A Meta-analysis Of Clinical Efficacy And Safety Of Oral Administration Of Traditional Chinese Medicine In The Treatment Of Knee Osteoarthritis

Objective: To systematically evaluate the efficacy and safety of oral administration of traditional chinese medicine in the treatment of knee osteoarthritis based on evidence-based medicine.Methods: According to the research objectives,search terms and search strategies were established.The search duration was from the databases of How Net,VIP,Wanfang,China Biomedical Literature(CBM),Pub Med,Embase,Cochrane Library,China Clinical Trials Registration Center(Chi CTR)and American Clinical Trials Registration Center(Clinical Trials.gov)by computer until November 14,2020.Two researchers independently screened the articles using Note Express3.2according to the inclusion and exclusion criteria established in this study.In case of dispute,a third researcher assisted in deciding whether to include the article.The Cochrane risk bias assessment tool was used for literature quality evaluation.From the included articles,the outcome indicators of this study were extracted:(1)Total effective rate;(2)WOMAC score;(3)VAS pain score;(4)Lequesne function score;(5)TCM syndrome score;(6)SF-36 health survey summary table;(7)Inflammation indicators(IL-1,IL-6,TNF-α,hs-CRP in blood);(8)Safety indicators:incidence of adverse drug reactions.Data processing was performed using Review Manager5.3 and Stata15.1software,and meta-results were interpreted and analyzed in combination with clinical practices.Result:(1)Total effective rate: Chinese medicine or the combination of Chinese and western medicine was superior to western medicine,with RR=1.16,95%CI[1.11,1.21],and RR(Chinese medicine VS western medicine)> RR(Chinese medicine VS western medicine),RR(1–4 weeks)=1.13,RR(5–8 weeks)=1.19,and RR(more than 8 weeks)=1.15;(2)WOMAC score:TCM or the combination of TCM and western medicine was superior to western medicine,with MD=1.16,MD(TCM VS western medicine)=-6.38,MD(TCM VS western medicine)=-6.33,MD(1-4 weeks)> MD(5-8weeks)> MD(more than 8 weeks);(3)VAS score:TCM or the combination of TCM and western medicine was superior to western medicine,with MD=-1.04,MD(TCM and western medicine VS western medicine)< MD(TCM VS western medicine),MD(over 8 weeks)>MD(1-4 weeks)>MD(5-8 weeks);(4)Lequesne function score:The efficacy of Chinese medicine or the combination of Chinese and western medicine was similar to that of western medicine;(5)TCM syndrome score:TCM or the combination of TCM and western medicine was superior to western medicine,with SMD=-1.18,SMD(TCM and western medicine VS western medicine)<SMD(TCM VS western medicine),SMD(over 8 weeks)>SMD(1-4 weeks)>SMD(5-8weeks);(6)SF-36 scores:In the two studies of traditional Chinese medicine(TCM)compared with non-steroidal anti-inflammatory drugs,the MD of efficacy was 2.48,5.60,4.54,and4.77 for physiological function,general health,vitality,and role-based emotion,respectively,both of which were statistically significant,with no statistical significance for the scores of the remaining four aspects;(7)Inflammatory indexes:The combination of Chinese medicine and western medicine was superior to western medicine in reducing the levels of IL-1 and TNF-α,with SMD of-0.61 and -1.05,respectively.Besides,in reducing the blood TNF-α content of KOA patients,SMD(4–6 weeks)<SMD(8–12 weeks)was observed.In addition,the combination of Chinese medicine and western medicine was better than western medicine in reducing blood IL-6 and hs-CRP levels,with SMD of-0.90 and-0.85,respectively;(8)The incidence of adverse drug reactions:Chinese medicine was better than western medicine,RR=0.28,where RR(1–4 weeks)=0.74,no statistical significance,RR(more than 8weeks)<RR(5–8 weeks),statistically significant,while the safety of Chinese and western medicine was similar to that of western medicine,RR=0.73;(9)The traditional Chinese medicines summarized in this study were divided into five categories,namely,tonifying liver and kidney,replenishing qi and blood,invigorating spleen resolving phlegm,soothing liver and moving qi,activating blood,dredging collaterals,relieving pain,expelling wind,dissipating cold,clearing heat and removing dampness,which exactly corresponded to the etiology and pathogenesis of KOA in traditional Chinese medicine—based on liver and kidney deficiency and qi and blood deficiency,with phlegm-dampness,qi stagnation,blood stasis,wind-cold-damp-heat external pathogen as the criteria.The rattan and insect drugs were also commonly used.Conclusion: Oral administration of traditional Chinese medicine or combined with western medicine in treating KOA patients is superior to western medicine in total effective rate,WOMAC score,VAS score,TCM syndrome score,SF-36(physiological function,general health,vitality and role emotion)and reducing inflammation index,while the effect of improving Lequesne score,SF-36(role physical strength,body pain,social function and mental health)is similar to that of western medicine.In terms of drug safety,compared with western medicine,there is no difference in the combination of traditional Chinese medicine and western medicine,but with the increase of treatment course,the drug safety of traditional Chinese medicine is higher.It shows that the efficacy and drug safety of oral administration of traditional Chinese medicine or combined with western medicine in treating KOA patients are generally higher than those of western medicine.Oral administration of traditional Chinese medicine is a safe and effective treatment measure,which is worthy of clinical promotion.However,due to the low quality of the included literature,small sample size,and possible problems in the methodology of experimental design and implementation,this conclusion needs to be further demonstrated by the research with high quality and large sample.