针灸随机对照试验中的报告不完整与倾向性报告：一项横断面元流行病学研究。

Incomplete reporting and spin in acupuncture randomised controlled trials: a cross-sectional meta-epidemiological study.

作者信息

Duan Yuting, Zhao Pinge, Deng Yuening, Xu Zhirui, Wu Siqi, Shi Lin, Jiang Feng, Liu Shujuan, Li Xinyu, Tang Binbin, Zhou Jinjin, Yu Lin

机构信息

Evidence Based Medicine Center, The Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China

Clinical School of Integrated Traditional Chinese and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China.

出版信息

BMJ Evid Based Med. 2025 Jul 21;30(4):259-267. doi: 10.1136/bmjebm-2024-113364.

DOI:10.1136/bmjebm-2024-113364

PMID:40180445

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12320602/

Abstract

OBJECTIVES

To investigate the reporting, data sharing and spin (using reporting strategies to emphasise the benefit of non-significant results) in acupuncture randomised controlled trials (RCTs).

DESIGN

Cross-sectional meta-epidemiological study.

DATA SOURCES

Eligible studies indexed in MEDLINE, Embase, CENTRAL, CBM, CNKI, Wanfang Data and VIP Database between 1 January 2014 and 1 May 2024.

ELIGIBILITY CRITERIA

Peer-reviewed acupuncture RCTs used traditional medicine (TM), published in English or Chinese, two parallel arms for humans.

MAIN OUTCOME MEASURES

We assessed (1) the reporting of acupuncture RCTs by the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) checklist; (2) the data sharing level by the International Committee of Medical Journal Editors (ICMJE) data sharing statement; (3) spin frequency and level by the prespecified spin strategies.

RESULTS

This study evaluated 476 eligible studies, of which 166 (34.9%) explored the specific efficacy or safety of acupuncture in the nervous system, 68 (14.3%) in the motor system and 61 (12.8%) in the digestive system. 244 (57.7%) studies used conventional acupuncture, 296 (62.2%) used multicentre study design and 369 (77.5%) were supported by institutional funding. 312 (65.5%) eligible studies were poorly reported. The sufficiently reporting scores of the CONSORT 2010 statement and the STRICTA checklist differed from 0.63% to 97.5%, and 32 (59.3%) items were less than 50%. For the data sharing level of acupuncture RCTs, only 66 (17.2%) studies followed the ICMJE data sharing statement, but 49 (14.5%) need to require authors to obtain data, and only 5 (1.5%) provided data by open access. Spins were identified in 408 (85.7%) studies (average spin frequencies: 2.94). 59 (37.2%) studies with non-significant primary outcomes had spin levels.

CONCLUSIONS

This study found that the reporting of acupuncture RCTs was low compliance with the CONSORT 2010 statement, the STRICTA checklist and the ICMJE data sharing statement, and spin appeared frequently. Journal policies on using reporting guidelines, data sharing and equitable consideration of non-significant results might enhance the reporting of acupuncture RCTs.

TRIAL REGISTRATION NUMBER

This study was registered at the Open Science Framework (OSF): (https://doi.org/10.17605/OSF.IO/2WTE6, and https://doi.org/10.17605/OSF.IO/9XDN4,).

摘要

目的

探讨针灸随机对照试验（RCT）中的报告、数据共享及结果粉饰（利用报告策略强调非显著结果的益处）情况。

设计

横断面元流行病学研究。

数据来源

2014年1月1日至2024年5月1日期间在MEDLINE、Embase、CENTRAL、CBM、CNKI、万方数据和维普数据库中索引的符合条件的研究。

纳入标准

经同行评审的针灸RCT，采用传统医学（TM），以英文或中文发表，针对人类的两个平行组。

主要结局指标

我们评估了（1）针灸RCT根据《报告试验的统一标准》（CONSORT）2010声明和《针灸临床试验报告干预措施标准》（STRICTA）清单的报告情况；（2）根据国际医学期刊编辑委员会（ICMJE）数据共享声明的数据共享水平；（3）根据预先设定的结果粉饰策略的结果粉饰频率和程度。

结果

本研究评估了476项符合条件的研究，其中166项（34.9%）探讨了针灸在神经系统中的特定疗效或安全性，68项（14.3%）在运动系统中，61项（12.8%）在消化系统中。244项（57.7%）研究使用传统针灸，296项（62.2%）采用多中心研究设计，369项（77.5%）得到机构资助。312项（65.5%）符合条件的研究报告质量较差。CONSORT 2010声明和STRICTA清单的充分报告得分在0.63%至97.5%之间，32项（59.3%）条目低于50%。对于针灸RCT的数据共享水平，只有66项（17.2%）研究遵循ICMJE数据共享声明，但49项（14.5%）需要要求作者获取数据，只有5项（1.5%）通过开放获取提供数据。408项（85.7%）研究中发现了结果粉饰（平均结果粉饰频率：2.94）。59项（37.2%）主要结局无显著性的研究存在结果粉饰情况。