| BackgroundRadiographic axial spondyloarthritis(R-axSpA)is a common rheumatic disease characterized by back pain and stiffness in adolescence and early adulthood.This pain,stiffness will be reduced with exercise.With the further development of the disease,the spinal activity is limited,and finally the spine is ’ bamboo-like ’ change,and the activity is completely lost.In China,acupotomy therapy as an important physical therapy has been proved to be able to effectively improve the symptoms and signs of AS patients.This study intends to conduct a comprehensive and rigorous methodological assessment and analysis of relevant studies published in recent years,systematically evaluate the effectiveness of acupotomy therapy in the treatment of this disease,and provide high-level evidence-based basis.At present,randomized controlled trials(RCTs)are known as the ’ gold standard ’ for clinical trials because of their high level of evidence.However,most of the non-drug therapies of traditional Chinese medicine are treated with tools or special actions,which brings difficulties to the blind design of clinical trials.At the same time,patients choose traditional Chinese medicine treatment because of trust in traditional Chinese medicine non-drug therapy or poor effect of drug therapy.Therefore,randomized controlled trials(RCTs)are no longer applicable.Objective performance criteria(OPC)refers to a series of widely recognized indicators obtained from a large number of previous literature.This method can be considered when the clinical research is difficult to randomize,the control group is difficult to set up,the blind method cannot be realized,and the dropout rate during the study period is high.Methods1.Chinese biomedical literature database,Chongqing VIP database,China National Knowledge Infrastructure(CNKI),Wanfang,Science Network,Cochrane Library,PubMed and EMBASE,Web of Science,Physiotherapy Evidence Database,and International Clinical Trials Registry Platform(ICTRP)of the World Health Organization were retrieved.The National Institutes of Health Trial Registry(www.clinicaltrials.gov)and the Chinese Clinical Trial Control Registry are available for ongoing and unpublished studies regardless of their publication status.The deadline is 15 September 2021.Randomized controlled clinical trials were included to compare acupotomy versus non-acupotomy in the treatment of ankylosing spondylitis,regardless of publication status,language,and(whether or not)blinding methods.Two systematic evaluation authors extracted data from the included studies.The main efficacy indicators were Bath ankylosing spondylitis disease activity index(BASDAI),Bath ankylosing spondylitis functional index(BASFI),and ASAS group response criteria 20 score.ASAS20,ASAS40 improvement criteria(ASAS40),ASAS5/6 improvement criteria(ASAS5/6),visual analog scale(VAS)and clinical efficacy were the main results.The secondary results were chest enlargement,ESR,Schober test,CRP(C-reactive protein),finger-to-ground distance,and pillow-wall distance.Assess risk of bias using cochrane bias risk assessment tools;for binary variables,risk ratios(RRs)were used as combined effects and 95%confidence intervals(95%CI)were calculated.Continuous variables are standardized mean difference(SMD)and 95%confidence interval(CIs).All results will be presented intuitively by forest map and funnel map.We will conduct heterogeneity test by calculating H statistics and I2 statistics,and conduct sensitivity analysis by changing the effect amount.Subgroup analysis based on different types of interventions.Use the GRADE assessment tool to assess the quality of evidence.All statistical synthesis was completed by stata15.1.2.This study is a prospective,single-center,single-group study based on objective performance criteria.Patients with radiation-positive spinal arthropathy were included,except those with other autoimmune diseases.All patients received 1-2 times/week acupotomy treatment.The main efficacy endpoint of the patients was the compliance rate of ASAS group response criteria 20 score(ASAS20)at the end of 6 weeks of treatment.The performance target(PT)of this study was derived from the compliance rate of ASAS20 in the previous randomized controlled trials of sulfasalazine in the treatment of ankylosing spondylitis,namely 52%.The accurate binomial distribution method was used for statistical inference,and the 95%confidence interval(95%CI)of the effective rate was calculated and compared with the the performance goalResults1.Systematic review and meta-analysis:14 randomized clinical trials were included,involving 963 patients.ASAS20 comparison between the two groups of needle knife+conventional drug therapy and conventional drug therapy,RR=1.96,95%CI[1.42,2.72],I2=0,Z=4.06,P=0.00;RR=1.25,95%CI[1.17,1.34],Z=6.63,P<0.001;the VAS scores of the two groups were compared,SMD=-0.91,95%CI[-1.36,-0.46],Z=3.99,P=0.00;comparison of BASDAI between the two groups showed SMD=-1.34,95%CI[-1.88,0.90],Z=5.55,P=0.00;the BASFI comparison between the two groups showed SMD=0.82,95%CI[-1.14,-0.51],Z=5.09,P=0.00;the overall scores of doctors in the two groups were compared,MD=-0.80,95%CI[-1.12,-0.47],Z=4.82,P<0.00;SMD=0.35,95%CI[-0.45,1.16],Z=2.72,P=0.007;SMD=0.544,95%CI[0.22,0.87],Z=3.26,P=0.001;The chest mobility of the two groups was compared,SMD=0.65,95%CI[0.14,1.16],Z=2.51,P=0.012.SMD=-0.70,95%CI[-1.22,-0.180],Z=2.64,P=0.008;SMD=-0.94,95%CI[-1.27,-0.61],Z=5.62,P=0.000.GRADE evidence level evaluation results show that acupotomy combined with traditional Chinese medicine can reduce VAS score 0.78,BASDAI1.89,BASFI1.03,pillow wall distance 0.7 cm,finger-ground distance 0.94 cm,the curative effect is better than the control group(evidence level:medium),reduce ESR1.5 mm/h,the curative effect is better than the control group(evidence level:low);it could increase SCHOBER 0.73 cm and chest activity 0.79 cm,and the efficacy was better than that of the control group(evidence level:medium).The improvement of CRP by acupuncture and knife combined with traditional Chinese medicine was not better than that of the control group(evidence level:low).In the aspect of acupuncture-knife combined with routine western medicine treatment,acupuncture-knife combined with routine western medicine treatment can reduce VAS score by 1.13 points,BASDAI 0.78 points and BASFI 0.56 points,and the curative effect is better than that of the control group(evidence level:medium).Can improve SCHOBER0.08cm,thoracic activity0.41cm,curative effect is better than the control group(evidence level:medium),needle knife combined with conventional western medicine on CRP,ESR improvement is not better than the control group(evidence level:low).2.Between December 1,2020 and March 01,2022,35 patients(median age 40(34,45)years,course of disease 60(30,120.5)months,24 cases(65.58%)were male,11 cases(34.43%)were female.After 6 weeks of treatment,the ASAS20 compliance rate of AS treated with acupotomy was 68=57%,95%CI(95%CI 0.51-0.83),and the performance goal included 52%(p=0.06).It was not considered that the ASAS20 compliance rate of AS treated with acupotomy was better than that of sulfasalazine.The scores of B ASDAI,B ASFI,ASDAS,oswestry disability index and lumbar mobility were improved before and after needle knife treatment,and the difference was statistically significant.No serious adverse events occurred during treatment.Conclusion1.Acupotomy is superior to conventional therapy in improving clinical symptoms and signs of AS,but the effect of reducing inflammation is not clear.2.Needle-knife therapy is effective and safe in the treatment of AS,and it cannot be considered that the ASAS20 compliance rate after 6 weeks of needle-knife therapy is better than that of sulfasalazine.The efficacy was significant in improving ASDAS score,BASDAI,BASFI,oswestry disability index and lumbar mobility,and the difference was statistically significant. |
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