| Background:Migraine is a type of nervous and vascular headache with a cyclical nature. It’s a common disease which is difficult to cure. Epidemiological data shows that the morbidity of migraine is8.4%-28%, and its life time prevalence is14%. About23%of households have at least a migraine patient. Migraine is not peculiar to adult. It frequently occurs among children, too. At present, most of scholars believe that pediatric migraine is a common chronic recurrent nervous and vascular disease which is due to a variety of genetic and environmental factors. A study shows that42.6%of children aged between5and13suffer headache,3.4%of them are diagnosed with migraine, and8.7%of them are diagnosed with probable migraine. Between6and12years old, the morbidity of pediatric migraine is2%to5%; it increases in adolescence, it’s about10%around the age of14. Pediatric migraine which attacked repeatedly would bring them heavy mental and medical expenses burden, not only for children themselves, but also for their families. It also has serious effects on children’s social life and study. The situation of diagnoses and treatments of western medicine is not going well. Although there are many western medications of migraine so far, the safety and effectiveness of western medications used to control the acute attack of migraine for children and adolescent still need to be ensured by further researches. Some western medicine for the treatment or prevention of pediatric migraine is recognized by the evidence-based medicine, but it appears many side effects such as drug dependence after taking the western medicine of acute exacerbation of migraine. The long-term effect of those is unsatisfactory. There are many adverse reactions after taking the preventive western medicine of pediatric migraine. Children and adolescents are at important stages of physical development. Therefore, seeking safe and effective drugs for prevention and treatment of pediatric migraine becomes a problem which is urgent to be solved in medical at present.Pediatric migraine is in the scope of "unilateral brain wind, headache, and brain wind" of Traditional Chinese Medicine (TCM). It has been a long time for doctor of TCM to carry out research on headache. Headache was first recorded in "Huangdi Neijing"(Huangdi’s Classic of Internal Medicine), called "headache wind" and "brain wind"."Danxi Xinfa"(Danxi’s experiential therapy) mentions that unilateral headache called "unilateral head wind" and "migraine", attacks temporal or temples, the right or the left, involving eyes sometimes, accompanying nausea and vomit or other symptom. It believes that the etiology of headache is no more than exogenous and internal injuries. It takes the six climatic factors in excess as the cause of exogenous injuries. Headache attacks because of careless living, feeling the wind cold dampness hot evil, deterring yang, resulting in qi and blood stagnate. Internal injuries are associative with emotional disturbance, congenital deficient, irregular diet and physical exertion, weak or aeipathia, etc.TCM therapy follows the principle of treatment determination based on syndrome differentiation. The main therapy of exogenous headache is dispelling wind, and the adjuvant therapies are expelling the evil of cold, dampness and hot. Treatments of excessive pattern of internal headache are calming the liver, resolving phlegm, and removing blood stasis. The main treatments of deficient pattern are replenishing yin and nourishing blood, tonifying kidney and essence replenishment. It takes both of them as the guideline in treating the pattern of intermingled deficiency and excess.Based on his decades of clinical experience in studying the cause and treatment of pediatric migraine, Prof. Chen Baotian improved Zhengtian Pill, which is a very effective Chinese patent medicine for adult migraine, and created Toutong Xin NO.1(TX1). In the passed decades, TX1was very effective in curing pediatric migraine. This research observes and compares the clinical effects of TXl and treatment based on syndrome differentiation in the treatment of pediatric migraine. On one hand we verify the effect of TX1in curing pediatric migraine and discuss which treatment is better for pediatric migraine. On the other hand, we discuss the etiology and pathogenesis of pediatric migraine and provide clinical evidence to curing pediatric migraine with Chinese medicine.Objective:1. To observe and compare the clinical effects of Toutong Xin No.1and treatment based on syndrome differentiation in the treatment of pediatric migraine.2. To discuss the etiology and pathogenesis of pediatric migraine.Methods:1. Methods of cases selected:A total