| ObjectiveBased on evidence-based analysis of external treatment for neck pain and a clinical research, to estimate the clinical efficacy and safety of No.3 priscribtion of Lingnan Tianjiu Therapy for neck pain of cervical spondylosis by compairing with No.1 (original priscription) and placebo priscription, and to evaluate the efficacy and safety of external therapies for neck pain of cervical spondylosis.Methods1. Literature reviewBy retrieving a clear diagnosis of cervical spondylosis and neck pain chief complaint of randomized controlled trials research literature as an object, literature or test group treated with Traditional Chinese Medicinal included one or more integrated therapy, the control group with surgery, oral medications and other non-external treatment for intervention and application NDI Scale, VAS scale, or have an efficient or more as the outcome measure, through computer searches CBM, CNKI, VIP and other databases to“外治”、“'灸”、“'刺”、“外敷”、“药浴”、“推拿”、“熨帖”、“膏药”、“艾灸”、“天灸”、“颈椎病”、“颈痛”、“项痹”、“随机”、“对照”and other keywords and search terms were combined freely word retrieval, respectively, in the title, keywords, etc. read screening, and then read the summary, and finally Read more to confirm the included studies. Group recommended using the Cochrane Collaboration Review Manager 5.3 software for statistical analysis of the collected data, combined with a descriptive analysis of the external treatment of cervical spondylosis neck pain literature systematic literature review and meta-analysis.2. Clinical ResearchQuestionnaire was approached to NPQ neck pain scale, short form McGill pain scale as a template to design a questionnaire for patients who came to Guangdong Provincial Hospital of TCM for participation of Tianjiu therapy in 2013-2014, using Epidata 3.2 software package returned the questionnaire data entry, application SPSS 20.0 statistical software, through descriptive analysis of statistical methods for data analysis of the survey results.3. Pre-clinical trialsBy comparing with the No.1 priscribtion of Lingnan tradition Tianjiu therapy,36 patients were recruited, who were randomly divided into treatment group and control group by a ratio of 1:1, the treatment group using the No.3 priscribtion of Lingnan tradition Tianjiu therapy (yellow mustard, cooked tuber, Clematis, etc.) for the treatment and control group treated with No.1 priscribtion (yellow mustard, Asarum, euphorbia, fumarate, etc.). Select ① EX-HN-15, SI15, GB21, BL15, BL19, BL23;②EX-HN-21, SI14, BL11, Sill, BL14, BL22 as acupoints of treatment for both groups,2 groups of acupoints are used interchangeably, as a course of treatment once every five days of treatment, were treated 10 times. Respectively, before and after treatment five times, at the end of treatment, one month after the end of treatment, three months after the end of treatment, a total of five point evaluation, application NPQ neck pain scale and short form McGill Pain Scale Evaluation Lingnan traditional moxibustion clinical efficacy on the 3rd day party.4. Clinical ResearchBased on literature research and survey results, the establishment of a randomized controlled clinical trial recruited patients with cervical spondylosis 163 cases of neck pain, using simple random method,1:1:1 ratio were randomly divided into three groups, the treatment group (Lingnan traditional moxibustion on the 3rd day party group),53 patients in the control group (Lingnan traditional moxibustion on the 1st day party group) 56 cases, the placebo group (placebo group) 54 cases. Among them, the Lingnan traditional moxibustion on the 1st day party that is tianjiu casual side, there are yellow mustard, Asarum, euphorbia, fumarate, etc., Lingnan traditional tianjiu the 3rd party main square of yellow mustard, cooked tuber, Clematis, etc., compared with placebo plus buckwheat pigment modulation.3 groups were selecting①EX-HN-15, SI15, GB21, BL15, BL19, BL23;② EX-HN-21, SI14, BL11, Sill, BL14, BL22 as a treatment for both groups points each treatment used interchangeably, when treatment dispensary at the end about 10g, the old ginger (ginger, peeled wringer filter) 10ml reconcile into about 1cm × 1cm × 1cm size cake medicine, including placebo at 1/10-1/ 20 as a proportion of the ginger, add water to reconcile agent to tianjiu special tape (about 5cm diameter circular tape) affixed to the points, each time one hour Plaster ceiling, after the arrival time of the removal of the drug post tape, wash ointment can. Posts drugs such as local adverse reactions, adverse reactions by step processing.For a course of treatment once every five days of treatment,10 were treated and followed for three months. The use of patient-reported outcome evaluation model for efficacy evaluation, using