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 analyze the caregiver presence needs and their influencing factors among hospitalized elderly non-surgical patients and provide a basis for formulating relevant policies.Methods A descriptive qualitative study method was adopted.Through purposive sampling,semi-structured interviews were conducted on elderly non-surgical patients and their families and medical staff in Peking Union Medical College Hospital from September to October 2023.MAXQDA 2020 and the 7-step phenomenological analysis method of Colaizzi were used to classify and code the interview contents and identify themes.Results The categories of caregiver presence needs of elderly non-surgical patients included basic living assistance needs,disease monitoring needs,psychological support needs,as well as the needs for family members to provide economic support and participate in treatment decision-making.The influencing factors included advanced age,frailty,the lack of self-care ability in patients with comorbidities,the susceptibility of patients to sudden situations during the disease exacerbation period,the increased risk of unexpected events in patients with psychological distress,and patients' concerns about social support and medical decision-making.Conclusion The caregiver presence needs of elderly non-surgical patients during hospitalization are high and influenced by multiple factors.
Humans ; Caregivers/psychology* ; Aged ; Hospitalization ; Social Support ; Male ; Qualitative Research ; Female

Objective To explore the symptom prevalence in the patients with pulmonary nodules in Lingnan area and to investigate the influencing factors,thus to provide data support for the construction of differentiation and treatment system of symptoms-syndrome elements-syndromes-constitutions for patients with pulmonary nodules,and to promote the establishment of secondary prevention system of lung cancer with the in-depth participation of traditional Chinese medicine(TCM).Methods A cross-sectional study was adopted to investigate patients with pulmonary nodules who admitted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine from August 2023 to January 2024.Data collection covered the basic information,clinical characteristics and symptoms of the patients.Likert four-level scale was used for the grading of the severity of the symptoms,multivariate linear regression was adopted to construct three regression models,and then the factors influencing the severity of symptoms of patients with pulmonary nodules were explored.Results(1)A total of 274 patients were enrolled in the analysis,including 160 females and 114 males,with a mean age of(54.44±12.00)years old and the symptom scores averaging(3.97±3.80)point.The included patients with pulmonary nodules were characterized by females outnumbering males,a higher proportion of middle-aged and elderly people,multiple pulmonary nodules being more common.(2)The analysis of the symptoms of the 274 patients showed that symptoms with an incidence over 30%were fatigue(116 cases,42.34%),cough(105 cases,38.32%),expectoration of white sputum(89 cases,32.48%),and irritability and distress(87 cases,31.75%).(3)Multivariate linear regression analysis after variable adjustment suggested that the overall symptomatic severity in the male was milder than that in the female[β=-1.67,95%CI(-2.67,-0.68),P<0.001],and symptom score was positively correlated with age[β=0.07,95%CI(0.03,0.10),P<0.001],history of exposure to secondhand smoke[β=1.27,95%CI(0.26,2.27),P=0.015],history of exposure to other hazardous substances[β=1.96,95%CI(0.39,3.53),P=0.015],and history of allergy[β=2.38,95%CI(1.22,3.54),P<0.001]significantly.Conclusion The overall symptoms of patients with pulmonary nodules in Lingnan area are mild,and the high prevalence of symptoms are fatigue,cough,expectoration of white sputum,and irritability and distress.The symptom severity is correlated with gender,age,history of exposure to secondhand smoke,history of exposure to other hazardous substances,and history of allergy.

Objective To assess the exposure levels of heavy metals,including lead,arsenic,mercury,and cadmium,in the local population in Sichuan and Chongqing,China,to compare and analyze the differences in reference intervals(RIs)obtained from direct and indirect sampling methods,and to explore the interchangeability and limitations of these two sampling methods.Methods RIs were obtained by the direct sampling method and the indirect sampling method.In the direct sample method,the levels of blood arsenic,urinary cadmium,urinary mercury,and blood lead levels of 5562 healthy participants aged 22-50 years in Sichuan and Chongqing,China were measured by atomic absorption spectrometry and inductively coupled plasma-mass spectrometry.Using the human biomonitoring(HBM)data,we established RIs for the population by a nonparametric method.On the other hand,in the indirect sampling method,RIs were established via a nonparametric method based on data from the laboratory information system(LIS)of a local hospital after stratifying healthy individuals using a Gaussian mixture model(GMM).Comparative analysis of the RIs derived from the two sampling methods were then conducted.Results The RI for blood arsenic was 0.11-1.3 μmol/L.The RI for urinary cadmium was 0.51-2.80 μmol/mol creatine for adults aged 22 to under 43 years and 0.66-2.96 μmol/mol creatine for adults aged 43-50 years.The RI for urinary mercury was 0.12-1.10 μmol/mol creatine.The RI for blood lead was 14.00-47.00 pg/L for adults aged 22 to under 41 year,16.00-53.38 pg/L for males aged 41-50 year,and 15.00-51.02 pg/L for females aged 41-50 year.Most of the RIs established by the direct sampling method had a narrower range compared to those established by the indirect sampling method,and the RIs established by both sampling methods were partially biased.Conclusions The RIs for blood arsenic,urine cadmium,urine mercury,and blood lead in healthy individuals aged 22-50 years in Sichuan and Chongqing,China were established using both direct and indirect sampling methods,which contributes to a better understanding of environmental exposure to metals in the general population and provides a reference for metal poisoning.For data from the same lab,the GMM-based indirect sampling method demonstrated relatively consistent performance in establishing RIs compared with the direct sampling method.

