FWD 2 Expanded Commission E: Echinacea Purpurea herb

Herbal Medicine: Expanded Commission E

Echinacea Purpurea herb

Latin Name: Echinacea purpurea
Pharmacopeial Name: Echinaceae purpureae herba
Other Names: echinacea, coneflower, purple coneflower, purple echinacea


One of the most popular herbs in the United States marketplace is the native American medicinal plant echinacea. The term refers to several plants in the genus Echinacea, derived from the aboveground parts and roots of Echinacea purpurea (L.) Moench, E. angustifolia D.C., and E. pallida (Nutt.) Nutt. [Fam. Asteraceae]. Herbalists and pharmacognosists point out the irony that almost all of the scientific research on this medicinal plant has been conducted not in the United States but in Germany. Echinacea preparations have become increasingly popular in Germany since the early 1900s. The herb was first analyzed and tested for homeopathic purposes in Germany and its medical use was later investigated by Dr. Gerhard Madaus in 1938. Echinacea was formerly used in the United States by native Americans and by Eclectic physicians in the late 1800s and early 1900s. Preparations made from various plants and plant parts of the genus Echinacea constituted the top-selling herbal medicine in health food stores in the United States from 1995 to 1998, with an estimated 9.6% of the total health-food dollar spent on herbs, according to a survey of about two hundred independent stores in 1996 (Richman and Witkowski, 1996, 1997, 1998).

Echinacea is used for preventing and treating the common cold, flu, and upper respiratory tract infections (URIs). It is also used to increase general immune system function and to treat vaginal candidiasis. The clinical literature tends to support the treatment for symptoms of colds, the flus, and URIs. Recent studies do not support its use to prevent URI.

Of the four echinacea monographs published by Commission E, two are positive (i.e., approved) (E. pallida root and E. purpurea herb) and two are negative (i.e., unapproved) (E. purpurea root and E. angustifolia root). The latter were given negative assessments due to lack of clinical trials for the specific plant parts. Work on the chemistry of vouchered Echinacea species from 1988 onward by Rudolf Bauer and Hildebert Wagner at the Institute for Pharmaceutical Biology in Munich revealed clear chemical profiles for E. angustifolia and E. pallida (Bauer and Wagner, 1991). It became obvious that earlier pharmacological studies of E. angustifolia actually involved E. pallida. Historically, E. pallida and E. angustifolia have been offered to the trade in mixed lots as "Kansas snake root." Therefore, lack of current pharmacological and clinical studies on E. angustifolia root and E. angustifolia/E. pallida aerial parts resulted in the issuance of a negative monograph until further supporting scientific information becomes available (Leung and Foster, 1996).

However, despite previous problems concerning the botanical identity of Echinacea species in commercial preparations and research materials, another reason for the disparity in approvals by Commission E is based on the availability of the research on the respective species. According to Prof. Heinz Schilcher, vice president of Commission E, at the time the monographs were being considered for publication, experimental and clinical studies were available only on the flowering tops and roots of E. purpurea, roots of E. pallida, and roots of E. angustifolia. The Commission decided that only the results from the research conducted on the fresh plant juice from the flowering herb of E. purpurea and from the water-alcohol extract of E. pallida roots were adequate for a positive monograph. In the meantime, there have been additional studies based on the alcoholic extract of the roots of E. purpurea that in Schilcher's opinion should support a positive monograph (Schilcher, 1997). A clinical trial was carried out in 1992 on an extract of the root of E. purpurea, suggesting therapeutic benefits in patients with colds and flu (Brunig et al., 1992). The same year Commission E published a monograph on E. purpurea root as an Unapproved Component Characteristic, based on the lack of research of this species and part, although not all members of the Commission supported this decision (Schilcher, 1997).

Since there is a variety of echinacea preparations derived from either one plant or plant part or a variety of plant parts (root, leaf, flower, seed) from various species (E. purpurea, E. pallida, E. angustifolia), it is necessary to clarify which plants and plant parts were used in each clinical trial. Professor R. Bauer of the Institute for Pharmaceutical Biology at Heinrich-Heine University inin vitro and in vivo for the expressed juice of the aboveground parts of E. purpurea (i.e., Echinacin®) and for alcoholic extracts of the roots of E. pallida, E. angustifolia, and E. purpurea (Bauer, 1996). The effects act mainly on the nonspecific cellular immune system. He reports several active constituent groups: polysaccharides, glycoproteins, caffeic acid derivatives (cichoric acid), and alkamides.

