|
|
The Commission E Monographs |
| | |
THE COMPLETE GERMAN COMMISSION E MONOGRAPHS
THERAPEUTIC GUIDE TO HERBAL MEDICINES
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 Phytomedicines |
|
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
Demographics
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 |
|
|
Sales 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 $) on Jan. 26, 1998.
Source: German Public Health Insurance Drug Index as published in the Arzneiverordnungsreport
— 1996 (Prescription Drug Report) (Schwabe and Pfaffrath, 1996), in Schulz,
Hänsel, and Tyler, 1997.
It should be noted that the market for urologic agents from phytomedicines
in Germany is quite healthy. According to Prof. Dr. H. Schilcher of Commission
E, over 80 percent of the products used for benign prostatic hyperplasia (BPH)
are phytomedicines. BPH medicines thus constitute one of the leading
categories of phytomedicines; no other indication has such a high rate of
phytomedicinal use (Schilcher, 1997b).
Leading
Phytomedicines
A review of the best-selling phytomedicines composed of single herbs can be
instructive in understanding the extent of their use, both as nonprescription
and prescription medications. According to the Arzneiverordnungsreport ( Prescription
Drug Report ) published in 1997 by Schwabe, the following sales were recorded
for the most frequently prescribed herbal monopreparations in 1996 (Schwabe,
1997). These figures reflect sales for semi-ethical phytomedicines, i.e., herbal
drugs with nonprescription status prescribed by physicians.
Table 9: Most
Frequently Prescribed Monopreparation Phytomedicines in Germany, According
to Sales — 1996 |
Herb/ Phytomedicine (Number of Products) |
Therapeutic Category |
Retail Sales in millions(US$)(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 >>
|
|
| |
|
|
|