Available online 9 September 2023

Author links open overlay panel, , Abstract

Adequate preliminary research is a prerequisite for ensuring the quality of randomized controlled trials (RCTs) on acupuncture. This paper proposes that prior to conducting a new RCT of acupuncture, an evidence-based research (EBR) approach and exploratory studies should be adopted to ensure value and avoid waste of research. EBR, defined as using systematic reviews of relevant clinical studies and obtain the perspectives of end users in a systematic and transparent way to justify research questions and inform trial design, is recommended as the first step before embarking on an acupuncture RCT to ensure its value and rationality. The subsequent exploratory studies can aid researchers in pre-evaluating the effect of acupuncture treatment protocols, identifying key factors that influence the outcome, and test trial feasibility for protocol optimization. This article elucidates the significance and implementation of the EBR approach and exploratory studies, with the aim of providing a methodology to enhance the quality of acupuncture RCTs.

Section snippetsUsing EBR approach for justification and design of a new RCT

None of the research is isolated. New studies should be based on previous research, to either address the existing problems or fill the evidence gaps, so as to be connected with the existing evidence and eventually be a part of the body of evidence. In 2009, Robinson proposed that EBR should be used to ensure value and avoid waste of research, that is, ‘the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid,

Why exploratory studies are important for preparation of a new acupuncture RCT

It is neither scientific nor ethical to embark directly on new RCTs, especially large-scale RCTs without optimization by early phase studies, which will waste the limited resource and put more patients at risk of receiving sub-optimal treatment [17]. Therefore, having justified research questions and study design using the EBR approach, researchers should subsequently perform exploratory studies before starting a new acupuncture RCT. We defined exploratory studies as a series of clinical

Conclusion

As Professor Altman called for, “We need less research, better research, and research done for the right reasons.”[26] Evidence-based research and exploratory clinical studies ensure the rationality and value of a new acupuncture RCT.[27,28] We recommend that acupuncture researchers use the EBR approach and perform exploratory studies in preparation for a trial.

CRediT authorship contribution statement

Xiang-hong JING had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Xiao-yi HU, Wei-juan GANG, Xiang-hong JING.

Drafting of the manuscript: Xiao-yi HU.

Critical revision of the manuscript for important intellectual content: Wei-juan GANG, Xiang-hong JING.

Role of the funder

The study sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

State of human/animal rights

No need to declare in this paper.

Data sharing statement

You can contact the corresponding author for the data.

Declaration of Competing Interest

The authors declare that there is no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgment

Nothing to declare.

Reference (28)TJ. LiWhat comparative effectiveness research is needed? A framework for using guidelines and systematic reviews to identify evidence gaps and research priorities

Ann Intern Med

(2012)

Hu XY, Tian ZY, Chen H, Hu XY, Ming TY, Peng HX et al. The Use of Evidence-Based Research Approach to Justify...E Bartels et al.Aquatic exercise for the treatment of knee and hip osteoarthritis

Cochrane Database Syst Rev

(2016)

H Wei et al.Series papers 3: Clinical acupuncture from experience to evidence–Discussion on the methods of acupuncture effect

Guid J Trad Chin Med

(2021)

View full text

© 2023 Published by Elsevier B.V. on behalf of World Journal of Acupuncture Moxibustion House.