Preliminary Study Of Chinese Medicine. Lyme Disease Syndrome, Certificate Distribution Characteristics, And Its Etiology And Pathogenesis

Lyme Disease (LD) is an infectious disease of natural origin that was officially named in the U.S. in the 1980's. LD is caused by Borrelia burgdorferi (B.b.) introduced into the human bloodstream by tick bite and spread to the entire body. Spread of LD occurs more during the summer and early fall, and is prevalent in wooded areas. Major clinical symptoms are erythema migrans (EM), flu-like symptoms, and neurological, muscular, cardiac, and other multi-system damage.Western medicine usually treats chronic LD with antibiotics, often with poor results and persistent side-effects, with a prolonged disability rate of 60%.LD has been discovered in over 70 countries and is currently ranked as the second most prevalent infectious disease in the U.S, after hepatitis C. In 1992 the WHO classified LD as a newly-discovered infectious disease which required research to determine effective prevention and treatment. In 1986 the first case of LD was reported in China. China's CDC has reported that people in 29 provinces have already been affected by LD, that people living in forested areas have an infection rate of 5.33%, and that every year more than 10,000 new cases are reported.There is no description of this disease in ancient Chinese medical literature, but the major symptoms of various stages of LD are similar to some of different TCM diseases, so that we can use these diseases as a reference for possible diagnosis and treatment strategies for LD,for example, "Dan du", "Damp-warmth", "Bi syndrome","vacuity taxation", "dizziness", "palpitations", "poor memory", "headache", etc.Although TCM treatment has already shown some potential in improving the symptoms of LD, there has to date been no systematic research concerning TCM syndrome diagnosis with respect to LD. Therefore, in order to improve the level of clinical diagnosis and to find an effective treatment method, it is important to explore the distribution of symptoms, syndrome diagnosis, etiology and pathology of LD from the point of view of TCM. In recent years some TCM scholars have brought up a strategy for standardized syndrome research based on the combination of disease and syndrome and syndrome elements. A syndrome element is the minimum unit making up a syndrome; out of a small number of syndrome elements a large number of syndromes can be formed. Syndrome elements can reflect the location and the character of the disease, they are easy to utilize and they are conducive to easy comprehension.This research used LD patients as research subjects and carried on in the following steps. First, retrospective analysis was performed on disease symptoms and symptom improvement following administration of TCM treatment. Through prospective cross-sectional clinical survey combined with clustering analysis, specific distribution of LD common symptoms, syndromes and syndrome elements was then arrived at and analyzed. Based on these steps, LD pathology and advantageous of TCM treatment was inferred. This research can provide a basis for exploring LD etiology, pathology, advantageous TCM diagnosis and treatment, and syndrome standardization.Objectives1 Through retrospective analysis and prospective cross-sectional clinical survey, specific distribution of LD patients'TCM symptoms was systematically analyzed to provide a basis for exploring LD etiology, pathology, and TCM diagnosis and treatment.2 Through cross-sectional clinical survey, data from four diagnoses and practitioner's experienced syndrome diagnosis was gather. Based on this and on cluster analysis, common syndromes and syndrome elements of LD were extracted and distribution was analyzed. These provided a basis for further understanding of syndromes and syndrome elements of LD and improve clinical diagnosis and treatment.3 By analyzing the retrospective data of LD symptom improvement after TCM treatment, by taking into account the Western medicine pathological mechanism of LD along with the drawbacks of Western treatment, by using the TCM understanding of the etiology and pathology of infectious diseases as a theoretical basis, and by combining specific data of symptom and syndrome distribution from the prospective cross-sectional clinical survey, elaborate the TCM pathological mechanism of LD and explore the advantages and research strategy of TCM diagnosis and treatment within the combination of disease and syndrome diagnosis model.Methods1 Study of specific distribution of TCM symptoms of LD1.1 Study of specific distribution of symptoms of LD based on retrospective analysisUse EXCEL to set up retrospective analysis database. Enter all patient data, including symptoms and physical data, from 292 original records from the clinic of Sino-Med Research Institute. Patient records had to meet acceptable criteria. Use SPSS 17.0 software to perform data analysis—general distribution of symptoms and comparison