1.Current situation of clinical trial registration in acupuncture anesthesia: A scoping review.
Yue LI ; You-Ning LIU ; Zhen GUO ; Mu-En GU ; Wen-Jia WANG ; Yi ZHU ; Xiao-Jun ZHUANG ; Li-Ming CHEN ; Jia ZHOU ; Jing LI
Journal of Integrative Medicine 2025;23(3):256-263
BACKGROUND:
Modern acupuncture anesthesia is a combination of Chinese and Western medicine that integrates the theories of acupuncture with anesthesia. However, some clinical studies of acupuncture anesthesia lack specific descriptions of randomization, allocation concealment, and blinding processes, with subsequent systematic reviews indicating a risk of bias.
OBJECTIVE:
Clinical trial registration is essential for the enhancement of the quality of clinical trials. This study aims to summarize the status of clinical trial registrations for acupuncture anesthesia listed on the World Health Organization International Clinical Trials Registry Platform (ICTRP).
SEARCH STRATEGY:
We searched the ICTRP for clinical trials related to acupuncture anesthesia registered between January 1, 2001 and May 31, 2023. Additionally, related publications were retrieved from PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Data. Registrations and publications were analyzed for consistency in trial design characteristics.
INCLUSION CRITERIA:
Clinical trials that utilized one of several acupuncture-related therapies in combination with pharmacological anesthesia during the perioperative period were eligible for this review.
DATA EXTRACTION AND ANALYSIS:
Data extracted from articles included type of surgical procedure, perioperative symptoms, study methodology, type of intervention, trial recruitment information, and publication information related to clinical enrollment.
RESULTS:
A total of 166 trials related to acupuncture anesthesia from 21 countries were included in the analysis. The commonly reported symptoms in the included studies were postoperative nausea and vomiting (19.9%) and postoperative pain (13.3%). The concordance between the publications and the trial protocols in the clinical registry records was poor, with only 31.7% of the studies being fully compatible. Inconsistency rates were high for sample size (39.0%, 16/41), blinding (36.6%, 15/41), and secondary outcome indicators (24.4%, 10/41).
CONCLUSION
The volume of acupuncture anesthesia clinical trials registered in international trial registries over the last 20 years is low, with insufficient disclosure of results. Postoperative nausea and vomiting as well as postoperative pain, are the most investigated for acupuncture intervention. Please cite this article as: Li Y, Liu YN, Guo Z, Gu ME, Wang WJ, Zhu Y, Zhuang XJ, Chen LM, Zhou J, Li J. Current situation of clinical trial registration in acupuncture anesthesia: A scoping review. J Integr Med. 2025; 23(3): 256-263.
Humans
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Acupuncture Analgesia
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Acupuncture Therapy
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Anesthesia
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Clinical Trials as Topic
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Registries
2.Effects of moxibustion on the P2X7R/STAT3/VEGF pathway in rats with colitis-associated colon cancer
Ya-Ying LIN ; Di WANG ; Huan-Gan WU ; Mu-En GU ; Qi LI ; Zhe MA ; Yan HUANG ; Yuan LU ; Kun-Shan LI ; Lu-Yi WU
Journal of Acupuncture and Tuina Science 2021;19(2):83-94
Objective: To observe the effects of herb-partitioned moxibustion and ginger-partitioned moxibustion on the growth of colon tumors in rats with colitis-associated colon cancer (CACC), and explore the mechanism of moxibustion intervening CACC through the purinergic receptor P2X ligand-gated ion channel 7 (P2X7R)/signal transducer and activator of transcription 3 (STAT3)/vascular endothelial growth factor (VEGF) pathway. Methods: A total of 26 male Sprague-Dawley rats were selected. According to the random number table method, 6 rats were selected as the normal group. The remaining 20 rats were injected intraperitoneally with azoxymethane (AOM) combined with oral dextran sodium sulfate (DSS) to prepare the CACC model. After the model was successfully established, 2 rats were randomly selected for model identification. The remaining 18 rats which were successfully modeled were randomly divided into a model group, a herb-partitioned moxibustion group and a ginger-partitioned moxibustion group, with 6 rats in each group. Moxibustion intervention was performed in the herb-partitioned moxibustion group and the ginger-partitioned moxibustion group at Qihai (CV 6) and bilateral Tianshu (ST 25). Moxibustion was performed twice at each point each time, once a day, at a 1-day interval after 6 consecutive interventions, for a total of 30 interventions. After intervention, the colon tumor load, pathological change and histopathological score were observed. Immunohistochemistry was used to detect the expressions of VEGF, P2X7R, phospho-STAT3 (p-STAT3), and nuclear factor-kappa B p65 (NF-κB p65) proteins in rat colon tissue. Western blot was used to detect the levels of p-STAT3 and NF-κB p65 proteins in rat colon tissue. Results: Compared with the normal group, the colon tumor load and histopathological score in the model group were significantly increased (both P<0.001), and different grades of dysplasia were observed in colon tissue from the model group, reaching the degree of adenocarcinoma; the expression level of P2X7R protein in colon tissue was significantly decreased (P<0.001), and the expression levels of p-STAT3, NF-κB p65 and VEGF proteins were significantly increased (all P<0.001) in the model group. Compared with the model group, the colon tumor load, colon histopathological score and the levels of p-STAT3, NF-κB p65 and VEGF proteins in colon tissue were significantly decreased (all P<0.05) in the herb-partitioned moxibustion group and the ginger-partitioned moxibustion group while the expression levels of P2X7R protein in colon tissue were significantly increased (both P<0.05). Conclusion: Both herb-partitioned moxibustion and ginger-partitioned moxibustion can reduce the colon tumor load in CACC rats and delay the progression of colon adenomas. The mechanism may be mediated by the P2X7R/STAT3 pathway to inhibit STAT3 phosphorylation, thereby reducing VEGF protein expression.
