近3年针刺治疗抑郁症临床试验结局指标报告情况调查
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国家自然科学基金青年科学基金项目(81804000)


Outcome Indexes of Clinical Trials on Acupuncture Treatment of Depression in Recent Three Years
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    摘要:

    目的:目前针对抑郁症的随机对照试验(RCT)中普遍使用汉密尔顿量表(HAMD)评价抑郁程度。本研究旨在调查该评分细节报告的完整性,尤其是研究者对研究结果解释中临床意义的重视程度。方法:检索2020年10月至2022年10月发表于国家知识基础设施数据库(CNKI)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、临床试验注册系统(ChiCTR)、PUBMED、Cochrane、EMBASE、Web of Science、PROQUEST共9个数据库的以“针刺治疗抑郁症”为主题并报告HAMD结果的RCT。2名研究者独立提取了各研究对HAMD评分的报告细节以及对结果临床意义的报告和解释。结果:共检索到符合标准的RCT91项,超过95%的文献报道了均值、标准差及P值,但仅有3.3%的文献报道95%置信区间。93.4%的文献直接或间接地报道了HAMD值所代表的意义,73.6%报道了HAMD量表类型,19.8%文献报道HAMD的总分,34.1%的文献报道了HAMD具体的评价方法。统计学意义的报道在75%以上,纳入文献均报道了临床意义,但临床意义的解读仅基于统计学意义,并未结合临床实际有效值来判定。组间比较结果显示,学位论文各项报道的百分比均高于普通文献。国外研究报道的完整性普遍高于国内文献。结论:针刺治疗抑郁症随机对照试验的中文文献HAMD评分报道尚且不够完整。建议研究者在试验报告中参考高质量RCT结果,更详细地描述评分类指标的细节、合理解读其临床意义,以提高结局指标报道的质量。

    Abstract:

    Among the massive randomized controlled trials(RCTs) regarding acupuncture treatment of depression,Hamilton Depression Rating Scale(HAM-D) is most frequently used to evaluate the severity of depression.This study aimed to determine the integrity of the reported HAM-D results,especially the researchers' attention to the interpretation of the clinical significance of the results.Methods:RCTs on acupuncture treatment of depression and with reported HAM-D results published on 9 databases [China National Knowledge Infrastructure(CNKI),China Science Periodical Database(CSPD),Chinese Citation Database(CCD),Chinese Clinical Trial Register(ChiCTR),PubMed,Cochrane,Embase,Web of Science,and ProQuest] from October 2020 to October 2022 were selected.Two researchers independently extracted the details of HAM-D scores in each RCT and the clinical significance of the results.Results:A total of 91 RCTs meeting the criteria were included in this review.Among them,more than 95% reported the mean,standard deviation and P value,while only 3.3% reported the 95% confidence interval; 93.4% directly or indirectly studied the meaning of HAMD values; 73.6% discussed the classification of HAM-D; 19.8% reported the total HAM-D score; 34.1% elucidated the specific evaluation method of HAM-D.Statistical significance was found in more than 75% of the RCTs.In addition,all included RCTs interpreted the clinical significance,but the interpretation was only made based on statistical significance,and failed to combine the actual clinical effective values.Inter-group comparison showed that the percentage of each item reported in the dissertations was higher than that in the general literature.And foreign reports had higher integrity than those in China.Conclusion:The HAM-D results in Chinese RCTs on acupuncture treatment of depression need to be improved in integrity.It is suggested that future studies should consult high-quality RCT results,describe the scoring indexes in detail,and reasonably interpret the clinical significance of the results,to improve the quality of outcome indexes.

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程诺,王瑞婷,崔灵珺,曹卉娟.近3年针刺治疗抑郁症临床试验结局指标报告情况调查[J].世界中医药,2022,(23).

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  • 收稿日期:2020-06-15
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  • 在线发布日期: 2022-12-16
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