DefinitionThis section has been translated automatically.
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 that requires at least ten years of medical use as a medicinal product in an EU country with sufficient bibliographic documentation and accepted and professionally recognized data. In the view of the HMPC, at least one good clinical study is required for assignment to this category. In the case of heterogeneous data, the available findings must be considered in their 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 are considered well-established:
- Agni casti fructus: premenstrual syndrome
- Aloe: short-term for occasional constipation
- Valerian root + hop cones: sleep disorders
- Capsici fructus: muscle pain
- Cimicifugae racemosae rhizoma: menopausal symptoms (hot flushes and profuse sweating)
- Echinaceae purpureae herba: prevention and treatment of colds
- Frangula alnus: short-term constipation
- Frangulae cortex: short-term for occasional constipation
- Ginkgo folium: age-related cognitive impairment, mild dementia
- Hederae helicis folium: expectorant for productive coughs
- Hippocastani semen: chronic venous insufficiency
- Hyperici herba: Mental stress and mood disorders, mild to moderate depressive episodes
- Lini semen: habitual constipation, requiring easy defecation with soft stools
- Menthae piperitae aetheroleum: Symptomatic relief of mild cramps of the gastrointestinal tract, flatulence and abdominal pain, especially in irritable bowel syndrome; symptomatic relief of mild tension, headache
- Plantaginis ovatae semen: common constipation, to soften the bowel movements, e.g. painful bowel movements after surgical interventions in the anal area (fissures or hemorrhoids)
- Psyllii semen: habitual constipation¸ to soften bowel movements, e.g. painful bowel movements after surgical interventions in the anal area (fissures or haemorrhoids)
- Rhamni purshianae cortex: short-term for occasional constipation
- Rhei radix: short-term for occasional constipation
- Ricini oleum: short-term for occasional constipation
- Sabalis serrulatae fructus: benign prostatic hyperplasia
- 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 for productive coughs
- 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
