以针刺治疗单纯性肥胖临床随机对照试验为例对针刺对照设计问题分析

Analysing the defect of control design of acupuncture: taking RCTs of treating simple obesity with acupuncture for example

目的:通过对针刺治疗单纯性肥胖临床随机对照试验中针刺对照设计的问题分析,提出临床对照试验设计应考虑的因素,以促进提高临床研究质量。方法:以针刺对照治疗单纯性肥胖的临床随机对照试验为例,检索国内外数据库针刺对照治疗肥胖的临床随机对照试验,按照针刺疗法的自身特点从取穴、针的刺入与否、针刺深度等方面整理和分析试验干预措施的对照方法,统计对照组间差异因素数量,分析其合理性。结果:符合纳入标准的15篇(英文7篇、中文8篇)临床随机对照试验中,组间差异因素的个数大于1者有6篇(占40%),其中4篇在国外以英文发表,2篇以中文在国内期刊发表;组间差异因素个数只有1个者有9篇(占60%),其中英文3篇、中文6篇。结论:部分针刺临床随机对照试验的针刺对照设计不够合理,未考虑到控制组间差异因素的数量。

Obejective By analysing the defect of control design in randomized controlled trials（RCTs） of simple obesity treated with acupuncture and using acupuncture as the contrast, presenting the essential factors which should be taken into account as designing the control of clinical trial to further improve the clinical research. Methods Setting RCTs of acupuncture treating simple obesity as a example, we searched RCTs of acupuncture treating simple obesity with acupuncture control.According to the characteristics of acupuncture therapy, this research sorted and analysed the control approach of intervention from aspects of acupoint selection, the penetration of needle, the depth of insertion, etc, then calculated the amount of difference factor between the two groups and analyzed the rationality. Results In 15 RCTs meeting the inclusion criterias, 7 published in English, 8 in Chinese, the amount of difference factors between two groups greater than 1 was 6（40%）, 4 published in English abroad, 2 in Chinese, while only 1 was 9（60%）, 3 published in English, 6 in Chinese. Conclusion Control design of acupuncture in some clinical RCTs is unreasonable for not considering the amount of difference factors between the two groups.