Sham acupuncture reporting guidelines and a checklist in clinical trials_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Xiaoyu ¹ , MA Peihong ² , LIU Zhishun ³ , GUO Yi ⁴ , ZHOU Kehua ⁵ , BIAN Zhaoxiang ⁶ , SUN Chengyi ¹ , LIU Tinglan ¹ , XIONG Zhiyi ¹ , XIE Yixuan ¹ , LU Ying ⁷ , LAO Lixing ⁸ , HE Liyun ⁹ ,  LIU Baoyan ¹⁰ ,  LIU Cunzhi ¹ ,  YAN Shiyan ¹ , SHARE Workgroup

1. Acupuncture and Moxibustion Department, Beijing University of Chinese Medicine, Beijing 100105, P. R. China;
2. School of Medical Technology, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China;
3. Department of Acupuncture and Moxibustion, Guang’an Men Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, P. R. China;
4. School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China;
5. Department of Hospital Medicine, ThedaCare Regional Medical Center, Wisconsin 54911, USA;
6. Department of Chinese Medicine Development, Hong Kong Baptist University, Hong Kong 999077, P. R. China;
7. Department of Biomedical Data Science, Stanford University School of Medicine, California 94305, USA;
8. Virginia University of Integrative Medicine, Virginia 22182, USA;
9. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
10. China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;

Corresponding author：

LIU Baoyan, Email: baoyanjournal@163.com; LIU Cunzhi, Email: lcz623780@126.com; YAN Shiyan, Email: yanshiyan@bucm.edu.cn

Keywords：

Sham acupuncture; Acupuncture; Clinical trials; Reporting guideline; Guideline; Reporting checklist

DOI：

10.7507/1672-2531.202403003

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective Sham acupuncture control is a commonly employed method to assess the specific effects of acupuncture in clinical trials. However, due to the absence of specific reporting standards, the reporting quality of sham acupuncture in these trials is low. In order to standardize the reporting of sham acupuncture and improve the reporting quality of sham acupuncture, our project team has developed SHam Acupuncture REporting guidelines and a checklist in clinical trials (SHARE). Methods The development process included four parts: we conducted literature research to form initial items of sham acupuncture reporting; two rounds of Delphi surveys were carried out to evaluate the reporting necessity of these initial items; two expert consensus meetings were held to further discuss and agree upon the Delphi results and approve the SHARE checklist; a pilot testing was conducted to assess the feasibility and practicality of the list and make necessary revisions to generate the final SHARE checklist. Results The SHARE checklist consisted of 10 categories with 19 items. The requirements for reporting sham acupuncture primarily focused on sham acupuncture detailed information as well as relevant background factors. Conclusion The SHARE serves as specialized reporting guidelines for sham acupuncture that offers clear guidance on comprehensive and concise reporting of sham acupuncture.

Citation： LIU Xiaoyu, MA Peihong, LIU Zhishun, GUO Yi, ZHOU Kehua, BIAN Zhaoxiang, SUN Chengyi, LIU Tinglan, XIONG Zhiyi, XIE Yixuan, LU Ying, LAO Lixing, HE Liyun, LIU Baoyan, LIU Cunzhi, YAN Shiyan, SHARE Workgroup. Sham acupuncture reporting guidelines and a checklist in clinical trials. Chinese Journal of Evidence-Based Medicine, 2024, 24(7): 745-750. doi: 10.7507/1672-2531.202403003 Copy

