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The Commission E Monographs |
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THE COMPLETE GERMAN COMMISSION E MONOGRAPHS
THERAPEUTIC GUIDE TO HERBAL MEDICINES
Copyright © 1999 American Botanical Council
Part One Introduction
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Explanation of Monograph
Sections
Monograph Title
In most monographs we have chosen the preferred English common name for the
monograph title. Whenever possible, we also list the plant part or parts covered
by the monograph. In some cases, an herbal drug used in Germany has no accepted
English common name. When this has occurred, we have titled the monograph by the
designation of the genus, from which it is derived, which may become the
accepted common name. An example is Mentzelia for Mentzelia cordifolia. Listed
below the English title are the Latin pharmacopeial and German names. The
official title of each monograph published in the original German version of the
Bundesanzeiger was the pharmacopeial name for the herbal drug. Although
pharmacopeial names are normally used in Europe and should be well-known to
scientists the world over, in order to simplify matters for the English reader,
we have employed the preferred English common name for the monograph title.
Revisions and
Corrections
The Commission published a total of 81 revisions to the monographs. These
reflect the relatively fluid nature of the available data on herbs and
phytomedicines; as new information was reviewed, some changes in the monograph
were justified. Revisions include changes in dosage, changes in warning, side
effects, contraindications, and even approved uses. In some cases, an entire
monograph was replaced with a new monograph, or, as is the case with Hawthorn,
three monographs (see below).
Common Names
We have chosen the common name most widely used in the U.S. For most of the
herbs we relied on Herbs of Commerce , a listing of the appropriate common
names as compiled and published by the American Herbal Products Association, the
leading herb industry trade association (Foster et al., 1992). Herbs of
Commerce is a self-regulatory initiative which establishes uniform common
names for the most popular herbs sold in the U.S. The book lists approximately
550 herbs in U.S. commerce, including their proper Latin binomials. In the
frequent situation where an herb has more than one commonly used name, or when
an herb name is spelled several ways, we have made our choice based on the term
preferred by the AHPA, if it is listed. As examples, we have used the term
"stinging nettle" instead of "nettle" for nettle herb and
nettle root and we have spelled "passionflower" as one word instead of
the also commonly used two words.
In most cases we have also listed the plant part on which the monograph is
based in the monograph title. This is particularly important in cases where one
plant part is approved (e.g., Echinacea purpurea herb; Hawthorn leaf and flower)
while another part of the same plant is not approved (e.g., Echinacea purpurea
root; Hawthorn berry, leaf, or flower). In a few monographs, only the name of
the herb is used for the monograph title (e.g., Hibiscus, Hyssop). This is also
true where more than one plant part is included. For example, for Borage, the
monograph includes both the flower and the herb; however, rather than title the
monograph "Borage flower and herb" we chose to call it Borage.
The common names of some herbs presented problems not only with nomenclature
but also with proper alphabetization. For example, should Red Clover be in the
C's or R's? Similarly, should Red Sandalwood be listed under R or S? With
respect to herbs like Red Clover where "Red" is an integral part of
the herb's name, we have included it as the first word of the herb, in the R
section. However, there are monographs for both Red Sandalwood and White
Sandalwood (two different plants); we have put both in the S section, as
"Sandalwood, Red" and "Sandalwood, White." Similarly,
"Blonde Psyllium Seed" is found as "Psyllium Seed, Blonde"
in the P's with Psyllium Seed, Black. "German Chamomile" is found
under "Chamomile, German" since Chamomile is the primary name. In
general, the naming of other herbs follows this policy in this publication.
The German name of each preparation, listed in italics, includes the name of
the plant and the plant part used, in the compound nature of the German
language. For example, Purple Coneflower herb ( Echinacea purpurea )
is called Purpursonnenhutkraut while Purple Coneflower root is Purpursonnenhutwurzel .
Some German names actually include the type of preparation, such as Peppermint
oil, Pfefferminzöl .
Publication Date
The original date of the publication of each monograph is provided with the
date of any revision or replacement. Many monographs were revised more than
once; this is noted with multiple revision dates. The Bundesanzeiger
numbers for the publications are provided in the section, List of All Commission
E Monographs Published in the German Federal Gazette ( Bundesanzeiger )
on page 593.
