FWD 2 Commission E: Herbs and Phytomedicines in Germany

  The Commission E Monographs

Copyright © 1999 American Botanical Council

Part One Introduction
<< Previous | Table Of Contents | Next >>

Herbs and Phytomedicines in Germany

Education of Health Professionals and Phytomedicine Research

One of the driving forces that has resulted in mainstream acceptance of phytomedicine in Germany is the inclusion of phytotherapy in the medical and pharmacy school curricula. In the opinion of several medical groups, "modern phytotherapy is not perceived as alternative medicine, but as a part of so-called traditional medicine" [i.e., conventional medicine] (Schilcher, 1997c). Since 1993 all medical school students in Germany must successfully complete a portion of their board examinations in the area of phytotherapy as a precondition for practicing medicine (Schilcher, 1991). Medical education on medicinal plants and phytomedicines includes regular lectures in universities and medical schools, four one-week courses with 26 hours of lectures in phytotherapy in Weiterbildung (continuing education), lectures and courses in Fortbildung (postgraduate education), the publication of scientific literature (papers and books), the Commission E Monographs, and directions on product uses according to section 11 of the Second Medicines Act (AMG 76) (Schilcher, 1991, 1997c).

Basic Rules for Rational Phytotherapy

According to Prof. H. Schilcher, Vice President of Commission E, "rational phytotherapy" in Germany is based on four basic rules for phytomedicines (also known as phytopharmaca):

1. Dose-response relationship. Phytomedicines in the therapeutic arena can be applied in a dose-effectiveness manner. Possible dosage-dependent reversals of effects should not be interpreted as "homeopathic effects" — a reference to the observation that homeopathic medicines produce symptoms at higher potencies in healthy individuals. That is, sometimes a variation in the dosage of a phytomedicine can produce a different effect than a higher or lower dosage of the same herbal drug and this cannot be dismissed as homeopathic. For example, in phytotherapy extracts of Goldenrod ( Solidago virgaurea ) in low doses have no diuretic (aquaretic) effect. However, in therapeutically adequate doses (6 - 12 gram dried herb daily dose per the monograph) they do produce aquaretic effects; however, in very high doses (in animal experiments) they have shown diuretic-inhibiting effects (Schilcher, 1998c).

2. Efficacy-constituent relationship. Efficacy (experimentally demonstrated from clinical studies) or effectiveness (observed in a patient in a clinical setting) can be deduced, in most cases, from the specific ingredients. They are co-determined for the effectiveness; that is, in most cases, not one but two or three different plant constituents are known to be responsible for the observed effectiveness. For example, the activity of the herb St. John's Wort in the treatment of mild to moderate cases of depression is now believed to be attributable to at least three types of substances found in the flowers and leaves: hypericins, hyperforin, and flavonoids.

3. Total extracts vs. isolated constituents. Typically, phytomedicines that are standardized extracts consisting of primary active components, secondary components, and accompanying compounds (coeffectors) manifest better effects and a greater therapeutic range of activity than individual isolated compounds (i.e., conventional drugs).

4. Pharmaceutical quality. Phytomedicines with a high level of pharmaceutical and medical quality are the basic requirement for successful phytotherapy. For example, some reports of herbal medicines that produced negative outcomes can be attributed to the administration of unsuitable materials, which, after close expert examination, were deemed of poor quality (Schilcher, 1997c).

Scientific Research and Medical Use of Phytomedicines

Because of the high level of professional interest in herbs and phytomedicines in Germany, there is a considerable amount of scientific research conducted. Pharmacological and experimental studies are available mainly for the most important herbs and herbal preparations on the market, such as Valerian root, Echinacea herb and root, Ginkgo leaf special extract, St. John's Wort, Chamomile flowers, Milk Thistle fruit extract, and Hawthorn leaf and flower extracts. However, the concentration of research on these botanicals should not be misinterpreted to mean that other herbs are ineffective. The lack of pharmacological and experimental studies on other botanicals can be attributed to the fact that, since the end of World War II, testing of phytopharmaca (phytomedicines) was no longer included in the research programs of the schools of pharmacology. Phytopharmacology was pursued in the laboratories of only a few commercial companies specializing in plant medicines. However, at that time there was not a pressing need for phytopharmacological research because the effectiveness and safety of the drug, not the mechanisms of action, were of greater interest, because of the special status of phytomedicines under the first German drug law. Also, herbal medicines were not as widely employed in medical specialties; most previous practitioners of phytotherapy had been doctors of naturopathy and general practitioners. More recent testing, however, has revealed mechanisms of action of some phytomedicines that yield greater effectiveness. This can reveal parameters for standardization of a given phytomedicine and its correct dosage, thereby making it more suitable for specialized branches of clinical medicine (Schilcher, 1997c).

