| Objective1 To explore the methods of developing clinical practice guidelines of TCM,and take it as the guidance in the making of clinical practice guidelines of CG in TCM.2 To evaluate the factors related to therapeutic literature of CG in the contribution of clinical therapeutic effect in order to provide references for clinical trials in TCM.Method1 Research on the making of clinical practice guidelines of CG in TCMOn the basis of analyzing the methods of the making and evaluation of clinical practice guidelines abroad systematically,we developed the procedure of clinical practice guidelines of CG in TCM,combining with the character of TCM and TCM literature.Following by the practical operation,the former procedure was amended.2 Research on influential factors in quality assessment of therapeutic literature of CGLiterature of CG clinical trials in 1998.3 to 2008.3 was collected and clinical design factors such as clinical trial methods,sample size,diagnostic criteria,and curative effect criteria were recorded.By statistic analysis,we appraised the factors which affected quality of clinical trials of TCM.Result1 Research on the making of clinical practice guidelines of CG in TCM1.1 The completeness of CG clinical practice guideline of TCMIn the making of CG clinical practice guidelines of TCM,the following work had been done:establishing the guideline development group;pre-examining the literature; decomposing and defining clinical questions;literature searching;appraising literature and forming evidence;evaluating evidence and composing the recommendations;the writing of guideline draft;experts review;rectifying and completing the final draft. The quality assessment methods of literature was especially discussed and used in the guideline development.1.2 The appraisal of CG clinical practice guideline of TCM (1)The appraisal of CG guideline by AGREE instrument:①The score by AGREE instrument appraisal:the standardized domain score of scope and purpose is 71.4%;score of stakeholder involvement is 50.0%;score of rigor of development is 80.6%;score of clarity and presentation is 66.7%;score of editorial independence is 83.3%;for the independence of the implementation and dissemination of the guideline, the standardized score of applicability(item 19,20,21) is low.②The comments of the guideline:the guideline should be tested in local area first;proper adjustment should be taken in the implementation according to clinical practice locally.(2)The comments of experts:This guideline was established by introducing the world modern advanced guideline development methods,which was modified with the clinical practice of CG in the treatment of TCM.The content of the guideline embodies the characteristic of CG treatment of TCM,and is wholly scientific and applicable.Dissemination can be performed after local implementation.2 Research on influential factors in quality assessment of therapeutic literature of CG2.1 Clinical typeClinical type of CG has impacts on the therapeutic effect.CG,CSG has a better curative effect,BRG is second to CG and CSG,and CAG is relatively lower than above.2.2 Sample sizeSample size influences on the recovery power of CSG,and to CG,CSG,CAG,it mainly impacts on the effective power.Clinical trials of big samples have a better curative effect than the ones of small sample size.2.3 Diagnostic criteriaDiagnostic criteria impacts on recovery power of CG,CAG.BRG,and to CSG, CAG,it mainly influences on effective power.Clinical trials of improper diagnostic criteria have a higher effective power than the ones of proper diagnostic criteria.2.4 Therapeutic effect criteriaTherapeutic effect criteria impacts on recovery power of CG,BRG,and has influences on the effective power of CSG.Clinical trials of improper therapeutic effect criteria have a better therapeutic effect than the ones of proper therapeutic effect criteria.2.5 Clinical trial methodClinical trial method has no impact on CG and CSG,while to CAG and BRG,it affects on both recovery power and effective power.Clinical trials of CSS have a higher recovery and effective power than the ones of RCT.To trials of CBAS,the therapeutic rate is lower than the ones of CSS,but compared to the ones of RCT,the result is not a fixed one.2.6 Recovery power and effective powerThere are differences in the recovery power of symptoms,gastroscope and pathological changes in all types of CG but BRG.The recovery power of symptoms and the total recovery power are higher,the recovery power of gastroscope is second to the former ones,and the recovery power of pathological changes is relatively lower. There are differences in the effective power in all types of CG.The effective power of symptoms and the total effective rate are higher,the effective power of gastroscope is second to the former ones,and the effective power of pathological changes is relatively lower.Conclusion1 This clinical practice guideline development procedure of TCM is consistent with the characteristic of TCM treatment,and corresponds with the feature of clinical literature of TCM,which can be use as the guidance of the making of CG guideline development of TCM.2 The draft of CG clinical practice guideline of TCM is the embodiment of clinical practice of CG in TCM,and is scientific and applicable.3 Factors in clinical trial designs such as clinical type,sample size,diagnostic criteria, therapeutic effect criteria,clinical trial method have certain effects in the curative effect.Improper diagnostic criteria and therapeutic effect criteria,lack of controlled group can exaggerate the curative effect.It is necessary to raise the quality of clinical research and establish standards of articles of TCM clinical trials.4 Each pattern of CG should be researched independently.The therapeutic effect index should be specifically chosen in clinical trials.In the evaluation of recovery power,recovery power of symptoms,gastroscope,and pathological changes should be calculated separately,things are the same to the effective power. |
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