Specific effect of inserted sham acupuncture and its impact on the estimation of acupuncture treatment effect in randomized controlled trials: A systematic survey.

Xiao-Chao LUO; Jia-Li LIU; Ming-Hong YAO; Ye-Meng CHEN; Arthur Yin FAN; Fan-Rong LIANG; Ji-Ping ZHAO; Ling ZHAO; Xu ZHOU; Xiao-Ying ZHONG; Jia-Hui YANG; Bo LI; Ying ZHANG; Xin SUN; Ling LI

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Specific effect of inserted sham acupuncture and its impact on the estimation of acupuncture treatment effect in randomized controlled trials: A systematic survey.

Author: Xiao-Chao LUO ¹ ; Jia-Li LIU ¹ ; Ming-Hong YAO ¹ ; Ye-Meng CHEN ² ; Arthur Yin FAN ³ ; Fan-Rong LIANG ⁴ ; Ji-Ping ZHAO ⁵ ; Ling ZHAO ⁴ ; Xu ZHOU ⁶ ; Xiao-Ying ZHONG ⁷ ; Jia-Hui YANG ⁸ ; Bo LI ⁹ ; Ying ZHANG ¹⁰ ; Xin SUN ¹¹ ; Ling LI ¹²
Author Information

1. Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, Cochrane China Center and MAGIC China Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China; NMPA Key Laboratory for Real-world Data Research and Evaluation in Hainan, Chengdu 610041, Sichuan Province, China; Sichuan Center of Technology Innovation for Real-world Data, Chengdu 610041, Sichuan Province, China.
2. New York College of Traditional Chinese Medicine, Mineola, NY 11501, USA.
3. McLean Center for Complementary and Alternative Medicine, PLC, Vienna, VA 22182, USA.
4. Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, Sichuan Province, China.
5. Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
6. Evidence-based Medicine Research Center, School of Basic Science, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, Jiangxi Province, China.
7. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
8. College of Acupuncture and Massage, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, Jiangxi Province, China.
9. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China; National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China.
10. Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
11. Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, Cochrane China Center and MAGIC China Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China; NMPA Key Laboratory for Real-world Data Research and Evaluation in Hainan, Chengdu 610041, Sichuan Province, China; Sichuan Center of Technology Innovation for Real-world Data, Chengdu 610041, Sichuan Province, China; Department of Epidemiology and Biostatistics, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China. Electronic address: sunxin@wchscu.cn.
12. Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, Cochrane China Center and MAGIC China Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China; NMPA Key Laboratory for Real-world Data Research and Evaluation in Hainan, Chengdu 610041, Sichuan Province, China; Sichuan Center of Technology Innovation for Real-world Data, Chengdu 610041, Sichuan Province, China; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON L8S 4K1, Canada. Electronic address: liling@wchscu.cn.
Publication Type:Meta-Analysis
Keywords: Acupuncture; Placebos; Randomized controlled trial; Treatment outcome
MeSH: Acupuncture Therapy/methods*; Humans; Randomized Controlled Trials as Topic; Placebo Effect; Placebos; Treatment Outcome
From: Journal of Integrative Medicine 2025;23(6):630-640
CountryChina
Language:English
Abstract: BACKGROUND:The use of inserted sham acupuncture as a placebo in randomized controlled trials (RCTs) is controversial, because it may produce specific effects that cause an underestimation of the effect of acupuncture treatment.
OBJECTIVE:This systematic survey investigates the magnitude of insert-specific effects of sham acupuncture and whether they affect the estimation of acupuncture treatment effects.
SEARCH STRATEGY:PubMed, Embase and Cochrane Central Register of Controlled Trials were searched to identify acupuncture RCTs from their inception until December 2022.
INCLUSION CRITERIA:RCTs that evaluated the effects of acupuncture compared to sham acupuncture and no treatment.
DATA EXTRACTION AND ANALYSIS:The total effect measured for an acupuncture treatment group in RCTs were divided into three components, including the natural history and/or regression to the mean effect (controlled for no-treatment group), the placebo effect, and the specific effect of acupuncture. The first two constituted the contextual effect of acupuncture, which is mimicked by a sham acupuncture treatment group. The proportion of acupuncture total effect size was considered to be 1. The proportion of natural history and/or regression to the mean effect (PNE) and proportional contextual effect (PCE) of included RCTs were pooled using meta-analyses with a random-effect model. The proportion of acupuncture placebo effect was the difference between PCE and PNE in RCTs with non-inserted sham acupuncture. The proportion of insert-specific effect of sham acupuncture (PIES) was obtained by subtracting the proportion of acupuncture placebo effect and PNE from PCE in RCTs with inserted sham acupuncture. The impact of PIES on the estimation of acupuncture's treatment effect was evaluated by quantifying the percentage of RCTs that the effect of outcome changed from no statistical difference to statistical difference after removing PIES in the included studies, and the impact of PIES was externally validated in other acupuncture RCTs with an inserted sham acupuncture group that were not used to calculate PIES.
RESULTS:This analysis included 32 studies with 5492 patients. The overall PNE was 0.335 (95% confidence interval [CI], 0.255-0.415) and the PCE of acupuncture was 0.639 (95% CI, 0.567-0.710) of acupuncture's total effect. The proportional contribution of the placebo effect to acupuncture's total effect was 0.191, and the PIES was 0.189. When we modeled the exclusion of the insert-specific effect of sham acupuncture, the acupuncture treatment effect changed from no difference to a significant difference in 45.45% of the included RCTs, and in 40.91% of the external validated RCTs.
CONCLUSION:The insert-specific effect of sham acupuncture in RCTs represents 18.90% of acupuncture's total effect and significantly affects the evaluation of the acupuncture treatment effect. More than 40% of RCTs that used inserted sham acupuncture would draw different conclusions if the PIES had been controlled for. Considering the impact of the insert-specific effect of sham acupuncture, caution should be taken when using inserted sham acupuncture placebos in RCTs. Please cite this article as: Luo XC, Liu JL, Yao MH, Chen YM, Fan AY, Liang FR, Zhao JP, Zhao L, Zhou X, Zhong XY, Yang JH, Li B, Zhang Y, Sun X, Li L. Specific effect of inserted sham acupuncture and its impact on the estimation of acupuncture treatment effect in randomized controlled trials: A systematic survey. J Integr Med. 2025; 23(6):630-640.