5.Analysis of clinical characteristics of patients with chronic critical illness after sepsis
Liang CHEN ; Rijin CAO ; Jinli WANG ; Xingwen LU ; En MU
Chinese Critical Care Medicine 2021;33(12):1414-1417
Objective:To investigate the clinical characteristics of patients who develop chronic critical illness (CCI) after sepsis.Methods:The survival patients with sepsis admitted to the department of critical medicine of Baoan Central Hospital of Shenzhen for the first time from April 2019 to October 2020 were enrolled. According to clinical outcomes, patients were divided into CCI group [intensive care unit (ICU) stay ≥14 days, with persistent organ dysfunction] and rapid recovery (RAP) group. The baseline characteristic on admission and clinical outcomes of patients in the two groups were collected and compared. Blood samples were collected to measure serum interleukins (IL-6, IL-10) levels and peripheral blood lymphocyte count (LYM) count were obtained from all patients after admission. The differences of above indexes on the 1st, 7th and 14th day in ICU between the two groups were compared, the 180 day cumulative survival rate of the two groups was observed.Results:① Twenty-two septic patients developed CCI and 28 patients with RAP were included. There were no significant differences in gender and infection site between the two groups. The age, acute physiology and chronic health evaluationⅡ(APACHEⅡ), sequential organ failure assessment (SOFA), proportion of septic shock, mechanical ventilation time, length of ICU stay, total length of hospital stay and proportion of secondary infection of CCI patients were higher than those in RAP group [age (years old): 61.0±13.8 vs. 50.3±13.9, proportion of patients aged ≥ 65 years old: 54.5% (12/22) vs. 25.0% (7/28), APACHEⅡscore: 20.5±4.4 vs. 14.4±4.3, SOFA score: 10 (7, 12) vs. 5 (3, 8), septic shock ratio: 40.9% (9/22) vs. 17.9% (5/28), time of mechanical ventilation (days): 18.5 (12.0, 28.0) vs. 5.0 (3.0, 7.0), length of ICU stay (days): 26 (18, 46) vs. 8 (6, 12), total length of hospital stay (days): 31 (26, 51) vs. 14 (12, 17), secondary infection ratio: 72.7% (16/22) vs. 7.1% (2/28), all P < 0.05]. ② The IL-6 levels of CCI group were higher than that of RAP group at all time points (ng/L: 176.86±103.54 vs. 113.32±71.34 on the 1st day, 84.72±46.06 vs. 54.98±26.61 on the 7th day, 44.28±20.20 vs. 17.76±4.70 on the 14th day, all P < 0.05). On the 1st and 7th day of admission, there were no significant differences in IL-10 and LYM levels between the two groups. On the 14th day of admission, IL-10 levels in CCI group were higher than that in RAP group (ng/L: 15.09±3.61 vs. 8.92±1.98, P < 0.05), while LYM was relatively lower [×10 9/L: 0.62 (0.43, 1.02) vs. 1.17 (0.93, 1.71), P < 0.05]. ③ The Log-Rank test results of Kaplan-Meier survival curve showed that the 180-day cumulative survival rate of CCI group was significantly lower than that of RAP group (63.6% vs. 96.4%, Log-Rank:χ 2 = 9.024, P = 0.007). Conclusions:Septic patients with advanced age, high APAHCEⅡscore and high SOFA score are prone to secondary CCI, resulting in long hospital stay, high secondary infection rate and poor prognosis. The occurrence of CCI may be related to the continuous expression of proinflammatory mediators and subsequent immunosuppression.