internationally accepted scale NPQ neck pain, soft tissue tension tester for the primary outcome measure, Short Form McGill Pain Scale, SF-36 quality of life scale as secondary outcome measures, after TESS (TESS) and other safety indicators as before treatment, five times, at the end of treatment, one month after the end of treatment, three months after the end of treatment, respectively Lingnan traditional day moxibustion cervical spondylosis neck pain measurements.Measurement results using SPSS 20.0 statistical analysis method using the intention to treat (ITT) analysis, through descriptive analysis, paired t test, Wilcoxon signed rank test, analysis of variance, rank sum test (Kruskal-Wallis), chi-square test test methods and other differences in the three groups and the differences among the three groups were compared. Using two-sided test, a baseline comparison test level α=0.10, inter-group comparison test efficacy level a=0.05, comparison between the two groups α=0.0167.Results1. The results of the literatureThe evaluation of the literature showed that a total of 1294 selected research literature, and through reading titles and abstracts, read the full text, mail or telephone consultation author eventually have seven met the inclusion criteria, I studied the wrong way because of random, intervention or evaluation does not meet the inclusion criteria, the authors reject the reply and other reasons were excluded, the aggregate total of 687 cases included in the study patients, including 380 cases of external treatment group, 307 cases of non-external group.(1) a relatively efficientSeven included studies are effective as its primary outcome measure, test for heterogeneity:P=0.43,12=0%, so the analysis to obtain OR=0.89,95% CI (0.57,1.40) combined effect size, Z=0.50, P=0.62, the difference was not statistically significant, suggesting that in order to evaluate the outcome of the effective rate, External External than non-therapeutic advantages, and about non-clinical effects External External 0.89 times.(2) VAS Scale ComparisonIncluded studies, there are two applications of the VAS scale studies for efficacy evaluation, two studies for the treatment of nerve root type cervical spondylosis. The test for heterogeneity, P=0.12,12=58%, it can not merge the extracted data. VAS scale evaluation results, where Liu’s study suggests that the clinical effects than non External External, and Wu’s research is the opposite.(3) NDI scale evaluation and analysisSeven included studies, only Liu NDI scale applied research results were evaluated, and the results are the results of its evaluation of the application VAS scale agreement that is better than non-External External clinical effect.2. Survey ResultsThe survey questionnaires returned a total of 5282 copies, of which the subject of investigation for asthma, rhinitis, pharyngitis and other lung diseases were a total of 3824 people,72.4% of the total number of surveys, and neck pain were a total of 1222 people, the total number of survey 23.14%. Research in visual analogue rating scale (VAS) for evaluation, where 0 is divided into inactive,10 is divided into recovery, the results showed that the surveyed population, efficacy evaluation lung diseases such as rhinitis, asthma, pharyngitis display, VAS The average score was 7.25±2.06 points, ie, the average effective rate of 72.5%, with the increase of the course, its efficiency is also increased. The effect of neck pain reached 6.07±1.91 points, namely its efficiency up to 60.7%, while the stratified according to different course, and found that most were the incidence of 1-3 years, accounting for 82.24% of all the number and duration In 5-7 years the best efficacy, efficiency up to 72.4%, indicating that this therapy for cervical spondylosis neck pain have a certain effect.3. Pre-test resultsPre-trial included 36 patients with valid cases in which the treatment group,18 patients in the control group,18 patients, of gender, there were 17 males,19 females, comparing two different sex by chi-square test, the difference was not statistically significant (2=2.362, P=0.264). Education, diagnostic classification and TCM syndrome type, the difference between the two groups by chi-square test was not statistically significant (2=7.136, P=0.313; 2=9.723, P=0.162; 2=10.167, P=0.167). Age, treatment group, the average age of 52.11±18.49 years old, the average age of the control group 51.06±17.86 years of age between the two groups by analysis of variance, the difference was not statistically significant (F =1.644, P=0.194). Two sets of course, the treatment group, the average prevalence of 89.42±55.73 months, the control group, the average prevalence of 92.92±63.68 months, and between-group differences by analysis of variance showed no statistically significant (F=0.656, P=0.519). In addition, patients treated with a daily average down time was 7.61±3.32 hours, while the control group was 6.33±5.05 hours, and no significant difference between groups (F=1.518, P=0.220). Found that among its group general information statistical analysis showed no significant difference between the groups, between groups were comparable.