Seite 2
Echinacea
Dry Extract
For the Treatment of respiratory infections and influenza
CONEFLOWER ROOT EXTRACT
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Introduction
is a company specialized in making botanical extracts
and active principles used as phytomedicines in pharmacy.
develops and produces therapeutically active raw
materials.
The botanical raw materials are subject to strict selection and
inspection, and products are manufactured according to methods
developed by the company. They include inspections to
guarantee a standard quality from both analyticochemical and
therapeutical points of view and take into consideration the state
of art in different fields: research and development, analyses,
processes and devices, therapeutic applications on a scientific
basis.
guarantees the quality of its products by a broad
phytochemical know-how.
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Table of Contents Page
1 Coneflower Extract: General Information 5 1.1 Description 5 1.2 Indications 5 1.3 Extract Specifications 5 1.4 Dosage and Methods of Administration 5 1.5 Contraindications and Interactions 6 1.6 Side-effects 6 2 From Plant to Extract 8 2.1 Coneflower root (Echinacea angustifolia DC root ): Botanical
Data 8 Echinacea angustifolia root 8 2.1.2 Purple Coneflower root (Echinacea purpurea root): Botanical
Data 9 2.2 Historic Use 10 2.3 Chemistry of Coneflower Extract 11 Echinacea angustifolia 11 2. 4 Preparation of the Extract and Quality Control 14 ControlControl 14 2.5 Standardization 16 3 Common Cold 17 3.1 The human immune system 17 3.2 Epidemiology 19 3.3 Etiology 20 3.4 Symptoms 21 3.5 Stages 21 3.7 Therapy 21 4 Pharmacology 22 4.1 Pharmacodynamic 22 4.1.1 Phagocytosis-stimulating action 23 4.1.2 Effect on immunfunctions 24 4.1.3 Antibacterial and virustatic action 25 4.1.4 Antioedema action 26 4.1.5 Tumor inhibiting action 27 4.1.6 Antioxidative actions 27 4.2 Pharmacokinetics 28 5 Toxicology 28 6 Clinical Pharmacology 29 7. Proof of Clinical Efficacy 30 7.1 Multi-Center Studies 35 7.2 Therapeutic Safety 35 8 Bibliography 36
44
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1 Coneflower Extract:
General Information
1.1 Description
The coneflower root dry extract is a standardized herbal extract of the
roots of Echinacea angustifolia DC , Echinacea pallida (Nutt.) Nutt.
or Echinacea purpurea (L.) Moench (all Asteraceae).
All natural
The extract of Echinacea root is an herbal preventive and therapeutic
agent for moderately severe upper respiratory infections, influenza. It
is also used for the treatment of slow healing wounds and for
inflammatory skin conditions.
1.2 Indications
Prophylaxis and therapy of mild to moderate severe upper respiratory
infections, influenza and septic conditions. Locally, Echinacea extracts
are used for treatment of slow healing wounds and inflammatory skin
conditions.
Herbal remedy
for therapy and
prophylaxis of
respiratory
infections and
influenza
1.3 Extract Specifications
Coneflower root preparations (as available from ) contain
several groups of ingredients like volatile oil, poliacetilenes,
alkamides, caffeic acid derivatives and other nitrogenous substances.
1.4 Dosage and Methods of Administration
An oral dose of 20 to 50 drops of extract given twice to three times a
day.
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1.5 Contraindications and Interactions
Internal administration: not to be used in patients with
progressive systemic diseases such as tuberculosis.,
leukemia, collagenoses, multiple sclerois, AIDS, HIV or
other autoimmune diseases. Also not to be used in patients
with allergic tendencies, in particular patients with known
allergic reactions to plants of the daisy family and pregnant
woman.
1.6 Side-effects
Well
tolerated
Very seldom: Parenteral administration: Rigors, febrile
reactions , nausea and vomiting. These side effects are
dose-dependent.
