one other problem before we go to SJW effective in Eastern Europe and could be put into effect in China. marketing and cultivation from a farmer's viewpoint. SJW is To motivate a subsistence farmer to grow an herbal or considered, by law, a noxious weed in California, Oregon, Wash nutraceutical crop or SJW means you must finance the seed, ington, Idaho, Montana, Maine, Nova Scotia, and many other fertilizer, and water, and then buy the crop. To do less will places. Normally, noxious weed laws have exceptions in which destroy his cash flow (i.e., his survival) and, normally, he just will you can get a permit to grow them, if the grower meets certain not do this without some security such as advances for cost and conditions of control. living expenses. Some state and local weed committees, due to their lack of The other type of farmer, the commercial farmer, grows crops information, refuse to even consider issuing an exception to make a profit. This type of farmer knows they can make a permit. In reality, you should not let your crop go to seed, as only living of some type working in town for someone else, but prefer buds and flowering tops are marketable. In reality, SJW to farm because they can either make more profit than work in seedlings, the first year, cannot survive in an active pasture, culti town or because they prefer the lifestyle - even though it may vated field, or a plowed field. They will only survive on disturbed provide only equal profit to town work. soil that is not further disturbed for one year, such as roadsides, To motivate this commercial farmer to grow herbs or new road cuts, and abandoned fields. nutraceutical crops, the crop must provide a reasonable chance From personal experience, I can tell you of several areas in the of profit, superior to growing commodities such as food or fiber. northwestern US where local and state committees did refuse to Food or fiber you can always sell somewhere, even if there is an even consider our application for an exception to their noxious oversupply. One can even sell at a low price to recover (most) weed restrictions. Don't assume that these noxious weed laws are costs and some cash flow. Commodity production such as food or fiber on a good year returns a 4-10% profit margin. In an oversupply year, commod ity production can cause a 4-10% or more decrease in cash flow, but it will produce some cost protection and cash flow and with cash flow, however poor, the farmer and his family will eat and be able, normally, to borrow enough money from local bankers to put another crop in next year. A 4-10% gross profit margin is a small margin compared to most other industries, but the volume is high and the margin is somewhat secure on a commodity. So, it is cash flow that first motivates the commercial farmer; second, it is secure cash flow; and, third, it is profits. The commercial farmer must see a return supporting his cash flow and profit. He must feel secure that he has the technology to grow and harvest the crop and a profitable, secure market to sell the crop at profits superior to growing food or fiber. St.John's wort Hypericum perforatum Photo© 2004 stevenfoster.com On our farms, both foreign and domestic, we can grow herbs and nutraceutical crops. But what interests our company (and we are typical) is, we must see extremely good gross margins toothless, as my company has already run into two near disasters (50-100%) if we are growing for speculation market. We must with this type of thinking. If you plan to cultivate SJW, contact have the 20-100% margins to cover the risk of several years' local authorities and get a written commitment from them. exposure until maturity, as most nutraceutical crops are multi year to harvest and we must have the possibility of getting our SJW Marketing investment money back, plus 10% interest. et's discuss SJW marketing from a farmer's perspective. First let's divide farmers into two groups: subsistence How can any farmer or our company do this on SJW? Lfarmers and commercial farmers. ne way is to have a firm, legally enforceable contract at A subsistence farmer's primary (and often only) motivation is a fixed selling price. No farmer wants to risk selling his survival of his family. Survival of his family depends upon cash 0 crop for less than market price or below cost, so we, or flow, even more than actual profits. His farm is small. He may or any other commercial farmer, must set this contract price high. may not own the farm, but food and shelter for his family is his To motivate us to contract, we and most other commercial farm main concern. The subsistence farmer, if advanced production ers will only take a specialty crop on a firm contract for volume costs by the front line buyer, can be motivated to grow small lots and price, which has security of a high return. of SJW using low technology. This is typical of what has been 42 I HerbaiGram 61 2004 www.herbalgram .org This is the only situation that interests us in contracting for What do I see as the future for our company in SJW 100-500 tons of SJW, and we are typical. cultivation? The manufacturer/buyer in this type of contract gets the serv ven though we have 1,000 kg/2,200 pounds of good ice of security of supply at what usually sounds like a high price. northwestern US seed, we do not feel comfortable to spec However, the manufacturer/buyer from the farmer's viewpoint Eulate on this crazy market without firm contracts at good has to pay for the risk the farmer takes and the service the farmer prices or joint venture partners who are manufacturers and will gives in providing a secure volume at a firm price. share the risk with us. The other situation we and most other commercial farmers Why? As I said in the beginning, from our contacts worldwide will consider is a joint venture. In a joint venture, we, the farmer, along the 45th parallel North and South everyone with a little commit to providing the land land, a hoe and a shovel, and a and day-to-day management, knowledge of present SJW and the agricultural technol prices and demand is trying to ogy. The manufacturer/buyer put in some SJW. puts up the cost of seed, labor, This goes for Argentina, fuel, and special equipment Chile, Australia, Western and needed; and we two parties Eastern Europe, Russia, and split the profits produced by China. The states in the US the venture. include California, Oregon, Thus, the manufacturer - Washington State, Idaho, for the security of the supply Montana, Maine and even the and for security of getting northern part of middle states. product at market prices - I predict 90% of these farm commits to guaranteeing the ers will fail or only produce direct costs. Further, the very low quality and will give manufacturer gets half of the up. But some 10% of the total net profit back as return on group will succeed in doing his investment. We, the well enough to continue. farmer, risk 2 to 3 years of St. John's wort Hypericum perforatum Photo © 2004 stevenfoster.com The successful ones, land cost and management, predict, will be commercial office and bookkeeping services, and non-special equipment use farms. Whether large or small, I do not know. Farmers in and farm overhead for the possibility of half the profits from the Germany, northern France and, most certainly, the larger players end results. in Chile will be successful and probably a couple farmers in the Other than these two possible arrangements of firm legal US. In time, we can also expect the Chinese to succeed. contract at attractive prices based on today's market or a joint As I just mentioned, it will be the commercial farmers and venture, we and most other commercial farmers will have little thus at the first signs of good profits, many hundreds, if not interest in growing. thousands of hectares (2.5 acres) will be planted by the success Now, I can assure you that there are hundreds and maybe even ful producers, neighbors, and friends and the price of raw prod thousands of small and large landowners in the US, Europe, uct will gain commodity status. South America, Australia, and China who will jump at the So, if present demand continues or increases, we will see high opportunity to grow SJW since they have heard of its popularity, prices for at least 2 more years and maybe 3, then an oversupply demand, and price. and much lower prices ...... - But, I ask you, are these people truly commercial farmers with References: current agriculture technology and persons who have an 1. Hypericum Depression Trial Study Group. Effect of Hypericum adequately stable financial base, and the machinery, and perforatum (St. John's Wort) in major depressive disorder-A management skills to produce the product? Most of these randomized controlled trial. lAMA 2002;287: 1807-14. opportunists will not meet these criteria. 2. Sampson AW, Parker KW. St. Johns-wort on rangelands of Califor Plantation Medicinals has substantial SJW acreage under firm nia. Berkeley, California: California Agriculture Experiment contracts and is working on a positive joint venture, but we have Station; 1930. Bulletin 503. Cited in Crompton CW, Hall IV, Jensen only a small acreage of uncontracted production ready to KIN, Hilderbrand PD. The Biology of Canadian Weeds. 83. Hyper harvest this year. We are going to plant this year only another icum perforatum L. Canadian Journal of Plant Science 1988;68: 149- small acreage for these speculation sales. 162 www.herbalgram.org 2004 HerbaiGram 61 I 43 Because these books were intended as onions they used to eat in Egypt. "We a compendium of the most essential remember the fish, which we were knowledge, they left out information wont to eat freely in Egypt for about many things, including the art nought; the cucumbers, and the of medicine and the medicinal uses of melons, and the leeks, and the onions plants in the land of Israel. However, and the garlic ... " Qewish Publication by studying the references to medi Society version, Numbers 11:5). cine, nutrition, and the use of plants Garlic and onion are mentioned here in Talmudic discourses, we can find as edible vegetables, dear and familiar traces of the lost knowledge and learn to everyone. a great deal about every-day life in In the collection of Jewish oral law ancient Israel, the attitudes of the and tradition known as the Mishna Sages towards health and illness, and the Talmud, garlic and onion are doctors and pharmacists, and the use always mentioned in connection with of indigenous and imported plants. In regulations concerning the Sabbath, a few places, we find interesting and the sabbatical year, hybridization, apparently valuable medical prescrip tithing, etc. Thus, there is much tions, though we cannot tell what the information to be gleaned from these plants they refer to are and conse references. quently can make no use of them. For example, among the numerous The present article on the uses of species of garlic and onion known in garlic and onions in Jewish sources is Talmudic days, some were cultivated part of the ongoing research into what locally while others were imported a people returned from the four from neighboring lands. The onion, corners of the Earth to the land of in Hebrew batzal, is rendered vari their ancestors can learn from the ously as batzal, betzalim, butzlana or ancient books about their medical in Aramaic, (the language commonly tradition. spoken by the Hebrews from approx Garlic and onion have been known imately 700 B.C.E. to 900 C.E.) as to humankind since the dawn of shamcha. A distinction is drawn history, and were among the first between batzal and betzaltzul, but plants ever to be cultivated. Already in there is no rule against cross breeding ancient times a great many species them (Kilaayim, Chapter 1, Mishna and varieties of garlic and onion were 3) , for although ancient Jewish law recognized. Garlic (Allium sativum forbade the cross-breeding of different L.), onion (A. cepa L.), and leek (A. species of plants and animals, it did porrum L.) all belong to the family not forbid the hybridization of sub Liliaceae (also placed in family Alli species or varieties. aceae). The genus Allium includes Immanuel Loew, the German about 320 species. In Israel, more Jewish scholar who pioneered the than 40 of these grow wild. 1 study of plants mentioned in ancient The Israelites, like other ancient Jewish sources, designated the peoples in the Middle East, were fond betzaltzul as A. ascalonicum.2 ·3 This of eating garlic and onion and like species is referred to in the writings of wise valued them as medicinal plants. Theophrastus who lived in the fourth There are numerous references to century B.C.E.4 Theophrastus specifies garlic and onion in Jewish sources that the askolonion does not have containing information about their cloves, is cultivated from seeds, and cultivation, their importation from grows at an extremely fast rate. other lands, and the diversity of uses Why was there a need to import made of them, whether as food, onions and garlic to ancient Israel seasonings, or remedies. from other lands? Was the yield of Garlic and onions are frequently local crops insufficient or were there mentioned in the Bible in the Book of years of drought? One reason might Numbers, where the people of Israel, be the need to provide fruits and wandering through the desert, cry out vegetables during sabbatical years, to Moses that they miss the garlic and every seventh year in which, accord- Top: Garlic Allium sativum Photo © 2004 stevenfoster.com Bottom: Onion Allium cepa Photo © 2004 stevenfoster.com ing to Biblical mandate, fields are required to lie fallow (Ex. 23:10- The onion was a common and inexpensive food: "Said Rabbi 11 , Lev. 25:1-7, 18-22): > the laws of tithes and the sabbatical year Yohanan quoting Rabbi Yehuda Berabbi Elai: Eat onions [batza~ pertai ned solely to the Land of Israel and did not apply to and sit in the shade [batze~, and refrain from eating goose and imported fruits and vegetables. As stated in Tithes 5, Mishna 8: chicken lest your heart overcome yo u" [lest the gluttony of eating "Garlic [baal-bekhtl and onions of Rikhpa .. . are exempt from the rich and expensive foods lead yo u to poverry] (Pesachim 114a). tithes taken from every man in the seventh [and may thus be freely Onions here signify a cheap and simple diet. purchased]." Garlic of the baal-bekhi variery grew in Baalbek The leaves of the onion were eaten raw. It was customary to pick (Heliopolis) in Lebanon, and Rikhpa too seems to be the name of green onion leaves while they were still growing and to leave the a place outside the Land of Israel. In Talmudic literature it is bulbs in the ground till they were full-grown. This comes from a described thus: "What is garlic baal-bekhi? One that has a single Talmudic discussion about the laborers who picked onions. (Baby bulb and no cloves. And what is the onion ofRikhpa? One that has lonian Talmud, Babba Metzi'a 89a). The law discussed here refers a crushed stalk. Rabbi Shimon ben Gamliel says, any [variery] that to what agricultural laborers were allowed to eat while they has a single skin." These species or varieties were morphologically worked. Usually, they were permitted to eat freely of the fruits and different from the ones cultivated in the Land of Israel, and were vegetables they harvested when the job was done, but not the thus easily identifiable. leaves of the onion, because they were not harvesting the onions Maimonides, who lived in the 12th century C. E., writes: "The themselves, and therefore ·their work was not finished. baal-bekhi garlic is extremely pungent [bekhi is the Hebrew word A number of passages in the Talmud refer to onion bulbs as "the for crying] and causes the eyes of whomsoever eats it to lachrymate mothers," as distinct from onion leaves. Clearly, the significance of .. . The onion of Rikhpa is likewise very pungent, and when it this appellation is that when planted in the ground, the bulbs comes in contact with the eye, causes it to fill with tears" (explica produce new leaves. tion of the Mishna, Tithes 5, 8). Maimonides adds that the two Onions were roasted over coals, baked in ovens, pickled in vine imported varieties differed both in taste and in physiological effect gar or salt, or cooked together with foods like lentils (Terumot, from local varieties: they were more pungent than the garlic and Chapter 10, Mishna 1) . They could be cooked whole and eaten as onions grown in Israel and were known to be lachrymatory. a vegetable, or sliced and chopped and added as a flavo ring to Another variery of onion is referred to in tractate Nedarim 9, other dishes. Mishna 8: "I vow that I will not eat onion because it is bad for the It was customary to eat the onion one leaf at a time, much the heart. They [the sages] told him: But the kofri onion is good for way people eat artichokes today. The "heart" of the onion and the the heart, thus the kofri variery is permitted to you." The Jews of bud were considered the best parts and were saved for last. A this period deliberately imported varieties that were different and person who ate an onion in the reverse order was considered a glut easily identifiable in order to prevent fraud during Sabbatical years ton. "One should not eat garlic or onion from the base but from when it was forbidden to sell local produce. the top, and anyone who does otherwise is a glutton" (Babylonian In the period of the Mishna and Talmud, there were varieties of Talmud, Beitza 25b). Onions were sold as they are today, either onion that were cultivated solely as food and not for seed produc green or dried (Pe'ah, Chapter 3, Mishna 3). tion: "Deprive the eunuch onions and the Egyptian cow bean of water for 30 days before Rosh Hashana (the new year) [after which The Physiolo~ical Properties of the they are harvested] and they will be tithed for the previous year." Onion in JeWish Sources (Sheviit 2, Mishna 9). Eunuch onions were grown as food and The onion is considered a hot, tonic, lachrymatory plant that were prevented from flowering and producing seed. It was custom stimulates salivation, and also an emmenagogue [s timulating the ary to stop watering them one month before the harvest so that flow and activiry of menstruation] (Nida 63b). It is usually praised they would harden and dry a little. The ancients knew that lack of in the sources for its healing properties, but there are several water would prevent further growth because the onion roots caveats: against the eating of stale, peeled garlic or onions for degenerate in dry soil. Thus, if irrigation was terminated 30 days instance, thought to have fatal consequences, though it is not before the New Year, it was permissible to eat the onions after the exactly clear why this was so (Nida, 17a). new year on a sabbatical year. The same held true with regard to Likewise, it was considered advisable to avoid eating the hot, tithes: though the onion was culled after the New Year, it was pungent onion after letting blood and to stick rather to foods with tithed according to the previous year because it had ceased to grow. cooling and calming effects (Avoda Zara, 29a). In the Talmud, garlic, onion and leek are referred to generically The following Midrashic tale suggests that onion was thought to as khassiot, or in the singular, khasit: "These are the different vari be an antiseptic. ''A story is told about Rabbi [Yehuda] that as he eties of khassiot: Luf and garlic and onions and kajlotot [presumably walked to Jerusalem, he met a boy. He asked the boy, Is the water leek]. Rabbi Yehuda says: the only variery of khassiot is the kajlot" clean enough to drink in this ciry [Jerusalem]? The boy answered, (Tosefta Terumot, p. 41). Why worry? There are onions and garlic aplenry here" (Midrash The leek is known by different names in various Jewish sources: Eicha Rabba, 1, 19). The young Jerusalemite of this story is khatzir, karti, krisha, krishin and kajlotot. Loew writes that these thought to be clever because he understands that even if the water are all varieties of the leek cultivated in different ways, either for were not pure, the antiseptic effect of the garlic and onions would their green leaves or for the white leaves that grow underground.3 reduce the level of pollution. These examples show the difficulry of identifying plants with Throughout the history of the Jewish Diaspora (the dispersion any certainry. The leek, as shown above, is referred to in Jewish of the Jews after the Babylonian exile), there are references to the sources by at least 10 different names, under the influence of the medicinal use of onion both externally and internally. The Jews of languages of surrounding cultures. In any case, according to Loew, Yemen use onion to treat respiratory ailments. They eat it crushed, the A. porrum is intended here. mixed with sour goat's milk and crystallized sugar. To treat liver ailments, they recommend swallowing a large spoonful of crushed The Use of Onions onion and lying on the belly. 