Table 5 shows various health problems general practitioners in Germany treat on a daily basis that can be effectively treated with phytomedicines, usually at a reasonable cost. (See also Table 6 for consumer use patterns and Table 12 for an overview of clinical studies on leading phytomedicines.)

Table 5: Conditions Treated with Phytomedicines
by General Practitioners in Germany
Condition % Treated With

Psychovegetative syndrome 25
Diseases of:
  respiratory tract (esp. types of bronchitis) 16
  heart and circulation (esp. arterial, venous, cerebral) 13
  digestive organs (gastritis to Crohn’s) 9
  locomotor apparatus (movement of limbs) 6
  urogenital tract (dysuria in women or BPH in men) 8

Source: Schilcher, 1997c based on Härter, Klimm and Salz.

The Market for Herbs and Phytomedicines in Germany


As noted in Table 3, the use of herbs and phytomedicines in the European Union totaled about $7 billion in retail sales in 1996, with about half ($3.5 billion) being sold in Germany (Gruenwald, 1998). In 1970 an estimated 52 percent of the general public in Germany used herbal remedies. That number had grown in 1993 to about 62 percent as reported in a major survey conducted by the Institute for Demoscopy (IfD) in Allensbach (IfD, 1997) and to 65 percent in 1997 (Steinhoff, 1997b).

In general, self-medication with medicinal plants and related products in Germany is as follows: 66 percent of herb users utilize herb products for colds; 38 percent for flu; 25 percent for digestive upsets, headaches, and insomnia (see Table 6). The demographics of herb use reveal that 72 percent are people with at least some college education. The survey also noted a decrease in the number of phytomedicines being dispensed by prescription due to a corresponding increase in self-medication (IfD, 1997; Steinhoff, 1997b).

The Institute for Demoscopy survey also noted other interesting aspects of popular uses of herbs in Germany. "According to the study, significant importance is given to medicines used for prevention. About 39 percent of the polled individuals use the remedies exclusively for prevention, while an additional 45 percent also use other natural medicines. Furthermore, natural remedies are increasingly used in combination with other drugs. For an acute disease, only 3 percent of consumers using natural remedies would take these exclusively, while 64 percent would take natural remedies with other drugs." (Steinhoff, 1997b.) The survey indicated that natural remedies are used mostly for cold and flu symptoms, indigestion, headaches, insomnia, gastric discomforts, nervousness, cardiovascular disorders, exhaustion, and fatigue (Steinhoff, 1997b).

Gender plays an important role in the use of herbal medicines. According to the IfD survey, in 1970 55 percent of women used herbs; this increased to 74 percent in 1997. The use by men has increased as well, from 49 percent in 1970 to 55 percent in 1997. Regarding age, the use of phytomedicines increased in the 16 to 29 age group from 36 percent to 54 percent from 1970 to 1997 (Schilcher, 1998b).

Surprisingly, a poll published in July 1997 by the Cologne Institute of Social Psychology in conjunction with the Institute for Pharmaceutical Biology at the University of Tubingen revealed that, in some cases, German consumers still prefer conventional (synthetic) medications. In 310 interviews laypeople were asked about their perceptions of botanical and conventional medicines. About 80 percent could differentiate between the two types and could name specific examples of each. While 70 percent could correlate correctly a phytomedicine and its proper use, 83.9 percent were able to correctly identify the uses of synthetic medicines. Those questioned in the poll indicated a preference for phytomedicines for the following uses: common cold, digestive or intestinal upset, nervousness, and kidney-bladder illness. However, they preferred to treat liver and gallbladder diseases and cardiovascular disorders with synthetic drugs (Schilcher, 1998b).

Table 6: Conditions for which German Consumers Use Phytomedicines
Condition 1970 Poll 1997 Poll

Common cold 41% 66%
Flu 31 38
Digestive or Intestinal Complaints 24 25
Headache 13 25
Insomnia 13 25
Stomach Ulcer 21 24
Nervousness 12 21
Circulatory disorders 15 17
Bronchitis 12 15
Skin diseases 8 12
Fatigue & exhaustion 8 12

Statistics are derived from consumer polls conducted by the Institute for Demoscopy in Allensbach, Germany.
Source: IfD, 1997; Schilcher, 1998c.


