Medicinal plant products (MPPs) including herbal medicines, food supplements and functional foods, are being traded globally. Whereas once these products belonged to relatively short value chains, typically consisting of a herbal practitioner or healer growing plants, making simple recipes and dispensing to local clients, this process has transformed into a complex global industry where plants may be grown or collected in one country, transformed into a variety of products, often using complex techniques and processes, and then transported anywhere in the world.
This globalization of MPPs has led to significant benefits to producers, especially those in less economically developed countries, where access to international markets has increased productivity and sales and consequently allowed the consumer to benefit from access to exotic products claiming a wide range of health benefits.
However, this trend in globalization has led to an increase in fake, adulterated and contaminated products being distributed worldwide and raising concerns over quality and safety. With complex value chains, comes complex manufacturing and logistical supply problems that are often not adequately planned for and managed by small industries that are typically new to trading internationally. Moreover, increased consumer demand can elevate prices of products leading to deliberate adulteration in an attempt to cut costs and increase profits.
Whereas the quality assurance of products produced in a short, simple chain remains a simple process, complex global chains often require complex and sophisticated techniques and procedures in an attempt assure quality and safety. However, complex solutions have their own inherent weaknesses and often only highlight poor practice but without solving the underlying problems associated with quality failures and sub standard products. There is no doubt that detection of sub standard products is a priority but in the longer term an alternative approach may be called for and one that relies less on policing and increasing the detection power of analytical hardware and more on good practice and better governance of the manufacture, supply and distribution of MPPs.
In this Research Topic, we aim to provide a forum to discuss quality and safety related to medicinal plant products. We welcome submissions covering the below sub-Topic themes in the form of Original Research, Reviews, but not limited to:
-Adulteration and contamination of medicinal plant products, including herbal medicines, food supplements and functional foods.
- Supply chain governance
- Globalization of medicinal plant products
- Schemes and initiatives that tackle quality problems along the supply chain
- Organic cultivation of medicinal plants
- Blockchain strategies for improving quality along the supply chain
- The work of the Pharmacopoeias in promoting good quality
- The role of botanical gardens and research institutes
All manuscripts must comply with the four pillars of best practice in Ethnopharmacology.
1) Pharmacological Requirements:a)
Traditional context - The traditional context must be described in the introduction.
b)
Credible experimental models - methods must be state of the art, or a credible alternative. The following have specific requirements:
Antioxidant:
- FRAP, ABTS, DPPH, and Trolox equivalent antioxidant capacity assays are not accepted.
-
in silico studies are not accepted as a main method.
Antimicrobial:
- Disc diffusion experiments must be followed by
in vitro or
in vivo experiments.
- Specificity must be assessed to rule out general toxic effects, e.g. by including parallel cytotoxicity testing (
cf. Cos et al. 2006)
- The mechanism of action must be assessed in sufficient detail (for crude extracts, the effects of contaminants should also be addressed).
Inflammation:
- Experiments on the rat hind paw oedema model are not acceptable unless they are part of a larger pharmacological – phytochemical study.
Docking studies:
- These will not be accepted unless followed by benchwork confirming affinity.
- A proposed mechanism of action is required.
in silico network pharmacology studies
-Network pharmacology studies must critically assess the evidence to evaluate the potential pharmacological effects of a preparation / herbal (medical) product.
- The identification of the compounds must be sound. This information may be derived from the existing literature or from benchwork. It is essential that the quantities of the compounds in the preparation or plant are stated and are high enough to be of pharmacological relevance.
- The bioavailability of the compounds must be assessed.
- Ubiquitous or very widely known compounds are highly unlikely to be ‘active’.
- Transcriptomic data need to be validated using RT-PCR, and proteomic data with Western blots.
Single dose studies:
- These are not accepted unless they focus on a species / compound not yet studied in detail, and can be justified on specific ethical grounds
c)
Dose - ranges must be therapeutically relevant:
- Implausibly high doses will not be considered.
