| Objective: This study is a clinical randomized controlled experiment,which evaluates the effect of probiotics on the adjuvant treatment of patients with knee osteoarthritis by comparing the changes of knee osteoarthritis-related indicators between the experimental group and the placebo control group before and after treatment.Methods: In this study,76 eligible patients with knee osteoarthritis who attended the Affiliated Hospital of Inner Mongolia Medical University were enrolled.Patients were randomly divided into experimental group and control group based on 1:1: the experimental group was given probiotics and basic drugs and the control group was given placebo and basic drugs.The treatment period was three months.Anti-inflammatory and analgesic drugs and foods containing probiotics are banned during the period.A three-month follow-up period would start after the end of the treatment and no probiotics or placebo were given during this period.WOMAC scale,VAS,BMI and abdominal circumference data were collected and serum IL-8,TNF-α,MMP-1,MMP-1,MMP-3 and MMP-13 were measured before treatment,at the end of one month of treatment and at the end of follow-up period.Knee synovitis is assessed by knee ultrasound prior to treatment and at the end of follow-up by observing the patient’s suprapatellar capsule effusion and synovial thickness.The pre-treatment data were used as the baseline data and all data were statistically compared between and within groups.Results:The baseline data of two groups were balanced and comparable and there were no significant differences between WOMAC and VAS(P>0.05).During the treatment and follow-up period,the WOMAC scores of two groups continued to decrease,especially the WOMAC score of experimental group decreased more at the end of first month of treatment.There were statistical differences between both groups.At the end of the follow-up period(end of the 6th month),there was still a significant decrease in the experimental group compared with prior treatment(P<0.05),but there was no significant differences between both groups.The VAS score in the experimental group decreased more than the control group throughout whole research,but there was no significant differences in groups at the end of first month of treatment and the end of the follow-up period(P>0.05).It should be noted that at the end of the follow-up period,VAS decreased significantly in the experimental group compared with before treatment and the difference was statistically significant.IL-8 levels in the experimental group and control group were higher than prior treatment at the end of first month of treatment and at the end of follow-up.There were statistically significant differences in the experimental group at the end of the first month of treatment and the end of follow-up compared with prior intervention(P<0.05,P<0.001).There was no significant difference in TNF-α between both groups before treatment.TNF-α decreased during the treatment period and TNF-α decreased more significantly in the experimental group than the control group at the end of first month of treatment.There were statistically significant differences between both groups and before and after treatment in the experimental group.There was a significant difference in MMP-3 between both groups before treatment(P<0.05)and both groups decreased compared with prior treatment at the end of first month of treatment.The experimental group had a greater decrease than the control group.There was a statistical difference within the experimental group.In the follow-up period,MMP-3 in both groups increased and there was statistical difference between groups.There were no significant differences in MMP-1,MMP-13,BMI,abdominal circumference,suprapatellar capsule fluid thickness and synovial thickness under knee ultrasound before and after the intervention.Conclusion: Bifidobacterium infantis BX-01 combined with glucosamine hydrochloride has better clinical effect in the treatment of knee osteoarthritis than glucosamine hydrochloride alone,mainly manifested in the relief of knee pain,stiffness and function improvement,which can significantly reduce the levels of inflammatory factors TNF-α and improve the quality of life of KOA patients. |