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Randomised trial, 1997

Does tamoxifen or danazol help severe cyclical breast pain?

Yes. Both drugs reduced pain more than placebo during treatment, but tamoxifen was more effective and longer-lasting, with 53% still symptom-free 12 months after stopping.

Strong study design 93 women with severe cyclical breast pain lasting more than 6 months

What they did

Ninety-three women with severe cyclical breast pain lasting more than 6 months were randomly assigned to tamoxifen, danazol, or placebo for 6 consecutive menstrual cycles. Pain relief was measured on a linear analog scale. Women were followed for 12 months after treatment ended.

What they found

During treatment, pain relief was achieved in 72% (23 of 32) taking tamoxifen, 65% (21 of 32) taking danazol, and 38% (11 of 29) taking placebo. At 12 months follow-up, 53% (17 of 32) of the tamoxifen group were still symptom-free, compared to 37% (12 of 32) of the danazol group and 0% of the placebo group.

What it means for you

For severe cyclical breast pain, tamoxifen works better than danazol and much better than placebo, with longer-lasting relief. The main limit is that the abstract does not describe side effects or which women might experience them.

93

Women studied

72%

Pain relief with tamoxifen during treatment

53%

Symptom-free at 12 months after tamoxifen

About the study

Original title
Comparison of tamoxifen with danazol for treatment of cyclical mastalgia
Authors
Kontostolis E, Stefanidis K, Navrozoglou I et al.
Journal
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology
Year
1997
Study design
Randomised trial
Participants
32
What was tested
Tamoxifen or danazol taken for 6 consecutive menstrual cycles

Topics