Retail Outlets

In Germany herbal products of various classes are sold in a variety of retail outlets. An Apotheke (pharmacy) has registered pharmacists who recommend and dispense nonprescription drugs (within limits), as well as drugs prescribed by physicians. In Drogerien (drugstores) one can find preparations for minor illnesses, such as colds, strains, and pains from overexertion. The type of preparations sold in Drogerien is defined by law. Reformhäusern (health food stores) and Märkte (markets, including Supermärkte , supermarkets) tend to offer products that boost health, as contrasted to products that fight disease. They also offer herbal teas and products that do not meet the pharmaceutical standards of phytomedicines (often chemically standardized) and are thus not approved as drugs. These products are sold outside pharmacies as "Traditional Medicines" under provisions of Article 109a of the Second Medicines Act. (See below.)

In Germany, approved herbs have nonprescription drug status; this is not the same as OTC status. Many herbal drugs are available only from a licensed pharmacist ( Apothekenpflicht , a word that implies ethical drugs from pharmacies), but are not available from drugstores or health food stores. Article 42 of the Second Medicines Act (AMG 76) lists medicinal plants that are not allowed to be sold outside pharmacies (a so-called "negative list"). These include Henbane (Approved by Commission E), Foxglove leaf ( Digitalis purpurea ) — not reviewed by the Commission, and, interestingly, the common laxative, Senna leaf (Approved) (Shilcher, 1997b.)

Articles 44 and 45 of the Second Medicines Act regulate the "exceptions to the obligation to supply drugs (conventional and herbal) in pharmacies only" by the creation of three categories of drugs: prescription only (new drugs and drugs with risks), pharmacy only, and outside pharmacy. The first two classes may be prescribed by a physician and reimbursed by the health insurance system, but the third is never reimbursed by medical insurance (Keller, 1998b). This class consists of "drugs which are intended by the pharmaceutical entrepreneur solely to serve purposes other than the curing or alleviation of diseases, suffering, bodily injuries or sickness symptoms shall be released for trade outside pharmacies." (Keller, 1998b.) Such products include natural curative waters, their salts, therapeutic clays and muds, bath oils, plants and parts of plants, mixtures of whole or cut plants or parts of plants as finished drugs, distillates of plants and plant parts (essential oils), and juices pressed from fresh plants if they are made without the use of solvents other than water (from Article 44 of the Second Medicines Act) (Keller, 1998b).

Physician Prescriptions and Reimbursement

All phytomedicines prescribed by a physician must be supplied by pharmacists. According to some estimates, in addition to the 25,000 doctors conducting a natural medical practice, up to 80 percent of German physicians (particularly general practitioners) routinely prescribe phytomedicines as part of clinical therapy (Gruenwald, 1995; Shilcher, 1998b). Prescribed phytomedicines are also known as "semi-ethical" drugs. In 1996 semi-ethical phytomedicine sales constituted 17 percent of total nonprescription drug sales in Germany and 54 percent of all nonprescription phytomedicines (see Table 7). According to the 5th Social Act, phytomedicines that conform to the Commission E positive monographs (approved) are financed by the national health insurance system (Schilcher, 1998c).

In some cases, phytomedicines are preferred to conventional drugs. For drugs prescribed for benign prostatic hyperplasia (BPH), for example, almost 90 percent are phytomedicines, owing mainly to their lower rates of adverse side effects. In the area of physician prescriptions of psychoactive herbal drugs (e.g., St. John's Wort and Kava Kava), the strong increase in medical use is not a result of increased demands from patients but more from "scientific assurances in the form of convincing clinical and pharmacological studies." (Schilcher, 1998b.)

Number of Products

In 1978 when the Second Medicines Act became law, new regulations covering medicinal products included items sold in pharmacies, drug stores, health food stores, and other retail outlets. Because of the broad coverage and due to the fact that differing forms of administration and dosage sizes were considered separate products, herbal drug products in 1990 numbered about 60,000, compared to 126,000 registered finished drugs (including conventional medications). Of the 60,000 herbal products, about 40,000 are herbal teas. These herbal products are based on about 1,400 medicinal plant parts (flowers, leaves, herbs, roots, etc.) derived from 600 to 700 plant species (Keller, 1991). (For example, three different parts from one plant can be sold as three different products.) Another source notes that only about 100 of these medicinal plants are significant from a clinical and economic perspective (Schilcher, 1998b).

For comparison, in 1978 there were about 78,000 herbal products on the German market (Schilcher, 1997b) that "were produced by about 180 medium-sized and smaller pharmaceutical operations." (Schilcher, 1998b.) Thus, the Commission's work helped to remove unsafe and questionable products from the market.