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Monopreparations containing Echinacea root extract (Source:
Rote Liste 2000)
Preparation name Total Extract/day [mg]
Salus Echinacea Tropfen ( E. angustifolia) 120-300
Echinacea-ratiopharm Tabletten ( E.pallida) 24-96
Pascotox mono Tabletten (E.pallida) 54-108
SX Echinacea Lösung ( E. pallida) 144
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2 From Plant to Extract
2.1 Coneflower root (Echinacea angustifolia
DC root ): Botanical Data
Echinacea angustifolia DC is perennial plant coming
from the US states of Nebraska, Iowa, Minnesota and
North Carolina. The plant is 10 – 50 cm tall,
branched, glabrous or hairy below; leaves elongate-
lanceolate to elliptical, dark green. Flowers pink or
purple with relatively short ray florets.1,2
The dried roots are cylindrical, mostly 10 –20 cm in
length and 4 – 20 mm in thickness irregularly
branched an of gray - brown color. They were
collected in autumn.3
Echinacea
angustifolia root
2.1.1 Pale Coneflower root (Echinacea pallida
root): Botanical Data
Echinacea pallida ( Nutt.) Nutt. is a perennial plant
growing in the area of the great lakes and southern
Canada. The plant is 40-120 cm tall, unbranched with
spars hairs below and denser hairs covering above;
leaves linear-lanceolate to linear- elliptical, entire dark
green. Flowers purple, pink or white with deflexed ray
florets 4-9 cm in length, pollen grains white2.
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2.1.2 Purple Coneflower root (Echinacea
purpurea root): Botanical Data
Echinacea purpurea (L.) Moench is a perennial plant
native in the North American Central Plateau between
the Great Lakes and Southern Canada. The plant is
about 60-180 cm tall; stem erect, branched glabrous or
with a few rough hairs. Leaves ovate to ovate-
lanceolate; flowers purple; pollen grains yellow2.
Fig. 1: Coneflower (Echinacea angustifolia DC )
Fig. 2: Pale Coneflower ( Echinacea pallida (Nutt.) Nutt.)
Fig. 3: Purple Coneflower ( Echinacea purpurea (L.)
Moench)
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2.2 Historic Use
Ancient medicinal
plant
Medicinal uses for Echinacea angustifolia varied.
It was used by the Indians of the great Plains
since ancient times. It is remarkable to see that
the distribution of Echinacea angustifolia was in
close proximity to the Indian settlements where it
was used.
The Omaha-Ponca e.g. placed the whole root on
toothaches until the pain subsided.
It was also used for treatment of snakebites, stings
and other poisons. The juice of the root was used
to bath burns.
In 1868 4 the Californian Eclectic Medical
Journal reported on Echinacea angustifolia as a
highly recommended Indian remedy against
snakebites and stings.
Some years later H.F.C. Meyer, a German
physician stated in Pwanee City produced
"Meyer`s Blood Purifier" as a remedy against
Rheumatism, Headache, Dyspepsia and several
other diseases. He began the broad application of
Echinacea angustifolia root in the US AND it
became a very popular herbal preparations.
Often Echinacea pallida was used instead of
Echinacea angustifolia, due to a misidentification
of both species.
In Europe Echinacea purpurea was already
mentioned in 1898 by Dragendorff5
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2.3 Chemistry of Coneflower Extract
Tab. 2: Chemical composition of Echinacea extracts
Compounds/
Species Echinacea
angustifolia
Echinacea pallida Echinacea purpurea
Volatile Oil Root of Echinacea
angustifolia usually
contain less than
0.1 %. Main
constituents are
compounds of the
type of dodeca-2,
4-diene-1-
ylisovalerate,
palmitic and
linolenic acid6,7
Root of Echinacea pallida has 0.2 to
more than 2.0,%6,7. Main compounds
are pentadeca-8Z-ene-2-one and 1-
pentadecane.8
Overground parts and roots of
the plants show only small
amounts of volatile oil< 0.1 %8
Polyacetylenes About 2%
polyacetylenes (
calculated in terms
of air dried
material). The
most important are
trideca-1-en-
3,5,7,9,11-
pentaene and
ponticaepoxide.
Both are very
unstable8,9 .
About 2 mg % polyacetylenes (
calculated in terms of air dried
material).
The most important are trideca-1-en-
3,5,7,9,11-pentaene and
ponticaepoxide. Both are very
unstable. Besides these main
constituents are several more minor
polyactetylenes found8.
Several similar polyacetylenes as
in the other species were found8
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Alkamides About 15
alkamides have
been identified.
The main
compounds are the
isomericdodeca-
2E, 4E, 8Z, 10E/Z-
tetraenic acid
isobutylamides 10,11
.
0.001% of a poly unsaturated
alkamide, echinacein ( dodeca-
2E,6Z,8E,10E/tetraenic acid
butylamide9,10
The principal compound from
dried herbal material were the
isobutylamides of undeca-2E
,4Zdiene-8,10-diynic acid and
dodeca-2E, 4E, 8Z, 10E/Z-
tetraenic acid12
Caffeic acid
derivatives
0,3- 1,3%
echinacoside . The
quinic acid
derivative Cynarin
( 1,5-O-dicaffeoyl
quinic acid) has
been identified as a
main constituent13 .
