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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

5 April 2016 EMA/147173/2016

Herbal medicine: summary for the public

Horsetail herb

Equisetum arvense L., herba

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

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

What is horsetail herb?

Horsetail herb is the common name for the aerial parts of the plant Equisetum arvense L.

The HMPC conclusions only cover horsetail herb preparations which are obtained by drying and comminuting (reducing into tiny pieces) the aerial parts of the plant, by expressing the juice of the fresh aerial parts and as dry or liquid extracts from the dried aerial parts. Extracts are prepared using a technique to extract compounds from plant material by putting the plant material in a solvent (such as ethanol or water) to dissolve compounds and form a liquid extract. For dry extracts the solvent is then evaporated.

Herbal medicines containing comminuted horsetail herb are usually available as herbal tea to be drunk or as infusion or decoction to be applied to the skin. The other herbal preparations of horsetail herb are available in solid or liquid forms to be taken by mouth and in liquid forms to be applied to the skin.

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

What are the HMPC conclusions on its medicinal uses?

The HMPC concluded that, on the basis of its long-standing use, these horsetail herb preparations can be used in minor problems affecting the urinary tract (structures that carry urine) to increase the

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production of urine in order to achieve flushing of the urinary tract. Horsetail herb preparations can also be used for treating superficial wounds.

Horsetail herb medicines should be used only in adults and adolescents over the age of 12 years. If symptoms last longer than one week a doctor or a qualified healthcare practitioner should be consulted. Detailed instructions on how to take horsetail herb medicines and who can use them can be found in the package leaflet that comes with the medicine.

What evidence supports the use of horsetail herb medicines?

The HMPC conclusions on the use of horsetail herb medicines for minor urinary complaints and for superficial wounds 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 a clinical study in healthy male volunteers comparing a horsetail herb preparation with a dummy treatment and a medicine that increases the volume of urine produced (a diuretic). Although the results from this study indicated that the horsetail herb preparation did have a mild diuretic effect, only a few individuals were included in the study and the information on the preparation used was limited. The HMPC also noted the lack of clinical studies with horsetail herb for treating superficial wounds. Therefore, the HMPC conclusions on the uses of horsetail herb medicines are based on their long-standing use.

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

What are the risks associated with horsetail herb medicines?

Side effects have been reported with horsetail herb medicines. These include allergic reactions and, when used for minor urinary conditions, mild stomach and gut complaints.

Horsetail herb medicines must not be used for minor urinary complaints if a reduced fluid intake is recommended for existing conditions (e.g. severe heart or kidney disease).

Further information on the risks associated with horsetail herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab 'All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.

How are horsetail herb medicines approved in the EU?

Any applications for the licensing of medicines containing horsetail herb 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 horsetail herb medicines in EU Member States should be obtained from the relevant national authorities.

Other information about horsetail herb medicines

Further information on the HMPC assessment of horsetail herb medicines, including details of the Committee's conclusions, can be found under the tab 'All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. For more information about treatment with horsetail herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Horsetail herb EMA/147173/2016