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对国外针刺临床试验存在的问题的思考——以JAMA为例 被引量:10

Reflection and suggestion on the existing problems in acupuncture clinical trials published in foreign journals and suggestions: Taking JAMA as an example
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摘要 本文以美国医学会会刊(JAMA)为例,分析其刊载的针刺随机对照临床试验结果报告,发现其中存在的问题主要有:1)真针不真;2)假针不假;3)针灸师资质偏低;4)研究结论的泛化;5)研究目标不明确;6)结局测量指标与治疗方案不匹配。结合针刺疗法特点,针对上述问题提出以下建议:1)明确研究目标;2)选择合理的对照组;3)设置参加试验的针灸师准入标准;4)优化针刺治疗方案;5)明确干预措施方案能解决研究疾病的临床结局,保证结局测量指标的合理设置;6)限定研究结论。逐步探索建立符合针灸临床特点的临床研究方法,使针灸临床研究更符合临床特点,以促进针灸学科的健康发展。 By taking the randomized controlled trials(RCTs)of acupuncture published in the Journal of the American Medical Association(JAMA)as an example,in this study the reports of acupuncture RCTs are analyzed and the problems are found out as follows:1)true acupuncture is less than optimal;2)sham acupuncture is not inert;3)participating acupuncturists are less experienced;4)conclusions are generalized;5)trial object is ambiguous;and 6)main outcomes don't match therapeutic regimen.In combination with the characteristics of acupuncture therapy and in response to the aforementioned problems the authors put forward the following suggestions:1)clearly putting forward research objectives in the design stage;2)choosing appropriate control intervention;3)setting up criteria for acupuncturist participation;4)optimizing acupuncture therapeutic regimen;5)determining clinical outcomes that can be solved by intervention so as to ensure rationalization of outcomes;and 6)defining trial conclusion.The clinical research methods of acupuncture should be stepwise explored and developed so as to enable them to more tightly accord with the characteristics of acupuncture and promote a sound development of acupuncture discipline.
作者 岗卫娟 景向红 GANG Weijuan;JING Xianghong(Institute of Acupuncture and Moxibuation,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处 《科技导报》 CAS CSCD 北大核心 2019年第15期67-76,共10页 Science & Technology Review
基金 中央级公益性科研院所基本科研业务费专项项目(ZZ201711010)
关键词 针刺 临床试验 真针不针 假针不假 美国医学会会刊 acupuncture clinical trial true acupuncture is less than optimal sham acupuncture is not inert JAMA
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