| Objective and significanceHeadaches are classified into two categories:primary headaches and secondary headaches. Tension-type headache (TTH), which is the most common type of primary headaches, refers to pain in the bilateral occipital head or the whole head with tightness or pressure. It is also called psychogenic headache, tension headache, muscle contraction headache, unexplained headache, and so on. Accompanied with the accelerated pace of modern life and increasing social pressure, the prevalence rate of TTH increased gradually. The prevalence of TTH in general population varied according to different studies, among 30.00%-78.00%. Though the prevalence of TTH seems to be higher in women, It declined with age in both gender. In a recent epidemiological study by mailed questionnaire, the 1-year prevalence of TTH in 40-years old general population was 48.20% for infrequent ETTH,33.80% for frequent ETTH, and 2.30% for chronic TTH. In 2004, The International Classification of Headache Disorders, second edition (ICHD-II) published. According to the new diagnostic criteria, TTH was divided into infrequent episodic tension-type headache, frequent episodic tension-type headache, chronic tension-type headache and probable tension-type headache. The first three types of TTH can be respectively divided into two subtypes according to whether associated with pericranial tenderness. Probable tension-type headache can also be devided into three subtyes:probable infrequent episodic tension-type headache, probable frequent episodic tension-type headache, probable chronic tension-type headache.Although TTH is the most common headache in primary headaches, the pathophysiology and likely mechanism remain unclear, which may relate to a variety of factors:①cranial muscle disorders, and dysfunction of central sensitization and regulation.②anxiety, depression and other psychological factors.③Platelet dysfunction and changes of central monoamine nervous system.④damaged central modulation of pain.⑤Others:such as the vertebral-basilar artery blood flow velocity changes, head and scapula fixed in a bad posture for a long time, heredity, infection, taking certain drugs, smoking, alcohol consumption, autonomic nerve dysfunction, and so on. Jensen R. found that peripheral myofascial factors are predominant in episodic tension-type headache (ETTH), whereas central mechanisms are the main factor involved in chronic tension-type headache (CTTH).Western Medicine is still lack of targeted or specific treatment measures for TTH at present. There are drug therapies, psychological therapies, behavioral therapies, physical therapies, and so on. Drug therapies for TTH can be divided into short-term, abortive treatment of each attack and long-term, prophylactic treatments. The most commonly used drugs for acute exacerbation include non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxant, nitric oxide synthase inhibitors, etc. drug used for prevention include tricyclic antidepressants, monoamine oxidase A inhibitor and propranolol. Overall, The efficacy of Western Medicine for TTH is not ideal at present. Furthermore, various side effects are obvious due to a long-term period of medication in most cases.TTH can be categorised into Headache in Traditional Chinese Medicine (TCM). The symptom of "Headache" originated from Huang Di Nei Jing (Huangdi's Canon of Medicine), called "Headache", "Head Wind" or "Brain Wind". The causes of this symptom were due to no more than exogenous and internal injuries. "Headache, like wrapped" also firstly appeared in Huang Di Nei Jing. ShengQiTongTianLun third chater. "Due to wet, headache as been wrapped, hot and humidity occlusion, large muscle contracture, small muscle relaxation". There were lots of studies to investigate the effect of TCM in treating TTH in the recent decade. To sum up, these studies can be classified into two categoies:treatment based on syndrome differentiation and treatment based on a basic decoction, and the latter were more than the former as reported. So far, there is no common understanding on etiology, pathogenesis and treatment principles of TTH in TCM.The pain of TTH is mild or moderate and often described as tightness, pressure, or dull pain. Futhermore, the pain is usually experienced as a band extending bilaterally from the forehead across the sides of the head back to the occiput. The pain and pressure radiates from the occiput to the posterior neck muscles. In its most extensive pattern, the pain distribution is described as "cape like", radiating along the medial and lateral trapezius muscles covered the shoulders, scapular, and interscapular areas. As mentioned above, the feature of TTH is similar to the main symptom of Wind-Damp Headache "Headache, like wrapped" in TCM. So, TTH should belong to Wind-Damp Headache in TCM. According to