Interpretation of SHam Acupuncture REporting (SHARE) guidelines and a checklist in clinical trials_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Xiaoyu ¹ , MA Peihong ² ,  LIU Baoyan ³ ,  YAN Shiyan ^1,4

1. School of Acupuncture-Moxibustion and Tuina, 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. China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
4. International Institute of Acupuncture Innovation, Beijing University of Chinese Medicine, Beijing 100105, P. R. China;

Corresponding author：

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

Keywords：

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

DOI：

10.7507/1672-2531.202401166

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

In order to standardize the reporting of sham acupuncture and improve the quality of reporting of sham acupuncture, Beijing University of Chinese Medicine has developed a specific reporting guideline for sham acupuncture: SHam Acupuncture REporting (SHARE) which contains ten categories with nineteen items. This paper introduces the development methods and main contents of the guidelines to provide a reference for researchers to correctly understand and reasonably apply the guidelines.

Citation： LIU Xiaoyu, MA Peihong, LIU Baoyan, YAN Shiyan. Interpretation of SHam Acupuncture REporting (SHARE) guidelines and a checklist in clinical trials. Chinese Journal of Evidence-Based Medicine, 2024, 24(7): 838-844. doi: 10.7507/1672-2531.202401166 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.	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.
4.	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.
5.	Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
6.	Endres HG, Böwing G, Diener HC, et al. Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial. J Headache Pain, 2007, 8(5): 306-314.
7.	王京京, 宋玉静, 吴中朝, 等. 针刺对慢性疲劳综合征患者疲劳程度影响的随机对照观察. 针刺研究, 2009, 34(2): 120-124.
8.	Teoh AYB, Chong CCN, Leung WW, et al. Electroacupuncture-reduced sedative and analgesic requirements for diagnostic EUS: a prospective, randomized, double-blinded, sham-controlled study. Gastrointest Endosc, 2018, 87(2): 476-485.
9.	Deng G, Giralt S, Chung DJ, et al. Acupuncture for reduction of symptom burden in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation: a randomized sham-controlled trial. Support Care Cancer, 2018, 26(2): 657-665.
10.	Liu Y, Liu L, Wang X. Electroacupuncture at points Baliao and Huiyang (BL35) for post-stroke detrusor overactivity. Neural Regen Res, 2013, 8(18): 1663-1672.
11.	Qin Z, Ding Y, Xu C, et al. Acupuncture vs. noninsertive sham acupuncture in aging patients with degenerative lumbar spinal stenosis: a randomized controlled trial. Am J Med, 2020, 133(4): 500-507.
12.	韩莹, 周友龙, 郭现辉, 等. 三阴交穴真假针刺对原发性痛经镇痛作用临床观察. 中国针灸, 2015, 35(4): 318-322.
13.	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.
14.	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.
15.	Vas J, Aranda JM, Modesto M, et al. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial. Pain, 2012, 153(9): 1883-1889.
16.	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.
17.	Liang Z, Zhu X, Yang X, et al. Assessment of a traditional acupuncture therapy for chronic neck pain: a pilot randomised controlled study. Complement Ther Med, 2011, 19(Suppl 1): S26-S32.
18.	McDonald JL, Smith PK, Smith CA, et al. Effect of acupuncture on house dust mite specific IgE, substance P, and symptoms in persistent allergic rhinitis. Ann Allergy Asthma Immunol, 2016, 116(6): 497-505.
19.	Smith CA, de Lacey S, Chapman M, et al. Effect of acupuncture vs sham acupuncture on live births among women undergoing in vitro fertilization: a randomized clinical trial. JAMA, 2018, 319(19): 1990-1998.
20.	Mao JJ, Bowman MA, Xie SX, et al. Electroacupuncture versus gabapentin for hot flashes among breast cancer survivors: a randomized placebo-controlled trial. J Clin Oncol, 2015, 33(31): 3615-3620.
21.	Yin C, Seo B, Park HJ, et al. Acupuncture, a promising adjunctive therapy for essential hypertension: a double-blind, randomized, controlled trial. Neurol Res, 2007, 29(Suppl 1): S98-S103.
22.	Liu Z, Yan S, Wu J, et al. Acupuncture for chronic severe functional constipation: a randomized trial. Ann Intern Med, 2016, 165(11): 761-769.
23.	Yang JW, Wang LQ, Zou X, et al. Effect of acupuncture for postprandial distress syndrome: a randomized clinical trial. Ann Intern Med, 2020, 172(12): 777-785.
24.	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.
25.	Wells M, Williams B, Treweek S, et al. Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions. Trials, 2012, 13: 95.
26.	马彦韬, 赵佳敏, 黄强民, 等. 针刺肌筋膜疼痛激痛点治疗髌股疼痛综合征的疗效: 随机对照试验. 中国疼痛医学杂志, 2019, 25(12): 919-923.
27.	Paterson C, Britten N. Acupuncture as a complex intervention: a holistic model. J Altern Complement Med, 2004, 10(5): 791-801.
28.	de Luca AC, da Fonseca AM, Lopes CM, et al. Acupuncture-ameliorated menopausal symptoms: single-blind, placebo-controlled, randomized trial. Climacteric, 2011, 14(1): 140-145.
29.	Takakura N, Takayama M, Nasu M, et al. Patient blinding with blunt tip placebo acupuncture needles: comparison between 1 mm and 2 mm skin press. J Integr Med, 2018, 16(3): 164-171.
30.	Boutron I, Guittet L, Estellat C, et al. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med, 2007, 4(2): e61.
31.	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.
32.	Painovich JM, Shufelt CL, Azziz R, et al. A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause. Menopause, 2012, 19(1): 54-61.
33.	刘晓玉, 闫世艳, 刘保延. 针刺临床研究中的假针刺与安慰针刺. 中国针灸, 2023, 43(7): 821-824.
34.	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.

