Evaluating the Effect of Ormeloxifene on Multiple Fibroadenomas and Mastalgia

Abstract

Introduction: Most common benign breast conditions presenting in the breast clinics include fibroadenomas and mastalgia, both these conditions cause considerable anxiety in the patients. Among other treatment modalities, the hormonal drug treatments are gaining popularity. Ormeloxifene (centchroman) is an antiestrogenic drug which is shown to have effect in reducing the pain in mastalgia patients and the size of fibroadenoma. Objectives: Ormeloxifene is selective antiestrogen and a nonsteroidal drug. It has a discerning antiestrogen action and hence is useful for the treatment of mastalgia and multiple small fibroadenomas. Hence, the objective of our study was to assess the effect of Ormeloxifene (centchroman) on multiple fibroadenoma and mastalgia. Materials and Methods: Patients with benign breast disease attending our surgery outpatient department from June 2016 to July 2017. Patients were started on Ormeloxifene 30 mg on alternate days for a period of 3 months. Patients were followed up to 6 months after the inception of the study. Parameters recorded include the Visual Analog Scale (VAS) for pain and ultrasonography for breast lump size. Results: Thirty patients were included in the study. We found very good response in the mastalgia; the VAS scores in these patients dropped from 10 to 3 in 90% in the 1st week of introduction of the drug, and at the end of 1 month, almost all of the patients were painless. Overall final response was noted in terms of complete dissolution and change in the size was noted in 34% partial response in 46 %, no changes in 17 % and increase in size of fibroadenoma was noted in only one case. Conclusion: Novex is proved to be safe drug for the treatment of mastalgia and fibroadenoma. Its results were great in mastalgia group. At the end of 6 months, the number of surgeries (if needed) decrease and there is considerable improvement in the patient satisfaction rate.

Double blind randomized controlled trial of efficacy of ormeloxifene for the treatment of fibroadenoma (The FIBROCENT study)

“…Another observational study by Brahmachari et al 17 . reported that only 3% patients had complete regression of fibroadenoma at the end of 3 months with 30 mg Ormeloxifene on alternate days and it increased to 30% at the end of 6 months.…”

“…[14][15][16] However, previous studies of Centchroman for the medical management of fibroadenoma have shown contradictory effects. 10,17 We evaluated the efficacy of Ormeloxifene (Centchroman) on regression of Fibroadenoma in this double-blind placebo-controlled trial.…”

“…Estrogen‐dependent growth of fibroadenomas has formed the basis of use of anti‐estrogen drugs for the regression of fibroadenoma 14–16 . However, previous studies of Centchroman for the medical management of fibroadenoma have shown contradictory effects 10,17 …”

A Comprehensive Review of Breast Fibroadenoma: Correlating Clinical and Pathological Findings

“…Hormones, such as estrogen and progesterone, influence the size and behavior of fibroadenomas, leading to variations in pain perception. This clinical feature highlights fibroadenomas' dynamic nature and responsiveness to hormonal changes, underscoring the importance of considering hormonal influences in their clinical evaluation [ 32 ].…”