Name of Drug
This section provides the pharmacopeial name or names of the plant parts. In
the original German monograph, the German common name also was provided. We have
thus added the English name in this section.
Pharmacopeial Names
For several hundred years pharmacopeial (aka pharmaceutical) names have
provided a convenient system for pharmacists, physicians, and botanists to
identify a substance used as materia medica by referring to its Latin name plus
the plant part or type of preparation being used. Pharmacopeial names are not to
be confused with Latin binomials, which consist of the genus and species of the
plant according to taxonomic rules of botanical classification initially
established by the 18th century Swedish botanist Carl von Linné (Linnaeus).
For example, peppermint is known technically by its Latin binomial Mentha
x piperita (always italicized) where Mentha is the genus for
various mints, x refers to a hybrid and piperita refers to that
particular species, peppermint. This allows peppermint to be distinguished from
other related mints such as spearmint ( M. spicata ) or field or common
mint ( M. arvensis ). Thus, the pharmacopeial name for peppermint leaf
would be Menthae piperitae folium (non-italicized) where folium refers to leaf.
The pharmacopeial name for peppermint herb (the entire aerial or aboveground
part of the plant) would be Menthae piperitae herba. Similarly, the
pharmacopeial name for the distilled oil of peppermint is Menthae piperitae
aetheroleum, where aetheroleum refers to the volatile or essential oil.
Accordingly, a preparation made from the plant's root is called radix, rhizome
is rhizoma, flower is flos, fruit is fructus, seed is semen, seed husk is testa,
bark is cortex, and so on. (These Latin names are written in the singular form;
some national pharmacopeias use the plural form.)
It is a common practice in botany for scientists who study plant
classification to reclassify or rename a plant. For example, the popular
European herb milk thistle, sometimes called Marian thistle or Mary's thistle,
is currently written as Silybum marianum in its Latin binomial form;
however, an earlier name for this plant was Carduus marianus .
Consequently, the pharmacopeial name for milk thistle is Cardui marianum, based
on the archaic Latin binomial. Accordingly, the approved monograph for drug
preparations made from the fruits (seeds) of milk thistle is described as Cardui
mariae fructus, whereas the separate unapproved monograph for the herb (i.e.,
the aerial parts, particularly the leaves) is Cardui mariae herba. Similarly,
the pharmacopeial name for Burdock root is Bardanae radix, referring to previous
nomenclature for this botanical.
In some monographs, pharmacopeial names were not used as the official title
by Commission E. This is particularly the case where two plant parts are
described in the same monograph. An example would be Mugwort (Unapproved) where
the monograph covers both the herb and root (Artemisiae vulgaris herba and
Artemisiae vulgaris radix); the original monograph title was Artemisia vulgaris,
the Latin binomial for the herb. In such cases, we use the most appropriate
common name and list the Latin binomial in the second line. Another example of
this type is the monograph for Belladonna (Approved) where both the belladonna
leaf (Belladonnae folium) and the Belladonna root (Belladonnae radix) are
included in the monograph. In this example, the official title of the monograph
was Atropa belladonna , the Latin binomial. We have chosen the English
common name Belladonna as the monograph title; however, we also might have used
Deadly Nightshade, another common term for this herb. Both common names are
listed in Herbs of Commerce , although Belladonna is preferred (Foster,
1992).
Composition of Drug
This section includes the plant part, botanical name, plant family, required
time of harvest, and, in some cases, some of the primary chemical constituents.
We have attempted to preserve the integrity of the monographs by retaining the
original nomenclature. However, in some monographs we have added in brackets
taxonomic revisions, synonyms, and notes on species actually found in trade,
when we thought such an addition was warranted.
Botanical Name
In the body of the monograph we have reprinted the precise Latin names
published by Commission E, including parenthetical synonyms. In some instances
we have inserted revised synonyms in brackets after the Latin binomial published
by Commission E. These synonyms are based on taxonomic revisions supplied by
Professor Arthur O. Tucker of Delaware State University. In some instances, we
have adopted the International Code of Botanical Nomenclature (Greuter et
al., 1988) and Herbs of Commerce (Foster, 1992) as the basic criteria for
publishing synonyms of the Latin binomials used in the monographs.
