To investigate the clinical effect of Biqi Capsules combined with western medicine in the treatment of knee osteoarthritis.Methods:From February 2018 to January 2021，104 patients with knee osteoarthritis who were treated in the Department of Orthopedics，Bozhou Hospital of Traditional Chinese Medicine were selected as the research objects.According to the method of random number table，they were divided into control group(n＝52) and observation group(n＝52).The control group was comprehensively treated with western medicine.The observation group was treated with Biqi Capsule on the basis of western medicine treatment in the control group.Compare the efficacy，knee symptom score，quality of life(SF-36) score，pain degree(VAS) score，osteoarthritis index(WOMAC) score，cyclooxygenase-2(COX-2)，cartilage Polymatrix protein(COMP)，matrix metalloproteinase-2(MMP-2)，matrix metalloproteinase-9(MMP-9)，recurrence rate，adverse reactions were compared.Results:The treatment effect of the observation group was better than that of the control group; after treatment，the knee symptom scores，VAS，WOMAC，COX-2，COMP，MMP-2，and MMP-9 of the two groups decreased，and the SF-36 scores increased.The knee symptom scores，VAS，WOMAC，COX-2，COMP，MMP-2，and MMP-9 of the observation group were lower than those of the control group，and the SF-36 score was higher than that of the control group.The recurrence rate of patients in the observation group 3 months after completing the treatment was lower than that of the control group(P<0.05).There was no statistically significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:The addition of Biqi Capsules on the basis of western medicine combination therapy can further improve the symptoms of knee osteoarthritis patients，improve the quality of life，improve a variety of serum-related indicators，reduce the recurrence rate，and have good safety.