(1) NPQ neck pain scaleTwo scores before treatment was not statistically significant (F=7.924, P=0.151), NPQ scores at each time point after treatment in both groups decreased, there was a significant difference (P=0.000) comparing before and after the intervention, and treatment group NPQ score declined more than the control group, the difference between statistical significance and the group (P=0.006, P=0.000, P=0.003, P=0.001), prompted the two programs can relieve pain, but the treatment group is more significant.(2) Short Form McGill Pain ScaleScores before treatment groups was not statistically significant (P= 0.067), with a possible sex. After treatment, the two groups of patients before treatment compared MPQ scores decreased, there was a significant difference (P=0.000) in the intervention group before and after scores, indicating that the two programs are effective. At the end of treatment, follow-up of one month time point, the treatment group MPQ scores decline slightly larger than the control group, and between the two groups showed that the difference was statistically significant (P=0.000), and five times after treatment, the control group score decreased obviously (P=0.022),3-month follow-up point, the two groups have a certain degree of MPQ scores rise between the two groups was statistically significant (P=0.000) difference, therefore, inferred that the short-term efficacy of the control group Obviously, while the medium-term efficacy of the treatment group than the control group and the long-term efficacy.The clinical study results(1) General InformationThe study included 163 cases of subjects, including the treatment group, 53 patients in the control group 56 cases,54 cases of the placebo group, dropout rate was 9.53%. There are 59 cases in which the male, female 104 cases, the average treatment group was 36.5±12.3 years, mean duration of illness 12.3±7.7 months, the daily average down time was 6.4±4.2 hours, and the control group was 36.9±11.9 years, mean suffering disease duration of 13.6 ±17.5 months, the daily average down time was 6.7±2.7 hours, and the placebo group on average 37.4±10.5 years, mean illness duration of 11.5±9.2 months, the average daily down time was 5.9±3.0 hours.Three groups of patients before treatment, sex, chi-square test or analysis of variance and other general information age, disease duration, bow habits, previous treatment were compared, the difference was not statistically significant (P>0.05), while the three groups of TCM Syndrome and clinical diagnosis by chi-square test, the difference was statistically significant (P=0.011, P=0.001), explained between treatment group and control group of basic balance, but the basis having different Chinese medicine, Western medicine diagnosis stratified analysis. Patients were included occupational composition analysis, all references in the test volunteers to students and staff, accounting for 74.8% of all subjects, including the treatment of these two occupational groups accounted for 77.3% in the control group accounted for 76.8%, accounting for 70.4% of the placebo group. Three groups of professional patient by chi-square test, a statistically significant difference between groups (2=37.417, P=0.040), illustrate the different occupations is one of the factors of cervical spondylosis neck pain affects the effects, so the need for different occupations compare efficacy between.(2) NPQ scale score results①NPQ Scale total scoreThree groups of patients before treatment NPQ score was not statistically significant (2=1.511, P=0.470), baseline equilibrium. Three groups of patients after treatment NPQ scores were decreased, the difference was statistically significant (P=0.000) at different time points within and between groups; three groups were rebounded certain extent at follow-up three months, which treatment group the largest decline, followed by declines in the control group, the smallest decline in the placebo group, scores at the end of treatment and follow-up time point between the two groups was statistically significant (P=0.000) difference, but in the post-treatment time points five times, scores among the three groups showed no significant difference (P=0.106).Pairwise comparison showed that before treatment point, pairwise comparisons among the three groups showed no significant difference NPQ scores (P> 0.05), in the treatment of five times point in time, only to see between the treatment group and the placebo group NPQ scores the difference was statistically significant (P=0.013), at the end of treatment and follow-up one month time point, pairwise comparisons among the three groups were statistically significant (P<0.01), in the three-month follow-up point, treatment group and the control group, the treatment group pairwise comparison with the placebo group showed statistically significant between the two groups (P=0.000) difference between the control group and the placebo group with no significant difference (P=0.054).