Echinacoside about 1 % in the roots
and small amounts of 6-caffeoyl
echinacoside14
2, 3-O-dicaffeoyl tartic acid (
chicoric acid was found up to 1-3
% 15and some other derivatives of
caffeic acid in minor
concentrations
Other nitrogenous
compounds
Betain
hydrochloride16
and the
pyrrolizidine
alkaloids
tussilaginine
(0.006%) and
isotussilaginine17,18
.
Glycine-betain about 0.2% in
fresh leaves19
Polysaccharides PSI a 4-O-methyl
glucuronoarabinoxylan with
molecular weight 35,000 D and
PSII an acid
arabinorhamogalactan ( MW
450,000 D)20,21,22
And a pectin-like
polysaccharide23
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Fig. 5: Lipophilic constituents of Echinacea species24
Fig. 6: Caffeic acid derivatives of Echinacea species24
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2. 4 Preparation of the Extract and Quality
Control
ControlControl
Standard
quality
assured
Coneflower roots come from plants grown in Europe and
USA. Using these specially identified roots and according
to a standard quality , manufactures coneflower
root extract.
The quality of coneflower root extract is steadily
improved. Permanent professional botanical inspections
are part of the growth of the plant.
Adequate size and condition of the plants are of great
importance to the quality of the extract of Coneflower root. The roots are collected manually only.
Inspection of
the drug upon
its arrival at
When the plant material arrives at an exhaustive
inspection of the raw material is carried out in order to
guarantee the quality of the final product.
Furthermore evaluates the possible
contamination of the plant material. Only high-quality raw
plant material is selected according to strict criteria.
Strict quality
control of the
extracts
applies an extraction process in a careful manner,
which provides a high yield of valuable constituents and a
high-grade extract.
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According to an original process produces a dry extract from the roots of
Echinacae angustifolia and Echinacea purpurea:
EXTR. ECHINACEAE. SICCUM
(ECHINACEA DRY EXTRACT)
Fine powder brown color, characteristic odor and
savor.
An extract of
the root is used
coneflower root extract satisfies the
highest quality standards. It is produced to meet
the requirements for an effective and safe
medication.
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2.5 Standardization
The consistent batch to batch quality of the
coneflower root extract is guaranteed by
the standardized production process.
Consistent batch
to batch quality
The analytical specifications of the coneflower root extract are
E. angustifolia root E. purpurea root
Aspect Fine powder, brown color,
characteristic savor and odor
Fine powder, brown color,
characteristic savor and odor
Identification HPLC Fingerprint HPLC Fingerprint
Loss on drying --- Max. 5%
Water Max. 5.0 %(KF) ---
Assay Echinacoside min. 4.0% (HPLC) Total phenols as sum of caftartic
acid, chicoric acid, chlorogenic acid
and echinacoside min. 4% (HPLC)
Microbiology Acc. Ph. Eur. 3rd ed., 5.1.4.,
category 3B
Acc. Ph. Eur. 3rd ed., 5.1.4., category
3B
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3 Common Cold
3.1 The human immune system
The human body is in communication with its
environment not only through the nutrients which it
takes in and the metabolic products which it
discharges. The environment also contains potentially
harmful toxins and pathogenic microorganisms. With
the aid of the immune system the human body can
defend itself against the harmful agents in the
environment that cause disease.
Several organs of the human body are involved in the
defense mechanisms
Fig. 7: The organs of the human immune defense25
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The immune system recognizes these agents as foreign and
distinguishes them from the intrinsic substances, cells and
tissues of the body. An immunologist would say that the
immune system distinguishes between "self" and "not self".
The intact immune system mounts defenses against toxic
substances, viruses, bacteria, pathogenic fungi and parasites
that have gained entry into the body, and also against its own
infected cells, tumor cells and foreign tissue; it recognizes
them as foreign and in most cases successfully repels them.
Together with its capability for recognizing "not self", the
immune system has a kind of memory which endows it with
the capacity of responding better and faster in the event of a
renewed threat from a toxic substance or pathogenic
microorganism which it has previously encountered 26.
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Fig. 8: The human immune system
[Not available]
3.2 Epidemiology
The importance of the interactions between these
complex defense mechanisms is illustrated by
patients who have to be treated with cytostatics or
antibiotics. During the period of treatment many of
these drugs suppress the defense mechanisms of the
immune system, e.g., those which deal with
invading pathogens or virus-infected cells.
