|Chinese to English: Quality analysis of the design methodology of clinical randomized controlled trials of acupuncture to treat simple obesity|
General field: Medical
Detailed field: Medical (general)
|Source text - Chinese|
摘要：目的：分析研究近23年发表在国内主要期刊杂志的针灸治疗单纯性肥胖的临床随机对照试验（Randomized controlled trail/RCT）的质量，了解该方向当前临床科研方法学的现状，并为临床进一步研究提供参考。方法：通过检索中国期刊全文数据库，中国科技文献数据库，并按照临床流行病学对随机对照试验设计质量的评价标准，对检出的临床随机对照试验的设计质量进行分析评价，了解其科研设计方法学质量。结果：在纳入的152篇文章中，有4篇文献出现了“随机抽样”和“随机分组”概念上的混淆；无一篇提出具体的隐蔽分组的方案；仅有3篇提及盲法，但未具体说明施盲的对象；135篇文章提出了具体的诊断纳入标准；无一篇文章提及样本量估算的方法，99篇文献提出了具体的统计学方法。这些设计缺陷降低了文章的最终结论的质量。结论：当前针灸治疗单纯性肥胖病临床随机对照试验方法学设计质量较低，在今后的临床科研设计中，要进一步改进方法学设计。
|Translation - English|
Goals: To analyze the quality of clinical randomized controlled trials (RCTs) of acupuncture to treat simple obesity as reported in mainstream Chinese journals over the last 23 years; to understand the present state of clinical research methodologies in this area; and to provide reference materials for further clinical research.
Methods: Published articles were collected from the Chinese journal full-text database and the Chinese scientific journal database. Analysis and evaluation of RCT design quality was based on clinical epidemiological standards, in order to determine the value of the research design methodology used.
Results: Of the 152 articles examined in this report, 4 articles confused the concepts of “random sampling” and “randomized grouping”; none of the articles described specific methods for allocation concealment; only 3 of the articles mentioned blinding, and of these none stated who was blinded; 135 articles described specific diagnostic criterion for admission to the study; none of the articles described the method used to estimate sample size; and 99 articles described specific statistical methods. These design flaws reduced the value of the final conclusions reached in the articles.
Conclusion: Currently, design methodology for RCTs of acupuncture to treat simple obesity is of relatively poor quality. In future clinical research, design methodology should be improved.