the sixth edition of the National TCM colleges and universities teaching materials, the treatment principle for Wind-Damp Headache is "Expelling Wind and Removing Damness", the recommended prescription is Qianghuoshengshi Decoction.The Jiaweitoutongxinyihao Decoction was created by Chen Bao-tian, professor in the Department of TCM, Southern Hospital, affiliated to Southern Medical University, This prescription was seemingly to be effective in treating TTH. The aim of this study was to estimate the efficacy of Jiaweitoutongxinyihao Decoction in treating TTH by comparison with Qianghuoshengshi Decoction and conventional western medicine treatment. Furthermore, the etiology, pathogenesis and treatment principle of TTH in TCM were discussed.Methods and content1. General information and treatment methods120 candidates were ramdomly selected from TTH patients who visited the Specialized Clinical Department of headache of TCM, which belongs to internal Chinese Medicine of Nanfang Hospital, Southern Medical University, Guangzhou, from October 1,2007 to October 30,2008. The Western and Traditional Chinese Medicine diagnostic criterias for these patients were according to the diagnostic criteria mentioned in International Headache Classification of Diseases (2nd edition) (ICHD-II) and the diagnosic standard of Wind-Damp Headache in Clinical Diagnostic and Improvement or Cure Criterias for Deseases,2nd edition. All the patients were ramdomized into three groups according to random number table:the Jiaweitoutongxinyihao Decoction group, the Qianghuoshengshi Decoction group and the Eperisone group,40 patients in each groups. Comparison of sex, age, course of disease, subtype diagnosis and pre-treatment headache indexes among groups showed no significant differences (P>0.050). Patients in the former two groups were respectively treated with Jiaweitoutongxinyihao Decoction and Qianghuoshengshi Decoction, decocted in water, orally taking once a day. The administration for all female patients in these two groups were temporaryly suspended in menstrual period. Patients in the Eperisone group were given Eperisone Hydrochloride tablets (Eisai Pharmaceutical Co., Ltd. China Production, batch number:070519A),50mg three times daily. The treatment course for all groups was three months. Patients in each groups should not take other similar drugs, tea, coffee, spicy food and drinks. Light diet was advised during treatment period.2. Efficacy Standards2.1 Headache Index and comprehensive efficacyThe frequency, duration and severity of headache attack per month were recorded for all patients before and after treatment, as well as ssociated symptoms and signs, tongue and pulse condition. Headache indexes were calculated according to headache attack frequency, duration and degree of pain. The comprehensive efficacy was evaluated by the headache indexes before and after treatment.2.2 Improvement of other symptoms and signsThe five most commonly accompanying symptoms and signs of TTH, namely, cephalic and cervical muscular tenderness, feeling of head-wrapped, feeling of heavy-head, tired, insomnia, were all quantified by degree of none, mild, moderate, heavy. These scores were recorded before and after treatment to compare the efficacy of each drugs in improving these symptoms and signs.2.3 Indexes of hemorheologyThe indexes of blood rheology of all patients were detected by venous blood sample phlebotomized in the right elbow on morning before and after treatment, using three quantitative conventional anticoagulant EDTA-K2 tubes (purple cap) collected venous blood 6ml (2ml in each tubes). The test equipment was MVIS-2030 Automatic Blood Hemorheometer (producted by Chongqing Tianhai Medical Equipment Co., Ltd.), manual operation. 3. Safety EvaluationIndicators for safety evaluation include general physical examination items, routine examination of blood, urine, stool, ECG and function of liver and kidney. All these indicators were examined in all patients before and after treatment. Possible adverse reactions of patients were observed and recorded carefully during treatment course, corresponding treatment measures should be given when necessary.4. Statistical MethodsSPSS 13.0 statistical software was used for statistical analysis. Measurement data were presented by mean±standard deviation(X±S), analyzed by variance analysis (One-Way ANOVA). Nonparametric test was adopted when the data did not suit for parametric test. Ranked data were analyzed by Ridit analysis, numeration data withχ2 test. P score were measured by two tails, less than 0.05 demonstrates statistical difference.Results1. Comparison of comprehensive efficacy in each groupsAccording to the standard of headache index, the total efficiency rate of the Jiaweitoutongxinyihao Decoction group was 95.00%, clinical cured in 12 patients, markedly