Consequently, patients become more susceptible to
infections and suffer from more frequent recurrences 27, 28.
Respiratory
infections, a
extremely common
disease
Infections of the upper respiratory system are very
common. Averaging two infections each year and
only one day of unfitness per year, about 72 million
of lost working days result each year in Germany
(population 70 million). This represents loss of
about 20 Billion DM calculated on basis of the
German GNP 1997.
For these reasons adequate treatment or prophylaxis
with immunemodulating agents like Echinacea
angustifolia root extract can save 10 billion DM
annually 29.
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3.3 Etiology
Causes of a weakened immune system
Because the structure of the human immune system
is so complex, there is a wide range of adverse
factors that can impair its working.
Inborn immune deficiency
Non-specific
Genetic defects which impair the numbers and
functioning of active phagocytes. Genetic defects of
the complement system.
Specific
T cell defects (numbers and functions).
B cell defects (numbers and functions).
Combined defects
Acquired immune deficiency
Behavioral disorders
Faulty nutrition; Excessive alcohol consumption;
Heavy smoking; Lack of sleep; Physical
exhaustion/stress
Infection-induced disorders
Acute viral infections often weaken the immune
defenses against superadded infections.
Immune deficiencies due to metabolic disorders,
therapeutic measures or ageing
Diabetes mellitus, Hepatic cirrhosis, Uraemia
Operations, Radiotherapy,Cytostatic therapy
Immunosuppressive antibiotic therapy
Advanced age (the immune defences weaken as age
advances) 30
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3.4 Symptoms
Physical exhaustion / stress
Fever
Cough, hoarseness, irritable cough
Shortness of breath
Stuffed nose and sinuses
Perspiring
3.5 Stages
Colds develop normally within a few days. They
begin with soreness in the throat, stuffed nose and
nocturnal perspiring. Later cough or bronchitis
may follow.
3.7 Therapy
Early prophylaxis
is important in
Cough
It is important to treat of common colds with
immunmodulating substances as early as possible,
preferably as soon as the first soreness in the
throat is noticed.
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4 Pharmacology
4.1 Pharmacodynamic
Most of the pharmacological effects of Echinacea
root extract preparations involve the human
immune system31. Its action results from
synergistic effects of multiple chemical
components in the herb.
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4.1.1 Phagocytosis-stimulating action
In vitro a solution of dried residue from an
ethanol extract (1:10) of Echinacea angustifolia
in a concentration of 10-3% raises the
phagocytosis index of human granulocytes for
yeast by 17%. A dose depending action could be
shown, as below concentration of 10-5% this
effect was no longer detectable. Also a the dried
residue from a chloroform extract at a
concentration of 10-1% produced a stimulation up
to 34%32,33.
In vivo the application of a solution of 0.5 ml of
the ethanol extract in 30 ml physiological saline
given orally to mice over two days the
phagocytosis rate showed a significant increase (
factor 1.7) of carbon particle injected
intravenously on day 3 ( as compared with
controls) Under same test conditions the lipohilic
alkamide fraction given in doses of 0.33 mg/kg
bodyweight /day increased the carbon elimination
a factor of 1.5 on day 3.
The ethanol extract (1:10) from Echinacea
pallida root, in a concentration of 10-2 % , raised
phagocytosis rate of human granulocytes by 23 %.
The in vivo carbon clearance test in mice showed,
in a two days treatment with a solution of 0,5 ml
of the ethanol extract in 30 ml of isotonic saline,
given p.o. in a dose of 10 ml/ Kg bodyweight
three times daily, a raised elimination rate of the
carbon particle by factor of 2.2 as compared to the
control group.
Stimulation of phagocytosis
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A lyophilisate of pressed juice from Echinacea
purpurea used in a concentration of 0,5 mg/ml,
significantly increased the phagocytosis rate 79%
to 95% 34.
Stimulation of phagocytosis has also been
demonstrated in vitro and in vivo for the
ethanolic extract (1:10) in the carbon clearance
test. There was shown, that by p.o. application of
10 ml/ Kg bodyweight ( 0,5 ml of extract in30 ml
isotonic saline), tree time daily for 2 days raise
the carbon excretion by factor 4 in comparison to
controls.
