Study On Evaluation Method For RCT About Insomnia By Different Treatment Based On Syndrome Differentiation Methods

Objective:The study is carried as the physicians who are the actors of the treatment based on syndrome differentiation to the object, the effective of the treatment based on syndrome differentiation carried of different physicians to the index, to explore whether the character and individuality experience rules influence the result of the treatment based on syndrome differentiation. The research is also to set about the methods of the evaluation of the experience of the different physicians that suffered insomnia, premising not distort the theory of the characteristic of the treatment based on syndrome differentiation, to search for the methods to fit for clinical study design evaluating to the therapeutic effect of the treatment based syndrome differentiation.Methods:Practicing randomly:The visit turn of the patients, every selected patient will be diagnosed by three physicians, and the turn in succession is also to be decided randomly. All the physicians will be grouped randomly to A, B, C groups, that included six random programs. The visit turn of every patient diagnosed by the three physicians every diagnose time will be carried out by the software of Statistical Analysis System (SAS) deal with by the engineers from the Clinical Evaluation Center of China Academy of China Medical Sciences. Every diagnose time, the patient visits in the turn of the three physicians that random coding also.Randomness of the real prescription of every patient: a patient will to be cured one of the three physicians after diagnosed by them, the random program will be carried out by the software of Statistical Analysis System (SAS) deal with by the engineers from the Clinical Evaluation Center of China Academy of China Medical Sciences and will be determined in the first visiting, then the patient will be treated according to the prescription of the selected physician till the course of treatment end. Blind trial method:The researchers handle the random results with blind-method:a researcher that have nothing to do with the program will be assigned to apply for the random numbers, the random visiting turn and the designating prescription on the basis of the visiting turn according to central stochastic system "applying random number (the Clinical Evaluation Center of China Academy of China Medical Sciences).The researchers handle the prescription and the drug with blind-method:a researcher that have nothing to do with the program will be assigned to hand in the prescription to the decoct medicinal herbs room and take back the herbal soup to hand out the patients according to random results of the healing prescription. Control method:All the three traditional Chinese physicians diagnose the whole patients, compare the treatment based on syndrome differentiation considerations with they medication; comparing with three group patients that selected drug prescribed by different medicines to evaluate the clinical curative effect.The methods to collect the data: according to the request of the FangLue out-patient clinic EMR system to structure enter and retrieve these collected cases.The methods to statistical analysis:the baseline analysis and the clinical curative effect analysis deal with by the SPSS, the experience and character analysis deal with by the erected analysis mining data platform that involved in the "the National Basic Research Program of China (973 Program)-the basis principle, method and the technical platform of clinical evaluating the treatment based on syndrome differentiation, these methods included multidimensional inquest and searching, free-scale networks analysis and point wise mutual information et al.Results:1. Curative effect1.1. The main index the therapeutic effect basis on the Pittsburgh measuring scaleThe total effective rate is 66.67%, the total effective rate of the A medicine group is 66.67%, in the B medicine group is 72.73%, in the C medicine group is 60%. 1.2. The secondary index The therapeutic effect basis on the TCM symptoms measuring scale: the total effective rate is 80%, the total effective rate of the A medicine group is 66.66%, in the B medicine group is 81.82%, in the C medicine group is 90%.The therapeutic effect basis on the main TCM symptoms measuring scale:the total effective rate is 63.33%, the total effective rate of the main symptoms of insomnia in the A medicine group is 55.56%, in the B medicine group is 72.73%, in the C medicine group is 60%.The therapeutic effect basis on the secondary TCM symptoms measuring scale:the total effective rate is 80%, the total effective rate of the secondary symptoms of insomnia in the A medicine group is 55.55%, in the B medicine group is 90.91%, in the C medicine group is 90%.In addition to the changing of the symptoms out of the measuring scale, there are exactly therapeutic effect for curing the accompany symptoms of the patients that cured by the three medicines.1.3 Social benefit evaluation indexMost the appreciation to these medicines therapeutic effect are satisfying, and the social benefit is better.2. The characteristics of treatment based on syndrome differentiationThe common parts of the three medicines' treatment based on syndrome differentiation are that the frequency of the syndrome of heat disturbing heart-mind mostly, following the phlegm-heat syndrome and the syndrome of disharmony between heart and kidney. The physician A lay particular emphasis on the syndrome differentiation of blood deficiency and liver stagnation. The physician B thought about mainly the syndrome of heat disturbing heart-mind, i.e. the main pathogenesis of insomnia is the phlegm-heat disturbing the mind. The physician C realized the insomnia concentrating on the "blood" and thought the blood deficiency and blood stasis that are the breakthrough point of curing the insomnia.3. The using of the herbsThe physician A prescribe several kinds herbs to all the insomnias such as Semen Ziziphi Spinosae, Acorus gramineus Soland, Long Gu, oyster, Polygala Tenuifolia Willd, coptis chinensis franch, Cinnamomum cassia Presl, Poria cocos and addend another herbs according the different syndrome type. The physician B prescribe some herbs to the whole insomnias such as Semen Ziziphi Spinosae, plumula nelumbinis, bamboo leaves, Juncus Effuses, Long Chi, Polygala Tenuifolia Willd, Acorus gramineus Soland, otherwise, physician B used Huanglian Wendan Tang much times, tuber fleeceflower stem, Radix Bupleuri, oyster, Long Gu, Juncus Effuses are the key herbs mainly used by physician C.Conclusions:1. The evaluation methods that designed by this study is fit for evaluating the TDS.2. The results are different among the three physicians'treatment based on syndrome differentiation, and so the using of the herbs, while the therapeutic effects are so obviously and there is no statistical significance among their difference.3. The common of three medicines'prescribing curing the insomnia is to use Semen Ziziphi Spinosae, Acorus gramineus Soland, tuber fleeceflower stem, Long Gu, Long Chi, oyster, Polygala Tenuifolia Willd that named tranquilizer and the frequency used mostly, what's more the combination among them is more.4. The using of the herbs is serving for the physicians'thought of treatment based on syndrome difference. For example, the result of the syndrome differentiation of the physician A is blood deficiency more.so Angelica sinensis, Angelica sinensis, Polygala Tenuifolia Willd are used in frequency and in combination. The result of the syndrome differentiation of the physician B is most of the syndrome of heat disturbing heart-mind, coptis chinensis franch, plumula nelumbinis, Juncus Effuses, those efficacy is to clear heart fire and to tranquilize mind that are most used in frequency and in combination, the result of the syndrome differentiation of the physician C is most of the syndrome of blood stasis, so he prescribe Radix Bupleuri and Angelica sinensis in frequency and in combination to Soothe the liver qi, to activate blood circulation, to nourish Blood. 5. The cause of the similarities and differences among the three physicians in using herbs to cure the insomnia according to the analysis of the dig data, integrating their viewpoint is to summarize tow point roughly, the first, different thoughts of treatment based on syndrome differentiation guide different plans of choosing herbs, physicians prescribe different herbs to cure the insomnia result of the different syndrome differentiation, secondary, some physicians have been influenced foe the modern herbal pharmacology research.