Editorial: NEJM Examines Echinacea - Does It Mean Anything?

By Len Monheit, NPIcenter

[email protected]

An already flat botanicals category got another blow it could hardly afford when this week's New England Journal of Medicine published results of an echinacea study (Abstract) on 399 patients conducted by researchers at the University of Virginia School of Medicine and in Austria. The study used Echinacea angustifolia and involved university lab prepared extracts being presented to patients (university students) who had been exposed to rhinovirus. The research itself was funded by a grant from the NationalCenter for Complimentary and Alternative Medicine (NCCAM) and involved treating the subjects for a period of seven days prior to administering a challenge virus, with extracts in dosage of 1.5 mL three times daily, representing 300 mg per dose or 900 mg per day of Echinacea angustifolia root.

The researchers concluded that Echinacea angustifolia extracts (either alone or in a combination) did not treat or prevent colds (rhinovirus), a result that, quite predictably, got widespread media pickup, as these stories exclaimed that echinacea was useless. Most of the stories, in an attempt to provide some context, did also include comments from Mark Blumenthal, executive director of the American Botanical Council (ABC), who pointed out that the extract used in the study was prepared in the lab and not sold in stores, and added that the herb might work better if higher doses were used. "This is not a definitive trial on the efficacy of echinacea, nor should the results be generalized to echinacea preparations widely available," Blumenthal said. (AP Story on Fox News Channel)

In an attempt to put these results in context, ABC and the American Herbal Products Association (AHPA) each issued press releases with ABC observing that the results were based on using a specific rhinovirus, the extract was university lab prepared, the dose and dosing intervals might have been sub-optimal, and the population (university students) were not immune challenged. AHPA noted the concern expressed by one of the researchers that the dose may have been too low to be effective for use in colds, and suggested that dose or brand selection would have improved the study quality.

One Canadian-based company that produces a number of well known and characterized Echinacea-based products, the Factors Grouptook serious exception to the study, saying that it was incorrect on several different levels, including the fact that the dose should have been tripled. According to Dr. Michael Murray, the Director of Education for Factors Group of Nutritional Companies, "What determines the effectiveness of any herbal product is its ability to deliver an effective dosage of active compounds. The specific components of Echinacea responsible for its immune-enhancing effects are the polysaccharides, alkylamides and the cichoric acid. While each of these components is effective alone, the greatest degree of effectiveness occurs when the three active components are combined and at a specific ratio." None of the three extracts used on the 399 study participants actually contained all of the three necessary compounds.

Dr. Murray added that even the National Health Products Directorate of Health Canada, which is known to be very conservative in the area of dosing, recommends a minimum dosage of three grams of Echinacea for therapeutic results. (http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/mono_echinacea_e.html )

It seems that there are a series of observations that can be made about this week's dialogue and coverage.

First of all, research is being done (at least the correct plant and part was used), and industry has long been asking for funding for projects such as this. Secondly, with the good comes also the bad, and we must be prepared to either deal with negative results or to effectively put these results in context - as ABC and AHPA have attempted to do. Unfortunately, the media message was intended to be simply 'It (Echinacea) doesn't work'.

To me the message that can effectively come out of this is that not all products are equal, as well as an awareness of dose and the fact that any product used at a sub-efficacious dose is likely to be either a waste of time and unsuitable for research consideration, is misleading and misrepresentative, or is generally a disservice to the industry as a whole. For those companies deliberately using this type of dose in their finished products, I have no sympathy when studies like this erode product credibility. Unfortunately the pick up on the 'story' tarnishes the entire category. (I can’t help but wonder whether, if the researchers had used many of the currently available store brands, they wouldn’t have ended up with similar results.)

So what needs to happen?

Well, part of it leads to alternative strategies of product differentiation, a focus on product education and a continuation of progress towards a more transparent marketplace and value chain. Consumers' and retailers' awareness and understanding of the fact that not all products are created equal must be encouraged. Questions must be solicited, especially to get consumers to go 'beyond the brand' and to 'investigate the label'.

The Canadian Natural Health Products Regulations are intended to ensure that for a product to obtain a Natural Product Number and be approved for the marketplace, it demonstrate that there is a rationale for the ingredient combination and that the ingredient(s) be at an efficacious dose so as to support the claim being made.

That can't be bad, can it?

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