Objective To analyze the current status of clinical trial registration of common anorectal diseases in Chinese Clinical Trial Registry(ChiCTR)and the research of TCM.Methods The ChiCTR database was retrieved to collect and organize clinical trials related to hemorrhoids,anal fissures,anal fistulas,perianal abscesses,and perianal eczema.The retrieval time was from the establishment of the database to December 10,2023.Characterization of included registration trials was analyzed.Results A total of 148 registered projects were included,75 of which were TCM-related clinical trials.Among them,134 clinical trials were pre-registered and 121 passed the ethical review.Shanghai,Jiangsu,Guangdong,Beijing and Sichuan accounted for 76.35％of the total number of registrations,and the largest number of registered projects was in Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine.The top 3 funding sources were local finance,self-funding and hospital funding.The registered projects were mainly intervention studies.114 studies used randomized methods and 34 studies were blinded.Conclusion At present,the number of ChiCTR-registered clinical trials on anorectal diseases is on an increasing trend,and the treatment of anorectal diseases with TCM has obvious characteristics.However,there are cases of irregular filling of registration content and uneven regional distribution.

Objective To investigate the distribution characteristics and future trends of clinical trials related to TCM prevention and treatment of constipation by analyzing the clinical trials registered in the Chinese Clinical Trial Registry(ChiCTR).Methods The clinical trials data related to TCM prevention and treatment of constipation in the ChiCTR database were retrieved from the establishment of the database to April 15,2024.Excel 2019 was utilized for de-duplication.Subsequently,SPSS 26.0 was employed to analyze the general characteristics,research types,intervention measures,etc.of the included trials,charts were drawn,and the clinical trial characteristics were summarized.Results A total of 107 clinical trials were included,with 102 being pre-registered,involving 21 provincial-level administrative regions and 75 clinical institutions.The top five regions in terms of the number of registered clinical trials were Beijing(19.63%),Shanghai(15.89%),Guangdong(14.02%),Sichuan(10.28%)and Jiangsu(9.35%).The top three sources of funding were local finance(28.97%),self-raised funds(18.69%)and hospital-funded funds(15.89%).The research types were mostly intervention studies(92.52%),of which 41 explicitly stated the use of blinding methods,and the main research design type is randomized parallel controlled trial.Conclusion The number of clinical trials related to TCM prevention and treatment of constipation registered in ChiCTR is on an upward trend.However,there is a noticeable geographical imbalance in the distribution of these trials,and there is a need for further improvement in the quality of trial design and the standardization of registration information.

Objective To explore the distribution characteristics and development trend of TCM prevention and treatment for irritable bowel syndrome(IBS)by analyzing the clinical trials of TCM prevention and treatment for IBS registered in China Clinical Trial Registry(ChiCTR).Methods The ChiCTR database was retrieved to collect and organize clinical trials related to the TCM prevention and treatment of IBS from the establishment of the database to May 1,2024.Characteristics of the included trials were analyzed and summarized using SPSS 25.0 and Excel 2021.Results A total of 73 clinical trials were included,of which 65 were pre-registered.The registered research projects involved 14 provincial-level administrative regions,including Beijing,Jiangsu,Guangdong,Shanghai,and Sichuan,and 46 clinical trial institutions,among which Beijing University of Chinese Medicine(6 items,7.89%)registered a higher number.The top three sources of research funding were,in order,local finance(26 items,35.62%),state finance(20 items,27.40%),and hospital funding(10 items,13.70%).The types of studies were predominantly interventional(68 items,93.15%),and the study designs were predominantly randomized parallel controlled studies(64 items,87.67%),but only 27 studies(36.99%)used a blinded approach.The main interventions included acupuncture and moxibustion,Chinese patent medicines,classic prescriptions/hospital-prepared remedies,etc.Conclusion The number of clinical research registrations in this field has been gradually increasing in recent years,but there are problems such as uneven regional distribution,low use of blinding,and lack of standardization of registration information.

Objective To analyze the clinical trial projects of TCM treatment for psoriasis registered at the China Clinical Trial Registry(ChiCTR);To provide references for clinical research in this field.Methods Clinical trial studies on the TCM treatment for psoriasis were retrieved from the ChiCTR database from the establishment of the database to June 17,2024.Excel 2019 and GraphPad Prism 9.0 were used to organize and analyze the general characteristics included in registered clinical trials.Results Totally 65 TCM-related trials were included,of which 58(89.23%)were prospectively registered,and 55(84.62%)had undergone ethical review.The majority of trials were registered in Guangdong,Beijing and Shanghai,collectively accounting for 78.46%(n=51)of the total.The leading institution,Guangdong Provincial Hospital of Chinese Medicine,contributed 19 trials.Funding was predominantly sourced from governmental bodies,with 72.31%(n=47)supported by national or regional grants.Among the registered studies,interventional trials predominated(n=56),including 46 randomised parallel-controlled designs.Blinding was implemented in 23 trials,and biospecimen collection was reported in 48 studies.40 trials were single-centre studies,and a cumulative sample size was 17 695 participants.Common interventions included oral administration of classical TCM formulations or hospital-prepared remedies,alongside topical applications such as medicated baths and ointments.The primary outcome measure in most trials was the Psoriasis Area and Severity Index.Conclusion While the number of registered clinical trials on TCM for psoriasis in China demonstrates a fluctuating yet upward trend,the overall volume remains modest.Disparities in regional distribution,methodological variability,and incomplete trial registration details highlight areas for improvement.

