Thinking and practice of designing a single-blind, double-dummy clinical trial for acupuncture: Taking “comparative study of manual acupuncture and electroacupuncture for menopausal hot flush” as an example

IF 0.6 4区 医学 Q4 INTEGRATIVE & COMPLEMENTARY MEDICINE World Journal of Acupuncture-Moxibustion Pub Date : 2023-10-01 DOI:10.1016/j.wjam.2023.09.001
Wen-ying SHI (石文英), Wei ZHANG (章薇)
{"title":"Thinking and practice of designing a single-blind, double-dummy clinical trial for acupuncture: Taking “comparative study of manual acupuncture and electroacupuncture for menopausal hot flush” as an example","authors":"Wen-ying SHI (石文英),&nbsp;Wei ZHANG (章薇)","doi":"10.1016/j.wjam.2023.09.001","DOIUrl":null,"url":null,"abstract":"<div><p><span>Randomized controlled trial<span> (RCT) is the golden standard for evaluation of clinical evidence. To assess the effect of acupuncture, due to the specificity of acupuncture intervention, the blinding and control methods are the difficulties in study design. It is not practical to blind investigators, participants and evaluators simultaneously. At present, blinding is generally conducted for the participants and evaluators in </span></span>clinical trial<span><span>. We took a comparative study of manual acupuncture and electroacupuncture<span> for menopausal hot flush as an example to explore a new way with the reference of double-dummy design in new </span></span>drug study. A single-blind and double-dummy clinical trial model of acupuncture was established. Based on individual acupuncture intervention in each group, the placebo intervention was combined to ensure the form consistency of two groups. Such a study design may eliminate non-specific effect of acupuncture, and can be conductive to comparing the specific effect of acupuncture and can provide the references and regimens for study design.</span></p></div>","PeriodicalId":44648,"journal":{"name":"World Journal of Acupuncture-Moxibustion","volume":"33 4","pages":"Pages 367-371"},"PeriodicalIF":0.6000,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"World Journal of Acupuncture-Moxibustion","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1003525723000569","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
引用次数: 0

Abstract

Randomized controlled trial (RCT) is the golden standard for evaluation of clinical evidence. To assess the effect of acupuncture, due to the specificity of acupuncture intervention, the blinding and control methods are the difficulties in study design. It is not practical to blind investigators, participants and evaluators simultaneously. At present, blinding is generally conducted for the participants and evaluators in clinical trial. We took a comparative study of manual acupuncture and electroacupuncture for menopausal hot flush as an example to explore a new way with the reference of double-dummy design in new drug study. A single-blind and double-dummy clinical trial model of acupuncture was established. Based on individual acupuncture intervention in each group, the placebo intervention was combined to ensure the form consistency of two groups. Such a study design may eliminate non-specific effect of acupuncture, and can be conductive to comparing the specific effect of acupuncture and can provide the references and regimens for study design.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
针刺单盲双盲临床试验设计的思考与实践——以“手针与电针治疗绝经期潮热的比较研究”为例
随机对照试验(RCT)是评价临床证据的黄金标准。为了评估针灸的疗效,由于针灸干预的特殊性,盲法和对照法是研究设计的难点。同时使研究者、参与者和评价者盲目是不现实的。目前在临床试验中,一般对参与者和评价者进行盲法。我们以手针与电针治疗绝经期潮热的对比研究为例,探索双假人设计在新药研究中的新途径。建立单盲双假人针刺临床试验模型。在每组单独针灸干预的基础上,结合安慰剂干预,以保证两组形式的一致性。这样的研究设计可以消除针灸的非特异性效应,并有助于比较针灸的特异性效应,为研究设计提供参考和方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
World Journal of Acupuncture-Moxibustion
World Journal of Acupuncture-Moxibustion INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
1.30
自引率
28.60%
发文量
1089
审稿时长
50 days
期刊介绍: The focus of the journal includes, but is not confined to, clinical research, summaries of clinical experiences, experimental research and clinical reports on needling techniques, moxibustion techniques, acupuncture analgesia and acupuncture anesthesia.
期刊最新文献
World Federation of Acupuncture-Moxibustion Societies (WFAS) Technical Benchmark of Acupuncture and Moxibustion: Cupping World Federation of Acupuncture–Moxibustion Societies (WFAS) Technical Benchmark of Acupuncture and Moxibustion: Moxibustion World Federation of Acupuncture-Moxibustion Societies (WFAS) Clinical Practice Guidelines on Acupuncture and Moxibustion: Female Urinary Incontinence recommendation summaries Clinical Practice Guideline on Acupuncture and Moxibustion: Adult Major Depressive Disorder (Mild-Moderate Degree): Determination of clinical questions Full process of recommendation formulation for clinical practice guidelines: Taking World Federation of Acupuncture-Moxibustion Societies Clinical Practice Guideline on Acupuncture and Moxibustion: Allergic Rhinitis as an example
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1