Exploratory Clinical Trial of Honghua Xiaoyao Pills for the Treatment of Liver Depression and Haemostasis‐Type Hyperplasia of Mammary Glands: A Single‐Centre, Single‐Arm Study

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Abstract
Background: Hyperplasia of mammary glands (HMG) is a common benign disease of the female breast. Objective: This study aimed to observe the clinical efficacy and safety of Honghua Xiaoyao pills in the treatment of liver depression and haemostasis‐type HMG, as well as their impact on menstruation. Methods: Sixty patients diagnosed with liver depression and haemostasis‐type HMG in the breast disease department of our hospital were selected as the study participants. The treatment involved oral administration of Honghua Xiaoyao pills: four pills per dose, three times a day, for a duration of 3 months without interruption during menstruation. Hormones, Western painkillers and similar Chinese herbal medicines were prohibited during the trial. Changes in breast pain, breast masses, menstrual volume and safety indicators were observed. Results: Three patients were lost to follow‐up after 2 months of treatment, and four patients voluntarily withdrew from the study. The changes in breast pain scores, breast mass size scores and breast mass texture scores relative to baseline and their respective change rates showed statistically significant differences ( p < 0.0001). Changes in lower abdominal distension, breast distension, menstrual blood clots, chest tightness/discomfort and emotional scores relative to baseline were also statistically significant ( p < 0.0001). Conclusion: Honghua Xiaoyao pills are effective in reducing breast pain, shrinking breast masses and improving lower abdominal distension, breast distension, menstrual blood clots, chest tightness/discomfort and emotional symptoms in patients with liver depression and haemostasis‐type HMG. Trial Registration: International Traditional Medicine Clinical Trial Registry: ITMCTR2024000165

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