6·8 To cure sore throat, the Jews of Onions were eaten fresh or dry, raw, or cooked in sundry ways. Kochin (an ancient Jewish settlement in India) use a decoction of 46 I HerbaiGram 61 2004 www.herbalgram.org onion and lemon juice. For swelling around the eyes, the Jews of garlic. It satisfies the appetite, heats the body, gives a good color to Morocco make a poultice with warm oil and onion.6 the complexion, increases semen production and kills li ce [para Among many ethnic groups a poultice made with fried or baked sites], and some say that it brings love and dispels jealousy because onion is used to treat swelling or pain. Onion juice is used exter it gladdens the heart" (Saba Kama, 82a). nally to relieve ear ache and eye strain, snake bite and scorpion Tractate Gittin contains this suggestion for the use of garlic as a sting, to disinfect wounds, and to treatment for toothache: "For remove warts. To treat burns a toothache, said Rabba, son of Rav mixture of onion juice, egg white, Huna, one should find a whole and a little coarse salt is spread on garlic growing wild, crush it with the affected area. Syrup for treat oil and salt and put it on the ing respiratory ailments is made thumbnail on the same side where with finely chopped onion the pain is with a ring of dough soaked in honey overnight.6·B around it to prevent injury to the skin" (Gittin 69a). The garlic that Garlic in Jewish grew wild was a particularly Sources aromatic variety without cloves. The Israelites' well-known This suggested external use of predilection for garlic ("We garlic for the treatment of an inter remember ... the leeks, and the nal problem indicates that the onions and the garlic" [Numbers Talmudic sages were aware that 11 :5)) was abhorrent to the aromatic plant ingredients pene Romans who called them "garlic trate the body through the skin eaters." and that aromatic oils could burn The Samaritans who were Garlic Allium sativum Photo © 2004 stevenfoster.com the skin (thus the protective ring of settled in Samaria by the king of dough). Like most ancient Assyria to replace the exiled Hebrew tribes adopted many of the cultures, they knew that garlic had to be crushed in order to extract latters' customs and were also called "garlic eaters." In the Talmud its active ingredients. they are sometimes referred to as Kutim. "He who makes a vow [to That the skins of both onion and garlic were used to relieve pain avoid people who] eat garlic, must avoid both the Israelites and the is apparent from the laws of the Sabbath Observance, where their Kutim," (Tractate Mishnayot Nedarim 3, Mishna 10) the reason use on the Sabbath was permitted since they were considered reme for this being that the Kutim, like the Israelites, observed the dies (Maimonides, The Rules of Sabbath Observance, Hilkhot custom of eating garlic on the Sabbath Eve. This was one of ten Shabbat, 19, 13). precepts decreed by Ezra the Scribe upon his return from Baby Notwithstanding the high esteem in which garlic was held by lonian captivity, and is observed by most ultra-Orthodox commu many Talmudic sages, some express their abhorrence to its smell, nities to this day. The reason behind this strange rule seems to be as evident in this story told in the Talmud about the piety of Rabbi that garlic, considered an aphrodisiac, would induce sexual rela Hiya: "Rabbi [Rabbi Judah Hanassi] was sitting and teaching tions as advocated on the Sabbath eve. In Tractate Shabbat the when he caught a whiff of garlic. Because he was squeamish, he question is asked, "What increases pleasure on the Sabbath?" to could not stand the smell. He said: He who has eaten garlic, let which one answer, among others, is garlic (Shabbat, 118b). him leave. Rabbi Hiya departed. After him, everyone left, to honor Rabbi Hiya. The following morning Rabbi Shimon, the son of The Uses of Garlic Rabbi Judah Hanassi met with Rabbi Hiya. He said to him, Are It was customary to eat the leaves of yo ung garlic bulbs picked yo u the one who vexed my father? Answered he, Never" while the plant was still growing. Garlic was eaten both as a (Sanhedrin 1la). Though Rabbi Hiya had not eaten garlic himself, vegetable and a seasoning: it was crushed in a mortar and pestle he left the room in order not to shame the one who had, and he and added to other dishes: "Garlic crushed before the Sabbath Eve knew that the one who had would leave with him. may be added to beans and barley." Used as a seasoning, garlic could be added to cooked food, though cooking of food is forbid Garlic and Onion in Later Sources den during the Sabbath. Garlic was also crushed in oil and eaten Garlic and onion play a part in Jewish medical writings through with bread. Garlic was eaten roasted or baked, and like the onion, out the centuries. The book of AssafHarofeh (the doctor) is the first it was eaten from top to bottom, that is, in the direction of the known medical text in Hebrew. Written in the 6th century C.E., it heart of the garlic. is a compilation of earlier works by Theophrastus, Oioscorides, and others. Assaf Harofeh recommends the use of onion juice to Tahnudic References to the Physiological stimulate hair growth, to treat eye infections, to neutralize the Effects of Garlic effects of strong poisons, and to cure snakebite.9 Garlic was thought to possess hot and stimulating properties Shabbatai Donnollo, a tenth century doctor and the first Euro that boost the production of semen. Thus, the High Priest was pean to compose medical treatises in Hebrew, recommends a diet forbidden to eat garlic during the week before the fast of Yom that includes many vegetables, and especially onion, garlic, and Kippur lest he have an emission which would render him impure leek, for sufferers from melancholy. 1o and unfit to enter the Temple on the holiest of days (Yoma, 18a). Rabbi Zahalon in his book Otzar Hahayim (The Treasury ofLife ) Even more than onion, garlic was considered an emmenagogue published in 1683, notes the curative effects of garlic and onion in (stimulating the flow and activity of menstruation) (Nida, 63b) as treating asthma and neutralizing poisons and lists a number of well as a sialogogue (stimulating salivation) (Yevamot, 106b). The other internal and external uses. 11 sages enumerated its virtues: "Five things have been said about Continues on page 53 www.herbalgram.org 2004 HerbaiGram 61 I 47 he traditional herb sage, as commonly used in West long period of rime,8·9 and also in people regularly raking high ern Europe and European cultures in North America, doses of foods, such as tea, containing high levels of antioxi T consists of several species of Salvia (family Lamiaceae), dants. 10 At one time there was thought ro be a correlation with estrogen replacement therapy with low incidence, but this has a fairly large genus containing hundreds of species used in • since been discredited .The ancient reports, rogether with traditional medicine in rhe pans of the world where they are currenF- usage that indicates sage might possess anti-inflamma endemic. Notable examples include Chinese salvia (5. mi!ttOr tory properties, suggested that sage might be of possible use in rhiza Bunge), the roots and rhizomes of which are extensively AD. Preliminary inves tiga tions were conducted at the Medical used as an ingredient of Chinese medicines (known as dan Research Council Neurochemistry Laboratories at Newcastle shen); and divining sage (5. divinorum Epling & Jariva) from General Hospital in Northeast England into the bioactivity of Mexico, which has a reputation as a hallucinogen. The species sage that might be relevant to irs reputation as an ai d to fa iling most often encountered in Western European medicine an,d m c:~ mo ry. 10 These initial studies formed rh e basis for a more cookery are common sage (5. officina/is L. ) and Spanish sage detailed investigati on in King's Coll ege London into other rele (5. lavandulifolia Vahl), bur several other species are encoun vant activities and the chemical constituents responsible for tered in commerce. It is difficult to determine from old litera such activity. ture sources which species is being referred to and both are In Vitro Tests Carried Out on Sage Extracts and Oils used extensively for flavoring meat, especially porJv.u)d poul- try (stuffing is made with common sage). / I The in vitro rests were des igned ro monitor the effects of sage In current herbal medicine, sage is used ro treat )ndigesrion e;h racts on most of rhe factors thought at the rime to be asso and inflammation of the throat, and to reduce sweaci g, ciated with AD or with a reducti on in its incidence. including that associated with hot flashes durin~ peri HOLINESTERASE INHIBITION - Inhibition of the enzyme menopause. 1 In the Commission E monographs ir is recom acetylcholinesterase (AChE) is the bas is of most drugs used mended to be taken internally for dys pepsia, and excessive cl'nically for symptomatic relief of the early stages of AD. perspiration and used 1externally for inflammation of the Inhibition of AChE (i. e., reduction of the enzyme responsible membranes of rhe mburh and nose.2 Ir has a reputation in for breaking down ACh) res ults in elevated levels of ACh in Central Europe of being useful in suppressing lactation in nurs the brain, which is associated with improvement of cognitive ing morhers.3 function including memory. Preliminary tests using the assay Although some of these mO'dern reference sources· vaguely ~ for choline esterase inhibition were conducted on both rh e discuss irs effects on 1:b.e..c~n tral nervous sys tem, research into .96% ethanoli c extract and the steam-distilled oil of three older literature reveals rft:tt s Jge had so me activities rhar rhay be samples of S. officina/is and three sa mples of oil of S. lavan considered today ro be relevan t to the treatment of Al:z.heimds duiifolia. It was found that all 6 samples produced inhibition 11 disease (AD), particularly irs radirional reP, ration as being of the enzy eat quite low concentrations (Table 1). The good for the memory. 4 Thus, in Ws late 16r~ century English activity was·-cop-}idered of interest since all previous choline herbal text, rhe English herbalist )1n Ge r~rd (154 5-1607) es terase in:llib~~ts wete amines, the naturally occurring types wrote about sage, "Ir is singi;Llarly geod forJtlle head and brain in planw being.i Illustration of Salvia officina/is, from: Medical botany: containing sysremaric and general desuiprions, wirh places, of all rhe medicinal planes, indigenous and exor1c, comprehended m rhe catalogues of rhe materia medica, as published by rhe Royal Colleges of Physicians of London and Edinburgh: accompanied wirh a orcumstanrial detail of their medicinal effects, and of rhe diseases in which rhey have been mosr successfully employed Volume 1 of 4, by William Woodville. © 1995-2004 Missouri Botan ical Garden http://ridgwaydb.mobot.arg/mobot/rarebooks/ www.herbalgram.org 2004 HerbaiGram 61 I 49 EFFECT OF EXTRACT ON EICOSANOID SYNTHESIS - was only Eicosanoid synthesis is part of the inflammatory res ponse and r ece ntl y Table I. Acetylcholine esterase a reduced level of these compounds is indicative of reduction in r e p o rted , inhibition of samples of different inflammati on. Eicosanoids include thro mboxanes and although it sage oils at 0.03 mcglmL leukotrienes. T he 5. lavandulifolia ethanol extract at 50 should be noted microg/mL showed only weak inhibition of eicosanoid synthe that they are Sample % inhibition sis, giving only about 10% inhibition of thromboxane 8 2 considerably less (TX82) synthesis but more inhibition (60%) of leukotriene 84 active, by a 12 Salvia officina/is A 34.1 (LT8 4) synthes is. When the ethanol extract was fractionated, fac tor of at least the chloroform-soluble portion produced a greater inhibition 10 3, than the than the water-soluble fracti on. a lk a l o id 5. officina/is B 39.9 BINDING TO ESTROGEN RECEPTOR - Estrogen-receptor inhibito rs such binding studies were carried out at a time when AD was as physos tig- 5. officina/is C 46.9 formerly thought to be prevented by estrogen replacement mme deri ved therapy. Estrogeni c activity was obse rved in the ethanoli c from the S. lavandulifolia A 31.2 extract and the essential oil of 5. lavandulifolia. 12 A dose ca l a bar-b ea n dependent activity was obse rved with the ethanol extract over ( Physostigma S. lavandulifolia B 45.8 the range 1 to 5 mg/mL and appeared to be concentrated in the venenosum 8alf., water-soluble fraction. No dose-response ac tivity was obtained Fa b ace a e) . 11 S. lavandulifolia C 44.6 by the essential oil and the possible explanation offered was the H owever, it was volatility of components of the oil that may have evaporated noted that the and sp read their activity to surrounding cells across the glass inhibitory activi plate. ties of the major terpene constituents did not readily account for the inhibitory effect of the total essential oil. It was calcu Identification of Compounds Responsible for lated that 50% enzyme inhibition for the oil would occur at Activity Detected approxi mately 160 mg/L if the values of the constituent CHOLINESTERASE INHIBITION - T he oil of 5. favandu/ifo/ia terpenes individually we re taken into account - approxi was fractionated by droplet counter-current chromatography mately 5,000 times the concentrati on of essential oil (0.03 and the chemical composition of the fractions analyzed by mg/L) providing 50% inhibitio n. This suggested either that thin-layer and gas chromatography (TLC and GC). The there was a high degree of synergy in the combined action of cholinesterase inhibitory activity of each fraction was also the terpenes, or, less likely, that there was present in the oil an meas ured and, from the acti ve fractions, several cycl ic monoter as-yet unidentified minor constituent of high potency. T he penes were identified as the most active compounds. T hese are argument in herbalism fo r the use of extracts, rather than shown in Table 2, together with their isolated compounds, is based to a considerable extent on the inhibitory activities. T he extent of inhi concept of synergy (i.e., the activity of an extract is much bition was found to be directly related greater than might be expected from the activities of its isolated to the amount of compound used in components). The data for sage oil appears to support this the tes t and could be removed by occurring as regards its anticholines terase effectsY ceasing to add the extract to the ANTIOXIDANT ACTMTY - No compounds were isolated sys tem. Attempts at relating the fro m the fractions showing activity, but some of the individual chemical structure of the components of the volatile oil were tes ted for antioxidant effec t compounds to their strength of since these would be expected to be present in the chloroform enzyme inhibition we re unsuccess- soluble fracti on. 12•13 An tioxidant effects were noted with 1,8- ful. It can be seen that, of the cineole, alpha-pinene and beta- pinene, but a pro-oxidant effec t active components, 1 ,S-eine was produced by camphor, a relatively major component of the ole is likely to contribute oil. Given that the monoterpenoids with antioxidant activity in most to the activity of the this study are present in the essential oil at a slightly higher rela oil since it is present in tive perce ntage (coll ectively over 30%) than camphor (27% of the greatest concentrati on. essential oil), it is likely that the pro-oxidant activity of Irs ability to inhibit camphor is eclipsed by the antioxidant compounds so that the cholines terase has al so total oil would have an overall antioxidant effect. bee n reported by other The activi ty of the water-soluble fraction, which was also research.14·15 It should be active, was not investi gated bur it is likely to contain fl avo noids noted that 1,8 -cineole is a and other phenolic compounds that might well be antioxidant. relatively common compound in EFFECT ON EICOSANOID SYNTHESIS - T he 5. favandu /ifo/ia essential oils and is fo und in several extracts showed only weak inhibition of eicosanoid synthesis. 13 other plant species. T he cholines terase Since the chl oroform-soluble fraction showed greater activity, inhibitory pro perties of these monorerpenes some of the oil constituents likely to be present we re tested in Il lustration ©2004 Gem Rig sby 50 I HerbaiGram 61 2004 www.herbalgram .org Chinese salvia S. miltiorrhiza Ph oto © 2004 stevenfoster.com the system. Alpha-pinene, comprising 5% of the esse ntial oil, beta-estradiol (1 ,000 nM). The highest concenrrati ons of all was the only constituent present which gave significant activiry the monoterpenoids interfered with cell growth. Thus, it seems (52% inhibition at 200mcM) and showed weak selectiviry for unlikely that the constituents tested contribute very much to the leukotriene LTB4. LTB4 is produced via the enzyme 5- the effect of the oil. It should be noted that compounds that lipoxygenase, the gene of which is upregulated during neurode produce estrogenic activiry in the in vitro test system used may generation and, although the role of this inflammatory media not produce activity in an in vivo environmenr where tor in AD is not entirely apparent, selective inhibition over compounds can be metabolized and the metabolites can have cyclo-oxygenase may be relevant therapeutica lly since this more, less, no, or differenr effects. That is , one must be very would reduce the activiry of the upregulated 5-lipoxgenase, careful to impute results from such in vitro tests for estrogenic which is associated with this. 16 The three other monoter activiry to human physiology and thus, their clinical signifi penoids (collectively 44% of essential oil) tested did not show cance is unclear. anti-inflammatory action in this analysis. B INDING TO ESTROGEN Table l.Acetylcholine esterase inhibitory activity of major constituents in sage oil RECEPTOR - Since the oil gave indication of Constituent % in oil % inhibition IC50 mM* binding to the es trogen (gas chromatography) 4.7 mM receptors, some of the major components were (-)-Bornyl acetate 14.8 48 -4.7 also tested. 