EMEA singles out Premular as the only evidence-based Vitex |
| May 04 2011 |
The European Medicines Agency (EMEA) has granted Premular, specific extract of Vitex agnus-castus (Ze 440) a “well-established use” classification “for the treatment of premenstrual syndrome” based on proof of efficacy and safety.1,2
Premular is the only Vitex product to be assigned this status by the EMEA with all other Vitex products assigned to “traditional use” status because of insufficient evidence.1,2
Of fundamental relevance to the EMEA classification of Premular was the double-blind, placebo-controlled trial in 170 women over 3 months, published in the British Medical Journal. Premular was shown to be better than placebo (p<0.001) in reducing Premenstrual Syndrome including symptoms of headaches, irritability and anger.1,2,3
References
1. European Medicines Agency: Evaluation of Medicines for Human Use, 17 September 2009. ‘Committee on Herbal Medicine Products, Draft Assessment Report on Vitex Agnus-castus L., Fructus’, Doc. Ref.: EMEA/HMPC/144003/2009.
2. European Medicines Agency: 25 November 2010, ‘Committee on Herbal Medicinal Products, Community herbal monograph on Vitex agnus-castus L., fructus Final’, Doc.Ref.: EMEA/HMPC/144006/2009.
3. Schellenberg R BMJ 2001; 322:134-137
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