| Objectives1.To review the classification, distribution of Dynasty, the name of disease, etiology and pathogenesis, clinical symptoms and treatment of skin lesions, age and site content and so on through the retrieval of ancient literature in atopic dermatitis, and so as to provide new ideas for the clinical research of AD.2.To evaluate the clinical Efficacy and Safety of acupuncture in the treatment of atopic dermatitis by a systematic review on acupuncture therapy in modern literature.3. To totally evaluate the clinical effect of acupuncture combined with Chinese Herbal Medicine therapy for the syndrome of wind-dryness due toblood deficiency of AD through the randomized controlled trial. So as to provide new ideas and treatment methods for the clinical treatment of AD.4. To clarify the mechanism of acupuncture adjustment for type Ⅰ allergic mice atopic dermatitis model due to the imbalance in the body T cells through animal research on acupuncture treatment for atopic dermatitis in rat, and moderate the effect of acupuncture on Thl/Th2 immune imbalances.so as to provide experimental basis for clinical research.Methods1. Ancient literature researchThrough the study of the research of modern bibliography cec experts, determine the search term and reference value of ancient books bibliography, literature inclusion criteria and exclusion criteria, prepare the AD information collection table of ancient books, using Epidata3.1 input andthe establishment of database, all data were statistically analyzed with SPSS13.0, mainly adopts content analysis method are analyzed.2. Systematic review of modern literatureThrough analyzing and evaluating the randomized controlled trials of acupuncture in the treatment of AD published in formal academic journals from January of 1989 to March of 2014, asessed the curative effect of the present study, the current research deficiency and the research direction of acupuncture in the treatment of AD. "Atopic dermatitis " or "AD" and "acupuncture" were the search words. In literature search from Chinese Biomedical Literature database (CBM), China Academic Journal(CNKI), Chinese Biomedical database (VIP), WangFang Medline, Cochrane CENTRAL, PubMed database and Embase medical database. Using the evaluation tools in Cochrane reviews handbook 5.3.0 to evaluate risk of bias for research, and the statistical analysis and Meta analysis were conducted with Review Manage 5.3 software or separate descriptive analysis.3. Clinical StudyThe subjects were recruited from the AD outpatients of dermatology department and traditional therapy center of Guangdong Provincial Hospital of TCM. According to clinical trials, treatmentrelated statistical principles of requirements, combined with the feasibility of clinical practice,as well as cases of exit, lost, and eliminate other factors,10% of the budget dropout rate was taken,99 case of AD patients who met the inclusion criteria were andomly divided into 3 groups according to the proportion of 1:1:1, acupuncture combined with medication group (group A), acupuncture group (group B) and medication group (group C). There were 33 patients in each group.Treatment protocol:Acupuncture combined with Chinese Herbal Medicine group (group A): Acupuncture and Chinese Herbal Medicine, combined with regular skin care. Disposable sterile stainless steel needle was used for the acupuncture appliance (produce in Tianjin HuaHong Medical business,0.30X25 mm or 0.30 ×40 mm). The needle length was selected according to the obesity degree of the patient. Acupuncture prescript ion:QuChi (LI 11), YinLingQuan(SP9), ZuSanLi(ST 36), XueHai(SP 10), NeiGuan(PC 6), GuanYuan(RN 4) and ZhaoHai(KI 6).Lateral position was selected for acupuncture. Selected the proper needle and inserted needle with fast rotation, hand-manipulated needle with mild reinforcing and reducing method, and the needle was retained for 30min. Each patient received three-time-a-week treatment with 4 weeks for 1 course, the study consisted of a 3-month cycle treatment with a treatment interval of two days. Referring to Chen Deyu’s Syndrome Standards of Atopic Dermatitis in Integrative (Chinese Medicine Press, August 2012,16th Edition,1st printing), take Angelica Yinzi addition and subtraction for winddryness due to blood deficiency of AD. one dose a day, each dose boiling twice on morning and evening.Acupuncture group (group B):acupuncture manipulation method as the same as group A. Regular skin care was employed as the same time.Chinese Herbal Medicine group (group C):the same medication taking method as group A, was employed with regular skin care.All patients received treatment for 12 weeks,4 weeks for 1 course, total 3-month cycle treatment with 4-week follow-up. All physical examinations of pruritus, skin lesions, the Pittsburgh Sleep Index and SCORAD were performed before treatment and after 4 weeks,8 weeks,12 weeks and 16 weeks of treatment. All data were statistically analyzed with SPSS19.0.4. Animal TrialC57BL/6 mice were bought from animal experiment center of guangdong province, which was 6 to 7 weeks, weight 16-22 g, according to random number table method to 24 C57BL/6 mice were divided into blank group, modelgroup, acupuncture group, the sham acupuncture group a total of fore groups, each group of 6.Experimental Protocol:Duplicate the atopic dermatitis model by 2,4-dinitrofluorobenzene reference the method of Chen Dacan induced atopic dermatitis-related symptoms by 2,4-dinitrofluorobenzene(DNFB) as animal models in mice. The acupuncture therapy reference the method of South Korea DONG-YOON NAM treat the mice symptoms. Bland group with normal feeding, no