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FACT
Focus on Alternative and Complementary Therapies

Treatment of mastalgia with a preparation containing Vitex agnus castus (Mastyodynon) - results of two double-blind studies

Beles P1, Peithner KG1, Halaska M1, Sieder Ch2, Gorkow C2
1Clinics of Gynaecology & Obstetrics, University of Prague
2Bionorica Arzneimittel GmbH, Neumarkt, Germany

Objective

Efficacy of Mastodynon, a preparation which contains Vitex agnus castus was investigated in two clinical trials.

Materials and methods

The preparation has been used for more than two decades to treat patients suffering from cyclical mastalgia. Two similar double blind, placebo controlled studies were carried out using a visual analogue scale as main outcome criterion.

Results

In both studies, a significant reduction of mastalgia complaints measured by a VAS was found. In the first study, the difference from placebo was significant (p < 0.05) at all 3 follow-up visits. In the second study, a similar significant (p < 0.05) decrease was observed after the first and second follow-up visit. After the last follow-up, the difference between both groups failed to reach significance due to an additional small decrease under placebo.

Conclusions

Although, comparing both studies and the development of the score under verum, there is no doubt that the preparation is effective in this indication with a percentage of 71.4% of the patients showing a response (defined by a reduction below a value of 35 mm VAS). The score has shown to be reproducible as well as the results of a Mastodynon treatment over 3 cycles.

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