1.Safety and efficacy of immunoadsorption therapy for rheumatoid arthritis:a network meta-analysis and systematic review
Yin ZHENG ; Zhenhua WU ; Cheng ZHANG ; Kexin RUAN ; Xiaolin GANG ; Hong JI
Chinese Journal of Tissue Engineering Research 2026;30(5):1260-1268
OBJECTIVE:To evaluate the efficacy and safety of different immunosorbent columns in the treatment of rheumatoid arthritis through a network meta-analysis,and provide evidence-based basis for clinical diagnosis and treatment.METHODS:By computer,the databases of VIP,WanFang,CNKI,PubMed,CBM,CochraneLibrary,and Web of Science were searched for published cohort studies of immunosorbent column for the treatment of rheumatoid arthritis,with a time limit until August 2024.The quality of the included randomized controlled trials was assessed using the Cochrane5.4 manual.The quality of retrospective cohort studies were evaluated via the Newcastle-Ottawa Scale(NOS).Bayesian network meta-analysis was performed using R4.1.1 software.RESULTS:A total of 13 studies were included,with a total sample size of 891 cases,and 4 immunosorbent columns were included.The results of the network meta-analysis showed that the top three orders that reduce C-reactive protein level:HA280 adsorption column+conventional Western medicine>PH-350 adsorption column+conventional Western medicine>A protein adsorption column;the top three orders that reduce erythrocyte sedimentation rates:leukocyte adsorption column>HA280 adsorption column+conventional Western medicine>PH-350 adsorption column+conventional western medicine;the top three orders that reduce swollen joint count:leukocyte adsorption column>A protein adsorption column+conventional western medicine>PH-350 type adsorption column+conventional Western medicine;the top three orders that reduce tenderness joint counts:leukocyte adsorption column>A protein adsorption column+conventional western medicine>PH-350 adsorption column+conventional Western medicine;the top three orders that reduce patients' disease activity evaluation:PH-350 adsorption column+conventional western medicine>leukocyte adsorption column>A protein adsorption column;the top three orders that reduce visual analogue scale scores:PH-350 adsorption column+conventional Western medicine>A protein adsorption column>leukocyte adsorption column;the top three orders that reduce physician's disease activity assessment:PH-350 adsorption column+conventional Western medicine>leukocyte adsorption column>conventional Western medicine.CONCLUSION:Based on the 13 articles,in terms of reducing C-reactive protein level,HA280 adsorption column and conventional Western medicine are the preferred choice.In terms of reducing erythrocyte sedimentation rate,swollen joint count,and tender joint count,leukocyte adsorption column is the preferred choice.In terms of reducing patient's disease activity evaluation,physician's disease activity evaluation and visual analogue scale scores,PH-350 adsorption column and conventional Western medicine are the first choice.Different immunosorbent columns can be reasonably and accurately selected according to the patient's specific conditions.
