| Objective1.Through the meta-analysis of the results of acupuncture and moxibustion treatment combined with dopaminergic drug therapy in the treatment of Parkinson’s disease in the past five years,to explore the evidence-based medicine evidence for acupuncture and moxibustion as adjuvant treatment of Parkinson’s disease.2.A randomized controlled clinical trial was conducted to evaluate the effectiveness of the acupuncture and moxibustion treatment for rigidity in Parkinson’s disease from the theory of yang by comparing the acupuncture treatment group and placebo acupuncture control group,and the shear wave elastography(SWE)technology was used to objectively quantify the efficacy,and using Unified Parkinson’s Disease Rating Scale(UPDRS),Modified Webster symptom score,Parkinson’s Disease Questionniare-39(PDQ-39)and other indicators to evaluate the effectiveness and safety of this therapy in the treatment of Parkinson’s disease.3.To explore the possible molecular biological mechanism of acupuncture treatment of Parkinson’s disease from the perspective of oxidative stress and lipid metabolism by detecting the levels of uric acid,triglyceride(TG),total cholesterol(TC),high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C)and homocysteine(Hcy).MethodPart I Literature evaluationSearch CNKI,VIP,WF,CBM,PubMed,EMBASE,Cochrane Central Register of controlled trails and Web of science databases for the randomized controlled trials(RCTs)of acupuncture adjuvant treatment of Parkinson’s disease published from December 31,2014 to December 31,2019,to evaluate the clinical effect of acupuncture adjuvant treatment of Parkinson’ s disease.1.Retrieval strategyChinese key words:Parkinson’s disease,tremor paralysis,tremor syndrome,tremor disease,acupuncture,acupuncture,moxibustion,moxibustion,heat sensitive moxibustion,electroacupuncture,scalp acupuncture,abdominal acupuncture,body acupuncture,ear acupuncture.English search terms:Parkinson disease,Parkinson’s disease,paralysis agitans,parkinsonism,shaking palsy,acupuncture,moxibustion,electroacupuncture,auriculoacupuncture,needle,moxa.The above search words are combined with subject words,free words and key words,and the keywords are connected with OR,AND,NOT.2.Quality evaluationThe "bias risk assessment" worksheet produced by Cochrane collaborative network is used for quality assessment.The assessment are conducted by two independent researchers.In the assessment and screening process,if two researchers have different opinions,they will make a decision through consultation.If the consultation still fails to reach an agreement,the third researcher will make a decision through analysis.3.statistical analysisRevman 5.3 software was used for statistical analysis,funnel chart drawing,and detected publication bias according to the degree of literature dispersion.Ratio(OR)and relative risk(RR)were used to describe the data of binary variables.Mean difference(MD)or standardized mean difference(SMD)were used for variable data.In the calculation of the results,the confidence interval(CI)was selected as 95%,and the difference was considered statistically significant when P<0.05.For the heterogeneity test of data,if the heterogeneity is small,the fixed effect model is used for analysis,if the heterogeneity is large,the subgroup analysis is carried out first,and the random effect model is used for analysis if the heterogeneity is still large after the subgroup analysis.Part Ⅱ clinical researchRandom number and grouping results were generated by spss22.0 statistical software,and 60 patients with Parkinson’s disease and with rigidity symptom recruited in Guangdong Provincial Hospital of Traditional Chinese Medicine were divided into acupuncture group and control group according to the ration of 1:1.The acupuncture group was treated with“treatment from the theory of yang" acupuncture therapy,and the control group was treated with placebo acupuncture and moxibustion treatment.1.Intervention(1)Acupuncture group(1)acupoint selection:Acupuncture:Baihui,Lianquan,Zhongwan,Xiawan,Qihai,Guanyuan,and Touwei,Waiguan,Sanyinjiao,Zulinqi of both sides.Moxibustion:Group I:Every points of the first siding line of the urinary bladder channel from Tianzhu to Pangguangshu and Juegu(bilateral).Group Ⅱ:Every points of the Du meridian from Fengfu to Yaoyangguan and Yongquan(bilateral).Group Ⅰ and Ⅱ alternated.Intradermal auricular acupuncture:auricular points of heart(C015),liver(C012)and kidney(CO10)area,take one side of the points for each treatment,Left-right alternation.Location of the acupoints refer to the national standard of the people’s Republic of China(GB/T 12346-2006)Name and location of acupoints and(GB/T 13734-2008)Nomenclature and location of auricular points.