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一项关于假针刺验证研究的系统评价。

A systematic review of sham acupuncture validation studies.

机构信息

Department of Clinical Research on Rehabilitation, Korea National Rehabilitation Research Institute, 58 Samgaksan-Ro, Gangbuk-Gu, Seoul, 142-070, Republic of Korea.

出版信息

BMC Complement Med Ther. 2024 Jun 5;24(1):215. doi: 10.1186/s12906-024-04506-1.

DOI:10.1186/s12906-024-04506-1
PMID:38840076
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11155071/
Abstract

BACKGROUND

Acupuncture is widely used worldwide; however, studies on its effectiveness have been impeded by limitations regarding the design of appropriate control groups. In clinical research, noninvasive sham acupuncture techniques can only be applied through validation studies. Therefore, this systematic review aimed to evaluate the scope of existing literature on this topic to identify trends.

METHODS

We queried Pubmed, EMBASE, and the Cochrane Central Register of Controlled Trials databases from inception to July 2022 for relevant articles. Author names were used to identify additional relevant articles. Two independent reviewers assessed the identified articles based on the inclusion and exclusion criteria. The following data were extracted: study design, information regarding acupuncturists and participants, general and treatment-related characteristics of the intervention and control groups, participants' experience of acupuncture, and research findings.

RESULTS

The database query yielded 673 articles, of which 29 articles were included in the final review. Among these, 18 involved the use of one of three devices: Streitberger (n = 5), Park (n = 7), and Takakura (n = 6) devices. The remaining 11 studies used other devices, including self-developed needles. All the included studies were randomized controlled trials. The methodological details of the included studies were heterogeneous with respect to outcomes assessed, blinding, and results.

CONCLUSIONS

Sham acupuncture validation studies have been conducted using healthy volunteers, with a focus on blind review and technological developments in sham acupuncture devices. However, theren may be language bias in our findings since we could not query Chinese and Japanese databases due to language barriers. There is a need for more efforts toward establishing control groups suitable for various acupuncture therapy interventions. Moreover, there is a need for more rigorous sham acupuncture validation studies, which could lead to higher-quality clinical studies.

摘要

背景

针灸在全球范围内广泛应用;然而,由于设计合适的对照组存在局限性,其有效性研究受到阻碍。在临床研究中,非侵入性的假针灸技术只能通过验证研究来应用。因此,本系统评价旨在评估关于这一主题的现有文献范围,以确定趋势。

方法

我们从建库到 2022 年 7 月,在 Pubmed、EMBASE 和 Cochrane 中央对照试验注册库中查询了相关文章。通过作者姓名来确定其他相关文章。两名独立的审查员根据纳入和排除标准评估确定的文章。提取的数据包括:研究设计、针灸师和参与者的信息、干预组和对照组的一般和治疗相关特征、参与者的针灸体验和研究结果。

结果

数据库查询产生了 673 篇文章,其中 29 篇文章被纳入最终综述。其中,18 项研究使用了三种设备之一:Streitberger(n=5)、Park(n=7)和 Takakura(n=6)设备。其余 11 项研究使用了其他设备,包括自制针。所有纳入的研究都是随机对照试验。纳入研究的方法细节在评估结果、盲法和结果方面存在异质性。

结论

已经使用健康志愿者进行了假针灸验证研究,重点是盲法审查和假针灸设备的技术发展。然而,由于语言障碍,我们无法查询中文和日文数据库,因此我们的发现可能存在语言偏倚。需要更多的努力来建立适合各种针灸治疗干预的对照组。此外,需要进行更严格的假针灸验证研究,这可能会导致更高质量的临床研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3a7/11155071/59bdaa138025/12906_2024_4506_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3a7/11155071/b4849d5302c7/12906_2024_4506_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3a7/11155071/59bdaa138025/12906_2024_4506_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3a7/11155071/b4849d5302c7/12906_2024_4506_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3a7/11155071/59bdaa138025/12906_2024_4506_Fig2_HTML.jpg

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本文引用的文献

1
Acupuncture for the Treatment of Pain - A Mega-Placebo?针刺疗法治疗疼痛——一种超级安慰剂?
Front Neurosci. 2019 Oct 17;13:1110. doi: 10.3389/fnins.2019.01110. eCollection 2019.
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Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis.针刺治疗慢性疼痛:一项个体患者数据荟萃分析的更新。
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Evaluating validity of various acupuncture device types: a random sequence clinical trial.评估各种针灸器械类型的有效性:一项随机序列临床试验。
BMC Complement Altern Med. 2016 Feb 2;16:43. doi: 10.1186/s12906-016-1026-z.
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Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review.安慰剂装置作为针灸临床试验中的有效对照方法:一项系统评价。
PLoS One. 2015 Nov 4;10(11):e0140825. doi: 10.1371/journal.pone.0140825. eCollection 2015.
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A New Method for Sham-Controlled Acupuncture in Experimental Visceral Pain - a Randomized, Single-Blinded Study.实验性内脏痛中假针刺对照的新方法——一项随机单盲研究
Pain Pract. 2016 Jul;16(6):669-79. doi: 10.1111/papr.12309. Epub 2015 May 26.
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Placebo acupuncture in an acupuncture clinical trial. How good is the blinding effect?针灸临床试验中的安慰剂针灸。盲法效果如何?
J Acupunct Meridian Stud. 2015 Feb;8(1):40-3. doi: 10.1016/j.jams.2014.10.010. Epub 2014 Oct 20.
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The effects of Park sham needles: a pilot study.假针刺的效果:一项初步研究。
J Integr Med. 2015 Jan;13(1):20-4. doi: 10.1016/S2095-4964(15)60153-4.
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Effect of blinding with a new pragmatic placebo needle: a randomized controlled crossover study.新型实用安慰剂针的盲法效应:一项随机对照交叉研究。
Medicine (Baltimore). 2014 Dec;93(27):e200. doi: 10.1097/MD.0000000000000200.
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Double-blind acupuncture needle: a potential tool to investigate the nature of pain and pleasure.双盲针灸针:一种探究疼痛与愉悦本质的潜在工具。
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Deqi sensation in placebo acupuncture: a crossover study on chinese medicine students.针刺安慰剂效应中的得气感:一项针对中医药学生的交叉研究。
Evid Based Complement Alternat Med. 2013;2013:620671. doi: 10.1155/2013/620671. Epub 2013 Jul 29.