Botanical Genericism: Duplicitous or Delusional?

If you were fitted with a scanning device discerned a botanical product with an evidence base (a collection of randomized controlled clinical trials on the actual botanical, published in reviewed journals), where do you think it would light up? Let’s start with Ginkgo biloba extract. Like a divining rod passing by an oasis in the desert, one product emerges with impact: Ginkgold®.Ginkgold (AKA EGb 761®—which I wrote about in my “Key Ingredient” blog post earlier this year—is one of the incredibly rare botanicals that has been comparatively evaluated against other “generic” versions in humans.

In the 2008 movie Bottle Shock a freestyling Briton orchestrates a wine tasting in Paris, France, juxtaposing California wines to their French titan counterparts—with only militant French wine critics as the scoring judge. The Californian wines prevailed. Some of the Californian wines may have been progeny from French vine cuttings, transplanted far out West, with perhaps the grapes being of the same species. The alcohol content was quite similar. But because they did not share exact bioequivalence—defined as the exact same taste and aroma profile—they differed in their rankings.

In the early 1990s a clinical trial comparing three different, commercially marketed Ginkgo biloba extract finished goods were evaluated in a pharmacodynamic equivalence study. This study, led by Dr. Turan Itil (then at New York University Medical Center and a co-author of the 1997 randomized controlled study in JAMA that assessed the safety and efficacy of EGb 761 in patients with dementia over the course of a year) used ElectroEncephaloGram (EEG) to assess bioactivity of the three standardized Ginkgo biloba extracts. Each Ginkgo extract was standardized to a similar chemoprofile of EGb 761. Notably, only EGb 761 elicited significant changes in the EEG response profile. Recent studies employing metabolomics techniques have “chemo-discriminated” between a variety of commercial Ginkgo biloba extracts, showing adulteration and notable inter-product variability.

At a number of presentations I’ve given over the past several years I’ve created a hypothetical scenario, concluding with a question: You are an expert winemaker and are invited to a premium vineyard with nine other winemakers. You are taken to a small fenced-in plot of vineyard with ripe grapes (of the exact same variety and planting time). Your host has her staff harvest 500 kilos of these grapes before your eyes, and then has the grapes transported in climate-controlled conditions to your winemaking facility. You are asked to produce ONE case of wine from this batch of grapes exactly one year later, and are prohibited from adding flavors (a surprisingly uncommon, undeclared practice) or blend in any other grapes or wines. Your wine will be rigorously chemically analyzed AND then “biologically tested” by a blinded taste panel of eight wine experts. Would you expect your wine to be chemically and/or biologically IDENTICAL to that of your competitors? Know that your winemaking process is a trade secret, using barrels fashioned from Northern California coast old growth forest oak, that your yeast strain was obtained from a Chilean winemaking colleague, and…

How many clinical trials have been performed and published, wherein different commercial botanical materials or finished goods were assessed for biological activities, in the same persons through a crossover design? I’d like to see comments on this. Why is it that certain botanical extracts fail in clinical trials and different versions of the same plant thrive in others? Both media and marketers assume or hope that Ginkgo is Ginkgo and Saw Palmetto is Saw Palmetto, yet most marketers know that they cannot buy (or “afford”) the evidence-based version of a botanical. And what “evidence” is typically cited to support the botanical in question? The evidence for a botanical extract that is NOT their own. Bravo and santé to the companies that invest in the creation of an evidence base for THEIR botanicals…