1 1 Of the 5 monot e rpenoid C~ mphor 27.3 27 >4.7 constituents of S. lavan I ,8-Cineole 17.2 0.67 dulifolia essential oil sc reened, only geraniol Beta-pinene 12.6 68 (0 .1-2 mM; <1% of essential oil) exhibited Alpha-pinene 5.0 0.63 estrogenic activiry (P < 0.001), which was weak Total oil 100 0.05 mcg/ml in comparison to 17- * Decreased enzyme activity by SO%. www.herbalgra m.org 2004 HerbaiGra m 61 I 51 Recent research has shown that estrogenic compounds actu ally increase the incidence of AD rather than reduce it so, with hindsight, these findings are of little consequence. CONCLUSIONS REGARDING ACTMTIES NOTED - It appears that rhe cholinesterase inhibition shown by the oil of sage is most likely due to the cyclic monoterpenes 1,8-cineole and alpha-pinene with some contribution from camphor. There seems to be some evidence that synergistic effects occur. The identity of the active compounds responsible for the other effects noted are less clear bur the antioxidant effect is due, at least in part, to 1,8-cineole, alpha-pinene, and beta-pinene. These compounds are present in several other essential oils, but little work has been done on the antioxidant activity of these. In Vivo and Clinical Studies Most of the activities of sage so far reported in the scientific literature are concerned with in vitro studies, bur it is impor tant that work is carried our to show that these activities are retained in vivo. Normal rats were orally administered on separate occasions (4 months apart) either 20 meL or 50 meL of S. favandulifolia essential oil in a standard dose of sunflower oil once per day for 5 days, with a control group given sunflower oil alone. After the 5-day period (during which the behavior, eating, and motor lthit tffinulil l. function of both groups of animals was observed as normal/healthy), the rats were sacrificed and three parts of the Illustration of Salvia officina/is, from: Kohler's Medizinai-Pflanzen in naturge brai n were assessed for AChE acrivityY treuen Abbildungen mit kurz erlduterndem Texte ·Atlas zur Pharmacopoea At the lower dose there was a trend for decreased AChE germanica, Volume 1 of 3 by Kohler, F. E. (Franz Eugen) © 1995-2004 Missou ri activity in the striatum (the parr of the brain associated with Botanical Garden http://ridgwaydb.mobot.org/mobot!rarebooks/ excitatory responses) of the 5. Lavandulifolia-treated rats both accuracy and speed of attention. The same dose was asso compared to the control group without prior inhibition of ciated with reductions in self-rated "alertness" and "calmness." butylcholine esterase (BuChE). The difference was more Following the highest dose, both "calmness" and "contented pronounced and significant when BuChE was inhibited prior ness" were reduced across most time-points. These results to analysis, suggesting that only AChE and nor BuChE had represent the first systematic evidence that Salvia oil is capable been inhibited in vivo by 5. lavandulifolia. At the higher dose of acute modulation of mood and cognition in healthy yo ung there was also a trend for decreased striatal AChE activity. At adults. both doses there was no change in rhe AChE activity in the cortex of the 5. favandulifolia-treared rats compared to the General Conclusions control group. The recent in vivo studies provide some evidence that the in These results suggested that one or more constituents of the vitro activities observed for sage oil may translate into effects S. favandulifolia oil , or their metabolites, following oral admin that may be clinically relevant to AD. The activity of major istration, reach the brain (crossing the gastrointestinal and importance is the inhibition of cholinesterase but the possibil blood-brain barriers) and inhibit cholinesterase in select brain ity of a combination of effects , all contributing to some degree areas, consistent with evidence of inhibition of the brain of prevention or alleviation of early symptoms, merits further enzyme in vitro. research, particularly as clinical studies. It is particularly impor So far, no clinical studies using sage preparations on patients tant to determine a dose which would achieve observable with AD have been reported, but a recent study describes the improvement. The fact that sage is widely used in food suggests effect of sage in healthy volunteers. 18 In this placebo that its use is associated with comparatively low risk. controlled, double-blind, balanced, crossover design study, Even if sage is never accepted as a treatment for AD - and participants received 3 doses of a standardized extract of 5. that is a conclusion that is too early to predict - the work Lavandulifolia in sunflower oil as well as the sunflower oil alone performed so far is an interesting example of how a traditional (34 female, 10 male; 18-37 years old, mean age 23.2 years). use has been given some credence through modern scientific Doses were administered on different days, each separated by a studies. _.- 7 -day wash-our period using a pseudo-random treatment order. Cognitive assessment and subjective mood ratings meas Peter Houghton has taught pharmacognosy in the Department urements took place immediately prior to treatment and 1 of Pharmacy, Kings College London, UK, since 197 1. He was hour, 2.5 h, 4 h and 6 h thereafter. A number of significant awarded a personal chair as Professor ofPha rmacognosy in 1999 effects on cognition were associated with the lowest (50 meL) and heads the Largest research group in the UK investigating dose of Salvia. These included improvements in both immedi medicinal plants. He has published more than 175 research arti ate and delayed word recall scores coupled with decreases in cles on the chemistry and biological activity of medicinal plants. 52 I HerbaiGram 61 2004 www.herbalgram.org GARLIC AND ONION He is a member ofthe Board ofthe Society for M edicinal Continued .from page 47 Plant Research and President of the Medicinal and The approach in these Jewish sources is preventative, seeking ro teach Aromatic Plants Section ofthe International Pharmaceu people how ro avoid illness. tical Federation (FIP). Conclusion References: Throughout their hisrory, the Jewish people have consumed garli c and I. Barnes J, Anderson LA, Phillipso n JD. Herbal Medi onions both as commo n foods and medicinal plants, as shown by the many cines: A Guide for Health Professionals. 2nd ed. London references ro them in Jewish sources. (UK): Pharmaceutical Press; 2002:408-11. 2. Blumenthal M, Busse WR, Goldberg A, Gruenwa ld J, W e have chosen ro investigate the uses of garlic and onions with the aim Hall T, Riggins CW, Rister RS, eds. Klein S, Rister RS , of filling in the gap between the knowledge of an ancient people living in trans. The CompLete German Commission E Mono their land and the medical arts as practiced in our rimes. Modern medi graphs: Therapeutic Guide to HerbaL Medicines. Austin , cine, which in the Land of Israel em erged in the late nineteenth century, TX: American Botanical Council; 1998. h as ignored a vast body of knowledge gathered over several millennia and 3. Bisset NG. Herbal Drugs and Phytopharmaceuticals. passed down through the populations that continued ro dwell in the land London (U K): CRC Press; 1994. in the years after its destruction. 4. Perry EK, Pickering AT, Wang WW, Houghton PJ , Through the study of this ancient knowledge, we hope ro encourage Perry NSL. Medicinal plants and Alzheimer's disease: integrating ethnobotanical and contemporary scientific future research that will result in the cultivation and use of the medicinal evidence. J Aft CompLementary Medicine 1998;4:419- plants of Israel for the benefit of al l. _...- 28. 5. Gerard J. The HerbaLL or GeneraLL Historie of Plants. Born in jerusalem, Mina Ferne is a biologist who has always been interested London (UK); 1597. in botany. She earned her ESc and MSc in botany and biochemistry at the 6. Hill J. The Family H erbal. London (U K); 1755. j erusalem University, then her PhD on plant biochemistry at the University of 7. American Psychiatric Association. Practice guideline Strasbourg, France. From 1972-1990 she worked at Hadassah Hospital and for the treatment of patients with Alzheimer's disease the Ministry of Health, j erulsalem, on medical research in Biochemistry, and other dementias of late li fe . Am Psychiatry Immunology and Microbiology, especially Strepococci. In 1983 she began 1997;154(5 Suppl. ): l-39. studying Chinese medicine, and continues these studies in Israel and France. 8. Aisen PS . Inflammation and Alzheimer's disease. MoLe cular and Chemical Neuropathology 1996;28:83-8. Since 1990 she has taught and researched medicinal plants, writing two books 9. Cooper NR, Kalaria RN, McGeer PL, Rogers J. Key in Hebrew and many articles. issues in Alzheimer's disease: inflammation. Neurobiol Aging 2000;21 :4 51 -3. References I 0. Pratico D, Delancy N. Oxidative injury in diseases of I. Zohary M, Fei nbrun N, Dothan A. Flora Palestina, I-III. Jerusalem: The Israel the central nervous sys tem: focus on Alzheimer's Academy of Sciences and Humanities; 1966- 1978. disease. Am j Med2000; 109:577-85. 2. emlich H . Botanical Lexicon (in Hebrew) . Jerusalem-Tel Aviv: Devir 11. Perry , Court G, Bidet , Court J, Perry E. European Publishers; 1982. herbs with cholinergic activities: potential in dementia 3. Loew I. Die Flora der juden (in German). Vol. II. Vienna: Kohut Sriftung; 1934. therapy. lnt J Geriatr Psychiatry 1996; II: I 063-9. reprinted Hildesheim: Georg Olms Verlagsbuch handlung; 1967:128, 226. 12. Perry NSL, Houghton PJ , T heobald AE, Jenner P, 4. Theophrastus. Enquiry into Plants. 3rd ed. Hort AF, trans. London: Harvard Perry EK. In-vitro inhibition of human erythrocyte University Press; 1961 , first printed 19 16. acetylcholine esterase by Salvia lavandulaefolia essential 5. Encyclopaedia judaica. Vol. 14. Jerusa lem: Keter Publishing House; oil and constituent terpenes. J Pharm Pharmacal 1972:574. 2000;52:895-902. 6. Krispil N. Yalkut Hazmachim (Medicinal Plants of israel 1448-1462, in 13. Perry NSL, Houghton PJ , Sampson J, H art S, Lis Hebrew). Jerusalem: Yaara Press; 1988. Balchin M, Hoult JRS et al. In vitro activities of S. 7. Krisp il N. Yalkut Hazmachim (Medicinal Plants of Israel), Vol. I. Jerusalem: lavandulaefolia relevant to treatment of Alzheimer's Kana Publishers; 1983. disease. J Pharm Pharmacol200 1;53: 1347-56. 8. Rayan i Y. Medicines used by Yemeni jews [M.Sc. thesis] (in Hebrew) . School 14. Ryan MF, Byrne 0. Plant-insect coevolu tion and inhi of Ph armacy, Jerusalem, 1962. bition of acetylc holines terase . j Chern Ecol 9. Munrner Z. Assaf Harofeh (Assaf the Doctor). Jerusalem: Geniza; 1957. 1988; 14(1 0): 1965-75. I 0. Donnolo S. The Book of Pharmaceutics (i n Hebrew). Muntner Z, ed. 15. Gracza L. Molecular and pharmacological investi ga tion Jerusalem: Mosad Harav Kook; 1949. of medicinal plant substances II. Inhibition of acetyl II. Zahalon Y. Sefer Otzar Ha 'Hayyim (The Treasury of Life, in Hebrew). Ve ni ce; cholinesterase by monoterpene deri va tives in vitro. Z 1683. Naturforsch 1985;40: 151-153. 16. Sugaya K, Uz T, Kumar V, Manev H. New anti-inflam General Bibliography matory treatment strategy in Alzheim er's disease. jpn j Munrner Z. Maimonides, The Meanings of Medicinal Names. Jerusalem: Mosad Pharmacol2000;82(2):85-94. Harav Kook; 1969. 17. Perry, NSL, Houghton, PJ, Jenner P, Keith A, Perry Harriso n RH. Healing Herbs ofthe Bible, Leiden: E.J. Brill; 1966. EK. Salvia lavandulaefolia essential oil inhibits Walk W. ALL the Plants ofthe Bible. London: Lutterworth Press; 1958. cholinesterase in vivo. Phytomedicine 2002;9:48-5 1. Zohary M. Plants ofthe Bible. Cambridge: Cambridge University Press; 1982. 18. Tildesley TJ , Kennedy DO, Perry EK, Ballard C., Manniche L. An Ancient Egyptian Herbal. London: British Museum Press; 1993. Savelev S, Wesnes KA, et al. Salvia lavandulaefolia Foster S. Garlic: ALLium sativum. Botanical Seri es, o. 3 11 , Austin, T x: American (Spanish Sage) enhances on memory in hea lthy young Botani cal Council , 1991. volunteers. Pharmacology, Biochemistry and Behaviour Preuss J. BiblicaL and Talmudic Medicine. Rosner F, M.D., trans. and ed. New York 2003;75:669-74. London: Sanhedrin Press: 1978. Ferne M. Garlic and onion in Jewish sources (in Hebrew). Korot 1996-7; 12:29-39. www.herbalgram .org 2004 HerbaiGram 61 I 53 legal & regulatory FDA Announces Ban on Ephedra Supplements: Federal Move Follows Bans by California, Illinois and New York by Mark Bl umenthal story describing how many consumers call ed this "a tremendous burden of who successfully use ephedra-based proof'." "We have to prove scientifically n December 30 rhe Food and Drug supplements were stocking up in anticipa rhar they're unsafe. That's a completely 0 Administration (F DA) announced its tion of the ban.3 different burden of proof that FDA has intentions to ban the sale of dietary Secretary T hompson said, "First, I am [than it had prior to OSHEA] . Now, supplements containing the popular but pleased that we were able to take the strong Congress should take a look at whether or controversial herb ephedra, also known by action against ephedra. For too long nor they want that to continue." In irs Chinese name mahuang (Ephedra sinica dietary products containing ephedrine response to a reporter's question, he said Stapf, Ephedraceae) .1 alkaloids have been heavi ly promoted and that he was not working with members of At the press conference, Secretary of widely used. They are simply roo risky to Congress to change OSHEA, calling it the Health and Human Services (HHS) be used, whether by people who want to prerogative of Congress, not HHS or Tommy Thompson and FDA Commis lose weight or by elite athletes seeking to FDA.4 sion Mark B. McLellan, MD, PhD, enhance their performance, or by young [Editor's Note: The question surrounding presented the government's case against sters who want to be like these arhleres."4 FDA's authority to protect rhe public herb when sold as dietary supplements. against unsafe dietary supplements has FDA's forthcoming regulations to ban New Legal Framework been at the core of the debate on ephedra. ephedra were said as being in the final T hompson continued, "Second, the To clarify this issue, a leading Washington, administrative stages and would be regulation that FDA will be publishing D.C. regulatory attorney, Stephen McNa published in the Federal Register some time will set a new significant legal precedent. mara, formerly an attorney for the FDA, in January, and would go into effect 60 For rhe first time, we wi ll be articulating has written that, according to federal law, days after irs publication, possibly in mid rhe legal standard for protecting rh e public FDA does have adequate aurhority.S] March. After that dare, it wi ll be illegal to health under the standards of the dietary T he iss ue of FDA's authority was the manufacture or se ll dietary supplements supplement law which Congress passed subject of editorials in The New York Times that contain ephedrine and related ephedra approximately 10 years ago [OSHEA]. and USA Today which both decried the alkaloids, including ephedra weight-loss This is a workable and I think coherent fact that it the ban took too long and supplements. standard that will enable Americans to suggested that increased safety regulation FDA also issued a Consumer Alert in have access to dietary supplements while was necessary. 6.? which ir urged consumers "to stop buying enabling FDA to be abl e to protect In an action related to the announce and using [ephedra] products immedi consumers from ad ulterated producrs. "4 ment, FDA sent letters to 62 firms that ately. "2 Secretary Thompson stated that As intimated by Thompson, HHS and marker dietary supplements containing the reason for the timing of the announce FDA announced the creation of a forth ephedrine alkaloids "to give yo u advance ment came from the agency's wanting to coming new "framework" for determining notice of the publication of this rule to discourage consumers from using supple if a dietary supplement "presents a signifi facilitate your earliest compliance," and to ments containi ng the herb as millions of cant or unreasonable risk of illness or inform these firms that "FDA intends to people traditionally begin new diet regi injury under conditions of use suggested in begin enforcing rhe rule as soon as it mens at the end of rhe Winter H olidays. the labeling or under ordinary conditions becomes effective" (i.e., 60 days from rhe "The rime to stop raking these products is of use." The new framework will be dare it is issued). 1 The contents of the letter now," HHS T hompson said. "They are published in the upcoming Federal Register and the list of companies to whom the simply too risky to be used." notice with the proposed rule. letters were are also posted on the FDA's Secretary Thompson and Commiss ioner T he impact of the proposed ban on website (see below). McClellan urged retailers, manufacturers ephedra on other herbs and supplements Questions from reporters sought the and marketers to immediately cease sales of was unclear. Despite the good safety record identity of additional herbs whose safety all ephedra products prior to rhe publica of most popular herbs in the U.S. market, may be considered questionable that FDA tion of the rule in January. "By issuing the language used in announcing the may consider banning. At the press confer these letters today, we're sending a strong ephedra ban implicated some of FDA's ence, Commiss ioner McClell an did not and unambiguous signal about the safety long- held irritation with the "burden of reveal any names, but stared, "Many of dietary supplement products containing proof" provision of the Dietary Supple dietary supplements have important ephedrine alkaloids," said McClellan. ment H ealth an d Education Act of 1994 values."4 Consumers should stop buying and using (OSHEA). Thompson said that the FDA On three separate occasions Secretary ephedra products right away, and FDA will could not have acted any sooner because Thompson expressed his desire to have the make sure consumers are protected by OSHEA does not require manufacturers to authority to receive [mandatory] reports of removing these products from the market prove a product safe prior to bringing it to adverse events from supplement manufac as soon as the rule becomes effecrive."1 rhe market. To remove an unsafe supple turers. This position is supported by a Citi Curiously, bur perhaps predictably, the ment from the market, FDA must prove a zen Petition filed by AHPA last March in next day the Associated Press carried a clear danger to public health. Thompson regard to serious adverse events.s 54 I HerbaiGram 61 2004 www.herbalgram .org legal & regulatory The FDA ban marks the first time the remove dietary supplements fro m the about Ephedra Dietary Supplements" agency has removed a popular dietary marker rhar ir deems unsafe. "This deci section rhar suggests rhar rhe Agency will supplement from the market under the sion by FDA is evidence that the agency continue to allow ephedra to be dispensed provisions of OSHEA. "We are going to has acknowledged its authority under the for such conditions as appropriate within iss ue a rule that clarifies and applies a legal current law," said Michael McGuffin, Pres the practice ofTCM by licensed acupunc standard that that has never been used ident of the American H erbal Products turists and doctors of Oriental medici ne. before. Us ing the challenging standard Association. H e added , "AHPA will atten The FDA stared, "Essentially all currently provided under the law, we have done all tively evaluate the data on which this deci m arketed dietary supplements will be we can to make sure our regulatory action sion to ban ephedrine-containing supple affected by the rule. The rule does not wi ll succeed,"said Dr. McCiellan.1 ments was based as soon as that informa pertain to traditional C hinese herbal reme FDA's actions come after several high tion is available." 12 dies. It generally doesn't apply to products profile deaths of sports figures, most "What the ephedra ban proves is that like herbal teas that are regulated as notably the untimely death of Baltimore OSHEA works," said D avid Seckman, conventional foods." 16 Such exemptions Orioles pitcher Steve Bechler at a Florida executive director and CEO of the await clarification in the final rules. training camp in February 2003. Bechler's National Nutritional Foods Association Criti zed by some for dragging its feet, death and previous controversies about rhe (NNFA) in a press release. 13 "The FDA has the FDA is now clearly raking a leadership safety of ephedra supplements have had the authority since the passage of role. "We are laying the strongest possible resulted in many calls for the ban from OSHEA to remove products from the foundation to not only take the product Congressional members and medical marketplace it deems unsafe. For years, off the marker, bur to kee p i r off," groups. Numerous profess ional and NNFA has urged the agency to use its Commiss ioner McC lellan said at the press amateur sports associations, including the powers to resolve rhe debate over ephedra." conference in D ecember.4-"' International Olympic Committee, and Ir was nor clear at press rime Oanuary various branches of the military have 12) whether any industry group or indi For details about the ban in the three banned ephedra supplements. In the past vidual companies would sue rhe FDA to states, please refer to the extended version of year California, Illinois and New York have challenge rhe ban. Industry veteran Loren this article at Congress Increasingly Active on Herbs and Dietary Supplements Durbin's Bill Intends to Clamp Down on Supplement Safety while Hatch and Harkin Propose More Funding for FDA Enforcement of OSHEA by Mark Bl umenthal he year 2003 witnessed an increasing level of involvement by ening condition; (3) inpatient hospitalization or prolonged hospi Tthe U.S. Congress in matters dealing with the regulation, qual talization; (4) a persistent or significant disability or incapacity; (5) ity, safety and claims for herbs and other dietary supplements. In a congenital anomaly, birth defect, or other effect regarding preg March 2003, Sen. Richard Durbin (D-IL) introduced the Dietary nancy, including premature labor or low birth weight; or (6) Supplement Safety Act (S. 722) into the U.S. Senate proposing requires medical or surgical intervention to prevent one of the significant changes to the regulation of herb and dietary supple outcomes described above. 