TREATMENT OF CYCLICAL MASTALGIA - RESULTS OF A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY

,,Treatment of Cyclical Mastalgia'': Results of a Randomised, Placebo- Controlled, Double-Blind Study: Objective: The efficacy of a preparati on containing Agnus castus, formulated as a solution() (Mastodynon(R) ) and as corresponding tablets (MA 1025 E1), was compared with placebo in mastalgia. Design: Multicentre, randomised, placebo-controlled, pa rallel groups, double-blind, double-dummy technique. Subjects: Patient s had to have suffered mastalgia for at least three cycles and to comp lain of breast pain on at least three days in the cycle before treatme nt was initiated. 104 patients were included in the ,,intention-to-tre at'' analysis (solution: n=34; tablets: n=32; placebo: n=38). Methods and main outcome measures: The duration of treatment was three cycles. To assess the efficacy, patients were required to indicate the intens ity of breast pain on the visual, linear analogue scale (VAS). As a co nfirmatory test, an analysis of covariance of the baseline-endpoint di fference with the factor ,,treatment group'' and the covariate ,,VAS, cycle 0'' was carried out. Estradiol, progesterone, FSH, LH and basal prolactin were measured in the premenstrual weeks of cycles 0, 1, 2 an d 3. Analysis of prolactin values after metoclopramide stimulation was carried out in cycles 0 and 3. Results: At the end of treatment, ther e was a significant difference between the VAS values for the solution and the tablets, respectively p=0.0067; p=0.0076 and those for the pl acebo group. The solution demonstrated onset of action after the first treatment cycle, which was faster than the tablet formulation. The tr eatment had no effect on progesterone, FSH and LH. tinder both active formulations, the estradiol values decreased somewhat more strongly th an under placebo. The basal prolactin levels fell significantly in com parison with placebo, by 4.35 ng/ml (p = 0.039) under the active solut ion and by 3.7 ng/ mi (p = 0.015) under the active tablets. In compari son with placebo, the stimulated pro(actin levels at the end of treatm ent tended to be lower under both active formulations. Conclusion: The solution and the tablets of the preparation containing Agnus castus a re effective in mastalgia. Basal prolactin levels dropped significantl y with both forms of the preparation.