The SHARE: SHam Acupuncture REporting guidelines and a checklist in clinical trials

Abstract

Sham acupuncture is commonly utilized as the control to evaluate the specific effects of acupuncture. Due to the complexity of acupuncture, establishing sham acupuncture control to maintain physiological inertness while indistinguishable from real acupuncture for successful blinding is challenging. Various sham acupuncture designs were developed.^{1, 2} Unsurprisingly, many sham acupuncture designs were not inert, and their effects varied. Specific details of each sham acupuncture design, including stimulation location (stimulated points),^{3, 4} needle stimulation methods,^{5, 6} and insertion technique^{1, 2} largely influenced the effects of the sham acupuncture control. Besides, indispensable contextual factors, such as practitioner experience, practitioner-patient interaction, and patients’ expectations of acupuncture were also important determinants, resulting in nonspecific (potentially specific) yet statistically and clinically significant influenced on outcomes.⁷ Transparent reporting about sham acupuncture could help researchers comprehensively interpret the details and the contexts of its implementation.

However, the reporting quality of sham acupuncture in acupuncture trials was low,⁸ hindering an accurate understanding of sham acupuncture effects and leading to misunderstandings about the specific effects of acupuncture. It also jeopardized the interpretations of the heterogeneities across trials caused by the variation of effects from the different sham acupuncture, hindering the synthesis of high-quality evidence for acupuncture. While tremendous progress had been made in standardizing the reporting of acupuncture trials, the development of specific guidelines for reporting sham acupuncture remained a prominent issue. Item 6 of STandards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) was specifically a target item for the control of acupuncture.⁹ However, the items about sham acupuncture were insufficient.¹⁰ The “Template for Intervention Description and Replication-Placebo” (TIDieR-Placebo) was developed to enhance the reporting quality of sham or placebo interventions,¹¹ but it was a generic guideline for sham or placebo control. Given the complexity and uniqueness of sham acupuncture, specific guidelines tailored to its reporting are required.

The SHARE includes the specific reporting guidelines and a checklist for sham acupuncture in clinical trials. The SHARE is recommended for the extension of the STRICTA checklist and could apply to any clinical trials relevant to sham acupuncture, not limited to acupuncture trials. The final SHARE checklist has 10 categories with 19 subitems, including sections: brief name, rationale, details of sham acupuncture, treatment regimen of sham acupuncture, and other concomitant nontreatment factors.

The SHARE retained some same items from the STRICTA and added new contents to the “Details of sham acupuncture” section, covering the patient's positioning during treatment, needle insertion methods, angle, and direction of sham acupuncture. Differences in these factors might elicit different physiological responses and diverse nonspecific and even specific effects of sham acupuncture. Reporting these details might facilitate understanding, replication, and consequently better interpretation of the effects of sham acupuncture. Additionally, six new items about the contextual factors in sham acupuncture were developed: the information conveyed to patients, practitioner information, modification, practitioner-patient communication, practitioner adherence, and blinding. It was suggested that the different communications between practitioners and patients might generate different placebo effects and cause different clinical outcomes.⁷ Moreover, the reporting items about practitioner adherence and modification of sham acupuncture regimen were also included to assess the consistency of sham acupuncture procedures. Modification or low practitioner adherence might indicate deviations from the predefined protocol in the implementation or environment of sham acupuncture; insufficient reporting might hinder the accurate interpretation of sham acupuncture effects.

The SHARE checklist differed from the recently published ACURATE checklist¹³ in several ways. First, the structure was different. In the SHARE, categories about the characteristics of sham acupuncture were mainly derived from the STRICTA, adopting similar descriptions. Other nontreatment factors were referenced from the TIDieR-Placebo and presented as separate categories. While the ACURATE categorized items based on the procedures of applying sham acupuncture needles.¹³ Second, each checklist had its own distinct content, respectively. The SHARE concentrated on detailed aspects of sham acupuncture manipulation, such as patient posture, needle insertion methods, depth, angle, direction of needle insertion, and practitioners’ information, while the ACURATE specialized the combination therapies and different treatment settings between real and sham acupuncture. Third, the SHARE featured more concrete content, particularly in reporting needle stimulation details, precise descriptions of needles or assisted tools employed, relevant information about sham acupuncture implementation, and details of blinding assessment. For example, the SHARE provided comprehensive details about needle stimulation (Item 3.7) including frequency, duration, number of times, and other information, while the ACURATE reported as “2d: Report if there was any stimulation using sham acupuncture.” Importantly, certain sham acupuncture included stimulation, making it crucial to report specific stimulation details when applied. Lastly, the developing process of the SHARE involved an initial literature review, two-round Delphi surveys, two-round consensus meetings, and pilot testing, while the ACURATE comprised an initial literature review and three-round Delphi surveys.

The SHARE would likely enhance the quality of acupuncture research and provide high-quality evidence for acupuncture clinical practices. 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 studies. We recommend referencing both the STRICTA and the SHARE checklist when conducting the trial involving sham acupuncture control. Similarly, when reporting real acupuncture, if there were items not included in the STRICTA but newly developed in the SHARE, we recommend following the SHARE checklist. Meanwhile, we advocate that STRICTA should be continuously reviewed and timely updated.

The SHARE project involved participants in Delphi surveys and consensus meetings from diverse geographical regions and multidisciplinary fields. Considering the widespread application of acupuncture, and diversity in acupuncture practices across countries due to the different native cultures and acceptance of acupuncture,^{14, 15} involving participants from diverse geographical regions would capture a broader range of perspectives and enhance the checklist's future applicability.

However, there were some limitations to this study. The consensus meetings were conducted via online video conference due to COVID-19, which affected adequate discussions. To address this, the SHARE workgroup sent the results of the Delphi surveys, the drafting checklist, and other meeting materials at least a week ahead of the meetings. During the meetings, enough time was allocated for experts to provide comments and feedback. A further limitation was the relatively small sample size in the pilot test. In the future, broader dissemination and application with a larger sample would be essential for revising and updating the SHARE.

In conclusion, the SHARE is specially developed for reporting sham acupuncture in clinical trials, emphasizing more concrete details of sham acupuncture manipulation and addressing the concomitant nontreatment factors during acupuncture implementation. Its application will facilitate the transparency and replication of sham acupuncture procedures and improve the accuracy and credibility of results in clinical trials using sham acupuncture controls.

All authors revised the manuscript critically and gave the final approval of the manuscript submitted. Shiyan Yan had full access to all the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Shiyan Yan, Baoyan Liu, and Cunzhi Liu. Arrange and hold the Delphi survey and consensus meeting: Xiaoyu Liu, Peihong Ma, Zhiyi Xiong, and Yixuan Xie. Acquisition, analysis, or interpretation of data: Xiaoyu Liu, Chengyi Sun, and Tinglan Liu. Drafting of the manuscript: Peihong Ma and Xiaoyu Liu. Critical revision of the manuscript for important intellectual content: Shiyan Yan, Xiaoyu Liu, Baoyan Liu, Zhishun Liu, Yi Guo, Zhaoxiang Bian, Kehua Zhou, Ying Lu, Lixing Lao, and Liyun He.

Zhaoxiang Bian is the director of the Chinese EQUATOR Centre. Baoyan Liu is the chairman of World Federation of Acupuncture-moxibustion Societies. All other authors have no competing interests to disclose.

This work was funded by National Natural Science Foundation of China (No. 82174234). National Science Fund for Distinguished Young Scholars (No. 81825024).