The HMPC conclusions on the use of the agnus castus fruit dry extract for the treatment of premenstrual syndrome are based on ‘well-established use’. This means that there are bibliographic data providing scientific evidence of 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 one study in 178 women where this dry extract of agnus castus fruit was compared with placebo (a dummy treatment). Results showed that women with premenstrual syndrome treated with the agnus castus extract had improvements in menstrual symptoms such as irritability, mood alteration, anger, headache and breast fullness.

The HMPC conclusions on the use of the other agnus castus preparations for relief of minor symptoms in the days before a period 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 on premenstrual syndrome with the other agnus castus preparations. Although a possible effect in relieving symptoms was observed, firm conclusions could not be drawn because of poor study design. Therefore, the HMPC conclusions on the use of these preparations are based on their long-standing use.

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