Meliloti herba

Melilot is the common name for the above-ground parts of the plant Melilotus officinalis (L.) Lam.

The HMPC conclusions only cover melilot preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the above-ground parts, or by putting the plant material in a solvent (such as ethanol and rapeseed oil) to dissolve compounds and form a liquid extract.

Herbal medicines containing these melilot preparations are usually available as herbal tea to be drunk, in solid forms to be taken by mouth and in semi-solid forms to be applied to the skin.

Melilot 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 melilot preparations can be used to relieve discomfort and heaviness of legs related to minor problems related to blood circulation or to treat minor skin inflammation.

Melilot medicines should only be used in adults. If symptoms worsen or last longer than 2 weeks when taking the medicine for minor blood circulation problems or more than 1 week for skin inflammation, a doctor or healthcare practitioner should be consulted. Detailed instructions on how to take melilot 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 melilot medicines for minor blood circulation problems and skin inflammation 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 also considered clinical studies with melilot in patients with minor blood circulation problems. Although the results indicate a possible effect in relieving symptoms of discomfort and heaviness of the legs, firm conclusions could not be drawn since melilot was often not compared with any other treatment and the studies lacked objective measures of effectiveness.

There was a lack of studies on the use of melilot in patients with skin inflammation, however the HMPC noted that laboratory studies had shown it to have an anti-inflammatory effect.

Overall, the HMPC conclusions on the use of these melilot medicines in these two conditions are based on their long-standing use.

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

Stomach and gut complaints and allergic reactions have been reported with melilot. The frequency of these side effects is unknown.

Further information on the risks associated with these melilot 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.

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

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

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