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

This study aimed 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.

Citation： LIU Chuanyang, LI Binyan, DUAN Yanshan, ZHOU Hang, WANG Yu, TU Jianfeng, WANG Liqiong. Comparative analysis of ACURATE and SHARE reporting guidelines for sham acupuncture in clinical trials of acupuncture. Chinese Journal of Evidence-Based Medicine, 2025, 25(4): 485-490. doi: 10.7507/1672-2531.202411066 Copy

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.	楊海永, 王東巖, 董旭, 等. 針刺研究中安慰針刺對照的研究現狀. 中國針灸, 2020, 40(3): 337-341.
5.	孫俊俊, 李云芬, 朱勉生. 針灸臨床試驗中安慰針刺對照的應用現狀. 世界中醫藥, 2019, 14(8): 1959-1962, 1968.
6.	黃梅芳, 俞昌德. 介紹國外針灸臨床研究中幾種安慰對照方法. 中國針灸, 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.	劉曉玉, 閆世艷, 郭義, 等. 針刺臨床研究中模擬針刺對照報告相關指南比較分析. 針刺研究, 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.	李仲賢, 徐海燕, 閻路達, 等. 基于CONSORT聲明、STRICTA標準、SHARE清單的針刺治療抑郁癥隨機對照試驗報告質量評價. 中國針灸, 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.	劉曉玉, 馬培宏, 劉保延, 等. 針刺臨床試驗中假針刺對照報告指南與清單(SHARE)解讀. 中國循證醫學雜志, 2024, 24(7): 838-844.
17.	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.
18.	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.
19.	Lee YS, Kim SY, Lee H, et al. ACURATE: a guide for reporting sham controls in trials using acupuncture. Perspect Integr Med, 2023, 2(2): 100-106.
20.	劉曉玉, 馬培宏, 劉志順, 等. 針刺臨床試驗中假針刺對照報告指南與清單(SHARE). 中國循證醫學雜志, 2024, 24(7): 745-750.
21.	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.
22.	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.
23.	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.
24.	Fei YT, Cao HJ, Xia RY, et al. Methodological challenges in design and conduct of randomised controlled trials in acupuncture. BMJ, 2022, 376: e064345.
25.	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.
26.	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.
27.	劉曉玉, 孫承頤, 孫重陽, 等. 外科安慰手術應用指南及其對針刺臨床研究中假針刺應用的借鑒. 針刺研究, 2023, 48(4): 404-410.
28.	Wu J, Chen B, Yin X, et al. Effect of acupuncture on post-hemorrhoidectomy pain: a randomized controlled trial. J Pain Res, 2018, 11: 1489-1496.
29.	施蘭君, 崗衛娟, 田紫煜, 等. 保真度及其在針灸臨床研究中的應用與思考. 中國針灸, 2023, 43(7): 813-817.
30.	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.
31.	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.
32.	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. 楊海永, 王東巖, 董旭, 等. 針刺研究中安慰針刺對照的研究現狀. 中國針灸, 2020, 40(3): 337-341.
5. 孫俊俊, 李云芬, 朱勉生. 針灸臨床試驗中安慰針刺對照的應用現狀. 世界中醫藥, 2019, 14(8): 1959-1962, 1968.
6. 黃梅芳, 俞昌德. 介紹國外針灸臨床研究中幾種安慰對照方法. 中國針灸, 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. 劉曉玉, 閆世艷, 郭義, 等. 針刺臨床研究中模擬針刺對照報告相關指南比較分析. 針刺研究, 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. 李仲賢, 徐海燕, 閻路達, 等. 基于CONSORT聲明、STRICTA標準、SHARE清單的針刺治療抑郁癥隨機對照試驗報告質量評價. 中國針灸, 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. 劉曉玉, 馬培宏, 劉保延, 等. 針刺臨床試驗中假針刺對照報告指南與清單(SHARE)解讀. 中國循證醫學雜志, 2024, 24(7): 838-844.
17. 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.
18. 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.
19. Lee YS, Kim SY, Lee H, et al. ACURATE: a guide for reporting sham controls in trials using acupuncture. Perspect Integr Med, 2023, 2(2): 100-106.
20. 劉曉玉, 馬培宏, 劉志順, 等. 針刺臨床試驗中假針刺對照報告指南與清單(SHARE). 中國循證醫學雜志, 2024, 24(7): 745-750.
21. 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.
22. 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.
23. 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.
24. Fei YT, Cao HJ, Xia RY, et al. Methodological challenges in design and conduct of randomised controlled trials in acupuncture. BMJ, 2022, 376: e064345.
25. 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.
26. 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.
27. 劉曉玉, 孫承頤, 孫重陽, 等. 外科安慰手術應用指南及其對針刺臨床研究中假針刺應用的借鑒. 針刺研究, 2023, 48(4): 404-410.
28. Wu J, Chen B, Yin X, et al. Effect of acupuncture on post-hemorrhoidectomy pain: a randomized controlled trial. J Pain Res, 2018, 11: 1489-1496.
29. 施蘭君, 崗衛娟, 田紫煜, 等. 保真度及其在針灸臨床研究中的應用與思考. 中國針灸, 2023, 43(7): 813-817.
30. 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.
31. 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.
32. 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.

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