of distribution according to sex, age and duration of disease.1.2 Study of specific distribution of symptoms of LD based on cross-sectional clinical surveyBased on literature review, select common LD symptoms and set up severity level rating methodology. Consult with expert advisor. Optimize LD survey form structure and content. Based on these steps, design and complete survey form. Collect four-diagnostic data from 208 LD patients. Based on collected data, define disease stages, TCM disease diagnoses, and experiential syndrome diagnoses. Based on standardized experiential syndrome diagnoses, divide into disease location and disease nature syndrome elements. Use Epidata 3.0 software to set up database. Use SPSS 17.0 software to perform statistical analysis. Systematically and comprehensively analyze LD symptom-specific distribution and compare symptom distribution differences in different disease stages.2 Study of specific distribution of TCM syndromes and syndrome elements of LD based on cross-sectional clinical survey.Use SPSS 17.0 software to analyze general distribution of TCM syndromes elements related to location and disease nature. Compare specific distribution differences among different sexes and different disease stages. Use cluster analysis to classify 208 patients'symptoms into different categories and relate each category to different syndrome elements.3 Exploration of TCM etiology, pathology, and advantageous diagnosis and treatment for LD3.1 Study of LD symptom improvement after TCM treatment based on retrospective analysis According to the first and last visits'records of 141 patients, use symptom change after TCM treatment to set up EXCEL database. Use SPSS 17.0 software to analyze percentage of symptom improvement after treatment. Formulate preliminary summary of LD patient symptom improvement after treatment. 3.2 Analysis of TCM etiology, pathology, and advantageous diagnosis and treatment for LDBased on Western medical understanding of LD combined with all above clinical data analysis, and based on the principle of "seeking the cause from identification of symptom/syndrome", LD etiology and pathology were explored systematically. Formulate diagnosis and treatment strategy within the combination of disease and syndrome diagnosis model.Results1 Study of specific distribution of TCM symptoms of LD1.1 Study of specific distribution of symptoms of LD based on retrospective analysis1.1.1 General distribution of symptomsThere were 33 symptoms identified in the records of 292 patients analyzed. The following symptoms were experienced by over 20% of the patients (listed from high to low frequency):joint pain, fatigue, poor memory, reduced concentration, headache, dizziness, increased sensitivity to light, limb numbness, sweating, palpitations, muscle weakness, aversion to cold, nasal congestion, tremors, skin rash, fever, insomnia, shortness of breath, tinnitus.1.1.2 Distribution of symptoms according to sex, duration of disease, and ageThe following results are statistically significant:(1) fatigue and poor memory appeared with higher frequency in females than in males;(2) skin rash appeared with higher frequency when the disease duration was under three months; skin rash appeared with lower frequency when the disease duration was over one year; fever appeared with higher frequency when the disease duration was under six months; limb numbness appeared with higher frequency when the disease duration was under one year; (3) chest pain appeared with lower frequency and nausea appeared with higher frequency when the age of the patient was under 20 years; reduced libido appeared with higher frequency when the age of the patient was between 40 and 59; frequent urination was seldom seen in patients aged 20-29.1.2 Study of specific distribution of symptoms of LD based on cross-sectional clinical survey1.2.1 Chief complaint The following symptoms were experienced as chief complaint by over 10% of the patients (listed from high to low frequency):joint pain, fatigue, poor memory, headache, chills and fever.1.2.2 General symptomsThe following symptoms were experienced by over 50% of the patients (listed from high to low frequency):fatigue, poor concentration, poor memory, aversion to cold, night sweats, spontaneous sweating, anxiety.1.2.3 Other symptoms:(1) Head and four limbs symptoms-the following symptoms were experienced by over 50% of the patients (listed from high to low frequency):dizziness, limb numbness, limb heaviness and weakness.(2) Reproductive system symptoms-most commonly-seen symptoms were menstrual clotting, scanty periods, and reduced libido.(3) Pain-most commonly-seen symptoms were joint pain and headache. Characters of the pain were most usually achey, sore, fixed location, worse at night, and better with heat.1.2.4 Tongue and pulse(1) Shape:more commonly-seen were teeth-marked tongue (42.2%), swollen tongue (37.5%).