What information should be reported for sham acupuncture control in clinical trials?
Published 22 June, 2025
Sham acupuncture, widely used as a control to evaluate the specific effects of acupuncture, faces limitations due to its various designs and effect. Inconsistent reporting has hindered accurate interpretation of trial results and understanding of sham acupuncture's role. To that end, an international team supported by the World Federation of Acupuncture-Moxibustion Societies and the China Association of Acupuncture-Moxibustion Society released the SHARE guidelines, providing the first systematic checklist for reporting sham acupuncture control in clinical trials.
Developed over two years with input from more than 100 multidisciplinary experts across four continents, the guidelines underwent two Delphi surveys, two consensus meetings, and pilot testing. The final SHARE checklist includes 19 items across 10 categories: brief name, rationale, details of sham acupuncture, treatment regimen of sham acupuncture, and other concomitant nontreatment factors.
SHARE mainly emphasizes the elements of sham acupuncture itself and the related indispensable contextual factors. In terms of the elements of sham acupuncture itself, SHARE added new elements to the "Details of sham acupuncture" section, covering patient's positioning during treatment, needle insertion methods, angle, and direction of sham acupuncture.
"Differences in these elements might elicit different physiological responses and diverse nonspecific and even specific effects of sham acupuncture," says lead author Shiyan Yan from Beijing University of Chinese Medicine. "For the contextual factors, six items are developed: the information conveyed to patients, practitioner information, modification, practitioner-patient communication, practitioner adherence, and blinding."
The sufficient reporting for this information promotes accurate interpretation of sham acupuncture effects. Beyond the reporting procedure, it could help researchers consider factors influencing the efficacy of sham acupuncture when designing and conducting trials, thereby enhancing the quality of sham acupuncture-controlled clinical trials.
"It's necessary to report not only on the elements of sham acupuncture itself but also on the contextual factors like practitioner-patient communication and patient expectations, which are often underreported,"adds Yan. "Differences in the contextual factors can lead to variations in the effects of sham acupuncture, necessitating their inclusion to ensure accurate interpretation of trial results."
The authors believe SHARE will ensure comprehensive documentation of sham acupuncture procedures, minimizing bias from incomplete information and fostering high-quality evidence synthesis.
Contact author: Shiyan Yan
Department of Acupuncture and Moxibustion, Beijing University of Chinese Medicine
Email: yanshiyan@bucm.edu.cn
Conflict of interest: The authors declare no competing interests.
See the article: Liu X, Ma P, Liu B, Yan S. Interpretation of SHARE: SHam acupuncture REporting guidelines and a checklist in clinical trials: 《针刺临床试验中假针刺对照报告指南与清单 (SHARE) 》解读. World Journal of Acupuncture - Moxibustion 2025;35:27–31. https://doi.org/10.1016/j.wjam.2024.12.001.