ACURATE: a guide for reporting sham controls in trials using acupuncture

Article type
Lee Y1, Ang L2, Lee B2, Kim S3, Lee H4, Chae Y4, Lee MS2
1Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation
2KM Science Research Division, Korea Institute of Oriental Medicine
3College of Korean Medicine, Gachon University
4College of Korean Medicine, Kyung Hee University
Background: Evidence shows that the quality of reporting of trials using sham controls is not ideal and has yet to improve over time. The lack of proper reporting impedes readers from fully understanding the validity of acupuncture trial findings and their relevant effectiveness.

Objectives: To promote better reporting quality regarding sham acupuncture in clinical trials, for a precise appraisal of the adequacy of sham acupuncture procedure.

Methods: A three-stage online Delphi survey was used to explore expert consensus and identify items that needed to be reported for trials using sham acupuncture. Items with higher than 80% consensus from the initial checklist were selected as the final candidates. Further discussion among the working group was convened to preclude potential redundancy among the items.

Results: A total of 23 experts out of 35 (66%) responded to the Delphi process. A consensus of >80% was achieved on many items. The final checklist consists of 22 items in six categories: types of sham acupuncture, details of sham acupuncture manipulation, location of sham acupuncture, treatment regimen, practitioner, and protocol and settings. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal.

Conclusions: This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, which is an extension of The Consolidated Standards for Reporting of Trials (CONSORT). This checklist can be used along with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when both real and sham acupuncture needles are used in the study. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist in reporting sham acupuncture procedures and the related components.

Patient, public and/or healthcare consumer involvement: None.