(2) Sublingual vein:abnormality of sublingual vein relatively common-bluish/purplish color (98.5%)(3) Tongue coating:white tongue coating more common (68.8%)(4) Pulse:weak pulse most common (43.4%) 1.2.5 Disease stages and symptom distribution according to disease stageThere were less cases in StageⅠandⅡ(1.4% and 5.8% respectively). StageⅢcases were in vast majority (92.8%).12 symptoms showed statistically significant distribution among the three stages:skin rash was the highest frequency in StageⅠ, least in StageⅢ; poor memory, poor concentration, depression, chest pain, limb heaviness and weakness all were the highest frequency in StageⅢ; tremors highest in StageⅡ, second highest in StageⅠ; anxiety was highest frequency in StageⅠ, StageⅢfrequency 59.1%; headache with heavy sensation was highest (100%) in StageⅠ; deviation of eye and mouth, and dry mouth were the highest frequency in StageⅠ; distending headache was highest frequency (100%) in StageⅡ.2 Study of specific distribution of TCM syndromes and syndrome elements of LD based on cross-sectional clinical surveyAccording to TCM disease diagnosis, bi syndrome is the most common (64.9%) and the following disease diagnoses all had a frequency over 10%(listed from high to low frequency):poor memory, vacuity taxation, headache, damp-warmth, erysipelas. Practitioner experiential syndrome diagnosis came up with many different complicated results-75 different kinds of syndrome diagnoses. Among these 75 kinds, the top five were:(1) Qi and blood stagnation, qi and yin deficiency; (2) Damp heat accumulation, qi and blood stagnation; (3) Heart and spleen deficiency, qi and blood stagnation, kidney qi deficiency; (4) Heart and spleen deficiency, kidney yin deficiency, qi and blood stagnation; (5) Damp heat accumulation, qi and blood stagnation, qi and yin deficiency.2.1 Study of specific distribution of TCM syndromes of LD based on experiential diagnosisThe top ten TCM syndromes, listed from highest to lowest frequency, were: qi and blood stagnation, heart and spleen deficiency, qi deficiency, damp heat accumulation, kidney yin deficiency, kidney qi deficiency, spleen qi deficiency, damp heat encumbers exterior, toxic heat trapped in skin, and heat in ying level.The following are statistically significant differences in distribution of syndromes among the two sexes and the three disease stages:heart spleen deficiency was more frequently found in females than in males; damp heat encumbers exterior and spleen qi deficiency were highest in StageⅠ(66.7%), lowest in StageⅢ.2.2 Study of specific distribution of TCM syndrome elements of LD based on experiential diagnosis2.2.1 Location syndrome elements distribution(1) Out of the eight location syndrome elements, six were found to be more common-kidney, spleen, heart, liver, ying level, wei level.Blood level and stomach were not common.(2) The following are statistically significant differences in distribution of syndrome elements among the two sexes and the three disease stages:heart, spleen were found more frequently in females than in males; stomach was found more frequently in males than in females; heart, kidney were found most frequently in StageⅢ(0 frequency in StageⅠ); wei level and ying level were found most frequently in StageⅠand least frequently in StageⅢ.2.2.2 Disease nature syndrome elements distributionDisease nature syndrome elements appearing in over 30% of cases (from highest to lowest) were as follows:qi deficiency, qi stagnation, blood stasis, blood deficiency, dampness, heat (fire), yin deficiency.2.3 Preliminary study of LD syndrome elements based on cluster analysis2.4 Results showed that disease nature syndrome elements possibly are:dampness, heat (fire), qi stagnation, qi deficiency, blood deficiency, yin deficiency, hyperactive yang, wind.Location elements possibly are:wei level, heart, kidney, spleen, liver.3 Exploration of TCM etiology, pathology, and advantageous diagnosis and treatment for LD3.1 Study of LD symptom improvement after TCM treatment based on retrospective analysis(1) The results showed that after TCM treatment all symptoms except irregular menstruation improved at a greater than 50% rate. Four of the symptoms—skin rash, cough, hair loss, and irregular pulse—disappeared completely (100%). Ten symptoms—sweating, fever, chest pains, constipation, muscle weakness, aversion to cold, sensitivity to light, tidal fever, nasal congestion, and headache—improved at a rate of 90%.(2) Statistically significant results concerning symptom improvement classified by age group are as follows:skin rash improvement rate was highest in patients aged 50-59 and lowest in patients under 20 years old; dizziness improvement rate was highest in patients under 20 years old (85.7%), and as age increased the dizziness improvement rate progressively decreased; insomnia improvement rate was highest in patients aged 20-29 and lowest in patients under 20 years old; tremors improvement rate was highest in patients aged 30-39 years old and lowest in patients under 20 years old; muscle weakness improvement rate was highest in patients aged 20-29 and over 60 years old and lowest in patients 40-49; decreased libido improvement rate was highest in patients aged 20-39 and other age groups showed no change. (3) There was no significant difference in improvement rates between the 2 sexes and between the 2 time durations (under 6 months and over 6 months).