Clinical Study Of Lingnan Tianjiu Therapy For Knee Osteoarthrits

ObjectiveTo estimate the clinical efficacy and safety of No.3 priscribtion of Lingnan Tianjiu Therapy for knee-osteoarthritis, by compairing with the original priscribtion (No.1 priscribtion) group and placebo group.Methods1. clinical researchQuestionnaire method, west of Ontario and McMaster Osteoarthritis Questionnaire (WOMAC) as a template, design questionnaires for 2013--2014 years, Guangdong Provincial Hospital to participate in dog day every day every day moxibustion moxibustion or thirty-nine crowd payment tianjiu questionnaire, use Epidata 3.2 software package returned questionnaires for data entry, application SPSS 20.0 statistical software, through descriptive analysis of statistical methods for data analysis of the survey results.2. Pre-clinical trialsBy Lingnan traditional tianjiu the 1st party control, to carry out pre-trial,24 patients were enrolled in a 1:1 ratio were randomly divided into treatment group and control group, treatment group Lingnan traditional tianjiu No.3 (yellow mustard, cooked tuber, Clematis, etc.) in the treatment and control group treated with traditional Lingnan tianjiu the 1st party (yellow mustard, Asarum, euphorbia, fumarate, etc.). Both groups choose ① Jue Yin Yu, spleen, bladder Yu, Zusanli knee eye; ② Xinyu, bile Yu, Shenshu, knee Yang Guan, yinlingquan, Hedingshan acupuncture as a treatment, two points each alternate therapy, treatment course of treatment once every five days, were treated 10 times. Respectively, before treatment, before 6th treatment, at the end of treatment and one month after the end of treatment altogether four time points for evaluation, application of Western Ontario and McMaster Osteoarthritis Questionnaire (WOMAC) and visual simulation assessment scoring (VAS) to evaluate the clinical efficacy of Lingnan traditional tianjiu the 3rd party.3. Clinical ResearchBased on pre-clinical research and test results, the establishment of a randomized controlled trial, recruited 143 cases of knee osteoarthritis patients, using simple random method, according to 1:1:1 ratio were randomly divided into three groups, treatment group 47 cases in the control group of 50 cases,46 cases of the control group 2. Treatment group Lingnan traditional parties on the 3rd day moxibustion treatment, the main component of yellow mustard, cooked tuber, Clematis, etc., the control group using traditional Lingnan day moxibustion treatment on the 1st side, that is the day moxibustion casual side, the main yellow mustard, Asarum, euphorbia, fumarate, etc. control group 2 placebo intervention, placebo was raised from buckwheat flour pigments to blend.Three groups have chosen ① Jue Yin Yu, spleen, bladder Yu, Zusanli knee eye; ② Xinyu, bile Yu, Shenshu, knee Yang Guan, yinlingquan, Hedingshan as a treatment points, two points each alternate treatment, treatment dispensary at the end of about 10g, with ginger (ginger, peeled wringer filter) 10ml reconcile into about 1cm × 1cm × 1cm-sized drug cake, which placebo 1/10-1/20 proportion ginger, add water to make reconcile agent to tianjiu special tape (approximately 5cm diameter circular tape) affixed to the points, each time one hour paste medicine, blankets, wash the cream can be removed after the arrival time of administration posts. As post local drug adverse reactions, adverse reactions by step process.1 course of treatment once every 5 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 WOMAC scale, soft tissue tension tester for the primary outcome measure, the subjective evaluation of knee function table (IKDC), VAS scale, SF-36 quality of life scale as secondary outcomes, TESS (TESS), etc., as safety indicators, before treatment, at the end of treatment, one month after the end of treatment, three months after the end of treatment, respectively, three groups to evaluate the treatment of knee osteoarthritis.Using SPSS 20.0 statistical analysis of the measurement results, the results of using the intention to treat analysis, through descriptive analysis, paired t test, Wilcoxon signed rank test, analysis of variance, rank sum test (Kruskal-Wallis), chi-square test and other test methods Three groups of the discrepancy and differences between the three groups were compared. The use of two-sided test, a baseline comparison test level α=0.10, between groups test the efficacy level α=0.05, pairwise comparison between α=0.0167.Results1. Survey resultsThe survey questionnaires returned a total of 5282 copies, of which 298 patients with knee osteoarthritis,5.6% of the total. The average age was 54.67 ± 12.59 years; mean duration of 38.77 ± 59.82 populations months, the maximum duration of 360 months were (30 years); respect for the severity, 21.1% mild discomfort,32.2% can affect the daily work and life,36.9 percent can significantly affect the daily work and life,9.7% can not even conduct a serious impact on daily life and work; Lingnan tradition tianjiu on lung diseases such as rhinitis, asthma, pharyngitis, and so the average effective