How to design high quality acupuncture trials-a consensus informed by evidence

Yu-Qing Zhang^{1

2

3

4}, Rui-Min Jiao^{1

5}, Claudia M Witt⁶, Lixing Lao⁷, Jian-Ping Liu^{8

9}, Lehana Thabane¹⁰, Karen J Sherman^{11

12}, Mike Cummings¹³, Dawn P Richards¹⁴, Eun-Kyung Anna Kim¹⁵, Tae-Hun Kim^{16

17

18}, Myeong Soo Lee^{19

20}, Michael E Wechsler²¹, Benno Brinkhaus²², Jun J Mao²³, Caroline A Smith²⁴, Wei-Juan Gang^{1

5}, Bao-Yan Liu²⁵, Zhi-Shun Liu²⁶, Yan Liu²⁷, Hui Zheng²⁸, Jia-Ni Wu²⁶, Alonso Carrasco-Labra²⁹, Mohit Bhandari¹⁰, Philip J Devereaux¹⁰, Xiang-Hong Jing^{1

5}, Gordon Guyatt^{3

10}

Affiliations

¹ Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.
² CEBIM (Center for Evidence-Based Integrative Medicine)-Clarity Collaboration, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
³ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
⁴ Nottingham Ningbo GRADE Centre, University of Nottingham Ningbo, China.
⁵ China Center for Evidence-Based Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
⁶ Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
⁷ Virginia University of Integrative Medicine, Fairfax, VA, USA.
⁸ Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
⁹ Institute for Excellence in Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
¹⁰ Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
¹¹ Kaiser Permanente Washington Health Research Institute, Seattle WA, USA.
¹² Department of Epidemiology, University of Washington, Seattle WA, USA.
¹³ British Medical Acupuncture Society, London, UK.
¹⁴ Patient and Public Engagement, Clinical Trials Ontario, Toronto, ON, Canada.
¹⁵ Department of Western Medicine, Virginia University of Integrative Medicine, Fairfax, VA, USA.
¹⁶ Korean Medicine Clinical Trial Center, Seoul, Republic of Korea.
¹⁷ Korean Medicine Hospital, Seoul, Republic of Korea.
¹⁸ Kyung Hee University, Seoul, Republic of Korea.
¹⁹ Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
²⁰ Korean Convergence Medicine, University of Science and Technology, Daejeon, Republic of Korea.
²¹ National Jewish Health, Denver, CO, USA.
²² Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
²³ Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, Bendheim Integrative Medicine Center, New York, NY USA.
²⁴ Translational Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.
²⁵ China Academy of Chinese Medical Sciences, Beijing, China.
²⁶ Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
²⁷ Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
²⁸ School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Chengdu University of Traditional Chinese Medicine, Sichuan, China.
²⁹ Center for Integrative Global Oral Health, School of Dental Medicine, University of Pennsylvania, Philadelphia, PA, USA.

PMID: 35354583
PMCID: PMC8965655
DOI: 10.1136/bmj-2021-067476

How to design high quality acupuncture trials-a consensus informed by evidence

Yu-Qing Zhang et al. BMJ. 2022.

. 2022 Mar 30:376:e067476.

doi: 10.1136/bmj-2021-067476.

Authors

Affiliations

¹ Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.
² CEBIM (Center for Evidence-Based Integrative Medicine)-Clarity Collaboration, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
³ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
⁴ Nottingham Ningbo GRADE Centre, University of Nottingham Ningbo, China.
⁵ China Center for Evidence-Based Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
⁶ Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
⁷ Virginia University of Integrative Medicine, Fairfax, VA, USA.
⁸ Center for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
⁹ Institute for Excellence in Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
¹⁰ Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
¹¹ Kaiser Permanente Washington Health Research Institute, Seattle WA, USA.
¹² Department of Epidemiology, University of Washington, Seattle WA, USA.
¹³ British Medical Acupuncture Society, London, UK.
¹⁴ Patient and Public Engagement, Clinical Trials Ontario, Toronto, ON, Canada.
¹⁵ Department of Western Medicine, Virginia University of Integrative Medicine, Fairfax, VA, USA.
¹⁶ Korean Medicine Clinical Trial Center, Seoul, Republic of Korea.
¹⁷ Korean Medicine Hospital, Seoul, Republic of Korea.
¹⁸ Kyung Hee University, Seoul, Republic of Korea.
¹⁹ Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
²⁰ Korean Convergence Medicine, University of Science and Technology, Daejeon, Republic of Korea.
²¹ National Jewish Health, Denver, CO, USA.
²² Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
²³ Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, Bendheim Integrative Medicine Center, New York, NY USA.
²⁴ Translational Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.
²⁵ China Academy of Chinese Medical Sciences, Beijing, China.
²⁶ Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
²⁷ Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
²⁸ School of Acupuncture-Moxibustion and Tuina/The Third Affiliated Hospital, Chengdu University of Traditional Chinese Medicine, Sichuan, China.
²⁹ Center for Integrative Global Oral Health, School of Dental Medicine, University of Pennsylvania, Philadelphia, PA, USA.

