Background: Premenstrual syndrome (PMS), which was first described by Frank in 1931, is a clinical condition that is not easy to classify in terms of either symptoms or from a diagnostic and therapeutic point of view.
Aims: The aim of this study was to evaluate the efficacy of tamoxifen, an antiestrogen drug, using a double-blind study with placebo in the treatment of mastodynia, one of the most frequent symptoms of PMS, given that an absolute or relative increase in estrogens is one of the most controversial etiopathogenetic hypotheses.
Methods: The study included a group of 88 outpatients aged between 22 and 40 with regular menstrual cycles and intense mastodynia. Before commencing therapy, a detailed medical history was compiled for each subject and all underwent a gynecological and breast examination, hematochemical and instrumental tests (scan and mammography) in order to rule out other PMS-related organic pathologies. The patients were randomly divided into two groups of 44: one group received tamoxifen at a dose of 10 mg by mouth from day 5 to day 24 of the menstrual cycle, whilst a placebo was administered to the other group using the same dosage scheme. All women underwent a thorough control examination at the end of treatment and two months after the end of treatment.
Results: At the end of treatment 90% of patients reported a complete resolution of symptoms, whilst 10% only showed a slight improvement. In the control group, 86% showed a transitory reduction in symptoms and 13% did not report any improvement.
Conclusions: On the basis of the results obtained, the authors affirm the validity and efficacy of tamoxifen in the treatment of mastodynia in PMS owing to both its innocuity and its atoxity.