Clinical Research On Acupuncture Treatment Of Eczema With The Concept Of Heart And Gallbladder From TCM's Aspect

Object iveThis randomized controlled clinical trial observes the clinical efficacy of treating eczema using acupuncture with the concept of heart and gallbladder from TCM's Aspect combined with the blood-letting therapy and do the evaluation of quality of life in order to explore the theoretical basis for the better in clinical practice.MethodA randomized controlled trial method is used to assign 80 subjects who meet the established inclusion and exclusion criteria to treatment group (western medicine+acupuncture treatment) and control group (western medicine)with a ratio of 1:1, each group 40 cases, do chi-square test or T test for both groups'cases on gender, age, disease duration, diagnostic criteria, to make sure there is no difference in gender, age, disease duration, disease type between both groups, then do the observation. The control group uses western medicine alone, zyrtec 10mg, po,1 capsule per time, taking 1 time for the morning and for the night until the end of treatment; for acute phase,uses dexamethasone 0.75mg, po,plus,1 capsule per time, taking 1 time for the morning and for the night, combining with application of topical clobetasol cream (each gram contains 0.5mg clobetasol propionate), applies 2 times for the morning and for the night,4 weeks makes 1 course of treatment. For treatment group, in addition to the western medicine listed above, adding acupuncture, acupuncture points:Baihui, Yintang, Neiguan, Xuehai, Yanglingquan. For the heat-dampness syndrome,add Quchi,for blood deficiency and wind dryness syndrome, add Ganshu; use conventional body acupuncture, the needle is retained for 30 minutes;do the blood-letting therapy after acupuncture:Xinshu, Danshu, Weizhong. Both groups have undergone 8 weeks of treatment, observer whether there is adverse reaction during the treatment. Symptoms and signs of all subjects before and after the trial should be recorded in detail at the same time, to use established evaluation methods to evaluate the clinical efficacy of each group.To do the evaluation of the quality of life of all the included subjects, combined with Chinese medicine theory,use the Dermatology Life Quality Index (dermatology life quality Index, DLQI) and non-specific quality of life scale (the shor form-36 health survey, SF-36) to evaluate the quality of life of 80 subjects who meet the inclusion criteria and exclusion criteria, and compare the difference between the two methods.Data processing method:statistical analysis method:use chi-square test for classification data, use Ridit analysis for comparison of both samples which belong to the ranked data, use t-test for comparison of two samples'means, use paired t test for one-sample. For comparison between groups, use one-way ANOVA analysis of variance. Establish a database with Epi Data3.01 software and use SPSS17.0 software for statistical analysis, use Graph Pad Prism4.03 software for statistical graphics rendering. Use SPSS 17.0 software for evaluation of quality of life, do t-test for the results of DLQI index, SF-36,use multiple regression for further analysis of quality of life, if P <0.05, it is considered as statistically significant.ResultIn this study,80 cases of qualified subjects were assigned to the control group (treated with western medicine) and treatment group(acupuncture+ western medicine), the age of control group:29.7±12.0 years, treatment group:30.4±12.8 years, after independent samples T test, T=-0.252 (p = 0.802), compared two groups of age, there was no significant difference. Control group, there are 16 males,24 females. Treatment group:21 males,19 females. After chi-square test, X2= 6; p= 0.112. There was no significant gender differences between the two groups. For control group, means of disease duration are:1.3500±0.48305; treatment group:1.2750±0.45220. Through independent T test, p= 0.476, p> 0.05. There was no significant difference for both groups before treatment. In control group, there are 21 people who have the heat-dampness syndrome,8 patients having spleen deficiency syndrome and 11 patients having blood deficiency syndrome;for treatment group, heat-dampness syndrome:18 spleen deficiency syndrome:9, blood deficiency syndrome:13; chi-square test results:X2= 0.456, p= 0.796, there was no significant difference between two groups before the trial. For the control group, there are 16 people with acute eczema,6 with subacute eczema and 18 with chronic eczema;for the treatment group, there are 19 people with acute eczema,10 with sub-acute eczema and 11 with chronic eczema. Chi-square test results showed that:X2= 2.9467, p= 0.2291, there was no significant difference between the two groups before the trial. The total scores of signs of the control