From my Leung’s (Chinese) Herb News (LCHN-37, Mar/Apr 2002), reprinted in My Life & Rollercoaster Career (MLRC 2018, pp. 466-472); the following is just one of 3 topics and on pp. 470-472:
HOW TO IMPROVE THE QUALITY OF SCIENTIFIC DATA ON HERBS
In order to do this, we have to address the problem at 3 levels:
(1) research; (2) publication; and (3) abstracting, indexing, and data input into databases.
I am not too concerned about basic scientific research technologies. We all learned those in college and then graduate school, and further honed our skill in our ‘real’ research jobs. What I am concerned about is that most researchers who have not been trained in natural medicines don’t seem to have a feel for the importance of the clear definition of these materials before using them as objects of research. Although we have all been trained in the use of good science in our research, we often ignore it when it comes to herb research. We all know the importance of applying the right quality control to the research material (e.g., a chemical or drug substance) and would never accept one that is not well defined. For instance, we would never think of investigating the effects of alcohol on, say, human cognitive function, by using a liquid called ‘alcohol.’ Based on our training, it is almost second nature for us to clearly define the alcohol (in this case, obviously ethanol, because it’s not ethical or permissible to use other alcohols on human experimentation), its concentration, purity (does it contain toxic adulterants?), etc. We would never accept just any ‘alcohol’ because it is an ‘alcohol’ or close enough, such as methyl alcohol or isopropyl alcohol. Yet many research studies on herbal medicines/supplements use test materials that are vaguely defined, if at all. Terms such as “ginseng,” “echinacea,” “kava kava,” and “St. John’s wort” have been routinely used alone as sole description of the test materials used in the studies, in at least 1 of the 3 levels mentioned above. In some of the better-defined (but still grossly inadequate) materials used, researchers may use the Latin binomials of the plant species (from which the material is derived), believing that that would be the definitive proof of identity. However, without providing which part of the plant supplies the test material, the scientific name of the plant is meaningless, and the study using this still-basically-undefined material will produce dubious and meaningless results. For example, again using hawthorn, how meaningful would the study of “Crataegus monogyna Jacq.” be? Here we have ‘scientifically identified’ English or one-seed hawthorn. But it has no relevance to the material under study. Is it the leaf, the seed, the fruit, the flowers, the root, or a combination of these parts? Also, is it the powdered crude material (whatever plant part) or is it an extract in water, ethanol (%?), or other organic solvent? And if so, how concentrated is it? Also, is it standardized to chemical markers, and which ones? These are just a few variables that must be clearly defined for resulting data to be reproducible and usable. Amazingly, many reports still simply use the name of the species (e.g., ‘hawthorn’ or ‘Crataegus monogyna’) to describe the materials used in the studies, at least in level 3 and sometimes also in level 2. No wonder we are suddenly being inundated with so much herb research data that are dubious or ambiguous and controversial! Which reminds me of how the use of Latin binomials to define a plant species is only as valid as the competence of the person who uses it. I used to know a flavor chemist who was in charge of the laboratories of an extraction company. He had the Latin binomials of most plant species associated with the materials being extracted at his plant memorized, though he had no clue as to how to identify the plant materials other than a few very common ones used in flavors, such as fenugreek seed, carob pod, chili pepper, coffee bean, etc. He was quick to put in the Latin binomials on his certificates of analysis, even though he might have no idea whether the materials extracted were actually from the plant species he put down on his certificates of analysis. Yet he was very proud of the fact that he knew the Latin binomials of plants and followed ‘standard scientific protocol’ when making his reports (certificates of analysis). To me, this is a typical case of a theoretical intention that does not always lead to a proper successful execution. Furthermore, in this case, it gives one a false sense of security by believing a correctly identified test material has been used. I suspect this situation is not unique. It probably applies to many companies involved in herb research and/or manufacture as well as to academia and other research institutions. The key to improving the quality of scientific herb research data lies in the clear definition of the test materials (crude botanicals and different forms of extracts) used in any research.
Currently, there are no official or universally recognized guidelines (or criteria) for defining such materials. The late Dr. Varro (Tip) Tyler and I have independently addressed this issue (Issues 19 & 35 160). In my article, I have actually provided guidelines for defining these test materials, which can and should be used at all 3 levels. Those criteria were first published in the March/April 1999 issue of this Newsletter and later reprinted in the November/December 2001 issue. Yet to date, none of the journals in our fields (pharmacognosy, natural products, phytomedicine, herbal medicine, Chinese medicines, ethnomedicine, etc.) which should be the leaders in herb research, has set minimal criteria for defining test materials as conditions in accepting manuscripts for publication. I just don’t get it. How can my colleagues, who are publishers, editors, or reviewers of these journals and who are supposed to be experts in this field, continue to allow the publication of herb research data that are often not worth the paper on which they are printed?
Furthermore, the longer these publications are allowed to continue to inundate us with ambiguous and dubious (some egregious) information, the more expensive and difficult it will be for us to rectify the problem. Without reliable scientific research data on which to base further research on botanical medicines or dietary supplements, we will continue to generate irreproducible, ambiguous, dubious, and, yes, controversial data. And we will be wasting our taxpayers’ money by continuing to support such research. The end result would be a declaration by the pharmaceutical and medical professions telling the world ‘I told you so,’ supported by scientific ‘evidence’ from research sponsored by our government. The only way to rectify this whole mess and stop wasting any more money and energy (first to produce dubious/ambiguous data and then try to deal with the controversy and more misinformation generated by these data) is to immediately institute criteria or guidelines for researchers, journal editors/reviewers, and data entry professionals (abstractors, indexers, database managers) to clearly define test materials before being accepted for research, publication, and/or incorporation into databases. These criteria should be instituted at all 3 levels – research, publication, and database. To start, they don’t need to be all-at-once comprehensive. The most urgent need is for these criteria to be there so that professionals at all 3 levels of the information generation and dissemination chain will be aware of the futility and wastefulness of dealing with undefined research materials.
The key is to get them to stop equating a natural test material to a pure chemical drug or a plant species (common or scientific name), and to start thinking about what that test material actually is or should be. This will be the only way to ensure that the information generated from botanical medicine/supplement research has a universally acceptable level of quality, which scientific researchers from healthcare and related fields may use with confidence to develop new, credible, and useful data.161
160 Tyler, V.E., Scientific Review of Alt. Med. 4(2): 17-21(2000).
161 C.A. Swanson, “Suggested guidelines for articles about botanical dietary supplements,” Am J Clin Nutr 2002; 75: 8-10.;