Treating from the Liver Perspective: Efficacy of

DOI: 10.12201/bmr.202604.00043

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  Abstract: Objective: To investigate the clinical efficacy of traditional Chinese medicine external treatment Ruxianning Babu Patch from the liver perspective in treating liver qi stagnation and phlegm coagulation type breast hyperplasia and its effects on serum sex hormone levels.Methods: A total of 120 patients with breast hyperplasia (liver qi stagnation and phlegm coagulation type) who visited the breast department of a traditional Chinese medicine hospital from April 2023 to April 2025 were selected and randomly divided into control group and treatment group with 60 cases each. The control group was given oral tamoxifen citrate tablets (10 mg/time, twice daily). The treatment group received additional external application of Ruxianning Babu Patch on the affected breast, once daily for 8 hours each time, with a treatment course of 2 months. The traditional Chinese medicine syndrome scores (breast distension and pain, masses, nipple discharge, chest tightness and hypochondriac distension, irritability and bitter taste), breast ultrasound indicators breast glandular thickness, cyst diameter, hypoechoic area diameter, serum sex hormone levels estradiol (E?), progesterone (P), prolactin (PRL), total treatment effectiveness rate, and recurrence rates at 3 and 6 months were observed before and after treatment in both groups.Results: After treatment, the traditional Chinese medicine syndrome scores and breast ultrasound indicators in both groups were significantly reduced compared to before treatment (P<0.05), and the treatment group was superior to the control group (P<0.05). After treatment, E? and PRL levels decreased in both groups (P<0.05), while P levels increased (P<0.05), with more significant improvement in the treatment group (P<0.05). The total clinical effectiveness rate was 93.33% in the treatment group and 78.33% in the control group (P<0.05). The 6-month recurrence rate was 4.17% in the treatment group, lower than 20.00% in the control group (P<0.05). No serious adverse reactions were observed in either group during treatment.Conclusion: Ruxianning Babu Patch treating from the liver perspective shows definite efficacy in treating liver qi stagnation and phlegm coagulation type breast hyperplasia, can significantly improve breast ultrasound indicators, regulate estrogen-progesterone balance, alleviate clinical symptoms, reduce recurrence rate, and has good safety profile.

  Key words: breast hyperplasia; Ruxianning Babu Patch; liver qi stagnation and phlegm coagulation; serum sex hormones; traditional Chinese medicine external treatment

  Submit time: 7 April 2026

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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