Impact of Demographic Variables on the Long-term Regression of Fibroadenoma with Different Therapeutic Agents

Background: Fibroadenoma is the most common benign breast tumour in young women. While spontaneous regression is common, agents such as tamoxifen, ormeloxifene and evening primrose oil (EPO) are often used to enhance regression. Demographic variables, including age, marital status, parity, family history, education and body mass index (BMI), may influence treatment outcomes, although evidence is limited. Aim: To assess the impact of demographic variables on fibroadenoma regression and to compare the long-term efficacy of tamoxifen, ormeloxifene and EPO concerning these variables. Methodology: This prospective randomised controlled study was conducted at S.R.N. Hospital, M.L.N. Medical College, Prayagraj (September 2020–September 2021). A total of 142 women aged 15–40 years with clinically and radiologically confirmed fibroadenoma (2–10 cm) were randomised into four groups: Ormeloxifene (30 mg daily), tamoxifen (10 mg twice daily), EPO (1000 mg twice daily) and placebo (Vitamin B complex). Treatment lasted 3 months with an additional 3-month follow-up. Demographic variables included age, marital status, residence, parity, family history, BMI and education. Data were analysed using the SPSS v15.0; P < 0.05 was considered statistically significant. Results: Most patients were aged 26–30 years (35.2%), with rural (55.7%), literate (80.3%) and married (52.1%) predominance. Unilateral involvement (59.9%) and normal BMI (92.9%) were the most common. Baseline demographic factors showed no significant association with therapeutic response across groups ( P > 0.05). Conclusion: Fibroadenoma predominantly affects young women with normal BMI and unilateral breast involvement. Regression with ormeloxifene, tamoxifen or EPO was independent of demographic variables.