Market Statistics

The primary market for medicinal herbs and phytomedicinal products in Germany is expressed via sales in licensed pharmacies where these products have the status of drugs approved by the Ministry of Health. The total market for such products in relation to conventional nonprescription medicines sold in pharmacies is shown in Table 7a.

Phytomedicines comprise about 30 percent of all drugs sold in German pharmacies. Prescribed phytomedicines (i.e., semi-ethical) constitute approximately 17 percent of the total drug market, while nonprescription phytomedicines comprise about 13 percent of the total market. These statistics can be viewed another way: about 30 percent of all phytomedicines sold in Germany are prescribed by physicians, with the balance (70 percent) being sold as nonprescription medicines (Fresenius, Niklas, and Schilcher, 1997). Despite widespread acceptance and recommendation by health professionals, in Germany, as in other developed countries, the trend toward self-medication has increased. In 1978, 44 percent of the public chose not to see a physician for minor conditions but to self-medicate instead; that figure rose to 58 percent in early 1997, according to the survey conducted by the Institute for Demoscopy in Allensbach (IfD, 1997). However, despite the increase in the rate of self-medication, the survey also noted, "For many consumers, it is important that natural remedies can be prescribed by the physician and that they are paid for by their health insurance. Consumers are prepared to provide a co-payment for drugs up to approximately 30 percent of the total costs." (Steinhoff, 1997b.)

Table 7a: The Market for Phytomedicines Sold in German Pharmacies — 1996


in millions(US $)(1)
Market Share
Change From
1995 (%)
Total OTC market 8,654 100 +2
Non-herbal drugs 6,011 70 +2
All herbal drugs 2,644 30 +3
Prescribed herbal drugs (semi-ethical) 1,437 17 +1
Self-medication withherbal drugs 1,207 13 +5
(1)based on US$ to DM exchange rate of $1 = 1.80 DM (0.55 DM per $) on Jan. 26, 1998.

Source: Institute for Medical Statistics (IMS); courtesy PhytoPharm Consulting, Berlin (Gruenwald, 1998).

Table 7b: Retail Sales of Herbal Medicines in German Pharmacies by Indication — 1996
Indication/Use Sales in millions(US$)(1)

Tonics & geriatric $240.9
Cough & cold 196.4
Stomach & digestion 156.2
Heart & circulation 152.9
Sedation & sleep 112.8
All others 336.1

Total $1,195.2


Table 8: Indications for the 100 Most Commonly Prescribed Herbal Medications in Germany, Listed in Order of Gross Sales in Pharmacies — 1995
  Number of Products Sales Indication
in millions(US$)(1)

Central nervous system disorders 19 $345.38
Respiratory disorders 29 143.27
Urinary tract disorders 11 118.26
Cardiovascular disorders 10 115.76
Stomach, Bowel, Liver, orbiliary tract disorders 10 82.03
Promoting resistance to diseases 6 50.75
Skin and connective tissue disorders 11 44.21
Gynecological disorders 4 17.34

(1)based on US$ to DM exchange rate of $1 = 1.80 DM (0.55 DM per $) on Jan. 26, 1998.

Source: German Public Health Insurance Drug Index as published in the Arzneiverordnungsreport — 1996 (Prescription Drug Report) (Schwabe and Pfaffrath, 1996), in Schulz, Hänsel, and Tyler, 1997.

It should be noted that the market for urologic agents from phytomedicines in Germany is quite healthy. According to Prof. Dr. H. Schilcher of Commission E, over 80 percent of the products used for benign prostatic hyperplasia (BPH) are phytomedicines. BPH medicines thus constitute one of the leading categories of phytomedicines; no other indication has such a high rate of phytomedicinal use (Schilcher, 1997b).

Leading Phytomedicines

A review of the best-selling phytomedicines composed of single herbs can be instructive in understanding the extent of their use, both as nonprescription and prescription medications. According to the Arzneiverordnungsreport ( Prescription Drug Report ) published in 1997 by Schwabe, the following sales were recorded for the most frequently prescribed herbal monopreparations in 1996 (Schwabe, 1997). These figures reflect sales for semi-ethical phytomedicines, i.e., herbal drugs with nonprescription status prescribed by physicians.

