Treatment Of Using Chinese Medicine To Reinforce Healthy "Qi", And To Dredge "Qi" Mechanism As Add-on Therapy In Type 2 Diabetes Mellitus After Secondary Failure Of The Oral Anti-diabetic Regimen

Part 1:Theoretical and literature studyAlong with the lifting of living standard, changes of living habits, the incident rate of Type 2 diabetes mellitus (T2DM) is soaring, particularly the trend towards youngsters. T2DM is metabolic diseases which seriously undermines the health, Although the pathogenesis is still not well-defined, most of the scholars recognized that it should relate to heredity, immune system and multi-environmental factors. The disease is characterized by insulin resistance and progressiveβ-cell dysfunction.Insufficient Insulin secretion or dysfunction of insulin will lead to metabolic abnormality of glucose, lipid, protein, water and electrolyte. Persistent high level of blood glucose may provoke Diabetic complications, affecting the heart, brain, kidneys, eyes, feet and nerves. For instance, heart disease, stroke, kidney disease will result to final-stage renal failure; retinopathy, cataract and glaucoma will develop to blindness; the serious lower limbs ulcers will end up to amputation.Controlling glycemic levels as close to the non-diabetic range as possible has demonstrated to have a powerful beneficial effect on diabetes-specific micro-vascular complications, including retinopathy, nephropathy, and neuropathy. In consequence, it made the effective treatment of hyperglycemia a top priority. Treatment with oral agents has clearly improved glycemic control in patients with T2DM at beginning stage. However, long-term glycemic control with these agents is hardly to achieve. Secondary failure is a consequence of increasing loss ofβ-cell function and insulin sensitivity due to disease progression.To reinforce the treatment, usually will maximize the doses of the agent, or switch to another oral anti-diabetic agent or the addition of another agent (combination therapy). Current standards of practice recommends the addition of oral agents or insulin to a patient's ongoing therapy. However, many patients ultimately require insulin therapy to maintain glycemic control.We could not find the terms of "Secondary failure of the oral anti-diabetic regimen " in the Ancient Chinese medicine scripts or treatises. This is the terms appearing in the course of healing T2DM by Western Medicine for the treatment of glycemic control. With the integration of laboratory data, it is used to monitor the level of blood glucose such that we could switch the medicine for the prevention of complications as soon as the control of blood glucose level deteriorates.Despite the fact that there is no direct reflection of the terms "Diabetes Mellitus" from literatures or treatises of Chinese Medicine, we could categorize this T2DM to the scope of "Xiao Ke". However, for this disease, the majority of Traditional Chinese Medicine practitioners follow the rule of nourishing "Ying" and clearing "internal heat", because they believed "Yin" deficiency is the primary cause while dryness and heat are the secondary ones. Nevertheless, the healing results as per long terms clinical studies indicated that this method in prevention and healing of T2DM is far behind expectation.This study adopted "the Six Meridian Syndrome from《Treatise of "Shang Han"》" as the fundamental, addressed that the issue of "Three Yin disease of Interior-cold syndrome" is playing a key role in T2DM. The cause of T2DM is due to inferior endowment, or the one with inherent insufficiency. The main argument is, due to the weakness of kidney (the inherent essence) and the deficiency of spleen (supplement after birth), they could not function well to fortify and warm the viscera, it is "Tai Yin" and "Xiao Yin" diseases in kidney and spleen of "Yang" deficiency. In consequence, nutrients is losing which in turn the body is even weaker. Above all, the vital essence become hollowized and at last T2DM will develop under such circumstance. As the vital essence is inadequate, the energy is too weak to sweep the body waste and so the circulation of "Qi" and fluid will be hindered and at last the body is being piled up with coldness and dampness. This is the stage towards T2DM complications. Therefore, in this research, we will formulate another method-reinforce the healthy "Qi", dredge "Qi" mechanism in order to fortify the healthy "Qi" and sweep away the piled up pathogens. This method pinpoints both the cause and the indication of T2DM, has achieved a satisfactory and significant result.Part 2:Clinical ResearchObjective:Based on the information from Chinese Medicine literatures, the support of modern medicine studies and instructions of my academic advisor, Prof. Zhu, this research is to prove the theory that deficiency in "Yang" is the major problem of T2DM, it also comes with blockage of "Qi" mechanism. We will observe the clinical results of using the method of warming and fortifying "Qi", dredging "Qi" mechanism to deal with T2DM in order to testify the correctness and beneficial to future studies.Methods:This study is a prospective study, with the clinical observation of 60 patients on secondary failure of the oral antidiabetic regime in type 2 diabetes, in No.1 Affiliated Hospital of Guangzhou University of Chinese Medicine during the period from July 2009 to April 2010. The 60 cases those were diagnosed as the six-meridian differentiation in three "Yin" disease and/or with the blockage of "Qi" mechanism, were randomized into three groups, treatment group (add Chinese medicine) n=30, and control group 1 (add Acarbose, Rosiglitazone) n= 15, and control 2 group(add insulin) n= 15 (inpatient and outpatient). All patients received the same education course for diabetes, eating instruction and suggested quantity of physical activities. Before and after 12 weeks treatment period, we have taken the measuring data of FBG,2hPBG, HbAlc and observed clinical symptom score and create a " Vital Qi and pathogens Scale Points " and the six-meridian distribution. We compared the change of data before and after treatment, the data then was processed by SPSS17.0(PASW 17) statistic software. For all statistical test, aP value of less than 0.05 was considered to be statistically significant.Results:1. All cases cannot be generalized into (initial diagnosis) single six-meridians diseases, but with combination of syndromes and complications. 