| ObjectiveA multicenter randomized controlled clinical trial was conducted to evaluate the efficacy of traditional Chinese medicine"Tian moxibustion No.1"in the treatment of neck pain due to cervical spondylosis through the comparison of South of the Five Ridges traditional moxibustion 1 Prescription(moxibustion powder),grain moxibustion and placebo.Methods1.literature evaluationOn December 30.2017 until the moxibustion treatment of cervical spondylosis RCT experimental analysis of quality evaluation and meta evaluation of clinical curative effect of Moxibustion in the treatment of cervical spondylosis.A searchable database of CNKI database for China(CNKI),Wanfang database,CBM database,VIP database and PubMed database China network.The literature database was established by NoteExpress3.2,and meta analysis was carried out through the literature reading.(1)retrieval strategySearch for Chinese(moxibustion or or or warm acupuncture moxibustion moxibustion moxibustion moxibustion moxibustion or or or and(or)of cervical spondylosis neck pain or Xiangbi).The English retrieval formula is(Moxibustion or Moxibustion treatment)and(Cervical spondylosis or Neck pain or Cervical).(2)quality evaluationBy using the Cochrane collaboration custom"bias risk assessment worksheet assessment is divided into 6 aspects:the random allocation method;the hidden scheme;the object of study,treatment scheme using blind method;Study on measurement results by blind method;the data integrity and selectivity;the results reported.Each of the included documents is based on the judgment of"L"(low bias),"H"(Gao Pianyi),"U"(uncertainty)The evaluators were carried out independently by Zhou JUNHE and Luo Boyang.When the difference of opinion was resolved by the two sides and the consultation opinions were not unified,third evaluators(Li Weihan)were evaluated.(3)statistical analysisRevMan5.3 software was used to analyze,and MD was used to express variable data.When there was no heterogeneity between studies,a fixed effect model was used.When the heterogeneity existed between studies,the random effect model was selected or the source of heterogeneity was found out.In the result calculation,the 95%confidence interval is used.When the P is less than or equal to 0.05 for the difference was statistically significant heterogeneity test,when I2 is less than 50,using fixed effect model,whereas the random effects model.2.clinical studyAccording to the previous study on cervical pain of cervical spondylosis treated with traditional south of the Five Ridges traditional moxibustion 1,the samples were divided into three groups according to the proportion of 1:1:1.Three clinical centers were recruited in Guangdong Province Traditional Chinese Medical Hospital were included as follows:the number of cases effective 98 cases(tianjiutreated group 33 cases,32 cases of moxibustion group and the placebo group 33 cases),Chinese Medicine Hospital of Hainan province were included in the 105 effective cases(tianjiutreated group 35cases,37 cases of moxibustion group and the placebo group of 33 cases)Gaozhou City Hospital of traditional Chinese medicine,a total of 107 effective cases(tianjiutreated group 36 cases,36 cases of moxibustion group and the placebo group 35 cases),total day moxibustion group 104 cases,105 cases of moxibustion group and the placebo group in 101 cases.Acupoints1.Bailao(double),jianzhongshu(double),Jianjing(double),Xinshu(double),tanshu(double)and Shenshu(double);2.the new(double),jianwaishu(double),Dazhu(double)and Tianzong(double),jueyinshu(double),Jiao Yu(double)In the three groups,the acupoints were the same,and the above two groups were used alternately.Acupoint standards are used in 1990 People's Republic of China national standard.Point of acupointoperation1 days,south of the Five Ridges traditional moxibustion group:application of Tianjiu No.1(Tianjiu powder)treatment,according to the corresponding acupoint paste,each acupoint with 1cm*1cm*1cm herbal cake size,by day moxibustion with tape(5cm tape circular diameter)onto acupoints,each plaster to heat hard to endure pain in patients with consciousness of time to 1 hours for the upper limit.2.moxibustion group:application of Moxa Moxibustion Therapy of moxa cone moxibustion operation according to the corresponding points,each point is the specification of conical moxa high 1cm,diameter 0.8cm,weight 0.1g moxibustion,when the points covered with appropriate universal oil,the moxa at the point,lit by line sweet,between 1/3 and 1/4 burning moxa cone,the patient was burning with forceps go moxa,a