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[Interpretation of reporting standards for acupuncture clinical trials based on the CONSORT 2025 statement]
Fang Han1, Jiaxin Zuo2, Tiantian Zhou2
1Beijing Hospital of TCM, Capital Medical University, Beijing 100010, China.
Abstract:
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.