Shaoyang Xibi Decoction Based On The Theory Of 'Shaoyang Dominating Bone' In Treating Knee Osteoarthritis With Kidney-marrow Deficiency Syndrome:A Single-center,Single-blind,Randomized Controlled Trial

Purpose:To observe the efficacy and safety of Shaoyang Xibi decoction(SYXBD)in treating knee osteoarthritis with kidney-marrow deficiency syndrome.To preliminarily verify and deeply elaborate that the theory of 'Shaoyang dominating bone' can be a fundamental theory for treating knee osteoarthritis.Methods:28 participants are randomly allocated to two groups:treatment group(SYXBD,n=14)and control group(Meloxicam,n=14).Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)and 36-Item Short Form Health Survey(SF-36)are used to assess efficacy before treatment and 8 weeks after treatment.Monitoring safety indicators and recording adverse events are utilized to evaluate the security of drugs.Results:Baseline data before treatment between the two groups are similar.The WOMAC scores significantly decreased and the SF-36 scores significantly increased after 8 weeks treatment in both groups compared with baseline(P<0.05).SYXBD significantly decreased stiffness scores(P=0.005),physical function scores(P=0.001)and total scores(P=0.002)in WOMAC compared to Meloxicam while pain scores in both groups don't show any difference statistically(P>0.05).SYXBD significantly improved physical function(P=:0.021),bodily pain(P=0.002)and general health(P=0.014),with no significant difference in role emotional(P=0.053),role physical(P=0.517),vitality(P=0.241),social function(P=0.712)and mental health(P=0.800)in SF-36 compared to Meloxicam.There is no abnormal safety indicator among all the subjects except 2 with chronic hepatitis;No adverse events were reported in the treatment group while 5 adverse events happened in the control group during the study.Conclusion:Compared with Meloxicam,SYXBD,based on the theory of 'Shaoyang dominating bone',has a better curative effect and safety in treating knee osteoarthritis with kidney-marrow deficiency syndrome.Also,as for the current data,the theory of 'Shaoyang dominating bone' is deemed to be an available fundamental theory for treating knee osteoarthritis.