Objective To establish a stable,reliable,and clinically relevant porcine model of endotoxin-induced acute respiratory distress syndrome(ARDS).Methods Ten 8-month-old male Bama minipigs were deeply sedated,followed by invasive mechanical ventilation and electrocardiographic monitoring.Lipopolysaccharide(LPS)was intravenously pumped at 600 μg/(kg·h)for 3 hours,then maintained at 15 μg/(kg·h)thereafter.Dynamic monitoring was performed at five time points after LPS injection(LPS 0,1,3,5,and 8 h),including arterial blood gas analysis and chest computed tomography(CT)scans.Pathological examination of lung tissues obtained via bronchoscopic biopsy(HE staining and transmission electron microscopy)was conducted.These indicators were comprehensively used to evaluate the success of the animal model.Results At 5 hours after LPS administration,8 minipigs developed symptoms such as skin cyanosis,elevated body temperature,and respiratory distress.The oxygenation index decreased to<300 mmHg.Chest CT scans showed diffuse pulmonary infiltrates.Histopathology revealed alveolar edema and hyaline membrane formation.Transmission electron microscopy demonstrated disruption of pulmonary blood-air barrier,depletion of lamellar bodies in type Ⅱ pneumocytes,inflammatory cell infiltration,and exudation of plasma proteins and fibrin.Compared with LPS 0 h,at LPS 8 h,the oxygenation index and arterial blood pH were significantly decreased(P<0.001),while blood lactic acid and serum potassium were significantly increased(P<0.05);serum calcium and base excess were significantly decreased(P<0.05),and the lung injury score based on HE-stained lung sections was significantly increased(P<0.01).Conclusion The porcine ARDS model established by continuous LPS injection can dynamically simulate the pathophysiological characteristics and typical pathological manifestations of clinical septic ARDS,making it an effective tool to study the pathogenesis,prevention,and treatment strategies of septic ARDS.

Objective To investigate the clinical effect and safety of bronchial arterial chemoembolization(BACE)combined with micro wave ablation(MW A)and immunotherapy in treating patients with advanced lung squamous cell carcinoma.Methods The clinical data of 68 patients with advanced lung squamous cell carcinoma,who were admitted to the North Jiangsu People's Hospital of China from June 2020 to June 2022 to receive treatment,were retrospectively analyzed.According to the therapeutic method,the patients were divided into control group(n=30,receiving BACE combined with immunotherapy)and observation group(n=38,receiving BACE followed by MW A,which was performed with CT-guided localization of the lung lesion,and immunotherapy in 3-5 days after BACE).Results The surgical success rate in both the 30 patients of the observation group and the 38 patients of the control group was 100％.After treatment,no surgery-related or chemoembolization-related serious complications occurred in both groups.In the control group and the observation group,the mean progression-free survival(PFS)was(5.70±1.61)months and(12.10±0.72)months respectively,the mean overall survival(OS)was(11.80±1.10)months and(13.00±1.13)months respectively.The PFS of the observation group was obviously longer than that of the control group(P＜0.05),and no statistically significant difference in OS existed between the two groups(P=0.255).Conclusion BACE combined with MW A and immunotherapy can effectively control the advanced lung squamous cell carcinoma,it has reliable short-term efficacy when compared with BACE plus immunotherapy,and it can inhibit tumor growth and prolong the PFS of patients,with a trend of extending OS and a satisfactory clinical safety.

Hematologic malignancies, including leukemia, lymphoma, and multiple myeloma, are hazardous diseases characterized by the uncontrolled proliferation of cancer cells. Dysregulated cell cycle resulting from genetic and epigenetic abnormalities constitutes one of the central events. Importantly, cyclin-dependent kinases (CDKs), complexed with their functional partner cyclins, play dominating roles in cell cycle control. Yet, efforts in translating CDK inhibitors into clinical benefits have demonstrated disappointing outcomes. Recently, mounting evidence highlights the emerging significance of WEE1 G2 checkpoint kinase (WEE1) to modulate CDK activity, and correspondingly, a variety of therapeutic inhibitors have been developed to achieve clinical benefits. Thus, WEE1 may become a promising target to modulate the abnormal cell cycle. However, its function in hematologic diseases remains poorly elucidated. In this review, focusing on hematologic malignancies, we describe the biological structure of WEE1, emphasize the latest reported function of WEE1 in the carcinogenesis, progression, as well as prognosis, and finally summarize the therapeutic strategies by targeting WEE1.
Humans ; Protein-Tyrosine Kinases/physiology* ; Hematologic Neoplasms/drug therapy* ; Cell Cycle Proteins/antagonists & inhibitors* ; Nuclear Proteins/antagonists & inhibitors* ; Cyclin-Dependent Kinases ; Molecular Targeted Therapy ; Animals

