The Texas-based non-profit group, the American Botanical Council, has published its fourth paid-for proprietary monograph for the versatile maritime pine bark extract, Pycnogenol.
Pycnogenol is the exclusive property of Swiss supplier Horphag Research (distributed in the US by Natural Health Sciences), which notes 64 clinical studies have been conducted on Pycnogenol and more than 220 published papers highlighting its diabetes, cardiovascular, joint and other health benefits.
Of these, Seventeen clinical trials were evaluated in the 19-page monograph written by toxicologist Heather S. Oliff, PhD. ABC said it had been peer-reviewed “by scientific and medical experts for its accuracy”.
Horphag Research CEO, Victor Ferrari, said the monograph was one of the most detailed ever produced and backed Pycnogenol’s safety and efficacy credentials.
The making of a monograph
ABC founder and executive director, Mark Blumenthal, said the monograph reflected the strength of the science behind the ingredient, especially in regard to human, clinical data. But he noted this was not always the case and his group had refused companies seeking to pay for monographs because their data was not strong enough.
Steven Dentali, the chief scientific officer at the American Herbal Products Association (AHPA) refused to comment on the Pycnogenol monograph because he had not seen it but observed: "Official monographs establish minimum quality standards for ingredients and sometimes finished products. Knowledge of what constitutes quality specifications is clearly important. Some monographs also provide history and therapeutic information."
Blumenthal said the cost of the monograph depended on the quantity of research to be analyzed. Horphag paid in the vicinity of $30-50,000 for its monograph.
While issuing a statement including quotes from Horphag, Blumenthal in the same statement said that the monograph was not an endorsement of Pycnogenol or Horphag, which it notes spends about $1.5m on research annually.
“ABC has had a long history of documenting the specific herbal products and ingredients that have been clinically tested,” Blumenthal said. “As part of our non-profit educational mission, we believe it is in the public interest to identify clinically tested natural plant-based products and ingredients which the scientific literature suggests are safe and beneficial.”
In the statement, he added: “Pycnogenol is an excellent example of a natural plant-based product which is the subject of extensive clinical research. ABC acknowledges Horphag Research, the manufacturer, for its singular focus and for its commitment to funding continued clinical trials to investigate and document the beneficial role Pycnogenol might have in selfcare and healthcare.”
The other three ingredients/products ABC has issued monographs for are CVT-E002 (ginseng), POMWonderful pomegranate juice, and the herbal combination product Sinupret.
The monograph includes Pycnogenol’s production and chemistry; applications; dosage data; pharmacology and mechanisms of action; safety data; summaries of selected clinical trials and regulatory appraisal in 10 countries.
It can be accessed here .