rate of 72.5% for knee Pain efficiency of about 61.9% on average, seen Lingnan traditional tianjiu can relieve knee osteoarthritis symptoms to some extent.2. Pre-test resultsPre-trial included 20 patients with valid cases,10 cases of treatment group,10 cases in the control group. The chi-square test, compare two groups of patients in terms of gender, occupational structure, the difference was not statistically significant (P= 0.606); educational level distribution of the two groups, the difference was not statistically significant (P= 0.912), Both groups were age, duration of the treatment group mean age was 55.30 ± 6.13 years, mean disease duration was 84.70 ± 114.78 months, the control group, the average age was 55.70 ± 11.25 years, mean disease duration was 88.80 ± 115.63 months, and the difference between the two groups no statistically significant (P> 0.05).(1) WOMAC scaleThe chi-square test, two groups of patients with baseline WOMAC scale score minus points equal (P= 0.181), the two groups were comparable. After treatment and therapy before six point WOMAC score between the two groups was not statistically significant (P= 0.267, P= 0.180), and followed up a month of scores between the two groups were statistically significant (P = 0.042). Within group comparison shows that the two groups at each time point after the intervention score, WOMAC score compared with previous decline, the generally downward trend, at each time point comparison results indicate statistically significant (P= 0.000). After the intervention, the treatment group minus points higher, by rank sum test between the two groups showed no significant difference (P> 0.05).(2) VAS scaleWithin group comparison shows that the two groups at each time point after the intervention score, VAS score decline than before, the overall downward trend, compare different points of the group showed that the treatment group and the control group before and after treatment VAS scores at each time point There were significant differences between the groups were compared at each time point and the results showed no significant difference (P> 0.05).3. The results of clinical studies(1) General InformationThe study included patients with 143 cases, the treatment group (Lingnan traditional tianjiu No.3 group) 47 patients in the control group (tianjiu scattered group) 50 cases,46 cases of placebo, dropout rate was 6.54%. The subjects included in the average age of the patients was 58.42 ± 11.13 years old, the oldest 69-year-old person, the smallest in 41 years; mean disease duration was 77.45 ± 53.16 months. In terms of TCM syndromes, liver and kidney deficiency, tendons and stasis card as the main syndromes, accounting for 76.9%. Three groups of patients were chi-square test in the pre-treatment of gender, age, education level, duration of previous treatment, TCM syndrome type and previous course of treatment and other general information, analysis of variance or the difference was not statistically significant KW inspection (all P> 0.05), described three groups of groups may be balanced, comparable data.(2) the Western Ontario and McMaster Osteoarthritis Questionnaire (WOMAC) analysisThree groups in baseline values before treatment compared with no significant difference between groups (P= 0.769), illustrate the balance among the three groups at baseline were comparable. After treatment, the three groups of patients before treatment than WOMAC score decreased, and the treatment group the largest decline, followed by the control group decreased, the placebo group decreased slightly, by analysis of variance and pairwise comparison showed that each evaluation after treatment point difference between the groups in the three groups was statistically significant (P= 0.002, P= 0.000, P= 0.000), before and after treatment WOMAC scores at each time point repeated measures analysis, between-subjects effects test showed different groups of test P= 0.000, indicating that the treatment effect of differences between groups was statistically significant; at the same time, the three groups after treatment were reduced rate WOMAC were analyzed, the results show after the end of treatment, follow one month and three-month follow-up point, the reduced rate of the treatment group were 52.89%,73.85%,73.87%, the reduced rate of the control group were 34.51%, 56.35%,51.49%, reduced rate for the placebo group were 15.04%,9.68%,6.97%, and between the two groups was statistically significant (P= 0.036, P= 0.004, P= 0.015) difference. To sum up the results, indicating to the WOMAC scale for the efficacy evaluation of the results, the treatment group than the control group and the placebo group, the control group than the placebo group.