Comparison of tamoxifen with danazol for treatment of cyclical mastalgia.

This study evaluates the benefits and side-effects of two drugs (tamoxifen or danazol) used randomly in women with severe cyclical mastalgia. Ninety-three patients with severe cyclical mastalgia of more than 6 months duration were randomly selected for treatment with tamoxifen (32 women), danazol (32 women) or placebo (29 women) for six consecutive cycles. A standard protocol was used, which included pain relief as measured by linear analog, side-effects and cost. Statistical analysis was performed using the non-parametric Mann-Whitney U or Kruskall-Wallis tests and Student's t-test. As measured by linear analog scoring, pain relief was achieved in 23/32 (72%) of those receiving tamoxifen, 21/32 (65%) of those taking danazol (p < or = 0.001) and 11/29 (38%) of those taking placebo. Twelve months after the end of treatment, 17 (53%) women who received tamoxifen were still free of symptoms, as compared with 12 (37%) of the danazol-treated patients (p < 0.001) and none of the placebo-treated patients. These results suggest that tamoxifen is highly efficaceous and cost effective for the management of severe cyclical mastalgia.

RCT Entities:   Population Interventions Outcomes