中西医治疗紧张性头痛临床研究的有效率定义及其判定标准差异:一项概况性评价OA

Objective:To investigate the current application status of effective rate as a composite outcome measure in clinical studies of integrated traditional Chinese and Western medicine for tension-type headache,and to provide a reference for the rational selection of composite outcome indicators in future tension-type headache research.Methods:Computer-based searches were conducted in PubMed,EMBase,Cochrane Library,China National Knowledge Infrastructure(CNKI),VIP Chinese Science and Technology Periodical Database,and Wanfang Database to identify clinical studies on tension-type headache treated with integrated traditional Chinese and Western medicine.Descriptive analyses were performed using Excel 2016,CiteSpace 16.0,and Cytoscape 3.7.2 software,covering keywords,research institutions,disease classification,treatment course,definitions and criteria for evaluating therapeutic effectiveness,grading of efficacy assessment,and the frequency and utilization rates of outcome indicators.Results:A total of 132 studies were included,of which 92 explicitly stated the reference standards or self-defined criteria for effective rate.The most frequently cited reference was the literature source(34 studies),followed by different versions of the Guiding Principles for Clinical Research of New Chinese Medicines(29 studies).The composite outcome measures comprised 21 specific indicators,with a total of 39 combination patterns.The top three combinations were:Visual Analogue Scale,combined with headache attack frequency and duration(7 studies),headache severity/symptoms combined with recurrence(6 studies),and headache severity/symptoms combined with attack frequency and duration(6 studies).Accordingly,four-level,three-level,and even two-level grading systems for efficacy evaluation were established.Conclusion:There are numerous problems in the evaluation of effective rate in the treatment of tension-type headache with integrated traditional Chinese and Western medicine.It is necessary to standardize effective rate as a composite outcome measure to guide clinical application,thereby improving the quality and value of relevant clinical research.