Latin names in the Composition of Drug section: In the original German
versions of the monographs multiple mentions of a genus are written with the
genus name spelled in full each time. For example, in Black Psyllium, the genus Plantago
is mentioned four times: two taxa are represented as being suitable for use as
the drug ( P. psyllium and P. indica ), with a botanical synonym
listed for each taxon ( P. afra and P. arenaria respectively). In
accordance with conventional botanical notation, we have abbreviated subsequent
mention of the names in the style used above.
As with some Plantago species, several species of plants are sometimes
found in the same monograph. Another example is the monograph for Goldenrod
which includes the species Solidago virgaurea , S. gigantea , and S.
canadensis .
A stylistic note: When Latin names are used for the title of the monograph,
we have taken the editorial liberty of capitalizing both the genus and species
names. Plant parts (e.g., leaf, root, flower) are not capitalized in the
monograph title heading. We have repeated this style when referring to the
particular monograph anywhere else in the text. Accordingly, the title for the
monograph for the leaf of Echinacea purpurea is written "Echinacea
Purpurea leaf" where the specific name "Purpurea" is being
capitalized to denote its being the title of a monograph. The same is true for
our treatment of "Ginkgo Biloba Leaf Extract." Nowhere else would we
write Ginkgo biloba with a capital "B" — the term usually being
italicized to denote its use as a Latin binomial. We hope this does not cause
any confusion for our readers.
Plant Family
The original monographs usually do not mention the family name for the plant
drug in the "Composition" section. However, we have inserted the
family name in brackets after the Latin binomial because knowledge of a plant's
botanical relationships can increase general awareness of the plant, its
potential chemical profile, and possible similarities of pharmacological
actions.
Botanists sometimes use more than one name for a plant family. For example,
for members of the composite family, such as the genera Arnica (Arnica), Matricaria
(Chamomile), Echinacea (Echinacea, Purple Coneflower), and Inula
(Elecampane), we have used the newer synonym Asteraceae, although Commission E
sometimes uses the term Compositae, the older term and the one still widely
employed both in Europe and the U.S. Both names are acceptable. Similarly, we
have used Apiaceae instead of Umbelliferae for members of the carrot family,
although both terms are accepted by taxonomists. Commission E published the
latter name in its monographs. Modern botanical nomenclature requires all plant
family names to end in "-aceae."
Chemical Constituents
The Commission E monographs do not include the complete chemistry of herbal
drugs. Some of the monographs mention a specific main compound or compounds that
are important in contributing to the plant's effectiveness; however, in most
cases, a general class of compounds is usually listed, e.g., bitter principles,
tannins, essential oil.
Uses
We have chosen the word "Uses" as the section heading, although
"Indication" is also an appropriate translation of Anwendungsgebiete .
The Uses in the Approved Herbs monographs include only those indications
approved by the Commission based on the evaluation of the relevant literature.
However, this does not represent the total possible range of applications of the
herbal drug in folk medicine or in clinical practice.
Phytomedicines licensed in Germany are allowed to be labeled for the approved
Commission E use only. Thus, this section becomes one of the most significant
sections of the monograph, particularly in Germany where it is an official guide
for patients and healthcare practitioners, but also for those outside Germany
who are viewing the Commission E process as a potential model for the rational
evaluation and regulation of the therapeutic uses of herbs. Where both external
and internal uses are given, they are listed separately.
Most of the Uses can be divided into 11 general medical categories:
Cardiovascular; Dermatological; Endocrinology, Reproductive System,
Obstetrics/Gynecology, and Prostate; Gastrointestinal; Hematology, Lymphatic,
and Cancer; Immunology, AIDS, and Infectious Diseases; Liver and Gallbladder;
Neurology and Psychiatry; Ophthalmology; Respiratory (lower and upper
respiratory tract including ears, nose, throat, sinuses); and Urinary Tract
System (kidney, ureter, bladder). A key indicating these categories is given in
the Uses Index on page 419.
