Abstract:Objective To observe the clinical effect of Qingxiao Formula combined with silk seton therapy by applying Badu Shengji Powder on areola fistula of non-lactating mastitis with liver meridian stagnation heat syndrome. Methods Sixty patients with non-lactation mastitis and areolar fistula who visited the Department of Breast Surgery at Jiangsu Province Hospital of Chinese Medicine from October 2018 to December 2020 were selected as the research subjects. A block randomization, controlled clinical trial method was employed. The participants were divided into an observation group and a control group at a ratio of 1∶1, with 30 cases in each group. Both groups received oral administration of Qingxiao Formula. The observation group was additionally treated with silk seton therapy by applyin Badu Shengji Powder，while the control group was treated with traditional silk seton therapy. The setons were replaced every three or four days, for a total of four replacements. The recovery time, fistula opening time, VAS score and safety indicators (blood routine, liver and kidney function) of the two groups were observed, and the recurrence of the patients was followed up. Results At the third seton therapy, the length of the fistula opening in the oberration group was significantly longer than that in the control group, with a statistically significant difference (P＜0.05). Compared with the control group, the observation group had a shorter time of fistula complete opening ［(12.00±2.22)d vs (14.46±3.76)d,t=3.860,P＜0.01］ and fistula healing ［(19.75±2.94)d vs (23.40±3.22)d,t=4.585,P＜0.01］. With the increase of the number of seton therapy, the fistula was gradually opened, and the pain from the seton therapy obviously relieved in both groups (P＜0.05), but there was no statistical difference between the two groups (P＞0.05). No adverse reactions occurred in either group of patients. Conclusion The combination of Qingxiao Formula and silk seton therapy by applying Badu Shengji Powder is an effective treatment for non-lactation mastitis with areolar fistula in liver meridian stagnation heat syndrome, which can shorten the time required for the fistula to open completely, accelerate healing, reduce the rate of wound infection, and decrease recurrence.