- Both positive and negative controls are essential.
- Multiple doses are strongly recommended, as single dose studies are rarely accepted - only in some specific complex models.
2. Composition Requirements:Whether the material under investigation is a crude plant extract, a multi-herbal preparation, a single compound from a commercial source or extracted from plant, chemical and botanical composition must be explicitly stated.
a) Chemical:
- The concentrations of the dominating compounds must be listed, including dominant impurities if these compounds have been identified in previous studies. Stating the class of compounds present (such as “alkaloids”) is insufficient. We will usually ask for a HPLC or UPLC to establish the compounds present to ensure replicability, if this is not possible a credible alternative can be used.
- Referring to a previously used preparation in the literature is not acceptable, unless it has come from the same preparation or has the same batch number.
- For purchased compounds, purity (%) and the supplier name must be included.
- For extracted compounds, purity (%) and the method used to determine the purity must be stated.
- The structure of active compounds should be included as figures.
b) Botanical:
- Species names must be fully validated and should be described in their full taxonomy, using the
Kew Medicinal plant names service.
- Samples must be deposited in a recognised herbarium, and accessible if necessary. To find out if your institution is indexed, please use the
NYBG Steere Herbarium Search tool- Voucher numbers from the herbarium must be included in the Methods.
- Coordinates of plant picking should also be included, or the commercial source of a preparation, which must include a batch number and details on the preparation’s composition.
3. Basic Experimental and Ethical Requirements:a)
The study must contribute substantially to the existing literature. How it does so must be explicitly stated. The most up-to-date surrounding literature should be discussed, including related compounds, to demonstrate the contribution of the study to the field.
b)
Compliance with all international ethical standards is essential.
The Convention on Biological Diversity and the Nagoya Protocol are of particular relevance. This includes that research in the field should benefit the original users and consider their traditions.
c)
The use of animals must be justified. If a material is well-characterised, and its properties well-known, performing another in vivo study is considered an unethical use of animals. A thorough knowledge of the literature is essential to avoid this mistake. Conversely, if a material is not well characterised, initial experiments in cell-based models are necessary to justify moving onto animal experiments.
d)
The effects of traditional medicinal preparations must be testable in scientific terms. We acknowledge the importance of the understanding of medicinal preparations in their cultural context, and it may be that the treatment of symptoms as defined by traditional practices forms a basis for such investigations. However, pharmacological studies generally do not provide evidence for such uses, but rather for the established therapeutic targets of the model. Experimental outcomes should be linked to and described in these terms. For example, a series of in vitro tests will not demonstrate relevant evidence that will contribute to a physiological understanding of traditional therapeutic concepts, e.g. “dispelling wind” or “dampness” in Traditional Chinese Medicine. A justification must therefore be given for choosing a certain model to test a certain preparation.
4. Article-type Specific Requirements:a) FIELD STUDIES
- Data must be substantial and original.
- The study must be discussed in the context of previous studies carried out in the region. How the study contributes to the development of the field must be made explicit.
- Must comply to the
ConsEFS standards, including any updates.
b) REVIEWS
- The objective of the review must be clearly defined.
- They must provide a specific, critical assessment of the literature. The scientific quality of the original articles must be critically assessed. This includes the experimental design, and reliability of the studies.
- The traditional use must be linked to scientific evidence.
- Future needs and priorities must be clearly defined.
c) SYSTEMATIC REVIEWS & META ANALYSES
- To assure the quality of the studies included, we ask for the inclusion of a summary table (templates available on the
Ethnopharmacology About page).
- We ask that a chemical analysis is included, taken from one of the included studies. The chemical composition of the study material must be well defined. If the composition is poorly characterised, this must be highlighted.
- Quality control measures taken, as defined by a pharmacopoeia, must also be included.
- If the included studies do not use full botanical taxonomic names, this should be highlighted, as must any naming inconsistency between studies.