Herb Science Group’s Letter Regarding Low Dosage in Echinacea Trial Published in New England Journal of Medicine
FOR IMMEDIATE RELEASE
News Release
(Austin, TX, December 1, 2005) The New England Journal of Medicine [NEJM] has published a letter to the editor from the American Botanical Council (ABC) regarding the low dosage of Echinacea extracts used in a recent clinical trial.1
The letter, written by ABC Founder and Executive Director Mark Blumenthal and Norman R. Farnsworth, PhD, Research Professor of Pharmacognosy and Senior University Scholar at the College of Pharmacy at the University of Illinois at Chicago (and a founding member of the Board of Trustees of ABC), was written in response to a clinical trial published by NEJM in July. 2
That trial employed three extracts of Echinacea angustifolia root to college students with rhinovirus infections. The study was conducted by Ronald B. Turner, MD, a virologist at the University of Virginia, and various co-authors, including Prof. Rudolf Bauer, PhD of the Karl-Franzens University in Graz, Austria (an acknowledged expert on the chemistry and pharmacology of echinacea), and David J Gangemi PhD of Clemson University. The study failed to show any measurable beneficial effect of the three extracts in either preventing infections or lessening the severity or duration of symptoms of the resulting upper respiratory tract infections. (The full text of the letter, as originally submitted, is provided below.)
The ABC letter suggested that the dosage administered in the trial may have been too low to produce an appreciable benefit. The dosage of 1.5 ml of the extract given 3 times daily was reported to be equivalent to 900 mg per day of the dried root of E. angustifolia. ABC’s letter explained that this dose was based on the German Commission E monograph for E. pallida root, not E. angustifolia root. ABC emphasized that both the World Health Organization and the Canadian Natural Health Products Directorate recommend a dosage of 3000 mg per day of dried E. angustifolia root or equivalent preparations, a dose 330 percent higher than the dose in the trial. ABC has previously communicated this message to the media, per its press release in July and numerous interviews. 3
“Recognizing that there may be a problem with the relatively low dosage is essential in interpreting the results of this study,” said ABC’s Mark Blumenthal. “We have received comments from numerous experts, including physicians, supporting our view that the dosage used in this trial was either too low, or at least the trial should also have included a higher dose.”
Blumenthal added that two of the study’s authors have publicly acknowledged that a higher dosing regimen would have been helpful in determining whether the echinacea extracts used in this trial might have produced any beneficial trends. “This is particularly important considering the widespread publicity generated by this trial,” he added.
When asked to comment on the ABC letter and the dosage issue, trial co-author David J. Gangemi, PhD wrote in an email, “I would like to see results from a higher dosage group, but NIH funding limitations didn't allow for this [in this trial]….I do think that a second trial with a higher dose is needed to answer the question on echinacea's effectiveness in limiting the symptoms resulting from rhinovirus infection.” [Gangemi, DJ. Personal communication (e-mail) to M. Blumenthal, Nov. 18, 2005]
The study received significant coverage in the media, including articles from the Associated Press 4, the Los Angeles Times 5, the New York Times 6, the Wall Street Journal 7, plus television news, websites, etc. Many of these news stories included information from the ABC press release and interviews with ABC emphasizing the potential problem with the low dose. 3
About the American Botanical Council
The American Botanical Council is the nation's leading nonprofit organization addressing research and educational issues regarding herbs, phytomedicines, and related plant-derived preparations. 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. More information on echinacea is available on ABC’s extensive website, http://www.herbalgram.org/.
References
1. Blumenthal M, Farnsworth NR. Echinacea angustifolia rhinovirus infections [letter]. N Engl J Med. Nov.3, 2005;353(18):1971-1972. Available at: http://content.nejm.org/cgi/content/short/353/18/1971.
2. 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
3. Anon. Herbal Science Group Says Dosage Too Low in New Echinacea Trial [press release]. Austin, TX: American Botanical Council, Jul. 27, 2005.
4. Chang A. Study: Herbal remedy echinacea fails to treat or prevent colds, Associated Press, Jul. 27, 2005.
5. Kaplan K. Cold relief from echinacea might be all in your head. Los Angeles Times, Jul., 27, 2005.
6. Kolata G. Study says echinacea has no effect on colds. New York Times, Jul. 28, 2005.
7. Winstein KJ. Still no cure for the common cold -- Popular herb is dealt blow amid broad federal review of alternative remedies. The Wall Street Journal. Jul 28, 2005.
Editor’s Note: Mark Blumenthal is available for interviews. Please contact Nancy Moon for scheduling.
AMERICAN BOTANICAL COUNCIL
P.O. Box 144345, Austin, TX 78714-4345
Phone: 512-926-4900 x121; Fax: 512-926-234
Contact: Nancy Moon
Email: the American Botanical Council
Web site: http://www.herbalgram.org/
The full letter, as it was originally submitted to NEJM, is below:
August 10, 2005
To the Editor
New England Journal of Medicine
Re: Turner et al. An evaluation of Echinacea angustifolia preparations in experimental rhinovirus infections. N Engl J Med 2005;353:341-348.
Dear Sir or Madam:
This trial 1 could have benefited from additional treatment groups with higher daily doses. The dose equivalent of 900 mg of dried root derives from the German Commission E monograph for E. pallida root, a different species. 2 Echinacea angustifolia root is not officially approved and thus has no recommended dosage in Germany, due to lack of sufficient supporting data when the pharmacological and clinical literature on this species was evaluated in 1992. The 1999 WHO E. angustifolia root monograph contains a 3 g daily dose, 330 percent higher than this trial. 3 The 3 gram daily dose is also recommended by the Canadian Natural Health Products Directorate. 4
Outcomes of rigorously-designed clinical trials usually pertain only to the specific designs of such trials. A higher dosage reasonably approximating the levels employed by many consumers and recommended by many “alternative” healthcare providers - as documented in official international monographs -- might have made this trial more relevant to the real-world use and potential benefits of this type of Echinacea.
Sincerely,
Mark Blumenthal
Founder & Executive Director, American Botanical Council
Editor, HerbalGram
Senior Editor, The Complete German Commission E Monographs Therapeutic Guide to Herbal Medicines
Norman R. Farnsworth, PhD
Research Professor of Pharmacognosy and UIC Distinguished Professor
Director, World Health Organization Collaborating Center for Traditional Medicine
Principal Investigator, UIC/NIH Center for Botanical Dietary Supplements Research
College of Pharmacy, University of Illinois at Chicago
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. Echinacea. 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.