The History Of Traditional Chinese Medicine Clinical Trials With Pain As A Major Disease Evaluation Of The Efficacy Of 15 Years

Purpose：To explore the features and changes of common diseasesdiagnosis and treat evaluation based on the pain as the primary symptomon TCM clinical trials.Material and method：The study included the pain as the primarysymptom of116projects，34885cases about common diseases TCM clinicaltrials between1999and2013, which were conducted and participated by70National drug clinical trial institutions approved by the State Foodand Drug Administration.Which included angina pectoris（57project）,throat or laryngitis（13project）, headache（7project）,chronic pelvicinflammatory disease（21project）, dysmenorrhea（18project）.By analyzingthe three aspects of pain observations, primary and secondary efficacyobservations and efficacy evaluation,I discuss the features and changesof common diseases diagnosis and treat evaluation based on the pain asthe primary symptom on TCM clinical trials.Results：1.The observations of disease (angina pectoris, headache) ischaracterized by extent, duration, frequency effects：15years,painduration, number of episodes of angina pectoris and headache wereevaluated using quantitative scoring method; for pain evaluation ofangina pectoris15years are used to quantify score,headache07years ago,the use of quantitative scoring method and NRS score, which quantify thescore is2times the NRS score. After2007using the NRS score accountedfor50%, quantify and VAS score score accounted for25%respectively.2.The observations of disease (dysmenorrhea) is characterized by extent,evaluation of dysmenorrhea pain for more than07years ago,50%of the use of quantitative scoring method, with the highest proportion of VASscore and NRS score after2007, accounting for45.5%. Evaluation of painduration of15years in all quantitative scoring method.3. The observations of disease (throat or laryngitis, chronic pelvicinflammatory disease) is characterized by extent:15years, pharynx orthroat pain level evaluation of all the use of quantitative scoring method.07years ago,Chronic pelvic inflammatory disease are used to quantifythe degree of pain assessment score, after07years the adoption ofproportional VAS score increased54.5%.4. Common diseases and pain disorders in clinical trials of pain medicineprimary, secondary efficacy observations:①angina pectoris in2007after more than07years ago as the main indicator of pain only increasedthe proportion of4.1%, mainly pain but also for secondary indexes bothincreased the proportion of14.8%, the pain is not the main point, reducethe proportion of the secondary efficacy endpoint of18.9%.②Afterpharyngitis or laryngitis2007than07years ago, only the proportion ofpain as the primary indicator increased by15%, the proportion of primaryand secondary not to index reduced by15%, also did not use both for themain secondary indicators may be due to throat The main clinicalmanifestations of inflammation not only pain, but also including thethroat, swelling, etc..③headache in2007after more than07yearsago, only to reduce the proportion of pain as the primary indicator of33.3%, also for minor pain in both the main index and not of a primaryand secondary targets were increased by16.7%.④chronic pelvicinflammatory disease in2007after more than07years ago as the primaryefficacy endpoint of pain only to reduce the proportion of13.6%undividedprimary, secondary indicators reduce the proportion of1.9%, mainly painboth secondary indexes also increased the proportion of15.5%.⑤ dysmenorrhea07years ago, only the pain as the primary efficacyobservations, compared with07years ago, the pain in2007after bothmajor proportion of secondary indexes also increased by36.4%, theproportion of primary and secondary unallocated index increased to27.2%.5.To common diseases and pain disorders pain medicine clinical trialefficacy evaluation criteria:①angina pectoris15years were evaluatedusing TCM syndromes: nimodipine method. Western evaluate the use of morethan50%of angina pectoris Ⅰ-Ⅲ grade evaluation method, an increaseof4.4%reduced rate in recent years, the use of evaluation.②throator laryngitis15years were evaluated using syndromes: nimodipine method.Western evaluate pharyngitis or laryngitis are used to reduce thepercentage and lower-level evaluation. Evaluation method adopted inrecent years to reduce the percentage increase of10%.③headache15years were evaluated using syndromes: nimodipine law; Western evaluatethe use of more than75percent lower percentage evaluation in recent yearshas increased the difference between the comparative method.④chronicpelvic inflammatory medicine evaluation of more than80%using syndromesRating: nimodipine law in recent years added a dichotomy18.2%.07yearsago, mainly in Western evaluate lower level+evaluation method to reducethe percentage of80%,07+years after the use of lower-level evaluationmethod to reduce the proportion of lower percentage of36.4%, thedifference between the relatively new law.⑤dysmenorrhea medicineevaluation are used syndromes Rating: nimodipine law, more than07yearsago, Western evaluated using70percent lower level evaluation method,07years after the evaluation method used mainly to reduce the percentageof64%, using the difference between the year of comparative lawincreased.Conclusion: 1to the extent, duration, frequency characteristics of the disease onthe effect of duration and number of episodes of pain were evaluated usingquantitative scoring method. Evaluation can be used to quantify the degreeof pain score or NRS score.2to the extent of disease is characterized by time effect on the durationof pain were evaluated using quantitative scoring method. Can be used forevaluation of the degree of VAS, or NRS score.3to the extent of the effect of the disease on the characteristics ofthe evaluation can be used to quantify the degree of pain VAS score orscore.4to common diseases and pain disorders in clinical trials of pain medicineto primary and secondary efficacy observations: It is recommended settingthe pain both primary efficacy observations, but also set a secondaryefficacy observations.5clinical medicine and pain symptoms of common diseases to test theefficacy of evaluation criteria: Western group should adopt thedifference between pain scores Comparative Law; medicine should be usedby "valid","invalid" dichotomy efficacy evaluation.