②Operation:Patients were placed in the supine position.Acupuncture on bilateral Waiguan,Zulinqi and Sanyinjiao at firts,followed by Baihui,Touwei and Lianquan,and Zhongwan,Xiawan,Qihai and Guanyuan at last.After the routine disinfection,a set of casing acupuncture apparatus was placed on the acupoint and general acupuncture needle was inserted trough the foam pad into the skin.The twist manipulation was performed until the patient felt local acid and numbness,then leaved the needle for 30 minutes.After acupuncture,the moxa cones of 0.3mm high with diameter of 0.2mm were used for the moxibustion.Placed the moxa cones on the acupoints with Wanhua oil and lit it by a slender stick of incense,removed it when it was ignited to the remaining 1/3～1/4 and 2 cones per point.After moxibustion,the intradermal auricular acupuncture was conventionally operated,and the needle was retained for 3 days if there is no discomfort or take it off when feeling uncomfortable.(2)Control group① Acupoint selectionThe same acupoints as acupuncture group② OperationPatients were placed in the supine position.The acupuncture sequence is the same as that of the acupuncture group.After the routine disinfection,a set of casing acupuncture apparatus was placed on the acupoint,then special blunt acupuncture needle was inserted into the foam pad and touch the skin that produced certain sense of pain but no skin piercing.The needle retaining time was 30 minutes.The operation of placebo moxibustion was similar to the acupuncture group,but more Wanhua oil was applied to the acupoints to soak the moxa cones so that it could not be ignited.The sham intradermal auricular acupuncture used a small plaster to stick on the acupoints,then stuck the intradermal needle on the plaster by adhesive tape that the needle would not pierce the skin,and retained for 3 days.2.Course of treatmentSix weeks is one course,the total courses of the treatment is two course(12 weeks).The patients were treated twice a week,the interval of each treatment was not less than 48h,24 times in total.Patients which completed 80%of the course were effective cases.3.Evaluation indicators and time pointsMain outcome measures:Young’ s modulus of limbs muscle measured by SWE.Secondary evaluation indexes:UPDRS score,modified Webster symptom scale and PDQ-39 score;Other observation indexes:uric acid,TC,TG,LDL-C,HDL-C,Hcy,medication record,safety evaluation,compliance evaluation and masking effect evaluation,Masking effect evaluation scale,adverse reactions,etc.Evaluation time pointthree time points in weeks 0,6 and 12 were selected as evaluation time points.Time point ①:SWE examination,scale evaluation(including UPDRS score,Webster improved scale score,PDQ-39 score),biochemical index detection(including blood routine,blood lipid,uric acid,homocysteine).time point ②:SWE examination,scale evaluation;time point ③:SWE examination,scale evaluation,compliance assessment Evaluation scale of blinding effect of price and blind method.Recording at any time:drug use,adverse reactions,etc.4.Data statisticsSpss22.0 software was used to establish the database and carry out statistical analysis on the data.According to the types of data properties(classification,grading,measurement,etc.),appropriate statistical methods were selected for statistical analysis.The measurement data were first tested by normality test and homogeneity of variance test.ANOVA was used to compare the satisfied samples and Wilcoxon rank sum test was used to compare the unsatisfied samples.Ranking data were tested by Wilcoxon rank sum test.Repeated measurement ANOVA was used for quantitative main outcome indicators at multiple observation points.Using a bilateral test,baseline comparison test level was α=0.05,pairwise comparison between groups was a=0.0167.Result1.Literature evaluation resultsThrough literature retrieval,192 literatures were preliminarily selected.After reading the full text,23 Chinese literatures and 4 English literatures were finally included,a total of 27 literatures,including 1951 cases.All the included literatures were randomized controlled clinical studies with mixed quality.In the comparison of acupuncture combined with dopamine efficacy drugs and dopamine