| Objective1.Based on evidence-based methods,to evaluate literature quality of various moxibustion methods for neck pain of cervical spondylosis,and meta-analysis was carried out on clinical efficiency.2.Bottom temperature and burning time of elaborate-moxibustion and placebo moxibutstion moxa were tested by thermocouple.3.To observe the difference of the curative effect on different dose elaborate-moxibustion for neck pain of cervical spondylosis and compare with the false moxibustion,objectively evaluate the safety and effectiveness on elaborate-moxibustion for neck pain of cervical spondylosis,and explore the optimal dose-effect relationship on elaborate-moxibustion for neck pain of cervical spondylosis.Methods1.Literature researchLiterature about clinical randomized controlled study on moxibustion for cervical spondylosis was retrieved based on systematic review.The treatment group was treated with single moxibustion method and the moxa must be ignited by traditional method(except crude herb moxibustion).The control group was treated with single treatment,such as pure drugs or pure acupuncture,etc.,clinical efficiency was observed.China National Knowledge Infrastructure Database(CNMI),Chinese Biomedical Literature Database(CBM),Chinese Vickers database,Wanfang database and PubMed database were retrieved by computer,the keywords of Moxibustion,Cervical Spondylosis,neck pain,cervical vertigo,etc.were used in the process of retrieval,and confirmed the incruded literature finally after reading the title,abstract and full text.Quality evaluation and meta-analysis of the literature were performed by renferencing 2010 version of the CONSORT statement and the Review Manager 5.3 software recommended by the Cochrane Collaboration Group.2.Bottom temperature of moxa was tested by Thermocouple probe after connected with temperature converter,thermoelectric effect was generated in the closed loop and the the change of temperature was diaplayed on the temperature converter screen,the burning time of moxa and change of temperature were recorded.3.Clinical Research120 patients with cervical spondylosis who met the included criteria were recruited in the Acupuncture and Moxibustion outpatient Department of Guangdong Provincial Hospital of Traditional Chinese Medicine from December 2015 to December 2016.They were divided into four groups with randomized single blind:elaborate-moxibustion with 1 moxa cone group,elaborate-moxibustion with 2 moxa cones group,elaborate-moxibustion with 3 moxa cones group and placebo elaborate-moxibustion group,each group of 30 cases.The same acupoints were used in 4 groups of patients,they were GB20(double),EX-HN-15(double),SI15(double),GB21(double),BL15(double),BL19(double).Patients of elaborate-moxibustion with 1 moxa cone group,elaborate-moxibustion with 2 moxa cones group,elaborate-moxibustion with 3 moxa cones group were treated respectively with 1 moxa cone,2 moxa cones,3 moxa cones.The operation of the three groups were the same,a small amount of moxa floss was taken and kneaded into a tight and approximate cone of diameter about 2mm and height about 5mm,the moxa cone was ignited with line incense after putting it on the acupoint,then the moxa was removed when patient felt hot and pain.Placebo elaborate-moxibustion group was treated with placebo elaborate-moxibustion,a small amount of moxa floss was taken and kneaded into a tight and approximate cone of diameter about 2mm and height about 5mm,the bottom height of about 1.5mm of moxa cone was saturated with oil and ignited with line incense after putting it on the acupoint,the moxa cone was automatically extinguished when burn to the bottom.Course of treatment of four groups were the same of 10 times,twice a week,once every three days,and interval of 48 hours between treatments.Neck Pain scale score(NPQ),McGill Pain Questionnaire(MPQ),Pressure Pain threshold(PPT),displacement threshold of soft tissue tension were observed before treatment,after treatment,1 month follow-up,3 months follow-up,and the overall clinical curative effect of four groups were compared after treatment,1 month follow-up,3 months follow-up.Data was processed with SPSS20.0 statistical software.Difference was statistically significant when P<0.05.The cases of fell off,exited,lost to follow-up were analysed by intention to treat anslysis(ITT).The measurement data was expressed as mean ± standard deviation,and the counting data was expressed by the composition ratio and the ratio.Variance analysis or rank sum test was adopted for baseline comparison of measurement data,chi-square test or Fisher test was adopted for baseline comparison of counting data,(Kruskal-Wallis)rank sum test was used for grade data of group comparison.Variance analysis of repeated measurements was used for measurement data of multiple observation points,multivariate variance analysis was used for comparison between groups at each observation point.The repeated measurement of binary classification data was analyzed by the generalized estimating equation.Results1 Literature research482 articles were screened out in databases,literature such as repeated,review or case study,animal experiment,non-random experiment,and technical application etc.were excluded after reading title,abstract,full text,or after sending e-mail,telephoning author for consulting,29 documents were finally included.(1)Moxibustion groups VS control group.A total of 25 studies reported the efficacy on moxibustion for cervical spondylosis with an OR of 3.16 and 95%confidence interval of[2.14,4.66].The overall effect test was of Z =5.80,P<0.00001,indicated total effective rate in the treatment group was higher than control group,suggested that moxibustion treatment for cervical spondylosis was of obvious advantages.