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.
Acupuncture Therapy/methods* ; Humans ; Randomized Controlled Trials as Topic ; Placebo Effect ; Placebos ; Treatment Outcome

Objective:To study the effects of modified maxillary protraction therapy on the changes in facial soft tissue in patients with maxillary hypoplasia using cephalometric measurements.Methods:26 cases(16 males and 10 females)of Class Ⅲ skeletal malocclu-sion with maxillary hypoplasia during the later period of pubertal peak(CVM Ⅴ to Ⅵ)were included.Treatment was carried out using modified palatal anchorage with a combination of a modified bite-jumping appliance and bilateral maxillary anterior traction.Cephalo-metric measurements were taken before and after treatment using lateral cephalograms,the changes in facial soft tissue-related parame-ters were compared.Results:(1)After treatment,the measurements of soft tissue landmarks in the midfacial region showed a signifi-cant increase(P＜0.05),with the average anterior movement exceeding 3 mm for the nasal tip,subnasale,soft tissue A point and upper lip protrusion point.(2)The changes in the G-Sn-Pos,Ns-Prn-Pos,and S-Ns-Sn were highly significant(P＜0.01),with an average increase in the G-Sn-Pos of 3.23°±3.74°,a decrease in Ns-Prn-Pos of 2.56°±4.99°,and an average increase in S-Ns-Sn of 2.63° ±3.39°.(3)Changes in soft tissue tension and facial height proportion after treatment were not statistically significant(P＞0.05).Con-clusion:The use of a modified pad type intraoral appliance in conjunction with bilateral maxillary anterior traction can effectively pro-mote the improvement of mid facial soft tissue profile in patients with maxillary underdevelopment during the peak growth and develop-ment period,and coordinate the relationship between nasal,lip and chin soft tissue.