efficacy drugs alone,there were 17 literatures used clinical efficacy as the outcome index.The heterogeneity test showed that P=0.80,I~2=0%,using fixed effect model,the results showed that[MD=3.49,CI=(2.59,4.70),Z=8.21,P<0.00001],suggesting that the clinical efficacy of acupuncture combined with drugs is better than drugs only.There were 11 literatures reported the total score of UPDRS,totally 828 cases were included,the heterogeneity test result was P<0.00001,I~2=91%.The subgroup analysis showed that the heterogeneity test result of studies which treatment courses were<12 weeks was P=0.80,I~2=0%,the fixed effect model was selected and the 95%CI of the UPDRS scores after treatment was[MD=6.14 CI=(4.26,8.02),Z=6.41,P<0.00001].The heterogeneity of the studies≥12 weeks was high(P<0.00001;I~2=89%),after excluded the literature with high heterogeneity the homogeneity was high(P=0.96,I~2=0%).Using the fixed effect model,and the result was[MD=10.36 CI=(8.77,11.94),Z=12.81,P<0.00001],suggesting that acupuncture combined with drugs has better efficacy than drugs only in reducing the total UPDRS score.In parts of UPDRS scores,4 parts were included 4,4,7,4 literatures,and the test results showed that there were differences between the two interventions(P<0.05),suggesting that acupuncture combined with drug treatment was better than treatment of drugs only in reducing the scores of 4 parts of UPDRS.In terms of the score of Webster symptom scale,among the 4 included literatures,the heterogeneity is high(P<0,00001;I~2=98%).After analyzing the heterogeneity source and eliminating the heterogeneity source literature,the heterogeneity is still high P<0.00001;I~2=98%),select the random effect model,the analysis result is P=0.0008,the conclusion is reversed.It shows that Acupuncture combined with drugs therapy is superior to the drugs only therapy in reducing the score of Webster symptom scale,but the results are unstable.In terms of comparing the therapy of acupuncture combined with drugs and placebo acupuncture combined with drugs,UPDRS daily life activity score was included in 2 literatures,UPDRS motor function score was included in 4 literatures,and PDQ-39 total score was included in 3 literatures.The results showed that there was no significant difference between the two intervention methods,suggesting that acupuncture group and placebo acupuncture group had the same effect.The results showed that acupuncture combined with dopamine efficacy drugs was better than dopamine efficacy drugs alone in the treatment of Parkinson’s disease,the effect between acupuncture combined with dopamine efficacy drugs and placebo acupuncture combined with drugs on the activities of daily life,motor function and quality of life of PD patients is similar.2.Clinical trial results(1)General demography data52 effective cases were included in this study,including 28 cases in acupuncture group and 24 cases in control group.There was no significant difference between the two groups in age,gender,education,height,weight,Parkinson’s disease course,rigidity course,ever received acupuncture treatment or not,current medications,and rigidity condition.(2)RigidityUPDRS rigidity scoreIn terms of intra-group comparison,the scores in the acupuncture group at the 6th week of treatment and after treatment were significantly lower than those before treatment(P<0.05),while the scores in the control group at the 6th week of treatment and at the end of treatment were not significantly different from those before treatment(P>0.05).In terms of inter-group comparison,the scores in the two groups before treatment,at the 6th week of treatment and after treatment were not significantly different(P>0.05).In terms of difference comparison,the difference of UPDRS rigidity score between the two groups before and after treatment was statistically significant(P<0.05).Young’s modulus measured by SWEThere was no significant difference in Young’s modulus of biceps,brachioradialis,rectus femoris and triceps surae between the two groups before treatment(P>0.05).In terms of Young’s modulus of biceps brachii,it was significantly lower in the acupuncture group at the 6th week and after treatment than before treatment(P<0.05),and there was no significant difference in the control group at the 6th week and at the end of treatment compared with before treatment(P>0.05).Acupuncture group was superior to control group in reducing Young’s modulus of biceps brachii(P<0.05).In terms of