Comparative analysis of ACURATE and SHARE reporting guidelines for sham acupuncture in clinical trials of acupuncture_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Chuanyang ^1,2 , LI Binyan ^3,4 , DUAN Yanshan ^3,4 , ZHOU Hang ^3,4 , WANG Yu ^3,4 , TU Jianfeng ^3,4 ,  WANG Liqiong ^3,4

1. School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
2. Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, P. R. China;
3. International Institute of Acupuncture and Moxibustion Innovation, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
4. School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;

Corresponding author：

WANG Liqiong, Email: wangliqiongwork@163.com

Keywords：

Acupuncture; Reporting guideline; Acupuncture clinical trial; ACURATE; SHARE

DOI：

10.7507/1672-2531.202411066

Video：

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Abstract Full text Figures/Tables Video References Cited by

To provide suggestions for future researchers to select and optimize sham acupuncture reporting guidelines in acupuncture clinical trials. Through qualitative analysis, we compared the basic information and concrete contents between Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) and Sham Acupuncture REporting guidelines in clinical trials (SHARE) developed by researchers from China and Korea. In addition, the similarities and differences of the two guidelines were illustrated through a specific case. We found that the two guidelines had their own characteristics and emphasis in content, but both emphasized the reports of detailed information and background factors of sham acupuncture compared with the previous STRICTA and TIDieR-Placebo checklist. In terms of item division, we found that the ACURATE split the same topic into several items to emphasize the importance of each item content. SHARE emphasized the comprehensive reports of sham acupuncture by combining several items into a single item. In terms of item content, ACURATE also focused on combination therapy, the information regarding sham acupuncture provided to participants, and any differences in treatment settings between versus/sham acupuncture, which had some referential meaning for setting sham acupuncture control. SHARE also focused on sham acupuncture detailed information, practitioner, and modifications, etc. Case analysis showed that there were some “not reported” or “partially reported” items in both guidelines. Therefore, it is suggested that researchers can use the above two guidelines to complement and learn from each other to report sham acupuncture. In addition, it is necessary for researchers to verify the operability and practicability of the above two guidelines, and provide suggestions for optimizing and updating them in the future.

