The treatment of symptomatic benign breast disease with danazol.

A prospective randomized double blind trial, using danazol in a dose of 200 mg twice a day, was carried out on 80 women presenting with severe cyclical symptomatic benign mammary dysplasia. Standardized scores for 4 parameters of disease severity (breast pain, breast tenderness, breast nodularity and breast cysts) were defined and measured monthly on all patients admitted to the trial. Using nonparametric statistical analysis, significant improvement in breast pain, tenderness and nodularity, was found in both the double blind and crossover arms of the trial. An insufficient number of patients presented with breast cysts to draw any conclusions regarding the efficacy of danazol on cysts. Six months of treatment may produce a more sustained response, than 3 months of treatment. Danazol appears to be efficacious in managing patients with severe breast symptoms due to benign disease.