Rai Priyanka, Nityanand Soniya, Singh Amarjot, Singh Sunil Kumar, Singh Neha, Singh Arvind Kumar, Singh Dhananjay
Department of General Surgery, Dr. RMLIMS, Lucknow, Uttar Pradesh, India.
Department of Hematology, SGPGIMS, (VC, King George Medical University), Lucknow, Uttar Pradesh, India.
Clinics (Sao Paulo). 2024 Dec 26;80:100567. doi: 10.1016/j.clinsp.2024.100567. eCollection 2025.
Fibroadenomas are common benign breast lumps that can cause anxiety due to malignancy concerns, and Centchroman, a selective estrogen receptor modulator, has shown promise in reducing their size. This study aimed to evaluate the efficacy of Centchroman in reducing fibroadenoma size, mastalgia, anxiety, and depression in affected patients.
A parallel-arm randomized controlled trial was conducted at a tertiary care Breast Clinic with 104 patients aged 18‒45 years having fibroadenomas ≤ 3 cm. Group A received Centchroman (30 mg on alternate days) and Group B received a placebo for 12 weeks. The primary outcome was fibroadenoma volume reduction measured by ultrasound, while secondary outcomes included reductions in mastalgia and improvements in anxiety and depression (HADS scores).
Both groups showed fibroadenoma volume reduction over 12-weeks, with a greater reduction in the intervention group (3.67 ± 1.65 cm to 2.29 ± 1.04 cm) than the control group (3.12 ± 1.16 cm to 2.73 ± 0.78 cm), though the difference was not statistically significant (p = 0.342 and p = 0.781). However, 28.8 % of the intervention group experienced over 50 % volume reduction compared to 13.5 % in the control group (p = 0.007). Mastalgia significantly improved in the intervention group (VAS: 5.76 ± 2.13 to 2.24 ± 0.93, p = 0.023), with minimal improvement in controls. Anxiety and depression scores significantly decreased in the intervention group, with anxiety dropping from 9 to 5 and depression from 6 to 4 (p = 0.001).
Centchroman effectively reduces fibroadenoma size especially those with multiple fibroadenoma, mastalgia, and psychological distress in patients with fibroadenoma.
纤维腺瘤是常见的乳腺良性肿块，因对恶性病变的担忧可导致焦虑，而选择性雌激素受体调节剂色满卡林已显示出缩小其大小的前景。本研究旨在评估色满卡林在缩小纤维腺瘤大小、缓解患侧乳房疼痛、焦虑和抑郁方面对患者的疗效。
在一家三级护理乳腺诊所进行了一项平行组随机对照试验，纳入104例年龄在18至45岁之间、纤维腺瘤直径≤3 cm的患者。A组隔日服用色满卡林（30 mg），B组服用安慰剂，为期12周。主要结局是通过超声测量纤维腺瘤体积的减小，次要结局包括乳房疼痛的减轻以及焦虑和抑郁的改善（医院焦虑抑郁量表评分）。
两组在12周内纤维腺瘤体积均减小，干预组（从3.67±1.65 cm减小至2.29±1.04 cm）的减小幅度大于对照组（从3.12±1.16 cm减小至2.73±0.78 cm），尽管差异无统计学意义（p = 0.342和p = 0.781）。然而，干预组中有28.8%的患者体积减小超过50%，而对照组为13.5%（p = 0.007）。干预组乳房疼痛明显改善（视觉模拟评分：从5.76±2.13降至2.24±0.93，p = 0.023），对照组改善极小。干预组焦虑和抑郁评分显著降低，焦虑从9分降至5分，抑郁从6分降至4分（p = 0.001）。
色满卡林能有效缩小纤维腺瘤大小，尤其是对患有多发性纤维腺瘤的患者，还能缓解纤维腺瘤患者的乳房疼痛和心理困扰。
