Breast magnetic resonance imaging findings in women treated with toremifene for premenstrual mastalgia.

BACKGROUND: Toremifene, a selective estrogen receptor modulator, has been shown to be effective in alleviating premenstrual breast pain. However, the exact mechanism by which toremifene and related compounds work in premenstrual mastalgia is poorly understood. PURPOSE: To find out if the effect of toremifene on breast would be detectable with dynamic magnetic resonance imaging (MRI). MATERIAL AND METHODS: This randomized, double-blind crossover study was performed on women suffering from marked premenstrual mastalgia. Ten women were randomized to receive either toremifene (20 mg) or placebo from cycle day 15 until next menstruation for three menstrual cycles. After a washout period, the treatment was crossed over for three additional cycles. The MRI evaluations were performed premenstrually at the end of each treatment phase. Breast pain and quality-of-life scores were collected from one baseline cycle and from all the treatment cycles. RESULTS: Nine patients were evaluable for this analysis. Both the enhancement ratio and the maximum slope of enhancement tended to be smaller during the toremifene cycles as compared to placebo. On the left side, the difference in the maximum slope of enhancement between toremifene and placebo was statistically significant (median 5.150 [range 3.7-6.7] and 6.500 [range 4.9-9.5], respectively; P=0.047). T2 relaxation times as well as breast pain and quality-of-life scores were inconsistent. CONCLUSION: Use of toremifene is associated with measurable changes in dynamic breast MRI findings in women with cyclic breast pain.

Toremifene for premenstrual mastalgia: a randomised, placebo-controlled crossover study.

OBJECTIVE: To investigate the efficacy of toremifene in the treatment of premenstrual mastalgia. DESIGN: Double-blind, placebo-controlled crossover study. SETTING: Three Finnish general practices from the districts of Satakunta Central Hospital and Tampere University Hospital. POPULATION A total of 62 women aged 25-45 years with premenstrual mastalgia during at least three previous menstrual cycles. METHODS: Women were randomised to receive toremifene 20 mg daily or placebo from day 15 of the menstrual cycle until menstruation for three consecutive cycles. After a wash-out cycle, the women were crossed over to receive placebo or toremifene for three additional cycles. MAIN OUTCOME MEASURES: Cyclic breast pain relief assessed by visual analogue scale (VAS) score. Quality-of-life scores assessed by a modified 36-item Finnish Depression Scale, with a score ranging from 0 to 108. Acceptability of treatment. RESULTS: About 32 women were randomised to receive toremifene first and 30 to receive placebo first. Twenty-nine and 27 participants in the groups treated with toremifene first or placebo first completed the treatment, respectively. There were significant reductions in VAS scores in both groups after three treatment cycles. This was significantly greater in the toremifene-treated group (VAS: 1.8 in the toremifene group and 3.7 in the placebo group, P= 0.004). Treatment effect between treatment cycles was significant (P= 0.001). Quality of life was similar during the toremifene and placebo cycles. CONCLUSION This study demonstrates that the antiestrogenic compound, toremifene, is able to relieve premenstrual breast pain without major adverse effects. There was a 64% reduction in median pain scores in the toremifene-treated cycles compared with a 26% reduction in placebo-treated cycles.