Study On Clinical Effects Of Acupoint-application Therapy For Preventing And Treating Infant Bronchial Asthma (A Winter Disease) In Summer And Its Impact Factors

In the present project, the author reviews the related papers and recent clinical researches on the prevention and treatment of infant bronchial asthma (usually occurring during winter) with acupoint-application therapy in summer in the past 40 years and conducted clinical observation by using principles and thoughts of evidence-based medicine and methods of clinical epidemiology of modern medicine. On the basis of comprehensive collection of the related reports, clinical observation and experts' consensus, the author makes an analysis on the relationship between the clinical effects and the influential factors, so as to seek some scientific evidence for assessing its clinical efficacy and to provide valuable references for the operative methods and standards of the acupoint-application therapy.The study includes two parts:1. Literature research about the winter disease treated in summer with acupoint-application therapy for infant bronchial asthma;2. Clinical research on the curative effect of acupoint-application therapy for winter disease (infant bronchial asthma) treated in summer.Objective:Though collecting of modern literature and observing the clinical effect of acupoint application therapy fro treating child bronchial asthma in summer; we analyzed the relevant influential factors and make a preliminary analysis on the influential factors, such as:selection the effective medicinal herbs, acupoint prescriptions, preparation methods, and the opportunity and duration of intervention. The research will provide a scientific basis for. the therapy.Methods:According to the concepts and methods of Evidence-based Medicine, and combining characteristics of Chinese acupuncture academic literature, we selected winter-disease treated in summer, acupoint, and child bronchial asthma as keywords to retrieve full text databases, such as SinoMed etc., with computer and manual operation, to make a data table and conducted a statistical analysis. By adopting prospective clinic observation method and cohort study design, the present study was conducted in three top-class Chinese medicine hospitals of Liaoning Province, Hubei Province and Chengdu City. The bronchial asthma children during remission stage in three series of groups were observed, and the related data were analyzed preliminarily in the way of follow-up.Results:1. Literature researchThe author of the present paper collected a total of 45 qualified papers. General information and analysis about the children and clinical observation results are shown as follows:1) General information:The sick boys were more than sick girls, with an age from 2 month to 17 years,7.5 years at an average. The duration of disease was from 2 months to 10 years, averaging 3 years. Sixty-four point four percent of the papers described the asthma stages, and 55.6% of them belong to clinical reports in which the infant bronchial asthma was treated during the remission period.2) Herbal medicine application:The frequently used top 10 medicinal herbs, in sequence, were Sinapis alba, Asarum, Fumitory, Euphorbia kansui, Musk, Chinese ephedra, Chinese honey locust, Clove, Chinese Cinnamcn, and Perilla seed. The ratios of the components of the prescription, Sinapis alba, Fumitory, Euphorbia kansui, Asarum were mostly 2:2:1:1,75.6% of them selected the fresh ginger juice to be processed into ointment.3) Acupoint selection:The frequently used top 10 acupoint, in sequence, were Feishu (BL13), Dingchuan (EXB1), Gaohuang (BL43), Geshu (BL17), Shanzhong (CV17), Xinshu (BL15), Pishu (BL20), Dazhui (GV14), Shenshu (BL23) and Tiantu (CV22). Most of them belong to the Bladder Meridian of Foot-Taiyang, Conception Vessel, Governor Vessel, and extra-points, and were Back-shu acupoints.4) The opportunity of acupoint application:Seventy-seven point three percent of the infant patients were treated in dog days,11.3% treated in dog days and the coldest days in winter,8.9% treated in summer or between July and August, and 2.2% treated in other days.5) The duration of acupoint application in a treatment session: Twenty-four point four percent of the cases received treatment for 2h or more in a session,20.0% treatment for 2h or more than 2h; and 6.7% treatment for 1-3h. The shortest duration of treatment in one session was 0.5h, and the longest 24h, and mostly 2h.6) Skin reactions:Forty-two point two percent of the papers did not describe the skin reactions; 13.3% mentioned the local erubescence; 11.1% mentioned the pain; 8.9% reported burning sensation, tiny vesicles or other reactions, and 6.7% mentioned blisters.7) Research methods:Seventy-seven point eight percent of papers were clinical observation or clinical reports; 22.2% adopted numeral table, randomization table or computer-aided randomization for grouping. The number of the observed patients was fewer than 300 cases in 88.9% of the papers. 