1.	Lee YS, Kim SY, Lee H, et al. ACURATE: a guide for reporting sham controls in trials using acupuncture. J Evid Based Med, 2023, 16(1): 82-90.
2.	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.
3.	Shi GX, Yang XM, Liu CZ, et al. Factors contributing to therapeutic effects evaluated in acupuncture clinical trials. Trials, 2012, 13: 42.
4.	杨海永, 王东岩, 董旭, 等. 针刺研究中安慰针刺对照的研究现状. 中国针灸, 2020, 40(3): 337-341.
5.	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.
6.	黄梅芳, 俞昌德. 介绍国外针灸临床研究中几种安慰对照方法. 中国针灸, 2003, (10): 25-27.
7.	Lee B, Kwon CY, Lee HW, et al. The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: a systematic review and network meta-analysis. Heliyon, 2024, 10(4): e25650.
8.	Lee B, Kwon CY, Lee HW, et al. Different outcomes according to needling point location used in sham acupuncture for cancer-related pain: a systematic review and network meta-analysis. Cancers (Basel), 2023, 15(24): 5875.
9.	Lee B, Kim TH, Birch S, et al. Comparative effectiveness of acupuncture in sham-controlled trials for knee osteoarthritis: a systematic review and network meta-analysis. Front Med (Lausanne), 2023, 9: 1061878.
10.	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.
11.	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.
12.	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.
13.	Li X, Wang T, Shi W, et al. Reporting guidelines for traditional Chinese medicine could be improved: a cross-sectional study. J Clin Epidemiol, 2024, 168: 111279.
14.	李仲贤, 徐海燕, 阎路达, 等. 基于CONSORT声明、STRICTA标准、SHARE清单的针刺治疗抑郁症随机对照试验报告质量评价. 中国针灸, 2024, 44(8): 966-974.
15.	Zheng X, Ji R, Li C, et al. Efficacy of electro-acupuncture on pregnancy outcomes for women undergoing in vitro fertilization: study protocol for a pilot randomized controlled trial. Front Endocrinol (Lausanne), 2024, 15: 1380885.
16.	刘川杨, 李斌艳, 段炎珊, 等. 针刺临床试验中假针刺对照报告指南ACURATE与SHARE比较分析. 2024中国针灸学会年会论文集. 2024.
17.	刘晓玉, 马培宏, 刘保延, 等. 针刺临床试验中假针刺对照报告指南与清单(SHARE)解读. 中国循证医学杂志, 2024, 24(7): 838-844.
18.	Lee YS, Kim SY, Lee H, et al. ACURATE: A guide for reporting sham controls in trials using acupuncture. Integr Med Res, 2023, 12(2): 100955.
19.	Lee YS, Kim SY, Lee H, et al. ACURATE: a guide for reporting sham controls in trials using acupuncture. J Acupunct Meridian Stud, 2023, 16(3): 119-126.
20.	Lee YS, Kim SY, Lee H, et al. ACURATE: a guide for reporting sham controls in trials using acupuncture. Integr Med Res, 2023, 12(2): 100955.
21.	刘晓玉, 马培宏, 刘志顺, 等. 针刺临床试验中假针刺对照报告指南与清单(SHARE). 中国循证医学杂志, 2024, 24(7): 745-750.
22.	Barnes K, Wang R, Faasse K. Practitioner warmth and empathy attenuates the nocebo effect and enhances the placebo effect. Appl Psychol Health Well Being, 2024, 16(2): 421-441.
23.	Blasini M, Peiris N, Wright T, et al. The role of patient-practitioner relationships in placebo and nocebo phenomena. Int Rev Neurobiol, 2018, 139: 211-231.
24.	Linde K, Witt CM, Streng A, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain, 2007, 128(3): 264-271.
25.	Fei YT, Cao HJ, Xia RY, et al. Methodological challenges in design and conduct of randomised controlled trials in acupuncture. BMJ, 2022, 376: e064345.
26.	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.
27.	Usichenko TI, Klausenitz C, Hesse T, et al. Effectiveness of acupuncture for pain control after Cesarean section is associated with the length of experience of the acupuncturist: observational data from a randomized clinical trial. Acupunct Med, 2022, 40(6): 556-558.
28.	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.
29.	Wu J, Chen B, Yin X, et al. Effect of acupuncture on post-hemorrhoidectomy pain: a randomized controlled trial. J Pain Res, 2018 Aug 6: 11: 1489-1496.
30.	施兰君, 岗卫娟, 田紫煜, 等. 保真度及其在针灸临床研究中的应用与思考. 中国针灸, 2023, 43(7): 813-817.
31.	Hollifield M, Hsiao AF, Smith T, et al. Acupuncture for combat-related posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry, 2024, 81(6): 545-554.
32.	Hollifield M, Hsiao AF, Carrick K, et al. Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial. Trials, 2021, 22(1): 594.
33.	Cao HJ, Li X, Li XL, et al. Factors influencing participant compliance in acupuncture trials: an in-depth interview study. PLoS One, 2020, 15(4): e0231780.

