Echinacea - comments on the recent report on the flaawedresearch project

[Guest guest]

(Austin, TX, July 27, 2005). The nonprofit American Botanical Council

(ABC), an Austin, Texas-based research and education organization,

has reviewed a new clinical trial on the popular herb echinacea for

use in a specific kind of induced virus, being published Thursday in

the New England Journal of Medicine.1 The study concluded that the

echinacea preparations did not prevent or help treat symptoms of a

specific virus applied to the test subjects. ABC has found several

aspects of the design of the study worthy of clarification, and

comments on the potential misinterpretations of the significance of

this study.

 

First, the extracts used were made in a university laboratory and do

not correlate with commercial echinacea products currently available

to consumers. Second, the dosages used in this trial were probably

too low. The echinacea preparations used in the study might have

shown activity at more frequent dosing intervals and/or higher dosage

levels – as is often the case with contemporary echinacea use.

 

The new trial utilized extracts made from the roots of a species of

echinacea called Echinacea angustifolia. The randomized, double-

blind, placebo-controlled, seven-arm trial was conducted on 437

college students who had a particular type of rhinovirus inserted

into their nostrils (the results were calculated on 399 subjects). In

the trial, the echinacea preparations were tested to see if they had

a preventive effect or if they could help treat the symptoms caused

by the rhinovirus. The students who received the three different

echinacea preparations and were sequestered in a hotel room did not

experience fewer infections, fewer symptoms, or a reduction in the

duration of symptoms, compared with those who received the placebo.

 

The trial utilized three doses of 1.5 milliliters each of the three

laboratory-produced echinacea extracts, presumably equivalent to

about 300 milligrams of the dried powdered root in each dose

(equivalent to 900 mg per day of the dried root). This level was

chosen for the trial because it is the dose recommended by the German

government's expert herb panel called the Commission E, which had

conducted reviews of the research published on various types of

echinacea in the scientific and medical literature in the early

1990s.2

According to ABC various international monographs have acknowledged

the generally higher dose used for echinacea root products. The World

Health Organization (WHO) monograph for Echinacea root ( " Radix

Echniaceae " ) has a dosage for Echinacea angustifolia root at the

equivalence of 3 gm per day of the dried root.3 This same dosage is

also acknowledged in the more recently developed draft monographs on

Echinacea from the Canadian Natural Health Products Directorate.4

 

This dosage level is about 330% higher than the dosage of the

echinacea preparations given in the NEJM trial. This supports ABC's

contention that the preparations may have been under-dosed and that

the trial might have shown a potentially positive trend if a higher

dosage and/or increased frequency of administration had been followed.

 

" It would have been optimal if this trial had tested the echinacea

preparations at more frequent and/or higher doses, " said Mark

Blumenthal, Founder and Executive Director of ABC. " Dosage is one of

the most important aspects in assessing any therapeutic agent. Many

clinicians who recommend echinacea for treatment of upper respiratory

tract infections related to colds and flu normally utilize a

frequency of use and/or a total daily dose that is higher than the

one used in this trial. This is also true for consumer self-

medication with many commercial echinacea preparations according to

some label dosage suggestions. "

 

Blumenthal added. " The researchers have previous experience in

researching echinacea and have done an admirable job in testing a

species of echinacea (i.e., E. angustifolia) that has not been

adequately researched. " But he hastened to add, " The most accurate

statement that can be said about this trial is this: These specific

laboratory-produced echinacea extracts, at the dose given in the

trial, under the specific design of this trial, did not produce any

measurable effect. "

He emphasized, " This is not a definitive trial on the efficacy of

echinacea, nor should the results be generalized to echinacea

preparations widely available. Unfortunately, the conclusion that may

be drawn by some media who report this study may state

that `echinacea is ineffective,' but this would be an incorrect

conclusion based on the design of this study and the evidence in the

existing literature. "

 

" Dosing people for rhinovirus in a hotel does not necessarily mimic

real life, " said Bruce Barrett, MD, PhD, an Assistant Professor of

Family Medicine University of Wisconsin School of Medicine and an

author of several previous critical reviews on echinacea clinical

trials. He noted that the patients were possibly relatively resistant

to the echinacea treatment. " College kids are immunocompetent, " he

stated, referring to the relative health of the test subjects in the

trial. " It may have been better to test older people to see how they

might have faired. "

