Treatment of mastalgia with bromocriptine: a double-blind cross-over study.

Abstract

Treatment of mastalgia with bromocriptine: a double-blind cross-over study Mastalgia is often associated with fibrocystic disease of the breast.Treatments, however, often fail, probably owing to an unsatisfactory understanding of the nature of the condition.In this study we assess the therapeutic efficacy of bromocriptine. Patients, methods, and resultsSevere mastalgia was the dominant feature in 10 women with diffuse fibrocystic disease of the breast as judged by palpation and mammography and verified histologically.One patient (case 1) had galactorrhoea.None had prominent characteristics of the premenstrual syndrome.Mastalgia had been present for from six months to several years.In a double-blind cross- over trial patients were allocated at random to receive either bromocriptine or identical placebo capsules, each for a period of two months, in a dose of one capsule (bromocriptine 2-5 mg or placebo) daily during the first week of each period and thereafter two capsules daily.For one month before the trial and throughout the period of medication the presence and intensity of pain were recorded daily by each patient.They were seen in the outpatient clinic every four weeks.The code was broken at the end of each trial.Serum prolactin concentration was measured before the trial, on the day of cross- over, and on the final day of the trial (normal range 3-0-13-5 jug/l).During treatment with bromocriptine pain was totally or almost totally relieved in eight patients and in two the pain was much reduced (table).Placebo treatment failed to relieve mastalgia in any patient except one (case 9), in whom the relief during bromocriptine continued while taking placebo.Statistical analysis by Koch's method' showed that the relief obtained during bromocriptine therapy was significantly greater (P<002) than that during placebo medication, while period effects as well as carry-over effects were absent (P > 0-05).Mastalgia reappeared as soon as active medication was stopped, with the exception of the patient in case 9.The breasts became smaller, softer, and less tender during bromocriptine treatment.The pretrial serum prolactin concentration was slightly raised in three patients and normal in seven.During treatment with bromocriptine these concentrations were significantly lowered (P<0-01, sign test).There were no side effects from placebo.While taking bromocriptine five patients had slight, transitory nausea and dizziness, which is a recognised side effect.Three others had persistent and more pronounced nausea, dizziness, and general malaise.