Tae-Hun Kim1, Myeong Soo Lee2, Stephen Birch3, Terje Alraek3,4. 1. Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, Republic of Korea. 2. Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea. 3. School of Health Sciences, Kristiania University College, Oslo, Norway. 4. NAFKAM, National Research Center in Complementary and Alternative Medicine, Department of Community Medicine, Faculty of Medicine, UiT The Arctic University of Norway, Tromso, Norway.
Things are changing. Acupuncture, a specific procedure of traditional East Asian medicine, is now recommended in many countries as a viable treatment strategy for the management of various conditions and has found a growing place in integrative medicine. There is no denying that the successful acceptance of acupuncture is supported by scientific research such as clinical trials and systematic reviews (SRs) accumulated over decades. A recent series of articles published in the British Medical Journal (BMJ) summarizes the academic achievements of clinical acupuncture research to date and is a valuable milestone that indicates where evidence-based acupuncture research should be directed in the future. This in itself is a significant achievement, considering the problems that have been encountered in acupuncture research.The problems of clinical research and SRs on acupuncture have been known for a long time. In particular, the problems of the appropriateness of sham acupuncture, including the sham devices as appropriate control group interventions in the clinical trials used to evaluate the nonspecific effects of acupuncture, those of statistical power in clinical research, and those of the relatively short evaluation/follow-up period have been highlighted as significant limitations in clinical research evaluating the efficacy of acupuncture. These are perceived as negative factors that undermine the certainty of the evidence for acupuncture. In addition, the diversity of acupuncture treatment (acupuncture point selection, stimulation method, number of treatments, total treatment duration, etc.) is a factor that allows practitioners more freedom in clinical practice, but it is also a critical issue that reduces the certainty of the evidence for acupuncture in clinical practice guidelines (CPGs). For these reasons, there have been problems in evaluating evidence from trials and making accurate or clear recommendations about acupuncture in CPGs. In addition, economic evaluation is recognized as essential in order to be registered in national or private insurance systems, but there are relatively few economic evaluations of acupuncture that also have methodological limitations.Given this situation, this BMJ acupuncture collection is important because it provides guidance on clinical trials, economic analysis, and development of CPGs. In particular, the guidance on acupuncture clinical trials based on surveys of professional acupuncture clinical researchers, consumers, and policy makers from around the world are helpful. In addition, with recommendations on the use of acupuncture within CPGs published in the past 10 years, the article contributes to a more objective view of the current situation. When planning a clinical trial or SR on acupuncture or developing a CPG, this collection of articles contains basic and essential considerations that can serve as a primary reference.But there are also limitations. Consideration should be given to whether such guidance, which focuses on standardization of research design and conduct, helps to enable diversity-guaranteeing/optimal acupuncture in clinical practice. Moreover, even if the areas of medical policy or the insurance reimbursement system are based on scientific research evidence, they may be more closely related to the medical system, individual health behaviors, and national and societal perceptions of acupuncture. These issues cannot be assessed by quantitative research and have not been addressed here. In addition, it is unfortunate that the use of sham acupuncture, particularly the sham device, a central problem in clinical acupuncture research, is still recommended in the guideline without a description of how to deal with these problems. Finally, issues related to statistical analysis and the small sample size of many acupuncture studies were not sufficiently addressed. These last two issues will lead to continuing problems in interpreting the evidence. But for now, it is just a step forward. In the future, it is necessary to continue this type of discourse for clinical acupuncture research and evidence generation. Hopefully, high-quality clinical research on acupuncture, including mechanism of action studies, will continue to be encouraged.
Author contributions
Conceptualization: TA and MSL. Writing Original Draft: THK. Writing Review & Editing: THK, MSL, SB, and TA.
Conflict of interest
All the authors are part of the journal’s editorial board but it was externally reviewed. Otherwise, there are no other conflicts of interest regarding this paper.
Funding
None.
Ethical statement
There are no ethical issues with this paper.
Data availability
There are no available data beyond that cited in the references.
Authors: Yu-Qing Zhang; Rui-Min Jiao; Claudia M Witt; Lixing Lao; Jian-Ping Liu; Lehana Thabane; Karen J Sherman; Mike Cummings; Dawn P Richards; Eun-Kyung Anna Kim; Tae-Hun Kim; Myeong Soo Lee; Michael E Wechsler; Benno Brinkhaus; Jun J Mao; Caroline A Smith; Wei-Juan Gang; Bao-Yan Liu; Zhi-Shun Liu; Yan Liu; Hui Zheng; Jia-Ni Wu; Alonso Carrasco-Labra; Mohit Bhandari; Philip J Devereaux; Xiang-Hong Jing; Gordon Guyatt Journal: BMJ Date: 2022-03-30