1.	Chae Y, Lee YS, Enck P. How placebo needles differ from placebo pills. Front Psychiatry, 2018, 9: 243.
2.	Fei YT, Cao HJ, Xia RY, et al. Methodological challenges in design and conduct of randomised controlled trials in acupuncture. BMJ, 2022, 376: e064345.
3.	王毓婷, 刘鑫, 徐子乔, 等. 一种用于双盲安慰针刺研究的辅助装置. 中国针灸, 2022, 42(3): 351-354.
4.	Birch S, Lee MS, Kim TH, et al. Historical perspectives on using sham acupuncture in acupuncture clinical trials. Integr Med Res, 2022, 11(1): 100725.
5.	Zhu D, Gao Y, Chang J, et al. Placebo acupuncture devices: considerations for acupuncture research. Evid Based Complement Alternat Med, 2013, 2013: 628907.
6.	孙俊俊, 李云芬, 朱勉生. 针灸临床试验中安慰针刺对照的应用现状. 世界中医药, 2019, 14(8): 1959-1962, 1968.
7.	毛文超. 疼痛类疾病安慰针刺效应的关键影响因素研究. 北京: 中国中医科学院, 2013.
8.	Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet, 1998, 352(9125): 364-365.
9.	Park J, White A, Lee H, et al. Development of a new sham needle. Devel Zircon Alloys Part Ⅱ, 1999, 8(2): 110-112.
10.	Takakura N, Yajima H. A double-blind placebo needle for acupuncture research. BMC Complement Altern Med, 2007, 7: 31.
11.	刘静怡, 白鹏. Elastic针具: 一套一体式可弹缩双盲安慰针. 中国针灸, 2024, 44(2): 221-223.
12.	Liu Z, Ai Y, Wang W, et al. Acupuncture for symptoms in menopause transition: a randomized controlled trial. Am J Obstet Gynecol, 2018, 219(4): 373.
13.	Zheng H, Li J, Li Y, et al. Acupuncture for patients with mild hypertension: a randomized controlled trial. J Clin Hypertens (Greenwich), 2019, 21(3): 412-420.
14.	Scharf HP, Mansmann U, Streitberger K, et al. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med, 2006, 145(1): 12-20.
15.	Tu JF, Yang JW, Shi GX, et al. Efficacy of intensive acupuncture versus sham acupuncture in knee osteoarthritis: a randomized controlled trial. Arthritis Rheumatol, 2021, 73(3): 448-458.
16.	Hinman RS, McCrory P, Pirotta M, et al. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA, 2014, 312(13): 1313-1322.
17.	Foster NE, Thomas E, Barlas P, et al. Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial. BMJ, 2007, 335(7617): 436.
18.	Chen L, Li M, Fan L, et al. Optimized acupuncture treatment (acupuncture and intradermal needling) for cervical spondylosis-related neck pain: a multicenter randomized controlled trial. Pain, 2021, 162(3): 728-739.
19.	Kaptchuk TJ, Kelley JM, Conboy LA, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ, 2008, 336(7651): 999-1003.
20.	White P, Bishop FL, Prescott P, et al. Practice, practitioner, or placebo. A multifactorial, mixed-methods randomized controlled trial of acupuncture. Pain, 2012, 153(2): 455-462.
