| ObjectiveGeneralized anxiety disorder(GAD)is the most common mental illness in China.The aims of this study is to observe the efficacy and safety of Navel Acupunture for treating GAD?At the same time,through the analysis of literature published in the past 20 years on the clinical application of navel acupuncture,the operation rules of navel acupuncture therapy for mental disease are summarized.Such rules cart serve as the basic guidelines for the development of clinical trial design.MethodsThe study comprises two parts:"Literature Analysis" and "Clinical Research".Literature Analysis:covers material on navel acupuncture drawn from four sources:the China Knowledge Resource Integrated Database(CNKI),the Sino Medical Sciences Technology Inc(SINOMED),the Wanfang Data Knowledge Service Platform(WF),and the VIP Chinese Science and Periodicals Full-Text Database(VIP).The search key words are "Navel Acupunture" or "Umbilical Acupunture".The search period is from 1999.1.1 to 2019.8.15.Of the reports published during this period,those on the clinical research of navel acupuncture for mental illness are given special attention,and statistical analysis is carried out.Clinical studies:are conducted for 64 patients with GAD,32 patients in the treatment group and 32 in control group.The treatment group was treated with navel acupunture and control group was treated with conventional acupunture.All cases were diagnosed after examination as belonging to the dialectical syndrome type of TCM of the excess syndrome(the liver qi stagnation syndrome)and the deficiency syndrome(heart and kidney deficiency syndrome).The navel acupunture group is administered in accordance with the I-Ching Navel Acupuncture theory;the patient with excess syndrome is the Zhen position,Xun position,Kun position around the navel,whereas patients,whereas patient with deficiency syndrome(the heart and kidney deficiency syndrome)receive treatment in the Kan,Li,Kun and Qian position.Both groups receive treatment twice a week for 5 weeks in a course of 10 treatments in all,each with 30 minutes of needle retention time.For efficacy observation,the Hamilton Anxiety Scale(HAMA),the Self-rating Anxiety Scale(SAS),and the TCM syndromes score table are adopted as primary tools.Secondary evaluation tools include the Pittsburgh Sleep Quality Index(PSQI)total score.The scores derived from the primary and secondary evaluation tools are recorded before and after each treatment,one month after the treatment course,and three months after the treatment course respectively.Changes in the scores are analyzed for evaluating the efficacy of navel acupuncture.Statistical analysis of all data is performed using the PASW Statistics 18.0 statistical analysis software package.The measurement data were measured by the mean standard deviation(±)and its distribution is tested for normality.The count data is represented by the composition ratio,and the test level is set at a=0.05.For the normal distribution data,two independent sample t-tests are used for comparison between two independent sample groups.For non-normal distribution data,the rank sum test was used for comparison between the two independent sample groups;for trend comparison,repeated measures analysis of variance was used.The ratio between two groups is compared using a four-patter Pearson test or a fisher exact probability test.ResultsLiterature analysis:71 articles on navel acupuncture are sorted,of which only 42 are in compliance with requirements for clinical research.From these 42 articles,7 disease systems and 32 diseases can be identified.Disease systems are ranked according to the number of related documents sorted.There are 8 articles on insomnia,which account for 19%of the total literature.There are 12 articles on other mental diseases,accounting for 28.57%of the total.The average effective rate of clinical treatment is 93.27%,testifying that navel acupuncture is effective in treating mental illness.The most commonly adopted treatment course lasts 20 days,and the most commonly adopted treatment frequency is once a day.It is also found appropriate for needles to stay in the acupuncture points for 30 minutes per session.Much concern is focussed on the order and positioning of needle insertion.Those positions most frequently used for treating mental diseases are the Kan position and the Li position in the I Ching eight hexagrams.Clinical research:64 patients were enrolled for the trial,among them,60 patients completed the treatment course:31 in the navel acupunture group and 30 in the conventional acupuncture group.After the completion of treatment,the Hamilton Anxiety Scale(HAMA),the Self-rating Anxiety Scale(SAS),and the TCM syndromes Score Scale were used to evaluate its efficacy,showing that there was a general lowering of the patients'total scores after the treatment.The difference is statistically significant(P<0.05),indicating that both navel acupunture and conventional acupuncture can can alleviate the state of anxiety.Furthermore,the total scores generated via the HAMA,SAS,and TCM syndromes Score scales are not significantly different between the two groups(P>0.05),and the treatment effects on the anxiety state are similar in both groups.However,follow-up assessment one month after the completion of treatment shows a significant difference between the two groups(P<0.05),indicating that the sustained efficacy of navel acupuncture outperformed that of conventional acupuncture.Three months after treatment,the total scores derived from the HAMA,SAS,and TCM syndrome score scales indicate that anxiety levels in both groups rebounded.The navel acupuncture group was compared with the conventional acupuncture group using HAMA and SAS scales,and a statistical difference(P<0.05)is recorded,indicating better performance in the navel acupuncture group.There is however no statistical difference between the two groups(P>0.05)when the TCM syndromes Score scale is used.Post treatment assessment using the Pittsburgh Sleep Quality Index(PSQI)and TCM syndromes Score score shows similar results.Anxiety symptoms improved but there was no statistical difference between the two groups(P<0.05).In the follow-up assessment after one month,the efficacy of treatment is sustained in the navel acupuncture group while relapse appears in patients of the conventional acupuncture group,there being a significant difference between the two groups(P<0.05).In the follow-up assessment using the TCM syndromes Score score and PSQI three months after treatment,relapse appears in both groups,with the navel acupuncture group showing a greater degree of relapse.This suggests that effectiveness of treatment in improving TCM syndrome and insomnia has subsided.Although the overall scores of the navel acupuncture group were better than those of the conventional acupuncture group,there was no statistically significant difference between the two groups(P>0.05).Navel acupuncture and conventional acupuncture are considered to have similar effects in improving the quality of sleep of patients and alleviating their TCM syndromes.When considering the effectiveness in reducing anxiety after treatment,the scores achieved using the Hamilton Anxiety Scale(HAMA)was 74.19%in the navel acupuncture group and 43.33%in the conventional acupuncture group.The effective rate comparison between the two groups was P=0.01,showing a statistical difference(P<0.05).Navel acupuncture is found to be more effective in alleviating anxiety symptoms than conventional acupuncture.One month after the completion of treatment,the effective rate was 80.65%in the navel acupuncture group and 36.67%in the conventional acupuncture group.Three months after the treatment,the effective rate was 77.42%in the navel acupuncture group and 23.33%in the conventional acupuncture group.The effective rates at the three time lines were significantly different(P<0.05),and navel acupuncture is found to be more effective than conventional acupuncture in reducing anxiety in the long and medium-terms.The TCM syndromes Score Scale was also used to measure and compare the overall effective rates in the two groups after the completion of treatment and three months after the treatment.The respective P values were P=0.29(P>0.05)and P=0.2(P>0.05),with no significant statistical difference.This means navel acupuncture and conventional acupuncture are similar in effect in alleviating TCM symptoms.However,navel acupuncture is found to be more effective one month after the completion of treatment,and the difference between the two trial groups was statistically significant.During the entire period of clinical research/treatment,no adverse reactions from either the navel acupuncture group or the conventional acupuncture group were recorded.ConclusionThe curative effect of navel acupuncture on emotional disease is obvious,but what is lacking now are established procedures for its clinical application and evidence-based research on its efficacy when applied to GAD.This clinical study aims at filling such gaps and has initially established that navel acupuncture can be as effective as and even more effective than conventional acupuncture when treating GAD.Such effectiveness is most apparent one month after the completion of treatment,and this warrants further research. |
PDF Full Text Request