Contraindications
The Commission reviewed literature to establish conditions or diseases that
should be contraindicated with the use of a particular herb. A total of 67
separate contraindications are mentioned in the monographs. They are classified
into the same medical categories as noted in Uses above, with the addition of
Ophthalmology.
The range of contraindications includes allergy to particular constituents,
children and infants, diabetes, pregnancy and lactation, and specific
conventional medications (e.g., cardiac glycosides, as is the case for some
strong botanicals used clinically in Germany but not widely available in the
U.S., i.e., Lily-of-the-valley, Pheasant's Eye herb, and Squill).
In the case of allergies and hypersensitivities (23 herbs and three
combinations are noted) the Commission took the conservative view that
cross-sensitivities were possible. However, "If [a patient] is not allergic
towards these drugs [of a particular plant family] or towards the plant family,
there is no reason why he should not use the herbal remedy if it is indicated. But
still he must be informed on it ." [emphasis added] (Keller, 1992.)
Pregnancy was included as a contraindication if there were bibliographic data
that the herbal preparation had been successfully used for self-induced
abortion, or if there were experimental data proving a genotoxic risk for some
constituents present in the drug in significant amounts. The Commission used a
100-fold safety factor in considerations of genetic risk (Wiedenfeld, 1996). In
total, 26 herbs are contraindicated in pregnancy, plus 25 fixed combinations of
these herbs (mainly combinations containing either Anise oil or Fennel oil, not
the simple fruits/seeds). One herb in injectable form (Echinacea Purpurea herb)
is also contraindicated, but this does not apply to oral doses.
For lactation 11 herbs are contraindicated, plus one combination containing
Senna leaf. Of these 11, six are anthraquinone-containing stimulant laxatives.
(There are actually five herbs; Buckthorn bark and Buckthorn berry are listed in
individual monographs.)
Some herbs are contraindicated for conditions involving the liver and
gallbladder. A total of eight herbs, plus combinations containing some of these
herbs, are contraindicated for various liver disorders. The best known example
is Licorice: in cholestatic liver disorders (Licorice plus six combinations
containing Licorice) and cirrhosis (Licorice plus five combinations with
Licorice). Seven herbs plus 10 combinations are contraindicated for "Liver
Disease." Fourteen herbs and 19 fixed combinations are contraindicated in
gallstones. For bile duct obstruction, 13 herbs plus 13 combinations containing
these herbs are contraindicated.
If the Commission was aware that the diuretic (aka aquaretic) effect of an
herb was due to essential oils irritating the kidney, not only was the
indication eliminated, but a warning was included to ensure the herb not be used
by persons suffering kidney disease. This contraindication appears in at least
six monographs (Asparagus root, Juniper berry, Lovage root, Parsley herb and
root, Watercress, and White Sandalwood).
Many of the contraindications are based on theoretical considerations, not on
case studies. "In most cases the contraindications are not seen as
concretely associated with the mentioned herbs, but they were listed as general
considerations." (Schilcher, 1997b.)
Finally, the Commission was concerned about the issue of the safety of
pregnant and lactating women and children under 12 years of age. As noted above,
some of the monographs deal specifically with contraindications for pregnant and
nursing women. According to the Medicines Testing Guidelines (1994) and the
Fifth Amendment to the Second Medicines Act (2 AMG 76), physicians' observation
studies for these groups must be conducted to determine proper dose levels and
safety. Since such studies on crude herbs or advanced phytomedicines have been
conducted in only a few cases, the following terms apply to the herbal drugs
approved by Commission E: "Due to the absence of physician's observational
studies this phytomedicine should not be used by pregnant or nursing women or by
children under the age of 12." (Schilcher, 1998b).
An index of all contraindications for approved herbs can be found on page
433. As with the Uses section, there is a key in the Contraindications
cross-reference showing the groupings of the various conditions by physiological
system. An index of contraindications for unapproved herbs can be found on page
681.
