Refine the Approachability and Rigor of Acupuncture Research

Acupuncture, including manual and electro-acupuncture, is rooted in traditional Chinese medicine (TCM) and has been widely applied in clinical studies.1 Over the past two decades, there has been a remarkable surge in the number of acupuncture studies,2 leading to interest among decision makers regarding its clinical application. Recognizing the growing importance of acupuncture in healthcare, we believe that it is necessary to identify and address existing challenges in designing acupuncture research. This manuscript delves into the origins of these challenges and gives recommendations aimed at improving the quality and accessibility of future acupuncture studies. CLINICAL RELEVANCE: THE FOUNDATION OF APPROACHABILITY AND QUALITY Understanding the needs of patients and clinicians is pivotal to enhance the approachability of acupuncture studies. Randomized controlled trials (RCTs) of acupuncture, while often mechanical in the methodology, may fall short in meeting the complexity of real-world clinical scenarios. There is a need for acupuncture RCTs to shift towards a more patient-centric and clinically relevant framework. During setting up research questions, authors should extend beyond the experimental settings, incorporating a keen perspective of the broader healthcare system. For example, authors should consider comparisons not only between acupuncture and single conventional medication but also with first-line options available to patients. Understanding the landscape of existing treatment approaches and how acupuncture can integrate into these options is essential for designing studies that resonate with the real world needs of patients and clinicians. The emphasis on clinical relevance is intricately tied to the selection of comparison groups. Therefore, the establishment of a multidisciplinary team is strongly recommended. This will ensure a diverse range of comparison groups, facilitating the exploration of clinically available treatment approaches with optimal efficacy. Fundamentally, the optimization of trial design relies on a holistic understanding of the healthcare system and the dynamic interplay between various treatment modalities. COLLABORATIVE EFFORTS FOR COMPREHENSIVE INSIGHTS Standardize the concepts of acupuncture With a substantial number of acupuncture related RCTs published and available in both English and Chinese databases, they demonstrate the diversity of acupuncture approaches but at the same time, raise conceptual and language challenges in defining acupuncture. For instance, techniques like fire acupuncture, superficial acupuncture, and laser acupuncture are distinct from what people know as standard acupuncture.3–5 Moreover, in Chinese, the term "acupuncture" can be defined as needling plus moxibustion.6 Given the existence of various acupuncture related interventions, it becomes important for researchers to precisely define the intervention concept. This is essential for expressing the trial's novelty and demonstrating the appropriateness of blinding and control groups. Define clearly the clinical study designs Apart from the needling techniques, the definitions of critical terms, such as "RCT", may be represented in Chinese articles under titles like "observation", "efficacy observation", or other terms that may not explicitly indicate the nature of an RCT.7,8 To overcome these complexities, methodology training is highly recommended for investigators since the preparation phase. The training should include understanding the distinctions among clinical study types, terminology, and familiarity with international reporting guidelines, particularly for accurately identifying a randomized trial in the title. Establish collaboration with different medical systems and multiple cultures An effective collaborative team for designing acupuncture research trials should comprise members with diverse cultural backgrounds, including experienced acupuncturists and medical practitioners. In addition, the involvement of clinical research methodologists and statisticians would be beneficial for providing a comprehensive evaluation of the trial design and assisting in the development of an appropriate statistical plan. INCREASING THE TRANSPARENCY AND PRECISION IN RANDOMIZED CONTROLLED TRIALS Among published acupuncture literature included in systematic reviews, it is not uncommon to find RCTs of acupuncture are rated with uncertain risks of biases and incomplete reporting.9 This lack of transparency often starts from the design phases and results from inadequate reporting of procedural details, including randomization, blinding, and quality control measures. Consequently, readers may find it challenging to extract useful data or could be misled by conclusions drawn from reviews heavily comprised of potential biases. As the trial design should have been documented in the original protocols for review by ethics committees and regulatory bodies, we advocate for open access to the latest versions of clinical trial protocols to facilitate the tracking of study details. Furthermore, authors of original articles should strictly adhere to the Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines from the early stages of the design. This commitment to rigor will facilitate the conduct of robust trial design and foster a culture of precision in research reporting. THE SHAM DESIGN OF ACUPUNCTURE: FACTS AND CHALLENGES The use of sham control groups in acupuncture studies represents a strategic design aimed at evaluating the placebo effect. Two primary types, penetrative and non-penetrative sham acupuncture, are commonly employed.10 Penetrative sham acupuncture involves actual skin penetration, inserted in the same manner as real acupuncture but targeting sham-acupuncture points, making it indistinguishable from true acupuncture. Meanwhile, non-penetrative sham needles are affixed to the skin surface with training for investigators, creating a sensation of skin penetration without entering the skin for blinding. However, each method presents its own limitations. Penetrative sham acupuncture, based on TCM theories such as "qi", "meridians", and "acupoints", raises questions about its physiological grounds. On the other hand, non-penetrative sham acupuncture may potentially underestimate acupuncture's true treatment effects.11 In fact, the methods and combinations of sham acupuncture can vary, such as superficial needling on true acupuncture points or specific blinding method based on the type of acupuncture.12 Due to the lack of clear biological mechanisms for the therapeutic effects of acupuncture, controversy still exists regarding which type of sham acupuncture can be applied as a suitable control. When designing RCTs, investigators are suggested to have a sufficient understanding of the underlying dispute surrounding the sham approaches. The evolving field of acupuncture studies demands a dynamic response- one that aligns with the principles of openness, rigor, and relevance. In this manuscript, we placed our spotlights on the acupuncture trial design and provided suggestions to enhance internal validity and generalizability. Recognizing the role of the design phase in clinical trials, we emphasize its significance as it lays the foundation for the entire study. Building on our perspectives regarding the enhancement of patient-centric frameworks, clinical research training, multidisciplinary collaboration, transparency, precision, and addressing challenges in sham design, we advocate for further proactive, technology-driven approaches. For instance, exploring initiatives such as shared resources for medical research education, as well as developing guiding documents for reproducible study protocols and designs, can advance research methodologies and enhance the quality of future studies.