2.Safety and efficacy of immunoadsorption therapy for rheumatoid arthritis:a network meta-analysis and systematic review
Yin ZHENG ; Zhenhua WU ; Cheng ZHANG ; Kexin RUAN ; Xiaolin GANG ; Hong JI
Chinese Journal of Tissue Engineering Research 2026;30(5):1260-1268
OBJECTIVE:To evaluate the efficacy and safety of different immunosorbent columns in the treatment of rheumatoid arthritis through a network meta-analysis,and provide evidence-based basis for clinical diagnosis and treatment.METHODS:By computer,the databases of VIP,WanFang,CNKI,PubMed,CBM,CochraneLibrary,and Web of Science were searched for published cohort studies of immunosorbent column for the treatment of rheumatoid arthritis,with a time limit until August 2024.The quality of the included randomized controlled trials was assessed using the Cochrane5.4 manual.The quality of retrospective cohort studies were evaluated via the Newcastle-Ottawa Scale(NOS).Bayesian network meta-analysis was performed using R4.1.1 software.RESULTS:A total of 13 studies were included,with a total sample size of 891 cases,and 4 immunosorbent columns were included.The results of the network meta-analysis showed that the top three orders that reduce C-reactive protein level:HA280 adsorption column+conventional Western medicine>PH-350 adsorption column+conventional Western medicine>A protein adsorption column;the top three orders that reduce erythrocyte sedimentation rates:leukocyte adsorption column>HA280 adsorption column+conventional Western medicine>PH-350 adsorption column+conventional western medicine;the top three orders that reduce swollen joint count:leukocyte adsorption column>A protein adsorption column+conventional western medicine>PH-350 type adsorption column+conventional Western medicine;the top three orders that reduce tenderness joint counts:leukocyte adsorption column>A protein adsorption column+conventional western medicine>PH-350 adsorption column+conventional Western medicine;the top three orders that reduce patients' disease activity evaluation:PH-350 adsorption column+conventional western medicine>leukocyte adsorption column>A protein adsorption column;the top three orders that reduce visual analogue scale scores:PH-350 adsorption column+conventional Western medicine>A protein adsorption column>leukocyte adsorption column;the top three orders that reduce physician's disease activity assessment:PH-350 adsorption column+conventional Western medicine>leukocyte adsorption column>conventional Western medicine.CONCLUSION:Based on the 13 articles,in terms of reducing C-reactive protein level,HA280 adsorption column and conventional Western medicine are the preferred choice.In terms of reducing erythrocyte sedimentation rate,swollen joint count,and tender joint count,leukocyte adsorption column is the preferred choice.In terms of reducing patient's disease activity evaluation,physician's disease activity evaluation and visual analogue scale scores,PH-350 adsorption column and conventional Western medicine are the first choice.Different immunosorbent columns can be reasonably and accurately selected according to the patient's specific conditions.
3.Liuwei Dihuangwan Promote Mitophagy to Modulate Neuroinflammation and Behavioral Impairments in Rat Model of Autism Spectrum Disorder (ASD)
Pengjue HUANG ; Mingyue JIANG ; Ji WU ; Niya YIN ; Lei OUYANG ; Qinquan ZHU ; Di ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):52-60
ObjectiveTo observe the effect of Liuwei Dihuangwan on behavioral impairments in the rat model of autism spectrum disorder (ASD) and explore the mechanism of action. MethodsTwelve SD pregnant rats were intraperitoneally injected with valproic acid (VPA) (10 rats) or normal saline (2 rats), and male offspring were selected to establish the model of ASD and the control rats. Rats were randomly assigned into model, low-dose (0.75 g·kg-1) and high-dose (1.5 g·kg-1) Liuwei Dihuangwan, vitamin D (positive drug, 3.7×10-5 g·kg-1), and blank groups. Each group was administrated with the corresponding concentration of drugs or the same volume of normal saline by gavage for 2 weeks. After the intervention, the three-chamber social test was conducted to evaluate social interaction and social preference. The open field test was carried out to observe spontaneous behavior and anxiety state. Hematoxylin-eosin staining (HE) was used to observe the pathological changes of the prefrontal tissue. Transmission electron microscopy was employed to observe the ultrastructure of mitochondria in prefrontal neurons. Immunofluorescence was used to detect the expression of ionized calcium-binding adapter molecule-1 (Iba-1) in the prefrontal tissue. Enzyme-linked immunosorbent assay (ELISA) was adopted to measure the levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). Western blot was employed to assess the expression differences of phosphorylated adenosine monophosphate-activated protein kinase (p-AMPK), adenosine monophosphate-activated protein kinase (AMPK), phosphorylated Unc-51-like autophagy-activating kinase 1 (p-ULK1), Unc-51-like autophagy-activating kinase 1 (ULK1), and FUN14 domain-containing protein 1 (FUNDC1). ResultsCompared with the blank group, the model group spent less time