1 ments. In July, the House Committee on Energy and Commerce S. 722 is primarily a response to mounting concerns in Congress held a rwo-day hearing on safety issues related to the controversial and elsewhere over the safety of ephedra as well as other contro herb ephedra (Ephedra sinica Stapf, Ephedraceae). In July, Senators versial ingredients that have been misrepresented and sold as Tom Harkin (D-IA) and Orrin Hatch (R-UT) introduced the dietary supplements (e.g., androstenedione, a.k.a. andro). OSHEA Full Implementation and Enforcement Act of 2003 (S. In his press release announcing the submission of rhe bill, Sen. 1538), to promote full enforcement of the Dietary Supplement Durbin said, "A small number of products- primarily stimulants Health and Education Act of 1994 (OSHEA). Then, in October and steroids masquerading as herbal compounds - have proven Rep. Susan Davis (D-CA) introduced the Dietary Supplement lethal to consumers. My bill provides that before you can sell these Access and Awareness Act (HR 3377) which proposes to prohibit high-risk products, you must prove they are safe. This bill will save "high-risk" supplements to minors and other restrictions on li ves and restore America's confidence in the use of dietary supple supplements. In November, an amendment was attached to the ments."2 Agriculture Bill that would grant the U.S. Food and Drug Admin However, some herb industry leaders are not so sure. "By requir istration (FDA) $1 million in additional funding to enforce exist ing that all stimulants, except conventional foods such as coffee, tea, ing provisions of OSHEA, including $500,000 for enforcement of etc. as well as OTC drugs containing caffeine, be subjected to FDA provisions related to ephedra. Four other bills have impli cations for pre-market approval procedures, interpretation of this provision herbs and other supplements (Table 1). suggests that even green tea (Camellia sinensis (L.) Kuntze, At the close of Congress in December, these bills were still "on Theaceae) dried extract in dietary supplement dosage forms would be the table," although it is possible that they will be amended or subject to FDA pre-market approval - a scenario which is both given another designator number when Congress reconvenes in absurd and entirely unnecessary," Loren D. lsraelsen, executive January 2004. The following is a brief summary of each bill and director of the Utah Natural Products Al liance (UNPA), a trade their potential impact on the herb and d ietary supplement group representing large supplement manufacturers, primarily in industry. Utah, wrote to the author on Jan. 6, 2004. In an email sent in July 2003 to UNPA stakeholders, lsraelsen Dietary Supplement Safety Act claims that the provisions in S. 722 are "a dramatic and punitive Among numerous other provisions Sen. Durbin's bill (S. 722) attempt to rewrite OSHEA and impose unnecessary and impracti would require FDA pre-approval for any substance in a supple cal requirements on many safe and useful supplements. . . . In ment that meers the proposed definition of "stimulant" (see Table particular, the bill proposes what appears to be extraordinarily 2). It would al so require mandatory adverse event reporting for burdensome requirement for adverse event reporting, which has no serious adverse events and a FDA review and audit of such events. precedent under food or drug law. Not only is this requirement A serious adverse dietary supplement experience, as defined by the punitive but it would subject virtually every supplement company Act, means an experience that results in (1 ) death; (2) a li fe-threat- to tremendous economic and legal li abi li ty in trying to comply with these proposed provisions. " 3 Table 1: Bills in Congress Relating to Dietary Supplements In an open letter, Name Primary Sponsor(s) constitutional attor ney Jonathan Emard Dietary Supplement Safety Act (S 722) Durbin call ed S. 722 "redun OSHEA Full Implementation and Enforcement Act (S 1538) Harkin, Hatch dant." He wrote, Dietary Supplement Access & Awareness Act (HR 3377) Davis, Waxman, Dingell "FDA already has the authority conveyed Amendments to Agriculture Bill for $1.25 million to FDA for OS enforcement Durbin, Harkin, Hatch by SB 722. Indeed, The Dietary Supplement Information Act (HR 724) Davis FDA has the author The Access to Medical Treatment Act (HR 2085, S 1410) DeFazio, Harkin ity to remove, seize, The Dietary Supplement Tax Fairness Act (HR 2627) Burton, Pallone, Paul condemn and destroy products that The Anabolic Steroid Control Act of 2003 (S 1780) Biden, Grassley, Harkin, Hatch are misbranded, adulterated or other- 56 I HerbaiGram 61 2004 www.herbalgram.org legal & regulatory wise prese nt an unreasonable ri sk of harm to the public. Under DSHEA, a manufacturer cannot market a di etary supplement Table 2. Summary of the Proposed unless it is safe; if FDA determines that the product or an ingredi Dietary Supplement Safety Act (S 722)1· 14 ent in the product is unsafe, it has statutory authority to remove it from the market. Further, FDA has statutory authority to regulate 1. Adverse Event Reports (AERs) . All serious adverse experiences the types of ingredients that can be included in dietary supple with dietary supplement (DS) are to be investigated and reported ments. Fi nally, the proposed current good manufacturing practices to FDA within 15 days. FDA will conduct a clinical evaluation of will become final rules in the not roo distant future. Those regula each serious AER. All DS manufacturers must annually submit a tions grant FDA broad authority and will address any outstanding report to the FDA with respect to all AERs received by the safety issues in connection with dietary supplements. "4 company. Sources of AERs can include the following: direct from Predictably, S. 722 is being opposed by industry trade groups consumers plus "any other means" (i.e., information without American Herbal Products Association (AHPA), the Counci l for regard to the source, foreign or domestic, derived from these Responsible Nutrition (CRN), the National utritional Foods sources: commercial marketing experience, post-marketing investi Association (NNFA), UNPA, as wel l as some major supplement gations, post-marketing surveillance, clinical studies, case reports manufacturers - all of whom have joined a coalition to work in in the medical literature, and unpublished scientific papers, Congress to opposeS. 722 and S. 3377 and supportS. 1538. The presumably those in possession of the company, that is, those that newly formed Coalition to Preserve DSHEA (CPD) is being run the company may have sponsored but not published). chiefl y by large supplement co mpanies, with trade organizati ons as 2. Post-market Surveillance. The Department of Health and nonvoting members. C PD reportedly wi ll be spending funds on Human Services (HHS) and/or the FDA may order a company to specific, earmarked projects but will have no ongoing infrastructure conduct post-market surveillance if they determine there is a and no administrative overhead, according to NNFA Executive reasonable possibility that a use or expected use of a DS by a signif Director/CEO David Seckman.s icant number of consumers may result in serious adverse experi OSHEA Full Implementation and Enforcement Act of ences. 2003 3. Safety reviews for possibly dangerous DS. A clinical evaluation by FDA on one or more serious AERs may indicate that a DS or a On July 31, Senators H arkin and Hatch, the principle sponsors dietary ingredient (DI) appears to present a significant or unrea of OSHEA (with former Rep. Bill Richardson [D-NM]), intro sonable risk of illness. HHS/FDA may require manufacturers of duced the OSHEA Full Implementation and Enforcement Act of the DS or DI to submit to FDA data demonstrating that the DS 2003 (S. 1538) (Table 3). 6 T he bill is a res ponse to concerns or DI is safe in order for the DS/Dl to remain on the market. expressed by industry associations that many of the problems with 4. Approval/disapproval of continued marketing. As soon as prac dietary supplements heralded by the media and hi ghlighted in ticable, FDA shall review the data and determine if the DS is safe congressional heari ngs are the result of FDA's inadequate enforce and if continued marketing is approved, or, whether the DS is ment of DSHEA. According to the NNFA's Seckman, S. 1538 is unsafe and continued marketing is disapproved. basically a funding bill for 2004.5Th e proposed law would increase 5. Stimulants. The newly proposed definition of "stimulant" is a funding to the FDA to more fully enforce the provisions of DI that has a stimulant effect on the cardiovascular system or the OSHEA ($ 20 million for fiscal year 2005, growing up to $65 central nervous system of a human by any means, including speed million in 2008) . S. 1538 also proposes $30 million in funding in ing metabolism, increasing heart rate, constricting blood vessels, 2004 for the Office of Dietary Supplements (ODS) at the National and/or causing the body to release adrenaline. Institutes of Health, an agency created by DSHEA "for expanded 6. Pre-market approval for stimulants. No one shall sell a DS research and development of consumer informati on on dietary containing a stimulant unless an FDA approval of that DS is in supplements" and "such sums as may be necessary for each of the effect. FDA shall approve applications for pre-market approval for fiscal years 2005 through 2008." The bill also proposes that the a stimulant DS if the manufacturer demonstrates the DS is safe Secretary of the U.S. Department of Health and Human Services under ordinary or frequent conditions of use. In the case of a submit to Congress an annual "Accountability Report on the Regu combination of stimulants in a DS, FDA shall consider the inter lation of Dietary Supplements," which woul d require that FDA action of the various stimulants to assess and conclude a safety provide Congress with a detail ed accounting of its activities and determination. This law does not affect caffeine used as a food or resources spent in the area of regulating dietary supplements (DS). a drug. The provisions in this section will take effect 2 years after the date of enactment of the act. Dietary Supplement Access and Awareness Act 7. Steroid Precursors. Section 201 of the Food, Drug and Cosmetic On October 28, Rep. Susa n Davis introduced the Dietary Act would be amended to read, "Other than tobacco or a product Supplement Access and Awareness Act (HR 3377), which, among that bears or contains an anabolic steroid (including a substance other provisions, would prohibit the sale of DS to minors under the that is chemically or pharmacologically related to testosterone but not including an estrogen, progestin or corticosteroid.)" That is, age of 18 if such supplements were deemed by the FDA to pose a significant risk to minors (Table 4) .7 The bill is co-sponsored by the definition of "dietary supplement" would automatically preclude tobacco (as is currently the case in DSHEA) plus Representatives John Dingell (0-MI) and Henry Waxman (D anything that would be interpreted as an "anabolic steroid," which CA), two powerful representati ves who have long held critical views is defined as ''Anything that promotes muscle growth or is adver of the supplement industry. The bill proposes to class ify OS into tised or used to promote muscle growth." Such products would be two categories - those that are nutritionally based conventional subject to regulation under the Controlled Substances Act. supplements like vitamins and minerals and those others that are www.herbalgram .org 2004 HerbaiGram 61 \ 57 legal & regulatory nor normall y ass ociated with nurnuon (e.g., herbals) . T he sions by drug companies. Also, the idea of a product registration is pro posed act would deal wi th the latter category, not vitamins and one that may deserve discuss ion and cost evaluation, bur Repre minerals . In one of the most controve rsial provisions, the bill sentative Davis should fi rst explain why the proposed semi-annual would require that manufac turing companies submit adverse eve nt burden for supplements should exceed the annual burden for reports received for all supplements containing herbs, amino acids drugs. In addition, the subjective nature of FDA decision making and other related ingredients two rimes annually to the FDA. for each of their proposed new authorities must be challenged." 8 Industry leaders characterize this part of the bill as burdensome, T he bi ll was referred to the House Committee on Energy and unreasonable, and unprecedented, particul arly with respect to Commerce, chaired by Rep. Billy Tauzin (R-LA), who held the requirements fo r the pharmaceutical industry. hearing on ephedra in July, and who later said his vo re for OSH EA In a bulletin to AHPA members , AH PA President Michael in 1994 was an error. McGuffin wrote, "AHPA has long stared irs belief that submiss ion of se rious adve rse event reports should be mandatory for supple Other Bill s ments, bur it appears as if this bill fails to provide the pro tectio ns O ther bills introduced into Congress in 2003 may direcrly or to industry that are es tablished by law for adverse event submis- indirecrly affect herbs and other dietary supplements. Most of these bills are in committee and have an uncertain fare at this time. T he Dietary Supplement Information Act (HR 724). T his bill was also introduced on February 12 by Rep. Davis. It intends Table 3. Summary of OSHEA Full Implementation to require registrati on of all dietary supplement products with and Enforcement Act of 2003 (S 1 538)5· 14 FDA, establish an AER sys tem requiring annual reporting of 1. Increased funding for FDA to implement OSHEA: minor AER, es tablish broad inspecti on authority by FDA of • Additional $20 million in fiscal year 2004, growing to $65 supplement co mpanies' records, and require the 1-800- million in 2008. MEDWATCH phone number be placed on all supplement 2. Increased funding for Office of Dietary Supplements (ODS) for labels (a move previously required by the Stare ofTexas for all research and consumer education on dietary supplements. ephedra products marketed in that state). 9 T he reporting of • Additional $30 million in 2004 with further monies incre- minor AERs is currently a requirement for new drugs only, mentally until 2008. and is not requi red for over-the-counter drugs, and, report 3. The Secretary of HHS will submit to Congress an annual edly this bill would not guarantee dietary supplement manu "Accountability Report on the Regulation of Dietary Supplements," fac turers the protections that current federal regulati ons give which will include the following provisions on the implementation to pharmaceutical co mpanies with similar obligations. T he and enforcement of OSHEA: bill has no co-sponsors and has been referred to the House 1) The total funding and number of full-rime equivalent person Committee on Energy and Commerce. 10 nel in the FDA dedicated to: T he Access to Medical Treatment Act (HR 2085 & S 14 10). a) dietary supplement (OS) regulation over the prior fiscal T hese bills have bee n introduced in the House by Rep. Peter year. DeFazio (D-OR) on May 14 11 and the Senate by Sen. H arkin b) administering adverse event reports (AERs) as they relate 12 to DS regulation over the prior fiscal year. on July 15. If passed, the legislation would all ow treatment c) enforcement of OS labeling and claims requirements over by a licensed healrhcare practitioner using any medical modal the prior fiscal year and an explanation of their activities. ity that the patient reques ts, including a treatment that is not d) good manufacturing practice (GMP) inspections of OS approved, certified, or li censed. Ir would require a practitioner manufacturers over the prior fiscal year and an explanation of administering such treatment to report both the adverse and their activities. positive effects observed while administering an unconven 2) The number of GMP inspections of DS manufacturers by the ti onal medical treatment for a li fe-threatening medical condi FDA over the prior fiscal year and a summary of the results. ti on. The House bill currenrly has four co-sponso rs and has 3) The number of new ingredient reviews and safety reviews been referred to the Committee on Energy and Commerce; related to OS and the results of those reviews. rhe Senate vers ion also has fo ur co-sponsors and has been 4) An explanation of all enforcement actions taken by the FDA referred to the Committee on Health, Educatio n, Labor and and HHS related to dietary supplements over the prior fiscal Pensions. year, including the number and type of actions. • T he Dietary Supplement Tax Fairness Act (HR 2627) was 5) The number of OS claims for which the FDA requested introduced on June 26 by Representati ves Dan Burton (R substantiation from the manufacturer over the prior fiscal year, IN), Frank Pallone (D-NJ), and Ron Paul (R-TX). T he bill and the agency's response. would amend the Internal Revenue Code to treat amounts 6) The number of OS claims determined to be false, misleading, paid for foods for special dietary use, dietary supplements, and or nonsubstantiated by the FDA over the prior fiscal year. medical foods as medical expenses for purposes of rh e medical 7) The research and consumer education activities supported by expense deduction. It currenrly has three co-sponso rs and has the ODS. been referred to the Committee on Ways and Means. 13 8) Any recommendations for administrative or legislative actions • The Anabolic Steroid Control Act of 2003 (S 1780) was regarding the regulation of DS. introduced O ctober 23 by Senators Joseph Biden (O-DE) and 9) Any other information regarding the regulation of OS deter H arch.14 T he bill applies to substances that, once inges ted, mined appropriate by the Secretary of HHS or the Commis metabolize into anaboli c steroids and "would amend the sioner of FDA. Controll ed Substances Act to clarify the definition of anabolic 58 I HerbaiGram 61 2004 www. herbalgram .org legal & regulatory steroids and to provide for research and education activities rel ating to steroids and steroid precursors." The intent of the Table 4. Summary of Dietary Supplement Access and 6 14 bill is to treat the hormone androstenedione (andro) and simi Awareness Act (HR 3377) • lar chemicals as controll ed substances. While this might 1. Applies only to herbs, amino acids, and other ingredients to appear be a relatively simple issue on the surface, the ques described in OSHEA as "dietary substance(s) used by man to supple tion that arises for herbs is whether an herbal materi al ment the diet by increasing the total dietary intake"; vitamins and containing natural sterols and rel ated compounds might be minerals excluded. inappropriately relegated to the status of controlled 2. All manufacturers and processors of these dietary supplements substances . The bill has three co-sponsors and is currently must provide to FDA, and update every 6 months, the following: referred to the Judiciary committee. The bill appears to be a) a list of all products; strongly supported by a large coalition of medical and sports b) labeling for each product; organizations concerned about the availability of dietary c) a listing of all "major ingredients ... including active ingredi supplements containing anabolic steroid precursors and ents, as applicable"; ephedra. d) at the discretion of FDA, a quantitative listing of all ingredi- At this time it is not clear which of these bills, if any, will prevail ents; in the ensuing political process that has the inevitable effect of 3. Manufacturers and distributors of these products, unless specifi subtly and often significantly changing the intentions of the initial cally waived by FDA, must report serious adverse events to FDA sponsors of the bills. Sen. Durbin has indicated that he is not inter within 15 days of receipt, to investigate any such reports, and to es ted in accepting any significant changes or compromises to his maintain certain records; bill and would rather reintroduce it in the new session of Congress, 4. FDA would have new authority to order a manufacturer to which started this year. AI; for the future of the Hatch-Harkin bill, conduct post-market surveillance of supplements for which there is a step in its intended direction has already taken place: On "a reasonable possibiliry. .. [of] serious adverse health consequences"; November 6, Senators H arkin and Hatch, with the support of Sen. 5. FDA would have new authority to require a manufacturer to Durbin, were successful in getting a rider added to the Agriculture demonstrate safety of a supplement if the agency has "reasonable Bill in which $ 1 million in new funding was appropriated to FDA grounds for believing" that the supplement presents a significant or for enforcement of O SHEA. As a compromise to enlist the support unreasonable risk of illness or injury or is an imminent hazard to of other members, another provision sponsored by Sen. D urbin, public health or safety; and co-sponsored by H arkin and H atch, was attached to the bill 6. FDA would have new authority to establish criteria for determin providing for an additional $250,000 to be earmarked for FDA ing that a supplement may pose a significant risk to minors and for enforcement actions related directly to ephedra. deeming the act of selling such product to minors as misbranding. Regardless of the outcomes of the legislative process, it is quite 7. The bill would provide funding to educate health professionals on clear that powerful forces are converging with the intention of reporting adverse health experiences associated with DS to FDA and changing the way dietary supplements, particularly herbs, are regu to educate consumers about informing health professionals on the lated. One group wants to see full enforcement of the existing DS and drugs they take. regulations while the other wants to seriously amend the existing 8. The bill would also change the Food, Drug and Cosmetic Act, as regulatory landscape. If either or both prevail, the future of herbal amended by OSHEA, which states that the burden of proof is on the regulation will defin itely be different from the experiences of the federal government to demonstrate that a supplement is adulterated past decade. A or unsafe. References: 1. 