1.Current Status and Prospects of Research on Traditional Chinese Medicine Prevention and Treatment for Gastric Precancerous Lesions
Haiyan BAI ; Tai ZHANG ; Ping WANG ; Lin LIU ; Weichao XU ; Yaxin TIAN ; Lanshuo HU ; Qian YANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(4):410-415
Traditional Chinese medicine (TCM), through its multi-target and systematic regulatory effects, has demonstrated unique advantages in the treatment of gastric precancerous lesions (GPL). At present, TCM theoretical research on GPL is mainly reflected in three aspects, the integration of macroscopic syndrome differentiation, the inflammation-carcinoma transformation mechanism, as well as the systematization and scientization of theoretical inheritance from famous TCM practitioners. High-quality evidence-based research findings serve as the foundation for clinical practice guidelines on GPL, and TCM has gained international academic recognition in the field of GPL prevention and treatment. Research on TCM mechanisms has yielded a series of important outcomes in the aspects of signaling pathways, gene expression regulation, cellular epigenetics, histone modification, and intestinal microecology. It is proposed that future research on GPL should focus on four key directions, establishing multi-omics data, exploring targeted intervention strategies on key regulatory nodes, advancing the standardization process of integrated traditional Chinese and western medicine prevention and treatment technologies, and constructing stratified screening and intervention platforms. The in-depth integration of TCM microcosmic mechanism of action with its macroscopic syndrome differentiation and treatment system, coupled with interdisciplinary research, will provide valuable references for the clinical treatment and scientific research of GPL.
2.Evaluation of CARIFS Score and Negative Antigen Conversion Rate of Qingxuan Daozhi Formula in Treatment of Influenza in Children (Heat Accumulation in Lung and Stomach Syndrome):A Multi-center Randomized Controlled Clinical Study
Jing WANG ; Liqun WU ; Tiegang LIU ; Yongning CAO ; Jing QIU ; Jing LI ; Huaqing TAN ; Ying ZHANG ; Xulei GOU ; Jia WANG ; Jing LI ; Haipeng CHEN ; Xueying QIN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Lin JIANG ; Yingqi XU ; Jianping LIU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):188-196
ObjectiveThis paper aims to observe the syndrome improvement and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome). MethodsThrough a multi-center randomized controlled methodology design,confirmed influenza cases were collected from October 2022 to April 2023 in the pediatrics department of eight hospitals,such as Dongfang Hospital of Beijing University of Chinese Medicine. A total of 180 children with influenza and heat accumulation in the lung and stomach syndrome conforming to the standard were recruited through the clinic. The sick children meeting the inclusion criteria were randomly divided into groups by a block-randomized method. The children in the experimental group were treated with Qingxuan Daozhi formula for five days,and those in the control group were treated with Oseltamivir Phosphate Granules for five days. The primary efficacy indicator was the negative conversion rate of influenza antigen detection. Secondary efficacy indicators were the Canadian acute respiratory illness and flu scale (CARIFS) and the incidence of complications,severe cases, and critical cases. Follow-up observation was conducted on the day of enrollment,48 hours after medication,72 hours after medication, and (6+1) d after medication. ResultsOne hundred and eighty participants were randomly assigned to the experimental group (90 cases) or the control group (90 cases). All participants were followed up during the study. Comparison of influenza antigen detection results in the primary efficacy indicators showed that the average time of negative influenza antigen conversion in the experimental group was (5.29±1.25) d,and that in the control group was (5.40±1.68) d,without a statistically significant difference. After five days of intervention,52 cases in the experimental group and 51 cases in the control group converted to negative,without a statistically significant difference. CARIFS score results in the secondary efficacy indicators showed that during 72 hours after intervention,there were statistically significant differences between the experimental group and the control group in three dimensions, including headache,muscle soreness, and the need for extra care (P<0.05). On the (6+1) days after the intervention,the differences in both the experimental group and the control group were statistically significant in 10 dimensions, including sore throat,bad sleep,uncomfortable feeling,poor spirit and fatigue,crying more than usual,the need for extra care,symptom,function,influence on parents,and total score (P<0.05). The comparison results within the group in the dimensional scores of symptom, function, and influence on parents,as well as the CARIFS total score showed that with the delay of follow-up time,scores of both groups decreased significantly,with a statistically significant difference (P<0.01). Inter-group comparison results showed that the mean score of the experimental group was higher than that of the control group at the time of enrollment. With the progress of intervention,the score of the experimental group was significantly decreased compared with that of the control group. At the end of follow-up,the mean score of the experimental group was lower than that of the control group,with no statistically significant difference. In terms of the incidence of complications,severe cases, and critical cases, there were no complications,severe cases, and critical cases in the two groups,without a statistically significant difference. ConclusionThe symptom improvement effect and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome) are not inferior to Oseltamivir Phosphate granules, and children's acceptance is better. It can be more widely used in clinical treatment of influenza in children (heat accumulation in the lung and stomach syndrome).