13 cases were categorized to three "Yin" diseases with 22%, and 47 cases were categorized to "Yin and Yang" combination diseases with 78%.2. Distribution of six-meridian diseases were:1) Chief syndrome with "Shao Yin" accountable for 96.66%(58/60cases),2) Chief syndrome with "Shao Yang" accountable for 36.66%(22/60 cases),3) Chief syndrome with " Jue Yin" accountable for 31.66%(19/60 cases),4) Subordinate syndrome with "Tai Yin" accountable for 16.66%(10/60 cases),5) Subordinate syndrome with "Yang Ming" accountable for 13.33%(8/60 cases),6) Accompany syndrome with "Tai Yang" accountable for 5%(3/60 cases). Therefore, the majority of the patients in secondary failure of the oral anti-diabetic regimen with the aetiology is "Yang" deficiency in chief syndrome of "Shao Yin" and accompanied with blockage of "Qi" mechanism, that proves the correctness of our treatment by using the method of warming "Yang" and dredging the "Qi" mechanism.3. Through the statistical analysis of relevant indicators by comparing that of before and after treatments, the improvement of FBG,2hPBG and HbAlc in each group are statistically significant (P<0.05). However, the above indicators among the groups are insignificant (P>0.05).4. According to the comparison of syndrome scores, P< 0.01, it showed that there is significant difference of healing effect among groups, and that of the treatment group (with add-on Chinese Medicine) is the most outstanding one. Above all, The total effective rate of the treatment group (add Chinese medicine) is 100% with significant rate of 63.3%; The total effective rate of the control group 1(add Western medicine)is 100% with significant rate of 33.3%; The total effective rate of the control group 2(Insulin)is 60% with significant rate of 6.7%, and no effect 33.3%.5. For the ease of observation and data handling, we have complied a table of《The quantitative analysis of hollowness of "Qi" and degree of pathogens》, the result showed that if the syndrome is deficiency in vital "Qi", most of them are with deficiency of "Yang", heart and or kidney as well, this indication matches closely with "Shao Yin" syndrome in Six Meridian. On the other hand, if it is in excessive syndrome, most of them are in depressive syndromes, coldness and dampness, and heat bound, which are manifested as blockage of "Qi" mechanism. It proved that deficiency syndrome is mainly in deficiency in "Yang" while excessive syndrome is mainly shown as blockage of "Qi " mechanism which is attributable to stagnation of coldness and dampness.Conclusions and revelations:The patients with T2DM are usually deficiency of heredity, and then triggered by bad living habits, random diet, emotional frustration and excessive comfort. Owing to the dysfunction of spleen and kidney, energy to circulate the system is insufficient and lead to stagnation of pathogens (phlegm or stasis) which in turn block the flow of blood and meridians and at last, the disease will then evolve to irreversible stage. To focus on these features of T2DM, we utilize the Treatment of using Chinease medicine to reinforce healthy "qi", in associate with the dredging of "Qi" mechanism, to fortify the organs'functions so as to sweep away the pathogens. Supporting the "Qi" and clearing away pathogens, both superficial characteristics and fundamental causes were taken care and so enhance the healing effect significantly, improve patient's quality of life.T2DM is a thorny disease which is incurable even now with Modern Medicine Science, hence, the target is to control disease's development and glycemic control is the key. However, we found that the healing effect of prolonged use of oral anti-diabetic agent is not desirable. Secondary failure is a highly likely consequence, even with maximal doses or combination of multi-antidiabetic agents therapies. Patients will eventually rely on insulin therapy to maintain glycemic control, to survive. In spite of using the intensive therapy to restrict the blood glucose, diabetes complications are still inevitable.Therefore, The add-on of Chinese medicine in the course of treatment can have positive and aggressive effect. According to the systematical reviews of articles and treaties, Chinese medicine performs multi-targeting action and comprehensive adjustment, can lower the level of blood glucose, reduce the side effects from the Western medicine, improve the quality of life and avoid those serious diabetes complications. "Theory of pre-emptive treatment of disease" is our principal character in Chinese medicine. To use Chinese medicine as add on therapy in early stage of T2DM could have good chance to reverse the disease, can minimize the chance of occurring complications in mid-stage, can still lift up a great extent of the quality of life even in final stage of the disease.T2DM is associated with function declining ofβ-cell and degeneration of insulin sensitivity, neither oral anti-diabetic agents nor insulin are able to stop its deteriorating progression.With this research, it shows the healing effect with integration of Chinese medicine is encouraging. Chinese medicine will use a holistic view to scan and to regulate the body condition, it indicates that Chinese medicine could stabilize the blood glucose level, provided a much better option but just add up the doses of Western medicine.