any processing for it;Model group was used for building observation, don’t do any treatment; Acupuncture appliance was Global brandof disposable sterile stainless press needle (suzhou global acupuncture products business,0.22X1.5 mm) for Acupuncture group in first 5 days after sensitization, acupuncture prescription:ZuSanLi(ST 36)and NeiGuan(PC 6), referring to Lin WenZhu’s animalexperimental acupuncture(Shanghai science and technology publishing house,1999,1st printing). Treatment once a day, five days in a row with a interval of 1 day, continue to treatment 4 days, a total of nine times,10 days for a course of treatment. Sham acupuncture group took the non-acupuncture point stimulation according to the acupuncture treatment time of acupuncture group, in mice with spinal for midline, near 10 mm, distance fromthe anus 5 mm at the junction of normal skin and skin to stimulate the point (bilateral).Results1. Ancient literature researchThe research retrieved 294 articles.218 relevant ancient literatures and 5 repeated articles were excluded after carefully filtered.25 articles were included in the analysis, which mainly contained surgical monographs and were printed between the Song and Qing dynasties.51.4%(18/35) ofthe articles described the etiology and pathogenesis mainly including wind, dampness and heat.53.3%(8/15) of the articles described the majority age of onset with childhood.14 articles gave a description of consciously pruritus symptoms. Mostly the articles described skin lesions with "evaporation". The treatments include external therapy, internal and external therapy and oral therapy.15 external therapy were mentioned totally.2. Systematic review of modern literatureAccording to the search strategy and literature screening methods, a total of 322 papers published in formal academic journals were found. There were 138 papers written in Chinese and 184 papers written in English. After reading the title, abstract, text and doing bias risk assessment,5papers of randomized clinical literature were screened out. No report on side-effect was described in these 5 articles. Totally 285 cases involvedin the 5 articles. The research findings showed that acupuncture was safein the treatment of AD. The total effective rate of acupuncture group wasbetter than controlled group, 0R=3.7,95%CI (1.74,7.84).3. Clinical StudyAfter 12 weeks of therapy,9 cases fell off totally in the three groups of wind-dryness due to blood deficiency of AD patients.3 cases in group A, 4 cases in group B,2 cases in group C. Finally,30 cases in group A,29 cases in group B and 31 cases in group C were analyzed statistically.(1) Baseline analysisBefore treatment, in order to determine the comparability of the three groups, the data analysis was conducted on age, disease course, sex, SCORAD scores, atopic dermatitis symptom scale scores, Pittsburgh Sleep Index Scale score and Visual analogue scale respectively. There were no significant differences (P>0.05) among the three groups.(2) SCORAD scoresThrough analysis of the 5-point-score of SCROAD measure data respectively for A, B and C groups, before the treatment,4 weeks,8 weeks,12 weeks and 16 weeks of followed-up, the difference was found to be statistically significant (P<0.05) within groups. The between-group effect was F= 3.293, P= 0.042; and the difference was statistically significant (P<0.05); Pairwise comparison among the three groups A, B, C, and multivariatestatistical results suggest that difference between group A, group B and group C was statistically significant(P<0.05), difference between group C and group B was not statistically significant(P> 0.05).(3) Atopic dermatitis symptom scale scoresThrough analysis of the 5-point-score of SCROAD measure data respectively for A, B and C groups, before the treatment,4 weeks,8 weeks,12 weeks and 16 weeks of followed-up, the difference was found to be statistically significant (P<0.05) within groups. The between-group effect was F=3.298, P=0.042; and the difference was statistically significant (P<0.05); Pairwise comparison among the three groups A, B, C, and multivariate statistical results suggest that difference between group A and group C was statistically significant (P<0.05), difference between group A, group C and group B was not statistically significant(P>0.05).(4) Pittsburgh Sleep Index Scale scoreThrough analysis of the 5-point-score of SCROAD measure data respectively for A, B and C groups, before the treatment,4 weeks,8 weeks,12 weeks and 16 weeks of followed-up, the difference was found to be statistically significant (P<0.05) within groups. The between-group effect was F=3.129, P=0.049; and the difference was statistically significant(P<0.05); Pairwise comparison among the three groups A, B, C, and multivariate statistical results suggest that difference between group A and group C was statistically significant (P<0.05), difference between group A, group C and group B was not statistically significant(P>0.05).(5) Visual Analogue ScaleThrough analysis of the 5-point-score of SCROAD measure data respecti-vely for A, B and C groups, before the treatment,4 weeks,8 weeks,12 w-eeks and 16 weeks of followed-up, the difference was found to be statistically significant (P<0.05) within groups. The between-group effect was F=3.17, P =0.047; and the difference was statistically significant(P<0.05;Pairwise comparison among the three groups A, B, C, and multivariate statistical results suggest that difference between group A and group C was statistically significant (P<0.05), difference between group A, group C and group B was not statistically significant(P>0.05).