PMID: 35354583
PMCID: PMC8965655
DOI: 10.1136/bmj-2021-067476

Erratum in

How to design high quality acupuncture trials-a consensus informed by evidence.
[No authors listed] [No authors listed] BMJ. 2022 Apr 25;377:o1046. doi: 10.1136/bmj.o1046. BMJ. 2022. PMID: 35470144 Free PMC article. No abstract available.

Abstract

An international panel including patients, clinicians, researchers, acupuncture and surgery trialists, statisticians, and experts in clinical epidemiology and methodology have developed new guidance for randomised controlled trials in acupuncture. It addresses the most prevalent and critical concerns of current acupuncture trials and will help funding agencies, trial registers, and journal editors to evaluate the relevance, importance, and quality of submitted trial proposals and completed trials

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form (available on request from the corresponding author) and declare: CW received a grant at the University of Zurich from the Kelm Foundation for a randomized controlled trial on acupuncture for dysgeusia during chemotherapy. CW is an unpaid board Member of the Society of Acupuncture Research. KJS received a grant from NIH (National Center for Complementary and Integrative Health). KJS seats on a Data Safety Monitoring Board or Advisory Board from NIH-DoD (Department of Defence)-VA(Veterans Affairs) Collaboratory DSMB, and Advisory Board of the National Center for Complementary and Integrative Health of the US NIH with honorarium. MC receives royalties from non commercially used Medical Acupuncture textbooks.MC works as the Medical Director of the British Medical Acupuncture Society (BMAS) full time. DPR is a volunteer vice president of the Canadian Arthritis Patient Alliance, a patient-led and run arthritis organization that accepts arms-length funding from pharma companies, and an employee of Five02 Labs Inc, under Clinical Trials Ontario to support its patient and public engagement efforts. DPR received an honorarium attend meetings and travel support from Eli Lilly Canada for her speech about living with arthritis and arthritis patient organizations in Canada. MW received grants from the NIH, Sanofi, Astrazeneca Teva, and Jin Hua Foundation Cohero. MW received consulting fees from AstraZeneca, Amgen, Glaxosmithkline, Sanofi, Genzyme, Regeneron, Boehringer Ingelheim, Novartis, genentech, Pulmatrix, Teva, Equillium, cytoreason , Restorbio, Cohero Health, cerecor, incyte, sound biologics, and kinaset. MW received grants for payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Glaxosmithkline, Sanofi, and Regeneron. PJD received grants from Abbott Diagnostics, Roche Diagnostics, and Siemens, the monitoring device of CloudDX, and the medical device of Philips Healthcare. PJD reports as a Member of the Scientific Advisory Board of Bayer and Quidel. The study was supported by the China Academy of Chinese Medical Sciences Innovation Fund (CI 2021A03503 & CI2021B011) and “The Belt And Road” Traditional Chinese Medicine Cooperation Project of China Academy of Chinese Medical Sciences; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work of all authors.

References

1. State Council Information Office of the People’s Republic of China. Traditional Chinese medicine in China. 2016. http://www.china.org.cn/chinese/2017-01/17/content_40120942.htm
1. Su CX. Evaluation of bias in acupuncture randomized controlled trials. [In Chinsese]. Beijing University of Traditional Chinese Medicine, 2015.
1. Wang YY. Bibliometric study on randomized controlled trials of acupuncture in chinese journals and the influencing factors of positive results. [In Chinese.] Beijing University of Traditional Chinese Medicine, 2014.
1. Oxman AD, Lombard C, Treweek S, Gagnier JJ, Maclure M, Zwarenstein M. Why we will remain pragmatists: four problems with the impractical mechanistic framework and a better solution. J Clin Epidemiol 2009;62:485-8. 10.1016/j.jclinepi.2008.08.015 - DOI - PubMed
1. Karanicolas PJ, Montori VM, Devereaux PJ, Schünemann H, Guyatt GH. A new “mechanistic-practical” framework for designing and interpreting randomized trials. J Clin Epidemiol 2009;62:479-84. 10.1016/j.jclinepi.2008.02.009 - DOI - PubMed

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How to design high quality acupuncture trials-a consensus informed by evidence

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How to design high quality acupuncture trials-a consensus informed by evidence

Authors

Affiliations

Erratum in

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Conflict of interest statement

References

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