IDEAL-Acu: A Methodological Framework for Evaluating the Effects of Acupuncture

Jiali Liu , Xiaochao Luo , Yemeng Chen , Ling Zhao , Minghong Yao , Jiajie Yu , Jiahui Yang , Ling Li , Xin Sun

Journal of Evidence-Based Medicine ›› 2025, Vol. 18 ›› Issue (2) : e70043

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Journal of Evidence-Based Medicine ›› 2025, Vol. 18 ›› Issue (2) : e70043 DOI: 10.1111/jebm.70043
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IDEAL-Acu: A Methodological Framework for Evaluating the Effects of Acupuncture

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Abstract

Objectives: The demand for high-quality clinical evidence supporting acupuncture remains urgent, necessitating the establishment of a suitable methodological framework to promote its generation.

Methods: Following internal deliberations and extensive online discussions with experts in the IDEAL Collaboration, we proposed the IDEAL-Acu framework specifically for acupuncture, based on the surgery-focused IDEAL model with necessary modifications to accommodate the characteristics of acupuncture. To ensure consensus on recommendations, a panel of external experts and internal research team members was convened, and any disagreements were iteratively resolved through expert review.

Results: This article introduces an IDEAL-Acu framework with five stages for evaluating acupuncture outcome and improving practice to optimize treatment. The framework includes Idea (proposal of an acupuncture regime), Development (optimization or standardization of the acupuncture regime), Exploration (feasibility assessment for conducting a definitive RCT), Assessment (evaluation of effects through comparison with standard therapy or sham acupuncture), and Long-term monitoring (examination of long-term efficacy and safety) stages. We provide clear recommendations for each stage along with specific examples.

Conclusion: The framework highlights the importance of conducting studies at each stage in acupuncture evaluation process and can serve as a helpful guide for assessing its effects and promoting evidence-based practice in acupuncture.

Keywords

acupuncture / evaluation / methodological framework / recommendations

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Jiali Liu, Xiaochao Luo, Yemeng Chen, Ling Zhao, Minghong Yao, Jiajie Yu, Jiahui Yang, Ling Li, Xin Sun. IDEAL-Acu: A Methodological Framework for Evaluating the Effects of Acupuncture. Journal of Evidence-Based Medicine, 2025, 18(2): e70043 DOI:10.1111/jebm.70043

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References

[1]

T. Y. Chon and M. C. Lee, “Acupuncture,” Mayo Clinic Proceedings 88, no. 10 (2013): 1141-1146.

[2]

World Health Organization. WHO Traditional Medicine Strategy: 2014-2023, https://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/.

[3]

R. L. Nahin, A. Rhee, and B. Stussman, “Use of Complementary Health Approaches Overall and for Pain Management by US Adults,” Jama 331, no. 7 (2024): 613-615.

[4]

World Federation of Acupuncture-Moxibustion Societies. An Overview. 2013, http://www.wfas.org.cn/news/daodu-detail.html?nid=2497&cid=47.

[5]

World Health Organization. WHO Global Report on Traditional and Complementary Medicine. 2019, https://www.who.int/publications/i/item/978924151536.

[6]

S. Deng, X. Zhao, R. Du, et al., “Is Acupuncture no More Than a Placebo? Extensive Discussion Required About Possible Bias,” Experimental and Therapeutic Medicine 10, no. 4 (2015): 1247-1252.

[7]

B. E. McGeeney, “Acupuncture Is All Placebo and Here Is Why,” Headache 55, no. 3 (2015): 465-469.

[8]

J. McDonald and S Janz, The Acupuncture Evidence Project: A Comparative Literature Review (Australian Acupuncture and Chinese Medicine Association, 2017).

[9]

Y. Fei, H. Cao, R. Xia, et al., “Methodological Challenges in Design and Conduct of Randomised Controlled Trials in Acupuncture,” Bmj 376 (2022): e064345.

[10]

T. Liu, “Role of Acupuncturists in Acupuncture Treatment,” Evidence-Based Complementary and Alternative Medicine 4, no. 1 (2007): 3-6.

[11]

R. L. Street, V. Cox, M. A. Kallen, and M. E. Suarez-Almazor, “Exploring Communication Pathways to Better Health: Clinician Communication of Expectations for Acupuncture Effectiveness,” Patient Education and Counseling 89, no. 2 (2012): 245-251.

[12]

Y. Zhang, R. Jiao, C. M. Witt, et al., “How to Design High Quality Acupuncture Trials—A Consensus Informed by Evidence,” Bmj 376 (2022): e067476.

[13]

H. Chen, M. Yang, Z. Ning, et al., “A Guideline for Randomized Controlled Trials of Acupuncture,” American Journal of Chinese Medicine 47, no. 1 (2019): 1-18.

[14]

J. Liu, X. Luo, M. Yao, et al., “Use of Statistical Methods Among Acupuncture Randomized Controlled Trials Was Far From Satisfactory,” Journal of Clinical Epidemiology 152 (2022): 1-12.

[15]

P. McCulloch, D. G. Altman, W. B. Campbell, et al., “No Surgical Innovation Without Evaluation: The IDEAL Recommendations,” Lancet 374, no. 9695 (2009): 1105-1112.

[16]

J. S. Barkun, J. K. Aronson, L. S. Feldman, et al., “Evaluation and Stages of Surgical Innovations,” Lancet 374, no. 9695 (2009): 1089-1096.

[17]

A. Hirst, Y. Philippou, J. Blazeby, et al., “No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations,” Annals of Surgery 269, no. 2 (2019): 211-220.

[18]

K. Skivington, L. Matthews, S. A. Simpson, et al., “A New Framework for Developing and Evaluating Complex Interventions: Update of Medical Research Council Guidance,” Bmj 374 (2021): n2061.