② different diagnostic classification of NPQ scoreAs observed at different time points within individual factors, different diagnostic classification as poor inter-individual factors, multivariate analysis showed that the various types of cervical spondylosis neck pain decrease was observed in the different time points before NPQ scale score compared, and the difference has statistics significance (P=0.016), but also differences in the different types of statistical significance (P=0.003); pairwise comparisons suggest that between the neck and nerve root type of individual differences were statistically significant (P=0.001), neck type and Mixed among individuals was not statistically significant (P=0.071) difference, and radiculopathy with no statistical significance between the mixed type (P=0.115). The results suggest that the three intervention programs for different diagnostic classification of cervical spondylosis neck pain are effective, and the efficacy of cervical spondylosis cervical neck pain is better than the nerve root type cervical spondylosis neck pain, but the cervical syndrome, radiculopathy No significant difference in the efficacy of the efficacy of cervical disease and mixed type of cervical disease.③ different TCM syndromes NPQ scoreDifferent types of syndromes in patients NPQ each observation point measurements are shown in Table 22. The results showed that pre-treatment of different syndromes NPQ score was not statistically significant (P=0.708), a balanced description of the baseline, the different time points of comparison NPQ scale scores after the intervention, the score differences between different syndromes were not statistically significant (P> 0.05), the effect is quite prompt intervention programs for three different types of neck pain syndromes are.(3) efficiency comparison resultsIn the treatment of post-evaluation point five times, three points deduction rates were 32.95 ± 11.86,22.83 ± 17.93,16.31 ± 20.04, respectively,88.7% effective rate,55.4%,57.4%, a statistically significant difference between groups (2=18.994, P=0.000).After treatment, the reduction rate of the three groups were 55.32± 16.51,40.22 ± 24.84,23.79 ± 20.63, respectively,96.2% effective rate,73.2%, 53.7%, a statistically significant difference between groups (2= 29.337, P=0.000).1 month follow-up, three points deduction rates were 57.96±16.49,39.91 ± 22.41,25.66±25.00, respectively,98.1% effective rate,69.6%,68.5%, there are differences between the two groups was statistically significant (2= 23.621,P=0.000).3-month follow-up evaluation, three groups reduced rate of 55.39± 16.48,33.13 ± 19.91,24.49 ± 23.46 respectively, efficiency of 98.1%,62.5% and 68.5%, respectively, a statistically significant difference between groups (2=28.085, P=0.000).(4) The results of the analysis of soft tissue tensionThree groups of patients before and S measurements DO.5kg scores were not statistically significant treatment (P=0.163, P=0.724), baseline balance. End point of treatment, the three groups compared with the previous value measurements D0.5kg treatment increased 1 month follow-up point, the control group compared with the placebo group at the end of treatment decreased, while the follow-up of the three groups were decreased at 3 months and the scores before and after the intervention was significantly (P=0.000); and the S measured values, and the follow-up period before the treatment group compared with the control group increased after treatment intervention, while the placebo group is basically stable, and before and after intervention the difference was statistically significant (P<0.05).