Objective To analyze the efficacy of modified Qiankun Yudan Decoction combined with leuprorelin acetate in the treatment of patients with adenomyosis (AM) and its effect on serum carbohydrate antigen 125 (CA125) level and recurrence rate.

Methods A total of 120 patients with AM were randomly divided into control group (treated with leuprorelin acetate) and experimental group (treated with modified Qiankun Yudan Decoction on the basis of control group), with 60 cases in each group. Efficacy, the traditional Chinese medicine (TCM) syndrome score, dysmenorrhea score, serum CA125 level, uterine volume, occurrence of adverse reactions and recurrence rate were compared between the two groups.

Results The total effective rate in the experimental group was 95.00%, which was significantly higher than 80.00% in the control group (P < 0.05). After 3 and 6 months of treatment, the TCM syndrome score and dysmenorrhea score in both groups were significantly lower than those before treatment, and the scores in the experimental group were significantly lower than those in the control group (P < 0.05). After 3 and 6 months of treatment, serum CA125 and uterine volume in both groups were significantly lower or smaller than those before treatment, and the two indicators in the experimental group were significantly lower or shorter than those in the control group (P < 0.05). The total incidence rate of adverse reactions in the experimental group was 1.67%, which was significantly lower than 11.67% in the control group (P < 0.05). At the time point of follow-up to 3 months after the treatment, the experimental group had no recurrence cases, and the recurrence rate of control group was 5.00%, but there was no significant difference between two groups (P>0.05); at the time point of follow-up to 6 months after treatment, the recurrence rate was 1.67% in the experimental group, which was significantly lower than 13.33% in the control group (P < 0.05).

Conclusion Modified Qiankun Yudan Decoction combined with leuprorelin acetate can enhance the therapeutic efficacy in patients with AM, alleviate the TCM syndrome and dysmenorrhea symptoms, perform a good regulation effect on serum CA125, reduce the uterine volume, relieve the gastrointestinal discomfort and liver injury, and reduce the recurrence rate.