A review of 26 controlled clinical studies (18 randomized, 11 double-blind) that investigated the immunomodulatory activity of preparations containing echinacea extracts (Melchart et al., 1994). Six of the trials used echinacea alone, and 20 tested echinacea in combination with other ingredients. The methodological quality of the trials was assessed and deemed low. However, the authors concluded that existing controlled clinical trials indicated that preparations containing the juice or extracts of echinacea can be efficacious immunomodulators. Further methodologically sound, randomized clinical trials were recommended. Commenting on this study, Professor H. Wagner, a leading figure in European pharmacognosy, commented, "Of the investigated criteria the most striking effects were the reduction in susceptibility to infection and in the incidence of catarrh and pharyngeal inflammation" (Wagner, 1997). In reviewing clinical studies on echinacea, he has written, "The conclusion that can be drawn is that remedies containing echinacea can effect an improvement in immune defense systems where those systems are temporarily weakened." He pointed out that there is not yet sufficient evidence to give "clear therapeutic recommendations as to which preparation in which dosage and type of application has the optimal effect" (Wagner, 1997).

Many clinical studies on echinacea used fresh stabilized E. purpurea juice, in the injectable form, and others have been conducted with oral applications or an externally applied salve (Hobbs, 1994). The E. purpurea aerial parts preparations are usually a proprietary fresh-pressed leaf juice (22% ethanol by volume as a preservative), marketed as Echinacin® (manufactured by Madaus AG of Cologne, Germany). Echinacea is often used in combination products such as Esberitox® (Schaper and Br ümmer, Germany), which also contains extracts of Baptisia tinctoria (wild indigo) and Thuja occidentalis (arbor vitae). Clinical studies conducted with this combination product are not reviewed here due to the presence of these presumably active additional ingredients.

In the most recent literature review of clinical trials conducted on various echinacea preparations for prevention or treatment of URIs, focusing on 9 trials designed for treatment and 4 trials for prevention, the authors found that 8 of the 9 treatment trials reported generally positive results, while 3 of the prevention trials reported "marginal benefit" (Barrett et al., 1999). The authors assessed the methodological quality of the trials as "modest." They concluded that various types of preparations from various species of Echinacea may be beneficial for the early treatment of URIs, but that there was little evidence to support the extended use of echinacea for prevention of URI. They found it difficult to make specific dosage recommendations due to the variation in composition of commercial preparations. The authors emphasized that the highest quality trials suggest that early dosing of sufficient doses is important.

Another recent review of echinacea (Melchart and Linde, 1999) has found seven placebo-controlled, double-blind, randomized clinical trials testing the efficacy of two different echinacea monopreparations and three combination products in the treatment of non-specific URIs. Combination products are not reviewed in this monograph.

Several studies have examined echinacea's usefulness in the prevention and treatment of colds. A double-blind, placebo-controlled study was conducted with 108 volunteers who had chronic URIs (more than three occurrences in a half year) (Sch öneberger, 1992). Half of the patients received a dose of 8 ml/day of fresh-pressed juice of E. purpurea (Echinacin®) for eight weeks, with the other half receiving placebo. Compared to the placebo group, in the echinacea group there was a tendancy for more patients (36%) to suffer no infections, or the time between infections increased, the duration of illness shortened, and severity of symptoms lessened. The echinacea preparation was well tolerated, and patients with diminished immune response (expressed by a low T4/T8 cell ratio) seemed to benefit most from the treatment. This same study was recently re-interpreted and re-published with a less positive assessment given by the authors (Grimm and Müller, 1999).

In a more recent randomized, double-blind, placebo-controlled study on this fresh juice preparation (Hoheisel et al., 1997), the clinical efficacy of the proprietary E. purpurea expressed juice preparation (Echinagard®, Echinacin's trade name in the United States) was tested on 120 patients with initial symptoms of common cold. The preparation was effective in that significantly fewer patients developed full disease symptoms (40% versus 60%); recovery was much quicker with the echinacea preparation than with placebo (four days versus eight days).

