〔Abstract〕 Objective To explore the effects of Xiaoyao pills combined with Siwu decoction on menstrual volume and hormone levels in patients with irregular menstruation with blood stasis and deficiency. Methods 98 patients with irregular menstruation admitted to the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine from January 2020 to June 2022 were selected, 49 patients treated with Siwu decoction were selected to be included in a control group, 49 patients treated with Xiaoyao pills combined with Siwu decoction were selected to be included in an observation group, and the clinical efficacy and other clinical indicators were compared between the two groups of patients after treatment. Results The total effective rate of the observation group was 95.92 %, higher than 83.67 % of the control group, the difference was statistically significant (P < 0.05). After treatment, the scores of the cox menstrual symptom scale (CMSS), abnormal menstrual cycle, abnormal menstrual duration and abnormal menstrual volume in the observation group were lower than those in the control group, and the difference were statistically significant (P < 0.05). After treatment, the level of estradiol (E2) in the observation group was lower than that in the control group, and the levels of follicle stimulating hormone (FSH) and luteinizing hormone (LH) were higher than those in the control group, the differences were statistically significant (P < 0.05). Conclusion Xiaoyao pills combined with Siwu decoction is effective in the treatment of irregular menstruation, which can further improve the menstrual volume and hormone level.