Herbal Medicine: Expanded Commission E
Echinacea Pallida root
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Latin Name: Echinacea pallida
Pharmacopeial Name: Echinaceae pallidae radix Other Names: pale-flowered echinacea, pale purple coneflower root
Overview
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).
Description
Echinacea pallida root, consisting of fresh or dried root of E. pallida (Nutt.) Nutt. [Fam. Asteraceae] and its preparations in effective dosage.
Chemistry and Pharmacology
Echinacea pallida root contains caffeic acid derivatives, mainly echinacoside (0.71.0%), followed by isochlorogenic acid, 6-O-caffeoylechinacoside, and chlorogenic acid; 0.22.0% essential oil composed mainly of ketoalkynes and ketoalkenes (pentadeca-8Z-en-2-one, pentadeca-1,8Z-diene, and 1-pentadecene); polyacetylenes (trideca-1-en-3,5,7,9,11-pentayne and ponticaepoxide); polysaccharides; and glycoproteins (Bauer, 1999a; Bauer and Liersch, 1993; ESCOP, 1999; Pietta et al., 1998). The Commission E reported that in a carbon clearance test, alcohol root extracts showed an increase in the elimination of carbon particles by a factor of 2.2. In an in vitro test: Alcohol root extracts showed an increase in phagocytic elements by 23% when tested in granulocyte smears at a concentration of 10:410:2 mg/ml.
Uses
The Commission E approved the internal use of E. pallida root as supportive therapy for influenza-like infections. The German Standard License for infusion of E. pallida root recommends it to strengthen resistance to infectious conditions in the upper respiratory tract (Wichtl and Bisset, 1994). The WHO approved E. pallida root as supportive therapy for colds and infections of the respiratory and urinary tracts (WHO, 1999).
Contraindications
Commission E cautioned that echinacea preparations are not to be used when progressive systemic diseases such as the following exist: tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infection, and other autoimmune diseases. (As noted above, these cautions were made based on theoretical considerations and not on any reports of adverse findings.)
Side Effects
None known.
Use During Pregnancy and Lactation
No restrictions known.
Interactions with Other Drugs
None known.
Dosage and Administration
Unless otherwise prescribed: 900 mg of root per day in liquid forms for oral administration for a period of not longer than eight weeks. Tincture 1:5 (g/ml) with 50% (v/v) ethanol prepared from native dry extract (50% ethanol, 7-11:1): 90 drops (Bauer and Liersch, 1993; ESCOP, 1999). Decoction: Boil 1 g in 150 ml water for 10 minutes, three times daily (Newall et al., 1996).
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Additional Resources
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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
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This material was adapted from The Complete German Commission E
Monographs —Therapeutic 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.
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.
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