A third study highlighted the importance of dosage in the expected effectiveness of echinacea preparations (Bräunig et al., 1992). This double-blind, placebo-controlled trial examined the effectiveness of an ethanolic extract made from the root of E. purpurea (1:5, 55% ethanol) in relieving the symptoms and duration of flu-like infections in 180 volunteers. Subjects were divided into three groups of 60 each and administered the echinacea at 450 mg/dose, 900 mg/dose, or placebo. Those who received only 450 mg/dose showed improvement only comparable to the placebo. Those receiving 900 mg/dose showed a statistically significant improvement. An effect from the higher dose was seen after three to four days, but the full effect was not seen for 8 to 10 days. It is possible that the availability of this study to the Commission E at the time the E. purpurea root monograph was given a negative assessment (published in August, 1992) may have influenced a positive (approved) assessment.

In a recent Swedish placebo-controlled double-blind study conducted over eight days with tablets (daily dose, 3x2) made from a proprietary water-alcohol extract of the fresh herb (95%) and roots (5%) of E. purpurea (extract ratio 5.9:1; Echinaforce®, Bioforce, Switzerland), 55 patients were given the herbal preparation and 64 received placebo. Thirteen of the echinacea group were allowed to use additional approved medication, such as nose drops and the fever-reducing drug paracetamol. The examining physician concluded that the echinacea preparation was effective in 68% of the patients in reducing several of 12 symptoms (nasal catarrh and/or stuffy nose, sore throat, headache/dizziness, muscle pain, fever, cough, etc.); patients self-assessed the efficacy of the echinacea at 78% of the cases (Brinkeborn et al., 1998). The preparation evoked little concern about safety.

A critical summary of studies on the immunomodulatory activity of preparations of echinacea reported on five randomized trials conducted between 1984 and 1992 (Melchart et al., 1995). A total of 134 healthy, mostly male, volunteers between the ages of 18 and 40 were studied in Germany, using five different echinacea preparations. The results were mixed; not only were different preparations administered, but methods for analyzing the activity of targeted immune cells varied as well, making interpretation difficult. Two of the five studies showed activity of the measured immune cells to be significantly stimulated, while three did not.

In a highly publicized study, researchers ran a clinical study on 302 healthy people (revised to a total of 289 after dropouts) who were divided into three groups. Each group received either an alcoholic extract of E. purpurea root, E. angustifolia root, or a placebo. Neither echinacea preparation helped prevent the onset of the common cold; cold symptoms appeared within 69 days in the E. purpurea group (29.3% with infection), 66 days for the E. angustifolia group (32.0%), and 65 days for the placebo group (36.7%). The participants were instructed to take 50 drops (about 20 microliters per drop) twice per day from Monday through Friday for 12 weeks. The two ethanolic echinacea root extracts were prepared at a 1:11 ratio and were dissolved in 30% ethanol. The conclusion was that the study could not show that echinacea helps to prevent the common cold. The study states, "Based on the results of this and two other studies, one could speculate that there might be an effect of echinacea products in the order of magnitude of 10% to 20% relative risk reduction" (Melchart et al., 1998). The conclusion to be drawn from this research is that the study could not show preventive activity with the specific preparation according to the particular study design; the authors acknowledged the need for a larger population of subjects upon which to test for potential preventive activity.

Some new research findings have come from a recent placebo-controlled trial testing the exercise-induced immunological effects of E. purpurea aboveground fresh plant juice (Echinacin®) on 42 male athletes (Berg et al., 1998). The echinacea group had marked changes in concentration of the cytokines interleukin 6 (IL-6) and soluble interleukin 2 receptor (sIL-2R), proteins that stimulate various immune functions, in serum and urine and significantly increased serum. Exercise-induced cortisol usually lowers natural killer (NK) cell levels and inhibits macrophage activity, two variables of immune function. The echinacea group did not demonstrate a significant decrease in NK cells one hour after competition, suggesting that echinacea may counteract the immune suppressant effect of cortisol. However, another result of this study was that none of the echinacea group experienced URI, while 3 of 13 in the magnesium group and 4 of 13 in the placebo group developed URI. A total of six in both the magnesium and placebo groups reported symptoms of other infections, while none on echinacea did. The authors concluded that preventive treatment of athletes with the E. purpurea juice preparation counteracts the immunosuppressant effects of exhaustive exercise and reduces risk of URI in athletes.