sniffing stranger 1 and stranger 2 in the three-chamber social test (P<0.01) and showed reductions in the total distance traveled, average speed, distance traveled in the central area, and time spent in the central area in the open field test (P<0.01). In addition, the model group showed extensive apoptosis of neurons, with shrunken nuclei and red-stained cytoplasm, and extensive necrosis of neurons in the prefrontal tissue, mitochondrial swelling, decreased matrix density, disrupted cristae, and autophagic lysosomes in neurons, increases in the rate of Iba-1 positive cells in the prefrontal area (P<0.01) and the levels of TNF-α and IL-6 (P<0.01), and down-regulation in the expression of p-AMPK/AMPK, p-ULK1/ULK1, and FUNDC1 (P<0.01). Compared with the model group, low-dose and high-dose Liuwei Dihuangwan and the vitamin D prolonged the time spent sniffing stranger 1 and stranger 2 in the three-chamber social test (P<0.05, P<0.01), increased the total distance traveled, average speed, distance traveled in the central area, and time spent in the central area in the open field test (P<0.05, P<0.01), restored the morphology of neurons in the prefrontal tissue, decreased the number of apoptotic cells, alleviated the swelling of mitochondria in neurons, increased the matrix density, mitigated the fragmentation and disorder of cristae, and increased the number of autophagosomes. Moreover, the drugs decreased the rate of Iba-1 positive cells in the prefrontal area (P<0.01), lowered the levels of TNF-α and IL-6 (P<0.01), and up-regulated the expression of p-AMPK/AMPK, p-ULK1/ULK1, and FUNDC1 (P<0.01). ConclusionLiuwei Dihuangwan ameliorate autism-like behaviors and reduce neuronal apoptosis and neuroinflammatory damage in the rat model of ASD by promoting mitophagy mediated by the AMPK/ULK1/FUNDC1 pathway.
4.Criteria for pancreas donor selection in islet transplantation and the experience of Changzheng hospital
Hanxiang ZHONG ; Junfeng DONG ; Wenyuan GUO ; Shengxian LI ; Hao YIN ; Yuanyu ZHAO ; Junsong JI
Organ Transplantation 2026;17(1):164-169
Diabetes mellitus, characterized by glucose metabolism disorders and marked by insulin deficiency or insulin resistance, has seen a continuous rise in prevalence. In recent years, islet transplantation has matured as a therapeutic approach for diabetes, becoming an important method for glycemic control and the reduction of diabetes-related complications. Donor selection directly influences transplant outcomes, and various research institutions worldwide have proposed multiple scoring systems to optimize donor assessment, such as the University of Alberta scoring system and the North American Islet Donor Score. This article explores the impact of key factors such as donor age, body mass index and ischemia time on islet transplantation. Combining practical experience in pancreatic donor selection from Shanghai Changzheng Hospital, it proposes screening criteria for pancreatic donors suitable for China, aiming to provide new evidence for improving the success rate of islet transplantation.
5.Current status and influencing factors of work readiness in patients returning to work after lung cancer surgery
Yuanyuan YIN ; Xingxia LONG ; Jie ZHANG ; Yanli, JI ; Ying ZHU ; Lijun HE ; Mei YANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(07):1079-1084
Objective To investigate the current status of work readiness and its influencing factors among patients returning to work after lung cancer surgery. Methods A retrospective study was conducted on young and middle-aged postoperative lung cancer patients who were treated at the Department of Thoracic Surgery, West China Hospital, Sichuan University from March to September 2023 and returned to their jobs. Data were collected through a general information questionnaire, readiness for return-to-work scale (RRTW), general self-efficacy scale (GSES), and simplified coping style questionnaire (SCSQ). Univariate and multivariate logistic regression analyses were used to explore the factors affecting the work readiness of patients returning to work. Results A total of 219 patients were included, with 59 males and 160 females aged 18-60 years. Among the postoperative lung cancer patients returning to work, 73.1% were in the active maintenance stage of return-to-work readiness with a RRTW score of (17.59±1.48) points, and 26.9% were in the uncertain maintenance stage with a RRTW score of (16.22±1.50) points. Multivariate logistic regression analysis showed that patients aged≤30 years (OR=52.381), employees of enterprises and institutions (OR=7.682), agricultural, pastoral, fishery, forestry laborers (OR=15.665), positive coping (OR=5.043), those with higher self-efficacy (OR=1.157) and engaged in physically demanding work (OR=2.449) had higher return-to-work readiness, while patients with≥2 children (OR=0.055), self-payment (OR=0.044), and those working more than 40 hours per week (OR=0.122) had lower return-to-work readiness. Conclusion The return-to-work readiness of young and middle-aged postoperative lung cancer patients needs to be improved, and occupation, job nature, main coping styles, general self-efficacy and other factors are associated with return-to-work readiness.
