o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

2 February 2016 EMA/822538/2015

Herbal medicine: summary for the public

Willow herb

Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba

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

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

What is willow herb?

Willow herb is the common name for the aerial parts of the plant Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., collected before or during flowering time.

Willow herb preparations are obtained by drying and comminuting (reducing into tiny pieces) the aerial parts of the plant.

Herbal medicines containing willow herb are usually available as herbal tea to be drunk.

Willow herb can 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, willow herb can be used by patients with benign prostatic hyperplasia (BPH) for the relief of lower urinary tract symptoms such as difficulty starting urination or a frequent need to urinate. Willow herb should only be used after serious conditions have been excluded by a medical doctor. BPH is a non-cancerous increase in size of the prostate gland which surrounds the urethra, the tube that carries urine from the bladder out of the body.

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Willow herb may be taken long term. It has no relevant use in patients under 18 years of age. Detailed instructions on how to take willow 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 willow herb medicines?

The HMPC conclusions on the use of willow herb medicines for the relief of lower urinary tract symptoms related to BPH are based on their 'traditional use' in this condition. 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).

The HMPC noted the lack of clinical studies with willow herb. Results from laboratory studies indicate that willow herb may have an effect on the growth of prostate cells as well as anti-inflammatory and pain-relieving activity. However, firm conclusions could not be drawn and the HMPC conclusions on the use of willow herb 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 willow herb medicines?

At the time of the HMPC assessment, no side effects had been reported with these medicines.

Further information on the risks associated with willow 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 willow herb medicines approved in the EU?

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

Other information about willow herb medicines

Further information on the HMPC assessment of willow 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 willow herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Willow herb EMA/822538/2015