Treatment of recurrent cyclical mastodynia in patients with fibrocystic breast disease

. Thirty premenopausal women with recurrent, pronounced cyclical mastodynia associated with mammographically confirmed fibrocystic disease were studied. All patients had long‐standing symptoms, had undergone one previous course of treatment with danazol, and were recruited during long‐term follow‐up after original treatment, when cyclical mastodynia had again reached similar severity as before the original treatment (mean interval between treatments 9.5±3.9 (SD) months). Fifteen patients each were randomly allocated to double‐blind treatment with either danazol or placebo. During the first month, 2 capsules a day (each containing danazol 100 mg or placebo) were given, thereafter one capsule a day up to 6 months. Danazol caused a marked and sustained decrease in mastodynia, according to the clinician's assessment and according to each patient's self‐rating on a visual analogue scale. The response to danazol was fairly uniform and statistically significant (p < 0.005 or less), whereas the response to placebo was inconsistent and not statistically significant (p>0.10). Danazol proved significantly more effective than placebo (p<0.05 or less). Changes in palpatory and/or mammographic findings were also found more consistently after danazol treatment than after placebo. During treatment, there was a modest weight increase, which was statistically significant in the danazol group (p <0.01) but not in the placebo group. A greater frequency in menstrual irregularities was observed in the danazol group than in the placebo group, but not to an extent that would have caused ‘unblinding’ of the study. Other side effects were virtually the same in both groups with regard to type of complaint, total number of complaints (16 on danazol, 18 on placebo) and proportions of patients reporting one or more complaints (10/15 on danazol, 9/15 on placebo). Thus, unlike placebo, danazol largely abolished the cyclicity and periodicity of breast symptomatology and produced, in most cases, a sustained suppression of mastodynia, which was associated with a decrease in palpable structure and mammographic densityhpread of glandular tissue. These findings demonstrate the therapeutic efficacy of danazol even at these low doses, compared with placebo. However, a comparison of the response to danazol in this study and the response in the same patients during the original treatment course suggests that the dose of 100 mg a day is not as effective as 200 or 400 mg a day in severe cases.