108 th Congress. US Senate. Dietary Supplement Safery Act of 2003 9. 10 8th Congress. US House of Representatives. Dietary Supplement (S 722). Mar. 26, 2003. Ava il able online: www.herbalgram.org 2004 HerbaiGram 61 I 59 legal & regulatory Supreme Court Refuses Government Appeal on Medical Marijuana Advice by Doctors by Mariann Garner-Wizard urprising some observers, the U.S. allowed to stand, "The First Amendment for glaucoma21 and may help lower blood SSupreme Court on Oct. 14, 2003, protects the right of doctors to express pressure, through the same mechanism of refused to review a 9th Circuit Court of their opinions about the value of medical action. All of these uses, except reducing Appeals decision in a California case1 marijuana not just when they are giving a blood pressure, are recognized by all or affirming physicians' rights to recommend speech bur when they are giving advice to most of the state medical marijuana provi medical marijuana (Cannabis sativa L., individual patients. It is the patients who sions now in effect. A May 2003 article in Cannabinaceae) to their patients. The high will benefit mostly from today's announce The Lancet Neurology discussed the rapidly court rarely refuses to hear government ment."4 expanding body of knowledge about appeals of lower court decisions. The Bush administration, maintaining cannabinoids - the primary active California passed the first law in the its position that cannabis has no medical constituents of cannabis - and research United States legalizing cannabis for value and may not be legally grown, sold, ramifications. "That we are only just medical use when recommended by a or possessed for any purpose, had appealed beginning to appreciate the huge therapeu doctor (Proposition 215) in 1996. The tic potential of this Clinton Administration threatened family of compounds is doctors who recommended cannabis with clear There 1s . . . losing their federal Drug Enforcement mcreasmg expenmen- Administration (DEA) licenses to tal evidence of a neuro prescribe medications, exclusion from protective effect of Medicare and Medicaid programs, and cannabinoids."22·24 even criminal charges if they helped Medical marijuana patients obtain marijuana. Several Califor acnvtsts hailed the nia physicians and patients sued to protect Supreme Court's physicians' rights to free speech within the refusal to review the doctor-patient relationship. Friend of the Circuit Court's deci court briefs - submitted by such groups sion. The Drug Policy as the California Medical Association, Alliance, which American Academy of Pain Medicine, and provided financial the Society of General Internal Medicine assistance for the court compared physicians' discussing battle, called the non cannabis with advice to drink red wine to action "a major reduce risk of heart disease, take vitamin C victory."2 Rob Kampia, or drink chicken soup for colds, or to try Executive Director of acupuncture.2 Marijuana Cannabis sativa Photo © 2004 stevenfoster.com the Marijuana Policy The government argued that the case Project, a Washington, was about public health, not free speech, to the top court. Cannabis is classified as a D.C.-based lobbying group, said, "By claiming that "The provision of medical "Schedule I" prohibited drug, along with deciding not to hear this case, the Supreme advice - whether it be that the patient heroin and LSD. Responding to the Court has eliminated any doubt that states take aspirin or Vitamin C, lose or gain announced nonintervention, John Walters, have the right to protect medical mari weight, exercise or rest, smoke or refrain director of the White House Office of juana patients under state law, and that from smoking marijuana - is not pure National Drug Control Policy, pointed our physicians have the right to give patients speech. It is the conduct of the practice of that it concerned the doctor-patient rela honest advice ... The Supreme Court has medicine. As such, it is subject to reason tionship, and not any medical benefits of recognized that doctors and patients have a able regulation." cannabis, adding that public officials and right to honestly discuss potential treat The physicians and patients won at all medical professionals must "continue to ments, including marijuana, and (that) the levels, culminating in a unanimous Circuit protect the health of American citizens" First Amendment forbids the federal Court decision in Oct., 2002: "An integral from cannabis.5 government from intruding into those component of the practice of medicine is Various studies, many conducted in conversations."25 the communication between doctor and England, and a wealth of anecdotal testi Nine states all ow medical marijuana use patient."3 mony, indicate that cannabis can relieve (Alaska, Arizona, California, Colorado, Graham Boyd of the American Civil pain,6·12 stimulate appetite,l3·14 prevent Hawaii, Maine, Nevada, Oregon, and Liberties Union's Drug Policy Litigation nausea, 15 and reduce spasticity16 in a wide Washington; also, Maryland provides an Project argued the case in the 9th Circuit. range of ailments from AIDS to multiple affirmative legal defense for people arrested ACLU staff attorney and co-counsel Ann sclerosis, and in chemotherapy treatment while using cannabis medically). Because Brick commented, after the decision was for cancer_I7·20 It is an efficacious treatment all of them require at least a physician's 60 J HerbaiGram 61 2004 www.herbalgram.org legal & regulatory recommendation, if the high court had 2003. Ava il able from URL: ized, placebo-controlled clinical trial. Ann accepted the case, and ruled in favo r of the Bioterrorism Act: Administrative Detention, Record keeping Requirements by Paul D. Rubin T he "interim final" regulations for Upon detention, the FDA may require ditor's note: This article updates an "prior notice" and registration were the food to be moved to a secure facility if Eearlier article on the Bioterrorism Act by released by the FDA on October 9, 2003 the Agency believes such isolation is neces Mr. Rubin in HerbalGram 58. The article and published in rhe Federal Register the sary. For a "perishable food" (defined as refers to recordkeeping and potential FDA following day. 4 This article focuses exclu including foods that are not heat-treated or actions against 'Joods, "but the reader should sively on the administrative detention and frozen and not preserved in a manner to bear in mind that herbs and other ''dietary recordkeeping requirements of the Bioter prevent the quality of the food from being supplements" are considered foods under the rorism Act, including the respective adversely affected if held longer than 7 Dietary Supplement Health and Education proposed rules issued on May 9, 2003.5 days), a company may appeal the deten Act of 1994 (DSHEA). tion order within 2 days, and a hearing In the aftermath of the events of Administrative Detention must be held within 2 days after the appeal September 11, 2001, Congress recognized T he Bioterrorism Act authorizes FDA to is filed and a decision granted within 5 the need to enhance the security of the detain an article of food for which there is days after an appeal is filed. U.S. food supply. On June 12, 2002, Pres credible evidence or information indicat For nonperishable food, a notice of ident Bush signed into law the Public ing such article presents a threat of "serious intent to file an appeal must be fil ed H ealth Security and Bioterrorism adverse health consequences or death to wi thin 4 days, and the actual appeal must Preparedness and Response Act of 2002 humans or animals." This standard for be filed wi thin 10 days . If a hearing is (B ioterrorism Act), 1 a specific section of administrative detention is quite stringent, requested and granted, FDA must hold rhe which, Tide III, covers food products, and and basically tracks the standard for a Class hearing within 3 days after the appeal is which provides the US Food and Drug I recall (i.e., the most significant type of filed, and the Agency must issue its deci Administration (FDA or Agency) with recall administered by the FDA).6 FDA's sion wi thin 5 days after the appeal is filed. substantial new powers to regulate and administrative detention authority became review foods and dietary supplements effective when the Biorerrorism Acr was Record keeping imported in to the United Stares. A prior signed into law on June 12, 2002, and the FDA has indicated that it will iss ue a article published in HerbalGram 58 proposed rule iss ued by the FDA estab final rule for the es tablishment and mai n summarized the provisions of the Bioter lishes procedures for implementing the tenance of records not later than Decem rorism Act, and FDA's proposed regula requirement. ber 12, 2003, and such rule wi ll become tions associated with "pri or notice" and It should initiall y be noted that even effective within 6 months after its publica registration requirements.2 In short, all prior to the grant of administrative deten tion. The Agency has indicated that affected food facilities will have had to tion authority to the FDA under the companies need not comply with the register with FDA by December 12, 2003. Bioterrorism Act, 48 stares already had requi rements of the proposed rule at rhe Also, as of this dare, manufacturers, food detention authority (the only excep present time - but noted that some importers and/or processors will have to tions being Utah and South Dakota); recordkeeping and inspection require provide advance notice to FDA of any FDA has historically contacted state ments are already in effect under current shipment of human food imported or authorities to detain food products in law. It should be noted, however, that offered for import. Foreign exporters of situations where the Agency believed many legal experts question FDA's legal foods and dietary supplement ingredients detention was necessary. As detention authority to inspect company records that (including botanicals) for import into the authority is more limited in scope under are not expressly authorized for inspection United Stares will also have to designate a the Bioterrorism Act than under most under the Bioterrorism Act or Federal US-based agent. state laws, FDA is expected to co ntinue to Food, Drug, and Cosmetic Act. As explained in the prior article, es tab rely upon state enforcement except in In general, recordkeeping requirements lishments that are exempt from rhe regis situations where the Agency believes time require non-transporter co mpanies to tration req ui rements include the follow is of the essence, in which case rhe Agency identify both the immediate so urce and ing: farms; retail food operations; restau will take action under its own enforce immediate reci pienr of all food - along rants; non-profit operations that prepare ment mechanisms. with the transporter of the applicable fo od. food for, or serve food directl y to, FDA's proposed rule authorizes an offi Required information includes conract consumers; fishing vessels nor engaged in cer or qualified employee of FDA to order information, type of food, date received or processing; and faci lities regul ated excl u a detention of any article of food that is released, lot number (if available), quantity sively throughout the entire facility by the found during an inspection, examination, and method by which the food was pack US Department of Agriculture. or investigation if the FDA official has aged, and the co ntact information for each This new system will permit 400,000 credible evidence or information indicat and every mode of transportation (e.g., facilities to register worldwide in 60 days, ing such article presents a threat of serious company truck, private carrier, rail, air, and will give FDA new capabilities to work adverse health co nsequences or death to etc.). Transporters must maintain similar with everyone involved in our food supply humans or animals. A detention order records. to keep it safe and secure, said FDA must be approved by the District Director Records must generally be maintained Commissioner Mark McClellan, MD, of the district where the detained article of for one to two years, and such records PhD.3 food is located. must be made "reasonably available" to the 62 I HerbaiGram 61 2004 www.herbalgram .org legal & regulatory Agency during inspections (currently period required by the Agency. For EPHEDRA defined as within 4 hours of a request product liability and other reasons, Continued from page 55 during an inspection within normal busi companies should evaluate whether ness hours, and within 8 hours of a request certain records should be voluntarily Mar. 20, 2003. made at any other time). FDA has maintained for longer than the 9. U.S. Food and Drug Administration. Dietary supplements containing ephedrine proposed that companies can utilize exist mandatory period. Such an evaluation alkaloids; Reopening of the comment ing recordkeeping methods to maintain should be conducted on a case-by-case period Docker No. 95N-0304]. Federal records under the Bioterrorism Act - as bas is depending upon the type of Register Mar. 5, 2003;68(43): 10041 7-20. long as the existing records are made avail document, and other practical and I 0. Blumenthal M. FDA proposes strong warn able to FDA and contain all of the required legal considerations. ings for ephedra, releases independent information. Failure to maintain records More information on the interim final RAND report on ephedra safety and effi constitutes a prohibited act under the rules and additional information about the cacy. Herba!Gram . 2003;58:68-70. Federal Food, Drug, and Cosmetic Act - Bioterrorism Act can be found at the II. Shekell e P, Hardy ML, MortonS, Maglione M, Mojica WA, Sunorp MJ er al. Ephedra and may result in enforcement action. FDA's website: Doctor of Naturopathy Licensure Law Passes in California by Sally LaMont, ND, LAc n a move that promotes consumer access dies, hydrotherapy, and independently 907 is non-exclusive and does not prevent Iro natural medicine in California, lame prescribe both natural and synthetic anyone from providing health supportive duck Governor Grey Davis signed legisla hormones. NOs will be able ro furnish consultation, recommending or selling tion that extends licensure ro clinically other prescription medications in collabo dietary supplements, herbs, homeopathic trained naturopathic docrors (NOs) on ration with a medical or osteopathic physi remedies and other natural therapies. In September 2 1, 2003. Senate Bill 907, cian; an advisory committee will review 2002, California State Senator John which was authored by California Senate the education, testing and safety record of Burton (0-San Francisco) also sponsored President John Burron and sponsored by the profession and make recommendations SB 577, the "health freedom bill," which the California Association of Naturopathic ro the legislature by January 2006 regard became law in January 2003. SB 907 is in Physicians (CANP), rook effect on January ing this aspect of practice. complete harmony with SB 577 and repre 1, 2004. SB 907 reserves the titles "NO", sents the next step in improving consumer With licensure, NOs now can legally "Doctor of Naturopathy" and "Docror of access to an array of natural healthcare participate in public health projects, inte Naturopathic Medicine" for those licensed providers. grative heal thcare teams, and research under this law, and makes it a misde Establishing legal access to NOs in Cali opportunities in California. In addition, meanor ro use those tides without being fornia allows the profession the opportu licensure is a critical first step ro including licensed as a California NO. All states that nity to work hand-in-hand with the naturopathic doctors in HMOs, private license naturopathic phys icians require a conventional public health system and insurance plans, and government health docroral-level resident course of 4,100 other healthcare professionals to educate programs. Several schools, including hours (four full years) of study from a and empower Californians in cost-effec Bastyr University in Seattle, have expressed college or university recognized by the tive, health-promoting strategies and interest in starting NO training programs state regulatory body. Naturopathic disease prevention. in California in the near future. medical education includes the biomedical From rhe beginning of the legislative This new law 1 establishes the Bureau of sciences (such as anaromy and physiology, process of SB 907, the California Associa Naturopathic Medicine within California's biochemistry, pathology and differential tion of Naturopathic Phys icians articu Department of Consumer Affairs. The diagnosis) as well as the study and applica lated the principles of accessibility, afford Bureau will be charged with defining the tion of natural principles and therapies ability, and accountability in natural medi parameters of the licensure process, and (such as clinical nutrition, botanical medi cine. As SB 907 moved through the legis ensuring that the spirit of the new law is cine, homeopathy, physical medicine, and lature, support for these principles in the maintained as rules and regulations are health counseling). consumer, healthcare provider, legislative, developed. The process of issuing licenses SB 907 keeps the tide "naturopath" in and regulatory communities became to California's NOs will probably the public domain and allows its use by clearly evident. Passage of SB 907 makes commence in the fall of 2004 as the regu others who have not completed the educa California the 13th state to license larory bureau and infrastructure are put tion necessary to be licensed as a naturo NDs. --- into place. pathic doctor. Clarification of rhe educa Sally LaMont earned her ND degree at the Under this new bureau, NOs will be tional requirements for rhe use of rhe ride National College of Naturopathic Medicine licensed as independent docrors, able ro NO gives consumers the ability ro discern in Po rtland, Oregon in 1981 and trained