(3) The results of the analysis of soft tissue tensionAmong the three groups in the pre-treatment measurements and S D0.5kg measurement group, the difference was not statistically significant (P= 0.696, P= 0.910), illustrate comparable between the two groups. Among them, the relatively D0.5kg measured values, the three groups at each time point measured after treatment than before rise, measured during follow-up compared with the end of treatment is decreased, and the biggest decline placebo comparison between groups revealed At the end of treatment and follow-up one month evaluation point, the differences among the three groups was not statistically significant (P= 0.583, P= 0.105), in the three-month follow-up point, the difference between the three groups was statistically significant (P= 0.004); compares the measured values of S, the three groups at each time point in the evaluation after the intervention, the treatment group and the control group at each time point after intervention S measured value change is rising, while the placebo group showed a downward trend, among groups showed differences between the groups were statistically significant (P= 0.000). These results indicate that, for soft tissue tension, the three treatment options for knee osteoarthritis localized pain conditions improve, almost, no significant difference in the efficacy of the medium-term, and long-term efficacy differences between the groups with and the treatment group than the control group and the placebo group, the control group than the placebo group; treatment of soft tissue elasticity measurement functions, the treatment group and the control group can effectively improve the elasticity of soft tissue, and the treatment group than the control group, while the placebo group can not improve soft tissue elasticity.(4) visual analogue rating scale (VAS) ResultsThree groups of patients before treatment between VAS score was no difference (P= 0.716), baseline balance. After treatment, the three groups VAS score decline than before, and the treatment group declined more than in the control group, the smallest decline in the placebo group, between groups were compared by analysis of variance showed that the differences among the three groups at each time point after statistical treatment significance (P= 0.003, P= 0.020, P= 0.016); for each point VAS scores before and after treatment were repeated measures analysis on the impact of various factors on the VAS measurement time was statistically significant, VAS measured at different time points score on at least two time points are different (P= 0.000), between-subjects effects test showed different groups of test P= 0.000, indicating that treatment effect differences between groups were statistically significant; for the three groups after treatment were VAS reduction rate was analyzed, the results showed that after the end of treatment, follow one month and three-month follow-up point, the treatment group reduced rate of 35.40%,62.03% respectively,66.32, reduced rate of the control group were 26.62%,52.36%,52.36%, reduced rate for the placebo group were 18.01%,18.35%,18.01%, and between groups was statistically significant difference (P= 0.000). To sum up the results, indicating to the VAS scale for the efficacy evaluation of the results, three scenarios are on the pain of knee osteoarthritis have some improvement, and the optimal treatment group and the control group, the placebo group slightly ease the pain the role of the treatment group than the control group and the placebo group, the control group than the placebo group.(5) subjective knee function evaluation form (IKDC) ResultsThree groups of patients before treatment between IKDC score was no difference (P= 0.716), baseline balance. After treatment, the three groups of patients IKDC score decline than before, and the treatment group declined more than in the control group, the smallest decline in the placebo group, between groups were compared by analysis of variance showed that the differences among the three groups at each time point after statistical treatment significance (P= 0.003, P= 0.020, P= 0.016); between-subjects effects test showed different groups of test P= 0.000, indicating the treatment effect of differences between groups were statistically significant. To sum up the results, indicating to the IKDC scale as the efficacy assessment of the results, three scenarios are a function of knee osteoarthritis have some improvement, where the optimal treatment group and control group, the placebo group improved slightly, and treatment group than the control group and the placebo group, the control group than the placebo group.