(2)Traditional suspended moxibustion VS control group.A total of six studies reported the total effective rate of traditional suspended moxibustion treatment for cervical spondylosis with an OR value of 2.23 and 95%confidence interval of[0.80,6.22],the overall effect test was of Z = 1.53,P = 0.13,indicated that combined effect of two groups was not statistically significant,suggested that the therapeutic effect of the two groups was comparable.(3)Heat sensitive moxibustion VS control group.A total of seven studies reported the total effective rate of heat moxibustion treatment for cervical spondylosis with an OR value of 4.93 and 95%confidence interval of[1.71,14.18],the overall effect test was of Z = 2.96,P = 0.003,suggested that total effective rate of treatment group was higher than control group.(4)Direct moxibustion VS control group.A total of five studies reported the total effective rate of direct moxibustion treatment for cervical spondylosis with an OR value of 2.55 and 95%confidence interval of[1.21,5.37],the overall effect test was of Z = 2.46,P = 0.01,the differences of the two groups were statistically significant,indicated direct moxibustion treatment was better for cervical spondylos compared with the control group.2 The bottom temperature of elaborate-moxibustion moxa was 109.72±2.80?with burning time of 8.8±0.84s while placebo moxibustion was 31.66±1.61?with burning time of 6.0±1.41s.3 Clinical studiesA total of 120 subjects were included with male subjects 13 cases and female subjects 107 cases,the youngest patient was 25 years old,the largest patient was 66 years.The shortest course of disease was 6 months,the longest course of disease was 372 months.The sex difference of groups was not statistically significant(P>0.05)by Fisher test,age and course difference of groups was not statistically significant(P>0.05)by rank sum test.The difference of TCM syndrome type of cervical spondylosis between groups was not statistically significant(P>0.05)by Fisher test,difference of classification of cervical spondylosis between groups was not statistically significant(P>0.05)by chi-square test,difference of culture level of patients between groups was not statistically significant(P>0.05)by rank sum test.The difference of NPQ score,MPQ score,PPT and displacement threshold of soft tissue tension threshold between groups was not statistically significant(P>0.05)by rank sum test or the one-way ANOVA before treatment.The baseline of each observation index between groups was of equilibrium and comparability.(1)Results of NPQ scale.Results of variance analysis of repeated measurements showed difference of multiple observation points of NPQ within-subjucts was statistically significant(P<0.05),indicated that effect difference between multiple observation points was significant.Difference of NPQ between-subjects was statistically significant(P<0.05),indicated that the difference between groups was obvious.Difference of NPQ scores before treatment and 3 months follow-up was not statistically significant(P>0.05)in multiple comparisons of within-subjects,indicated curative effect was poor on 3 months follow-up,difference of NPQ scores after treatment and 1 month follow-up was not statistically significant(P>0.05),indicated curative effect can be maintained to 1 month follow-up.NPQ difference of 1 moxa group and 2 moxa group,1 moxa group and placebo group,2 moxa group and 3 moxa group were both not statistically significant(P>0.05)in multiple comparisons of between-subjects,indicated effect difference was not obvious between those groups.NPQ difference of 1 moxa group and3 moxa group,2 moxa group and placebo group,3 moxa group and placebo group were both statistically significant(P<0.05)in multiple comparisons of between-subjects,indicated effect difference was obvious between those groups.NPQ differences between groups after treatment and 1 month follow-up was statistically significant(P<0.05)while 3 months follow-up was not statistically significant(P>0.05).NPQ difference of multiple observation points of 1 moxa within-group,2 moxa within-group and 3 moxa within-group were both statistically significant(P<0.05)while placebo within-group was not statistically significant(P>0.05),indicated effect of elaborate-moxibustion was obvious between different observation point while placebo moxibustion was not.(2)Results of MPQ scale.Results of variance analysis of repeated measurements showed difference of multiple observation points of MPQ within-subjucts was statistically significant(P<0.05),indicated that effect difference between multiple observation points was significant.Difference of MPQ between-subjects was statistically significant(P<0.05),indicated that the difference between groups was obvious.Difference of MPQ scores before treatment and 3 months follow-up was not statistically significant(P>0.05)in multiple comparisons of within-subjects,indicated curative effect was poor on 3 months follow-up,difference of MPQ scores after treatment and 1 month follow-up was not statistically significant(P>0.05),indicated curative effect can be maintained to 1 month follow-up.MPQ difference of 1 moxa group and 2 moxa group,1 moxa group and placebo group,2 moxa group and 3 moxa group were both not statistically significant(P>0.05)in multiple comparisons of between-subjects,indicated effect difference was not obvious between those groups.MPQ difference of 1 moxa group and3 moxa group,2 moxa group and placebo group,3 moxa group and placebo group were both statistically significant(P<0.05)in multiple comparisons of between-subjects,indicated effect difference was obvious between those groups.MPQ differences between groups after treatment and 1 month follow-up was statistically significant(P<0.05)while 3 months follow-up was not statistically significant(P>0.05).MPQ difference of multiple observation points of 1 moxa within-group,2 moxa within-group and 3 moxa within-group were both statistically significant(P<0.05)while placebo within-group was not statistically significant(P>0.05),indicated effect of elaborate-moxibustion was obvious between different observation point while placebo moxibustion was not.