Echinacea Dry Extract - Euromed4 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

Seite 2

Echinacea

Dry Extract

For the Treatment of respiratory infections and influenza

CONEFLOWER ROOT EXTRACT

3

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


5

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.


6

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.


7

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


8

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.


9

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


12

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


13

Fig. 5: Lipophilic constituents of Echinacea species24

Fig. 6: Caffeic acid derivatives of Echinacea species24


14

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.


15

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


18

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.


19

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


25

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 %


26

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


27

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


28

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


Reproduction Toxicology


Genotoxicity/Carcinogenicity

There is no published information available49.


29

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.


31

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.


32

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


33

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.


34

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


35

7.1 Multi-Center Studies

Not available

7.2 Therapeutic Safety

High level

of

therapeutic

safety

No subjective side effects were reported


36

8 Bibliography

1 Schindler H, Geschichte, Systematik und Verbreitung der therapeutisch

wichtigen Echinacea- Arten: E. angustifolia DC, E. pallida Nutt. Und E.

purpurea Moench, Pharm Zentralh 81, 589-594 (1940) 2 McGregor RL, The Taxonomy of the Genus Echinacea (Compositae)

Univ Kansas Sci Bull 48,113-142 (1977) 3 American Pharmaceutical Association, National Formulary VI (1936) 4 Mitchel JB, Echinacea angustifolia, California Eclectic Med J, 2, 163-

166 (1909) 5 Dragendorff G, Die Heilpflanzen der verschiedenen Völker und Zeiten,

F. Enke Verlag, Stuttgart (1898) 6 Bauer R, Wagner H, Echinacea – Ein Handbuch für Ärzte, Apotheker

und andere Naturwissenschaftler, Wiss Verl Ges , Stuttgart (1990) 7 Heinzer F, Chavanne M, Meusy JP, Maitre HP, Giger E, Baumann TW,

Ein beitrag zur Klassifizierung der therapeutisch verwendeten Arten der

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Documents

Echinacea Dry Extract - Euromed4 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