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. 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.
4. 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.
5. Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
6. Endres HG, Böwing G, Diener HC, et al. Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial. J Headache Pain, 2007, 8(5): 306-314.
7. 王京京, 宋玉静, 吴中朝, 等. 针刺对慢性疲劳综合征患者疲劳程度影响的随机对照观察. 针刺研究, 2009, 34(2): 120-124.
8. Teoh AYB, Chong CCN, Leung WW, et al. Electroacupuncture-reduced sedative and analgesic requirements for diagnostic EUS: a prospective, randomized, double-blinded, sham-controlled study. Gastrointest Endosc, 2018, 87(2): 476-485.
9. Deng G, Giralt S, Chung DJ, et al. Acupuncture for reduction of symptom burden in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation: a randomized sham-controlled trial. Support Care Cancer, 2018, 26(2): 657-665.
10. Liu Y, Liu L, Wang X. Electroacupuncture at points Baliao and Huiyang (BL35) for post-stroke detrusor overactivity. Neural Regen Res, 2013, 8(18): 1663-1672.
11. Qin Z, Ding Y, Xu C, et al. Acupuncture vs. noninsertive sham acupuncture in aging patients with degenerative lumbar spinal stenosis: a randomized controlled trial. Am J Med, 2020, 133(4): 500-507.
12. 韩莹, 周友龙, 郭现辉, 等. 三阴交穴真假针刺对原发性痛经镇痛作用临床观察. 中国针灸, 2015, 35(4): 318-322.
13. 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.
14. 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.
15. Vas J, Aranda JM, Modesto M, et al. Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial. Pain, 2012, 153(9): 1883-1889.
16. 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.
17. Liang Z, Zhu X, Yang X, et al. Assessment of a traditional acupuncture therapy for chronic neck pain: a pilot randomised controlled study. Complement Ther Med, 2011, 19(Suppl 1): S26-S32.
18. McDonald JL, Smith PK, Smith CA, et al. Effect of acupuncture on house dust mite specific IgE, substance P, and symptoms in persistent allergic rhinitis. Ann Allergy Asthma Immunol, 2016, 116(6): 497-505.
19. Smith CA, de Lacey S, Chapman M, et al. Effect of acupuncture vs sham acupuncture on live births among women undergoing in vitro fertilization: a randomized clinical trial. JAMA, 2018, 319(19): 1990-1998.
20. Mao JJ, Bowman MA, Xie SX, et al. Electroacupuncture versus gabapentin for hot flashes among breast cancer survivors: a randomized placebo-controlled trial. J Clin Oncol, 2015, 33(31): 3615-3620.
21. Yin C, Seo B, Park HJ, et al. Acupuncture, a promising adjunctive therapy for essential hypertension: a double-blind, randomized, controlled trial. Neurol Res, 2007, 29(Suppl 1): S98-S103.
22. Liu Z, Yan S, Wu J, et al. Acupuncture for chronic severe functional constipation: a randomized trial. Ann Intern Med, 2016, 165(11): 761-769.
23. Yang JW, Wang LQ, Zou X, et al. Effect of acupuncture for postprandial distress syndrome: a randomized clinical trial. Ann Intern Med, 2020, 172(12): 777-785.
24. 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.
25. Wells M, Williams B, Treweek S, et al. Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions. Trials, 2012, 13: 95.
26. 马彦韬, 赵佳敏, 黄强民, 等. 针刺肌筋膜疼痛激痛点治疗髌股疼痛综合征的疗效: 随机对照试验. 中国疼痛医学杂志, 2019, 25(12): 919-923.
27. Paterson C, Britten N. Acupuncture as a complex intervention: a holistic model. J Altern Complement Med, 2004, 10(5): 791-801.
28. de Luca AC, da Fonseca AM, Lopes CM, et al. Acupuncture-ameliorated menopausal symptoms: single-blind, placebo-controlled, randomized trial. Climacteric, 2011, 14(1): 140-145.
29. Takakura N, Takayama M, Nasu M, et al. Patient blinding with blunt tip placebo acupuncture needles: comparison between 1 mm and 2 mm skin press. J Integr Med, 2018, 16(3): 164-171.
30. Boutron I, Guittet L, Estellat C, et al. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med, 2007, 4(2): e61.
31. 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.
32. Painovich JM, Shufelt CL, Azziz R, et al. A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause. Menopause, 2012, 19(1): 54-61.
33. 刘晓玉, 闫世艳, 刘保延. 针刺临床研究中的假针刺与安慰针刺. 中国针灸, 2023, 43(7): 821-824.
34. 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.

Chinese Journal of Evidence-Based Medicine

Interpretation of SHam Acupuncture REporting (SHARE) guidelines and a checklist in clinical trials

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content