Plant-based preparations are chosen by an ever-increasing number of people, so much so that the World Health Organization has estimated that 80% of the world’s population uses plants to heal themselves. Nothing to be surprised about if we consider that phytotherapy, or medicine that uses derivatives of medicinal plants, has its roots in antiquity.

The herbal medicine

The herbal medicine was at the center of a symposium, entitled “Evidence-based phytotherapy to guide the pharmacist’s choice in over-the-counter consultancy” at Cosmofarma Exhibition. The round table allowed us to delve deeper into the regulatory scenario, pre-clinical research and clinical practice, quality criteria, as well as evidence-based phytotherapy: a rational, effective and safe approach to guide the pharmacist’s choice in over-the-counter consultancy.

Among the speakers, Prof. Marco Biagi, General Secretary of the Italian Society of Phytotherapy, University of Siena and prof. Fabio Firenzuoli, director of CERFIT, Center for Research and Innovation in Phytotherapy and Integrated Medicine for Phytotherapy, Tuscany Region, Careggi University Hospital, Florence – Professor of General and Clinical Phytotherapy, University of Florence – Scientific Coordinator Master in “General and Clinical Phytotherapy” both scientific consultants of Schwabe Pharma Italia, a herbal medicine giant.

Herbal medicine between quality standards and safety

The traditional herbal medicinal product (THMP) represents a particular type of plant-based medicine, present in Europe since 2004, thanks to Directive 2004/24/EC which establishes the regulatory requirements to be able to register it.

One of the peculiar requirements is the tradition of use, i.e. use for at least 30 years of which 15 in the European community, in addition to the presence of a monograph of the botanical extract used drawn up by scientific-regulatory institutions (EMA, ESCOP, WHO). However, the use of products of plant origin today requires particular attention to the quality standards of the components and production processes and safety of the final product, because the word “natural” is not synonymous with healthy or harmless.

The pharmacological therapeutic action of the extract is in fact regulated by the European Medicines Agency (EMA), which verifies the quality, effectiveness and safety of any type of drug and naturally, this also applies to drugs that contain plant extracts, which, similarly to synthetic drugs, must be authorized for marketing by the regulatory authority. Herbal medicines are reported in pharmacopoeias and are based on reference texts and studies which can only be attributed to their specific molecular complexes and not generically to the plant or similar extracts.

The phytocomplex: from the heart of the plant like an orchestra the agreement between all the parts

A peculiar characteristic of drugs derived from medicinal plants compared to isolated active ingredients is the presence of the phytocomplex; it is a “biochemical entity” made up of the active ingredients and the set of substances with which the active ingredients are associated in the plant, working together in a complementary and synergistic way.

These elements are part of the “drug” of the plant, that is to say the part of the medicinal plant used for therapeutic purposes, and each play their own role. The term “biochemical entity” is intended to evoke a unicum, a whole deriving naturally from the plant, an organic set of biologically active natural substances.

The phytocomplex naturally expresses all these substances together as an orchestra metaphorically plays: the phytocomplex is a harmonious set of natural substances that act in synergy and the final action is the result of the agreement of all the parts. The phytocomplex is the heart of the plant: thanks to the extraction which will depend on the part of the plant of pharmacological interest (in jargon the drug, i.e. that part of the plant that contains the active substances) an extract of the phytocomplex will be obtained.

Titrating and standardizing a phytocomplex represents one of the critical phases of the production process, considering that each phytocomplex can contain up to a few hundred different molecules, and the concentration of active ingredients in each production batch is influenced by multiple variables such as vintage, climate, humidity , temperature, and others.

Marco Biagi, general secretary of the Italian Society of Phytotherapy

Botanical extract: titration and standardization

Compared to the isolated active ingredient typical of monomolecular drugs, the phytocomplex has a multi-target action, precisely because there are multiple components that act simultaneously. The two technological-production requirements that a botanical extract must satisfy to rise to the status of drug are titration and standardization: in this way the phytocomplex will express a constant profile from a phytochemical point of view, guaranteed only through rigorous pharmaceutical standards throughout the entire productive cycle.

This ensures batch-to-batch reproducibility, which protects the patient regarding the constancy of the pharmacological action of the product and the content of the product itself. “For example, the titrated and standardized botanical extract of Pelargonium sidoides can guarantee quality, efficacy and safety, which are taken for granted when it comes to a monomolecular drug – explains the prof. Marco Biagi – but which for a botanical extract can represent a critical step in the production chain“.

The term “titration” indicates the analysis, performed with particularly sophisticated techniques, of the quality and quantity of the active ingredients present in the phytocomplex which leads to the identification of the marker (one or more active ingredients recognized as identifying elements of a herbal drug ).

“Standardisation” instead allows us to guarantee the constant presence of the active ingredients in each production batch, allowing the reproducibility of the therapeutic effect, closely connected to the concept of effectiveness.

Herbal medicines, unique in the national scenario

“In the national scenario – underlined the prof. Fabio Firenzuoli – herbal medicines represent a very small percentage of the entire pharmaceutical armamentarium in the hands of doctors and pharmacists, on the contrary, generically “plant-based” preparations represent a constantly expanding market and are chosen by an ever-increasing number of patients . The role of the expert pharmacist in correctly orienting a conscious and appropriate choice, as well as being advantageous in pharmaco-economic terms and sustainability of healthcare spending, is therefore fundamental – concluded the specialist.

This aspect is accompanied by the importance of prescriptive appropriateness aimed at containing healthcare spending as a transversal issue with a view to approaching the sustainability of the healthcare service.