as diagnose and treat disease, order lab work between these two different practitioners an acupuncturist at Emperors College of and diagnostic imaging studies, perform who draw from rhe same philosophy but Oriental Medicine in Santa Monica, Cali physical exams, and utilize the full spec whose education and scope of practice is fornia. She practiced both naturopathic trum of natural therapies such as nutrition, significantly different. medicine and acupuncture in Oregon before botanical medicines, homeopathic reme- The scope of practice outlined in SB moving to San Rafael, California, in 1994. Frustrated by the inability to practice as an ND in California, she took a sabbaticalfrom Herba!Gram BackPacks practice to serve as Executive Director of the Don't leave any gaps in yo ur library. Herb,z!GI'tlm bac k iss ues California Association of Naturopathic provide a co mprehensive srore of inform ati on on herbs, book Physicians during its campaign to license reviews, research, co nte rence reports, and regul atory develop NDs in California. References: ments. BackPac ks are a set of HerbrTIGI'tzllls fro m 1989, except 1'1'1.1 the most current iss ue, and include a Cumulative Index . I ! o I. The Naturopathic Doctors Act (SB 907). Now codified as Section 36 10 in the Cali Order a complete set of BackPacks (Volumes II, III and IV) fornia Business Professions code. Available for $95 and receive 2 slipcases to protect and store those online: 64 I HerbaiGram 61 2004 www.herbalgram.org market report AHPA Issues Third Tonnage Survey of Wild-Harvested Plants by Mark Blu menthal alculating the size of the herb industry past few years the Ameri can H erbal Prod ingredients in herbal supplement products. Chas always bee n a daunting challenge. ucts Association (AHPA) has published The new survey also includes previously Numerous surveys and market research two Industry Tonnage Surveys in its published data from the 1997-1999 firms have arrempred to measure the arrempr to begin to harves ts in irs compila amount of retail sales in va rious channels quantify the wild tion of harvest data on of distribution. There are fai rl y solid harves ted raw materi 24 botanical econometric data from the food, drug, and als used in the manu commodities repre mass market retail segments - as reported fac ture of va ri ous senting 20 different in the Market Report section of this maga herbal products. plant species (see Table zi ne on many occasions - while develop Information dealing 1). This information ing data from other retail segments (e.g., only with the harves t includes rh e amounts the health food sectors, multi-level market of wi ld goldenseal of both cultivated and ing companies) are more difficult to get (Hydrastis canadensis wild-harvested mare meaningful statistics. L., Ranunculaceae) in 1998 was published rial, and of both fresh and dried materi al Obtaining statistics on the actual in 19991 and selected data on the 1999 for these co mmodities. Goldenseal wild amount of bulk herbal material grown or harvest of numerous additional plants were harvest and cultiva tion information from wi ld-harvested within rhe United States is published in the second survey2·3 in 2000. 1999-200 1 is derailed separately and also a challenge. The U.S. Department of AHPA's third survey! is the most ex ten constitutes almost a third of the 19-page Agriculture's Foreign Agricultural Service sive compil ation to dare. It quantifies report. maintains stati stics on imported herbs and annual harves ts of ce rtain North American In July 2003 rhe new survey was se nt via spices but there is no systematic process for herbal commodities sold in commerce in email to all 221 AHPA members, plus 20 meas uring wi ld-harvested (a. k.a. wild rhe United Stares, with a focus on the non-members who had been identified as crafted) or commercially cul tivated herbs 2000 and 2001 harves ts for pl ants that involved in the bulk trade or cultivation of used in the medicinal plant market. In the may be taken from the wild and used as the 24 plants being surveyed. AHPA received 59 responses (24% response rate; 49 AHPA members, 10 non-members). Of these 59, 21 indicated that they were Table I. Wild-Harvested Plants Surveyed in AHPA "primary raw material producers" (individ Tonnage Survey uals or companies that obtain plant mare Common Name Latin Binomial rial directly from a wild or cultivated source or by contracting, purchasing aletris Aletris farinosa and/or consolidating these plants from beth root Trillium erectum another individual or company who harvests them directly and who was nor black cohosh Actaea racemosa syn. Cimicifuga racemosa likely to fill out the survey). Thirry-eighr bloodroot Sanguinaria canadensis respondents noted rhar they do nor blue cohosh Caulophyllum thalictroides produce these plants, so no additional information was provided by the larrer. cascara sagrada Frangula purshiana The published survey reflects the informa echinacea Echinacea angustifolia, E pal/ida, E purpurea tion provided by the 21 respondents. false unicorn Chamae/irium luteum The first part of the survey contains two tables and discussion of the data in these goldenseal Hydrastis canadensis tables. T he first, "Aggregate H arvest of lady's sl ipper Cypripedium spp. DRIED Plants 1997-2001, in pounds," lomatium Lomatium dissectum contains data representing five years' infor mation on the cultivated and wi ld harvests osha Ugusticum porteri on 24 plants (including 6 li stings under saw palmetto Serenoa repens the ge nus Echinacea: E. angustifolia root slippery elm Ulmus rubra and herb, E. pallidd root and herb, and E. purpurea root and herb, family Asteraceae), sundew Drosera spp. plus various other wi ld-harvested plants usnea Usnea spp. (see table). American ginseng (Panax quin Virgin ia snakeroot Aristolochia serpentaria quefolius L, Araliaceae), both wild and cultivated, is nor included in the survey. wild yam Dioscorea villosa A second table, "Aggregate harvest of www.herbalgra m.org 2004 HerbaiGram 61 [ 65 market report FRESH plants, 2000-2001 (pounds)," coming years/ based on the trends of the Spring, MD: American Herbal Products contains I 8 plants, including 5 echinacea market and the initial goldenseal report by Association, March, 1999. species and parts (E. pal/ida herb is not AHPA. 1 These predictions appear to have 2. American Herbal Products Association. 1999 Tonnage Survey Report. Silver Spring, listed), and the same plants as listed in the bee n accurate. According to the new MD: American Herbal Products Associa survey, an average of approximately 140 first table, with the exception of aletris, tion, Sepr. 2000. cascara, lady's slipper, sundew, and acres of goldenseal are in cultivation with a 3. McGuffin M. AHPA's 1999 herb tonnage Virginia snakeroot. The tonnage in this yield rate ranging from 150-600 pounds survey: summary and analysis. Herbal table is significantly lower than the quanti per acre in woodland (wild simulated or Gram 2001;51:70. ties reported in the first for the obvious so-called "woodsgrown") farming and 4. American Herbal Products Association. reason that most herbs sold in the market 150-1,000 pounds per acre for intensive Tonnage Survey of North American Wild are dehydrated after cultivation or wild farming. harvested Plants, 2000-2001. Silver harvest. AHPA intends to conduct the next 2- Spring, MD: American Herbal Prod.ucts Association, 2003. The cultivation of goldenseal is given year survey for the 2002 and 2003 harvests 5. Convention on International Trade in special attention as international trade in in the first quarter of2004 and to continue Endangered Species (CITES) of Wild this native American herb has been desig biannual surveys for at least the immediate Flora and Fauna. Proposal for the inclu nated by CITES (Convention in Trade in future. sion of Hydrastis canadensis, Appendix II. Endangered Species) Appendix II as being Bound color copies of the 2000- 2001 Convention in Trade of Endangered in need of close controi.S·6 According to Tonnage Survey may be ordered through Species, 1997. data presented in a third table, the harvest the AHPA bookstore 66 I HerbalGram 61 2004 www.herbalgram.org conference report Fifth International Maca Festival Held in Peru by Josef Brinckmann he Fifth International Maca Festival cream-yellow, yellow banded with a purple also displayed products made from orher Ttook place July 10-13, 2003 in Junfn, waist, purple, and black. More rhan 40% Peruvian botanicals. Peru at the Colegio Estatal 6 de Agosto of all maca is processed into flour. The The Ministry of Agriculture also exhib (6th of August State School). Although leading importers of maca flour in 2002 ited, providing statisti cal information on Junfn is only 230 km (143 miles) from the were Japan (80.3 tons), the USA (43.9 maca cultivation, annual production clara coastal city of Lima, it is about a five-hour tons), Australia (1 0.1 tons), Germany (6. 1 by region, consumption and ex port quan drive into the Andes, to an altitude of tons), Portugal (5. 0 tons), Mexico (2.5 tities and values. Representatives from two 4,300 meters (ca. 14,100 feet). The four tons), and the Netherlands (2.3 tons). of the provi ncial maca trade associations day harvest festival and trade fair was co The Fifth International Maca Festival participated in the event, Javier Pablo sponsored by the Ministries of Agriculture included rrade exhibits representing grow- Castillo Gi.iero, President of the Asociacion of Junfn Province and of Pasco Province, de Productores de Maca and Luis respectively, and was held under rhe Oswaldo Castillo Huerra, President of auspices of the Asociaci6n de Productores rhe Asociaci6n de Productores de Maca de Maca Ecol6gica (Organic Maca Ecol6gica. About 450 maca-growing Producers Association), the Universidad families in Peru are members of the Nacional del Centro del Per-U (National national maca growers trade association University of Central Peru), and by a (Asociacion Nacional de Productores de private company Agroindusrrias Koken Maca) and there are another estimated del Peru S.R.L. Koken is one of Peru's 350 maca-growing families who are nor leading producers and exporters of maca members of eirher the national or flour (harina de maca). The primary provincial maca trade associations. objective of the festival was to introduce Throughout the four-day festival the thousand-year-old tradition of maca there was a full program of special cultivation in the high Andean Junfn Admission ticket to the maca festival (5 Peruvian Solas) events and presentations on the outdoor Plareau to prospective international main srage, including regional folk buyers and trading partners and to dance and traditional Andean music promote the use of maca as a nutritive food ers and raw material suppliers, manufac presentations as well as theatrical reenact and medicinal ingredient nationally and turers and marketers of maca consumer ments payi ng tribute to rhe ancient Inca internationally in order to increase local products, herbalists and traditional healers, rituals associated with rhe planting and production and export and wholesale distributors of harvesting of maca. There were also tech capacity. botanical raw materials and nical presentations and workshops on Junfn Province is the prepared maca products. topics including the industrial production center of cultivation in The consumer product of maca-based products, specialized farm Peru for the increasingly exhibitor profile included machinery for maca production, and the popular medicinal and regional vendors of maca international trade of maca. food plant maca (Lepid dietary supplements such as Although there were no formal presenta ium meyenii Walpers, maca extract or gelatinized tions concerning clinical research at the Brassicaceae) with about maca in capsules (capsulas de maca festival, one Peruvian medicinal 460 hectares (1,137 acres) harina gelatinizada de maca) maca product, La Molina® Maca (500 mg sown in 2003, followed by and maca instant rea, bever gelatinized maca per tablet, manufactured the Pasco region with ages such as maca juice by Laboratories Hersil S.A. of Lima), has about 322 hectares (820 nectar (nectar de maca) , maca been rhe subject of three recent clinical acres) under cultivation. liqueur (licor de maca con studies. In a 12-week uncontrolled study Maca is also cultivated to a uva), maca cream liqueur of 9 healthy adult men, maca (1 ,500 or lesser extent in the Peru (crema de maca), maca wine 3,000 mg I day) improved sperm produc vian Andean regions of (vino de maca) , and maca tion and sperm motility by mechanisms Huamuco, Ayacucho, and Ac tors in Inca clothing participat marinated in pisco sour nor related to se rum luteinizi ng hormone, ing in a reenactment of traditional Apurimac. Maca is an maca planting and harvest rituals. (ponche de maca y pisco), follicle stimulating hormone, prolactin, herbaceous, perennial Photo ©2004 Josef Brinckmann desserts such as maca yogurt, testosterone, or estradiol. ' plant, growing 12 to 20 maca marmalade, and maca In a subsequent 12-week double-blind, em in height. Irs hypocotyl ice cream (he/ado de chaco placebo-controlled, randomized, parallel (i.e., root ruber), which is rhe edible and maca), baked goods such as maca breads, trial, an improvement in sexual desi re in medicinally used parr, ranges from 2-5 cakes and cookies, and maca-based 45 healthy adult men was observed with em. Several cultivated varieties are differ cosmetic products such as soaps and sham maca (1 ,500 mg [n = 30], 3,000 mg [n = entiated by the color of the hypocotyls: poos, among other products. Exhibitors 15], placebo [n = 12]) after 8 weeks treat- www.herbalgram.org 2004 HerbaiGram 61 I 67 conference report ment; the study was based on subjective 011.51.64.967.9002, email: josef Brinckmann is the Vice President of self-reporting, including self-perception on <[email protected]. Research & Development for Traditional sexual desire, and the Hamilton tests for pe>. Medicinals, In c. , Sebastopol, CA, and serves depression and anxiety. Logistic regression • Luis Oswaldo Castillo Huerta, Presi as Consultant on Market Intelligence for analysis showed that 1.5-3.0 g maca for dent of the Asociacion de Productores Medicinal Plants & Extracts for the Interna 8-12 weeks improved sexual desire in tional Trade Centre of the United Nations, healthy men independently of mood Geneva, Switzerland. changes or serum testosterone and estra diol levels. 2 References: Most recently, in another 12-week I. Gonzales GF, Cordova A, Gonzales C, double-blind, placebo-controlled, Chung A, Vega K, Villena A. Lepidium meyenii (Maca) improved semen parame randomized, parallel trial, maca treatment ters in adult men. Asian j Androl 2001 (1,500 or 3,000 mg I day) in healthy men Dec;3:30 1-3. aged berween 21 and 56 years did not 2. Gonzales GF, Cordova A, Vega K, Chung affect serum reproductive hormone levels, A, Villena A, Gonez C, Castillo S. Effect including luteinizing hormone, fo ll icle of Lepidium meyenii (Maca) on sexual stimulating hormone, prolactin, 17 -alpha desire and irs absent relationship with hydroxyprogesterone, testosterone and 17- serum testosterone levels in adult healthy men. Andrologia 2002 Dec;34:367-72. beta estradiol. 3 3. Gonzales GF, Cordova A, Vega K, Chung For information on attending or partici A, Villena A, Gonez C. Effect of Lepidium pating in the 6th International Maca Festi meyenii (Maca), a root with aphrodisiac val to be held in July 2004, contact the and fertility-enhancing properties, on festival president: Lie. Toribio Yantas serum reproductive hormone levels in Hinostroza, Ph. : 011.51.64.967.8268, fax: adult healthy men. j Endocrinol 2003 011.51.64.964.9030, email Traditional Andean musicians performing Jan; 176: 163-8. 68 I HerbaiGram 61 2004 www. herbalgram.org conference report Kava Stakeholders Plan Regulatory Review and Market Return by Joerg Gruenwald, PhD he roads of the Fiji islands ofTaveuni are empty these days . A on the pharmacological and clinical documentation of kava Tthriving economy based on the export of the traditional Pacific (Phytopharm Report part IIA and B) and a derailed case analysis crop kava (Piper methysticum G. Forst., Piperaceae) collapsed in of all reported cases of hepatotoxic events (Phytopharm Report 2001 due to allegations in Europe that the plant extract caused part IIA Annex 1). The findings presented in the Phytopharm liver toxicity. 1 This shocked native island people as their ancestors Report clearly speak for the safety and efficacy of kava in the sy mp had been drinking kava exrracts for thousands of yea rs for ceremo tomatic treatment of anxiety and srress and, in most aspects, nial and social purposes without such apparent effect. An explana strongly supported the scientists' charges that the kava ban was nor tion of this surprising turn of events was suggested at the recent justified based on the available scientific and medical evidence. meeting in Brussels, Belgium, of Pacific and European kava stake Furthermore, the report criticized the German health authority holders. (Bundesinstitut for Arzneimitte! und Medizinprodukte or BfArM, The first-ever European-Pacific Kava Stakeholders meeting was the Federal Institute for Drugs and Medical Devices) for having held in Brussels on August 25 and 26, 2003, organized by the ignored and misinterpreted important scientific data in its evalua European Centre for the Development of Enterprise (CDE) and tion and for creating an obviously distorted image for kava. PROEINVEST, both based in Brussels. The main objective of the The meeting brought together key participants from the Pacific Region and Europe, representing a cross section of stakeholders, namely European manufactur Figure 1: Formation and Tasks of the International Kava Executive Committee ers, regulatory agencies, kava exporters, scientists and experts, and organizations such as the CDE, PROEINVEST, PIFS, Commonwealth Secre tariat (COMSEC), European Commiss ion (EC), the World Health Organization (WHO), and the Technical Centre for Agricultural and t t Rural Cooperation ACP-EU (CTA). The meet Information Information ing also revi ewed alternative strategies that might be used to reintroduce kava into Euro pean markets, established a derailed action plan, I Creation I and identified the possible roles and contribu International Kava Executive Committee tion of the different organizations and represen tatives in achieving these goals. Tasks Kava Strategy: The Way Forward Organization and Advise and Develop a detailed Search for funding The stakeholders acknowledged the signifi coordination of support national action plan and PR and financial further actions authorities campaign support cant economic, social and cultural damage done by the market recalls, restrictions, and bans. They noted that the negative publicity from the Kl Kava-Related Industry (Producers, Traders, ESCOP European Scientific Cooperative on Phytotherapy numerous kava bans, alerts, and marker recalls Pharmaceutical Industry, etc.) CDE Cen tre for the Development of Enterprise PIFS Secretary of the Pacific Islands Forum JndA Indust rial Associations (BAH, AESGP. etc.) had led to an adverse economic impact for the F!Cs Forum Island Countries BAH Association of German Pharmaceutical Industry South Pacific kava industry predominantly SeC Scientific Community (ESCOP,Commission E, Pacific AESGP Assoc iation of European Self-Medication Industry Based Kava Research, etc.) located in Fiji, Samoa, Tonga, and Vanuatu. Since 2001 loss of local export earnings in the South Pacific was more than US$200 million, and many thousands of jobs in both the South meeting was to explore ways to re-establish the kava trade berween Pacific and Europe. The ban especially affected the incomes of the European Union (EU) member states and South Pacific coun rural farmers and processors as well as foreign exchange, as exports tries. A major focus of discuss ion was the main findings of the are seriously adversely affected. The meeting further noted the loss study entitled "In-Depth Investigation of EU Member States of business for the European importers. Market Restrictions on Kava Products" (Phytopharm Report) The participants also endorsed the findings of the Phytopharm presented by Phytopharm Consulting at the end of March 2003. Report, and agreed to use its scientific evidence, whi ch clearly indi The entire report can be downloaded from relating ro the management of kava as proposed in the strategy of various activities. the Phyro pharm Report (see Figure 1). 