Commission E published a total of 462 monographs. This includes 81 revisions to monographs, which sometimes were revised two or three times. In some cases, new monographs were published to replace earlier versions (e.g., Hawthorn, noted above). Rather than show the revision as an addendum to a monograph, we have incorporated revisions directly into the body of the text. Thus, for example, if a monograph was published in 1988 and subsequently revised with a new warning or modified dosage, we have added the warning or new dosage in the text, noting the original date of publication and any subsequent revisions at the top of each monograph.

The original mission of Commission E was to evaluate approximately 1,400 herbal drug preparations made from 600 to 700 plant species (Keller, 1991). A total of 380 monographs are published in this book, representing about 360 plant species. According to the BfArM's Liste der Monographien der E-Kommission (Phytotherapie) , supplied to the American Botanical Council by Dr. Konstantin Keller, Referee of Commission E, as of January 23, 1996, there were 254 positively evaluated herbs, component characteristics, and fixed combinations plus 129 negatively (including "neutral") evaluated herbs, components, and fixed combinations (i.e., Unapproved). The number of monographs published is 472, including 81 revisions.

Regarding total numbers of species mentioned in the monographs, a count reveals the following statistics: There are approximately 360 species of plants referred to in the 308 single monographs (i.e., all monographs on single preparations, and component characteristics, excluding fixed combinations). Numerous monographs list two or more species in the same genus that contain suitable botanical material for the herbal drug. In some cases, a synonym is also included (we have added some where we deemed appropriate); in all, 45 synonyms are named. Thus, the total number of taxa mentioned in the monographs is about 405.

Most of the monographs deal with one specific plant part. In a few cases different parts of the same plant are monographed separately, e.g., Buckthorn berry and Buckthorn bark, Senna leaf and Senna pod. In at least 15 monographs more than one plant part is included in the monograph, e.g., Parsley herb and root, Witch Hazel leaf and bark, Yarrow flower and herb, Angelica seed and herb, and Echinacea Angustifolia herb and root with Echinacea Pallida herb.

The count of approved versus unapproved is skewed somewhat toward the negative because, in some instances, multiple parts of one single plant received negative evaluations. For example, as previously noted, there are three negative monographs for Hawthorn, unofficially considered "neutral." These evaluations were made on the basis that the clinical efficacy of preparations of leaf only, flower only, or fruit (berry) only were not sufficiently known; only field studies and patient case records were available for preparations made from either fruits or flowers only. The best research data available to the Commission members pertained to a standardized extract made of both leaf and flower having a range of minimum and maximum content of flavonoids or procyanidins. Hence, the extract received a positive evaluation while the three other types of preparations based solely on one plant part did not. Similarly, preparations made of dried Ginkgo leaf plus five distinct types of dry extracts or fluidextracts are negatively evaluated in one unapproved monograph but a standardized acetone-water extract does receive a positive evaluation.

Unapproved herb monographs contain a "Uses" section that refers to observations of historical or current use in Germany not documented by the available scientific literature. Thus, the Uses section in an unapproved monograph does not connote approved use by Commission E.

The Unapproved herbs with no risks are being allowed on the market until the end of 2004, after which they will cease to be available as licensed phytomedicines produced by a pharmaceutical company. Since January 1992 new regulations have allowed that they can be sold as Traditional Medicines, with the label noting that the product is "traditionally used for..." ( traditionell angewendet ). This exempts the product from having to undergo scientific evaluation and proving efficacy if it can be shown that the product has been marketed continuously since 1978 (the date of the Second Medicines Act) and that the herbal drug is safe. A new commission (Commission 109a AMG 76) was established to review traditional use claims, limited to terms such as "mild medicine" or "used within a traditional context" and with no pathologies listed. A revision now requires these products to be on the market continuously since 1978, if the monograph has a "low" or mild indication. If new clinical data is available, the traditional medicine can be registered (at least theoretically) without a "traditional" labeling (Keller, 1998; Steinhoff, 1997). "It should be noted that medicinal products that conform to Commission E monographs are not listed as traditionell angewendet ." (Keller, 1998.) Finally, a physician may continue to prescribe an unapproved herb after 2004 (Schilcher, 1997b).

The monographs were published in two formats. From 1983 to 1992 the information was presented in the original format of a package insert of an herb on a generic basis. Much of the input for the development of these monographs was provided by major German phytomedicine manufacturers. The dosage forms and specific parameters of the preparation types were not defined in every monograph in detail although they were in some. This resulted in monographs that manufacturers used as product inserts and in some cases as the basis for marketing authorization applications.

After 1992, the format was modified based on newer scientific research, often conducted on product-specific materials, and on the EU Directive 65/65/EEC. In these new monographs all therapeutic information has been subsumed under "Clinical Data." The new format corresponds to the information sheet for health professionals, or summary of product characteristics (SPCs) (Keller, 1998).