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REPLY

The Relative Safety of Ephedra Compared with Other Herbal Products

right arrow Stephen Bent, MD; Thomas N. Tiedt, PhD; and Michael G. Shlipak, MD, MPH

2 September 2003 | Volume 139 Issue 5 Part 1 | Pages 386-387


IN RESPONSE:

We disagree with the comments of Drs. Kingston and Borron, Dr. Whitaker, and Dr. Dickinson. The data from the national system of Poison Control Centers provide a critical safety valve for consumers. Health researchers, government agencies, and product manufacturers rely on these data to warn the public about product dangers and to design safer products.

Drs. Kingston and Borron note that, on average, 15.4% of adverse event reports that the Poison Control Centers receive are later judged to be unrelated to the herb under examination. If 15.4% of adverse event reports are removed from each of the herbs in our data set, then the relative risks we calculated remain exactly the same. In the extreme case, even if 15.4% of ephedra cases are judged to be unrelated versus 0% of cases reported for all other herbs, the relative risk for an adverse event with ephedra compared with all other herbs decreases only from 40 to 34 (95% CI, 31 to 38).

We agree with Dr. Whitaker's assessment that ephedra is a drug and a known stimulant (the pharmacologic basis for most of its adverse effects). While it would be interesting to compare the frequency of adverse events from ephedra with those from other sympathomimetic stimulants (for example, cocaine and amphetamines), we believe it is more important to distinguish the safety of ephedra from that of other herbal products. We found that ephedra had an enormous increased relative risk of 40, or a 3900% increase in risk, compared with other commonly used herbs, both individually and combined, which strongly supports the conclusion that ephedra use is unsafe.

We are perplexed at Dr. Dickinson's statistic of ephedra sales from the Nutrition Business Journal. We did not rely on this journal's data because the journal uses an unspecified combination of sales data and information from surveys of herbal manufacturers (1) and also uses dollar sales rather than unit sales (the relatively expensive cost of ephedra products biases the dollar sales estimates).

We stand by our conclusions that ephedra supplements pose a disproportionate health risk and that their use should be restricted (2). Our findings are in agreement with the RAND Corporation's analysis of case reports, which suggests a link between ephedra products and such catastrophic events as sudden death, heart attack, stroke, seizures, and serious psychiatric symptoms (3).


Author and Article Information
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From University of California, San Francisco; San Francisco, CA 94121; Med-Tox Group; Longboat Key, FL 34228; and San Francisco Veterans Affairs Medical Center; San Francisco, CA 94121.


References
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1. Research methodology. Nutrition Business Journal. Accessed at http://www.nutritionbusiness.com/research/methodology.cfm on 9 June 2003.

2. Kalman DS, Antonio J, Kreider RB. The relative safety of ephedra compared with other herbal products [Letter]. Ann Intern Med. 2003; 138:1006; author reply 1006-7. [PMID: 12809464].[Free Full Text]

3. Shekelle PG, Maglione M, Morton SC. Preponderance of evidence: judging what to do about ephedra. RAND review. 2003; 27:16-21. Accessed at http://www.rand.org/publications/randreview/issues/spring2003/rr.spring2003.pdf on 9 June 2003.

About Letters
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The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:

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Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.

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Related articles in Annals:

Letters
The Relative Safety of Ephedra Compared with Other Herbal Products
Douglas S. Kalman, Jose Antonio, AND Richard B. Kreider
Annals 2003 138: 1006. [Full Text]  

Brief Communications
The Relative Safety of Ephedra Compared with Other Herbal Products
Stephen Bent, Thomas N. Tiedt, Michelle C. Odden, AND Michael G. Shlipak
Annals 2003 138: 468-471. [ABSTRACT][SUMMARY][Full Text]  

Letters
The Relative Safety of Ephedra Compared with Other Herbal Products
Richard L. Kingston AND Stephen W. Borron
Annals 2003 139: 385. [Full Text]  

Letters
The Relative Safety of Ephedra Compared with Other Herbal Products
Julian M. Whitaker
Annals 2003 139: 385. [Full Text]  

Letters
The Relative Safety of Ephedra Compared with Other Herbal Products
Annette Dickinson
Annals 2003 139: 385. [Full Text]  




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