Hormonal management of fibrocystic disease of the breast.

Fibrocystic breast disease is a source of considerable discomfort in a sizeable percentage of women between 35 and 50 years of age. Earlier treatments designed to reduce the pain, tenderness and nodularity associated with this condition met with little success. It was not until 1971, when Danocrine (danazol) was introduced for the treatment of endometriosis, that the potential usefulness of this synthetic steroid in the management of benign breast disorders was recognized. Numerous studies have substantiated the efficacy and safety of danazol for this application. At one center involved in a multicenter study of danazol, the drug was administered in dosages of 400 mg/d for two months, followed by 200 mg/d for an additional four months, to 25 women with fibrocystic breast disease. Eighteen (79%) of the women demonstrated a marked improvement in or elimination of their symptoms. The majority remained asymptomatic for at least one year after treatment. The side effects were mild and of the "nuisance" variety. These findings are consistent with the overall data reported by the other centers participating in the study.