(6) SF-36 quality of life scale score resultsThree groups before treatment SF-36 scale scores in physical health (PCS) total score and mental health (MCS) total score of the two dimensions were not statistically significant (P= 0.843, P= 0.077), showed three treatment groups Baseline balance.Three groups of patients after treatment of SF-36 PCS rates have risen overall, the treatment group and the control group the largest increase, rising to a lesser extent in the placebo group; in one month follow-up point and followed up for 3 months point, three dimensions PCS scores have different degrees of decline compared with the end of treatment and the placebo group declined more than the treatment group and the control group; each point before and after treatment scores PCS Dimension repeated measures analysis showed that the time factor P= 0.000, the impact of various factors on the time dimension have significant PCS, PCS prove dimension measured at different time points score on at least two time points are different between the main effect test showed different groups of test P= 0.197, indicating that the treatment effect of differences between groups was not statistically significant, the results can not prove the merits of the three groups of interventions; pairwise comparisons suggest that no significant group differences among the three groups in the treatment group and the control group (P> 0.05), while the treatment group and the placebo group, between the control group and the placebo group comparison group differences were statistically significant (P<0.05). These results indicated that the three groups of intervention programs can improve local symptoms of knee osteoarthritis to some extent, the effect of the treatment group and the control group is quite, and the two groups were superior to placebo.After MCS total score, the results show after the intervention, the three groups of MCS scores were increased to certain extent, the treatment group and the control group the largest increase, the smallest increase in the placebo group,1 month follow-up point, the treatment group the placebo group showed an upward trend in rates, group rates are down slightly, up 3 months time point, three scores were decreased, and decreased significantly in the placebo group; each point before and’after treatment MCS dimensionality repeated measures analysis The results show that the time factor is P=0.000, prove MCS dimension measured at different time points scoring at different time points are different between the main effect test showed different groups of test P= 0.309, indicating that treatment effects of different groups the difference was not statistically significant, was unable to prove the merits of the three groups of interventions; pairwise comparisons suggest that no significant group differences among the three groups in the treatment group and the control group (P> 0.05), while the treatment group and comfort group, the control group and the placebo group comparison group differences were statistically significant (P<0.05); ANOVA showed that individual factors as an internal evaluation point within the group difference was statistically significant (P= 0.014), but as individuals different intervention programs difference between groups is statistically significant difference (P= 0.082). These results indicate that in SF-36 MCS scale total score dimension, the three groups of intervention programs can improve psychological symptoms in patients with osteoarthritis of the knee to a certain extent, and the treatment group and the control group the most obvious effect, are excellent in the placebo group, while the treatment group and the control group a considerable effect.(7) Evaluation ResultsAfter treatment, the three groups were 63.8% effective rate,66.0%,39.1%, effective rate is 31.9%,28.0%,0.0%, a statistically significant difference between groups (χ2=66.047,P=0.000), the follow-up one month, three groups were 70.2% efficiency,64.0%,37.0%, effective rate of 27.7%,30.0% and 0.0%, differences between the two groups was statistically significant (χ2=72.678, P=0.000),3-month follow-up evaluation, the three groups have efficiency of 72.3%,72.0%,21.7% respectively, effective rate of 21.3%,18.0%,0.0%, between the two groups was statistically significant difference (χ2=78.159, P=0.000). From the last results, the three groups after treatment observation point, the treatment group than the control group slightly, both superior to placebo; follow-up one month and three months of follow-up observation point, the treatment group was superior control group, and both were better than the placebo group.(8) Safety EvaluationIn this study, a total of six cases of adverse events were directly related to this study, two cases of adverse reactions are mild,4 cases belong to moderate adverse events were due to patient self-induced increase Plaster time; TESS scale in the research process Each system does not appear side effects, we can see that the traditional Lingnan tianjiu belonged safe treatment, fewer adverse reactions.Conclusion:1. No.4, No.1 prescribtions of Lingnan traditional Tianjiu therapy and placebo could improve the symptoms of knee osteoarthritis to a certain extent, with No.4 prescribtion is the best one.2. Clinical studies show:Lingnan traditional moxibustion on the 3rd day before to reduce knee osteoarthritis WOMAC scale score, VAS scale score improved soft tissue tension, improve the quality of life of patients, the efficacy in the treatment of knee osteoarthritis It is better than the traditional Lingnan Vesiculation the 1st party group and the placebo group; and the clinical treatment of knee osteoarthritis have some degree of placebo effect.