Cabergoline versus bromocriptine for symptomatic treatment of premenstrual mastalgia: a randomised, open-label study.

OBJECTIVE

To compare the effectiveness and side effects of cabergoline with bromocriptine for the symptomatic treatment of cyclic mastalgia as a part of the premenstrual syndrome.

METHODS

140 women with premenstrual mastalgia were enrolled in this randomised, open-label trial. Two groups were created (bromocriptine and cabergoline) and consisted of 61 and 67 patients respectively at the end of trial. Bromocriptine was administered 5 mg daily during second half of the menstrual cycle. Cabergoline was administered 0.5 mg weekly during the second half of the cycle. Relief of pain was evaluated using a visual analog scale (VAS). The mean percentage decrease in score for all patients in each group was calculated. A 50% or greater decrease at the end of the third month from the basal VAS score was accepted as a positive response to drug therapy. Data regarding side effects were collected systematically with review of a symptom diary.

RESULTS

The positive response rates to treatment were similar (bromocriptine 66.6% and cabergoline 68.4%). The pain reduction rates for each month were also similar. Moreover, the pain reduction rate was maximum in the second month of treatment for both groups. Vomiting (28%), nausea (39%) and headaches (23%) recorded in the bromocriptine group were significantly more frequent than vomiting (4.5%), nausea (20.9%) and headache (6%) recorded in the cabergoline group (p=0.023, p=0.001, p=0.006 respectively). A difference in the rate of dizziness was not statistically significant (26.4% vs. 14.9%). There was no correlation between the baseline breast pain score and prolactin level but post-treatment pain reduction was well correlated with prolactin level.

CONCLUSIONS

Cabergoline is as effective as bromocriptine for the treatment of cyclic mastalgia but has minimal side effects compared to bromocriptine.