of195patients with pediatric migraine is from the clinic and ward of TCM department in Nanfang Hospital, and the clinic of Traditional Chinese and Western Medicine Combined Hospital, Southern Medical University from October,2010to December,2012. Diagnostic criteria are criteria of Migraine without aura and Migraine with aura from ICHD-Ⅱ set by HIS and TCM syndrome differentiation standard. Age of onset of patients is18or under18years old. Age of patients is18or under18years old. Headache has attacked2-6times a month (including2times and6times) since12weeks ago. Since three months before participating in the study, all of patients have not taken any drugs which may prevent pediatric migraine from attacking. Not use of analgesic for long time and not analgesic dependence. Not pregnancy or lactation. Not combined serious primary diseases (such as the liver, kidney and blood illness) and severe mental illness. Not allergic constitution.2. Treatment and drug combination:(1) Treatment groups:All of treatment groups were treated with TX1decoction.(2) Control groups:①Wind-cold syndrome:treated with Chuanxiongchatiao powder.②Phlegm-damp syndrome:treated with Banxiabaizhutianma decoction.③Blood stasis syndrome:treated with Tongqiaohuoxue decoction.The course of treatment was3months. Children below7years old take one dose every two day, decocting with water for2times, twice a day after mixing them, taking50ml every time. Children between7and14years old take1/2doses a day, decocting with water for2times, twice a day after mixing them, taking100ml every time. Children above14years old take one dose a day, decocting with water for2times, twice a day after mixing them, taking100ml every time. Taking drugs or TCM which can prevent migraine from attacking during the treatment was prohibited for all patients of groups. If patients can’t bear the headache, he is allowed to take the effective analgesic which he takes at ordinary times temporarily. We consider it as invalid if the patient takes analgesic for over10consecutive days. Have light diet, and avoid excitant food and drinks, such as spicy food, chocolate, strong tea, coffee and so on.3. Observation indexes:including demographic data, influencing factors, physical examination, laboratory examination (if voluntary)4. Efficacy criteria: (1) Comprehensive curative effect of headache:Headache index is the aggregate of marks of the frequency, the lasting time, the degree and simultaneous phenomenon of headache. The assessment of comprehensive curative effect of headache is based on the difference in headache index before and after the treatment.(2) Curative effect of TCM syndrome:TCM syndrome grade is the aggregate of marks of special symptoms and signs of every TCM syndrome. The assessment of curative effect of TCM syndrome is based on the difference in TCM syndrome grade before and after the treatment.5. The recording method of adverse events:"Adverse events" contain the occurrence or exacerbation of any symptoms, syndrome or disease that affect patients’health during the study. Adverse events contain new illness, exacerbation of symptoms or signs, exacerbation of simultaneous illness, events caused by drug action, events that not associate with the study, events caused by combination of those factors(one or more than one). Therefore, it doesn’t mean that there is a cause-and-effect relationship between adverse events and the drug.6. Statistical methods:It uses SPSS13.0to process all data. Difference of measurement data was expressed with mean±standard deviation (X±S), and compared with analysis of Independent-Sample T Test. Difference of enumeration data was compared with analysis of chi-square test. Difference of ranked data was compared with analysis of Mann-Whitney U test and Wilcoxon W test. P<0.05is statistically significant.Results:1. Comparison of comprehensive curative effects of headache(1) Wind-cold syndrome:TXl group:14cases were clinical cured,17cases were markedly effective,9cases were improved,2cases were ineffective, the total effective rate was95.24%, the mean rank was49.54.Chuanxiongchatiao powder group:6cases were clinical cured,7cases were markedly effective,16cases were improved,10cases were ineffective, the total effective rate was74.36%, the mean rank was31.81.Mann-Whitney U test statistic was460.500. Wilcoxon W test statistic was1240.500. Z test statistic was-3.521. There was statistical difference between these two groups in comprehensive curative effect of headache (P=0.000<0.05) Comprehensive curative effect of headache of TX1group was better than that of Chuanxiongchatiao powder group.