1.Efficacy and safety of Babaodan Capsule in patients with chronic hepatitis B virus infection comorbid with gallbladder polyps
Qianqian NIU ; Huan CHEN ; Ying ZHENG ; Chunyan GOU ; Chen XU ; Li LI ; Xinxin WANG ; Jianping LIU ; Zhaolan LIU ; Xiuhui LI
Journal of Clinical Hepatology 2026;42(2):304-311
ObjectiveTo investigate the efficacy and safety of Babaodan Capsule (BBD) in the treatment of patients with chronic hepatitis B virus (HBV) infection with damp-heat in the liver and gallbladder comorbid with gallbladder polyps. MethodsA randomized, double-blinded, placebo-controlled single-center trial was conducted among 120 patients with chronic HBV infection who were admitted to Beijing YouAn Hospital, Capital Medical University, from August 2020 to April 2023, and they were divided into treatment group (BBD) and control group (placebo), with 60 patients in each group. The course of treatment was 24 weeks, and follow-up assessments were conducted every 4 weeks. The primary outcome measures were the number and maximum diameter of gallbladder polyps (assessed by ultrasound), and the secondary outcome measures included traditional Chinese medicine (TCM) syndrome score, blood lipid levels, and liver function parameters. The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups; the Wilcoxon rank-sum test was used for comparison of ranked data between two groups; the generalized estimating equation was used to analyze repeated measures data. ResultsAfter 8 weeks of treatment, the treatment group had a significantly smaller diameter of polyps and a significantly lower number of polyps than the control group (Z=-1.76 and -1.80, both P<0.05), and after 24 weeks of treatment, the treatment group had a significantly higher polyp reduction rate than the control group (30.51% vs 10.91%, P<0.05). The subgroup analysis showed that patients receiving combined antiviral therapy, male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps tended to achieve significantly greater benefits. At week 8 of treatment, the treatment group had a significantly better TCM syndrome score than the control group (Z=-2.35, P<0.05); after treatment, compared with the control group, the treatment group had a significantly greater increase in high-density lipoprotein (Z=-1.85, P<0.05) and significantly lower levels of alanine aminotransferase (Z=-2.06, P <0.05), aspartate aminotransferase (Z=-2.13, P<0.05), total bilirubin (Z=-2.12, P<0.05), and direct bilirubin (Z=-3.09, P<0.05). No serious adverse events were reported in either group. ConclusionBBD can effectively reduce the size of gallbladder polyps, improve TCM syndrome score, and reduce the level of bilirubin in patients with chronic HBV infection with damp-heat in the liver and gallbladder, with a favorable safety profile, and it may be more suitable for patients receiving combined antiviral therapy and specific subgroups (male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps.
2.Clinical Advantages of Traditional Chinese Medicine in Treatment of Childhood Simple Obesity: Insights from Expert Consensus
Qi ZHANG ; Yingke LIU ; Xiaoxiao ZHANG ; Guichen NI ; Heyin XIAO ; Junhong WANG ; Liqun WU ; Zhanfeng YAN ; Kundi WANG ; Jiajia CHEN ; Hong ZHENG ; Xinying GAO ; Liya WEI ; Qiang HE ; Qian ZHAO ; Huimin SU ; Zhaolan LIU ; Dafeng LONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):238-245
Childhood simple obesity has become a significant public health issue in China. Modern medicine primarily relies on lifestyle interventions and often suffers from poor long-term compliance, while pharmacological options are limited and associated with potential adverse effects. Traditional Chinese Medicine (TCM) has a long history in the prevention and management of this condition, demonstrating eight distinct advantages, including systematic theoretical foundation, diversified therapeutic approaches, definite therapeutic efficacy, high safety profile, good patient compliance, comprehensive intervention strategies, emphasis on prevention, and stepwise treatment protocols. Additionally, TCM is characterized by six distinctive features: the use of natural medicinal substances, non-invasive external therapies, integration of medicinal dietetics, simple exercise regimens, precise syndrome differentiation, and diverse dosage forms. By combining internal and external treatments, TCM facilitates individualized regimen adjustment and holistic regulation, demonstrating remarkable effects in improving obesity-related metabolic indicators, regulating constitutional imbalance, and promoting healthy behaviors. However, challenges remain, such as inconsistent operational standards, insufficient high-quality clinical evidence, and a gap between basic research and clinical application. Future efforts should focus on accelerating the standardization of TCM diagnosis and treatment, conducting multicenter randomized controlled trials, and fostering interdisciplinary integration, so as to enhance the scientific validity and international recognition of TCM in the prevention and treatment of childhood obesity.