6.Differences in deltamethrin resistance and kdr gene mutation in Culex tritaeniorhynchus population in and outside the Yellow Sea wetland
Xiao-er ZHANG ; Zhi-ming WU ; Ye TIAN ; Qian CUI ; Yu-qian JI ; Huan WANG ; Shu-juan YANG ; Yi-chao ZHAO ; Yu WANG ; Hua-yu YIN ; Yu DING ; Guo-jin YAN ; Min-sen ZHAO ; Shou-gang ZHANG ; Bing-dong SONG ; Hong-na CHEN ; Jian GAO ; Wei-fang YANG ; Yu-fu ZHANG ; Hui LIU ; Hong-liang CHU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(2):101-107
Objective To gain insights into the biological characteristics of different populations of Culex tritaeniorhynchus within and around the Yellow Sea wetland from the perspective of the occurrence of resistance, we investigated the levels of resistance to deltamethrin and kdr gene mutation in the wetland and its peripheral areas. Methods Specimens were collected from Cx. tritaeniorhynchus populations at two monitoring sites in the Rare Bird National Nature Reserve and Tiaozi Ni Wetland Scenic Area, and also from two populations in Yancheng City and the Liuhe District of Nanjing, and the resistance of these mosquitoes to deltamethrin was determined using the CDC biotest bottle method. For each concentration of deltamethrin assessed, a random subset of exposed specimens was selected for amplification of the kdr gene fragment, followed by Sanger sequencing to identify and analyze resistance-associated mutations. Results The LC50 levels of deltamethrin among mosquitoes from the four populations in Luhe, Yancheng, the Rare Bird National Nature Reserve and the Tiaozi Ni Wetland Scenic Area were 2.048 5, 7.798 2, 3.473 3, and 17.695 5 mg/mL, respectively, with corresponding concentrations of deltamethrin ranging from 0.005 to 5.000,0.050 to 50.000,0.050 to 25.000 and 0.050 to 50.000 mg/mL, respectively. Furthermore, the ranges of the KT50 values were 11.76-107.43, 67.05-216.30,29.77-107.43 and 28.40-329.51 min; the 1-h knockdown rates were 34.58%-99.15%, 9.52%-43.80%, 55.09%-73.01%, and 10.09%-68.07%; and the 24-h mortality rates were 12.15%-67.52%,9.52%-79.56%,13.17%-82.21%, and 11.01%-78.99%, respectively. With respect to kdr gene mutation, we assayed a total of 63,70,59, and 57 mosquitoes for the four populations, for which we detected L1014F mutation frequencies of 14.29%, 35.00%, 20.34%, and 31.58%, respectively, with a majority of these mutations being heterozygous for resistance. In addition, five adult mosquitoes were identified has having synonymous mutations at site 1011[i. e. , AAT(asparagine)mutation to AAC(asparagine)]. Conclusions Our findings revealed the clear resistance of Cx. tritaeniorhynchus to deltamethrin in the Yancheng region of the Yellow Sea wetland, and the resistance phenotype and kdr frequency of Cx. tritaeniorhynchus in the wetland environment were comparable to those of Cx. tritaeniorhynchus in the wetland environment, thereby indicating that the resistance of different populations of Cx. tritaeniorhynchus was homogeneous under the pressure of different insecticide selection within and around the wetland. However, the underlying mechanisms need to be further studied.