However, Dr. Barrett was generally complimentary about the trial in

general. " This is a very valuable study and quite helpful, although

it has some significant limitations, including product, sample, and

population, " he stated. " In general, you may want to have about 100

people per treatment group for more statistical significance rather

than only about 50 per group used in this trial. "

 

In general, products marketed as " Echinacea " are extremely popular in

the United States. Echinacea ranked second in sales in mainstream

market retail stores in 2004, according to an article in ABC's

journal HerbalGram.5 Total sales of echinacea products in all

channels of trade in the United States in 2004 was estimated at about

$155 million, according to data compiled by Nutrition Business

Journal.

Blumenthal also added that although it was formerly quite popular,

there has been a trend away from using Echinacea angustifolia root in

commercial herbal products based on increased concerns by many

responsible members of the herb community regarding conservation and

sustainability of wild medicinal plants. Echinacea angustifolia is

generally more difficult to cultivate commercially than the other two

more popular species of echinacea (E. pallida and E. purpurea), and

so more material from these species are found in products on the

North American market.

 

Blumenthal points to a body of clinical evidence that supports the

use of various echinacea preparations for treating symptoms

associated with colds and flus. A therapeutic monograph on Echinacea

is available in The ABC Clinical Guide to Herbs, ABC's reference

book and continuing medical education module.6 The monograph

summarizes 21 clinical trials on various echinacea preparations for

colds, flus, upper respiratory tract infections, and other uses. ABC

has posted the complete echinacea chapter including this monograph on

its website as an educational service to the public.

 

The study has generated significant media attention. ABC and

Blumenthal have been contacted by a variety of news sources,

including: the Associated Press, Bloomberg Business News, CNN, the

Los Angeles Times, NBC Nightly News with Brian Williams, the New York

Times and USA Today.

 

About the American Botanical Council

 

The American Botanical Council is the nation's leading nonprofit

organization addressing research and educational issues regarding

herbs and medicinal plants. The 17-year-old organization occupies a

2.5 acre site in Austin, Texas, where it publishes HerbalGram , a

peer-reviewed journal. ABC is also the publisher of The ABC Clinical

Guide to Herbs, a continuing education and reference book, which

contains extensive monographs on the safety and efficacy of 29

popular herbs, including echinacea.6 More information on echinacea is

available on ABC's extensive website, http://www.herbalgram.org/.

 

 

References

 

1. Turner RB, Bauer R, Woelkart K, Hulsey TC, Gangemi DJ. An

evaluation of Echinacea angustifolia preparations in experimental

rhinovirus infections. N Engl J Med 2005;353:341-348.

 

2. Blumenthal M, Busse WR, Goldberg A, Hall T, Riggins CW, Rister RS,

eds. Klein S, Rister RS, trans. The Complete German Commission E

Monographs – Therapeutic Guide to Herbal Medicines. Boston:

Integrative Medicine Communications; Austin, TX: American Botanical

Council, 1998.

 

3. Echinacea Radix. In: WHO monographs on selected medicinal plants.

Geneva: World Health Organization, 1999.

 

4. Ehinacea. Natural Health Products Directorate. Health Canada.

Draft Jan 2004. Available at: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-

dpsn/mono_echinacea_e.pdf Accessed, Jul 27, 2005.

 

5. Blumenthal M. Herb sales down 7.4 percent in mainstream market.

HerbalGram 2005;66:63.

 

6. Echinacea. In: Blumenthal M, Hall T, Goldberg A, Kunz T, Dinda K,

Brinckmann J, et al, eds. The ABC Clinical Guide to Herbs. Austin,

TX: American Botanical Council, 2003.

[Guest guest]

I have found that echinacea tincture works to stop a cold if you take

it very early and continue for ten days, or lessens the symptoms if

you start it once the cold has established. Of course, it is best to

take it for only a few weeks at a time otherwise it would be like

taking antibiotics all the time!

