| Objective:This clinical trial aims to observe the effect of intradermal needle therapy on the Back-shu points of the Five Zang organs for chronic fatigue syndrome(CFS).The therapeutic effect evaluation is based on the Fatigue Scale-14(FS-14)consisting of both physical fatigue and mental fatigue in order to figure out the efficacy and safety of the simultaneous regulation on both body constituents and spirits in the view of the Visceral Manifestation theory.Meanwhile,to optimize the therapeutic regimen by comparing the influence of unilateral,bilateral and non-acupoint point selection and provide clinical data for the classic acupuncture fundamentals.Methods:According to the diagnostic,inclusion,and exclusion criteria,90 patients of CFS from the department of acupuncture,Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine were selected as eligible subjects.They were randomly and equally divided into bilateral Back-shu point group,unilateral Back-shu point group and non-acupoint group according to the random numbers which were generated by SPSS 20.0.1.Bilateral Back-shu point group:Both sides of the Back-shu points of Five Zang organs were selected.2.Unilateral Back-shu point group:Only one side of the Back-shu points of Five Zang organs was selected,left or right alternately.3.Non-acupoint group:The location where non-acupoint group inserted by intradermal needles were 1.5cm to 2cm or so outward from the Back-shu points of Five Zang organs(approximately on the middle of the two side lines of the Foot Taiyang Bladder Channel).They must keep away from the acupoints of Foot Taiyang Bladder Channel or the positive reacted points and be treated left or right alternately.All the subjects from the three groups were in the supine position.Afterwards,the intradermal needles of SEIRIN brand(manufactured by Japan co.,LTD.)size 0.20mm×1.5mm were affixed to the selected points after routine alcohol sterilization.Only the subjects from bilateral Back-shu point group and unilateral Back-shu point group got needling sensation.The needle retention is 48 hours for each group.The subjects from all the groups were treated twice a week and 16 times for a period of treatment.FS-14 questionnaire was used to evaluate the fatigue for each subject before and after treatment.The adverse events during all the course were taken down as well.Finally,the efficacy and safety of the three groups were compared by statistical analysis of SPSS 20.0.The scores’ improvement of physical fatigue and mental fatigue was used to evaluate the therapeutic effect on body constituents and spirits of CFS patient.Results:1.There was no statistical difference among the three groups in the aspects of age,gender,course of CFS,and FS-14 level including total score,physical fatigue score and mental fatigue score before intradermal needle therapy(P>0.05).Accordingly,the three groups of CFS patients were comparable.2.After the 8-week intradermal needle therapy,the response rate was 83.33%in the bilateral Back-shu point group,which was 76.67%in the unilateral Back-shu point group and 50.00%in the non-acupoint group.The clinical efficacy among the three groups was statistical different significantly(P<0.01).In pairwise comparison,there was no significant difference in clinical efficacy between the bilateral Back-shu point group and the unilateral Back-shu point group(P>0.05).Furthermore,the curative effects of the two groups whose Back-shu points of Five Zang organ were inserted by intradermal needles were better than the non-acupoint group dramatically(P<0.01).It is suggested that the intradermal needle therapy on the Back-shu points of the Five Zang organs has a significant clinical effect in easing tiredness for CFS patients.In addition,there is no significant difference between needling the unilateral and bilateral acupoint.3.There were significant differences in FS-14 questionnaires including aggregate,physical and mental score between before and after the treatment in both bilateral Back-shu point group and unilateral Back-shu point group statistically(P<0.01).Only the scores of total and physical fatigue in FS-14 decreased after the treatment of non-acupoint group(P<0.01),which means it couldn’t help to alleviate mental fatigue.As a consequence,the three treatments are all helpful to alleviate the fatigue symptom of CFS patients,and have obvious effects on the overall level of fatigue and body fatigue.In terms of mental fatigue,only the therapies of the two back-shu acupoints groups can help.On the contrary,the non-acupoint can not relieve the mental fatigue of CFS patients.4.After the 8-week intradermal needle therapy,the total score,physical fatigue score and mental fatigue score of FS-14 were dramatically diverse among the three groups(P<0.01).In pairwise comparison,there was no significant difference in the aspect of aggregate score,physical fatigue score and mental fatigue score of FS-14 between the bilateral Back-shu point group and the unilateral Back-shu point group statistically(P>0.05).The bilateral Back-shu point group was significantly better than the non-acupoint group in the above three aspects(P<0.01).Compared with the non-acupoint group,the unilateral Back-shu point group’s aggregate score of FS-14 was better obviously(P<0.01),while its physical fatigue score and mental fatigue score were better statistically(P<0.05).It manifests that there is no difference in aggregate fatigue,physical fatigue and mental fatigue of FS-14 between the two back-shu point groups after treatment,and both of them are better than the non-acupoint group in the above three aspects.5.Since there was no adverse event during the course of treatment,intradermal needle therapy can be considered as a safe treatment for CFS.Conclusions:The intradermal needle therapy on the Back-shu points of Five Zang organs for CFS based on the Visceral Manifestation theory has a satisfying clinical efficacy in curing tiredness.It can help reduce both physical and mental fatigue for the patients.Hence,it can regulate both body constituents and spirits simultaneously.Moreover,needling the unilateral acupoint can get similar clinical efficacy to the bilateral one.And both of them are better than non-acupoint selection dramatically.In conclusion,this treatment is not only safe but also reliable and it’s easy to generalize as well.In the meantime,it can lay a foundation for the application of unilateral Back-shu point for the sake of saving medical resources... |
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