(4) Only two symptoms—headache and hair loss—showed significant differences in improvement based on treatment course. Headache improved most between 4 months and 6 months of treatment and hair loss improved after 6 of treatment but showed no change during the first 6 months of treatment.3.2 Analysis of TCM etiology, pathology, and advantageous diagnosis and treatment for LDBased on the TCM theory of Wen Bing, this research expounds the etiology and pathology of infectious diseases, taking into account the clinical data resulting from the above-discussed analyses. TCM etiology of LD is infectious insect bite inducing damp heat and toxic pathogen invasion. LD pathological mechanism can be summarized as follows:pathogen invading, fighting between pathogen and healthy qi, excess pathogen dominant. In case treatment is wrong or delayed, healthy qi is damaged and pathogen remains dominant, excess and deficiency appear at the same time. The disease may be prolonged—resulting in many different symptoms due to qi, blood, yin and/or yang deficiency or multi-zang fu organ damage.Based on the symptom improvement data from the retrospective analysis, it is recommended that an approach integrating Western medicine disease diagnosis with TCM syndrome diagnosis be adopted. This approach can serve as a guideline for LD diagnosis and treatment. The advantage of this is that the specific pathogen can be diagnosed and identified by Western medicine while TCM can be used in treatment not only to target the pathogen but to help the holistic healing of the entire body.Conclusions1 According to the retrospective analysis, LD is commonly characterized by joint pain, fatigue, poor memory, reduced concentration, and headache, along with many other symptoms. The prospective cross-sectional clinical survey resulted in a more standardized and comprehensive categorization of LD symptoms. By combining the two analyzed, the true complexity of the pathology of the disease in different stages, including mixed excess and deficiency patterns, can be seen.2 Based on the cross-sectional clinical survey, the common syndromes of LD are qi and blood stagnation, heart and spleen deficiency, qi deficiency, damp heat accumulation, kidney yin deficiency, kidney qi deficiency, spleen qi deficiency, damp heat encumbers the exterior, toxic heat trapped in the skin, and heat in the ying level. The common location syndrome elements are kidney, spleen, heart, liver, ying level, and wei level. The common disease nature syndrome elements are qi deficiency, qi stagnation, blood stasis, blood deficiency, dampness, heat (fire), and yin deficiency.3 TCM etiology of LD is infectious insect bite inducing damp heat and toxic pathogen invasion. LD pathology can be summarized as follows:(1) Early stage—damp heat and toxic pathogen invading, fighting between pathogen and healthy qi, excess pathogen dominant. Wei level syndrome is commonly seen in this stage. If patient constitution is weak, healthy qi is too weak to fight so pathogen invades ying level directly, causing wei level and ying level to both be attacked. Damp heat toxin obstructing the meridian causes pain syndrome. In case of weak constitution, qi deficiency may also result. (2) Middle stage—healthy qi is damaged and pathogen remains dominant, excess and deficiency appear at the same time. Excess results in damp heat syndrome or qi and blood stagnation syndrome; deficiency due to zang fu organ damage results in heart spleen deficiency or kidney yin deficiency. (3) Late stage—healthy qi more deficient, pathogen still remains. Deficiency syndrome is prominent, resulting in many different symptoms due to qi, blood, yin and/or yang deficiency or multi-zang fu organ damage. Advantage of TCM diagnosis and treatment for LD is supporting healthy qi and expelling the pathogen, treating the root and the branch, holistic treatment of whole body based on the combination of disease diagnosis and syndrome diagnosis. The strategy is to treat the disease as the key principle, looling for the basic causes in treating diseases,flexible syndrome differentiation. In this way, even when treating the same disease different treatment methods may be called for because of syndrome differences.Research innovationBased on the combination of disease and syndrome diagnosis, and using retrospective analysis and prospective cross-sectional survey techniques, LD symptoms and syndromes and syndrome elements were identified and their distribution analyzed. LD etiology, pathology, and advantage of TCM diagnosis and treatment were inferred based on a combination of clinical data analysis and exploration of TCM theory. This is the first time such research has been attempted.