 

Jo

 

, " heartwerk " <heartwork@c...> wrote:

> (Austin, TX, July 27, 2005). The nonprofit American Botanical

Council

> (ABC), an Austin, Texas-based research and education organization,

> has reviewed a new clinical trial on the popular herb echinacea for

> use in a specific kind of induced virus, being published Thursday

in

> the New England Journal of Medicine.1 The study concluded that the

> echinacea preparations did not prevent or help treat symptoms of a

> specific virus applied to the test subjects. ABC has found several

> aspects of the design of the study worthy of clarification, and

> comments on the potential misinterpretations of the significance of

> this study.

>

> First, the extracts used were made in a university laboratory and

do

> not correlate with commercial echinacea products currently

available

> to consumers. Second, the dosages used in this trial were probably

> too low. The echinacea preparations used in the study might have

> shown activity at more frequent dosing intervals and/or higher

dosage

> levels – as is often the case with contemporary echinacea use.

>

> The new trial utilized extracts made from the roots of a species of

> echinacea called Echinacea angustifolia. The randomized, double-

> blind, placebo-controlled, seven-arm trial was conducted on 437

> college students who had a particular type of rhinovirus inserted

> into their nostrils (the results were calculated on 399 subjects).

In

> the trial, the echinacea preparations were tested to see if they

had

> a preventive effect or if they could help treat the symptoms caused

> by the rhinovirus. The students who received the three different

> echinacea preparations and were sequestered in a hotel room did not

> experience fewer infections, fewer symptoms, or a reduction in the

> duration of symptoms, compared with those who received the placebo.

>

> The trial utilized three doses of 1.5 milliliters each of the three

> laboratory-produced echinacea extracts, presumably equivalent to

> about 300 milligrams of the dried powdered root in each dose

> (equivalent to 900 mg per day of the dried root). This level was

> chosen for the trial because it is the dose recommended by the

German

> government's expert herb panel called the Commission E, which had

> conducted reviews of the research published on various types of

> echinacea in the scientific and medical literature in the early

> 1990s.2

> According to ABC various international monographs have acknowledged

> the generally higher dose used for echinacea root products. The

World

> Health Organization (WHO) monograph for Echinacea root ( " Radix

> Echniaceae " ) has a dosage for Echinacea angustifolia root at the

> equivalence of 3 gm per day of the dried root.3 This same dosage is

> also acknowledged in the more recently developed draft monographs

on

> Echinacea from the Canadian Natural Health Products Directorate.4

>

> This dosage level is about 330% higher than the dosage of the

> echinacea preparations given in the NEJM trial. This supports ABC's

> contention that the preparations may have been under-dosed and that

> the trial might have shown a potentially positive trend if a higher

> dosage and/or increased frequency of administration had been

followed.

>

> " It would have been optimal if this trial had tested the echinacea

> preparations at more frequent and/or higher doses, " said Mark

> Blumenthal, Founder and Executive Director of ABC. " Dosage is one

of

> the most important aspects in assessing any therapeutic agent. Many

> clinicians who recommend echinacea for treatment of upper

respiratory

> tract infections related to colds and flu normally utilize a

> frequency of use and/or a total daily dose that is higher than the

> one used in this trial. This is also true for consumer self-

> medication with many commercial echinacea preparations according to

> some label dosage suggestions. "

>

> Blumenthal added. " The researchers have previous experience in

> researching echinacea and have done an admirable job in testing a

> species of echinacea (i.e., E. angustifolia) that has not been

> adequately researched. " But he hastened to add, " The most accurate

> statement that can be said about this trial is this: These specific

> laboratory-produced echinacea extracts, at the dose given in the

> trial, under the specific design of this trial, did not produce any

> measurable effect. "

> He emphasized, " This is not a definitive trial on the efficacy of

> echinacea, nor should the results be generalized to echinacea

> preparations widely available. Unfortunately, the conclusion that

may

> be drawn by some media who report this study may state

> that `echinacea is ineffective,' but this would be an incorrect

> conclusion based on the design of this study and the evidence in

the

> existing literature. "

>

> " Dosing people for rhinovirus in a hotel does not necessarily mimic

> real life, " said Bruce Barrett, MD, PhD, an Assistant Professor of

> Family Medicine University of Wisconsin School of Medicine and an

> author of several previous critical reviews on echinacea clinical

> trials. He noted that the patients were possibly relatively

resistant

> to the echinacea treatment. " College kids are immunocompetent, " he

> stated, referring to the relative health of the test subjects in

the

> trial. " It may have been better to test older people to see how

they

> might have faired. "

