Explanation of Monograph Sections

Contents

• Monograph Title
• Name of Drug
• Composition of Drug
• Uses
• Contraindications
• Side Effects
• Interactions with Other Drugs
• Dosage
• Mode of Administration
• Duration of Administration
• Risks
• Evaluation
• Actions

Monograph Title   (back totop)

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, Pfefferminzl .

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.

Name of Drug   (back totop)

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 Linn (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   (back totop)

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   (back totop)

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 theUses Index

Contraindications   (back totop)

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).

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 allcontraindicationshas been provided for Approved herbs.  As with the Uses section, there is a key in the Contraindications cross-reference showing the groupings of the various conditions by physiological system.  

Side Effects   (back totop)

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 forApproved herbsandUnapproved herbs.  In both indexes we have grouped into a key the reported side effects by physiological systems.

Interactions with Other Drugs   (back totop)

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).

Dosage   (back totop)

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.  Gtz Harnischfeger of the phytomedicine manufacturer Schaper and Brmmer 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   (back totop)

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).

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   (back totop)

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.

Risks   (back totop)

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   (back totop)

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   (back totop)

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.