European Herbal Tradition, Pharmacopoeias and Monographs

When people search for "Western herbalism" or "European herbal medicine", they often mean one of three different things: a tradition of plant use, a set of official reference books, or products sold under European medicines law. This page explains the second and third, using what the sources we read say. For the history of the tradition and its practice, see Western herbal traditions and the history of Western herbalism.

A herbal monograph is a reference document about a plant, not a recommendation for a person. Ask a pharmacist or clinician before using any herbal medicine, especially if you take other medicines (how interactions work).

What the sources call "phytotherapy"

The European Scientific Cooperative on Phytotherapy (ESCOP), an umbrella group of national phytotherapy societies founded in 1989, defines phytotherapy as the science-based medicinal use of plants and their preparations according to recognised standards of quality, safety and efficacy. [1] That is a modern, regulatory-minded definition, not a description of folk practice.

Four kinds of reference documents

We could not read the European Pharmacopoeia's own website (access was refused), so its description comes only from the EMA statement that its monographs cover quality requirements. For Commission E, EMA and WHO monographs side by side, see herbal monographs.

Traditional-use registration in the EU

EMA describes three regulatory pathways for herbal medicinal products in EU Member States. For the traditional use pathway, no clinical trials on safety and efficacy are required as long as sufficient safety data and plausible efficacy are shown; the product must have been used for at least 30 years, including at least 15 years within the EU. [3] A full quality dossier is still required for all herbal medicinal products. [3] This is why EMA public summaries can say a use is "plausible" rather than proven. See traditional herbal medicinal product registration.

Two worked examples

Devil's claw root (Harpagophytum procumbens and H. zeyheri; tuberous secondary root). HMPC concluded that, on the basis of long-standing use, preparations can be used for relief of minor joint pain and mild digestive disorders, in adults only. [5] The conclusion rests on traditional use because the studies were inconsistent in design and firm conclusions could not be drawn. [5] Reported side effects include stomach and gut symptoms, headache, vertigo and allergic reactions. [5] The plant's southern African origins and harvest are covered on the African herbal medicine page.

Pelargonium root (Pelargonium sidoides and P. reniforme; liquid or dry extracts). HMPC concluded that, on the basis of long-standing use, these preparations can be used for symptoms of the common cold in patients from age 6. [6] Very rare side effects were reported, and liver problems have been reported with unknown frequency. [6]

What these documents do not do

EMA states that its public summaries are not intended as practical advice on how to use a medicine. [5] Most individual herbal medicinal products continue to be licensed nationally by Member States rather than by EMA. [3]