Based on the consolidated standards of reporting trials (CONSORT) 2025 statement, the article introduces the interpretation and reporting examples of 9 key items that require special attention when conducting acupuncture randomized controlled trials (RCTs). The selected items cover patient and public involvement (item 8), eligibility criteria (item 12), intervention and control (items 13 and 24), outcomes (item 14), adverse events (items 15 and 27), sample size (item 16), and blinding (item 20). The article first elucidates the core reporting requirements of these items, and analyzes in detail the specific considerations and reporting points associated with the application of acupuncture RCTs in terms of the complexity of acupuncture interventions, the unique design of control groups, and the high operator-dependence of treatment delivery. Additionally, it demonstrates standardized reporting methods for each item by taking acupuncture RCTs published domestically and internationally in recent years as examples. The article aims to provide acupuncture researchers with specific and actionable reporting guidelines, thereby enhancing the credibility and clinical translational value of acupuncture research findings.
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Open Access
Issue
Sample size estimation is a crucial step in clinical trial design, directly impacting the reliability and reproducibility of research findings. Researchers currently face several methodological challenges when estimating sample sizes for acupuncture clinical trials, such as: whether sample size estimation is necessary for pilot trial; what parameters are required for sample size estimation; whether sample size estimation methods differ among various types of hypothesis tests; how to perform sample size estimation with multiple primary outcomes or multiple groups; and how to standardize the reporting of sample size estimation. Based on these, this article addressed common problems of sample size estimation in acupuncture pilot trial and confirmatory trial, put forward solving strategies accordingly, in order to provide reference for clinical researchers in acupuncture clinical trial sample size estimation.
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