> However, Dr. Barrett was generally complimentary about the trial

in

> general. " This is a very valuable study and quite helpful, although

> it has some significant limitations, including product, sample, and

> population, " he stated. " In general, you may want to have about 100

> people per treatment group for more statistical significance rather

> than only about 50 per group used in this trial. "

>

> In general, products marketed as " Echinacea " are extremely popular

in

> the United States. Echinacea ranked second in sales in mainstream

> market retail stores in 2004, according to an article in ABC's

> journal HerbalGram.5 Total sales of echinacea products in all

> channels of trade in the United States in 2004 was estimated at

about

> $155 million, according to data compiled by Nutrition Business

> Journal.

> Blumenthal also added that although it was formerly quite popular,

> there has been a trend away from using Echinacea angustifolia root

in

> commercial herbal products based on increased concerns by many

> responsible members of the herb community regarding conservation

and

> sustainability of wild medicinal plants. Echinacea angustifolia is

> generally more difficult to cultivate commercially than the other

two

> more popular species of echinacea (E. pallida and E. purpurea), and

> so more material from these species are found in products on the

> North American market.

>

> Blumenthal points to a body of clinical evidence that supports the

> use of various echinacea preparations for treating symptoms

> associated with colds and flus. A therapeutic monograph on

Echinacea

> is available in The ABC Clinical Guide to Herbs, ABC's reference

> book and continuing medical education module.6 The monograph

> summarizes 21 clinical trials on various echinacea preparations for

> colds, flus, upper respiratory tract infections, and other uses.

ABC

> has posted the complete echinacea chapter including this monograph

on

> its website as an educational service to the public.

>

> The study has generated significant media attention. ABC and

> Blumenthal have been contacted by a variety of news sources,

> including: the Associated Press, Bloomberg Business News, CNN, the

> Los Angeles Times, NBC Nightly News with Brian Williams, the New

York

> Times and USA Today.

>

> About the American Botanical Council

>

> The American Botanical Council is the nation's leading nonprofit

> organization addressing research and educational issues regarding

> herbs and medicinal plants. The 17-year-old organization occupies a

> 2.5 acre site in Austin, Texas, where it publishes HerbalGram , a

> peer-reviewed journal. ABC is also the publisher of The ABC

Clinical

> Guide to Herbs, a continuing education and reference book, which

> contains extensive monographs on the safety and efficacy of 29

> popular herbs, including echinacea.6 More information on echinacea

is

> available on ABC's extensive website, http://www.herbalgram.org/.

>

>

> References

>

> 1. Turner RB, Bauer R, Woelkart K, Hulsey TC, Gangemi DJ. An

> evaluation of Echinacea angustifolia preparations in experimental

> rhinovirus infections. N Engl J Med 2005;353:341-348.

>

> 2. Blumenthal M, Busse WR, Goldberg A, Hall T, Riggins CW, Rister

RS,

> eds. Klein S, Rister RS, trans. The Complete German Commission E

> Monographs – Therapeutic Guide to Herbal Medicines. Boston:

> Integrative Medicine Communications; Austin, TX: American Botanical

> Council, 1998.

>

> 3. Echinacea Radix. In: WHO monographs on selected medicinal

plants.

> Geneva: World Health Organization, 1999.

>

> 4. Ehinacea. Natural Health Products Directorate. Health Canada.

> Draft Jan 2004. Available at: http://www.hc-sc.gc.ca/hpfb-

dgpsa/nhpd-

> dpsn/mono_echinacea_e.pdf Accessed, Jul 27, 2005.

>

> 5. Blumenthal M. Herb sales down 7.4 percent in mainstream market.

> HerbalGram 2005;66:63.

>

> 6. Echinacea. In: Blumenthal M, Hall T, Goldberg A, Kunz T, Dinda

K,

> Brinckmann J, et al, eds. The ABC Clinical Guide to Herbs. Austin,

> TX: American Botanical Council, 2003.

[Guest guest]

I agree, it is a useful herb, and I use it to boost my imune system when I get the early signs of a cold. But your body will get used to it, and so it is only usually recomended to take it for 2-3 weeks max. before it looses its usefulness.