effective in 13 cases, effective in 13 cases and with no effect in 2 cases. The total efficiency rate of the Qianghuoshengshi Decoction group was 75.00%, clinical cured in 5 patients, markedly effective in 7 cases, effective in 18 cases and with no effect in 10 cases. The total efficiency rate of the Eperisone group was 70.00%, clinical cured in 9 patients, markedly effective in 8 cases, effective in 11 cases and ineffective in 12 cases. Total comparison among the three groups by Ridit analysis, F=5.385, P=0.006<0.050, showing significant difference in efficacy among the three groups. Compared between groups, there were significant differences between the Jiaweitoutongxinyihao Decoction group and the Qianghuoshengshi Decoction group, the Jiaweitoutongxinyihao Decoction group and the Eperisone group (respectively, P=0.002<0.050,P=0.018<0.050). Comparison between the Qianghuoshengshi Decoction group and the Eperisone group showed no significant statistical difference (P=0.454> 0.050).2. Improvement of other symptoms and signsThere were no significant differences (P>0.050) in the scores of other major accompanying symptoms and signs compared among three groups by analysis of variance before treatment. Compared within groups before and after treatment by 2 related sample test, the Jiaweitoutongxinyihao Decoction group and the Qianghuoshengshi Decoction group showed significant statistical differnences (P<0.010) in all symptoms and signs, while the Eperisone group showed significant statistical differnences in improvement of cervical muscular tenderness and feeling of head-wrapped (P<0.010).Compared the scores of accompanying symptoms and signs among all groups after treatment by K Independent Sample Test, there were significant statistical differnences in improvement of the five accompanying symptoms and signs (P<0.050). Furthermore comparison between groups by Nemenyi analysis, there were significantly statistical differnences in the improvement in cephalic and cervical muscular tenderness between the Jiaweitoutongxinyihao Decoction group and the Qianghuoshengshi Decoction group (P<0.010), the Jiaweitoutongxinyihao Decoction group and the Eperisone group (P<0.050). The differences also showed in improving feeling of head-wrapped and heavy-head, tired and insomnia between the Jiaweitoutongxinyihao Decoction group and the Eperisone group (P<0.050), but not between the Jiaweitoutongxinyihao Decoction group and the Qianghuo Shengshi Decoction group (P>0.050).3. Comparison of hemorheology indexes The hemorheology indexes of patients in each groups before treatment showed no significantly statistical difference, indicating that the hemorheology indexes of patients in each groups were comparable. Compared with that before treatment, the hemorheology indexes of patients in all three groups were improved to some degree. Compared with other two groups after treatment course, the Jiaweitoutongxinyihao Decoction group showed significant improvement in the levels of high shear (200/s), medium shear (30/s) and low shear (3/s) viscosity of whole blood, plasma viscosity, total blood reductive viscosity and erythrocyte aggregation indexes, erythrocyte rigid index as well as erythrocyte sedimentation rate (P<0.010). Still, the values of high shear viscosity of whole blood (100/s) and erythrocyte electrophoresis time in the treatment group were lower than those in the Qianghuo Shengshi Decoction group after treatment(P<0.010).4. Comparison of safetyIn addition to stool frequency of 1 patient slightly increased, there were no observed adverse reaction in the Jiaweitoutongxinyihao Decoction group.2 patients in Qianghuo Shengshi Decoction group developed dizziness and stomach discomfort in the treatment course, which relieved when taking the decoction after meals.2 patients in the Eperisone group developed dizziness in the first month of treatment course, another 2 cases of lethargy and limb weakness. All these discomfort relieved in natural course. Routine examination of blood, urine, stool, ECG and function of liver and kidney of all patients were examinated after treatment and showed no abnormality.Conclusions1. The Jiaweitoutongxinyihao Decoction is effective in treating TTH (Wind-Damp Headache), and can significantly improve and ease the major accompanying symptoms and signs of TTH. 2. The Jiaweitoutongxinyihao Decoction can significantly improve the hemorheology indexes in TTH patients.3. The probable mechanism of the Jiaweitoutongxinyihao Decoction in treating TTH may include:ease of muscle tension and tenderness, improvement of mental status and blood rheology.4. It is supposed that the proper TCM treatment priciples for TTH is Expelling Wind and Removing Damness, activating blood to resolve stasis, smoothing liver and tranquilizing mind. |
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