This study evaluates the benefits and side-effects of two drugs (tamox
ifen 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 (3
2 women), danazol (32 women) or placebo (29 women) for six consecutive
cycles. A standard protocol was used, which included pain relief as m
easured by linear analog, side-effects and cost. Statistical analysis
was performed using the non-parametric Mann-Whitney U or Kruskall-Wall
is tests and Student's t-test. As measured by linear analog scoring, p
ain relief was achieved in 23/32 (72%) of those receiving tamoxifen, 2
1/32 (65%) of those taking danazol (p less than or equal to 0.001) and
11/29 (38%) of those taking placebo. Twelve months after the end of t
reatment, 17 (53%) women who received tamoxifen were still free of sym
ptoms, 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 manag
ement of severe cyclical mastalgia.