Treatment of recurrent cyclical mastodynia in patients with fibrocystic breast disease. A double-blind placebo-controlled study--the Hjørring project.
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 less than 0.005 or less), whereas the response to placebo was inconsistent and not statistically significant (p greater than 0.10). Danazol proved significantly more effective than placebo (p less than 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 less than 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.(ABSTRACT TRUNCATED AT 250 WORDS)
D000328:Adult; D002986:Clinical Trials as Topic; D003613:Danazol / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005348:Fibrocystic Breast Disease / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D010919:Placebos; D011245:Pregnadienes / Q000008:administration & dosage*; D012008:Recurrence
D010919:Placebos; D011245:Pregnadienes; D003613:Danazol