Objective To investigate the distribution characteristics and future trends of clinical trials related to TCM prevention and treatment of constipation by analyzing the clinical trials registered in the Chinese Clinical Trial Registry(ChiCTR).Methods The clinical trials data related to TCM prevention and treatment of constipation in the ChiCTR database were retrieved from the establishment of the database to April 15,2024.Excel 2019 was utilized for de-duplication.Subsequently,SPSS 26.0 was employed to analyze the general characteristics,research types,intervention measures,etc.of the included trials,charts were drawn,and the clinical trial characteristics were summarized.Results A total of 107 clinical trials were included,with 102 being pre-registered,involving 21 provincial-level administrative regions and 75 clinical institutions.The top five regions in terms of the number of registered clinical trials were Beijing(19.63%),Shanghai(15.89%),Guangdong(14.02%),Sichuan(10.28%)and Jiangsu(9.35%).The top three sources of funding were local finance(28.97%),self-raised funds(18.69%)and hospital-funded funds(15.89%).The research types were mostly intervention studies(92.52%),of which 41 explicitly stated the use of blinding methods,and the main research design type is randomized parallel controlled trial.Conclusion The number of clinical trials related to TCM prevention and treatment of constipation registered in ChiCTR is on an upward trend.However,there is a noticeable geographical imbalance in the distribution of these trials,and there is a need for further improvement in the quality of trial design and the standardization of registration information.

Objective To explore the distribution characteristics and development trend of TCM prevention and treatment for irritable bowel syndrome(IBS)by analyzing the clinical trials of TCM prevention and treatment for IBS registered in China Clinical Trial Registry(ChiCTR).Methods The ChiCTR database was retrieved to collect and organize clinical trials related to the TCM prevention and treatment of IBS from the establishment of the database to May 1,2024.Characteristics of the included trials were analyzed and summarized using SPSS 25.0 and Excel 2021.Results A total of 73 clinical trials were included,of which 65 were pre-registered.The registered research projects involved 14 provincial-level administrative regions,including Beijing,Jiangsu,Guangdong,Shanghai,and Sichuan,and 46 clinical trial institutions,among which Beijing University of Chinese Medicine(6 items,7.89%)registered a higher number.The top three sources of research funding were,in order,local finance(26 items,35.62%),state finance(20 items,27.40%),and hospital funding(10 items,13.70%).The types of studies were predominantly interventional(68 items,93.15%),and the study designs were predominantly randomized parallel controlled studies(64 items,87.67%),but only 27 studies(36.99%)used a blinded approach.The main interventions included acupuncture and moxibustion,Chinese patent medicines,classic prescriptions/hospital-prepared remedies,etc.Conclusion The number of clinical research registrations in this field has been gradually increasing in recent years,but there are problems such as uneven regional distribution,low use of blinding,and lack of standardization of registration information.

Objective To analyze the clinical trial projects of TCM treatment for psoriasis registered at the China Clinical Trial Registry(ChiCTR);To provide references for clinical research in this field.Methods Clinical trial studies on the TCM treatment for psoriasis were retrieved from the ChiCTR database from the establishment of the database to June 17,2024.Excel 2019 and GraphPad Prism 9.0 were used to organize and analyze the general characteristics included in registered clinical trials.Results Totally 65 TCM-related trials were included,of which 58(89.23%)were prospectively registered,and 55(84.62%)had undergone ethical review.The majority of trials were registered in Guangdong,Beijing and Shanghai,collectively accounting for 78.46%(n=51)of the total.The leading institution,Guangdong Provincial Hospital of Chinese Medicine,contributed 19 trials.Funding was predominantly sourced from governmental bodies,with 72.31%(n=47)supported by national or regional grants.Among the registered studies,interventional trials predominated(n=56),including 46 randomised parallel-controlled designs.Blinding was implemented in 23 trials,and biospecimen collection was reported in 48 studies.40 trials were single-centre studies,and a cumulative sample size was 17 695 participants.Common interventions included oral administration of classical TCM formulations or hospital-prepared remedies,alongside topical applications such as medicated baths and ointments.The primary outcome measure in most trials was the Psoriasis Area and Severity Index.Conclusion While the number of registered clinical trials on TCM for psoriasis in China demonstrates a fluctuating yet upward trend,the overall volume remains modest.Disparities in regional distribution,methodological variability,and incomplete trial registration details highlight areas for improvement.