Side Effects
As Referee Dr. K. Keller notes, "the consumer probably does not
expect...side effects from natural remedies." (Keller, 1992). The
Commission took pains to point out possible adverse effects. The monographs also
note 74 adverse side effects that may be produced as a result of ingestion of
the 186 Approved Herbs. Not surprisingly, there are 96 side effects mentioned
for Unapproved Herbs, almost 30 percent more for 108 Unapproved Herbs compared
to the Approved. One would expect to see more adverse side effects noted for the
Unapproved Herbs — their relative toxicity is often the basis for a negative
evaluation.
As with the contraindications, side effects are arranged in a separate index
according to 11 medical categories. Side effects of approved herbs include the
following examples: ocular accommodation disturbances, albuminuria, allergies,
cramps, diarrhea, fever, gastrointestinal disturbance, headache, hematuria,
intestinal sluggishness associated with stimulant laxatives, nausea,
photosensitization, and vomiting. These include 44 monographs (31 single herbs
and 13 Fixed Combinations) listing gastrointestinal disorders (e.g., those
associated with ingestion of various saponins) and eight monographs (4 single, 4
combinations) listing photosensitizing properties.
Many of the side effects sections state that in "rare cases" or in
"sensitive individuals" the effect may occur, particularly when
discussing a possible adverse effect that is not typical of the herb but either
has been documented from the literature or is based on theoretical presumptions.
As with the Contraindications section, many monographs do not list adverse
side effects, but include the statement "None known." For these herbal
drugs for which there is documentation of potential or actual side effects, we
have developed two indexes: one each for Approved (page 443) and Unapproved
herbal drugs (page 451). In both indexes we have grouped into a key the reported
side effects by physiological systems.
Interactions with Other Drugs
One of the benefits the Commission E monographs offer to health professionals
and consumers is information on the potential adverse or synergistic reactions
associated with the simultaneous use of herbs and conventional drugs. Both
well-documented and proposed interactions are listed in a total of 53
monographs. These interactions are described in 38 monographs on single
preparations (37 Approved and one Unapproved, Sarsaparilla) plus 15 Fixed
Combinations of the Approved herbs. The 38 single herb monographs consist of a
total of 32 plants, occasionally with two or more monographs for different parts
of the same plant. For example, Buckthorn bark and berry are two monographs as
are Eucalyptus leaf and essential oil, Senna leaf and pod, etc. The herbs are
shown to interact with substances such as alcohol, conventional drugs (by type
or specific drug), caffeine-containing beverages, common nutrients (calcium),
and constituents in other herbal drugs.
Not all the interaction data is derived from studies and case histories.
Curiously, "Most interactions mentioned in the positive monographs are
based on theoretical grounds." (Schilcher, 1997b.) For example, some herbs
like Marshmallow root and combinations in which it is included and Flaxseed
contain mucilaginous constituents. Thus, at least seven monographs mention that
an herbal drug containing mucilage can delay the absorption of other drugs taken
simultaneously. These are typical examples of interactions inferred from a
theoretical basis (Schilcher, 1997b).
Five of the monographs on herbs with stimulant laxative action (e.g., Aloe,
Buckthorn (Approved - Approved), Senna (Approved - Approved)) contain the
following cautionary statement:
Drug preparations [i.e., herbal laxative drugs] have a
higher general toxicity than the pure glycosides, presumably due to the
content of aglycones. Experiments pertaining to the genotoxicity of [name of
herb] and its preparations are not available. Some positive data were obtained
for aloe-emodin, emodin, physcion and chrysophanol. No data are available for
their carcinogenicity .
The Commission's concern about this issue probably was based on a single case
of cancer in a young woman, allegedly due to danthrone, an anthraquinone
laxative that is not present in any Commission E herb, approved or unapproved.
There are data from the Salmonella Ames assay and mammalian cell cultures that
the laxative constituents lucidin, emodin, and aloe-emodin (three compounds
found in four Approved herbs, as far as data from the monograph reveals) could
have genotoxic effects, but there are no indications of this from in vitro or in
in vivo studies or human studies (Tyler, 1996; Steinhoff, 1997a).
An index of herb-drug interactions organized by herb begins on page 475. An
index of interactions by conventional pharmaceutical drugs and other substances
is found on page 479.
