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Randomised trial, 1998

Does tamoxifen treat premenstrual breast pain?

Yes, 90% of women taking tamoxifen had complete resolution of breast pain. However, 86% of the placebo group also improved, suggesting a strong placebo effect.

Moderate study design 88 women aged 22-40 with regular cycles and severe premenstrual breast pain

What they did

Double-blind placebo-controlled study of 88 women aged 22-40 with severe premenstrual breast pain and regular menstrual cycles. All had medical exams and imaging to rule out other breast problems. Women were randomly assigned to tamoxifen 10 mg daily on days 5-24 of their menstrual cycle (44 women) or placebo (44 women). They were examined at the end of treatment and again 2 months later.

What they found

In the tamoxifen group, 90% had complete resolution of symptoms and 10% had slight improvement. In the placebo group, 86% showed temporary improvement and 13% had no improvement.

What it means for you

Tamoxifen appears effective for premenstrual breast pain, but the placebo response was very high (86%), making it hard to know how much of the benefit comes from the drug itself versus placebo effect or natural improvement. This was a small single-center study.

88

women

90%

complete resolution with tamoxifen

86%

temporary improvement with placebo

About the study

Original title
[Clinical efficacy of tamoxifen in the treatment of premenstrual mastodynia]
Authors
Grio R, Cellura A, Geranio R et al.
Journal
Minerva ginecologica
Year
1998
Study design
Randomised trial
What was tested
Tamoxifen 10 mg daily on days 5-24 of menstrual cycle vs placebo

Topics