6.Risk of anticoagulation therapy in surgical intensive care unit patients predicted by thromboelastograph.
Zixia WU ; Zhiyong LIU ; Wei ZHANG ; Wenzheng ZHANG ; En MU
Chinese Critical Care Medicine 2018;30(7):658-661
OBJECTIVE:
To explore the correlation between thromboelastography (TEG) parameters and the risk of venous thromboembolism (VTE) and bleeding in patients receiving anticoagulant therapy in surgical intensive care unit (SICU).
METHODS:
205 patients received low molecular weight heparin (LMWH) anticoagulant therapy admitted to SICU of Tianjin Hospital from December 2016 to December 2017 were consecutively enrolled. TEG detection was performed in all patients at 1 day after anticoagulation therapy, and coagulation reaction time (R value), blood clot generation time (K value), blood clot generation rate (α angle) and maximum width value (MA value) were recorded. At the same time, the traditional coagulation function test was carried out, and prothrombin time (PT), activated partial thromboplastin time (APTT) and D-dimer levels were also recorded. The incidence of deep venous thrombosis (DVT), pulmonary embolism (PE) and bleeding during hospitalization were observed. Multivariate Logistic regression analysis was used to analyze the risk factors for VTE and bleeding in patients receiving anticoagulant therapy.
RESULTS:
Of 205 patients, during the anticoagulant treatment, 14 patients developed DVT, and 4 patients with PE (2 of them were combined with DVT) with an incidence of 7.8% (16/205). There were 2 patients suffering from cerebral hemorrhage, 2 patients with gastric bleeding, and 1 patient with intra-tracheal hemorrhage with an incidence of 2.4% (5/205). Compared with the patients without VTE or bleeding, the R value of TEG in patients with VTE was significantly lowered (minutes: 4.6±2.2 vs. 7.4±1.4, P < 0.01), which was significantly increased in patients with hemorrhagic complications (minutes: 12.1±1.1 vs. 7.4±1.4, P < 0.01). There was no significant difference in the K value, α angle, MA value of TEG, or PT, APTT, D-dimer between the patients with and without VTE or bleeding. Multivariate Logistic regression analysis revealed that the R value of TEG was independent risk factor for incidence of VTE and hemorrhagic complication in SICU patients who receiving anticoagulation therapy [VTE: β = 0.386, odds ratio (OR) = 1.096, 95% confidence interval (95%CI) = 1.021-2.361, P = 0.006; hemorrhagic complication: β = -1.213, OR = 1.051, 95%CI = 1.017-3.458, P = 0.045].
CONCLUSIONS
The R value of TEG is associated with the occurrence of VTE and hemorrhagic complications in patients receiving anticoagulant therapy in SICU.
Anticoagulants
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Critical Care
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Heparin, Low-Molecular-Weight
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Humans
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Pulmonary Embolism
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Risk Factors
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Thrombelastography
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Venous Thromboembolism
7. Risk of anticoagulation therapy in surgical intensive care unit patients predicted by thromboelastograph
Zixia WU ; Zhiyong LIU ; Wei ZHANG ; Wenzheng ZHANG ; En MU
Chinese Critical Care Medicine 2018;30(7):658-661
Objective:
To explore the correlation between thromboelastography (TEG) parameters and the risk of venous thromboembolism (VTE) and bleeding in patients receiving anticoagulant therapy in surgical intensive care unit (SICU).
Methods:
205 patients received low molecular weight heparin (LMWH) anticoagulant therapy admitted to SICU of Tianjin Hospital from December 2016 to December 2017 were consecutively enrolled. TEG detection was performed in all patients at 1 day after anticoagulation therapy, and coagulation reaction time (R value), blood clot generation time (K value), blood clot generation rate (α angle) and maximum width value (MA value) were recorded. At the same time, the traditional coagulation function test was carried out, and prothrombin time (PT), activated partial thromboplastin time (APTT) and D-dimer levels were also recorded. The incidence of deep venous thrombosis (DVT), pulmonary embolism (PE) and bleeding during hospitalization were observed. Multivariate Logistic regression analysis was used to analyze the risk factors for VTE and bleeding in patients receiving anticoagulant therapy.