7.Analysis of polonium-210 activity concentration in seafood from eastern coastal areas of China and its dose assessment
Ziyuan HE ; Liangliang YIN ; Yuhan XIE ; Yanqin JI
Chinese Journal of Radiological Health 2026;35(3):349-353
Objective To establish an alpha spectrometric method for the analysis of polonium-210 (210Po) in seafood, determine the activity concentration of 210Po in seafood from China’s eastern coastal areas, and assess the corresponding radiation doses. Methods A total of 21 types of seafood belonging to four categories (fish, shrimp, crab, and shellfish) were collected from eastern coastal cities in China. The activity concentration of 210Po in different tissues of the seafood was analyzed using the 209Po tracer-α spectrometry method. The annual effective dose was then estimated by combining seafood consumption rates and dose conversion factors. Results The activity concentrations of 210Po in the edible parts of fish, shrimp, and shellfish samples ranged from 0.65 to 17.89 Bq/kg, 0.81 to 5.95 Bq/kg, and 0.73 to 44.09 Bq/kg, respectively. In whole crab samples, the range was 1.77 to 11.43 Bq/kg. The activity concentration of 210Po in crab samples (whole crab) ranged from 1.77 to 11.43 Bq/kg. 210Po activity was mainly enriched in the head, internal organs, and shell. The annual effective ingestion dose for different age groups ranged from 91.39 to 251.33 μSv/a. Conclusion The annual effective dose resulting from 210Po ingestion via seafood consumption for residents in China’s eastern coastal regions is lower than the annual effective dose reference level recommended by the IAEA.
8.Liuwei Dihuangwan Reduces Valproic Acid-induced ASD-like Behaviors in Rats by Modulating mTOR-mediated Synaptic Plasticity in Prefrontal Cortex-hippocampus Circuit
Ji WU ; Niya YIN ; Lei OUYANG ; Siyu HE ; Fangyu PEI ; Ying XIE ; Fan LI ; Qian LEI ; Sha ZHAO ; Di ZHANG ; Qinquan ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):1-11
ObjectiveTo investigate the effects of Liuwei Dihuangwan on mammalian target of rapamycin (mTOR)-mediated synaptic plasticity in the prefrontal cortex-hippocampus circuit in the rat model of valproic acid (VPA)-induced autism spectrum disorder (ASD) and to explore its potential mechanism for reducing behavioral abnormalities in ASD rats. MethodsThirteen SD pregnant rats were randomized into the VPA group (10 rats) and the control group (3 rats). On gestational day 13, the VPA group was intraperitoneally injected with VPA solution (600 mg·kg-1), while the control group was injected with an equal volume of normal saline. Male pups of 21 days old from both groups underwent behavioral tests to screen the ASD model rats (32 rats). These rats were then randomly assigned to the model (distilled water), vitamin D (1 480 U·kg-1), low-dose (0.75 g·kg-1) Liuwei Dihuangwan, and high-dose (1.5 g·kg-1) Liuwei Dihuangwan groups, and normal male pups were selected as the blank group (distilled water), with 8 rats in each group. Each group was treated with the corresponding drug or an equal volume of distilled water via gavage daily. After drug administration, behavioral tests were conducted again, followed by anesthesia and tissue collection. Nissl staining was carried out to observe the morphological changes of neurons in the prefrontal cortex and hippocampus. Transmission electron microscopy was used to observe changes in hippocampal synaptic structure. Immunohistochemistry and Western blot were employed to determine the expression of mTOR, phosphatidylinositol 3-kinase (PI3K), and protein kinase B (Akt) in the prefrontal cortex, as well as synaptophysin-1 (SYP-1), postsynaptic density 95 (PSD95), and N-methyl-D-aspartate receptors (NMDARs) in the hippocampus. ResultsCompared with the control group, the model group exhibited severe growth retardation and developmental deformities, with abnormal behavioral performance and pathological damage to neurons and synapses in the prefrontal cortex and hippocampus. Compared with the model group, all treatment groups showed reduced behavioral abnormalities and pathological damage to neurons and synapses in the prefrontal cortex and hippocampus, with the most significant effects in the high-dose Liuwei Dihuangwan group. Immunohistochemistry