Treatment of cyclical mastalgia with a solution containing a Vitex agnus castus extract: results of a placebo-controlled double-blind study

In a placebo-controlled, randomized, double-blind study the efficacy of a Vitex agnus castus extract-containing solution* (VACS) was investigated in patients suffering from cyclical mastalgia. Patients had mastalgia on at least 5 days in the pre-treatment cycle. During this cycle and during treatment (3 cycles; 2 x 30 drops/day), the intensity of mastalgia was recorded once per cycle using a visual analogue scale (VAS). After one/two treatment cycles, the mean decrease in pain intensity (mm, VAS) was 21.4 mm/33.7 mm in women taking VACS (n = 48) and 10.6 mm/20.3 mm with placebo (n = 49). The differences of the VAS-values for VACS were significantly greater than those with placebo (p = 0.018; p = 0.006). After three cycles, the mean VAS-score reduction for women taking VACS was 34.3 mm, a reduction of 'borderline significance' (p = 0.064) on statistical testing compared with placebo (25.7 mm). There was no difference in the frequency of adverse events between both groups (VACS: n = 5; placebo: n = 4). VACS appears effective and was well tolerated and further evaluation of this agent in the treatment of cyclical mastalgia is warranted. (C) 1999 Harcourt Publishers Ltd.