Clinical efficacy, safety and tolerability of BIO-C (micronized Silymarin) as a galactagogue.

BACKGROUND AND AIM OF THE WORK The authors have previously reported the use of Silymarin (a Silybum marianum standardized extract) as a promoter of milk production in cows. Due to the important psychological impact of hypogalactia in women after delivery, we evaluated the role of Silymarin as a safe and effective galactogogue for human species. METHODS 50 healthy women during lactation were enrolled in order to verify the galactogogue role played by an oral treatment with micronized Silymarin (420 mg/day) in comparison with an undistinguishable placebo product. RESULTS Women orally treated for 63 days with Silymarin showed a clear galactagogue role for the product with an increase of 85.94% of the daily milk production (placebo: +32.09%). No drop out, nor unwanted effects were reported in both groups. Compliance and tolerability were also very good. CONCLUSIONS Silymarin may be considered as a safe and effective herbal product that can be orally administered in order to improve the daily milk production in healthy women after delivery, without affecting milk quality.