A French double-blind crossover study (danazol versus placebo) in the treatment of severe fibrocystic breast disease.

The Authors report their experience in a double-blind, crossover study (danazol versus placebo) in 38 patients suffering from severe benign mastopathy. The results were evaluated with regard to clinical data (mastodynia, breast nodularity) and data from comparative infrared thermography. Danazol was given in a dose of 400 mg/day for 3 months. Placebo, in identical packing, was also given for a three month period. In 32 cases out of 38, there was an improvement with Danazol treatment. For some patients, thermography was more precise than clinical part. Side effects consisted predominantly of menstrual disorders recorded in 30 cases and a generally moderate weight gain in 23 cases. In the light of these results it appears that danazol constitutes a powerful agent in the treatment of severe benign mastopathy of the breast. The best dosage and best duration of treatment remain to be specified. Finally, the original contribution of the thermographic document deserves to be underlined.