1. Lee YS, Kim SY, Lee H, et al. ACURATE: a guide for reporting sham controls in trials using acupuncture. J Evid Based Med, 2023, 16(1): 82-90.
2. 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.
3. Shi GX, Yang XM, Liu CZ, et al. Factors contributing to therapeutic effects evaluated in acupuncture clinical trials. Trials, 2012, 13: 42.
4. 杨海永, 王东岩, 董旭, 等. 针刺研究中安慰针刺对照的研究现状. 中国针灸, 2020, 40(3): 337-341.
5. 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.
6. 黄梅芳, 俞昌德. 介绍国外针灸临床研究中几种安慰对照方法. 中国针灸, 2003, (10): 25-27.
7. Lee B, Kwon CY, Lee HW, et al. The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: a systematic review and network meta-analysis. Heliyon, 2024, 10(4): e25650.
8. Lee B, Kwon CY, Lee HW, et al. Different outcomes according to needling point location used in sham acupuncture for cancer-related pain: a systematic review and network meta-analysis. Cancers (Basel), 2023, 15(24): 5875.
9. Lee B, Kim TH, Birch S, et al. Comparative effectiveness of acupuncture in sham-controlled trials for knee osteoarthritis: a systematic review and network meta-analysis. Front Med (Lausanne), 2023, 9: 1061878.
10. 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.
11. 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.
12. 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.
13. Li X, Wang T, Shi W, et al. Reporting guidelines for traditional Chinese medicine could be improved: a cross-sectional study. J Clin Epidemiol, 2024, 168: 111279.
14. 李仲贤, 徐海燕, 阎路达, 等. 基于CONSORT声明、STRICTA标准、SHARE清单的针刺治疗抑郁症随机对照试验报告质量评价. 中国针灸, 2024, 44(8): 966-974.
15. Zheng X, Ji R, Li C, et al. Efficacy of electro-acupuncture on pregnancy outcomes for women undergoing in vitro fertilization: study protocol for a pilot randomized controlled trial. Front Endocrinol (Lausanne), 2024, 15: 1380885.
16. 刘川杨, 李斌艳, 段炎珊, 等. 针刺临床试验中假针刺对照报告指南ACURATE与SHARE比较分析. 2024中国针灸学会年会论文集. 2024.
17. 刘晓玉, 马培宏, 刘保延, 等. 针刺临床试验中假针刺对照报告指南与清单(SHARE)解读. 中国循证医学杂志, 2024, 24(7): 838-844.
18. Lee YS, Kim SY, Lee H, et al. ACURATE: A guide for reporting sham controls in trials using acupuncture. Integr Med Res, 2023, 12(2): 100955.
19. Lee YS, Kim SY, Lee H, et al. ACURATE: a guide for reporting sham controls in trials using acupuncture. J Acupunct Meridian Stud, 2023, 16(3): 119-126.
20. Lee YS, Kim SY, Lee H, et al. ACURATE: a guide for reporting sham controls in trials using acupuncture. Integr Med Res, 2023, 12(2): 100955.
21. 刘晓玉, 马培宏, 刘志顺, 等. 针刺临床试验中假针刺对照报告指南与清单(SHARE). 中国循证医学杂志, 2024, 24(7): 745-750.
22. Barnes K, Wang R, Faasse K. Practitioner warmth and empathy attenuates the nocebo effect and enhances the placebo effect. Appl Psychol Health Well Being, 2024, 16(2): 421-441.
23. Blasini M, Peiris N, Wright T, et al. The role of patient-practitioner relationships in placebo and nocebo phenomena. Int Rev Neurobiol, 2018, 139: 211-231.
24. Linde K, Witt CM, Streng A, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain, 2007, 128(3): 264-271.
25. Fei YT, Cao HJ, Xia RY, et al. Methodological challenges in design and conduct of randomised controlled trials in acupuncture. BMJ, 2022, 376: e064345.
26. 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.
27. Usichenko TI, Klausenitz C, Hesse T, et al. Effectiveness of acupuncture for pain control after Cesarean section is associated with the length of experience of the acupuncturist: observational data from a randomized clinical trial. Acupunct Med, 2022, 40(6): 556-558.
28. 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.
29. Wu J, Chen B, Yin X, et al. Effect of acupuncture on post-hemorrhoidectomy pain: a randomized controlled trial. J Pain Res, 2018 Aug 6: 11: 1489-1496.
30. 施兰君, 岗卫娟, 田紫煜, 等. 保真度及其在针灸临床研究中的应用与思考. 中国针灸, 2023, 43(7): 813-817.
31. Hollifield M, Hsiao AF, Smith T, et al. Acupuncture for combat-related posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry, 2024, 81(6): 545-554.
32. Hollifield M, Hsiao AF, Carrick K, et al. Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial. Trials, 2021, 22(1): 594.
33. Cao HJ, Li X, Li XL, et al. Factors influencing participant compliance in acupuncture trials: an in-depth interview study. PLoS One, 2020, 15(4): e0231780.

Chinese Journal of Evidence-Based Medicine

Latest ArticlesComparative analysis of ACURATE and SHARE reporting guidelines for sham acupuncture in clinical trials of acupuncture

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