(6) Comprehensive clinical efficacyThree groups of patients’comprehensive clinical efficacy were compared by using the chi-square test.The efficacy was statistically significant (P＜0.05) between the three groups. Data show that there had was significant difference in improving the comprehensive clinical efficacy for atopic dermatitis patients between A, B and C groups.(7) Safety index and adverse reactionBlood, liver and kidney function damage were not found in all of the three groups. The differences among group A, B and C were statistically significant in adverse react ions (P＜0.05). The data showed that taking the medicine simply had bloating, stomach pain and other digestive regard; adverse reactions after acupuncture treatment showed more bleeding after acupuncture needle points out; and it may appropriately reduce the side reactions by combining the acupuncture with traditional Chinese medicine.4. Animal Trial(1) Ear thicknessAfter DNFB sensitization, mice ear of model group markedly swollen and thickening (P<0.05) compared with the blank group, the difference was statistically significant; ear swelling of sham acupuncture group were significantly decreased(P< 0.05) compared with model group,and acupuncture group extremely significantly reduce (P< 0.01); the difference was statistically significant. Comparison between each treatment group(P> 0.05), the difference was not statistically significant.(2) Pathological tissueStimulate skin lesions after pathological changes:blank group did not see her lesions hyperplasia, thickening, only a small amount of inflammatory cells infiltration; Model group was detected obvious hyperplasia, thickening, corneous layer appears diversification or parakeratosis, epidermis and the dermis appear a large number of inflammatory cells (neutrophils and lymphocytes) infiltration; The treatment group was detected in different degree of thickening and inflammatory cells infiltration.(3) Serum IgE, IL-4 levelSerum IgE level of each group of mice show that:the content of model group significantly increased (P< 0.05) compared with blank group, thedifference was statistically significant; Compared with model group, the IgE level of treatment group not seen significantly decreased (P> 0.05), the difference was no statistically significant. Comparison between each treatment group (P> 0.05), the difference was no statistically significant.Serum IL-4 level of each group of mice show that:the content of model group significantly increased (P<0.05) compared with blank group, the difference was statistically significant; Compared with model group, the IL-4 level of treatment group not seen significantly decreased(P>0.05), the difference was no statistically significant. Compared with the sham acupuncture group, the IL-4 level of acupuncture group significantly decreased (P<0.05), the difference was statistically significant.(4) Degree of skin inflammationThere was no skin lesions and inflammatory changes in Blank group, and skin lesions in Model group appeared obvious erythema, edema, skin peeling, scales, etc. The difference was statistically significant (P< 0.05). Compared with model group, the skin inflammation of acupuncture group significantly decreased, the difference was statistically significant (P< 0.05).Conclusion1. The research found ancient literatures of atopic dermatitis variesfrom the distribution of dynastic factors to treatments,but mainly included the external therapy. Clinical treatment should be based on syndrome differentiation of clinical manifestation of patients, and taking into account external therapy, selecting the appropriate dosage and medication according to the nature of the lesions, lesion location and seasonal factors, to improve clinical outcomes.2. Systematic review of modern literature found that acupuncture is effective and has no adverse reactions in the treatment of Atopic dermatitis, but it is not definite due to relatively low level of evidence. More high-quality evidences are needed.3. The present clinical study found that compared to the simple acupuncture or simple Chinese Herbal Medicine, the method of combination of acupuncture with Chinese Herbal Medicine for the treatment of wind-dryness due to blood deficiency of AD is effective in improving systemic itching, skin lesions, poor sleep quality of patients obviously. Acupuncture or acupuncture combined with Chinese Herbal Medicine has less adverse reaction, and it has a good application prospect and popularization value in further research.4. There had no abnormalities in Normal control group mice, the serum IgE, IL-4 of mice increased significantly after DNFB sensitization, meaning DNFB stimulate building successfully in mice. After treat the successful animal model, expression levels of total serum IgE and IL-4 had a varying degrees of drop in acupuncture and Sham acupuncture group, but the model group had not. It showed that the reduction of acupuncture for total serum IgE and IL-4 strength which elevated before treatment is limited. However, IL-4 showed a significant decrease between acupuncture group and sham acupuncture group, it shows that acupuncture on ST36, PC6 for level of IL-4 had impacts and regulatory role in mice.After treat with acupuncture and sham acupuncture for successful animal model, the Ear thickness, Degree of skin inflammation with varying degrees of improvement, difference between before and after treatment is significant. The animal trial results showed that acupuncture on ST36, PC6 can effectively reduce degree of skin inflammation and ear swelling and thickness in AD model mice. |
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