Objective To analyze the current status of clinical trial registration of common anorectal diseases in Chinese Clinical Trial Registry(ChiCTR)and the research of TCM.Methods The ChiCTR database was retrieved to collect and organize clinical trials related to hemorrhoids,anal fissures,anal fistulas,perianal abscesses,and perianal eczema.The retrieval time was from the establishment of the database to December 10,2023.Characterization of included registration trials was analyzed.Results A total of 148 registered projects were included,75 of which were TCM-related clinical trials.Among them,134 clinical trials were pre-registered and 121 passed the ethical review.Shanghai,Jiangsu,Guangdong,Beijing and Sichuan accounted for 76.35％of the total number of registrations,and the largest number of registered projects was in Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine.The top 3 funding sources were local finance,self-funding and hospital funding.The registered projects were mainly intervention studies.114 studies used randomized methods and 34 studies were blinded.Conclusion At present,the number of ChiCTR-registered clinical trials on anorectal diseases is on an increasing trend,and the treatment of anorectal diseases with TCM has obvious characteristics.However,there are cases of irregular filling of registration content and uneven regional distribution.

Objective To assess the value of multimodal ultrasonography for diagnosing thyroid nodules—atypia of undetermined significance (AUS) of thyroid imaging reporting and data system (TI-RADS) categories 3 to 5. Methods A total of 90 AUS thyroid nodules in TI-RADS 3-5 categories from 88 patients underwent conventional ultrasonography, ultrasound elastography, superb microvascular imaging, and multimodal ultrasonography at the same time. With fine needle aspiration biopsy results as the gold standard, the methods were compared in terms of the sensitivity, specificity, accuracy, false positive rate (FPR), false negative rate (FNR), and area under the receiver operating characteristic curve (AUC) for diagnosing thyroid nodules. Results There were no significant differences between patients with benign and those with malignant thyroid nodules in terms of sex, age, and nodule locations (all P > 0.05), but the proportion of thyroid nodules ≤ 1 cm in diameter was significantly higher for malignant thyroid nodules than for benign thyroid nodules (χ²=9.610, P=0.002). Compared with benign nodules, malignant nodules were significantly more frequent to have low-level echoes or very low-level echoes, a blurred margin, a vertical diameter/horizontal diameter ratio of > 1, and microcalcifications or no calcifications (all P < 0.05). An ultrasound elastography score of ≥ 3 and type III vascularity on superb microvascular imaging indicated a higher possibility of malignant thyroid nodules (both P < 0.001). The multivariable logistic regression analysis showed that the size, echogenicity, margin, and vertical diameter/horizontal diameter ratio, and superb microvascular imaging type of thyroid nodules were not significant markers for benign or malignant thyroid nodules (all P > 0.05), while microcalcifications/no calcifications and an ultrasound elastography score of ≥ 3 were independent risk factors for malignant AUS nodules (both P < 0.05). The diagnostic sensitivity, specificity, accuracy, FPR, and FNR of conventional ultrasonography for AUS nodules were 91.30%, 71.40%, 62.70%, 28.60%, and 8.70%, respectively; the values for ultrasound elastography were 85.50%, 66.70%, 52.20%, 33.30%, and 14.50%, respectively; the values for superb microvascular imaging were 66.70%, 76.20%, 42.90%, 23.80%, and 33.30%, respectively; and the values for multimodal ultrasonography were 75.20%, 92.50%, 67.70%, 24.80%, and 7.50%, respectively. For distinguishing between benign and malignant AUS nodules, the AUC values of conventional ultrasonography, ultrasound elastography, superb microvascular imaging, and multimodal ultrasonography were 0.866, 0.745, 0.774, and 0.918, respectively. Conclusion Multimodal ultrasonography shows better diagnostic efficacy for AUS nodules of TI-RADS 3-5 compared with conventional ultrasonography, ultrasound elastography, and superb microvascular imaging, which can facilitate the malignancy risk stratification and management of AUS thyroid nodules.

Objective:We aimed to develop a novel visualized model based on nomogram to predict postoperative overall survival.Methods:This was a multicenter, retrospective, observational cohort study, including participants with histologically confirmed gastric and colorectal cancer who underwent radical surgery from 11 medical centers in China from August 1, 2015 to June 30, 2018. Baseline characteristics, histopathological data and nutritional status, as assessed using Nutrition Risk Screening 2002 (NRS 2002) score and the scored Patient-Generated Subjective Global Assessment, were collected. The least absolute shrinkage and selection operator regression and Cox regression were used to identify variables to be included in the predictive model. Internal and external validations were performed.Results:There were 681 and 127 patients in the training and validation cohorts, respectively. A total of 188 deaths were observed over a median follow-up period of 59 (range: 58 to 60) months. Two independent predictors of NRS 2002 and Tumor-Node-Metastasis (TNM) stage were identified and incorporated into the prediction nomogram model together with the factor of age. The model's concordance index for 1-, 3- and 5-year overall survival was 0.696, 0.724, and 0.738 in the training cohort and 0.801, 0.812, and 0.793 in the validation cohort, respectively.Conclusions:In this study, a new nomogram prediction model based on NRS 2002 score was developed and validated for predicting the overall postoperative survival of patients with gastric colorectal cancer. This model has good differentiation, calibration and clinical practicability in predicting the long-term survival rate of patients with gastrointestinal cancer after radical surgery.