Overview

This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ginseng root. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ginseng root.

This summary is not intended to provide practical advice on how to use medicines containing ginseng root. For practical information about using ginseng root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.

Ginseng root is the common name for the root of the plant Panax ginseng C.A. Meyer. Ginseng root is either only dried (known as white ginseng) or may be treated first with steam and then dried (red ginseng).

The HMPC conclusions cover white and red ginseng root preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the root, or as dry, soft and liquid extracts. Extracts are obtained by putting the plant material in a solvent (such as ethanol or methanol) to dissolve compounds and form a liquid extract. The solvent is then partially or completely evaporated to obtain a soft or dry extract.

Herbal medicines containing these ginseng root preparations are usually available as herbal tea to be drunk and in liquid or solid forms to be taken by mouth.

Ginseng root preparations may also be found in combination with other herbal substances in some herbal medicines. These combinations are not covered in this summary.

The HMPC concluded that, on the basis of its long-standing use, these ginseng root preparations can be used for treating tiredness and weakness.

Ginseng root medicines should only be used in adults and may be taken for up to 3 months. If symptoms last longer than 2 weeks or worsen during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted. Detailed instructions on how to take ginseng root medicines and who can use them can be found in the package leaflet that comes with the medicine.

The HMPC conclusions on the use of these ginseng root medicines for tiredness and weakness are based on their 'traditional use'. This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU). Moreover, the intended use does not require medical supervision.

In its assessment, the HMPC considered numerous animal studies which showed effects of ginseng root medicines on the nervous system, metabolism, the heart and circulation, the immune system, sexual organs and skin. The HMPC also considered several clinical studies on the effects of ginseng root medicines in patients' brain function and vitality. Although some possible beneficial effects were observed, shortcomings in the design of the studies and inconsistent findings prevented any firm conclusions being drawn on the benefits of treating tiredness and weakness. Therefore, the HMPC conclusions on the use of these ginseng root medicines are based on their long-standing use.

For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

Side effects reported with ginseng medicines include allergic reactions (such as itching and itchy rash), insomnia (difficulty sleeping) and gastrointestinal problems such as stomach discomfort, nausea, vomiting, diarrhoea and constipation.

Further information on the risks associated with these ginseng root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab 'All documents'.

Any applications for the licensing of medicines containing ginseng root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.

Information on the use and licensing of ginseng root medicines in EU Member States should be obtained from the relevant national authorities.

Further information on the HMPC assessment of ginseng root medicines, including details of the Committee's conclusions, can be found under the tab 'All documents'.

For more information about treatment with ginseng root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Key facts

Latin name
Ginseng radix
English common name
Ginseng
Botanical name

Panax ginseng  C.A.Mey.

Therapeutic area
Fatigue and weakness
Status
F: Assessment finalised
Date added to the inventory
Date added to priority list
Outcome of European assessment
European Union herbal monograph

Documents

Consultation - Revision 1

First version

Consultation

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