Dosage
The dosage for each herbal drug or herbal combination is shown only in the
Approved monographs. Dosage information was gleaned from results of clinical
studies, clinical experience by physicians who routinely use herbal drugs in
Germany, experience drawn from self-medication, or calculations of a specified
active ingredient. For example, for Cascara Sagrada, the dosage range is listed
as 20 - 30 mg hydroxyanthracene derivatives daily; this is based on known safe
and effective dosage levels for such active ingredients in stimulant laxatives.
The phrase "calculated as..." is frequently used in the dosage
sections. This refers to the dosage of an herbal drug based on the calculation
of a particular active or marker compound in the herb or extract. In the case of
St. John's Wort, for example, the daily dose is 2 - 4 g of the crude herb or the
equivalent of 0.2 - 1 mg of total hypericin, usually in the form of a
standardized dry extract.
Although most dosages listed in the monographs appear reasonable based on the
available literature, a few monographs include what appear to be either
excessive or inadequate doses. For example, in the monograph for Rosemary, the
internal dose for rosemary essential oil is stated at between 10 to 20 drops.
This level appears to be excessive by a factor of 5 to 10. When Rosemary oil was
official in the United States Pharmacopeia (from 1840 - 1955) the
internal dose was specified as 0.1 ml, equivalent to 2 drops. Some authorities
say that internal use of rosemary oil may produce abortifacient action,
according to Tyler citing Pahlow (Tyler, 1996). However, Schilcher writes that
the old USP dosage is inadequate and that adverse reactions to Rosemary oil are
not noted in the dosage level recommended in the Commission E monograph
(Schilcher, 1997b).
In another example, a dose of 40 mg of crude powdered root of Black Cohosh
appears on the surface to be inadequate to produce the intended estrogenic
effect for menstrual and menopausal applications. Forty mg is less than 10
percent of the net weight of the average size of a "0" size gelatin
capsule of Black Cohosh root powder as it is customarily sold in the U.S. Much
of the clinical research upon which the monograph is based refers to 40 mg of
powdered root extract equivalent to 40 mg of dried root (1:1 ratio). We have
been assured by Dr. Götz Harnischfeger of the phytomedicine manufacturer
Schaper and Brümmer that the monograph indeed does stipulate 40 mg of the crude
dried root or rhizome (Harnischfeger, 1996).
Prof. Schilcher prefers the term "Posology" for this section but we
have translated Dosierung as Dosage. Posology is the pharmaceutical term
which can suggest both dosage (amount and frequency of administration) and mode
of administration, or the galenical form in which the dosage is given, such as
tea, tincture, or external ointment (Schilcher, 1997).
Mode of Administration
The mode of administration refers to the method of preparation and form of
taking the herb. The earlier monograph format contains a Mode of Administration
section. The later format includes Mode of Administration either with the Dosage
section or in a separate section.
Various types of pharmaceutical products made from medicinal plants are often
referred to as galenical preparations. Preparations are noted for both internal
and external uses. They include comminuted or powdered herbs for teas (either as
infusions or decoctions), essential oils for inhalation or for addition to
salves and ointments (often referred to as semi-solid preparations), pressed
juice from the fresh plant, liquid extracts in the form of tinctures and
fluidextracts, dry extracts, and solid forms for internal use (tablets and
capsules containing powdered herb or dry extract).
In some of the monographs the mode of administration can be quite specific,
e.g., in the stipulation of the range of alcohol required in an
aqueous-alcoholic extract (for example, 50 - 70 percent in Chaste Tree fruit).
Sometimes the mode of administration will correspond to particular approved
uses and plant constituents. For example, Iceland Moss is approved for two uses:
"(a) Irritation of the oral and pharyngeal mucous membranes and
accompanying dry cough. (b) Loss of appetite." The mode of administration
for use (a) is comminuted herb for infusions and other galenical formulations
for internal use, based on the mucilage content of the herb; however, a
different preparation is stipulated for use (b): "Comminuted herb,
preferably for cold macerates and other bitter-tasting preparations for internal
use," based on the second main constituent, the bitter principle.
