European randomized, multicenter study of goserelin (Zoladex) in the management of mastalgia.

BACKGROUND: Breast pain is a common symptom in patients attending breast clinics. The purpose of this study was to evaluate the efficacy of goserelin (Zoladex) as compared with sham injection in patients with mastalgia.

STUDY DESIGN: One hundred forty-seven premenopausal women were randomized to treatment with either goserelin injection (3.6 mg/month) or sham injection for a total of 6 injections. Patients' daily self-assessment of breast pain using Cardiff breast pain chart was recorded during the 6-month treatment period and for 6 months in the posttreatment period.

RESULTS: A significant treatment difference between the 2 groups in favor of goserelin was noted during the treatment period. Mean breast pain score improved by 67% in the goserelin group and 35% in the sham group during the treatment period. The mean pain scores increased in both groups in the posttreatment period. No significant posttreatment difference was found between the two groups. Side effects were more common with goserelin than sham injection. Patients receiving goserelin experienced vaginal dryness, hot flushes, decreased libido, oily skin or hair, and a decrease in breast size more frequently than sham patients.

CONCLUSION: Goserelin is an effective short-term treatment for mastalgia. However, side effects are common, and thus, goserelin should be kept in reserve for patients who are refractory to other forms of treatment. Potentially, goserelin could be used to induce a rapid relief of symptoms that could be maintained with alternative therapies.