total of 3 cones at each point.3.placebo:application of moxibustion of placebo,according to the corresponding acupoint paste,each acupoint with 1cm*1cm*1cm size with placebo,vesiculation with tape(5cm tape round diameter)affixed to the point,the time to 1 hours for the upper limitCourse of treatment30 days of treatment,once every 3 days treatment,each alternate choice of a group of acupoints,a total of 10 times the completion of the treatment,completed 8 times as effective cases.Evaluation of time points and indicatorsBefore the first treatment,at the end of the course of treatment,1 months of follow-up,and 3 months of follow-up.The Northwick Park neck pain scale(NPQ),short form McGill pain scale(MPQ)and SF-36 quality of life scale were observed at different time points within the group and component differences in efficacy,while the total center received test of local soft tissue displacement by soft tissue tension measuring instrument.StatisticsThe characteristics of the clinical trial data(measurement,classification data and grade data)are selected and the appropriate statistical analysis methods are selected.Categorical data using chi square test or exact method,measurement data test of normality and homogeneity of variance test first,meet the requirements of those samples were compared by t test,were compared using the paired t test;not meet samples were compared using Wilcoxon test,compared with before and after their Wilcoxon.The Wilcoxon rank sum test(correction)or multiple group comparison of the Kruskal-Wallis test of the grade data is compared with the sample.The quantitative main outcome indicators of multiple observation time points were analyzed by repeated measurements of variance.Bilateral tests were used,baseline comparison was used to test the level of alpha=0.10,and the level of a=0.05 was compared between the therapeutic groups,and the 22 groups were compared to a=0.0167.Results1.The results of literature researchAccording to the search strategy and full text reading,a total of 289relevant articles were found.80 papers were screened out,and the final inclusion of 15 literature,a total of 1393 subjects.(1)total efficiencyThe total efficiency was included in 15 papers.The heterogeneity test was I~2=5%,P<0.00001,and the fixed effect model was used.The result of meta analysis is[OR=3.65,95%CI(2.54,5.26)].The curative effect of the treatment group was better than that of the control group.The treatment group,divided into Moxibustion plus acupuncture moxibustion+drug VS VS western medicine,western medicine,western medicine moxibustion VS.The above 3 kinds of group subgroup analysis,VS+acupuncture moxibustion in western medicine,a total of 5 studies,the statistical results of P<0.00001,[OR=4.53,95%CI(2.34,8.77)].In the VS+drug moxibustion medicine,a total of 6 studies,the statistical results of P<0.0001,[OR=3.58,95%CI(1.98,6.48)].In the moxibustion VS medicine,a total of 4 studies,the heterogeneity test P=0.02,I~2=69%,there is a big difference,the random effect model,the statistical results of P=0.22,[OR=2.52,95%CI(0.57,11.13)].Moxibustion,moxibustion plus acupuncture and drug efficacy is superior to simple western medicine curative effect,single moxibustion and Western medicine curative effect had no difference.(2)outcome indicatorsTCD scoringOf the 15 studies,7 were analyzed by TCD.Subgroup analysis was performed according to systolic velocity,diastolic velocity,mean velocity and pulse index.In terms of systolic flow velocity(VS),the random effect model should be selected for P=0.006 and I~2=76%after heterogeneity test.The result is P=0.0003,[WMD=2.94,95%CI(2.94,10.01)].Thus,moxibustion can improve the vertebral artery systolic blood flow velocity effect.In terms of diastolic velocity(VD),I~2=0 after heterogeneity test,using fixed effect model,the result is P=0.01,[WMD=1.28,95%CI(0.27,2.29)],thus,moxibustion has improved vertebral artery diastolic function.In terms of the mean flow velocity(VM),after heterogeneity test I2=0,should use the fixed effect model,the result is P<0.00001,[WMD=3.48,95%(2.21,4.75)],which may have improved moxibustion has a mean blood flow velocity of vertebral artery.In the aspect of vascular pulsatility index(PI),after the heterogeneity test of I~2=84%,the random effect model should be selected.The result is P=0.20,[WMD=-0.06 and 95%CI(-0.14,0.03)].Therefore,it is concluded that there is no difference between groups in improving vascular pulse index.Clinical symptom score of TCMIn the traditional Chinese medicine syndrome score,the heterogeneity test I~2=0,select the