 

The Valley Vegan......heartwerk <heartwork wrote:

I have found that echinacea tincture works to stop a cold if you take it very early and continue for ten days, or lessens the symptoms if you start it once the cold has established. Of course, it is best to take it for only a few weeks at a time otherwise it would be like taking antibiotics all the time!Jo , "heartwerk" wrote:> (Austin, TX, July 27, 2005). The nonprofit American Botanical Council > (ABC), an Austin, Texas-based research and education organization, > has reviewed a new clinical trial on the popular herb echinacea for > use in a specific kind of induced virus, being published Thursday in > the New England Journal of Medicine.1 The study concluded that the > echinacea preparations did not prevent or help treat symptoms of a > specific

virus applied to the test subjects. ABC has found several > aspects of the design of the study worthy of clarification, and > comments on the potential misinterpretations of the significance of > this study.> > First, the extracts used were made in a university laboratory and do > not correlate with commercial echinacea products currently available > to consumers. Second, the dosages used in this trial were probably > too low. The echinacea preparations used in the study might have > shown activity at more frequent dosing intervals and/or higher dosage > levels – as is often the case with contemporary echinacea use. > > The new trial utilized extracts made from the roots of a species of > echinacea called Echinacea angustifolia. The randomized, double-> blind, placebo-controlled, seven-arm trial was conducted on 437 > college students who had a particular type of

rhinovirus inserted > into their nostrils (the results were calculated on 399 subjects). In > the trial, the echinacea preparations were tested to see if they had > a preventive effect or if they could help treat the symptoms caused > by the rhinovirus. The students who received the three different > echinacea preparations and were sequestered in a hotel room did not > experience fewer infections, fewer symptoms, or a reduction in the > duration of symptoms, compared with those who received the placebo.> > The trial utilized three doses of 1.5 milliliters each of the three > laboratory-produced echinacea extracts, presumably equivalent to > about 300 milligrams of the dried powdered root in each dose > (equivalent to 900 mg per day of the dried root). This level was > chosen for the trial because it is the dose recommended by the German > government's expert herb panel

called the Commission E, which had > conducted reviews of the research published on various types of > echinacea in the scientific and medical literature in the early > 1990s.2> According to ABC various international monographs have acknowledged > the generally higher dose used for echinacea root products. The World > Health Organization (WHO) monograph for Echinacea root ("Radix > Echniaceae") has a dosage for Echinacea angustifolia root at the > equivalence of 3 gm per day of the dried root.3 This same dosage is > also acknowledged in the more recently developed draft monographs on > Echinacea from the Canadian Natural Health Products Directorate.4 > > This dosage level is about 330% higher than the dosage of the > echinacea preparations given in the NEJM trial. This supports ABC's > contention that the preparations may have been under-dosed and that > the trial might

have shown a potentially positive trend if a higher > dosage and/or increased frequency of administration had been followed.> > "It would have been optimal if this trial had tested the echinacea > preparations at more frequent and/or higher doses," said Mark > Blumenthal, Founder and Executive Director of ABC. "Dosage is one of > the most important aspects in assessing any therapeutic agent. Many > clinicians who recommend echinacea for treatment of upper respiratory > tract infections related to colds and flu normally utilize a > frequency of use and/or a total daily dose that is higher than the > one used in this trial. This is also true for consumer self-> medication with many commercial echinacea preparations according to > some label dosage suggestions."> > Blumenthal added. "The researchers have previous experience in > researching echinacea and have done an

admirable job in testing a > species of echinacea (i.e., E. angustifolia) that has not been > adequately researched." But he hastened to add, "The most accurate > statement that can be said about this trial is this: These specific > laboratory-produced echinacea extracts, at the dose given in the > trial, under the specific design of this trial, did not produce any > measurable effect." > He emphasized, "This is not a definitive trial on the efficacy of > echinacea, nor should the results be generalized to echinacea > preparations widely available. Unfortunately, the conclusion that may > be drawn by some media who report this study may state > that `echinacea is ineffective,' but this would be an incorrect > conclusion based on the design of this study and the evidence in the > existing literature."> > "Dosing people for rhinovirus in a hotel does not necessarily mimic