3.Clinical Application of Green Prescription of Traditional Chinese Medicine:Problems and Solution Strategies
Yike SONG ; Zhijun BU ; Wenxin MA ; Kai LIU ; Yuyi WANG ; Yuan SUN ; Yang SHEN ; Hongkui LIU ; Jianping LIU ; Zhaolan LIU
Journal of Traditional Chinese Medicine 2025;66(11):1094-1098
Green prescription is a written prescription aimed at improving health by promoting physical activity and improving diet, with advantages such as high cost-effectiveness, strong feasibility, and minimal harm to patients. The theory of traditional Chinese medicine (TCM) green prescription integrates the health philosophy of "following rule of yin and yang, and adjusting ways to cultivating health", the exercise philosophy of balancing yin-yang and the five elements, and the dietary philosophy of moderation and balance, which embody core TCM concepts such as treating disease before its onset and harmony between humans and nature. It has also developed traditional exercise practices like Tai Chi, Baduanjin, Wuqinxi, Yi-Gin-Ching, and Qigong, as well as dietary adjustments like medicated diet and herbal wines. However, it is believed that the TCM green prescription currently suffers from insufficient evidence-based research, low patient awareness and acceptance, and weak basic research. Based on this, it is proposed that large-sample clinical trials should be conducted in the future to improve the quality of evidence-based medicine, basic research can be carried out with the help of artificial intelligence and other methods in research design, the hospital information system (HIS) can be used for control at the implementation level, and publicity and patient education can be strengthened through the new media, so as to promote the development and application of the TCM green prescriptions in the field of global health treatment.
4.Advances in Sequential Multiple Assignment Randomized Trial Methodology and Considerations for Its Application in Traditional Chinese Medicine
Wenxin MA ; Xuehui WANG ; Yuyi WANG ; Yuan SUN ; Yike SONG ; Zhijun BU ; Zeyang SHI ; Jianping LIU ; Zhaolan LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1530-1539
Traditional Chinese Medicine(TCM)emphasizes syndrome differentiation and treatment,characterized by"maintaining the prescription if effective"and"changing the prescription if ineffective".Traditional randomized controlled trials(RCTs)are inadequate for evaluating the efficacy of dynamic treatment adjustments.The Sequential Multiple Assignment Randomized Trial(SMART)is an emerging adaptive research design that incorporates randomization at multiple stages,allowing for adjustments in subsequent interventions based on treatment responses.This approach is suitable for evaluating dynamic treatment regimens while retaining the low bias risk of traditional RCTs,making it highly promising for clinical research in TCM.This paper summarizes recent methodological advancements in SMART design,including different sample size estimation and statistical analysis methods for primary effect objectives,embedded adaptive intervention objectives,and optimization objectives,along with providing corresponding operational software.Additionally,it offers considerations for applying SMART design in TCM research,such as the selection of disease types,interventions,decision points,tailoring variables,sample size calculation,statistical methods,the importance of pilot trials,ethical considerations,and limitations.The aim is to promote the exploration and practice of this method in the field of TCM,thereby contributing to the generation of high-quality evidence-based evidence for TCM.
5.Research advances in clinical subtypes of Alzheimer's disease based on clinical manifestations and pathological features
Juan ZHOU ; Deyang ZENG ; Xiaochang LIU ; Yan ZENG ; Zhaolan HUANG ; Xue YANG ; Xing WANG ; Wei TAN
Journal of Chongqing Medical University 2025;50(4):476-481
Alzheimer's disease(AD)is a neurodegenerative disease with highly heterogeneous pathological and clinical manifesta-tions,and it is the most common cause of dementia.This heterogeneity poses challenges for diagnosis,treatment,and evaluating novel pharmacological efficacy.This review summarizes the latest progress in the major clinical subtypes of AD based on clinical manifesta-tions,genetic,and pathological features.Early-onset and late-onset AD clinical subtypes may share the same symptoms but differ in etiology,age of onset,mode of presentation,disease progression,and associated comorbidities.Typical and atypical AD differ signifi-cantly in clinical manifestations,pathological features,and diagnostic criteria.Research on AD subtypes based on imaging and omics data has also made considerable progress.This review also outlines the molecular pathological heterogeneity of AD.A deep understand-ing of these heterogeneities is crucial for diagnosis,the formulation of pharmacological treatment strategies,and clinical management.