4.1.2 Effect on immunfunctions
New Results 35 indicate that extracts from
Echinacea angustifolia root enhance immune
function by increasing antigen-specific
immunoglobulin production. These results were
measured in rats that were injected with the
antigen keyhole limpet hemocyanin (KLH) and
treated over a 6 weeks period with Echinacea
angustifolia root extract. Immunoglobulin
production was monitored by ELISA over a
period of 6 weeks. The Echinacea treated group
showed a significant rise of their primary and
secondary IgG response to the antigen.
The polysaccharides isolated from Echinacea
purpurea herb, mainly 4-O-methy-glucurono-
arabinoxylan and Arabino-rhamo-galactan exhibit
a stimulation of cytokine liberation of TNF-, IL-
I and IL-6 from peritoneal macrophages36,37.
Enhancement of
immunfunctions
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4.1.3 Antibacterial and virustatic action
Echinacea angustifolia as well as Echinacea
pallida and Echinacea purpurea38 show
antibacterial and virustatic action.
Echinacoside has been found to have a weak
inhibitory action against Stapylococcus aureus.
The effect of 6.3 mg echinacoside in 8 x103 molar
solution was equivalent to that of about 10
Oxford units of penicillin.
At a concentration of 50 µg/ml inhibited the
growth of Escherichia coli totally. With
Pseudomonas aeruginosa the same effect was
reached at a concentration of 1000 µg/ml39.
Antibacterial effects
Tab. 2: Minimal inhibitory concentrations of Trideca-1-ene-3,5,7,9,11-pentaine against bacteria,
yeasts and fungi40
Organism MIC
Aspergillus niger 0.1 %
Candida albicans 0.2 %
Epidermophyton floccosum 0.01 %
Pseudomonas aeruginosa 0.1 %
Staphylococcus aureus 0.01 %
Trichphyton mentagrophytes 0.01 %
Trichphyton rubrum 0.01 %
Trichphyton schoenleinii 0.01 %
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Some publications report that echinacoside and
chicoric acid have some inhibitory action against
VSV (vesicular stomatitis virus) in L-929 mouse
cells. Chicoric acid (concentration 125 µg/ml)
reduced the VSV infection after 4 hours of
incubation by more then 50%. For comparison
caffeic acid had the same effect in a concentration of
62.5 µg/ml. Other results indicate that flavonoids
isolated from Echinacea angustifolia root extract
may act as an interferon like action against VSV
infection when the cells were pre-incubated with
active principle 41.
4.1.4 Antioedema action
In some animal models extracts of Echinacea
angustifolia root produced inhibition of about 65%
in the carrageenan-rat`s paw model at a dose of 0.1
mg/kg bodyweight. Topical application in the croton
oil mouse ear oedema test gave an ID50 value of
100.8 µg/ear (indometacin 41.6 µg/ear) 42.
An n-hexane extract from Echinacea angustifolia
root inhibited in vitro the formation of prostaglandin
E1 (cyclooxygenase fom sheep seminal vesicles) and
also 5-lipoxygenase from pig leucocytes. Among the
akamide group from Echinacea angustifolia root
extract there are compounds proven to be potent
inhibitors of 5-lipoxygenase 43, 44.
Weak antioedema
action
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4.1.5 Tumour inhibiting action
The pentane-soluble volatile oil obtained by
distillation from Echinacea angustifolia roots
reduced tumor weight in rats with Walker
carcinosarcoma at about 69%. In mice with
lymphocytic leukemia survival was lengthened by
100% 45.
In vitro experiences with expressed juice of
Echinacea purpurea have shown that activated
macrophage ( activation by pressed juice) have
cytotoxic effects on tumor cells46
An expressed juice of Echinacea purpurea
showed in vivo after oral application a
remarkable antitumor action.
In vitro tumor
inhibition
4.1.6 Antioxidative actions
Root extracts of Echinacea angustifolia,
Echinacea pallida and Echinacea purpurea
containing different amounts of echinacoside
exhibited in vitro antioxidant activity, depending
on the method used to evaluate peroxidation
reactions.
The methanolic extract derived from Echinacea
pallida root exhibited the greatest relative
antioxidant activity of the three species.47
Antioxidative
potential
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4.2 Pharmacokinetics
The extract of coneflower root is a complex
compound. Therefore pharmacokinetic
experiments are difficult, and data is not yet
available.
5 Toxicology
The toxicity of coneflower root extract and their
preparations is generally very low. The
pyrrolizidin alkaloids tussilagine and isotussilagin
do not contain the 1,2- unsaturated necine
structure and therefore do not have any
hepatotoxic action 48.