OBJECTIVES: To identify risk factors contributing to prolonged postoperative length of stay (LOS) in very elderly patients following hip fracture surgery, with a focus on postoperative complications and the impact of different anesthesia approaches. METHODS: This retrospective single-center cohort study enrolled patients aged 90 years or older who underwent hip fracture surgery at Peking Union Medical College Hospital between January 31, 2013 and December 31, 2023. Relevant perioperative data were collected. The primary outcome was postoperative LOS, and the study cohort was divided into two groups: postoperative LOS ≤ 7 days and LOS > 7 days. Logistic regression was performed to identify factors related to prolonged postoperative LOS. RESULTS: A total of 155 patients were included. The average age was 92.7 ± 2.6 years. There were 73 (47%) patients with postoperative LOS > 7 days. Postoperative pneumonia was the only factor associated with a prolonged postoperative LOS (OR = 2.12, 95% CI [1.09, 4.16], P = 0.028). Neither the type of anesthesia (regional vs. general anesthesia, OR = 1.00, 95% CI [0.53, 1.90], P = 0.993) nor the method of airway management (laryngeal mask ventilation vs. spontaneous breathing, OR = 1.46, 95% CI [0.58, 3.76], P = 0.424; endotracheal intubation vs. spontaneous breathing, OR = 0.82, 95% CI [0.39, 1.69], P = 0.592) showed a significant association with a prolonged postoperative LOS. Preoperative chronic obstructive pulmonary disease (OR = 2.78, 95% CI [1.05, 7.65], P = 0.040) and preoperative neutrophil count (OR = 1.13, 95% CI [1.01, 1.26], P = 0.029) were both significantly associated with the occurrence of postoperative pneumonia, while anesthesia type and airway management method were not. CONCLUSIONS Postoperative pneumonia was associated with prolonged postoperative LOS in very elderly patients undergoing hip fracture surgery, whereas anesthesia types and airway management methods show no association with prolonged postoperative LOS or postoperative pneumonia. Preoperative comorbidities, especially respiratory conditions and systemic inflammation, potentially play a substantial role in postoperative recovery.
Humans ; Hip Fractures/surgery* ; Aged, 80 and over ; Risk Factors ; Length of Stay ; Female ; Male ; Retrospective Studies ; Postoperative Complications/etiology*

OBJECTIVE: To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents. METHODS: This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs). RESULTS: This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed. CONCLUSION STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Middle Aged ; Angina, Stable/physiopathology* ; Aged ; Syndrome ; Treatment Outcome ; Placebos ; Tablets

Azvudine and nirmatrelvir/ritonavir (Paxlovid) are recommended for COVID-19 treatment in China, but their safety and efficacy in the elderly population are not fully known. In this multicenter, retrospective, cohort study, we identified 5131 elderly hospitalized COVID-19 patients from 32,864 COVID-19 patients admitted to nine hospitals in Henan Province, China, from December 5, 2022, to January 31, 2023. The primary outcome was all-cause death, and the secondary outcome was composite disease progression. Propensity score matching (PSM) was performed to control for confounding factors, including demographics, vaccination status, comorbidities, and laboratory tests. After 2:1 PSM, 1786 elderly patients receiving azvudine and 893 elderly patients receiving Paxlovid were included. Kaplan-Meier and Cox regression analyses revealed that compared with Paxlovid group, azvudine could significantly reduce the risk of all-cause death (log-rank P = 0.002; HR: 0.71, 95% CI: 0.573-0.883, P = 0.002), but there was no difference in composite disease progression (log-rank P = 0.52; HR: 1.05, 95% CI: 0.877-1.260, P = 0.588). Four sensitivity analyses verified the robustness of above results. Subgroup analysis suggested that a greater benefit of azvudine over Paxlovid was observed in elderly patients with primary malignant tumors (P for interaction = 0.005, HR: 0.32, 95% CI: 0.18-0.57) compared to patients without primary malignant tumors. Safety analysis revealed that azvudine treatment had a lower incidence of adverse events and higher lymphocyte levels than Paxlovid treatment. In conclusion, azvudine treatment is not inferior to Paxlovid treatment in terms of all-cause death, composite disease progression and adverse events in elderly hospitalized COVID-19 patients.