(2) Phlegm-damp syndrome:TX1group:10cases were clinical cured,11cases were markedly effective,5cases were improved,2cases were ineffective, the total effective rate was92.86%, the mean rank was32.50.Banxiabaizhutianma decoction group:4cases were clinical cured,5cases were markedly effective,7cases were improved,9cases were ineffective, the total effective rate was64.00%, the mean rank was20.80.Mann-Whitney U test statistic was195.500. Wilcoxon W test statistic was520.500. Z test statistic was-2.858. There was statistical difference between these two groups in comprehensive curative effect of headache (P=0.004<0.05) Comprehensive curative effect of headache of TX1group was better than that of Banxiabaizhutianma decoction group.(3) Blood stasis syndrome:TX1group:11cases were clinical cured,10cases were markedly effective,4cases were improved,3cases were ineffective, the total effective rate was89.29%, the mean rank was36.86. Tongqiaohuoxue decoction group:6cases were clinical cured,9cases were markedly effective,8cases were improved,10cases were ineffective, the total effective rate was69.70%, the mean rank was26.03.Mann-Whitney U test statistic was298.000. Wilcoxon W test statistic was859.000. Z test statistic was-2.460. There was statistical difference between these two groups in comprehensive curative effect of headache (P=0.014<0.05) Comprehensive curative effect of headache of TX1group was better than that of Tongqiaohuoxue decoction group.2. Comparison of curative effects of TCM syndrome:(1) Wind-cold syndrome:TX1group:12cases were clinical cured,19cases were markedly effective,10cases were improved,1case was ineffective, the total effective rate was97.62%, the mean rank was48.93.Chuanxiongchatiao powder group:6cases were clinical cured,8cases were markedly effective,17cases were improved,8cases were ineffective, the total effective rate was79.49%, the mean rank was32.46.Mann-Whitney U test statistic was486.000. Wilcoxon W test statistic was1266.000. Z test statistic was-3.293. There was statistical difference between these two groups in curative effect of TCM syndrome (P=0.001<0.05). Curative effect of TCM syndrome of TX1group was better than that of Chuanxiongchatiao powder group.(2) Phlegm-damp syndrome:TX1group:11cases were clinical cured,9cases were markedly effective,5cases were improved,3cases were ineffective, the total effective rate was89.29%, the mean rank was30.84. Banxiabaizhutianma decoction group:5cases were clinical cured,8cases were markedly effective,3cases were improved,9cases were ineffective, the total effective rate was64.00%, the mean rank was22.70. Mann-Whitney U test statistic was242.500. Wilcoxon W test statistic was567.500. Z test statistic was-1.992. There was statistical difference between these two groups in curative effect of TCM syndrome (P=0.046<0.05). Curative effect of TCM syndrome of TX1group was better than that of Banxiabaizhutianma decoction group.(3) Blood stasis syndrome:TX1group:12cases were clinical cured,10cases were markedly effective,4cases were improved,2cases were ineffective, the total effective rate was92.86%, the mean rank was35.96. Tongqiaohuoxue decoction group:9cases were clinical cured,8cases were markedly effective,7cases were improved,9cases were ineffective, the total effective rate was72.73%, the mean rank was26.79. Mann-Whitney U test statistic was323.000. Wilcoxon W test statistic was884.000. Z test statistic was-2.095. There was statistical difference between these two groups in curative effect of TCM syndrome (P=0.036<0.05). Curative effect of TCM syndrome of TX1group was better than that of Tongqiaohuoxue decoction group.3. Analysis of adverse events:There were2adverse events. One of TX1group’s patients had mild diarrhea without other symptoms such as abdominal pain and vomiting. We considered it as possibly related event. The diarrhea relieved after4days, without any special treatments. One of Banxiabaizhutianma decoction group’s patient had liquid stools without other symptoms such as abdominal pain and vomiting. We considered it as possibly related event. The symptom relieved after2days, without any special treatments.Conclusion:1. TX1is effective in pediatric migraine. It can effectively improve and relieve the headache and TCM syndrome of pediatric migraine patients.2. TX1shows better effects than treatment determination based on syndrome differentiation in improving and relieving the headache and TCM syndrome of pediatric migraine patients.3. Wind, damp, blood stasis, and deficiency could be the TCM etiology and pathogenesis of pediatric migraine.4. It’s suitable to treat pediatric migraine with the guideline of expelling the evil of wind cold, and dampness and tonifying deficiency. |
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