brachioradialis muscle,there was a significant decrease in the acupuncture group at the 6th week and after the treatment compared with that before the treatment(P<0.05),and there was no significant difference in the control group at the 6th week and at the end of the treatment compared with that before the treatment(P>0.05).Acupuncture group was superior to control group in reducing Young’s modulus of brachioradialis(P<0.05).In terms of rectus femoris,there was a significant decrease in the acupuncture group at the 6th week of treatment and at the end of treatment compared with that before treatment(P<0.05),while there was no significant difference between the control group at the 6th week of treatment and at the end of treatment compared with that before treatment(P>0.05),but there was no significant difference between the acupuncture group and the control group after treatment(P>0.05).Compared with the difference value of Young’s modulus of rectus femoris before and after treatment,there was a significant decrease in the acupuncture group compared with the control group(P<0.05).Acupuncture group was superior to control group in reducing Young’s modulus of rectus femoris(P<0.05).In terms of triceps,there was no significant difference between the 6th week of treatment and at the end of treatment compared with before treatment in both groups(P>0.05),and there was no significant difference between the two groups after treatment(P>0.05).There was no significant effect in reducing Young’s modulus of triceps in both groups.(3)UPDRS scoreThe total UPDRS scores of acupuncture group at the 6th week and after treatment were significantly lower than those before treatment(P<0.05),while the scores of control group at the 6th week and at the end of treatment were not significantly lower than those before treatment(P>0.05).The effect of acupuncture group in reducing the total score of UPDRS was better than that of the control group(P<0.05).The scores of Part Ⅰ(spirit,behavior and emotion)of acupuncture group at the 6th week and after treatment were significantly lower than those before treatment(P<0.05).There was no significant difference in the scores of control group before and after treatment(P>0.05).The efficacy of acupuncture group in reducing the score of UPDRS Part Ⅰ was better than that of control group(P<0.05).In terms of Part Ⅱ(daily activities),the scores of acupuncture group at the 6th week and after treatment were significantly lower than those before treatment(P<0.05),and there was no significant difference in the scores of control group before and after treatment(P>0.05).There was no significant difference between the two groups after treatment(P>0.05).In terms of Part Ⅲ(motor function),the scores of acupuncture group at the 6th week and after treatment were significantly lower than those before treatment(P<0.05),while the scores of control group before and after treatment had no significant difference(P>0.05),and the efficacy of acupuncture group in reducing the score of UPDRS Part Ⅲ was better than that of control group(P<0.05).In terms of PartⅣ(complications of treatment),the scores of acupuncture group at the 6th week and after treatment were significantly lower than those before treatment(P<0.05),while the scores of control group before and after treatment had no significant difference(P>0.05),and there was no significant difference between the two groups after treatment(P>0.05).(4)Webster symptom scale scoreThere was no significant difference in Webster symptom scale score between the two groups before treatment(P>0.05).In the acupuncture group,both the 6th week and the end of treatment were significantly lower than that before treatment(P<0.05).There was no significant difference between the control group at the 6th week and the end of treatment compared with before treatment(P>0.05).The difference between the two groups at the end of treatment was statistically significant.The effect of acupuncture group on the reduction of Webster symptom scale score was better than that of the control group(P<0.05).