Clinical Studies And Methodological Studies On The Differences In Acupuncture Manipulation

ObjectivesTo evaluate the consistence and difference of acupuncture manipulation provided by senior or junior acupuncturist in the same CINV patients when the manipulation of manual acupuncture was quantitatively recorded and the level of acupuncture prescriptions were under control.And to investigate the relationship between clinical effects and manipulating skills of acupuncturist for providing methodological suggestion of further clinical study.MethodBased on a randomized cross-over trial,inpatients from oncology department in Xiyuan hospital of China Academy of Chinese Medical Sciences diagnosed with cancer and received at least two continuous cycle of cisplatin chemotherapy,meanwhile used 5-HT3 as an anti-emetic treatment were enrolled.Eligible participants were randomly allocated to two groups(A or B).In group A,patients were treated by senior in the first cycle and changed to the junior in the next.In group B,the sequence was vice versa.There was a washout period(21 days)between two continuous cycles.The senior had over 15 years' clinical experience in acupuncture and the junior acupuncturist less than 5 years.Within each cycle,every patient received manual acupuncture treatments once per day for 5 days.Patients were under bedside interrogation by two acupuncturists at the same time.Two acupuncturists independently decided and recorded their own treatment regimens(acupoints selection,manipulation methods and needle retention time)but they only perform which senior determined.During the process of the acupuncture treatment,needle manipulation parameters including displacement amplitude(DA),displacement frequency(DF),rotation amplitude(RA)as well as rotation frequency(RF)were observed and saved by Acusensor in an objective and quantitative way.The evaluation of curative effect and the analysis of manipulation parameters were carried out for the comparison between the senior and the junior since the patients in the two groups were the same.After the statistical analysis,two acupuncturists were interviewed about the description and understanding of the whole trial.Through the NCI scale and Rhodes scale which rating respectively by doctors and patients themselves,to compare the efficacy of treatment within two acupuncturists.Besides,based on the manipulation parameters,to evaluate the difference and stability of two acupuncturists,the stability of manipulation for themselves and correlation between acupuncture manipulation and clinical curative effect.The stability of the senior regimens,acupuncture expectancy scale and patient communication satisfaction scale were also adopted and analyzed for evaluating the risk of bias.Paired-sample t test and Wilcoxon test were used for statistical analysis.Result39 participants were randomized(group A,n=20;group B,n=19)and analyzed for baseline characters.It turned out that there was no significant difference between group A and B.However,the evaluation of the differences of needle manipulation were analyzed according to the data from per-protocol set(25 cases for each doctor).Former studies showed that clinical effect had a statistical difference between two acupuncturists after the third-time acupuncture treatment based on NCI scale and Rhodes scale.Current results of the manipulation part showed that:1)Treating the same patients,DF had no statistical difference,but other three manipulation parameters were statistically different between two doctors.The DA of Zhongwan(P<0.001),Neiguan(P<0.001)and Zusanli(P<0.001)needling by the senior were much deeper than the junior,but the DA of Tianshu(P<0.001)was relatively shallower.The RA of Tianshu(P<0.001),Neiguan(P=0.046)and Zusanli(P<0.001)needling by the senior were much bigger than the junior,but the RA of Zhongwan(P=0.004)was relatively smaller.Only on Zhongwan(P=0.004)and Tianshu(P=0.004),the junior rotating the needles faster than the senior.2)The stability of DA on four acupoints and four manipulation parameters on neiguan between two doctors had statistically difference(P<0.001),the junior was more stable.3)At different time points,the manipulation parameters of the senior reflected the stability in 62.5%(10/16),while the junior doctors in 50%(8/16).The self-stability of the senior is more obviously,especially on neiguan.4)After treated by both doctors,acupuncture expectancy scale,patient communication satisfaction scale as well as treatment satisfaction scale showed no statistical difference.Current results of the treatment regimens part showed that:1)Within the first cycle,the acupoints selected by two doctors were basically consistent(P=0.724)but the depth,strength,manipulation methods and needle retention time were statistically different(P<0.05).2)During two cycle,treatment regimens decided by the senior including acupoints selection,manipulation methods and needle retention time had no significant difference.As for the qualitative study,it turned out that the dialectical results were greatly different in two doctors because of the different angles during interrogation.Both doctors pick up the same acupoints since the pathogenesis is relatively simple and acupoints always had two-way regulation,although the ideas and principles of acupoints selection are different.In order to achieve the purpose of reinforce insufficiency and reduce excessiveness,the junior considering to enhance acupuncture stimulation by increasing needle retaining time and reinforcing and reducing method which consistent with the results of the quantitative study.However,treatment regimens of the senior were stable which confirmed with quantitative results.As for manipulation parameters,the real acupuncture stimulation of the junior was weaker than expected due to lack of confidence and the manipulation experience.ConclusionTreating the same patient using similar acupuncture prescription,the manipulation of the senior could cause more stimulation than the junior since the lifting and twisting of the needles was more significant.Based on the body size and severity of disease,the senior would flexibly adjust the frequency and displacement of manipulation of needles,while the adjustment of the junior is not so obvious.Pulling together the results of the previous analysis of the project about the significant differences between the clinical therapeutic effects of the senior and junior acupuncturists,this study found that the differences in acupuncture manipulation would affect the clinical effects of acupuncture treatment.However,due to the limitation of small sample size and no blinding method for both participants and acupuncturists,the interpretation of the results need to be cautious.This study could provide some methodological suggestions for future acupuncture clinical trials.when evaluating or exploring the effect of acupuncture,the influence of qualification and acupuncture manipulation of acupuncturists should be fully considered.Training and quantitatively assessing the acupuncture manipulation before the launch of trials should be considered to maintain the quality of acupuncture treatment and the adherence of acupuncture treatment with the protocol.