Objective To evaluate the clinical efficacy and safety of soothing the liver and regulating the mind in the treatment of primary breast cancer complicated with generalized anxiety disorder, and to explore its immune mechanism. Methods A randomized controlled study was conducted to include patients who met the inclusion criteria in Guang'anmen Hospital, China Academy of Chinese Medical Sciences from August 2022 to February 2023. According to the 1: 1: 1 random principle, patients were divided into three groups: the traditional Chinese medicine group(n=30), the auricular acupuncture group(n=30), and the control group (n=28). The three groups all received Western medicine standard treatment. On the basis of Western medicine standard treatment, the traditional Chinese medicine group received modified prescriptions for soothing the liver and regulating the mind, and the auricular acupuncture group received auricular acupuncture therapy for soothing the liver and regulating the mind. The course of treatment was 8 weeks. The scores of Hamilton Anxiety Scale (HAMA), Self-rating Anxiety Scale (SAS) and World Health Organization Quality of Life-BREF (WHOQOL-BREF), and the contents of interleukin(IL)-1β, IL-8, IL-10, IL-6, IL-2, IL-4, interferon-γ (IFN-γ), tumor necrosis factor-α (TNF-α) were evaluated before and after treatment among the three groups. The HAMA score reduction rates of the three groups after treatment were calculated, and the total effective rates were compared. Results After treatment, the HAMA, SAS, and WHOQOL-BREF family friction scores in the traditional Chinese medicine group and the auricular acupuncture group were all lower than those before treatment (P<0.05), and the WHOQOL-BREF physiology dimension, social dimension, environment dimension, and self-assessment scores were higher than those before treatment (P<0.05). There were significant differences in HAMA, SAS, and WHOQOL-BREF physiology dimension, social dimension, environment dimension, self-assessment, and family friction scores among the three groups after treatment (P<0.05). The scores of HAMA, SAS and WHOQOL-BREF family friction in the traditional Chinese medicine group were lower than those in the control group, while the scores of WHOQOL-BREF physiology dimension, social dimension, environment dimension, and self-assessment score in the traditional Chinese medicine group were higher than those in the control group (P<0.05). The scores of HAMA and SAS in the auricular acupuncture group were lower than those in the control group, and the scores of WHOQOL-BREF physiology dimension, social dimension, and environment dimension in the auricular acupuncture group were higher than those in the control group (P<0.05). There was no significant difference between the traditional Chinese medicine group and the auricular acupuncture group in the scale score after treatment. After treatment, the contents of IL-1β, IL-8, IL-10, IL-2, IFN-γ, and TNF-α in the traditional Chinese medicine group were lower than those before treatment (P<0.05), while there was no significant difference in the auricular acupuncture group before and after treatment. The total effective rate of HAMA in the traditional Chinese medicine group was 83.3%, in the auricular acupuncture group it was 76.7%, and in the control group it was 10.7%. There was a statistical difference among the three groups (P<0.05), while there was no statistical difference between the traditional Chinese medicine group and the auricular acupuncture group. Conclusion Traditional Chinese medicine therapy of soothing the liver and regulating the mind, including prescriptions and auricular acupuncture, can effectively relieve the anxiety of breast cancer patients, improve the quality of life, and is safe without side effects, so it has a certain clinical value. [ABSTRACT FROM AUTHOR]