group before treatment:10.3500±4.64399; treatment group: 10.4250±4.36118; through independent sample T test, T=-0.074 (p= 0.941), because p> 0.05, so there was no significant difference signs total score between the two groups,.Therefore, after ruling out the age, gender, disease duration, type, diagnosis and signs of two groups before the trial, two groups were comparable at baseline.After two courses of treatment, efficacy results are compared as follows:After the intervention, there is significant difference in improving the degree of itching for both treatment and control groups (p<0.05), treatment group was significantly better than the control group in reducing the rash area (p< 0.05); in improving the rash morphology, there is no significant difference between the two groups (p> 0.05). In terms of overall effect, there is significant difference in the overall efficacy of both groups,the treatment group was significantly better than the control group in the efficacy (p<0.05). In terms of function of making patients feel better, there is no significant difference for the treatment group and control group. There are no adverse reactions for both groups during the trial.For evaluation of quality of Life of the trial subjects, making DLQI scores of 80 subjects as dependent variable, making gender, age, family history, course of disease, eczema area and recurrence as the independent variables, after doing multiple stepwise regression analysis, the course of disease ( 45 years= 2), family history (negative = 1, positive= 2) has not been put in the regression equation. Upon examination, the establishment of regression model is meaningful (F= 14.068, P<0.01). Multiple stepwise regression analysis showed that:the corresponding P of t values of the disease duration, eczema area and recurrence are<0.05, which is statistically significant, indicating that disease, eczema area and recurrence are the main factors influencing the DLQI, further analyze the influence of various factors. Because the standardized regression coefficients of disease duration, eczema area and recurrence is greater than 0, indicating that the factors have the positive correlation with the DLQI, the longer the duration is, the larger the eczema area is, the higher DLQI of living index of the patients who have recurrence is, the worse the quality of life is.Evaluation of SF-36 scale score, compare the treatment group with the control group, there was statistically significant difference for the vitality, emotional function, social function (P<0.05), the difference was not significant for the remaining aspects (P> 0.05). Making SF-36 scale score as dependent variable, making gender, age, family history, course of disease, eczema area and recurrence as the independent variables to do multiple stepwise regression analysis. Table 6 shows disease duration <8= 1,> August = 2), eczema area (<20%= 1,≥20%= 2), recurrence (initial incidence= 1, recurrent= 2) which have been put in the regression equation and having some influence on DLQI living index. However, gender, age, family history have not been put in the regression equation. Upon examination, the establishment of regression model is meaningful (F= 8.067, P= 0.001).Multiple stepwise regression analysis showed that corresponding P values of the t value duration of disease, eczema area and recurrence were<0.05, which has statistical significance, showing that disease duration, eczema area and recurrence are the main factor affecting SF-36 scores. Further analyze the influence of various factors, because the standard regression coefficient of disease duation, eczema area and recurrence are greater than 0, indicating that the factors had a negative correlation with SF-36 scores, that is, the longer the duration, the larger the area of eczema, the lower of SF-36 scores of the patients who have recurrence, the worse the quality of life is.Conelusion1. In improving the degree of pruritus, the treatment group is significantly better than the control group. 2. In reducing the rash area, the treatment group is better than the control group3. In improving the rash forms, there is no significant difference between the treatment group and control group.4. In terms of overall effect, both groups have significant difference, the treatment group is significantly better than the control group.5. For making the patients feel better, there is no significant difference between two groups.6. For the negative effects on quality of life of patients with Eczema, we should actively do the treatment; DLQI scale and the SF-36 scale are applicable for quality of life assessment in patients with eczema; the longer the disease duration, the larger the area of eczema and the higher scores of the DLQI and lower scores of SF-36 of the patients who have recurrence, the worse the quality of life is.