(5)PDQ-39 scoreIn terms of improving the overall quality of life,there was a significant decrease in the acupuncture group at the 6th week and the end of treatment compared with that before treatment(P<(0.05),while there was no significant difference in the control group at the 6th week and the end of treatment compared with that before treatment(P>0.05),but there was no significant difference between the acupuncture group and the control group after treatment Significant(P>0.05).After comparing the difference value of scores before and after treatment,the score of the acupuncture group decreased significantly compared with the control group(P<0.05).Overall,in terms of improving the overall quality of life,the acupuncture group has a certain effect,while the control group has no significant effect.Compared with the control group,the acupuncture group has a certain advantage in efficacy.There was no significant effect in both groups in terms of ①motor function,②daily life behavior,④sense of humiliation and ⑦social interaction(P>0.05).In terms of③mental emotion and⑥cognition,the acupuncture group decreased significantly at the 6th week and after the treatment compared with that before treatment(P<0.05),the control group had no significant difference at the 6th week and at the end of treatment compared with that before treatment(P>0.05),but there was no significant difference between the two groups at the end of treatment(P>0.05).In terms of ⑤social support and⑧physical discomfort,there was a significant decrease in the acupuncture group at the 6th week and after the treatment compared with that before treatment(P<0.05).There was no significant difference in the control group at the 6th week and at the end of treatment compared with that before treatment(P>0.05).The effect of acupuncture group was better than that of the control group(P<0.05).(6)Biochemical index of bloodThere was no significant difference in the levels of uric acid,TG,TC,HDL-C,LDL-C,Hcy between the two groups before treatment(P>0.05).After treatment,there was no significant change in each index in both groups(P>0.05),and there was no significant difference between two groups(P>0.05).(7)Correlation analysisThe difference of the young’s modulus of biceps brachii and the sum of the young’s modulus of four muscles before and after treatment was positively correlated with the difference between the UPDRS rigidity score,total score and part Ⅲ motor function score before and after treatment(P<0.05),the difference between the rectus femoris and the total score of UPDRS was positively correlated with the difference of low degree(P<0.05)and had no significant correlation with the difference of UPDRS rigidity score and part Ⅲ motor function score(P>0.05),and the difference between the triceps brachioradialis and crus was not significantly correlated with the difference of the UPDRS rigidity score,total score and part Ⅲ motor function score before and after treatment(P>0.05).(8)Evaluation of blinding effectThere was no significant difference between the control group and the acupuncture group in the feeling of acupuncture,moxibustion and buried ear acupuncture,as well as in the recognition degree of treatment(P>0.05).The blind method is effective.(9)MedicationDuring the study,3 participants changed their medication plan,including 1 case in acupuncture group and 2 cases in control group.Conclusion1.The results of meta analysis showed that acupuncture combined with dopaminergic drugs was better than dopaminergic drugs alone in the treatment of Parkinson’s disease,the effect between acupuncture combined with dopamine efficacy drugs and placebo acupuncture combined with drugs on the activities of daily life,motor function and quality of life of PD patients is similar.However,some of the studies are of low quality,with strong heterogeneity.2."Treatment from the theory of yang" acupuncture therapy can effectively improve the symptom of rigidity in Parkinson’s disease and reduce the stiffness of biceps brachii,brachioradialis and rectus femoris,but it has no significant effect on the muscle stiffness of triceps calf,and sham acupuncture has no significant effect.3.The acupuncture therapy of "Treatment from the theory of yang" can improve the symptoms of Parkinson’s disease patients,mainly in the aspects of motor function,spirit,behavior and emotion,and the improvement of the symptoms is related to the improvement of rigidity.This acupuncture therapy can improve the overall quality of life of Parkinson’s patients,mainly in the aspects of physical discomfort,mental emotion,social support and cognition,and the effect of sham acupuncture is not significant.4.There is no relationship has been found in this study between the effect of acupuncture on Parkinson’s disease and the mechanism of oxidative stress and lipid metabolism. |
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