Low toxicity
Acute Toxicity
There is no published information available
Chronic Toxicity
There is no published information available
Reproduction Toxicology
There is no published information available
Genotoxicity/Carcinogenicity
There is no published information available49.
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6 Clinical Pharmacology
A double blind placebo controlled randomized
clinical trial50 was conducted to investigate the
safety and efficacy of Echinacea extracts for
preventing upper respiratory tract infections.
Three hundred healthy volunteers were included
in this study. The main outcome measure was
time until first upper respiratory tract infection.
Ethanolic extracts of Echinacea angustifolia root
and Echinacea purpurea root or placebo were
given for 12 weeks.
Results indicate that the time until first
occurrence of the first upper respiratory tract
infection was 66 days in the Echinacea
angustifolia group and 69 days in the Echinacea
purpurea group and 65 days in the placebo group
( all at CI 95%).
In the placebo group 36.7% had an infection in
the Echinacea angustifolia group 32% and in the
Echinacea purpurea group 29.3%.
The benefit of medication was a slightly shorter
duration of infection and the subjective feeling of
symptomatic was better in the treatment groups.
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7. Proof of Clinical Efficacy
Similar results were reported by using different
combinations of Echinacea angustifolia and other
medicinal plants like Baptisia or Thuja. There were
five different placebo controlled randomized clinical
studies with healthy volunteers discussed 51
Over a period of 32 years (1961 to 1993) more than
26 controlled clinical trials have been conducted. A
critical review demonstrates the value of Echinacea
root extracts in the treatment of common cold52
One of the studies, a single blind study, has been
conducted with Echinacea angustifolia homeopathic
complex ( D1 and D4). In both studies phagocytic
activity of PNG (polymorphonuclear neutrophil
granulocytes) was significantly enhanced in
comparison to placebo.
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In a placebo-controlled unicentric study with an
Echinacea pallida root preparation comprising 160
patients, an alcohol-water tincture (1:5) given in a
dose of 90 drops ( ca. 900 mg of the herbal product)
/ day achieved considerably more rapid
improvement in patients of the upper respiratory
tract than a placebo group. The duration of illness
was shortened from 13 to 9.8 days in patients with
bacterial infections and from 12.9 to 9.1 in patients
with viral infections53.
Several clinical studies have been conducted with
the pressed juice fro Echinacea purpurea. A
placebo- controlled double blind study with patients
particularly susceptible to infection was conducted
in order to find whether a treatment with pressed
juice from Echinacea pupurea could reduce the
recurrence rate of infection.
108 patients, who in the winter half-year preceding
the study had suffered at least three attacks of
respiratory infection of coryzal type; received a dose
of 2 x 4 ml Echinacea purpurea pressed juice or
placebo juice over a 8 week treatment period .
The time elapsed before the first infection was
longer in the treatment group ( 40 days) than in the
placebo group (25 days)54.
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Fig. 9: Recurrence rate of infections
No. Patients
These results were recently confirmed in a GCP
conform study with 120 patients suffering of an infection
of the upper respiratory tract in a monocentric double –
blind study . Pressed juice of Echinacea purpurea (20
drops every two hours at the first day and 3 x 20 drops in
the following days) showed a significant shortening of
time for the reduction of the symptoms of infection in
comparison to the placebo group55.
Fig. 10: Time until disappearance of symptoms (days)
- Placebo – upper line
- Echinacea pressed juice – lower line
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In the treatment of skin conditions such as wounds,
eczema, herpes simplex or burns Echinacea
purpurea pressed juice ( ointment) showed in a
study with 4598 patients healing within one week in
about 85%. This is explained in terms of fibroblast
activation and hyaluronidase inhibition56
A 55% ethanolic extract fro Echinacea purpurea
roots was investigated in patients with influenza
infections in a single center placebo-controlled
double-blind study. The dose was 180 drops of
extract ( = 90 mg herbal product) daily. There was a
definitive improvement in the symptomatic picture
of the influenza infection ( overall score of various
symptoms) as compared with the placebo group. In
patients given half the daily dose no significant
effects were seen57.
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Fig. 10 Overall score of various symptoms as a mean
value dependent on time and the extract.
Placebo
+ Dose 1 ( = 450 mg extract) ,* Dose 2 ( = 900 mg
extract)
K0 = starting point
K1 = 3-4 days after treatment
K2 = 8-10 days after treatment
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7.1 Multi-Center Studies
Not available
7.2 Therapeutic Safety
High level
of
therapeutic
safety
No subjective side effects were reported
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8 Bibliography
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