The HMPC conclusions on the use of linseed for treating constipation are based on 'well-established use'. This means that there are bibliographic data providing scientific evidence of linseed's effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.

In its assessment, the HMPC considered a number of clinical studies showing linseed's effect on constipation and hard stool. The studies demonstrated that linseed reduced habitual constipation.

The HMPC conclusions on the use of linseed medicines for the relief of mild gastrointestinal discomfort 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). Moreover, the intended use does not require medical supervision.

Although an early clinical study on linseed for the treatment of gastrointestinal discomfort is available, it was too limited to be used them as evidence and the HMPC's conclusions for this indication are based on the medicines' long-standing use.

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