> real life," said Bruce Barrett, MD, PhD, an Assistant Professor of > Family Medicine University of Wisconsin School of Medicine and an > author of several previous critical reviews on echinacea clinical > trials. He noted that the patients were possibly relatively resistant > to the echinacea treatment. "College kids are immunocompetent," he > stated, referring to the relative health of the test subjects in the > trial. "It may have been better to test older people to see how they > might have faired."> However, Dr. Barrett was generally complimentary about the trial in > general. "This is a very valuable study and quite helpful, although > it has some significant limitations, including product, sample, and > population," he stated. "In general, you may want to have about 100 > people per treatment group for more statistical significance rather > than only about 50 per

group used in this trial." > > In general, products marketed as "Echinacea" are extremely popular in > the United States. Echinacea ranked second in sales in mainstream > market retail stores in 2004, according to an article in ABC's > journal HerbalGram.5 Total sales of echinacea products in all > channels of trade in the United States in 2004 was estimated at about > $155 million, according to data compiled by Nutrition Business > Journal.> Blumenthal also added that although it was formerly quite popular, > there has been a trend away from using Echinacea angustifolia root in > commercial herbal products based on increased concerns by many > responsible members of the herb community regarding conservation and > sustainability of wild medicinal plants. Echinacea angustifolia is > generally more difficult to cultivate commercially than the other two > more

popular species of echinacea (E. pallida and E. purpurea), and > so more material from these species are found in products on the > North American market.> > Blumenthal points to a body of clinical evidence that supports the > use of various echinacea preparations for treating symptoms > associated with colds and flus. A therapeutic monograph on Echinacea > is available in The ABC Clinical Guide to Herbs, ABC's reference > book and continuing medical education module.6 The monograph > summarizes 21 clinical trials on various echinacea preparations for > colds, flus, upper respiratory tract infections, and other uses. ABC > has posted the complete echinacea chapter including this monograph on > its website as an educational service to the public.> > The study has generated significant media attention. ABC and > Blumenthal have been contacted by a variety of news

sources, > including: the Associated Press, Bloomberg Business News, CNN, the > Los Angeles Times, NBC Nightly News with Brian Williams, the New York > Times and USA Today.> > About the American Botanical Council> > The American Botanical Council is the nation's leading nonprofit > organization addressing research and educational issues regarding > herbs and medicinal plants. The 17-year-old organization occupies a > 2.5 acre site in Austin, Texas, where it publishes HerbalGram , a > peer-reviewed journal. ABC is also the publisher of The ABC Clinical > Guide to Herbs, a continuing education and reference book, which > contains extensive monographs on the safety and efficacy of 29 > popular herbs, including echinacea.6 More information on echinacea is > available on ABC's extensive website, http://www.herbalgram.org/.> > > References>

> 1. Turner RB, Bauer R, Woelkart K, Hulsey TC, Gangemi DJ. An > evaluation of Echinacea angustifolia preparations in experimental > rhinovirus infections. N Engl J Med 2005;353:341-348.> > 2. Blumenthal M, Busse WR, Goldberg A, Hall T, Riggins CW, Rister RS, > eds. Klein S, Rister RS, trans. The Complete German Commission E > Monographs – Therapeutic Guide to Herbal Medicines. Boston: > Integrative Medicine Communications; Austin, TX: American Botanical > Council, 1998.> > 3. Echinacea Radix. In: WHO monographs on selected medicinal plants. > Geneva: World Health Organization, 1999.> > 4. Ehinacea. Natural Health Products Directorate. Health Canada. > Draft Jan 2004. Available at: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-> dpsn/mono_echinacea_e.pdf Accessed, Jul 27, 2005.> > 5. Blumenthal M. Herb sales down 7.4 percent in mainstream market.

> HerbalGram 2005;66:63.> > 6. Echinacea. In: Blumenthal M, Hall T, Goldberg A, Kunz T, Dinda K, > Brinckmann J, et al, eds. The ABC Clinical Guide to Herbs. Austin, > TX: American Botanical Council, 2003.

[Guest guest]

Waaaaaa!!! My usual computer is down until tomorrow (3 worms even with two

virus programs including one from the ISP). I have all the info on this

study on that computer complete with follow the money.

 

However, the study was a crock. It isn't complete. They are still taking

applications from folks to be part of the study. AND, it is a federal

program that has been put into place to do in anything natural or

homeopathic!