(3)Results of PPT.Results of variance analysis of repeated measurements showed difference of multiple observation points of PPT within-subjucts was statistically significant(P<0.05),indicated that effect difference between multiple observation points was significant.Difference of PPT between-subjects was statistically significant(P<0.05),indicated that the difference between groups was obvious.Difference of PPT scores before treatment and 3 months follow-up was not statistically significant(P>0.05)in multiple comparisons of within-subjects,indicated curative effect was poor on 3 months follow-up,difference of PPT scores after treatment and 1 month follow-up was not statistically significant(P>0.05),indicated curative effect can be maintained to 1 month follow-up.PPT difference of 1 moxa group and 2 moxa group,1 moxa group and placebo group,2 moxa group and 3 moxa group were both not statistically significant(P>0.05)in multiple comparisons of between-subjects,indicated effect difference was not obvious between those groups.PPT difference of 1 moxa group and3 moxa group,2 moxa group and placebo group,3 moxa group and placebo group were both statistically significant(P<0.05)in multiple comparisons of between-subjects,indicated effect difference was obvious between those groups.PPT differences between groups after treatment and 1 month follow-up was statistically significant(P<0.05)while 3 months follow-up was not statistically significant(P>0.05).PPT difference of multiple observation points of 1 moxa within-group,2 moxa within-group and 3 moxa within-group were both statistically significant(P<0.05)while placebo within-group was not statistically significant(P>0.05),indicated effect of elaborate-moxibustion was obvious between different observation point while placebo moxibustion was not.(4)Results of displacement threshold of soft tissue tension.Results of variance analysis of repeated measurements showed difference of multiple observation points of displacement threshold within-subjucts was statistically significant(P<0.05),indicated that effect difference between multiple observation points was significant.Difference of displacement threshold between-subjects was statistically significant(P<0.05),indicated that the difference between groups was obvious.Difference of displacement threshold before treatment and 3 months follow-up was not statistically significant(P>0.05)in multiple comparisons of within-subjects,indicated curative effect was poor on 3 months follow-up,difference of displacement threshold after treatment and 1 month follow-up was not statistically significant(P>0.05),indicated curative effect can be maintained to 1 month follow-up.Displacement threshold difference of 1 moxa group and 2 moxa group,1 moxa group and placebo group,2 moxa group and 3 moxa group were both not statistically significant(P>0.05)in multiple comparisons of between-subjects,indicated effect difference was not obvious between those groups.Displacement threshold difference of 1 moxa group and3 moxa group,2 moxa group and placebo group,3 moxa group and placebo group were both statistically significant(P<0.05)in multiple comparisons of between-subjects,indicated effect difference was obvious between those groups.Displacement threshold differences between groups after treatment and 1 month follow-up was statistically significant(P<0.05)while 3 months follow-up was not statistically significant(P>0.05).Displacement threshold difference of multiple observation points of 1 moxa within-group,2 moxa within-group and 3 moxa within-group were both statistically significant(P<0.05)while placebo within-group was not statistically significant(P>0.05),indicated effect of elaborate-moxibustion was obvious between different observation point while placebo moxibustion was not.(5)Comparison of overall efficiency.The generalized estimating equation was used for statistical analysis.It was found that the difference of curative effect between groups and observation points were both statistically significant(P<0.05).At the end of the treatment,the effective rates of 1 moxa group,2 moxa group,3 moxa group and placebo group were 33.3%,53.3%,56.7%and 23.3%respectively,difference of curative effect between groups was statistically significant(P<0.05).At 1 month follow-up,the effective rates of 1 moxa group,2 moxa group,3 moxa group and placebo group were 30%,50%,56.7%and 20%respectively,difference of curative effect between groups was statistically significant(P<0.05).At 3 months follow-up,effective rates of 1 moxa group,2 moxa group,3 moxa group and placebo group were 20%,30%,30%,13.3%respectively,difference of curative effect between groups was not statistically significant(P>0.05).(6)Safety analysis.A total of 120 patients were included with 4 case of adverse events with mild symptoms which didn' t affect the progress of research after simple treatment.The overall safety of this research is better with incidence of adverse events of 3.3%.Conclusion1.Meta-analysis showed that moxibustion treatment for cervical spondylosis is effective,but the literature quality is low with many bias factors and the data results have some limitations.A lot of clinical researches are needed to get more data support in future.2.Temperature of elaborate-moxibustion raised rapidly in short time with a rapid and intense burning pain stimulation while placebo moxibustion only around 30? which was lower than human normal body temperature,indicated the skin feeling of the two moxibustion was different obviously.3.Clinical study showed that elaborate-moxibustion treatment can effectively relieve cervical pain,improve soft tissue tension,the effect of 2 moxa group and 3 moxa group were better than placebo moxibustion group,the effect of 3 moxa group was better than 1 moxa group. |
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