Recommendations for the DesIgn of sham acupuncture in RandomizEd Controlled Trials (the DIRECT guidelines)

Abstract

Objective: Sham acupuncture control is essential for evaluating the specific efficacy of acupuncture. However, the complex nature of acupuncture components presents challenges in designing an inert sham acupuncture control while maintaining blinding. Currently, no standardized guidance exists for the design of sham acupuncture controls. This study aimed to propose guidelines for optimizing the design of sham acupuncture in randomized controlled trials.

Methods: The initial draft of the guidelines was developed through a literature review and expert interviews. The items in the guidelines were revised and finalized through consensus meetings.

Results: The resulting Recommendations for the DesIgn of sham acupuncture in RandomizEd Controlled Trials (the DIRECT guidelines) include issues to consider prior to adopting a sham acupuncture control, a five-stage framework for designing sham acupuncture, which addresses feasibility, risks, and recommendations for the implementation of sham acupuncture in clinical trials.

Conclusion: These guidelines offer practical recommendations for establishing appropriate sham acupuncture controls and optimizing their implementation in randomized controlled trials of acupuncture. Please cite this article as: Chen Y, Liu XY, Liu ZS, Guo Y, Zhou KH, Bian ZX, Wu M, Tian RH, Yang F, Zhang LY, Lu Y, Lao LX, He LY, Liu CZ, Liu BY, Yan SY. Recommendations for the DesIgn of sham acupuncture in RandomizEd Controlled Trials (the DIRECT guidelines). J Integr Med. 2026; Epub ahead of print.

Keywords: Acupuncture; Control; Guidelines; Randomized controlled trial; Sham acupuncture.