Role of Ormeloxifene in Regression of Benign Breast Diseases

Background: Benign breast diseases are common pathological entities with which women in their early reproductive age present to OPD with fear of malignancy and significant morbidity. Except for surgery and use of non-selective estrogen receptor blockers, there are no other treatment options, and these have lot of side effects. Ormeloxifene, a newer drug has shown promising results with minimal side effects and used as the first line of treatment reducing the morbidity of surgery and subjecting the patient to less hormonal side effects. Methods: Diagnosis of benign breast diseases was made by baseline investigation which included measurement of defect size of fibroadenoma using Vernier calliper and USG; fibroadenosis, ie nodularity measured using Lucknow-Cardiff scale and VAS score was used for pain assessment of mastalgia after which patients were given the drug and placebo and the response for the drug and its side effects were noted. Results: 61.9 % (44) were diagnosed with fibroadenoma, 16.9 % (12) with fibroadenosis and 21.1 % (15) with mastalgia. Lucknow Cardiff score for fibroadenosis exhibited 50 % having smooth breasts with no nodularity at the end of six months, in fibroadenoma group 52 % showed decrease in size and 31 % showed complete disappearance of the lump and in the mastalgia group 40 % had no pain (VAS score of 0). 16 (22.5 %) had menstrual abnormality as the major side effect. Conclusions: Ormeloxifene can be used as the first line of treatment in patients with fibroadenosis and mastalgia and used as an alternative to surgery for fibroadenoma.