This article, published by the American Botanical Council regarding a controversial study of a specialized Chinese ginko extract, highlights how and why it is so very difficult to rely on, or even to critique, studies on botanicals – if you don’t start with the correct plant, then what are you studying?
Each time you read a study, ask yourself these questions (the devil, as they say, is in the details):
- exactly what herb was used?
- · what part of the plant?
- · harvested from where?
- · processed in what ways?
- · stored how?
- · dose used?
- · concurrent medications?
- · co-morbidities and other confounding factors?
- · difficulty of blinding herbal medicines unless in capsules?
- · reliability of placebo not to have active constituents?
- · reliability of patient reporting and robustness of data collection and processing?
- · susceptibility of the individual patient?
- · and, last but not least, biases or conflicts of interest of the authors?
AMERICAN BOTANICAL COUNCIL
Many Ginkgo Extracts Safe, Says Herbal Science Group
American Botanical Council Clarifies Importance of Ginkgo Toxicology Report
(AUSTIN, Texas, April 18, 2013) The nonprofit American Botanical Council (ABC) says that clinically tested ginkgo extracts sold as dietary supplements in the United States are safe for most consumers. The ABC statement follows news of the publication of a report by the National Toxicology Program that showed that a special formulation of a Chinese ginkgo extract produced cancers in certain strains of rats and mice in a series of animal toxicology studies performed over two years In the conclusion of the report, the authors wrote, “We conclude that Ginkgo biloba extract caused cancers of the thyroid gland in male and female rats and male mice and cancers of the liver in male and female mice.”1
In February 2012, ABC sent public comments to NTP for the authors of the ginkgo study to consider in revising the draft report.2 The ABC comments were compiled by a committee of medicinal plant science and toxicology experts.
ABC emphasized that the Chinese ginkgo extract manufactured in Shanghai is not consistent with any compendial botanical and chemical standards for quality as set forth in various official pharmacopeias and does not conform to the well-established chemical profiles, quality, and purity of the leading, clinically tested ginkgo extracts produced by the pioneering Willmar Schwabe Pharmaceuticals of Karlsruhe, Germany, and Indena SpA in Milan, Italy. The ginkgo used in the NTP study was manufactured by the Shanghai Xing Ling Science and Technology Pharmaceutical Co., Ltd.
“The ginkgo extract used in this study is different from the high-quality ginkgo extracts used in published clinical trials showing safety and various beneficial activities of ginkgo,” said Mark Blumenthal, founder and executive director of ABC. “That is, the Shanghai ginkgo extract used by NTP does not represent the quality of German ginkgo extract that is the world standard for ginkgo. It is highly unfortunate that NTP chose to use this ginkgo extract as it means that the results of the NTP’s studies are not applicable to the standard-setting ginkgo extracts.”
In addition, ABC noted that the dosage levels administered to the test animals was significantly higher (up to 55-108 times higher) than the levels of ginkgo extract that are normally ingested by consumers (120-240 milligrams per day), as calculated by ABC’s consulting toxicologist.
“At best, what NTP can say is that significantly high doses of this particular Shanghai Chinese ginkgo extract – when added to a corn-oil base – produced cancer in the lab animals,” added Blumenthal.
ABC emphasized that the NTP studies are not intended to imply the potential adverse effect in humans.
“The NTP’s public message, and the resulting media reports, totally miss this point about the actual identity of the ginkgo extract and the high-dosage levels, and will probably cause confusion among consumers and health professionals alike,” added Blumenthal.
“Almost anything will create cancer in rats and mice when it’s fed to them at high doses for two years,” said Bill J. Gurley, PhD, professor of pharmaceutical sciences in the College of Pharmacy at the University of Arkansas School for Medical Sciences, Little Rock. “All toxicologists and pharmacologists are aware of the susceptibility of certain strains of rodents used for research purposes to develop various forms of cancer and other diseases when subjected to various substances.” Dr. Gurley was a co-author of the 2012 ABC public comments letter to NTP.
“This is disappointing, to say the least,” said Rick Kingston, PharmD, president of regulatory and scientific affairs at SafetyCall International in Minneapolis, MN, and professor of pharmacy at the University of Minnesota College of Pharmacy.
“Notwithstanding major design flaws in the study in identifying an appropriate compound to represent available ginkgo in the market,” continued Dr. Kingston, “even the reviewers voiced adamant proclamations that the results in this animal research were not intended for direct extrapolation to humans. For this oversight to not be reconciled by the NTP review group is disconcerting, especially since misinterpretation of the results by well-intentioned, but scientifically unsophisticated media outlets, and possibly even consumer groups, should have been an expected outcome.” Dr. Kingston also was a co-author of the public comments letter from ABC to NTP.
The ABC comments sent to NTP as part of the public comment process also called attention to other anomalies and/or problems with the NTP ginkgo studies as noted in the draft report. These include concerns that the Shanghai ginkgo extract used in the NTP study was from several different production batches, and that the ginkgo extract material used in the study was not analyzed for the presence of potential contaminants.
1. National Toxicology Program. NTP Technical Report on the Toxicology and Carcinogenesis Studies on Ginkgo Biloba Extract (CAS NO. 90045-36-6) IN F344/N Rats and B6C3F1/N Mice. (Gavage Studies). March 2013. Available at: http://ntp.niehs.nih.gov/ntp/htdocs/LT_rpts/TR578_508.pdf.
2. Blumenthal M, Gurley BJ, Kingston R, Low Dog T, Mackay D. American Botanical Council Revised Comment on NTP Draft Toxicology Report on Ginkgo Biloba Extract. Feb. 7, 2012. Available at: http://ntp.niehs.nih.gov/NTP/About_NTP/TRPanel/2012/February/PublicComm/Blumenthal20120125.pdf.