There is evidence to suggest that echinacea is a reliable supportive therapy for people with recurring candidiasis, particularly when antifungal therapy is failing (Brown, 1996). The positive effect of E. purpurea leaf juice was demonstrated in a study of 203 women with recurrent vaginal yeast infections (Coeugniet and K ühnast, 1986). All the women were being treated with a topical econazole nitrate cream (a commonly prescribed antifungal/antiyeast medication). Women using the econazole nitrate alone experienced a 60.5% recurrence rate, while the women taking echinacea (oral Echinacin®) had a recurrence rate lowered to 16.7%.

In a study in the United States the pharmacological basis for the immunological activity of echinacea was investigated by researchers at the Department of Medicine, University of California at Irvine Medical Center at Orange (See et al., 1997). Extracts of both E. purpurea (plant part not noted) and Panax ginseng root were tested for their capacity to stimulate cellular immune function by peripheral blood mononuclear cells (PBMC) from normal individuals and patients with either chronic fatigue syndrome or acquired immunodeficiency syndrome. Results indicated that the extracts enhanced cellular immune function of PBMC from both normal individuals and patients with depressed cellular immunity.

Bauer and Wagner note that various preparations of echinacea enhance leukocyte activity, have antibacterial properties, inhibit the enzyme hyaluronidase (thus retarding breakdown of hyaluronic acid, a gelatinous component of intercellular spaces), provide an interferon-like effect on viruses, and have (relatively mild) anti-inflammatory properties (Bauer and Wagner, 1991). Another potential use of echinacea preparations is for the treatment of otitis media in small children, an application that is gaining a small number of adherents among some pediatricians and naturopathic physicians in the United States (Blumenthal, 1993).

The monograph on E. pallida root is an example of a case where specifications based on a proprietary extract of an herb were approved. This preparation consists of a tincture (1:5) with 50% (v/v) ethanol from native dry extract (50% ethanol, 7–11:1) corresponding to 900 mg of the herb, i.e., dried root. A placebo-controlled, double-blind trial conducted on 160 adults indicated that a daily dose of 900 mg of the extract of E. pallida root was effective in shortening the duration of URIs (sinusitis, cough, pharyngitis) in infected adults, whether of bacterial or viral origin (Dorn et al., 1997).

There has been some confusion regarding the contraindications and side effects listed in the monographs, most of which are for injectible preparations. The contraindications noted below for echinacea preparations in cases of HIV and AIDS, tuberculosis, leukosis, collagenosis, and multiple sclerosis have been misinterpreted to mean that echinacea use can exacerbate such conditions; however, there is no clinical evidence to support this concern. The reason for the Commission's caution was based on theoretical concerns and because such conditions are not amenable to self-medication. A cogent argument by an Australian phytotherapist suggests that there is no rational basis for this contraindication and in fact, current clinical practice, previous prolonged use by Eclectic physicians in the United States in the latter nineteenth and early twentieth centuries, and proper evaluation of modern scientific data support long-term use of echinacea preparations for autoimmune disorders (Bone, 1997–1998).

Regarding the issue of Commission E's contraindication of echinacea preparations for various types of autoimmune disorders, Professor Bauer, the world's leading researcher on echinacea, writes, "As far as I know, these contraindications have only been included because of theoretical considerations. There is a paper by Shohan (1985) in which the possible risks of immunostimulating agents in general are discussed. These recommendations for Echinacea are as far as I know not based on any reported adverse effect in such indications. There is a recent paper by Parnham (1996) which reports that long-term treatment, e.g., with the expressed juice of E. purpurea, is well-tolerated" (Bauer, 1999b).

It should also be noted that in Germany, physicians previously had access to injectable (parenteral) drug products made from either a monopreparation of E. purpurea herb juice or a fixed combination that contained E. pallida. Thus, the monographs for E. purpurea herb and E. pallida root both note adverse side effects associated with injectable forms of these echinacea products.

