Yang Jiahui, Liu Jiali, Luo Xiaochao, Yao Minghong, Fu Yong, Li Ling, Sun Xin
Jiangxi University of Chinese Medicine, Nanchang City, Jiangxi Province, China.
Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
BMJ Open. 2025 Jan 22;15(1):e090238. doi: 10.1136/bmjopen-2024-090238.
Although various sham acupuncture techniques have been employed to ensure blinding in randomised controlled trials (RCTs) of acupuncture, the effectiveness of blinding in these trials and its influence on trial effect size estimates remain unclear. The objectives of this study are the following: (1) to investigate the proportion and study characteristics of sham-controlled trials reporting on blinding assessment, (2) to assess the blinding effectiveness of different types of sham acupuncture, (3) to investigate the relationship between blinding effectiveness and effect sizes in acupuncture RCTs.
We will search PubMed and EMBASE from inception to 1 January 2025 to identify RCTs that compared acupuncture with sham acupuncture in humans with any disease or symptom, with no restrictions on language. Paired investigators will independently determine eligibility and use pilot-tested standardised forms for data extraction. We will calculate the proportion of sham-controlled trials that assessed and reported blinding success and conduct descriptive analyses of general study characteristics, acupuncture treatment details, sham acupuncture details and blinding assessments for included trials. We will assess the effectiveness of blinding success using the James blinding index (BI) and Bang BI, and pool data from included trials using random-effects models. We will use Hedges' g, a standardised mean difference, with its 95% CI, to calculate treatment effects. We will use Pearson's r correlation coefficient to assess the relationship between blinding effectiveness and trial effect sizes when variable distributions meet the assumptions of normality and linearity; otherwise, we will consider employing non-parametric tests. When sufficient data are available, we will also use random-effects meta-regression to explore the relationship.
Ethical approval is not required. The findings of this study will be disseminated through peer-reviewed publications, conference presentations and condensed summaries for clinicians, health policymakers and guideline developers regarding the design, conduct, analysis and interpretation of blinded assessment of sham acupuncture RCTs.
Open Science Framework (https://doi.org/10.17605/OSF.IO/B3U7K).
尽管在针刺随机对照试验（RCT）中已采用多种假针刺技术来确保盲法，但这些试验中盲法的有效性及其对试验效应大小估计的影响仍不明确。本研究的目的如下：（1）调查报告盲法评估的假对照试验的比例和研究特征；（2）评估不同类型假针刺的盲法有效性；（3）调查针刺RCT中盲法有效性与效应大小之间的关系。
我们将检索PubMed和EMBASE数据库，时间范围从数据库建立至2025年1月1日，以识别比较针刺与假针刺治疗患有任何疾病或症状的人类的RCT，无语言限制。两名研究人员将独立确定纳入标准，并使用经过预试验的标准化表格进行数据提取。我们将计算评估并报告盲法成功的假对照试验的比例，并对纳入试验的一般研究特征、针刺治疗细节、假针刺细节和盲法评估进行描述性分析。我们将使用詹姆斯盲法指数（BI）和邦氏BI评估盲法成功的有效性，并使用随机效应模型汇总纳入试验的数据。我们将使用标准化均数差值Hedges' g及其95%置信区间来计算治疗效果。当变量分布满足正态性和线性假设时，我们将使用Pearson相关系数r评估盲法有效性与试验效应大小之间的关系；否则，我们将考虑采用非参数检验。当有足够数据时，我们还将使用随机效应Meta回归来探索这种关系。
本研究无需伦理批准。本研究的结果将通过同行评审出版物、会议报告以及为临床医生、卫生政策制定者和指南制定者提供的关于假针刺RCT盲法评估的设计、实施、分析和解释的简明摘要进行传播。