 

Lynda

-

" heartwerk " <heartwork

 

Monday, August 01, 2005 11:41 PM

Echinacea - comments on the recent report on the

flaawedresearch project

 

 

> (Austin, TX, July 27, 2005). The nonprofit American Botanical Council

> (ABC), an Austin, Texas-based research and education organization,

> has reviewed a new clinical trial on the popular herb echinacea for

> use in a specific kind of induced virus, being published Thursday in

> the New England Journal of Medicine.1 The study concluded that the

> echinacea preparations did not prevent or help treat symptoms of a

> specific virus applied to the test subjects. ABC has found several

> aspects of the design of the study worthy of clarification, and

> comments on the potential misinterpretations of the significance of

> this study.

>

> First, the extracts used were made in a university laboratory and do

> not correlate with commercial echinacea products currently available

> to consumers. Second, the dosages used in this trial were probably

> too low. The echinacea preparations used in the study might have

> shown activity at more frequent dosing intervals and/or higher dosage

> levels - as is often the case with contemporary echinacea use.

>

> The new trial utilized extracts made from the roots of a species of

> echinacea called Echinacea angustifolia. The randomized, double-

> blind, placebo-controlled, seven-arm trial was conducted on 437

> college students who had a particular type of rhinovirus inserted

> into their nostrils (the results were calculated on 399 subjects). In

> the trial, the echinacea preparations were tested to see if they had

> a preventive effect or if they could help treat the symptoms caused

> by the rhinovirus. The students who received the three different

> echinacea preparations and were sequestered in a hotel room did not

> experience fewer infections, fewer symptoms, or a reduction in the

> duration of symptoms, compared with those who received the placebo.

>

> The trial utilized three doses of 1.5 milliliters each of the three

> laboratory-produced echinacea extracts, presumably equivalent to

> about 300 milligrams of the dried powdered root in each dose

> (equivalent to 900 mg per day of the dried root). This level was

> chosen for the trial because it is the dose recommended by the German

> government's expert herb panel called the Commission E, which had

> conducted reviews of the research published on various types of

> echinacea in the scientific and medical literature in the early

> 1990s.2

> According to ABC various international monographs have acknowledged

> the generally higher dose used for echinacea root products. The World

> Health Organization (WHO) monograph for Echinacea root ( " Radix

> Echniaceae " ) has a dosage for Echinacea angustifolia root at the

> equivalence of 3 gm per day of the dried root.3 This same dosage is

> also acknowledged in the more recently developed draft monographs on

> Echinacea from the Canadian Natural Health Products Directorate.4

>

> This dosage level is about 330% higher than the dosage of the

> echinacea preparations given in the NEJM trial. This supports ABC's

> contention that the preparations may have been under-dosed and that

> the trial might have shown a potentially positive trend if a higher

> dosage and/or increased frequency of administration had been followed.

>

> " It would have been optimal if this trial had tested the echinacea

> preparations at more frequent and/or higher doses, " said Mark

> Blumenthal, Founder and Executive Director of ABC. " Dosage is one of

> the most important aspects in assessing any therapeutic agent. Many

> clinicians who recommend echinacea for treatment of upper respiratory

> tract infections related to colds and flu normally utilize a

> frequency of use and/or a total daily dose that is higher than the

> one used in this trial. This is also true for consumer self-

> medication with many commercial echinacea preparations according to

> some label dosage suggestions. "

>

> Blumenthal added. " The researchers have previous experience in

> researching echinacea and have done an admirable job in testing a

> species of echinacea (i.e., E. angustifolia) that has not been

> adequately researched. " But he hastened to add, " The most accurate

> statement that can be said about this trial is this: These specific

> laboratory-produced echinacea extracts, at the dose given in the

> trial, under the specific design of this trial, did not produce any

> measurable effect. "

> He emphasized, " This is not a definitive trial on the efficacy of

> echinacea, nor should the results be generalized to echinacea

> preparations widely available. Unfortunately, the conclusion that may

> be drawn by some media who report this study may state

> that `echinacea is ineffective,' but this would be an incorrect

> conclusion based on the design of this study and the evidence in the

> existing literature. "

