Herbals need better regulation to overcome quality control challenges, say researchers

By Nathan Gray

- Last updated on GMT

Related tags: Herbal medicines, Herbalism

Implementing better growing and manufacturing processes along with increasing the use of modern analytical techniques and greater international regulation would ‘undoubtedly’ reduce the issues surrounding the quality of herbal extracts, say researchers.

Writing in Complementary Therapies in Medicine​, researchers said that despite the growing popularity of herbal medicines worldwide, there are still many adverse events associated with herbal supplements – which can be attributed to the poor quality of the raw materials or the finished products.

Led by senior author Professor Edzard Ernst of Peninsula Medical School, UK, the research group explained that increases in the usage of herbal medicines worldwide means that these safety issues have become important.

“A large proportion of the adverse events are attributable to the poor quality of the finished products, some resulting from the raw herbal materials that were contaminated,”​ said the researchers.

Ernst and his colleagues warned that issues such as contamination with toxic metals, pesticides residues and microbes, in addition to the rise of adulteration and misidentification mean that greater quality controls are needed for herbals.

“Although the problems are universal, they seem to be more prevalent in Asian countries, especially in China and India, which are the largest producers and users of herbal medicines,”​ reported Ernst and his team.

Quality is key

Ernst and his colleagues explained that there are many factors which influence the quality of herbals products – from the cultivation of medicinal herbs to the final herbal product. These issues can be categorised into ‘external’ and ‘internal’ issues, they said.

External quality problems mainly include contamination, adulteration, and misidentification, they said – adding that such problems can lead to a serious risk of harm to consumers and can pose a serious obstacle to the reliable trade and exporting of such products.

“Heavy metals have been found in herbal medicines with some regularity,”​ they warned. “The three most commonly detected toxic metals are mercury, arsenic, and lead; others include cadmium, copper and thallium.”

The team also warned that instances of herbal medicines adulterated with orthodox drugs and plant materials “have repeatedly been documented.”

“Several pharmaceuticals have been found in herbal medicines, and the incidence of adulteration of commercially available herbal preparation was reported to be 7% in California, 5.5% in New York and 1.23% in Singapore,”​ they noted.

Ernst and his team added that ‘internal’ quality issues can be even more challenging – explaining that the “bewildering variety of phytochemicals”​ produced by some herbs, in addition regional variations in composition caused by a host of environmental factors can lead to important issues of quality.

“A recent analysis of 25 ginseng products found a 15–200-fold variation in the concentration of the two ingredients believed to have biological activity: ginsenosides and eleutherosides,”​ they noted.

Solutions

Ernst and his colleagues suggested that the “rigorous implementation”​ of Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) “would undoubtedly reduce the risk of external issues”​ such as contamination and adulteration.

They added that the used of modern pharmaceutical standard analytical methods would ensure herbal products with controllable quality can be manufactured.

The team said that in order to achieve an overall improvement of quality, efforts should be made to deepen methodological research and enhance regulation of herbals.

“Government organisations should assume responsibility to provide active guidance and effective regulation,”​ they concluded.

Source: Complementary Therapies in Medicine
Volume 20, Issues 1–2​, February–April 2012, Pages 100–106, doi: 10.1016/j.ctim.2011.09.004
"Quality of herbal medicines: Challenges and solutions"
Authors: J. Zhang, B. Wider, H. Shang, X. Li, E. Ernst

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2 comments

Ernst

Posted by robert rogers,

Ernst and others have been for years cloaking their bias against herbal products using Cochrane Review, meta-analysis that takes a double blind placebo control model and tries to adapt to natural products. It does not work, as the multi compound herbs cannot be measured like a single molecule. the whole thing is so Newtonian and pseudo-science.

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Edzart Ernst is he still at it?

Posted by Energetic,

Edzart Ernst, I thought he had retired, he is still on a one man mission to hamper alternative and traditional medicine? Ernst loves to court the media, stands behind his title, the press fall easily for his 'this is science' 'this is not science' approach.
The argument of safety is an interesting one, adverse events connected to herbal medicines are statisically extremely rare. When we compare the adverse events and deaths that happen every day from pharmaceutical drugs, which do go through rigourous quality assesments. The FDA, Adverse Events Reporting system, data shows "deaths" totaling 452,780 and "serious outcomes" equaling 2,816,297 occurred during the ten years from 2000 to 2010 as tabulated from the FDA's Adverse Event Reporting System for prescription drugs. IN PLAIN ENGLISH NEARLY HALF A MILLION AMERICANS HAVE DIED FROM PHARMA DRUGS IN THE PAST TEN YEARS.
So the argument is this, yes quality is a good idea, to know something is made well, with the right ingredients, free from contaminants and with consistancy from raw material to finished product is a good idea. However to argue this case on the grounds of safety in relation to herbals is a weak argument. Safety should be in reality about the effect of the substance on the body, this should be monitored far more, just because a drug has been made in a GMP environment and has been shown to be effective, does not mean it should not be monitored for at least a decade after it is on the market.
That is what safety should really mean as this is much more of a problem for pharma drugs than herbals and that is a statisical fact. No matter how much Ernst likes to press release isolated cases and bang on about how much he cannot except that human beings could use the plants that grow on this planet to treat their ills, because it is just not science! I wish the media would accept, his approach to science is entrenched, old fashioned and out of touch, he has demonstrated over the years an irrational dislike of herbal formulations, for reasons that are probably not based in science...

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