6.Effects of persuasion system-based health intervention in orthodontic patients treated with clear aligner
Yuqun WANG ; Danyan HU ; Zhaolan GUAN ; Jianlan ZHANG ; Mengnan ZHANG ; Jia LIU ; Hu LI
Chinese Journal of Modern Nursing 2025;31(2):233-238
Objective:To explore the effect of persuasion system-based health intervention in orthodontic patients treated with clear aligners.Methods:From January 2022 to December 2023, convenience sampling was used to select patients treated with clear aligners at the Department of Orthodontics in Affiliated Stomatological Hospital of Nanjing Medical University as participants. Patients admitted from January to December 2022 were included in the control group ( n=60), and those admitted from January to December 2023 were included in the observation group ( n=59). The control group received health guidance based on the theory of knowledge, attitude, and practice. Based on the control group, the observation group added health intervention with the assistance of a persuasion system. After one year of intervention, the oral care self-efficacy, enamel demineralization, periodontal health index (gingival index, plaque index, sulcus bleeding index, probing depth), and restart rate of both groups were evaluated. Results:After the intervention, the scores of the Self-efficacy Scale for Self-care in the observation group were higher than those in the control group, and the difference was statistically significant [ (71.03±1.97) vs. (57.82±2.58), P<0.01]. The enamel demineralization rate, periodontal health index (plaque index, gingival index, sulcus bleeding index, probing depth) score, and restart rate in observation group were all lower than those in control group ( P<0.05) . Conclusions:Persuasion system system-based health intervention can improve the oral care self-efficacy of orthodontic patients treated with clear aligners, alleviate oral health issues during clear aligners, and reduce the restart rate of clear aligner patients.
7.Advances in Sequential Multiple Assignment Randomized Trial Methodology and Considerations for Its Application in Traditional Chinese Medicine
Wenxin MA ; Xuehui WANG ; Yuyi WANG ; Yuan SUN ; Yike SONG ; Zhijun BU ; Zeyang SHI ; Jianping LIU ; Zhaolan LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1530-1539
Traditional Chinese Medicine(TCM)emphasizes syndrome differentiation and treatment,characterized by"maintaining the prescription if effective"and"changing the prescription if ineffective".Traditional randomized controlled trials(RCTs)are inadequate for evaluating the efficacy of dynamic treatment adjustments.The Sequential Multiple Assignment Randomized Trial(SMART)is an emerging adaptive research design that incorporates randomization at multiple stages,allowing for adjustments in subsequent interventions based on treatment responses.This approach is suitable for evaluating dynamic treatment regimens while retaining the low bias risk of traditional RCTs,making it highly promising for clinical research in TCM.This paper summarizes recent methodological advancements in SMART design,including different sample size estimation and statistical analysis methods for primary effect objectives,embedded adaptive intervention objectives,and optimization objectives,along with providing corresponding operational software.Additionally,it offers considerations for applying SMART design in TCM research,such as the selection of disease types,interventions,decision points,tailoring variables,sample size calculation,statistical methods,the importance of pilot trials,ethical considerations,and limitations.The aim is to promote the exploration and practice of this method in the field of TCM,thereby contributing to the generation of high-quality evidence-based evidence for TCM.
