The Study Of Clinical Efficacy Evaluation Of TCM In Ancient Time

Clinical efficacy of Traditional Chinese Medicine(TCM)is the fundament ofsurvival and development.TCM research has been focusing on clinical efficacyincreasingly in recent years.TCM clinical efficacy pays much attention to the efficacyevaluation methods,whether the evaluation system responds the efficacy ofintervention by virtue of justice,comprehension,equity and accuracy,which meansgreat importance for implementing the treatment project and the ends of treatment.Inthe long run TCM clinical efficacy evaluation research plays an important part inTCM developing,which could cause a revolution in medicine history,even withprofound social impacts.In the process of TCM modernization,TCM,more or less with some blindness,applied,have been applying or will apply a series of evaluation methods and indexesfrom modem medicine.However,TCM is so different from Western medicine thatboth of them have independent theories and qualities.More and more TCMresearchers leaned lessons that pure biomedical evaluation model can't reflect featuresand take good advantage of TCM treatment from their long term practice,which hashindered TCM sustained developing procedure.Thus,it is necessary that a model ofclinical efficacy evaluation that fits for TCM be built on the way.It is proved that TCM had attached importance,which including how to evaluate,judge and collect evidence,to clinical efficacy in ancient time by a large number ofliterature.We should make it clear form those literature that what evaluation methodsare,how they worked and what the ancient practitioners' evidence to evaluate,forexample the relative indexes and outcomes.In the first part of the thesis,there is a review of TCM literature about whetherthere is clinical efficacy evaluation and what the general picture is,by a pilotsurveying a small scale and in depth ancient literature.Some common and highrelative words about TCM clinical efficacy from different phases of TCM history were selected as the clues,from some famous and classic TCM books,to makeprimary exploring,after which rich resource about treatment evaluation has beenfound out and the directions for literature mining has been decided.Then,further andbroad literature has been selected to study including six types of eighteen famousand classic books,such as classics of TCM,classics related to Gold Damage andGolden Chamber,classics related to cause and diagnosis of disease,classics related toforrnularies,classics related to miscellaneous clinical medicine and classics related tomedical records.A formal table of evaluative words has been formed on base of thepilot study,according to which the software for labeling and counting has beendesigned,by which all the selected literature has been labeled as the fist step,screening of extracts with artificial correction as the second step,and then analyzedfrom three aspects such as evaluative methods,indexes,factors and characteristicswith the guidance of research aims.At last sum up all the literature and refined all theevaluative methods,indexes,factors and characteristics by make analysis in detail tosummarize some rules in TCM ancient literature about clinical efficacy evaluation.There are two main clinical efficacy evaluation methods and their relativeevaluative indexes from this study.The first method is that evaluation occurs before and after the treatmentaccording to the changed TCM syndromes,which is the most common method in theselected literature and is an ultimate and decisive evaluation for the end points oftreatment,in other words,for the long-term efficacy,but not a certain method forsome instant changing in the treatment course,especially in cases with complicatedconditions.The first method is almost made of intuitive feelings of patients,that is,patient-reporting,which completely reflects ancient TCM had put patients' individualperceptions and values that are the core aspects into consideration of clinical efficacyevaluation.The second method is that TCM doctors make judgments accompanying thechanging of disease developing mechanism after every treatment.Such a method,being important and unique in ancient TCM efficacy evaluation with TCM principleof syndrome differentiation and treatment,has not been mentioned by others,and is so inconspicuous that it is all but neglected by doctors now.The second methodbecomes essential and powerful for sake of insisting proper treating project makingright judgment and having good outcome,when the treatment procedure is unclear,when the disease transformation has multiple directions.Both the first method and the second one are common and important in ancientTCM efficacy evaluation,which have been more combined with each other than beenused alone,in its entirety in practice,being complementary and intimate.As we have known,evaluative indexes must be determined by the correspondingevaluative methods.On one hand,indexes not only are the changing syndromesbefore and after treatment,but also are divided into instant,short term and long termsyndrome changing,of which the last two are decisive changing,namely,end pointsor clinical outcomes,which are reported most by patients with little doctors' diagnosisinformation,such as pulse diagnosis and inspection of the complexion and so on.Onthe other hand,indexes are connected with interventions and different syndromesresulted from disease developing mechanism,for instance,sweat,blood,urine,vomits,secretions,etc..Just like the combining form of evaluation methods,both indexes aremade use of as a whole in practice.Sometimes some syndromes,which are not easyto find and think much of,is the index for evaluating syndrome as well as forevaluating disease mechanism that appears earlier