fixed effect model,the result is P=0.009,[WMD=-4.32,95%CI(-7.55,-1.08)],thus,moxibustion can improve the clinical symptoms in patients with cervical spondylosis.Score of cervical vertigoIn terms of cervical vertigo score,I~2=0 was selected by heterogeneity test.The fixed effect model was adopted.The conclusion is shown in Figure 15 below.Statistical analysis shows that P=0.62,[WMD=-0.87,95%CI(-4.29,2.56)]can be obtained.There is no difference between two groups in cervical vertigo.2.clinical trial results(1)baselineDays moxibustion group,moxibustion group and placebo group in three groups of demographic data,in gender(P=0.147),age(P=0.079)and duration(P=0.890),education(P=0.051)and Western medicine syndrome(P=0.210),TCM syndrome(P=0.496)had no obvious difference,werecomparable.In terms of efficacy indicators,there was no significant difference between the three groups before treatment in NPQ scale(P=0.214),MPQ scale(P=0.053),SF-36 quality of life scale(P=0.374)and soft tissue displacement(P=0.595).(2)NPQ scale scoreThere was no significant difference in the NPQ scale between the three groups before treatment(P=0.214).After treatment,the NPQ scores of the 3groups showed a downward trend,and the south of the Five Ridges traditional moxibustion 1 group and the wheat moxibustion group decreased significantly,the degree of decline was greater than that of the placebo group.At the end of treatment,day moxibustion group and moxibustion group than the placebo group had significant difference(P=0.001);1 months follow-up,day moxibustion group and moxibustion group than the placebo group had significant difference(<0.01);and 3 months follow-up,day moxibustion group than the moxibustion group and the placebo group there were significant differences(P<0.01).The analysis of repeated measurement variance showed that the group of day moxibustion and wheat grain moxibustion were all better than those of the consolation group(P=0.001,P=0.013).The difference was compared between 1 months and 3 months after treatment.The results showed that the reduction rate of NPQ in the three stages of moxibustion group and grain moxibustion group were all different from those in the consolation group(P<0.05).The above results indicated that the three treatments could relieve neck pain to some extent.The efficacy of moxibustion group and wheat moxibustion group were better than those of placebo group.In terms of long-term efficacy,moxibustion group was better than moxibustion group and placebo group.(2)soft tissue tension displacement(D0.2kg)There was no difference between the three groups before treatment(P=0.595),and the three groups showed an upward trend in the treatment period,and all showed a downward trend after the end of treatment.The results were(P=0.114,P=0.271,P=0.652)at the end of the treatment,1 months of follow-up,and 3 months of follow-up.The analysis of repeated measurements of variance showed that there was a difference between the moxibustion group and the consolation group(P=0.036).Before and after treatment,the difference between the 3 groups was(P=0.027,P=0.957,P=0.892)at the end of treatment,1 months follow-up and 3 months follow-up.22 it was found that there was a statistical difference between the moxibustion group and the consolation group(P=0.012).The above results suggest that the three groups can improve the displacement of the soft tissue.The curative effect of the moxibustion group and the moxibustion group in the day moxibustion group is equal,and the curative effect of the day moxibustion group is better than that of the consolation group.(3)McGill pain assessment scale(MPQ)There was no statistical difference between the three groups before treatment(P=0.053),and the three groups showed a downward trend in the MPQ score in the treatment period.At the end of treatment,day moxibustion group and moxibustion group than the placebo group had significant difference(P<0.01);and 1 months follow-up,tianjiutreated group compared to those of placebo group had significant difference(P<0.01);and 3 months follow-up,day moxibustion group than the moxibustion group and the placebo group significantly the difference(P<0.01).Repeated measurement of variance analysis,day moxibustion group and moxibustion group difference(P=0.018),tianjiutreated group and placebo groups have difference(P<0.01),moxibustion group and placebo group with difference(P=0.005),tianjiutreated group decreased significantly,moxibustion group and the placebo group decreased at least.For before and after the treatment,follow-up of 1 months,3 months follow-up difference compared with the end of the treatment,day moxibustion group and moxibustion group than the placebo group had significant difference(P<0.01);and 1 months follow-up,day moxibustion group and moxibustion group than the placebo group had significant difference(P=0.040).The above results suggest that the three groups in the MPQ scale,the day moxibustion group and the wheat grain moxibustion group are better than the consolation group.There was no significant difference in curative effect between the group of day moxibustion and the group of wheat grain moxibustion.