(5) MPQ scale resultsAmong the three groups at each time point after treatment MPQ scales compare average score, in addition to five times after treatment point, I point score differences were statistically significant (P=0.000), and the pre-treatment pairwise comparisons showed that the treatment group with the control group, between the treatment group and the placebo group, the control group and the placebo group differences were statistically significant (P= 0.044, P=0.000, P=0.041), baseline description MPQ scores ranging from baseline scores as covariates variable covariance analysis, the results suggest that different time points after the intervention as an individual within a factor analysis of different groups of pairwise comparison analysis between the three groups and each point in time, the three groups are not as inherent inter-individual variance diverse factors At the same time point evaluated statistically significant (F=5.055, P=0.008); 5th point in the treatment, the treatment group and the control group was not statistically significant (P=0.092), pairwise comparisons showed that the treatment group than comfort group (Z=-1.690, P=0.035), but the treatment group and the control group was not statistically significant (Z=-1.245, P=0.117), in the control group with no statistically significant difference between the placebo group (Z=-0.445, P=0.572); after the end of treatment, and follow-month follow-up of a three-month evaluation point, the treatment group than the control group (P=0.000), the control group than the placebo group (P=0.000), the treatment group better than the placebo group (P=0.000). The results suggest that, in the short-term effect of treatment five times, the treatment group than the placebo group, while the control group and the placebo group had no significant difference, but in the medium and long term efficacy evaluation after treatment, the treatment group than the control group and comfort group and the control group than the placebo group.(6) SF-36 quality of life scale score resultsIn the multivariate analysis of variance within different time points as individuals within the factor as between different groups of individual factors, PCS and MCS different time dimensions group difference was statistically significant (P=0.000), between different groups of groups difference was also statistically significant (P=0.000); pairwise comparison showed that, PCS dimensions compared to the end of treatment, and two follow-up time points, the treatment group than the control group and the placebo group (P= 0.000),the end of the course of treatment After the point, the control group and the placebo group was not significantly different (P=0.151), and were followed up for 1 month and 3-month follow-up point, the control group than the placebo group (P=0.007, P=0.026); MCS comparisons after the end of treatment, and two follow-up time points, the treatment group than the control group and the placebo group (P=0.000), while the control group and the placebo group was not significantly different (P=0.096, P=0.085, P =0.813). The results suggest that the physical health dimension of the total score, the short-term efficacy of the treatment group and the long-term effects are better than the control group and the placebo group, but there was no significant difference in the control group compared to the placebo group with a short-term effect, but excellent, the long-term efficacy in the placebo group; total score in mental health dimensions, the treatment groups in the short, medium and long term than the control group and the placebo group, no significant difference compared with the control group and the placebo group.(7) Evaluation of SafetyIn this study, a total of four cases of adverse events were directly related to the present study, two cases of adverse reactions are mild, one case of adverse events and adverse reactions are moderate, one case is moderate adverse events, is due to increased self-medicated patients stick time due; TESS scale research process does not appear in the side effects of each system, so we can see the whole sky moxibustion of traditional Lingnan belongs to secure treatment, fewer adverse reactions.Conclusion1. After the evaluation literature that External improve cervical spondylosis neck pain than non External effects.2. Through the research that improve the symptoms of cervical spondylosis neck pain Lingnan traditional moxibustion on the 1st day only to a certain extent, but the best results of its lung diseases.3. Clinical studies show:Lingnan traditional moxibustion on the 3rd day before the effective lower cervical spondylosis patients NPQ neck pain scale scores, MPQ scale score improved soft tissue tension, SF-36 scale scores two dimensions, in the treatment of cervical disease neck pain more effective than the traditional Lingnan vesiculation the 1st party group and the placebo group, and on the nerve root type cervical spondylosis slightly better; Lingnan traditional term effect on the 1st day of moxibustion treatment of this disease and the long-term efficacy versus placebo quite. |
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