usually.What's more,there is acondition should not be ignored that some disease have been cured without theindexes for disease mechanism,just by virtue of indexes for syndrome changing,thatis,end-point to judge.There were an abundance of describing and recording clinical efficacy evaluationin TCM literature in very early time,of which could be read now.Although there islack of monographs about efficacy evaluation,a series of concrete indexes,evaluativemethods and evaluation model have been at the disposal of TCM doctors in all agesfor thousands of years in TCM history,which has been handed down from generationto generation and put an original idea for clinical efficacy evaluation into practice.Four characteristics have been concluded as following by analyzing the selectedclassics of TCM. 1)Ancient TCM clinical efficacy evaluation incorporated one of the famousfeatures of TCM,that is,syndrome differentiation and treatment.TCM advocates theprinciple of treating disease's root that means the disease's nature and quality,in otherwords,the disease mechanism.Both the evaluation methods discussed above hasembodied TCM syndrome differentiation and treatment as well as the other feature ofTCM,namely,the holism,because of which ancient TCM efficacy evaluation evolvedfrom TCM's own features.2)Two sets of indexes implanted in two different evaluation methods arecombined with each other together and integrated intimately in practice,in whichshort-term and long-term efficacy of patients are measured as the ultimate teststandards.For a efficacy reporter,both evaluation methods are established on the baseof information provided by patients,which are full of TCM charm during efficacyevaluating process,such as respecting patients,patient-center and integratedpractioner-patient perception evaluation.3)Actually,there are no radical alternations for evaluation methods andevaluative indexes in the long history of TCM developing.Despite the fact thatexterior changing of the content about TCM evaluation seems to be increasingly richand multiple,the nature and quality always grasp the features of holism and syndromedifferentiation and treatment.And the evolution of the evaluative words representsadequately the consecutive and coherent modality of TCM evaluation development.Most TCM doctors from past to now reached an agreement on the other qualities ofancient TCM evaluation that include the impact factors,the safety evaluating and soon,which also involved the consecutive and coherent quality.Furthermore,TCM emphasizes the theory of correspondence between nature andhuman and all kinds of impact factors,such as environmental factors,individualfactors both form patients and doctors,social factors and so on.Thus thesecomplicated factors result in the uncertainty of clinical efficacy and become one of thereasons that TCM evaluation should be standardized.TCM classics opened a door thatfacilitated studying clinical efficacy through which a comprehensive overview ofefficacy impact factors has been read about,and other literature of clinical practice and records refer to more or less clinical efficacy evaluation for different aspect.According to these characteristics of TCM efficacy evaluation,this study rolledout a picture enlightening today's efficacy evaluation greatly,which can be concludedas three points.Firstly,TCM efficacy evaluation should proper for the feature ofsyndrome differentiation and treatment that is the primary principle for TCMdiagnosis and treatment which demands TCM treatment should accord with diseasemechanism changing,and such an evaluation could get hold of the nature,the qualityand the omen of TCM treatment.Besides,only the evaluation method that is involvedwith short-term and long-term syndrome transformation do prove the substancechanging of disease mechanism on behalf of the tenet of the primary principle.Secondly,efficacy evaluation should be patient-centered,which is in line with thefeatures of holism and syndrome differentiation and treatment.Only the end pointsevaluation of patients do reflect disease mechanism developing and changing and theultimate efficacy,otherwise,the doctors' evaluative presumptive from some objectiveindexes of patients' body would be secondary.No matter what evaluation method hasbeen used,patient-centered reporting should be the main information resource and thecomprehensive factors should be thought much of and made good use of.As fordoctors,the ins and outs are dealt with in practice,of which either the beneficial aretaken advantage of or the bad are avoided in time,in order to maximize all possiblegood efficacies.In addition,TCM evaluation innovation should hold a flexibleposition where keeping its own quality,meanwhile,absorbing other ideas,methodsand achievements from modem evaluation system and explore a new realm for TCMclinical efficacy evaluation.It is reported that clinical efficacy evaluation consists of a broad and complexsubject that include theory domain,thinking way,methodology and practice and so on.This thesis treats of an overview of ancient TCM efficacy evaluation that has beentested by thousands of years' clinical practice,whose evaluative methods and indexesaccord with TCM features of holism and syndrome differentiation and treatment byanalyzing a series of TCM classics.The analyzing results make significance formodem TCM developing efficacy evaluation.It suggests that TCM efficacy evaluation should be flexible with huge absorbency so that it can develop a newmodem efficacy evaluation system under the steering of the nature and quality ofTCM.The hope for improving human's health and developing TCM could be realizedby prompting the TCM efficacy evaluation methods and building an appropriate TCMclinical efficacy evaluation system.