Well-established use

Term used in phytotherapy. The Herbal Medicinal Product Committee(HMPC) of the EMA = European Medicines Agency, divides plants/drugs into well-established use and traditional-use.

Well-established use" is defined as a label whose prerequisite is at least ten years of medical use as a medicinal product in a country of the EU with sufficient bibliographic documentation as well as accepted and professionally recognized data. From the point of view of the HMPC, at least one good clinical study is required for assignment to this category. In case of heterogeneous data, the available evidence has to be considered in its entirety.

Well-established use means:

recognized medicinal effect and accepted safety, well-established use (marketing authorization, WEU): sufficient data on safety and efficacy demonstrated.

The following plants/drugs and their indications count as well-established:

• Agni casti fructus: premenstrual syndrome
• Aloe: short term for occasional constipation
• Capsici fructus: muscle pain
• Cimicifugae racemosae rhizoma: menopausal symptoms, (hot flashes and profuse sweating)
• Echinaceae purpureae herba: prevention and treatment of colds
• Frangulae cortex: short-term for occasional constipation
• Ginkgo folium: age-related cognitive impairment, mild dementia
• Hederae helicis fol ium: expectorant for productive coughs
• Hippocastani semen: chronic venous insufficiency
• Hyperici herba: mental stress and mood disorders, mild to moderate depressive episodes
• Lini semen: common constipation, requirement of easy defecation with soft stools
• Menthae piperitae aetheroleum: symptomatic relief of mild gastrointestinal spasms, flatulence and abdominal pain, especially in irritable bowel syndrome; symptomatic relief of mild tension, headache
• Plantaginis ovatae semen: common constipation, for softening of bowel movements, e.g. painful bowel movements after surgical interventions in the anal region (fissures or hemorrhoids)
• Psyllii semen: habitual constipation¸ for softening of bowel movements, e.g., painful bowel movements after surgical interventions in the anal region (fissures or hemorrhoids)
• Rhamni purshianae cortex: short-term for occasional constipation.
• Rhei radix: short-term for occasional constipation
• Ricini oleum: short-term for occasional constipation
• Salicis cortex: short-term for lower back pain
• Sennae folium: short-term for occasional constipation
• Sennae fructus: short-term for occasional constipation
• Thymi herba and Primulae radix: cough, expectorant in productive cough
• Valerianae radix: mental stress and affective disorders relief of mild nervous tension; sleep disorders
• Valerianae radix and Lupuli flos: sleep disorders, temporary insomnia
• Vitis viniferae folium: circulatory disorders, chronic venous insufficiency, swollen legs, varicose veins, heaviness, pain and cramps in the calves
• Zingiberis rhizoma: gastrointestinal disorders, preventive against nausea and vomiting in motion sickness

1. https://www.ema.europa.eu/en/documents/other/hmpc-monographs-overview-recommendations-uses-herbal-medicinal-products-paediatric-population_en.pdf