SCIENCE MEDICINES HEALTH
20 September 2016 EMA/304459/2016
Herbal medicine: summary for the public
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of hop strobile. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing hop strobile.
This summary is not intended to provide practical advice on how to use medicines containing hop strobile. For practical information about using hop strobile medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Hop strobile is the common name for the flowers of the plant Humulus lupulus L.
The HMPC conclusions only cover hop strobile preparations which are obtained by comminuting (reducing into tiny pieces) or by drying and powdering the flowers or as dry or liquid extracts. Extracts are obtained by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract. The solvent is then partially or completely evaporated to obtain a dry extract.
Herbal medicines containing these hop strobile preparations are usually available as herbal tea to be drunk or in liquid or solid forms to be taken by mouth.
Hop strobile 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 hop strobile preparations can be used for relief of mild symptoms of mental stress and to aid sleep.
Hop strobile medicines should only be used in adults and adolescents over the age of 12 years. If symptoms last more than two 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 hop strobile medicines and who can use them can be found in the package leaflet that comes with the medicine.
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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
The HMPC conclusions on the use of these hop strobile medicines for relief of mental stress and to aid sleep 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 laboratory studies which supported the use of hop strobile for aiding sleep. The HMPC also considered clinical studies but since these studies used combinations of hop strobile and valerian root preparations to aid sleep, firm conclusions on the effects of hop strobile could not be drawn. Therefore, the HMPC conclusions on the use of these hop strobile medicines are based on their long-standing use.
For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
At the time of the HMPC assessment, no side effects had been reported with these medicines.
Further information on the risks associated with these hop strobile 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.
Any applications for the licensing of medicines containing hop strobile 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 hop strobile medicines in EU Member States should be obtained from the relevant national authorities.
Further information on the HMPC assessment of hop strobile 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 hop strobile medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Hop strobile EMA/304459/2016