21.	Kelley JM, Lembo AJ, Ablon JS, et al. Patient and practitioner influences on the placebo effect in irritable bowel syndrome. Psychosom Med, 2009, 71(7): 789-797.
22.	Lee YS, Kim SY, Kim M, et al. Reporting quality of sham needles used as controls in acupuncture trials: a methodological evaluation. Chin Med, 2022, 17(1): 64.
23.	Xie Y, Liu X, Liu T, et al. Descriptions of sham acupuncture in randomised controlled trials: a critical review of the literature. BMC Complement Med Ther, 2023, 23(1): 173.
24.	MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med, 2010, 28(2): 83-93.
25.	Liu L, Skinner M, McDonough SM, et al. STRICTA: is it time to do more. BMC Complement Altern Med, 2015, 15: 190.
26.	Clark MT, Clark RJ, Toohey S, et al. Suggestions regarding adaptation of the STRICTA guidelines for reporting acupuncture practice and research. Acupunct Med, 2017, 35(1): 75-77.
27.	Howick J, Webster RK, Rees JL, et al. TIDieR-Placebo: a guide and checklist for reporting placebo and sham controls. PLoS Med, 2020, 17(9): e1003294.
28.	Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
29.	Ma P, Liu X, Liu Z, et al. The SHARE: SHam Acupuncture REporting guidelines and a checklist in clinical trials. J Evid Based Med, 2023, 16(4): 428-431.
30.	刘晓玉, 孙承颐, 孙重阳, 等. 外科安慰手术应用指南及其对针刺临床研究中假针刺应用的借鉴. 针刺研究, 2023, 48(4): 404-410.
31.	刘晓玉, 闫世艳, 郭义, 等. 针刺临床研究中模拟针刺对照报告相关指南比较分析. 针刺研究, 2022, 47(11): 1031-1035.
32.	Sabbagh Gol A, Rezaei Ardani A, Farahmand SK, et al. Additive effects of acupuncture in alleviating anxiety: a double-blind, three-arm, randomized clinical trial. Complement Ther Clin Pract, 2021, 45: 101466.
33.	殷萱, 吴焕淦, 勾明会, 等. 针灸治疗原发性失眠的随机对照试验. 世界科学技术-中医药现代化, 2018, 20(2): 198-202.
34.	曹燕, 严寅杰, 刘依萍, 等. 调督安神针刺治疗卒中后失眠的随机对照研究. 上海针灸杂志, 2020, 39(3): 280-284.
35.	王进忠, 覃小兰, 谢文源, 等. 平衡针疗法治疗无先兆偏头痛随机对照研究. 中国针灸, 2017, 37(8): 805-809.
36.	姚红, 陈健雄, 张子谦, 等. 针刺对单纯性肥胖症患者食欲的影响. 针刺研究, 2012, 37(6): 497-501.
37.	Horta D, Lira A, Sanchez-Lloansi M, et al. A prospective pilot randomized study: electroacupuncture vs. sham procedure for the treatment of fatigue in patients with quiescent inflammatory bowel disease. Inflamm Bowel Dis, 2020, 26(3): 484-492.
38.	Ferreira LA, de Oliveira RG, Guimarães JP, et al. Laser acupuncture in patients with temporomandibular dysfunction: a randomized controlled trial. Lasers Med Sci, 2013, 28(6): 1549-1558.
39.	Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for chronic pain: update of an individual patient data meta-analysis. J Pain, 2018, 19(5): 455-474.

