Objective To explore the clinical efficacy of modified Qingre Baidu Decoction on postoperative patients with granulomatous lobular mastitis(GLM).Methods Totally 120 GLM patients were randomly divided into the exposure group(n =75)and the non-exposure group(n =45).After surgery,all patients were treated with modified Qingre Baidu Decoction.The treatment time of the exposure group and the non-exposure group was no less than 3 months and less than 3 months,respec-tively.The clinical efficacy,recovery of postoperative breast appearance,and the recurrence rate of 3-month follow-up were compared between groups.The correlation between age,body mass index(BMI),the length of traditional Chinese medicine(TCM)treatment,the history of breast feeding,milk stasis,oral contraceptives,wound healing,nipples depression,nipple dis-charge,limb erythema nodosum,allergic diseases,with the recurrence was analyzed.The medication safety was assessed.Re-sults The difference was not statistically significant in the incidence of thrombocytopenia between the exposure group and the non-exposure group(100%[75/75]vs100%[45/45],[P>0.05],respectively).The breast appearance in the exposure group was significantly better than that of the non-exposure group(P<0.05).The recurrence rate in the exposure group was significantly lower than that in the non-exposure group(1.33%[1/75]vs 13.33%[6/45],[P<0.05],respectively).Af-ter treatment,usage time of modified Qingre Baidu Decoction,history of oral contraceptives,allergic diseases might be risk fac-tors for GLM recurrence(P<0.05).Usage time of modified Qingre Baidu Decoction≥3 months was an independent protective factor for GLM recurrence(P<0.05).The safety indexes of the both groups were in reference range,indicating clinical safety.Conclusion For postoperative patients with granulomatous lobular mastitis,usage time of modified Qingre Baidu Decoction≥3 months can significantly improve the treatment effect,protect the breast shape and reduce the recurrence rate of disease to a certain extent,which is safe and effective in clinic.