复方甘草酸苷治疗荨麻疹的随机对照试验报告质量评价

Quality assessment of randomized controlled trials of compound glycyrrhizin for urticaria

目的:评价复方甘草酸苷治疗荨麻疹的随机对照试验文献质量,了解临床随机对照试验的现状以提高治疗性临床研究质量。方法:计算机检索PubMed、Medline、Cochrane图书馆临床对照试验注册库、The National Research Rigester和CBM、VIP、CNKI数据库,纳入2000年1月-2011年12月中国人在国内外公开发表的关于复方甘草酸苷治疗荨麻疹的随机对照试验,采用修正后的Jadad评分量表、CONSORT条目、Cochrane系统评价手册推荐的方法和GRADE系统进行质量评价。结果:共纳入124篇RCT,修正后的Jadad评分结果显示:无5～7分文献,3篇(2.4%)4分,1篇(0.8%)3分,105篇(84.7%)2分,11篇(8.9%)1分,4篇(3.2%)0分。按CONSORT条目:仅7篇(5.6%)描述了随机方法,无文献报告如何执行随机,无采用安慰剂对照的文献,1篇(0.8%)采用了单盲,1篇(0.8%)采用了双盲,2篇(1.6%)报道了具体P值,5篇(4.0%)呈现了随访记录,无阴性报道结果及等效结果,79篇(63.7%)报道了不良反应,均未进行样本量计算、意向性分析和分层分析。按照Cochrane推荐的风险偏倚工具:3篇(2.4%)正确描述了随机方法,4篇(3.2%)随机方法错误,114篇(91.9%)不清楚随机,仅1篇(0.8%)采用了双盲,所有文献均不清楚隐藏分组,均有不完整资料偏倚,无选择性报道结果,不清楚其他偏倚。GRADE质量评价均为极低。无试验报告实行临床试验注册、伦理审批、知情同意。结论:现有复方甘草酸苷治疗荨麻疹的随机对照试验报告质量普遍较低,存在不同程度的方法学问题,影响了复方甘草酸苷治疗荨麻疹疗效的公信度,在随机序列产生、分配隐藏、盲法应用、样本量计算、报告随访和失防、不良反应报告等方面还需进一步提高,可参照改良的Jadad评分量表、CON-SORT条目、风险偏倚工具和GRADE评分进行质量评价及研究设计。

OBJECTIVE To investigate the quality of randomized controlled trials（RCTs） involving compound glycyrrhizin for urticaria,and try to improve therapeutic RCTs＇ quality by recognizing the current situation of Chinese RCTs.METHODS RCTs published from January 2000 to December 2011 about compound glycyrrhizin for urticaria were retrieved from PubMed,Medline,Cochrane Library,The National Research Rigester,CBM,VIP,CNKI databases.The methodological quality was evaluated according to the methods recommended by the revised Jadad scale,CONSORT checklist,recommendation by the Cochrane Collaboration,and GRADE system.RESULTS A total of 124 RCTs were included,the assessment of revised Jadad scale showed： there was no RCTs scored 5～7,3（2.4%） scored 4,1（0.8%） scored 3,105（84.7%） scored 2,11（8.9%） scored 1,and the other 4（3.2%） scored zero.According to the standard of CONSORT,only 7（5.6%） described the random method,no literatures explained how to execute randomization and use placebo control;1（0.8%） RCT performed single blind,1（0.8%） RCT performed double blind;2（1.6%） RCTs calculated statistic values;5（4.0%） RCTs reported follow-up;no RCTs reported equivalent results or negative results;79（63.7%） RCTs reported adverse events;no RCTs conducted sample size estimation,intention-to-treat analyses and stratified analyses.As to the risk of bias table：3（2.4%） RCTs described the random method correctly;4（3.2%） RCTs showed wrong random method;and the other 114（91.9%） RCTs were unclear of the random method,only 1（0.8%） RCT performed double blind,all RCTs were unclear of allocation concealment;all had incomplete outcome data and free of selective reporting and other bias.According to GRADE system： all RCTs were assessed as very low.Also,there was no RCT showed clinical trial registration,ethics approval and the informed consent.CONCLUSION The quality of RCTs about compound glycyrrhizin for urticaria is low in methodological aspects,which influenced on the authority of effect.Thus there is a huge room for improvement on adequate sequence generation,allocation concealment,blinding,sample size estimation,follow-up and adverse events,etc.And revised Jadad scale,CONSORT checklist,recommendation by the Cochrane Collaboration,and GRADE system can be used for quality assessment and study design.