7. C irculate the Phytopharm Report as widely as possible, Those present also adopted the proposed strategy m the including those EU countries that have not banned kava, ro Phyropharm Report presented in Figure 2 and the summarized use the report to prevent any future bans. and amended version of this strategy performed by the representa Finally, the stakeholders expressed their sincere appreciation to tive of the Pacific Islands Forum Secretariat. the CDE, PRO€INVEST, and PIFS for their effective roles in As a matter of immediate prioriry, the stakeholders agreed ro undertaking the study and organization of the mee ting. The meet undertake the following actions: ing also acknowledged the ongoing support of these organizations 1. Establish an International Kava Executive Committee (IKEC) and others such as C OMSEC, WHO, and the EU in addressing of EU and Pacific members ro implement the coordinated the problems associated with kava and kava products. A strategy for re-establishing the kava market in Europe, consisting of the Figure 2: Proposed Strategy following: Pacific Islands Stakeholders • Four Pacific Island countries: Josateki Nawalowalo (Fiji Kava Council); Eddi Wilson (Samoa Association of Manufacturers and Exporters); Toimoana Takataka (Tonga Kava Council ); Frank King (Va nuatu Kava Exporters Association); • Paci fic Islands Forum Secretariat. European Stakeholders • Barbara Steinhoff (Bundesverband der Arzneimittelhersteller or German Medicines Manufacturers' Associa tion); • Mathias Schmidt (Representative of the Kava Industry); • Anthony Bush (European Federation of Health Product Manufacturers WHO World Health Organization ACWL Advisory Committee on WTO law WTO Worl d Trade Organization ACP African Caribbean Pacific Associations); • Carlo Sessa (Associazione !taliana fra Coltivatori, Raccoglitori, Trasforma tori, !mportatori, Esportatori, Grossisti e Rappresentanti di Case Estere di Piante Medicinali e Aromatiche or Italian Medicinal and Aromatic Plants Producer joerg Gruenwald is president ofPh ytopharm Consulting, a special and Traders Associati on). ized business consulting company for herbal medicine, dietary supple Executive Director ments, and functional foods. He is author of the international refer • Joerg Gruenwald (Phytopharm Consulting) ence work for botanical medicines Physician Desk Reference for 2. Reques t funding from CDE/PRO€INVEST for Phytopharm Herbal Medicines, co-editor ofThe Complete German Commis to become the active coordinator of the activi ties in Europe. sion E Monographs, and editor in chief of Advances in Natural 3. Take immediate steps in addressing the fo ll owi ng: T herapy. Dr. Gruenwald is the executive director ofth e International Provide German and other relevant authorities with the Kava Executive Committee. He can be reached at Phytopharm Phytopharm Report; Consulting, Waldseeweg 6, 13467 Berlin, Germany; +49-30- Pacific members to request WHO for a re-evaluation of 400081 00, Fax: +49-30-40008500; e-mail: safery and efficacy of kava by an independent expert 70 I HerbaiGram 61 2004 www.herbalgram .org book revtews• rowing At-Risk Medicinal Plants: medicinal plants whose popularity has not G Cultivation, Conservation and Ecol yet reached mainstream market awareness, New Book Profiles ogy. Richo Cech. Illustrations by Sena probably due to the lack of clinical research Cech. Williams, OR: Horizon Herbs, 2002. documenting their benefits. ue to economic considerations 314 pp. $14.95. ISBN 0-9700312-1-1. While all are deemed to be "at-risk" (i.e., Dand the natural evolution of book Increased demand for medicinal plants in they are considered either officially endan marketing and sales, the American the past decade have brought the issues of gered or threatened, and/or are considered Botanical Council is adding to its cata conservation and sustainability to the fore at-risk by the United Plant Savers, a log very few of the good new books front among many herbalists, foragers , nonprofit organization that focuses on at that are being published. However, we collectors, and conscientious members of risk medicinal plants of North America), do intend to keep our readers informed the herbal industry. Many, possibly most, of some of these plants are in the top tier of of books of particular interest that have the medicinal plants sold in trade are still demand of native American plants, like arrived in our offices. In this ongoing collected from the wild. According to a those mentioned above, plus plants in the feature, we only describe these new recent report by the conservation group genus Echinacea, much of which now comes books; we have not yet had them TRAFFIC, up to 75% of all medicinal from cultivated sources (i.e., E. purpurea), reviewed. plants sold in commerce are sourced from while E. angustifolia and E. pal/ida are still If you are interested in purchasing wild populations. This is particularly true heavily wildcrafted. any of these books or those that have for medicinal plants native to North Amer However, most of the chapters deal with been reviewed fully, and you want ro ica (e.g., black cohosh, gold- the lesser-used plants (i.e., with help ABC at the same time, please go enseal, and saw palmetto). GrowingAt-Risk respect to the totality of their to the online version of this article on Fortunately, enterprising farm- Medicinal Herbs estimated use in mainstream our website discussed. In general, each contains the Carol Hooper, MD, MPH, practices inter plant and scientific evidence that backs up or following sections: a general overview, nal medicine and served as medical editor. refutes those claims. Pulmonarias and the Borage Family, by range, hardiness and adaptability (with This book is a welcome addition to the Masha Bennett. Timber Press, Inc.: Portland, range map); ecology; life cycle; germination literature as it offers a variety of little Oregon; 2003. 240 pp., index, bibliography, and development, including (as appropriate known botanical options for the prevention glossary, photos. $39.95 ISBN 0-88192-589- for each herb) culrivation from seed, from or treatment of a variety of conditions and 6. rhizome cuttings, and/or from root runners; diseases. Unlike some of the more evidence A book devoted to the taxonomic family Boraginaceae, with over 200 species and greenhouse management; general care; based botanical guides for healthcare hundreds of varieties. Some of the best yield; harvest process and storage; seed providers (e.g., The ABC Clinical Guide to known members of the family are covered, collection, cleaning, storage and longevity; Herbs, edited by this reviewer), the authors including forget-me-nots, comfrey, and and conservation status. There is also in of this book have taken several decidedly borage as well as the lesser-known plants. each chapter a reasonably accurate line different strategies in producing this While the book is light on information about the medicinal uses for the plants, it is an excel drawing of the herb. volume. First, the chapters are organized by lent reference source for botanists and garden With the explosion of growth in garden condition or disease, not by herb. Second, ers. ing, particularly herb gardening, this book the authors are not relying strictly on clini The ITIC International Dictionary of offers gardeners, herbalists, and other plant cal trial data to support their inclusion of an Toxicology, compiled and edited by Gaston Vettorazzi, MD, BA, MS , PhD, ATS (Fellow). enthusiasts the opportunity to diversify herb as a potentially useful treatment; phar ITIC Press: San Sebastian, Spain; 2001. 560 their back-yard plots to include many macological investigations and empirical pp., bibliographical sources, indices in increasingly important medicinal plants, data from traditional use provide a basis for English, French , Italian, Portuguese and besides the usual "Scarborough Quartet" (as consideration of an herbal therapy. Spanish. $185.00 ISBN 84-607-1803-4. Jim Duke calls them): parsley, sage, rose The authors explain their philosophy that More than 2,500 terms, abbreviations and acronyms frequently used in publications mary and thyme. A they want to see herbs being used in a around the world concerning food, food addi -Mark Blumenthal manner that transcends their use merely as tive, and food contaminant issues as well as substitutes for conventional drugs. "This environmental and toxicological areas. The linical Botanical Medicine by Eric use certainly has a place at times, but multilingual indices make this a useful refer ence tool when reading or writing interna CYarnell, Kathy Abascal, Carol G. ignores the fact that whole herbs are not tional copy. Hooper. Larchmont, NY: Mary Ann drugs but offer an important and expanded User's Guide to Nutritional Supple Liebert Publishers, 2003. 418 pp. ISBN 0- way of promoting healrh and healing." ments, edited by Jack Challem. Basic Health 913113-95-6. $99. They then support the traditional vitalist Publications: North Bergen, New Jersey; This book is based on a collection of arti view that "The medicines used in botanical 2003. 327 pp., softcover, index, charts. $19.95 ISBN 1-59120-067-9. cles by Yarnell and Abascal in ALternative medicine are living beings - part of the This book is a guide for anyone who wants and Complementary Therapies, incredibly complex web we call information on popular nutritional supple a bimonthly journal from the the Earth. One of the central ments. Summaries of research, suggestions for same publisher. All but one of goals is to serve as a counter dosage size and form and possible interactions the chapters reflects revisions point to the many recent botan between the supplements and foods and drugs are part of each chapter, each one focusing on of the previously published ical texts that increasingly a particular supplement. articles. Each chapter in the explain the use of herbs based Handbook of Pharmaceutical Excipi larger first part of the book are solely on a constituent-based ents, Fourth Edition, edited by Raymond C. condition or disease specific approach. We will illustrate that Rowe, Paul J. Sheskey, Paul J. Weller. Phar maceutical Press: Grayslake, Illinois; 2003. (i.e., they present a variety of botanical medicine is - and 776 pp., hardcover, index, photos, charts. botanicals that may be useful should be - much deeper and $299.95 ISBN 0-85369-472-9. in preventing or treating the more complex." Completely updated and revised, this condition or disease of which Much of this book deals with edition contains physical and chemical prop the article/ chapter is the combination formulas that the erties, uses and safety information for more than 200 excipients. Designed for profession focus). I have found these arti- authors claim can "exponen als that work with the development, produc cles to be of significant value over the years tially" increase the "range of possible inter tion or regulation of pharmaceuticals. and have chosen many of them for actions between the constituents in the vari Martindale: The Complete Drug Refer summary and critical review in ABC's ous herbs themselves as well as in the ence edited by Sean C. Sweetman. Pharma HerbClip service; to date, ABC has issued human body. Only the Asian scientists have ceutical Press: Grayslake, Illinois; 2002. 2483 pp., hardcover, index, manufacturer's direc 19 HerbClips covering these chapters (see begun to investigate this vast array of inter tory. $350.00 ISBN 0-85369-499-0. http:/ /www.herbalgram .org/herbclip/search actions." As an example they cite Asian Designed for use by pharmacists and physi .asp?s=yarnell&m=A). ginseng (Panax ginseng, C.A. Meyer, Arali cians, this book contains more than 5,000 Or. Yarnell is a naturopathic physician aceae) and its ability to enhance the absorp monographs on drugs and medicines used worldwide. Also included are proprietary who is an adjunct professor at Bastyr tion of saikosaponins in bupleurum preparations from different countries, both University and the Southwest College of (Bupleurum chinense DC., Apiaceae) where prescriptions and over-the-counter. A Naturopathic Medicine, both appropriately these saikosaponins were previously shown accredited schools of natural medicine. Or. to be lacking bioavailability. Abascal is an herbalist, holds a doctorate in The book is divided into four parts: jurisprudence, and is a recovering attorney. Treatment or Prevention of Specific Disease 72 I HerbalGram 61 2004 www.herbalgram.org book reviews Srares or Conditio ns, Special Formulas, prese nted in both Pinyin C hinese as we ll as cerebral vasorelaxant. Specific H erbal Medicines (prickl y pea r pharmaceutical Larin . It is one thing to say that an herb is good [ Opuntia spp., Cacraceae] lemon balm These days I seldom buy an herb book to fo r calming and relax ing rhe nerves but ir is [Melissa officina/is L. , Lamiaceae], stinging read from cover to cover, but rhis 200-page obviously important fo r herbali sts to know nettle [ Urtica dioica L. , Urricaceae] and four volume is an exception. Ir describes rh e whi ch herb in a category is stro ngest in a Ayurvedic herbs), and Iss ues in Botani cal major herbs of the C hinese materi a medica properry and when that stronger herb is the Medicine. T he latter contains an interes ting as used in the traditional C hinese energeti c mosr appropriate? T he same is true of the and useful chapter in whi ch rh e authors categori es, such as rel ease ex terior; clear mildest herb in a category. One can then clarify rhe relative roxiciry (or lack thereof) heat; ex tinguish wind, qi, blood; yi n and ex trapolate fro m this excellent book a simi of various popular herbs, e.g., pyrrolizidine ya ng ronics, and so fo rth, distinguishing lar approach ro depicting the relative differ alkaloid-containing herbs, lobelia (Lobelia berween their clinical uses and differentiat ences and stre ngths among all rh e herbs in a inflata L. , Campanaulaceae), wormwood ing them according to their srrengrhs. give n category, such as zizyphus seeds, (Artemisia absinthium L. , As reraceae), and I like the fac t rh ar each chapter is passionfl ower, polygonum stems, hops, kava (Piper methysticum G. Forsr. , Piper presented in a question-and-answer fo rmat. al bizia fl ower, and valeri an in the sedative aceae). The book contains guidance regard It al so offers a number of bite-sized ideas to herbs category. Unfo rtunately, this is not ing the potentially beneficial properties of facilitate a particular herb's being re mem usually done in most herb books. Thus, the these and other herbs when employed bered in frontline clinical prac ti ce. Exam informati on in this book can help many appropriately and properly dosed (an addi pl es are: "W hy is Xiang Ru Herba herbalists ro class ify and use non-Chinese tional Appendix provides dosing guidelines Elsholrziae seu Moslae call ed 'summer M a herbs according ro the TCM energetic for scores of herbs discussed in the book). Huang Herba Ephedrae'?" "Whar are the sys rem . W hile many books rhar have The contents of Parr I includes chapters di ffe rent indicati ons for the use of cinna attempted to do this are confusing, Yifa n's on the following conditions or diseases: mon rwig and ephedra?" "H ow can Bai book offers a valuable template as a kind of prevention of cancer with herbs used as Sh ao Paeoniae AJba soften the liver?" and "checks and balances" for understanding food, breast cancer, pros tate cancer, "W hat are the how to class ify and use non-Chinese herbs immunomodularors and HIV infec ti on, c h a rae te r is r i cs wirhin rh e timeless C hinese herbal sys tem. hypertension, diabetes, depression, kidney of the herbs rhar Chinese Herbal Medicines appropria tely srones, heroin addiction, nicotine addic tonify rhe Yin ?" makes no atrempr rowards a cross-cultural ti on, sporrs injuries and musculoskeletal Just as an asi de, understanding of C hinese phys iology and problems, pregnancy and lactati on, cystitis, has anyone ever Western scientific phys iology. It does not influenza and upper respirarory traer infec as ked an herb aspire ro ex plain C hinese herbal medici ne tion, chronic sinusitis, periodontal disease, found anywhere with irs ethnic and esoteric terms ro rhe and dermarologic conditions. 111 rhe wo rl d non-Chinese prac titi oner. H owever, irs This book offers some interesting, highly about irs ethnic value is such rhar rhe book may inspire useful, and clinically relevant insights into icy? many non-Chinese herbali sts ro deepen many botanicals that can be considered for Srudyi ng this their understanding of traditional Chinese treating or preventing vari ous conditions book has rerms and to then apply these for a tradi particularly for the practitioner who would evoked similar ti onal, clinically useful understanding of like to access a wider range of options than ques tions regarding non-C hinese herbs. For any herb. the "usual suspects" (i.e., those herbs that example, when I consider rhe important Madame Yifa n Yang studied both tradi have been srudied in the largest amount of sedative herb, Polygonum multiflorum seem ti onal and modern Western medicine and clinical trials). M any of rhe herbs covered in (ye jiao teng), rhe vine of the well -known was a graduate at Beijing Uni versity of this book may become parr of the "nex t hou shou wu root used as a blood and Traditional C hinese Medicine. She subse wave" of herbs upon which researchers, and longeviry tonic particularly to treat insom q uenrly receive d a Master's degree in the market, may focus their attention .... nia and restless ness (by ro ni fy ing blood), I C hinese H erbal Medicines and Formulas -Mark Blumenthal think of mirroring blood vessels and nerve and worked both as a doctor and reacher at fibers throughout the body, particul arly in Beij ing Uni ve rsity. In 1990 she moved to hinese Herbal Medicines: Compar relati on to cerebral circul ation. This the Netherl ands where she works in a TCM Cisons and Characteristics by Yi fa n conjures a possible understanding for cl inic. She lectures on C hinese herbal medi Yang. Lo ndon & N ew York: C hurchill pass ionflower (Passijlora incarnata), also a cine in coll eges in the N etherl ands and Livings tone, 2002. 223 pp. ISBN 0-443- vine that may suggest irs effects on enhanc Belgium. 