2. Clinical research1) General DataThere were 609 children with bronchial asthma who meet the standards in the remission stage, including 328 cases from Liaoning Province,139 from Hubei Province, and 142 from Chengdu City. The average age of the cases was 6.89±2.82 years from Liaoning Province,6.89±2.82 years from Hubei Province, and 6.77±3.23 years from Chengdu City respectively. Boys were more than girls in number. And the average duration of disease was 2-3 years. No significant differences were found in the age, sex, and duration of disease (P>0.05).2) First diagnosis(1) Clinic symptoms:According to the frequency (from high to low), clinical symptoms were asthma, cough, wheeze, expectoration, short of breath in infant cases from Liaoning Province, asthma, cough, expectoration, wheeze, and short of breath in those from Hubei Province, and asthma, cough, expectoration, wheeze, and short of breath in those from Chengdu City. Chi-Square Tests showed a very significant difference in clinical primary symptoms among the 3 groups (P<0.01). The sorted order of the aforementioned symptoms was asthma, cough, wheeze, expectoration, and short of breath.(2) Attack frequency and attack seasons:Infant patients from Liaoning Province group had no obvious seasonality in both the winter and spring; those of Hubei Province group and Chengdu City group were often seen in winter, spring and no obvious seasonality respectively. Chi-Square Tests showed a very significant difference among the 3 groups in the seasonality (P <0.01).(3) Disease condition analysis:It shows a very significant difference in acute onset or aggravation times of disease among the three hospital groups (P <0.05). And the average highest asthmatic attack or aggravation times who came to visit hospital was≤1 time a month,2-3 times a month, and 1-2 times a week, separately, and the fewest is≥3 times a week.(4) Self-evaluation and doctors'evaluation:No significant difference was found in the degree of severity of patients' condition in the light of children or their guardians'narration in the first diagnosis according to a sheet with 1-10 points about patients, self-feelings of the degree of severity by rank sum test (P>0.05). Doctor's conclusion on patient's condition for the first diagnosis, moderate is the most, mild is the second and severe condition is the last in the three hospital groups. It showed a significant difference in doctor's diagnosis about children's disease condition by CMH Tests (P<0.05)(5) Reaction of application skin:The dominating reactions of skin were itching, local hotness after application in dog days according to different therapeutic schedules of the three hospitals. A great significant difference was found in the reactions after CMH Tests (P<0.05)3) Analysis of influential factors(1) Analysis of individual factor:①There were no statistical significances in the children's age, sex, and duration of disease (P> 0.05). But the probability of asthma's reoccurrence declined with the increase of age.②A statistical significance was found in the seasonal variation of asthma's occurrence or aggravation (P<0.01)and the occurrence of asthma was higher with seasonal variation.③A statistical significance was found in the different levels of the number of occurrence of asthma in the first diagnosis (P< 0.01). The probability of asthma reoccurrence that children's acute occurrence was less than one time a month was much lower than that in those whose asthma acute occurred below one time a month. A statistical significance was found in different levels of periods of illness severity (P<0.05) and the children with mild type had a low probability of asthma reoccurrence.④A very significant difference was found on the first time between skin reactions and asthma reoccurrence by Chi-Square Tests (P<0.01), and on the second time the difference was significant (P<0.05). No significant difference was found in the skin reactions on the third time (P>0.05).⑤No statistical significance was found in the relationship between the time and the opportunity of application by Chi-Square Tests (P<0.01). The asthma children with 0.5-2h application in both dog days and cold days had a lower probability of asthma reoccurrence.⑥A statistical significance was found among the different treatment regimens of three hospital groups by chi-square test. (P<0.01) Prescription containing Corydalis had a lower probability of reoccurrence of asthma, and those containing Euphorbia kansui, Chinese honey locust and Asarum had a bigger probability of recurrence of asthma.⑦The three hospitals had different treatment acupoint prescriptions. Prescriptions containing Dingchuan (EX-B1) and Tiantu (CV22), and Shanzhong (CV17) had a smaller probability of recurrence of asthma (P<0.01). The reoccurrence of infant asthma by using acupoints Dazhui (GV14) and group points (i.e. Shenshu (BL23), Pishu (BL20), Guanyuan (CV4), Shenque (CV8) also had a bigger probability (P< 0.01).⑧The three different treatment programs using different drugs had a significant difference in the probability of reoccurrence of asthma by the Chi-Square Test (P<0.01). Ginger plus musk had a lower recurrence of asthma, followed by Ginger plus distilled water and Ginger plus garlic.