>

> " Dosing people for rhinovirus in a hotel does not necessarily mimic

> real life, " said Bruce Barrett, MD, PhD, an Assistant Professor of

> Family Medicine University of Wisconsin School of Medicine and an

> author of several previous critical reviews on echinacea clinical

> trials. He noted that the patients were possibly relatively resistant

> to the echinacea treatment. " College kids are immunocompetent, " he

> stated, referring to the relative health of the test subjects in the

> trial. " It may have been better to test older people to see how they

> might have faired. "

> However, Dr. Barrett was generally complimentary about the trial in

> general. " This is a very valuable study and quite helpful, although

> it has some significant limitations, including product, sample, and

> population, " he stated. " In general, you may want to have about 100

> people per treatment group for more statistical significance rather

> than only about 50 per group used in this trial. "

>

> In general, products marketed as " Echinacea " are extremely popular in

> the United States. Echinacea ranked second in sales in mainstream

> market retail stores in 2004, according to an article in ABC's

> journal HerbalGram.5 Total sales of echinacea products in all

> channels of trade in the United States in 2004 was estimated at about

> $155 million, according to data compiled by Nutrition Business

> Journal.

> Blumenthal also added that although it was formerly quite popular,

> there has been a trend away from using Echinacea angustifolia root in

> commercial herbal products based on increased concerns by many

> responsible members of the herb community regarding conservation and

> sustainability of wild medicinal plants. Echinacea angustifolia is

> generally more difficult to cultivate commercially than the other two

> more popular species of echinacea (E. pallida and E. purpurea), and

> so more material from these species are found in products on the

> North American market.

>

> Blumenthal points to a body of clinical evidence that supports the

> use of various echinacea preparations for treating symptoms

> associated with colds and flus. A therapeutic monograph on Echinacea

> is available in The ABC Clinical Guide to Herbs, ABC's reference

> book and continuing medical education module.6 The monograph

> summarizes 21 clinical trials on various echinacea preparations for

> colds, flus, upper respiratory tract infections, and other uses. ABC

> has posted the complete echinacea chapter including this monograph on

> its website as an educational service to the public.

>

> The study has generated significant media attention. ABC and

> Blumenthal have been contacted by a variety of news sources,

> including: the Associated Press, Bloomberg Business News, CNN, the

> Los Angeles Times, NBC Nightly News with Brian Williams, the New York

> Times and USA Today.

>

> About the American Botanical Council

>

> The American Botanical Council is the nation's leading nonprofit

> organization addressing research and educational issues regarding

> herbs and medicinal plants. The 17-year-old organization occupies a

> 2.5 acre site in Austin, Texas, where it publishes HerbalGram , a

> peer-reviewed journal. ABC is also the publisher of The ABC Clinical

> Guide to Herbs, a continuing education and reference book, which

> contains extensive monographs on the safety and efficacy of 29

> popular herbs, including echinacea.6 More information on echinacea is

> available on ABC's extensive website, http://www.herbalgram.org/.

>

>

> References

>

> 1. Turner RB, Bauer R, Woelkart K, Hulsey TC, Gangemi DJ. An

> evaluation of Echinacea angustifolia preparations in experimental

> rhinovirus infections. N Engl J Med 2005;353:341-348.

>

> 2. Blumenthal M, Busse WR, Goldberg A, Hall T, Riggins CW, Rister RS,

> eds. Klein S, Rister RS, trans. The Complete German Commission E

> Monographs - Therapeutic Guide to Herbal Medicines. Boston:

> Integrative Medicine Communications; Austin, TX: American Botanical

> Council, 1998.

>

> 3. Echinacea Radix. In: WHO monographs on selected medicinal plants.

> Geneva: World Health Organization, 1999.

>

> 4. Ehinacea. Natural Health Products Directorate. Health Canada.

> Draft Jan 2004. Available at: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-

> dpsn/mono_echinacea_e.pdf Accessed, Jul 27, 2005.

>

> 5. Blumenthal M. Herb sales down 7.4 percent in mainstream market.

> HerbalGram 2005;66:63.

>

> 6. Echinacea. In: Blumenthal M, Hall T, Goldberg A, Kunz T, Dinda K,

> Brinckmann J, et al, eds. The ABC Clinical Guide to Herbs. Austin,

> TX: American Botanical Council, 2003.

>

>

To send an email to -

>