Despite safety concerns with injectable echinacea, there are few significant adverse events reported for echinacea products taken orally. One such event was a case of anaphylaxis reported with ingestion of an echinacea preparation made of E. angustifolia (whole plant) and E. purpurea root (Mullins, 1998). Animal toxicology studies indicate a high degree of safety for echinacea: in experiments using oral (greater than 15 g per kg) or intravenous (greater than 5 g per kg) administration, it was impossible to kill rats or mice (Hoheisel et al., 1997). Thus, an average lethal dose has not been determinable. Rats and mice given prolonged (4 weeks) doses of an E. purpurea preparationup to 8 g per kg did not exhibit adverse effects on numerous end points measured (blood lipids, liver enzymes, weight loss, etc.) (Mengs et al., 1991).

Based on the data presented above, there are sufficient pharmacological and clinical research studies to support the safety and probable efficacy of preparations made from both the aerial parts of E. purpurea and the roots of at least two and possibly three species of echinacea (E. pallida and E. purpurea, and possibly, E. angustifolia).


Purple coneflower herb consists of fresh, aboveground parts, harvested at flowering time, of Echinacea purpurea (L.) Moench [Fam. Asteraceae], and its preparations in effective dosage.

Chemistry and Pharmacology

Echinacea purpurea herb contains caffeic acid derivatives, mainly cichoric acid (1.23.1% in the flowers), caftaric acid and chlorogenic acid; 0.0010.03% alkamides, mainly isomeric dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamides; water soluble polysaccharides, including PS I (a 4-0-methylglucoronylarabinoxylan) and PS II (an acidic rhamnoarabinogalactan), fructans; 0.48% flavonoids of quercetin and kaempferol type (e.g., rutoside); 0.080.32% essential oil composed of borneol, bornyl acetate, pentadeca-8-en-2-one, palmitic acid, and others (Bauer, 1999a; Bauer and Liersch, 1993).

The Commission E reported that in human and animal experiments, E. purpurea preparations given internally or parenterally have shown immunostimulant effects. Among others, the number of white blood cells and spleen cells is increased, the capacity for phagocytosis by human granulocytes is activated, and the body temperature is elevated. Echinacea has been studied for nonspecific stimulation of the immune system, involving an overall increase in phagocytosis by macrophages and granulocytes.

Oral dosage is as effective as parenteral dosage, though slower acting. The combined action of multiple constituents is apparently responsible for the immunostimulatory activity of both alcoholic and aqueous extracts of echinacea. The immunostimulant activity of alcoholic echinacea extracts is largely due to the lipophilic amides (alkylamides), as well as the polar caffeic acid derivatives (e.g., cichoric acid), whereas the water soluble polysaccharides are implicated in the expressed juice or aqueous preparations of E. purpurea. Expressed juice of fresh flowering E. purpurea applied topically on local tissues inhibits hyaluronidase, thereby stimulating wound healing (Bauer and Wagner, 1990, 1991).


The Commission E approved the internal use of E. purpurea herb as supportive therapy for colds and chronic infections of the respiratory tract and lower urinary tract. The Commission E approved external use for poorly healing wounds and chronic ulcerations.

The WHO supports the findings of Commission E regarding internal and external uses of E. purpurea herb. WHO added 'treatment of inflammatory skin conditions' to external use (WHO, 1999).


External: None known.

Internal: Progressive systemic diseases, such as tuberculosis, leukosis, collagenosis, and multiple sclerosis. (As noted above, these cautions were made based on theoretical considerations and not on any reports of adverse findings.)

No parenteral administration in case of tendencies to allergies, especially allergies to members of the Compositae (Asteraceae), as well as in pregnancy. (Parenteral use is no longer approved in Germany.)

Warning: The metabolic condition in diabetics can decline upon parenteral application.

Side Effects

Internal and external application:

None known.

Parenteral application: Depending upon dosage, short-term fever reactions, and nausea and vomiting can occur. In individual cases, immediate allergic reactions are possible.

Use During Pregnancy and Lactation

No restrictions known.

Interactions with Other Drugs

None known.

Dosage and Administration

Unless otherwise prescribed: Internal: 6-9 ml expressed juice of fresh plant or equivalent preparations, per day. External: Semi-solid preparations containing at least 15% pressed juice. Preparations for internal and external use: Not longer than eight weeks.


Succus, in 25% solution (95% ethanol): 6-9 ml (Bauer and Liersch, 1993; Commission E; ESCOP, 1999).