(2) Multi-factor analysis:By using diverse and multi-Logistic regression model, and by the SAS software program, it was found that the independent variables were the application opportunity and seasonality of the reoccurrence. Results showed no obvious seasonality, and the application duration of 0.5-2h had a smaller probability of recurrence. After acupoint application in Dog days, three times'follow-up and two-level hierarchical filtering fitting model derived from the severity of recurrence, the number of attacks, application opportunity, skin reactions, the onset season, preparation methods and other factors showed that the reoccurrence probability of infant asthma from data of the 3 hospital groups presented a decline tendency along with the extension of follow-up period. Results of every 3 months'follow-up showed the probability of asthma decreased by 0.7431-fold. The acupoint application in Dog Days and the coldest days in winter with duration of 0.5-2 hours had a lower probability of 0.5166-fold of reoccurrence.Conclusion:The results of literature analysis indicate that in acupoint application, the prescription, ratio, and preparation method of Chinese medicinal herbs, acupuncture prescription, the opportunity and the duration of application, and the quantity of the skin stimulation are all related to its clinical efficacy. The herbal medicines as Sinapis alba, Asarum, Fumitory, Euphorbia kansui, etc., are used more frequently. Ginger juice is the major one of the prepared drugs. Most of the prescriptions are mainly composed of Sinapis alba, Fumitory, Euphorbia kansui, Asarum in proportion of 2:2:1:1. The frequently used acupoints are Feishu (BL13), Dingchuan(EXB1), Gaohuang (BL43), Geshu (BL17), and Tanzhong (CV17), Xinshu (BL15), most of which belong to the Bladder Meridian of the Foot-Taiyang and Bach-shu points. The application of the therapy is more frequently in dog days than in both dog days and the coldest days in winter, and the suitable duration of application is 2h till appearance of erubescence and without occurrence of blisters on the skin. This study adopted classification method of literature classification according to evidence-based medicine. Although the level is not high, it still shows that the above mentioned factors are related to clinical effects. Also most of literatures are clinical reports, the sample is small, and the papers adopting random number table method, randomization table or computer-aided randomization controlled trials are rare. In accordance with evidence-based medicine, these papers lack enough evidence to prove the definite effectiveness of acupoint application. For this reason, we still need more studies adopting multi-centers, large sample observation of clinical randomized trials to provide scientific evidence for this therapy in the future.In 2008, a total 609 cases of 1-14-year-old asthma children were observed in "Dog Days" in three top-class hospitals. Their general clinical information in sex, ages and duration of disease were compared. First visit data showed that the onset of asthma was closely related with the environment, different regions had their own peculiarities. In northern China's Liaoning children, spasm occurred in any seasons, probably due to cold climate. However, in the south or southwest Hubei Province and Chengdu, the asthma children had a larger temperature difference in the incidence, being higher in winter and lower in summer. Winter sickness treating in summer with acupoint application therapy is more frequently used for children with mild to moderate asthma, cough-based disease. Acupoint application is conducted in the Dog Days on the 1st day of the first 10 days, the second 10 days and the last 10 days of summer. In Liaoning Province, they usually conduct acupoint application for 0.5-2h in Dog Days and the coldest days in winter, in Hubei and Chengdu provinces, they give the treatment for 2-4h in Dog Days. No apparently unfavorable reactions or only a mild itching was found at the skin in infant asthma patients from the 3 hospital groups.After acupoint application, we had a follow-up three times. We analyzed the impact of asthma in children with recurrent factors, such as the age, severity, seasonal factors, the amount of skin stimulated, etc. The major medicinal herbs of this treatment were Sinapis alba and Fumitory, and the acpoints used were Feishu (BL13), Gaohuang (BL43), Dingchuan (EX-B1), Tiantu (CV22), and Shanzhong (CV17). The best preparations of herbs were ginger and musk. The best time of acupoint application is the Dog Days and the coldest days in winter, and the application duration 0.5h to 2h. From analysis of the current data, it shows that all the factors may affect the clinical efficacy. And the therapeutic result was affected by the combination of these factors.The innovation point of this study is the using of a prospective formation study design. It contained a large sample of data, and revealed the complexity of the integrated intervention for winter disease treated in summer for children with bronchial asthma. This therapy can stimulate the yang-qi, enhance the resistance of body and control the onset of disease. This is the classic case of TCM for preventing diseases. The conclusion of the present research will be further confirmed in a series of randomized controlled trials in the future.