1. Chae Y, Lee YS, Enck P. How placebo needles differ from placebo pills. Front Psychiatry, 2018, 9: 243.
2. Fei YT, Cao HJ, Xia RY, et al. Methodological challenges in design and conduct of randomised controlled trials in acupuncture. BMJ, 2022, 376: e064345.
3. 王毓婷, 刘鑫, 徐子乔, 等. 一种用于双盲安慰针刺研究的辅助装置. 中国针灸, 2022, 42(3): 351-354.
4. Birch S, Lee MS, Kim TH, et al. Historical perspectives on using sham acupuncture in acupuncture clinical trials. Integr Med Res, 2022, 11(1): 100725.
5. Zhu D, Gao Y, Chang J, et al. Placebo acupuncture devices: considerations for acupuncture research. Evid Based Complement Alternat Med, 2013, 2013: 628907.
6. 孙俊俊, 李云芬, 朱勉生. 针灸临床试验中安慰针刺对照的应用现状. 世界中医药, 2019, 14(8): 1959-1962, 1968.
7. 毛文超. 疼痛类疾病安慰针刺效应的关键影响因素研究. 北京: 中国中医科学院, 2013.
8. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet, 1998, 352(9125): 364-365.
9. Park J, White A, Lee H, et al. Development of a new sham needle. Devel Zircon Alloys Part Ⅱ, 1999, 8(2): 110-112.
10. Takakura N, Yajima H. A double-blind placebo needle for acupuncture research. BMC Complement Altern Med, 2007, 7: 31.
11. 刘静怡, 白鹏. Elastic针具: 一套一体式可弹缩双盲安慰针. 中国针灸, 2024, 44(2): 221-223.
12. Liu Z, Ai Y, Wang W, et al. Acupuncture for symptoms in menopause transition: a randomized controlled trial. Am J Obstet Gynecol, 2018, 219(4): 373.
13. Zheng H, Li J, Li Y, et al. Acupuncture for patients with mild hypertension: a randomized controlled trial. J Clin Hypertens (Greenwich), 2019, 21(3): 412-420.
14. Scharf HP, Mansmann U, Streitberger K, et al. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med, 2006, 145(1): 12-20.
15. Tu JF, Yang JW, Shi GX, et al. Efficacy of intensive acupuncture versus sham acupuncture in knee osteoarthritis: a randomized controlled trial. Arthritis Rheumatol, 2021, 73(3): 448-458.
16. Hinman RS, McCrory P, Pirotta M, et al. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA, 2014, 312(13): 1313-1322.
17. Foster NE, Thomas E, Barlas P, et al. Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial. BMJ, 2007, 335(7617): 436.
18. Chen L, Li M, Fan L, et al. Optimized acupuncture treatment (acupuncture and intradermal needling) for cervical spondylosis-related neck pain: a multicenter randomized controlled trial. Pain, 2021, 162(3): 728-739.
19. Kaptchuk TJ, Kelley JM, Conboy LA, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ, 2008, 336(7651): 999-1003.
20. White P, Bishop FL, Prescott P, et al. Practice, practitioner, or placebo. A multifactorial, mixed-methods randomized controlled trial of acupuncture. Pain, 2012, 153(2): 455-462.
21. Kelley JM, Lembo AJ, Ablon JS, et al. Patient and practitioner influences on the placebo effect in irritable bowel syndrome. Psychosom Med, 2009, 71(7): 789-797.
22. Lee YS, Kim SY, Kim M, et al. Reporting quality of sham needles used as controls in acupuncture trials: a methodological evaluation. Chin Med, 2022, 17(1): 64.
23. Xie Y, Liu X, Liu T, et al. Descriptions of sham acupuncture in randomised controlled trials: a critical review of the literature. BMC Complement Med Ther, 2023, 23(1): 173.
24. MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med, 2010, 28(2): 83-93.
25. Liu L, Skinner M, McDonough SM, et al. STRICTA: is it time to do more. BMC Complement Altern Med, 2015, 15: 190.
26. Clark MT, Clark RJ, Toohey S, et al. Suggestions regarding adaptation of the STRICTA guidelines for reporting acupuncture practice and research. Acupunct Med, 2017, 35(1): 75-77.
27. Howick J, Webster RK, Rees JL, et al. TIDieR-Placebo: a guide and checklist for reporting placebo and sham controls. PLoS Med, 2020, 17(9): e1003294.
28. Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
29. Ma P, Liu X, Liu Z, et al. The SHARE: SHam Acupuncture REporting guidelines and a checklist in clinical trials. J Evid Based Med, 2023, 16(4): 428-431.
30. 刘晓玉, 孙承颐, 孙重阳, 等. 外科安慰手术应用指南及其对针刺临床研究中假针刺应用的借鉴. 针刺研究, 2023, 48(4): 404-410.
31. 刘晓玉, 闫世艳, 郭义, 等. 针刺临床研究中模拟针刺对照报告相关指南比较分析. 针刺研究, 2022, 47(11): 1031-1035.
32. Sabbagh Gol A, Rezaei Ardani A, Farahmand SK, et al. Additive effects of acupuncture in alleviating anxiety: a double-blind, three-arm, randomized clinical trial. Complement Ther Clin Pract, 2021, 45: 101466.
33. 殷萱, 吴焕淦, 勾明会, 等. 针灸治疗原发性失眠的随机对照试验. 世界科学技术-中医药现代化, 2018, 20(2): 198-202.
34. 曹燕, 严寅杰, 刘依萍, 等. 调督安神针刺治疗卒中后失眠的随机对照研究. 上海针灸杂志, 2020, 39(3): 280-284.
35. 王进忠, 覃小兰, 谢文源, 等. 平衡针疗法治疗无先兆偏头痛随机对照研究. 中国针灸, 2017, 37(8): 805-809.
36. 姚红, 陈健雄, 张子谦, 等. 针刺对单纯性肥胖症患者食欲的影响. 针刺研究, 2012, 37(6): 497-501.
37. Horta D, Lira A, Sanchez-Lloansi M, et al. A prospective pilot randomized study: electroacupuncture vs. sham procedure for the treatment of fatigue in patients with quiescent inflammatory bowel disease. Inflamm Bowel Dis, 2020, 26(3): 484-492.
38. Ferreira LA, de Oliveira RG, Guimarães JP, et al. Laser acupuncture in patients with temporomandibular dysfunction: a randomized controlled trial. Lasers Med Sci, 2013, 28(6): 1549-1558.
39. Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for chronic pain: update of an individual patient data meta-analysis. J Pain, 2018, 19(5): 455-474.

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