Table 9: Most Frequently Prescribed Monopreparation Phytomedicines in Germany,
According to Sales — 1996
(Number of Products)
Retail Sales
in millions(US$)(1)
Change From
1995 (%)

1. Ginkgo Biloba Leaf Extract (5) circulatory preparations 211.938 -8.7
2. St. John’s Wort (7) antidepressant 71.039 +31.1
3. Horse Chestnut seed (3) vein preparations 51.195 +10.8
4. Yeast (2) antidiarrheal, acne 33.049 +2.4
5. Hawthorn flower and leaf cardiac preparations 29.057 -6.8
6. Myrtle (Myrtus communis) (1) cough remedy 27.098 +0.6
7. Saw Palmetto urologic 24.400 +31.8
8. Stinging Nettle root (1) urologic 20.187 -4.4
9. Ivy (3) cough remedy 19.074 +8.0
10. Mistletoe (1) cancer treatment 18.060 +3.9
11. Milk Thistle (1) hepatoprotectant 16.867 +0.9
12. Bromelain — pineapple enzyme (2) antiinflammatory 13.219 +71.2
13. Echinacea (2) immunostimulant 10.799 -20.2
14. Chamomile dermatological 8.278 -7.3
15. Chaste Tree (Vitex) (2) gynecological 7.987 +83.9
16. Greater Celandine (1) gastrointestinal agent 6.342 -9.9
17. Black Cohosh (1) gynecological 6.302 +1.5
18. Kava Kava (1) tranquilizer 5.819 -38.8
19. Artichoke (1) hypocholesteremic 5.242      
20. Comfrey (1) dermatological 4.880 -11.4
(1) Currency in US$ based on 1.80 German marks (DM) (0.55 DM per $) on Jan. 26, 1998.

Sources: Schwabe, U. Arzneiverordnungsreport (Prescription Drug Report) — 1997. Courtesy PhytoPharm Consulting GmbH, Berlin (Gruenwald, 1998).

Table 10a: Leading Proprietary Monopreparation Phytomedicines in Germany
Herb   Trade Name   Manufacturer   Application

Black Cohosh   Remifemin   Schaper & Brümmer   menopause
Chaste Tree   Agnolyt   Madaus   premenstrual syndrome
Echinacea   Echinacin   Madaus   immunostimulant
Garlic   Kwai   Lichtwer Pharma   cardiovascular
Ginger   Zintona   Herbalist & Doc   motion sickness
Ginkgo   Tebonin   Schwabe   circulatory/cognitive
    Rokan   Intersan/Schwabe   circulatory/cognitive
Ginseng   Ginsana   Pharmaton   tonic
Hawthorn   Crataegutt   Schwabe   cardiotonic
    Faros   Lichtwer   cardiotonic
Horse Chestnut Seed Extract   Venostasin   Klinge Pharma   venous tonic
    Venoplant   Schwabe   venous tonic
Kava Kava   Antares   Krewel   anxiety
    Laitan   Schwabe   anxiety
Milk Thistle   Legalon   Madaus   hepatoprotection
Saw Palmetto   Prostagutt   Schwabe   prostate (BPH)
    Talso   Sanofi/Winthrop   prostate (BPH)
St. John’s Wort   Jarsin   Lichtwer Pharma   depression
    Kira   Lichtwer Pharma   depression
    Remotiv   Bayer   depression

Products are listed in alphabetical order by common name of herb, not by ranking in market status. Tebonin is the top-selling monopreparation phytomedicine in total sales value, ranking 3rd in all phytomedicine prescriptions written (both monopreparations and combinations) and 29th in all prescriptions written for all drugs (including conventional drugs). Although all these products are available nonprescription, this ranking does not include additional sales generated by self-medication purchases.

Table 10b: Selected Leading Proprietary Combination Phytomedicines in Germany
Herb Ingredients Manufacturer Application

Esberitox Echinacea purpurea root, Wild Indigo root (Baptisia tinctoria), Arbor vitae tips (Thuja occidentalis) Schaper & Brümmer immunostimulation colds and flu
Iberogast Wild candytuft (Iberis amara), Angelica root, Chamomile flowers, Caraway, Milk Thistle fruits, Lemon Balm, Peppermint, Greater Celandine Steigerwald stomach disorders
Kytta Sedativum F Valerian root, Hops, Passionflower Kytta-Siegfried sedative
Prostagutt Forte Saw Palmetto Stinging Nettle root Schwabe prostate (BPH)
Sinupret Gentian root, Primrose flowers, Sorrel, Elder flowers, Vervain Bionorica sinus
Sedariston Konzentrat Valerian root, St. John’s Wort Steiner sedative

Products are listed in alphabetical order, not by ranking in market status. Sinupret is the most frequently prescribed phytomedicine (both in monopreparations and combinations) and is ranked 10th in all prescriptions written for all drugs in 1995 (Schulz, Hänsel and Tyler, 1998). Although all these products are available nonprescription, this ranking is based on number of prescriptions written and does not include additional sales generated by self-medication purchases.

<< Previous | Table Of Contents | Next >>