| Objectives According to the requirements of evidence-based medicine,the “report standard of individualized diagnosis and treatment of traditional Chinese medicine” was established;take the individualized diagnosis and treatment experience of a famous TCM doctor in IBS as the research object,performing the single-arm clinical research using target value method(quantitative study);conducting the third-party confirmatory study of individualized diagnosis and treatment of TCM from the perspective of practitioners and users(quantitative research);to explore the establishment of a mixed method research mode combining the target value method(quantitative research)and the third-party confirmatory(qualitative research),for the purpose of promoting the evidence-based evidence of individual diagnosis and treatment experience of TCM.Methods1.Establishing an evidence-based standard in the report of individualized diagnosis and treatment of TCM Draw on the experience of other international reporting standards such as TREND,CONSORT,STROBE,establish the “report standard of individualized diagnosis and treatment of TCM” with the requirements of evidence-based medicine by using comprehensive qualitative research methods including applied literature research,expert questionnaire surveys,interviews and so on.2.Performing the single-arm clinical research with target value method in the assessment of individual diagnosis and treatment of TCM, Taking the individualized diagnosis and treatment experience of a famous TCM doctor in IBS as the research object,and adequate relief(AR)as the main effect indicator,we used the results of systematic review/meta-analysis in previous studies as the basis for determining the target value.By investigating whether the results of single-arm clinical research which with strict quality control and without concurrent control are within the specified target value range,the effect of individual diagnosis and treatment experience of this TCM doctor can be inferred.The statistical results of the target value method were expressed by the combination of point estimation and interval estimation.According to the sample size estimation requirements of the target value method,the sample size of this study was determined as 65 cases.3.Conducting the third-party confirmatory study model of individualized diagnosis and treatment of TCM After defining third-party practitioners,the views and feelings of them were obtained by using qualitative research methods such as questionnaire survey and interview.It mainly focused on the attributes of the diagnosis and treatment process(i.e.operability,feasibility,integrity and scientificity)and the repeatability of efficacy(i.e.the assessment of the individual diagnosis and treatment experience of this TCM doctor from the third-party practitioner).4.Exploring the evidence-based model of the mixed method in evaluating the efficacy of individualized diagnosis and treatment of TCM Exploring a hybrid research model combining qualitative and quantitative methods to complement and confirm the research conclusions,so as to improve the scientificity and reliability of them.Results1.Research on the standardization of individualized diagnosis and treatment reports of TCM Focusing on the concrete content of individualized diagnosis and treatment,a standardized framework for individualized diagnosis and treatment of TCM was initially established through literature research and the first round of expert consultation.And the report items were completed through the second round of nationwide expert surveys.Finally,the “report standard of individualized diagnosis and treatment of traditional Chinese medicine”(Draft)was established,including items of descriptions of the personality characteristics of the targeted patients,descriptions of the personality characteristics of the doctor's identification of diseases/syndrome/symptoms,descriptions of the personality characteristics of the doctor's treatment methods,descriptions of expected treatment effects and advantages analysis of treatment,etc.,and their interpretation and filling instructions.2.Clinical research on the single-arm trial of the assessment of individual diagnosis and treatment of TCM with the target value method A total of 65 patients were enrolled in this study,of which 5 patients had fallen out,only 60 of them were included for following analysis.(1)Routine statistical test results: after analysis,it is found that the effective rate of the main effect indicator,that is,adequate relief(AR),can reach 78.33% in the IBS individualized diagnosis and treatment experience of a famous TCM doctor;one of the secondary indicators was IBS symptom severity scale(IBS-SSS),which had a 68.33% response rate and the total score after treatment was significantly lower than that of baseline(P < 0.05);one of the secondary indicators was the IBS quality of life(IBS-QOL),and its total and average score of each dimension were higher than those at baseline,whose difference were statistically significant(P<0.05)except the two dimensions consist of food avoidance(FA)(P=0.17)and relationship expansion(RL)(P=0.10);other secondary indicators including severity of abdominal pain,severity of abdominal discomfort,severity of abdominal distension,stool characteristics,defecation frequency,urgency of defecation,feeling of incomplete defecation,and mucous stools all showed a significantly downward trend(P<0.05)with time,and the differences in various indicators before and after treatment are statistically significant(P<0.05);there was no significant difference between the baseline and post-treatment scores in hospital anxiety(HAD-A)and depression(HAD-D)(P= 1.00),which were also two of the secondary indicators.(2)Statistical inference results of the target value method: the rate of having an adequate relief in 60 patients with complete follow-up was 78.33%.According to the target value method,hypothesis test Pexactand the lower and upper limits of the confidence interval calculation formula was set,and the statistical results were as follows: 95% confidence interval(67.78%,86.68%),which is significantly better than the 45% target value,and the difference was statistically significant(P<0.00),and it was significantly better than the target value compared with the 64% target value(P=0.01).(3)Safety results:This prescription and medication in terms of individualized diagnosis and treatment experience was safe,and no obvious adverse events have been reported so far.3.Research on the third-party confirmatory study model of individualized diagnosis and treatment of TCM Taking practitioners who have participated in the study of the target value method as the research object,a third-party confirmatory study which revolved around the attributes of the individualized diagnosis and treatment experience of TCM itself and the reproducibility of the efficacy was established.The results showed that all of the three third-party practitioners had good satisfaction with the aspects of formulation,clinical practice,and the exact efficacy in the individualized diagnosis and treatment experience of TCM.They all believed that the diagnosis and treatment experience had ideal operability,feasibility,integrity and scientificity,achieving the expected requirements.Among them,one practitioner believed that the diagnosis and treatment experience is novel from the perspective of strengthening the spleen,nourishing the kidney and dispelling wind;one practitioner believed that the effect of individualized diagnosis and treatment experience on patients with intractable IBS should be strengthened;one practitioner believed that it is more critical to change the patient's cognitive model of the disease for patients with obvious anxiety and depression symptoms.4.Evidence-based model of research on mixed methods of assessment of efficacy in individualized diagnosis and treatment of TCM Establishing a mixed method research model which had combined target value method(quantitative research)and third-party reconfirmation(qualitative research).The two groups of research data has gone through the process of “display?combination?inference”,and concluded that a famous TCM doctor's experience in the treatment of IBS was effective and had strong operability and feasibility.For patients with anxiety and depression,the treatment of changing their cognitive mode should be strengthened,such as health education.Conclusion1.According to the requirements of evidence-based medicine,we established the “report standard of individualized diagnosis and treatment of traditional Chinese medicine ”,improving the objectivity and repeatability of TCM individualized diagnosis and treatment.2.Through this strict quality control study,we have gotten the conclusion that the individualized diagnosis and treatment experience of a famous TCM doctor in treating IBS is better than that of placebo.And the experience of individual diagnosis and treatment of TCM was applied to clinical practice from the perspective of the third-party,with all the users thought that the effect of the experience was good and reached the expectation.In this study,the target value method(quantitative research)and the third-party confirmatory(qualitative research)were combined to make the research results mutually corroborated and supplemented,thus getting a complete and reliable research conclusion and meeting the requirements of evidence-based medicine. |
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