Pakistan Journal of Pharmaceutical Sciences

Abstract: Granulomatous mastitis (GM) is a chronic inflammatory breast disease with a high recurrence rate and low effectiveness of the traditional treatments. This randomized controlled trial compared the effectiveness of the combined use of Xihuang Capsules and low-power High-Intensity Focused Ultrasound (HIFU) and their impact on macrophage infiltration (CD68) and cell proliferation (Ki67). Sixty women with histologically proven GM were randomized to experimental (HIFU + Xihuang) or control (HIFU alone) groups (n=30 each group). Follow-up was for 12 weeks and recurrence at 6 months. Compared with controls, the combination group experienced more lesion reduction (3.50±0.79 cm to 0.92±0.42 cm vs. 3.42±0.88 cm to 1.85±0.60 cm, p<0.001), improved complete resolution (86.7% vs. 60.0%, p = 0.023), earlier resolution (6.2±1.4 vs. 9.1±1.8 weeks, p<0.001) and greater pain reduction (VAS: 7.2±1.1 to 1.3±0.6 vs. 7.0±1.3 to 2.8±0.9, p<0.001). Immunohistochemistry also demonstrated marked reductions in CD68+ macrophages and Ki67 index, both blindly graded. Recurrence at 6 months reduced with combination therapy (6.7% vs. 20.0%, p=0.098). Both treatments were well tolerated. These data indicate that Xihuang Capsules plus low-power HIFU produce faster regression of lesions, disappearance of symptoms and modulation of macrophage infiltration and cell proliferation in GM, with tendency of decreased recurrence.