Duration of Administration
The amount of time that a person consumes any medicine, natural or synthetic,
is of considerable therapeutic relevance. Accordingly, Commission E has limited
the period of use of 45 approved herbal drugs. The old monograph format contains
a Duration of Use section after the Mode of Administration section; the new
format contains this information in the Special Cautions for Use section found
under the Clinical Data heading.
The Commission stipulated either specific ranges of use or a maximum period
of use for the approved remedy. This was done for two reasons. First, there were
safety concerns; second, in several of the monographs, duration of use was
specified as either a minimum or optimum period required for the botanical to
provide effective beneficial action. Examples include Ginkgo Biloba Leaf Extract
(six to eight weeks minimum use, depending on the indication), Ginseng root (up
to three months with a repeated regimen being "feasible"), and
Hawthorn leaf with flower (six weeks minimum).
Regarding issues of safety, of particular note is the limitation of the use
of stimulant laxatives (Aloe, Buckthorn bark and berry, Cascara Sagrada, Senna
leaf and pod, and Rhubarb root) for a period not to exceed one to two weeks.
With respect to herbal drugs used for diarrhea (Bilberry fruit, Blackberry leaf,
Jambolan bark, Lady's Mantle, Psyllium seed (Approved - Approved) and husk,
etc.), the monographs suggest that if the diarrhea persists more than three to
four days, a physician must be consulted. Licorice root preparations with a
content of 300 mg glycyrrhizin should not exceed four to six weeks. With respect
to the popular herb Uva Ursi, used as a urinary tract antiseptic, Commission E
stipulates that medicines containing the chemical arbutin should not be taken
more than one week or more than five times per year.
For herbs containing hepatotoxic pyrrolizidine alkaloids (PA) (Comfrey leaf
and herb, Comfrey root, Petasites root) a duration not to exceed four to six
weeks is advised. In both Comfrey monographs the PA level is required to be no
more than 100 micrograms per dose; the Comfrey preparations are approved for
external use only. In the German market there are specially cultivated varieties
(cultivars) of Comfrey that do not contain PAs (Schilcher, 1997b). At any rate,
the 100 micrograms PA in the Comfrey monographs is limited to external use only,
whereas the monograph for Petasites root is limited to only 1 microgram PA, due
to its approval for internal use. Chapter 15 consists of a table listing all the
limitations of Duration of Administration for Approved Herbs. See page 483.
Risks
The risks associated with the use of a particular botanical are enumerated in
the Unapproved Herbs monographs. In many cases, the risks cited constitute
concern by the Commission of the potential of the herb to produce adverse
effects. In cases where the assessment of known or potential risks was deemed
relatively high and without adequate documentation of benefit for the
preparation (high risk to benefit ratio), the Commission chose a negative
evaluation. In such cases the negatively evaluated medicinal plant should be
taken from the market soon and not in 2004. Nearly all products for internal use
made from Comfrey root were removed from the market in 1992 in accordance with
section 8 of the Second Medicines Act of 1976 (Schilcher, 1997b).
Evaluation
For all herbs in the Unapproved Herbs section the Commission has published a
justification for its negative assessment. In most cases, the available
literature did not adequately document the historical and current popular use of
the herbal drug. This does not mean that the particular medicinal plant is not
effective, just that when the Commission was making its evaluation, the
scientific material was inadequate in "a natural science sense."
(Schilcher, 1997b.) Also, for many of the Unapproved herbs, in light of the
potential risks involved, a positive assessment could not be allowed. Where no
clear benefit is present, the potential risks are given more weight than similar
risks applied to an Approved Herb with a better documented benefit.
Actions
In almost all of the Approved Monographs and in some of the Unapproved
Monographs, the Actions ( Wirkungen ) section refers to pharmacological
actions carried out in laboratory conditions, either experimentally in vitro, or
in vivo in test animals, and in animal organs. These actions usually do not
refer to observations based on human clinical trials and are meant to help
describe the potential activity of the herbal drug. Prof. Schilcher has
translated this section as "Medicinal Actions," a term that implies
(to us) medicinal applications, which we are not sure we are ready to accept.
Hence, we use only the word Actions, qualifying it here as pharmacological.
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