Clinical Application Research About Non-inferiority/equivalence Cutoff Being Used In The Re-evaluation Of Traditional Chinese Medicine

PurposeTo explore the role of non-inferiority/equivalence value in re-evaluation clinical trials for traditional Chinese medicine.Methods(1) Through theoretical research and clinical trials to explore the purpose, the clinical significance and evaluation of the current re-evaluation of traditional Chinese medicine.(2) To analyze the function, the determining principles and the application of non-inferiority/equivalence value in re-evaluation clinical trials for traditional Chinese medicine.Results(1)The current clinical re-evaluation of traditional Chinese medicine had some deficiencies:the smaller volume of test samples, the lack of randomized controlled trial, the existence of statistical error, non-standard evaluation criteria, unclear clinical orientation, limited application of the new methods and techniques in clinical re-evaluation of traditional Chinese medicine, little attention to clinical re-evaluation of important Chinese herbal pharmaceutics.(2)At present, literature research released that almost all of the non-inferiority /equivalence of clinical trials had not applied non-inferiority/equivalence cutoff values, which lead to the conclusions only have statistical significance. But the clinical significances did not take into account.(3)It is necessary to consider the non-inferiority/equivalence value in trials' designs in order to get credible results with more clinical significances.(4)According to the program's design, the non-inferiority of the sector value was 0.1. Based on the syndrome effects of non-inferiority test, FAS (u=5.597, P=0.000) and PP (u=6.388, P=0.000), the experimental group had non-inferiority efficacy compared with the control group. For anemia efficient non-inferiority test, FAS (u=4.993, P=0.000) and PP (u=5.317, P=0.000), the effective rate in experimental group had non-inferiority to that of the control group. For irregular menstruation efficient non-inferiority test, FAS (u=3979, P=0.000) and PP (u=4.888, P=0.000), the effective rate in experimental group had non-inferiority to that of the control group.Conclusion(1)The most important method of clinical re-evaluation of traditional Chinese medicine is forward-looking, multi-center randomized and controlled clinical trials.(2)The clinical significances had not been take into account in statistical results of herbals efficacy based on the significance test.(3)The application of Non-inferiority/equivalence was a vital factor to decide whether the statistical results have clinical meaning.(4)Circumspect consideration should be needed to determine the specific cutoff value of non-inferiority/equivalence. The values must be decided before trials design.(5)To determine the ultimate value of non-inferiority/equivalence cutoff, clinical experts of relevant disciplines must draw a common recognition with statisticians according to the clinical features of diseases.