Clinical Evaluation On The Effect Of Acupuncture For Primary Sj?gren Syndrome

Primary Sjogren Syndrome(pSS)is a systemic autoimmune disease,with dryness,fatigue and pain as the main symptoms,which seriously affect the quality of life of patients.Currently,feasible medical treatments are hitherto not satisfying to relieve pSS symptoms,which concerns numbers of clinical doctors.Acupuncture seems to be an alternative to treat pSS and conduces to good symptomatic results.However further research is necessary.This study aims:to evaluate the effectiveness and safety of of acupuncture on treating patients with pSS.Optimization on acupoints option and study designAncient and modern literature review shows that pSS causes great uncomfort to patients,and current treatments donnot satisfy both patients and doctors..Previous studies shows that acupuncture is a promising treatment for improving the clinical symptoms of patiets with pSS.Basing on the academic thought of professor Lu zhizheng and the study of ancient classic books,combining with the clinical experience of my supervisor Liu Zhishun,the acupoints for pSS were optimized First.Then,we realized that there are a number of methodological problems existing in current studies about acupuncture on pSS,including unreasonable design,unproperly set of control group,unstandardized evaluation indexes.,etc..We tried to fix them in this clinical research.Clinical ResearchMethods&Design:The study is designed as a randomized controlled trial of two arms with a single centre.We compare acupunctre with sham acupuncture on symptomatic improvements of pSS.A total of 120 pSS patients,aged at least 18,with DPF,will be randomly assigned to acupuncture or sham acupuncture groups,where they will have needle intervention for 8 weeks with 16 weeks of follow-up.Subjects will be assessed each time before interventions during the 8-week intervention.The primary outcome are the proportions of subjects that have 30%or greater reduction in at least 2 out of 3 items of DPF in Numeric Analog Scale(VAS)scores(0=the best,10=the severest),calculated between the baseline and the average scores of week 3 to 8.The secondary outcome are related to individual items of VAS scores,EULAR Sjogren's Syndrome Patient Reported Index(ESSPRI),EULAR Sjogren's Syndrome Disease Activity Index(ESSDAI),Schirmer test score and unstimulated salivary flow,serum Immunoglobulin G,A and M levels,Medical Outcome Study Short Form 36 Short-Form Health Survey(SF-36),Salivary glands ultrasounds,Hospital Anxiety and Depression(HAD)scale score.The secondary outcome scores are to be collected at baseline,in week 8,16,and 24.Besides,individual items of VAS will also be collected in week 12 and 20.Moreover,subjects' satisfaction and the proportion of the subjects who identified their allocation will also be measured and analyzed.Results:120 cases were randomized,58/60 and 55/60 patients finished the study in acupuncture and sham acupuncuture groups,respectively.The mean age was 56.2 ±13.7 and 58.9 ± 9.8 respectively.The symptoms of pSS were onset 45(6-99)and 49(12)-99)months ago in acupuncture and sham acupuncture.There are 46 and 45 cases with SSA positive.As shown in Table 1,no significant differences were found among two groups at baseline(P>0.05).Rate of symptom improvement showing as N/N(%):25/60(41.67)in acupuncture group,and 10/60(16.67)in sham-a as in FAS(full-text analysis set);and 25/58(43.1)V.S.10/55(18.18)as in PPS(pro-protocal set),P<0.05.The changes of Sjogren's Syndrome Patient Reported Index(ESSPRI)were-16.23 ± 14.18 in acu,-9.79 ± 14.16 in sham-a,p = 0.09,respectively.About the objective indexes,patients in both of two groups have an improvement in schirmner test and non-irritating mixed saliva flow rate;and the one in acupuncture group are improved better.The dynamic erythrocyte sedimentation rate decrease in the acupuncture group and increase in sham-a.C-reactive protein and immunoglobulin M are elevated in both groups.After teatment IgG reduces more in acupuncture group,P?0.055.And after treatment,IgA and ESR decreased in both groups,more reducement in acupuncture group,the difference with statistically significant(P<0.05).In addition,EULAR Sjogren's Syndrome Disease Activity Index(ESSDAI),the anxiety and depression of the patients were lower than those before treatment,and the overall health situation get improvement;within the four aspects,ESSDAI,patient anxiety,and SF-36 are improved better in acupuncture group,while the difference with no statistically significant(P>0.05).Adverse event:A total of five patients reported adverse events during the course of the study,with no serious adverse events observed.There was no significant difference between the two groups(P>0.05).Among them,2 cases in control group reported pain;2 patients in acupuncture group showed congestion pain in acupupoint aere,and 1 patient with localized itching caused by the adhensive paddle.Each of them got self remission.Conclusion:In this study,randomized,controlled clinical studies,acupuncture treatment of pSS clinical efficacy evaluation of the following conclusions:(1)Acupuncture can improve the main clinical symptoms of patients with pSS and improve clinical symptoms.The improvement of dryness and fatigue is superior to the relief of pain.(2)In terms of inflammatioin,acupuncture can reduce ESR;(3)In terms of immunoglobulins,acupuncture can reduce IgA,and has a good effect on the reduction of IgG.(4)Acupuncture can improve overall health status and depression,and has a positive impact on sleep and appetite.(5)Acupuncture improved the ink-absorption test,salivary flow rate,ESSPRI,ESSDAI,anxiety;(6)The acupuncture points and stimulation techniques selected in this study are safer.InnovationInnovations on the therapeutic ideas:aiming at the clinical difficulties of pSS,we inherited the academic experience of professor Lu zhizheng,combined with the ancient clssic literature and the clinical opinion of acupuncture expert,my superviser,and optimized the acupoints for pSS in this study,which has a better effect to improve the clinical symptoms of pSS.Method innovation:designed as a randomized,subject-blinded,parallel-controlled trials,we set a reasonable control group,using standard indicators and a therapeutic evaluation system to evaluate the efficacy of acupuncture on pSS;The evaluation was made by objective indicators such as Schimmer test,salivary flow rate,ESR,C-reactive protein,and immunoglobulin,making the results more reliable.