Infusion: 1 g in 150 ml water.

Fluidextract 1:1 (g/ml): 1 ml.

Tincture 1:5 (g/ml): 5 ml.


Ointment: Semi-solid preparation containing at least 15% pressed juice in a base of petroleum jelly or anhydrous lanolin and vegetable oil applied locally.

Poultice: Semi-solid paste or plaster containing at least 15% pressed juice applied locally.


Depends on kind and seriousness of condition as well as the nature of the preparation. Parenteral application requires a gradation of dosage, especially for children; the manufacturer is required to show this information for the particular preparation. Preparations for parenteral use: Not longer than three weeks. (No longer approved in Germany.)


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Additional Resources

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—. 1993. Neue Ergebnisse zur frage der wirksubstanzen von Echinacea-drogen. Natur und G Med 6:32-40.

Bauer, R. and H. Wagner. 1988. Echinacea—Der Sonnenhut—Stand der Forschung. Z Phytother 9(5):151-159.

Bauer, R., I.A. Khan, H. Wagner. 1988. TLC and HPLC analysis of Echinacea pallida and E. angustifolia roots. Planta Med 54:426-430.

Bauer, R., P. Remiger, H. Wagner. 1988. Echinacea-vergleichende DC- und HPLC-analyse der Herba-Drogen von Echinacea purpurea, Echinacea pallida und Echinacea angustifolia. DAZ 128:174-180.

Bauer, R., K. Jurcic, J. Puhlmann, H. Wagner. 1988. Immunologische in-vivo und in-vitro untersuchungen mit Echinacea extrakten [Immunologic in vivo and in vitro studies on Echinacea extracts]. Arzneimforsch 38(2):276-281.

Bauer, R. et al. 1987. Two acetylenic compounds from Echinacea pallida roots. Phytochem 26:1198-1200.

Bodinet, C., I. Willigmann, N. Beuscher. 1996. Host-resistance increasing activity of root extracts from Echinacea species. Poster: Schaper and Brümmer, D-38251 Salzgitter, F.R.G.

Bone, K. 1999. Echinacea: Fact and Mythology. HerbalGram 49 (in press).

Bradley, P.R. (ed.). 1992. British Herbal Compendium, Vol. 1. Bournemouth: British Herbal Medicine Association. 81-83.

Brinkeborn, R.M., D.V. Shah, F.H. Degenring. 1999. Echinaforce and other Echinacea fresh plant preparations in the treatment of the common cold. A randomized, placebo-controlled, double-blind clinical trial. Phytomedicine 6(1):1-6.

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Burger, R.A., A.R. Torres, R.P. Warren, V.D. Caldwell, B.G. Hughes. 1997. Echinacea-induced cytokine production by human macrophages. Int J Immunopharmacol 19(7):371-379.

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This material was adapted from The Complete German Commission E MonographsTherapeutic Guide to Herbal Medicines. M. Blumenthal, W.R. Busse, A. Goldberg, J. Gruenwald, T. Hall, C.W. Riggins, R.S. Rister (eds.) S. Klein and R.S. Rister (trans.). 1998. Austin: American Botanical Council; Boston: Integrative Medicine Communications.

1) The Overview section is new information.

2) Description, Chemistry and Pharmacology, Uses, Contraindications, Side Effects, Interactions with Other Drugs, and Dosage sections have been drawn from the original work. Additional information has been added in some or all of these sections, as noted with references.

3) The dosage for equivalent preparations (tea infusion, fluidextract, and tincture) have been provided based on the following example:

  • Unless otherwise prescribed: 2 g per day of [powdered, crushed, cut or whole] [plant part]
  • Infusion: 2 g in 150 ml of water
  • Fluidextract 1:1 (g/ml): 2 ml
  • Tincture 1:5 (g/ml): 10 ml

4) The References and Additional Resources sections are new sections. Additional Resources are not cited in the monograph but are included for research purposes.

This monograph, published by the Commission E in 1994, was modified based on new scientific research. It contains more extensive pharmacological and therapeutic information taken directly from the Commission E.

Excerpt from Herbal Medicine: Expanded Commission E Monographs
Copyright 2000 American Botanical Council
Published by Integrative Medicine Communications
Available from the American Botanical Council.