Results:
Of 205 patients, during the anticoagulant treatment, 14 patients developed DVT, and 4 patients with PE (2 of them were combined with DVT) with an incidence of 7.8% (16/205). There were 2 patients suffering from cerebral hemorrhage, 2 patients with gastric bleeding, and 1 patient with intra-tracheal hemorrhage with an incidence of 2.4% (5/205). Compared with the patients without VTE or bleeding, the R value of TEG in patients with VTE was significantly lowered (minutes: 4.6±2.2 vs. 7.4±1.4,
8.Awareness of diabetes and its influencing factors among the elderly population in Shanghai rural community
Chao-Yu ZHU ; Yue-Qin MAO ; Chun-Jun MA ; Zhi-Jun ZHU ; Mu-Song LIU ; En-Fang FAN ; Li WEI
Chinese Journal of Clinical Medicine 2017;24(4):611-614
Objective:To investigate the awareness of diabetes and to explore the influencing factors of it among the elderly population in Shanghai rural community.Methods:A cross-sectional study method was used in the research.Epidemiological investigation was undertaken in residents of 40-75 years old in Yunsong Commuinity of Pudong New Area in March to April,2014.Among the population,diabetic patients were selected to conducted questionnaire survey,physical examination,and laboratory testing.Objective:A total of 256 diabetic patients completed questionnaires.The awareness rate of diabetes was 50.78%(130/256).The awareness rate of diabetes indicated that the statistical significance was found in patients with different educational background,blood lipid level,fasting blood-glucose level,HbA1c and exercise habits(P<0.05).The multi-factor logistic stepwise regression analysis showed that the educational level,glycosylated hemoglobin level and exercise habits were the main independent influencing factors for the awareness rate of diabetes.Conclusions:The level of awareness rate of diabetes in Shanghai Yunsong community is in the moderate level.Education should be strengthened to increase the rate of diabetes awareness for patients with low educational background,worse glucose control and no exercise habit.
9.The application of regional citrate anti-coagulation for continuous veno-venous hemofiltration in severe trauma patients
Zixia WU ; En MU ; Xin WENG ; Zhonghui ZHANG ; Zhiyong LIU ; Zhenming ZHANG ; Jian WANG ; Yi LIU ; Wei ZHANG ; Jin LU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2016;23(3):307-309
Objective To investigate the efficacy and safety of regional citrate anticoagulation (RCA) for continuous veno-venous hemofiltration (CVVH) in patients with severe trauma.Methods Sixty-four patients with severe trauma who needed to apply continuous renal replacement therapy (CRRT) and were admitted into the department of critical care medicine in Tianjin Hospital from June 2013 to August 2015 were enrolled in the study.According to the patient's actual condition,they were divided into two groups:no anticoagulant group (29 cases) and RCA group (35 cases).The filter lifetime,after treatment the activated partial thromboplastin time (APTT),acid-base balance,free calcium ([Ca2+]i) and serum sodium (Na+) concentrations,bleeding episodes were compared between the two groups.Results The average filter lifetime in RCA group was longer than that in no anticoagulant group (hours:50.7 ± 11.3 vs.4.9 ± 1.2,P < 0.01).After the end of treatment,the levels of APTT (s:30.7 ± 8.8 vs.32.1 ± 7.3),pH value (7.41 ± 0.09 vs.7.40 ± 0.07),[Ca2+]i (mmol/L:2.13 ± 0.20 vs.2.21 ± 0.17),and Na+ (mmol/L:139 ± 8 vs.141 ± 6) were ofno significant differences between the RCA group and the no anticoagulant group (all P > 0.05).The incidence of clinicalbleeding in RCA group was lower than that in no anticoagulant group [2.9% (1/35) vs.13.8% (4/29)],but the differencewas not statistically significant (P > 0.05).Conclusions RCA-CVVH is a safe and effective therapeutic method inpatients with severe trauma who need for CRRT,the stability of internal environment is not affected and no incidence ofclinical bleeding event is increased.
10.Utility of thromboelastography in intensive care unit
En MU ; Zhiyong LIU ; Xiaochun MA
Chinese Critical Care Medicine 2016;28(5):474-477
Coagulopathy is very common in patients in intensive care unit (ICU) and often indicates organ dysfunction or underlying diseases.The application of traditional methods assessing the patients' coagulation status in ICU is limited because they can not reflect the whole process of coagulation.Thromboelastography (TEG),a point-of-care (POC) assay of coagulation,fibrinolysis and platelet function,developed in recent years has been widely used in organ transplant and cardiovascular surgery and so on.However,there is no standard for the use of TEG in ICU.The development and application of TEG in sepsis,multiple trauma,guiding blood transfusion,extracorporeal membrane oxygenation (ECMO),and anticoagulation monitoring were addressed in this review,and its value and application prospect in ICU were analyzed.

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