A Prospective Study to study the Efficacy and Side Effects of Ormeloxifene in Regression of Mastalgia and Fibroadenoma: Is It the Ideal Drug?

Abstract

ABSTRACT Ormeloxifene (Centchroman) is a novel nonsteroidal, selective estrogen receptor modulator birth control pill which has also been used recently for the treatment of mastalgia and fibroadenoma. Fibroadenomas are the most common benign breast tumors in women but worrisome for women fearing cancer. Mastalgia whether cyclic or noncyclic may be severely incapacitating for women. This study aims to analyze the effect of this new drug on the regression of mastalgia and fibroadenoma as an alternative to presently available steroid-based drugs with significant side effects. Materials and methods This was a prospective study involving 100 women of reproductive age group (up to 35 years of age) attending the outpatient department (OPD) in Malhotra Nursing Home, Agra and Rainbow Hospital Pvt Ltd., Agra, India, from August 2011 to August 2014, complaining of mastalgia and/ or fibroadenoma and fulfilling the inclusion criteria. After informed consent, these women were divided into a mastalgia group who had mastalgia with or without nodularity and a fibroadenoma group having sizes 1.5 to 2 cm, single or multiple in one or both breasts. Ormeloxifene 30 mg on alternate days was administered for 3 months in both the groups. Patients were followed at 1, 2, 4, 8, 12 and 24 weeks to assess response to therapy. Clinical examination, change in nodularity by palpation, breast lump size by ultrasonography, change in visual analog score (VAS) and breast tenderness were monitored. Results were analyzed using ‘t’ test. Results A total of 100 patients were included in this study. Eighty percent women belonged to the age group 25 to 35 years with a mean age of 28, 31.2 and 27.2 years in groups IA, IB and group B respectively. Mean interval between drug therapy and onset of response was 6 ± 2 days in mastalgia group and 15 ± 2 days in fibroadenoma group. 97.6 to 100% of women in the mastalgia group reported complete relief at 12 weeks of therapy with a decrease in VAS score from 10 to 3 in the first week of therapy itself while 28% of fibroadenoma group reported complete relief at 12 weeks of therapy, partial relief in 31% and equivocal response in 41%. Side effects observed were allergic rash development (2%) and a delay in menstruation of 7 to 10 days (14%) during therapy. Conclusion Ormeloxifene is a novel nonsteroidal drug found to be effective in treatment of mastalgia and partially in treatment of fibroadenoma in a short period of 3 months. As compared to the drugs presently in use namely danazol and bromocriptine, ormeloxifene is safer as suggested by its side-effect profile and is cost-effective too. There is need for prospective large randomized studies to compare this low-cost drug with the standard but costly drugs being prescribed at present. How to cite this article Gupta N. A Prospective Study to Study the Efficacy and Side Effects of Ormeloxifene in Regression of Mastalgia and Fibroadenoma: Is it the Ideal Drug? J South Asian Feder Obst Gynae 2016;8(1):48-56.