(4)SF-36 quality of life scaleThere was no statistically significant difference between the three groups before treatment(P=0.374).The scores of SF-36 scale in three groups showed an upward trend,and the trend of increase was almost the same.At the end of the treatment,there was no statistical difference between the three groups(P=0.266)between the three groups.After 1 months of follow-up,there was no statistical difference between the scores of SF-36 scores between the three groups(P=0.382).After 3 months of follow-up,there was a significant difference between the group of day moxibustion and the consolation group(P=0.006).The analysis of repeated measurement variance showed that there was no difference between the three groups on the score of the SF-36 scale(P=0.576).The difference was compared with the difference between the three groups at the end of the SF-36 scale,1 months of follow-up,and 3 months of follow-up.At the end of treatment,there was no significant difference between the two groups(P=0.906).There was no significant difference between the two groups at 1 months follow-up(P=0.058).There was a significant difference between the two groups at 3 months follow-up(P=0.037),but there was no significant difference between the 3 groups after 22 significant adjustment.The 9 dimensions of the SF-36 scale were compared between groups.There was no statistical difference between the 9 dimensions before treatment(P>0.05).In the 5 dimensions of general health status(GH),energy(VT),mental health(MH),physical pain(BP)and health change(HT),there are differences between groups.In the general health status(GH),there was a significant difference between the moxibustion group and the placebo group in the follow-up of 1 months(P=0.006).There was a significant difference between the moxibustion group and the placebo group during the 3 months follow-up(P=0.001).In terms of energy(VT),there were significant differences between the group of day moxibustion and the group of wheat grain moxibustion at 3 months of follow-up(P=0.007).In mental health(MH),after 1 months of follow-up,there was a significant difference between moxibustion group and moxibustion group and placebo group(P<0.01).After 3 months follow-up,there was a significant difference between moxibustion group and moxibustion group(P=0.004).In the aspect of somatic pain(BP),there were significant differences between the moxibustion group and the consolation group(P<0.01)after 3 months of follow-up.In the aspect of health change(HT),1 months of follow-up,the group of day moxibustion and grain moxibustion had significant difference compared with that of the consolation group(P=0.001).The above results indicated that the three groups all had the effect of improving the quality of life,and the moxibustion group was better than the placebo group in improving mental health and somatic pain.(5)efficiencyIn terms of efficiency,the total effective rates of the three groups were85.6%,77.1%and 51.5%respectively.There were statistical differences between groups(P<0.05).22 compared with the group of day moxibustion and wheat grain moxibustion,compared with the consolation group(P<0.05).Conclusion1.Meta analysis showed that moxibustion plus acupuncture or medicine therapy for the treatment of cervical spondylosis is superior to the western medicine group;no difference between single moxibustion and Western medicine contrast.2.South of the Five Ridges No.1,traditional moxibustion moxibustion and placebo in the NPQ scale,MPQ scale,soft tissue displacement,SF-36 scale scores were effective;NPQ scale,No.1,moxibustion therapy at the end of treatment and follow-up of 1 months,3 months of follow-up of 1 No.better than moxibustion;soft tissue displacement,at the end of treatment,day moxibustion group is better than the placebo group;SF-36,No.1,in improving the mental health of the patient(MH),bodily pain(BP)is better than moxibustion therapy and placebo. |
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