[MPWG] More on the Echinacea study

[Patricia_DeAngelis at fws.gov]

I've heard from a few members about the Echinacea study I just posted.  I
posted the article to stir discussion - and so it has!

Let me preface this by saying, I did not see the JAMA article (although I
plan to get ahold of it).  What I saw was the information that was
disseminated in the popular press, which interpretation, I believe, has a
more profound effect on the way people think about medicinal plants than
the actual study itself.

I had several questions after I read the article, to include:

1) What was the source of the Echinacea material?
-The material for the study was derived from one lot - How old was the
material?  What was the source of the material?  How was the material
prepared?

I understand, thanks to Teena, that the American Herbal Products
Association (AHPA) had similar questions about the preparation of the
materials - specifically with regard to dosage.  (See news release, pasted
below).

2) What was the placebo?
-You may recall that an earlier study that found Echinacea to be
ineffective used alfalfa as its placebo.  Alfalfa is purported to enhance
immune system function (an assertion that remains UNPROVEN , of course!).

3) Is it true, according to the msn article (at:
http://articles.health.msn.com/id/100108670/site/100000000),  that "in the
past 30 years...advocates of alternative medicine successfully turned
things around to put the burden of proof on the scientific community and
the taxpayers."
-Have alternative medicine advocates really been asking for these studies?

4) Perhaps the biggest question, does all this have any relevance to the
sustainable use and conservation of medicinals?
-There is no short answer to this question.  But, according to many folks
with a long history of delving into these issues, such as Mark Blumenthal,
founder and executive director of American Botanical Council, there is a
correlation between positive results from clinical trials and increased
consumer interest in a botanical product.  I would venture to say that
these consumers, the ones who seek the "assurances" of clinical trials, are
among the chief target audiences for  educational outreach about the
sustainable use and conservation of medicinal plants.

Please feel free to post your thoughts and suggestions.

-Patricia

Patricia S. De Angelis, Ph.D.
Botanist - Division of Scientific Authority
Chair - Plant Conservation Alliance - Medicinal Plant Working Group
US Fish & Wildlife Service
4401 N. Fairfax Dr., Suite 750
Arlington, VA  22203
703-358-1708 x1753
FAX: 703-358-2276
Working for the conservation and sustainable use of our green natural
resources.
<www.nps.gov/plants/medicinal>


FROM: http://www.ahpa.org/press_room.htm

For Immediate Release

CONTACT:
AHPA - Karen Robin (301) 588-1171, ext. 107 - krobin at ahpa.org


NEJM Publishes Study on Low-dose Echinacea for Colds


Silver Spring, MD (July 27, 2005) — An article in this week’s New England
Journal of Medicine reports that no significant differences in cold-related
measures were observed in a double-blind study in which volunteers who were
artificially infected with rhinovirus received either placebo or one of
three specially prepared extracts of Echinacea angustifolia root (Turner,
R.B. et al. An evaluation of Echinacea angustifolia in experimental
rhinovirus infections. NEJM 353(4):341-8. July 28, 2005). The researchers
are associated with universities in the United States and Austria, and one
of them has expressed concern that the dose may have been too low to be
effective for use in colds.


The study, funded by a grant from the National Center for Complimentary and
Alternative Medicine (NCCAM), involved 399 subjects who began treatment
seven days prior to administration of the challenge virus and continued
treatment for the next five days. The three Echinacea preparations were
manufactured for the study from a single lot of (presumably dried) root.
All were made at a concentration ration of 1 kilogram of root to 5 liters
of extract (1:5 tincture), and were extracted with supercritical CO2, 60
percent ethanol, and 20 percent ethanol respectively. The dosage for each
of the extracts was 1.5 mL three times daily, representing 300 mg per dose
or 900 mg per day of Echinacea angustifolia root.


“I’m not sure I would call this a ‘placebo versus placebo’ test,” commented
AHPA President Michael McGuffin, “but it is not unlike taking one-third or
less of the dose of cough syrup and wondering why you are still coughing.
The standard dosage for dried Echinacea angustifolia root used at the onset
of a cold is well established at 3 grams per day or more and this study
used less than one gram.”


Even one of the article’s authors has acknowledged that the amount of
Echinacea used in the study may have been insufficient. David Gangemi, PhD,
of Clemson University, responded to a question posed about this research at
last month’s Medicines from the Earth Symposium in Black Mountain, NC, by
stating, “I think in retrospect if we go back and we look at some of the
other products that are out there maybe we’re only one tenth the level we
should be” (emphasis added).


“Just this month (July 15) NCCAM announced a greater emphasis on the need
for preclinical research in the areas of complementary and alternative
medicine, where NCCAM provides funding,” noted Steven Dentali, PhD, AHPA’s
VP for Scientific & Technical Affairs. “Had this policy been in place when
this study was funded in 2002, it is doubtful that this clinical research
would have been supported in advance of a thorough understanding of the
dose that is known to produce a pharmacological effect."


“At this point AHPA members should question the seeming inability of NCCAM
to fund any legitimate clinical trial on botanicals,” added McGuffin. “It
may be that the only fair and useful conclusion from this study is that
consumers choose a reputable brand of Echinacea and use it at the right
dose.”


A summary of the article can be found at:
http://content.nejm.org/cgi/content/abstract/353/4/341