and Western blotting results showed that compared with the control group, the model group exhibited significantly increased protein levels and phosphorylation ratios of p-mTOR, p-Akt, and p-PI3K in the prefrontal cortex (P<0.05, P<0.01), and decreased protein levels of SYP-1 and PSD95 and increased protein level of NMDARs in the hippocampus (P<0.01). Compared with those in the model group, the protein levels of p-mTOR, p-Akt, and p-PI3K in the prefrontal cortex decreased in the vitamin D and high-dose Liuwei Dihuangwan groups (P<0.05), and the p-mTOR/mTOR, p-Akt/Akt, and p-PI3K/PI3K ratios in the prefrontal cortex declined in the vitamin D group (P<0.05). The high-dose Liuwei Dihuangwan group showed a reduction in p-PI3K/PI3K ratio (P<0.05). The protein level of SYP-1 and PSD95 in the hippocampus increased in the vitamin D, low-dose Liuwei Dihuangwan, and high-dose Liuwei Dihuangwan groups (P<0.05, P<0.01), while the protein level of NMDARs decreased in the vitamin D and high-dose Liuwei Dihuangwan groups (P<0.01). ConclusionLiuwei Dihuangwan significantly reduces VPA-induced ASD-like behaviors and enhances the regeneration and repair of neurons in the prefrontal cortex and synaptic structures in the hippocampus by downregulating of PI3K/Akt/mTOR expression in the prefrontal cortex, upregulating SYP-1 and PSD95 expression in the hippocampus, and inhibiting NMDARs expression.
9.Analysis of Mycoplasma pneumonia nucleic acid detection results at a children's medical center in Pudong,Shanghai from 2018 to 2023
Wengao CHEN ; Zhouli XIA ; Ji MA ; Xin ZHANG ; Yin WU ; Qiuhui PAN ; Li LIU
International Journal of Laboratory Medicine 2025;46(16):2029-2034
Objective To analyze the results of three nucleic acid detection for Mycoplasma pneumoniae(MP)in children,and explore the epidemiological characteristics of MP infection as well as the features of dif-ferent MP nucleic acid detection methods.Methods A total of 8 575 children who visited the hospital from 2018 to 2023 and had results from three different MP nucleic acid detection methods were enrolled as study subjects.The differences in positive detection rates across different years,genders,and ages,as well as the differences and consistency in positive detection rates among the different MP nucleic acid detection methods,were analyzed.Results The positive detection rate of MP in 2020 and 2021 was lower than that in 2018,2019,2022,and 2023(P<0.001).The positive detection rate of MP in male patients was lower than that in female patients(P<0.05).The highest positive detection rate of MP was observed in aged 6 to<12 years,followed by aged 12 to<18 years and aged 3 to<6 years,while the lowest rate was found in aged 0 to<3 years,with a statistically significant difference(P<0.001).The MP DNA fluorescent PCR method had the highest posi-tive detection rate(23.15%),followed by the MP RNA isothermal amplification method(12.82%),and the MP RNA dual amplification method had the lowest positive detection rate(11.67%),the differences were sta-tistically significant(P<0.001).The consistency between MP DNA fluorescent PCR method and MP RNA i-sothermal amplification method was relatively the best(Kappa=0.597,P<0.001),followed by MP RNA i-sothermal amplification method and MP RNA dual amplification method(Kappa=0.564,P<0.001),the consistency between MP DNA fluorescence PCR and MP RNA double amplification was the worst(Kappa=0.466,P<0.001).Conclusion The positive rate of MP decreased significantly in 2020 and 2021,and the posi-tive rate of MP was the highest in 6 to<12 years old.There were significant differences in the positive rate of MP among different nucleic acid detection methods.
10.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
Journal of Integrative Medicine 2025;23(6):630-640
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*
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Humans
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Randomized Controlled Trials as Topic
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Placebo Effect
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Placebos
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Treatment Outcome


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