07 166-7. $44.95. ing rh e central nervous system by affecting T his book is a welcome addition to the I recently picked up this treasure. It is ce rebral blood circul ati on. Such an under library of any herbalist who has an interest obviously written for rhe adva nced C hinese standing offers clinical herbalis ts more prac in Chinese herbal medicine. Being only 200 herbalist based on the fac t that it pres up ti cal understanding for which passionflower pages, it is a book that one can read fro m poses a bas ic understanding of terms, diag might be more appropriate than va lerian or cover to cover and should help all who aspire nosti cs and related concepts used in T C M skullcap for instance. Interes tingly, there's to become better clinical herbalists. _. (traditional Chinese medicine). H owever, positive corroboration in Sharol T il gner's -Michael Tierra , LAc, OMO, AHG founder for rhe non-Chinese herbalist there is much book, Herbal Medicine, where she describes that can be learned, and the herb names are passionflower's secondary indications as a www.herbalgram .org 2004 HerbaiGram 61 I 73 zn• memorzam• companies, and threatening to take them competitors on their toes, pushing a level of over. The Koethers' venture, Shamrock science and product integrity that set a high Partners, grew a financial warchest of $20 bar of achievement for the rest of the indus million, derived from companies who paid try. them wel l for their stock, and to go away. In She and Paul also were active in other 1985, Natalie Koether was featured in areas of the botanicals and natural products Fortune magazine for her financial savvy industries. They invested in Natural Busi and prowess in these efforts. ness, a magazine dealing with business In 1995, Natalie and Paul Koether aspects of the natural industries. Cofounder acquired Madis Botanicals in H ackensack, of Natural Business Communications and New Jersey. A financially weak company former editorial director of Natural Foods with a long history of service in medicinal Merchandiser Steven Hoffman recounts, botanicals, Aavors and fragrances, Madis "Paul and Natalie were very supportive as Natalie Koether required capital investment, upgraded facil original investors and advisors in Natural 1939-2003 ities, and a new business strategy. The Business. I learned much from them both Koethers re-named the company Pure about business, investment, finance, and he botanical industry lost a leader and World Botanicals, and Natalie assumed the ways of Wall Street. They saw a great T a tireless competitor on Friday, Octo day-to-day leadership for all aspects of oper opportunity in the herbal products industry ber 3. Natalie Koether, president of Pure ations. Under her leadership, PureWorld and in promoting health through business, World Botanicals, died at age 63 at Colum became the largest botanical extraction and through PureWorld and their support bia Presbyterian Hospital in New York, after company in North America. of other industry initiatives they have battling heart disease. Koether had led Pure Under Natalie's leadership, PureWorld conrributed much to the growth of the World Botanicals as president since 1995, Botanicals scored an early, significanr market. Paul is a friend and a mentor and I steering that company through good times victory in the kava trade. Catching the wave look forward to interacting with him well and tough times with determination and a before most of its competitors, PureWorld into the future. I'm sure I speak for an keen sense of market opportunity. Botanicals became a leader in kava science, industry in expressing heartfelt sympathy to The daughter of a pharmacist, Natalie ex traction, and marketing. Kava propelled him and his family." Hoffman is now presi was born in Wilmington, Delaware. She PureWorld Botanicals into prominence, dent of Compass Natural Marketing of attended University of Pennsylvania, where and the company garnered high-profile visi Boulder, Colorado. she graduated with high honors in 1961. In bility in numerous media venues, including The Koethers also invested in Gaia 1995, she graduated from Penn Law features in The Wall Street journal and on Herbs. Gaia founder Ric Scalzo said, "We School. She later served as a trustee of the ABC's television newsmagazine 20/20. will always remember Natalie as a vital, University of Pennsylvania for 13 years, and Natalie radically re-vamped the produc focused, and energetic leader - as well as a was Vice Chairwoman of the U. Penn tion facilities at PureWorld, expanding true ally and a woman of elegance and deep Trustee's Executive Committee at the time manufacturing capacity, funding state-of integrity. We will strive to honor her of her death. the-art laboratories, and initiating several memory." Scalzo said that Natalie always Natalie's contribution to U Penn was novel botanical projects. Under her leader conveyed insight into the industry that was summed up by Samuel Preston, Dean of the ship, PureWorld scored other significant coupled with an unwavering receptivity to School of Arts and Sciences, "We're devas market successes with maca, resveratrol, new perspectives. She stood tall on principle tated in the School of Arts and Sciences. black cohosh, St. John's wort, valerian, and and conviction and executed with passion She ... saw us through some tough times." a number of other botanicals. and integrity. "We will deeply miss her Natalie Koether led a life of generous Qun Yi Zheng, PhD, who assumed the heartfelt passion that she brought to her giving, beginning in childhood. In elemen role of chief operating officer of Pure World work and shared with us here at Gaia," he tary school, she sometimes gave her lunch when Natalie wenr to hospital just prior to added. money to poor srudenrs. Later, she paid her passing, had worked with Natalie to Natalie Koether is survived by her workers at Pure World Botanicals while they help her build Pure World into the leading husband Paul, her daughter Jennifer, grand attended English language classes. "She extractor it is today. "Natalie left me a way daughter Danielle, her sister Marilyn didn't speak to anyone any differently, to live that is dedicated to hard work, not to Todisco, and more than 100 employees at whether yo u were a prince or a mainrenance be afraid of challenges, to love and care for PureWorld Botanicals. A person at her planr," noted her sister Mari others, and to be fair," he said, honoring the -Chris Kilham lyn Todisco. woman who was his primary menror for the Exp lorer in Residence In 197 1, Natalie married Paul Koether, past seven years. University of Massachusetts at Am herst an investor and businessman with a history Natalie's passing has left a gap, nor only ar of financially successful venrures. The rwo PureWorld Botanicals, but in the botanical wenr inro business together, and carved out industry as well. During the past few years a powerful niche on Wall Street with a strat when numerous other companies went our egy known as "greenmailing." Employed by of business and fell into obscurity, Natalie's business titans such as T. Boone Pickens hard-driving spirit of competition kept and Carl Icahn, the practice involved PureWorld alive and well. She also kept buying stakes in undervalued public 74 I HerbaiGram 61 2004 www.herbalgram .org . . tn memortam rive work on this subject. In 1959 Halstead (Siberian Ginseng): An In troduction to the founded the nonprofit World Life Research Concepts of Adaptogenic Medicine, which Institute in Grand Terrace, California, was also published in the former Soviet containing a unique library, botanical Union. collections, artworks, and a wide range of After he returned from Russia, Halstead scientific documentation of botanical and continued his quest investigating traditional marine-derived medicines. medicine and applying modern analytical During his long career he served as a chemistry, physiology, and immunology to consultant to more than 40 governmental his research. He collaborated with scholars and international agencies, including the and scientists in most parts of the world, World Health O rganization (WHO); especially in China. In May 2002, Dr. UNESCO; the U.S. Army, Navy, and Air Halstead had the extreme satisfaction of Force; the equivalents of the National Insti seeing first-hand the remarkable effective Bruce Halstead tutes of Health of numerous foreign govern ness of Chinese herbs being used in Asia to 1920-2002 ments (e .g., the former Soviet Union, treat cancer. This story was documented in Peoples Republic of China, and Cuba); the book he and his wife completed shortly ruce W Halstead, MD, a pioneer in the domestic and foreign universities; research before his untimely death, entitled The Bfield of marine pharmacognosy and institutes; and the pharmaceutical industry. Scientific Basis of Chinese Integrative Cancer natural products research, died unexpect He was a member of the Group of Experts Therapy (by Halstead and Holcomb edly in December 2002, after suffering a on the Scientific Aspects of Marine Pollu Halstead, projected rel ease date May 2004). stroke. He was 82. In the words of his tion (GESAMP) of the United Nations. In There are several writings by Dr. Halstead college friend James Caner, MD, of New 1972, he was selected by WHO to serve as yet to be published. The greatest of all being Orleans, "We have lost a giant." a parricipant at the Stockholm Conference, an extensive investigation which Dr. Bruce W. Halstead was born Newton which brought 150 countries together to Halstead authored over a period of 16 years. Bruce Mellars, March 28, 1920 in San deal with global pollution. He served as a Upon completion, it reached more than Francisco, Cal ifornia. He was related to Sir consultant to both the Jacques Cousteau 1,000 pages. He had entitled this manu Isaac Newton, an ancestor of his father, and the Jean Michel Cousteau organiza script A Chinese Adaptogenic Approach to hence his given name Newton. At age nine, tions and accompanied the Cousteaus on Cancer, AIDS, and Radiation Sickness. This when his stepfather adopted him, Bruce's several of their expeditions. He was also a book includes a beautifully illustrated name was legally changed to Bruce Walter professional diver. In 1989, Halstead was colored atlas of more than 300 medicinal Halstead. appointed an honorary advisor to the Mili plants (projected publication 2008). He earned his bachelor's degree in zool tary Institute of Radiation Medicine, Dr. Halstead is survived by his first wife, ogy from the University of California at Beijing, China. Joy Arloa; their six children, Linda G. Berkeley and his medical degree from Lorna Dr. Halstead authored more than 17 Halstead, Sandra Lee Halstead, David Linda University. His medical and teaching books and more than 300 scientific publi Halstead, Larry Halstead, Shari Halstead positions included Assistant Director and cations. He was considered one of the and Claudia Halstead; his sister, Patrice Associate Professor of Preventative Medi global pioneers in chelation therapy, having Mellars; 11 grandchildren and 2 great ci ne, School of Tropical and Preventative used it in his practice as early as 1979 and grandchildren; his second wife, Terri Lee Medicine, Lorna Linda University; Assistant having authored in 1984 the first concise Holcomb-Halstead; and his dog, Toto. The Surgeon, U.S. Public Health Service; and scientific work on this medical modality, World Life Research Institute continues Instructor in Tropical Medicine, U.S. Naval The Scientific Basis of EDTA Chelation serving as a 501 (c)3 non-profit organiza Medical School. Therapy (second edition released in 1997 by tion. For more information about Dr. Halstead's scientific investigations led Halstead and Rozema). Halstead's lifework and publications, visit him to the world of natural-based medicine, His many scientific expeditions took him the websites ETHICAL BUSINESS 76 I HerbaiGram 61 2004 www.herbalgram.org letters that will prese rve the system of traditional I N SUPPORT OF NON-STANDARDIZATION rei mburse fo r an over-the-counter herbal prepa herbalism, ranging from wise women ro AND NON-LICENSURE OF HERBALISTS ration. The exclusions vary widely from insur shamans, that we cherish. An example on point tephen H arrod Buhner presented several ance ro insurance without a sense of what is in is a law that nea rl y was enacted a few years ago Sthoughtful insights on rhe certification of the patient's bes t interest. Rather, rhe economi cs in Washington. T he proposed law meant to herbalists in his article "Some Arguments agai nst of cutting costs usually guides such decisions. preserve traditional practitioners, and simply rhe Standardization of Herbalists" (HerbalGram Why would an herbalist want ro be parr of such intended to acknowledge (rather than certifY) 2003;58:54-8). a system? the existence of science-based practitioners. T hey are worthy of serious consideration, The Colorado model of licensure described by However, the statute as written ultimately es pecially, because he proposes an alternative Mr. Buhner is attractive for many reasons. It is all owed "non-acknowledged" practitioners to approach to the process of certification. The simple. Credentials are submitted, a li cense or practice provided they were not paid for their discuss ion occurring at present among herbalists certificate is issued and a peer review process services. This is true marginalization. relies heavily on methods used in allopathic (i. e., handles any al leged grievances. In fact, peer Ms. Carpenter also argues rhar patients can conventional) and osteopathic medicine, and review is the true standard now used in medicine eas il y find a suitable type of practitioner by dili all ied health profess ions. It is reaso nable toques within a practice, hospital or region. gently asking rhe right questions. We strongly tion whether this model achieves its goals. Mr. Herbalism presents a complex problem when disagree. In so me communities, holistic care is Buhner correctly concludes that it does not, and the issue of certification is raised. One can readily avail able and accessible. In some commu that other means exist that could be a better become an herbalist through many routes. From nities, traditional healing remai ns in place, and solution. naturopathic clinician ro community herbalist, well-respected traditional healers can easily be As a board-certified family physician and just what is the common denominator? How does found. H owever, in many communities across having compl eted the re-certificati on process for certification include a broad range of healers this country neither exist. As a res ult, most the third time, I have often wondered what it wirhour excluding a group or an individual? Is a consumers get their herbal advice from health achieves. Does it protec t patients from an healer who practices within the limits of his or food store employees and friends, and off the incompetent or unscrupulous physician? Does it her knowledge less quali fied than another from a Internet. (See for example, Goray CC, Dumitriu set a minimum standard of co mpetency? Is it the four-year program of study? Some herbalists D : H ealth food srore recommendations for best method? I have many doubts rhar the would nor join in any certification process breast cancer patients. Arch Fam Med 2000; process is working well. because of their ethical conce rns of in surance 9:692-699; H arn ack LJ , Rydell SA, Stang J: Certification requires resting at interva ls, practices, yet rhey might be rhe best healer in a Prevalence of use of herbal products by adults in usually every 7-10 yea rs, depending on the particular community. Minneapolis/St Paul , Minn. metropolitan area. medical specialty. Does it refl ect competency or Should the future of the practice of herbal Mayo Clin Proc 200 1; 76(7):688-694). These appropriate interperso nal skills with patients and medicin e be co ntrolled by the insurance indus sources may provide decent advice, but this is colleagues? Probably nor. Ar best, it sets a mini try? It would be in this case since an out-of-panel neither an ideal nor an acceptable sys tem of mum standard. I do not thi nk rhar is what the referral would cost more ro the patient, if it is botanical ca re. public desires. Most, if not all , phys icians who covered at all. With the cost of health care at O ur experience also convinces us rhar main have been sued, reprimanded, or convicted of present, rarely does a patient choose ro pay fully stream healrhcare practitioners cannot eas il y insurance fraud are board certified. In my expe our-of-pocket before exhausting the coverage locate herbalists they are comfortable working rience, the most common reason a patient does provided by the insurance. Is there a lesson ro be with. They are typically looking for practitioners not wish to return to a physician ro whom he or learned from this dialogue? In this rherorical well versed in science-based information and she was referred is lack of communication. A fas hi on, the lesso n ro all herbalists should be treatment. Although many herbalists may not difficult characteristic ro measure, certification caution and awareness of the pitfalls of certifica want to participate in that system, mainstream provides no means ro address rhis area of compe tion rather than the proposed benefits. professionals and patients have a right to access tency. State li censure, on rh e other hand, Ir is sad ro acknowledge the fragmented array the type of practitioner they prefer. Voluntary requires participation in continuing education of healthcare services in the United Stares. The certification will not "flush our" scientifically and it is a repository of medical complaints, leader of the economic world, the Uni ted Stares, trained herbalists, it will simply identifY rhem to malpractice outcomes, and any restriction on sirs near the bottom of the list of the 20 most a community that is already looking fo r them. one's clinical practice. The simpler licensure industrialized co untries in many cri tical areas of And, in our opinion, failing to satisfY this need practice creates a mea ns for public access ro my health and disease. Our paradi gms for a health wi ll necessarily result in efforts to legislate a credentials and review for grieva nces. Certifica ier country need an overhaul , perhaps a more system rhar does identifY them. tion adds little meas urable value ro a clinician's revolutionary revision of health and wellness Voluntary certification is a new way to deal level of co mpetency. than is possible at present. This issue extends with the issues arising as herbal ism becomes part In addition, Mr. Buhner is correct ro address beyond rhe scope of certification. Yet, the of mainstream health care and big business. If how insurance companies use the ce rtification shadow of this problem behooves us not to trained practitioners create a system that satisfi es process to restrict the access of phys icians who perpetuate the models that are failing. I applaud the needs of rhe new participants in rhe field wish to become a ca re provider. Solo practition Stephen Buhner fo r asserting his fea rs of repli wh il e working to preserve a full materi a medi ca, ers often are restricted from in surance plans, cati ng an aged, ineffective model of ce rtificati on. we wi ll traverse the slippery slope that is fri ght whereas members of a group practice have more Herbalists have an opportunity here ro maintain ening so many traditional practitioners. If we access to insured patients. the integri ty of their profession and help guide create a ce rtification system that also sin cerely Insurance companies often make decisions for all healers by setting a new standard by which and fully acknowledges the value of traditional economic reasons. Sometimes it reflects good they define their profession in the eyes of the healing, we will ultimately offer a fuller, richer ca re , but often it does nor. For example, public. spectrum of choices to rhe public. Medicare does nor pay for preventive health john Woytowicz, MD Eric YarnelL, ND, RH measures except in limited specifi c ways . Many Faculty, Maine-Dartmouth Family Practice President, Botanical Medicine Academy insurance programs would nor pay for a urine Residency Kathy Abascal, BS, JD, herbalist analysis or random blood suga r in an asympto Augusta, Maine Executive Director, Botanical Medicine matic patient with a strong fa mily hi srory of Academy di abetes mellitus. As medicines become accessi Vashon, Washington ble over-the-counter, they no longer reimburse for them, in which case they certainly wi ll nor www.herbalgram .org 2004 HerbaiGram 61 I 77 calendar rhy, flower essences, and man ual therapies; innova rhe globe, as well as buyers from rhe Midwest rhar 2004 tions in designs for observational or cl inical studies; generall y do nor rravel to rhe coasrs. Conracr: Raymond Cru z. Ph: 3 12/899-4832. Fax: 312/889- March 4-7: Natural Products Expo West. placebo srudies; prayer srudies; meas urement/derec rion srudies; and methodological advances, includ 0008. E-mail: 78 I HerbaiGra m61 2004 www.herbalgram .org calendar Colorado Springs, CO. This international event July 31-August 4: International Congress on Fall 2004: Natural Products Expo Asia. Wanchai, will bring scientists interested in rhe far-reach ing Natural Products Research. Wesrin Kierland Hong Kong. Websire: role of energy and spirit in healing together to pres Resort and Spa, Phoenix, AZ. This congress will be In this departmem of H~rba lGram , we lise resources such as publications, organizations, seminars, and networking for our readers. A listing in this section does nor constitute any endorsement or approval by HerbalGram, ABC, or irs Advisory Board. Foundation for Integrative AIDS Research. Over Exrracrs is a publication of the International Trade more chan 350,000 values for 80-plus food compo 95% ofHfV-infecred individuals do nor have access Centre (lTC) of the United ations. The MNS nents. Access the database rhrough rhe urrient to anti-retroviral drugs used to rrear rhe disease. presents prices, specifications, and marker intelli Dara Laboratory website to search for informacion Those who do ofren face significant and, some gence for botanical raw materials and extracts for on individual foods, download the database to yo ur times, life-threatening side effects. 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