A double-blind randomized controlled trial of toremifen therapy for mastalgia.
OBJECTIVE
Toremifen is effective in reducing breast pain and does not increase the incidence of adverse events as a therapy for moderate to severe mastalgia.


METHODS
In a double-blind randomized controlled trial, patients with moderate to severe mastalgia received toremifen citrate, 30 mg daily, or a placebo tablet for 3 menstrual cycles and were followed up for breast pain score and adverse events. The serum levels of estradiol, progesterone, and prolactin were examined before treatment and correlated with the response rate to toremifen treatment.


RESULTS
Seventy-two (69.2%) of 104 patients receiving toremifen and 29 (31.9%) of 91 receiving placebo responded to the treatment, with reduction in breast pain score of more than 50% (P<.001). Among the patients with cyclical mastalgia, the response rate for toremifen was 76.7% (59/77), whereas the response rate for placebo was 34.8% (23/66; P<.001). In contrast, the response rate of patients with noncyclical mastalgia was 48.1% (13/27) for toremifen and 24.0% (6/25) for placebo (P = .09). Adverse events were observed in 44 (42.9%) of 104 patients receiving placebo and 46 (50.5%) of 91 patients receiving toremifen (P = .45). A positive correlation between baseline breast pain score and serum estradiol level was observed in patients with cyclical mastalgia (r = 0.35, P = .003).


CONCLUSIONS
Toremifen effectively relieves moderate and severe cyclical mastalgia and tends to exert a positive therapeutic effect on noncyclical mastalgia. In addition, toremifen therapy does not increase the incidence of intolerable adverse event. Therefore, it is a feasible therapy for mastalgia, especially cyclical mastalgia.
Gong
Chang
C
Department of Breast Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, 107 Yanjiang West Road, Guangzhou 510120, People's Republic of China.
Song
Erwei
E
Jia
Weijuan
W
Qin
Li
L
Guo
Jujiang
J
Jia
Haixia
H
Hu
Xiaoqu
X
Su
Fengxi
F
D001941:Breast Diseases / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004958:Estradiol / Q000097:blood; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011374:Progesterone / Q000097:blood; D011388:Prolactin / Q000097:blood; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects / Q000627:therapeutic use; D017312:Toremifene / Q000009:adverse effects / Q000627:therapeutic use*
D020845:Selective Estrogen Receptor Modulators; D011374:Progesterone; D004958:Estradiol; D017312:Toremifene; D011388:Prolactin