8.Effects of persuasion system-based health intervention in orthodontic patients treated with clear aligner
Yuqun WANG ; Danyan HU ; Zhaolan GUAN ; Jianlan ZHANG ; Mengnan ZHANG ; Jia LIU ; Hu LI
Chinese Journal of Modern Nursing 2025;31(2):233-238
Objective:To explore the effect of persuasion system-based health intervention in orthodontic patients treated with clear aligners.Methods:From January 2022 to December 2023, convenience sampling was used to select patients treated with clear aligners at the Department of Orthodontics in Affiliated Stomatological Hospital of Nanjing Medical University as participants. Patients admitted from January to December 2022 were included in the control group ( n=60), and those admitted from January to December 2023 were included in the observation group ( n=59). The control group received health guidance based on the theory of knowledge, attitude, and practice. Based on the control group, the observation group added health intervention with the assistance of a persuasion system. After one year of intervention, the oral care self-efficacy, enamel demineralization, periodontal health index (gingival index, plaque index, sulcus bleeding index, probing depth), and restart rate of both groups were evaluated. Results:After the intervention, the scores of the Self-efficacy Scale for Self-care in the observation group were higher than those in the control group, and the difference was statistically significant [ (71.03±1.97) vs. (57.82±2.58), P<0.01]. The enamel demineralization rate, periodontal health index (plaque index, gingival index, sulcus bleeding index, probing depth) score, and restart rate in observation group were all lower than those in control group ( P<0.05) . Conclusions:Persuasion system system-based health intervention can improve the oral care self-efficacy of orthodontic patients treated with clear aligners, alleviate oral health issues during clear aligners, and reduce the restart rate of clear aligner patients.
9.The thought and method of constructing diagnostic specification for syndrome/pattern of defensive qi deficiency
Yuwen CHE ; Tianfang WANG ; Yang JIAO ; Yan ZHAO ; Zhisong WU ; Xiuyan WU ; Zhaolan LIU ; Xiaolin XUE ; Ning LI
Journal of Beijing University of Traditional Chinese Medicine 2024;47(8):1180-1184
The syndrome/pattern of defensive qi deficiency is a common basic syndrome of traditional Chinese medicine in clinical practice. However,there is a lack of standardized and operable diagnostic specifications in practical applications. Based on the previous literature,this study proposed the idea of starting from the elements of the syndrome,qualitative diagnostic criteria for the syndrome/pattern of defensive qi deficiency oriented to the entire region of the disease were constructed based on the two dimensions of " deficient defensive qi failing to consolidate the exterior" and " qi deficiency" and constructing a set of quantitative evaluation criteria as the supporting content for the diagnostic items. The core members of the research group attempted to formulate the draft standard,then reached a consensus through the Delphi method expert questionnaire consultation and the Nominal group technique,and finally evaluated the reliability and validity of the standard through clinical verification to provide ideas for the standardization and normalization of research on syndromes.
10.Current Situation of Health Technology Assessment in Traditional Chinese Medicine Hospitals
Simin XU ; Hui ZHAO ; Jing HU ; Zhaolan LIU ; Weiwei SUN ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(4):190-197
ObjectiveThis study aims to understand the recognition of practitioners in traditional Chinese medicine (TCM) hospitals on hospital-based health technology assessment (HB-HTA), assessment needs, challenges, and suggestions, so as to provide references for the future work. MethodThe convenient sampling method was adopted to survey the relevant practitioners in TCM hospitals. The questionnaire included 39 questions in 4 dimensions and was distributed through the online platform Weijuanxing. ResultA total of 244 questionnaires were recovered, and the obtained data were analyzed in SPSS. The results showed that 137 practitioners were very familiar with HB-HTA and there was no significant difference in the recognition of practitioners in different occupations (F=0.251; P=0.778). The practitioners in Hong Kong, Macao, and Taiwan had lower recognition than those in other regions. In terms of the assessment needs, 127 practitioners believed that it was very necessary to carry out HB-HTA in TCM hospitals in the future. Chinese patent medicines/Chinese herbal medicine decoction pieces (5.91) and TCM appropriate technology (5.57) had higher assessment priority scores. The assessment needs were high for the effectiveness (235 practitioners) and safety (224 practitioners) of health technology. The lack of specialized organization and standardized evaluation process system and the shortage of talents were considered to be the major challenges for the future development in this field. ConclusionThe stakeholders carrying out the health technology assessment in TCM hospitals had certain awareness of HB-HTA. Most practitioners believed that it was necessary to carry out HB-HTA in TCM hospitals in the future, while the work might face challenges such as the lack of organizations and system and the shortage of talents, which requires policy support.

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