[19]

A. Sedrakyan, B. Campbell, J. G. Merino, R. Kuntz, A. Hirst, and P. McCulloch, “IDEAL-D: A Rational Framework for Evaluating and Regulating the Use of Medical Devices,” Bmj 353 (2016): i2372.

[20]

H. M. Verkooijen, L. G. W. Kerkmeijer, C. D. Fuller, et al., “R-IDEAL: A Framework for Systematic Clinical Evaluation of Technical Innovations in Radiation Oncology,” Frontiers in Oncology 7 (2017): 59.

[21]

D. Beard, D. Hamilton, L. Davies, et al., “Evidence-Based Evaluation of Practice and Innovation in Physical Therapy Using the IDEAL-Physio Framework,” Physical Therapy 98, no. 2 (2018): 108-121.

[22]

C. M. Witt, D. Pach, B. Brinkhaus, et al., “Safety of Acupuncture: Results of a Prospective Observational Study With 229,230 Patients and Introduction of a Medical Information and Consent Form,” Forschende Komplementarmedizin (2006) 16, no. 2 (2009): 91-97.

[23]

P. McCulloch, J. Feinberg, Y. Philippou, et al., “Progress in Clinical Research in Surgery and IDEAL,” Lancet 392, no. 10141 (2018): 88-94.

[24]

H. Li, H. Liu, C. Liu, et al., “Effect of “Deqi” During the Study of Needling “Wang's Jiaji” Acupoints Treating Spasticity After Stroke,” Evidence-Based Complementary and Alternative Medicine 2014 (2014): 715351.

[25]

Y. Yang, G. Litscher, Z. Sun, and W. Sun, “The Application of Laser Acupuncture in Animal Experiments: A Narrative Review of Biological Aspects,” Evidence-Based Complementary and Alternative Medicine 2021 (2021): 6646237.

[26]

W. Xu, Y. Xiao, M. Zhao, et al., “Effective Treatment of Knee Osteoarthritis Using a Nano-Enabled Drug Acupuncture Technology in Mice,” Advanced Science (Weinh) 10, no. 28 (2023): e2302586.

[27]

X. Zheng, Y. Nie, C. Sun, et al., “Long-term Electroacupuncture Stimulation Prevents Osteoporosis in Ovariectomised Osteopaenic Rats Through Multiple Signalling Pathways,” Acupuncture in Medicine 36, no. 3 (2018): 176-182.

[28]

H. Tan, S. Tumilty, C. Chapple, et al., “Understanding Acupoint Sensitization: A Narrative Review on Phenomena, Potential Mechanism, and Clinical Application,” Evidence-Based Complementary and Alternative Medicine 2019 (2019): 6064358.

[29]

P. L. Ergina, J. A. Cook, J. M. Blazeby, et al., “Challenges in Evaluating Surgical Innovation,” Lancet 374, no. 9695 (2009): 1097-1104.

[30]

P. McCulloch, J. A. Cook, D. G. Altman, C. Heneghan, and M. K. Diener, “IDEAL Framework for Surgical Innovation 1: The Idea and Development Stages,” Bmj 346 (2013): f3012.

[31]

W. Lin, L. Luo, Y. Zhou, et al., “Dynamic Clinical Observation of the Characteristics and Patterns of Pain Sensitivity Points in Patients With Knee Osteoarthritis,” Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology 23, no. 08 (2021): 2777-2783.

[32]

D. B. Fogel, “Factors Associated With Clinical Trials That Fail and Opportunities for Improving the Likelihood of Success: A Review,” Contemporary Clinical Trials Communications 11 (2018): 156-164.

[33]

L. L. Lin, J. F. Tu, L. Q. Wang, et al., “Acupuncture of Different Treatment Frequencies in Knee Osteoarthritis: A Pilot Randomised Controlled Trial,” Pain 161, no. 11 (2020): 2532-2538.

[34]

P. Jia, J. Liu, L. Li, et al., “Acupuncture for Knee Osteoarthritis With Sensitized Acupoints: Results From a Pilot, Feasibility Randomized Controlled Trial,” Pilot and Feasibility Studies 6 (2020): 144.

[35]

J. A. Cook, P. McCulloch, J. M. Blazeby, D. J. Beard, D. Marinac-Dabic, and A. Sedrakyan, “IDEAL Framework for Surgical Innovation 3: Randomised Controlled Trials in the Assessment Stage and Evaluations in the Long Term Study Stage,” Bmj 346 (2013): f2820.

[36]

J. Liu, Y. Li, L. Li, et al., “Effects of Acupuncture at Acupoints With Lower Versus Higher Pain Threshold for Knee Osteoarthritis: A Multicenter Randomized Controlled Trial,” Chinese Medicine 17, no. 1 (2022): 67.

[37]

Z. G. Xu, S. Q. Ge, and L. M. Lu, “Application of Expertise-based Pragmatic Randomized Controlled Trial in Acupuncture-moxibustion Clinical Research,” Zhongguo Zhen Jiu 40, no. 5 (2020): 538-542.

[38]

T. Zhao, J. Liu, Y. Li, et al., “Acupuncture Case Registry Study: Rationale, Implementations, and Achievements,” Evidence-Based Complementary and Alternative Medicine 2022 (2022): 3860231.

[39]

K. F. Schulz, D. G. Altman, and D. Moher, “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials,” Bmj 340 (2010): c332.

[40]

H. MacPherson, D. G. Altman, R. Hammerschlag, et al., “Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement,” PLOS Medicine 7, no. 6 (2010): e1000261.

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2025 The Author(s). Journal of Evidence-Based Medicine published by Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

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