3.Xianglian Huazhuo Prescription Regulates miR-34b-5p/PFKFB1 Signaling Pathway to Inhibit Glycolysis and Ameliorate Chronic Atrophic Gastritis
Yuxi GUO ; Pengli DU ; Ziqi JIN ; Yican LIN ; Yanru DU ; Haiyan BAI ; Xinran YANG ; Danyang ZHAO ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):29-38
ObjectiveTo investigate the mechanism by which Xianglian Huazhuo prescription (XLHZ) ameliorates chronic atrophic gastritis (CAG) through regulating glycolysis via the microRNA-34b-5p (miR-34b-5p)/6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 1 (PFKFB1) signaling pathway. MethodsBioinformatic screening was performed to identify the target genes of miR-34b-5p. In the animal experiments, a mouse model of CAG was established through a combination of N-methyl-N′-nitro-N-nitrosoguanidine (MNNG), ranitidine, and irregular feeding. The mice were randomized into the following groups: normal, model, Morodan group (2 g·kg-1), and high-, medium-, and low-dose XLHZ groups(7.2,3.8,1.9 g·kg-1). In the cell experiments, GES-1 cells were treated with MNNG for the modeling of CAG and grouped as follows: GES-1, MNNG+GES-1, MNNG+GES-1+XLHZ(10%), MNNG+GES-1+miR-34b-5p mimics, MNNG+GES-1+miR-34b-5p inhibitor, MNNG+GES-1+PFKFB1 inhibitor, and MNNG+GES-1+PFKFB1 mimics+XLHZ(10%). The general conditions of mice were observed. Real-time PCR was adopted to measure the expression levels of miRNA-34b-5p and PFKFB1 mRNA in the gastric mucosa of mice in each group. Dual luciferase reporter gene was used to verify the targeting interaction between miR-34b-5p and PFKFB1 in GES-1 cells exposed to MNNG. The cell-counting kit-8 (CCK-8) was used to screen the drug-containing serum concentration. Real-time PCR was employed to verify the transfection efficiency. Fluorescent probes were used to detect the expression and nuclear translocation of hypoxia-inducible factor-1α (HIF-1α) in each group of cells. The protein levels of HIF-1α, hexokinase 2 (HK2), PFKFB1, phosphofructokinase 1 (PFK1), and lactate dehydrogenase (LDHA) in the gastric mucosa of mice were determined by Western blot. The levels of glucose consumption and lactate in the serum and cells were measured by biochemical methods. Enzyme-linked immunosorbent assay (ELISA) was adopted to measure the content of adenosine triphosphate (ATP) in the gastric mucosa tissue and cells. ResultsThe animal experiments showed that compared with the normal group, the model group exhibited symptoms including mental fatigue, lethargy, sparse and dull fur, a tendency to curl up, sluggish responses, reduced food and water intake, and slow body weight gain. In addition, the model group showed decreased expression of miRNA-34b-5p (P<0.01), increased mRNA level of PFKFB1 (P<0.01), upregulated protein levels of HIF-1α, HK2, PFKFB1, PFK1, and LDHA (P<0.01), and increased glucose consumption, lactate content, and ATP content (P<0.01). Compared with the model group, the XLHZ group and Morodan group showed improved mental state, gradually improved fur, increased activity, food and water intake, and body weight. HE showed that each treatment group exhibited well arranged and increased gastric mucosal glands, reduced inflammatory cells, and recovered gastric pits. Transmission electron microscopy showed that the size of mitochondria in each treatment group returned to normal, with no obvious irregular shape, complete and clear cristae, and uniform matrix. Furthermore, each treatment group showed increased expression of miRNA-34b-5p (P<0.05), reduced mRNA level of PFKFB1 (P<0.05), downregulated protein levels of HIF-1α, HK2, PFKFB1, PFK1, and LDHA (P<0.05), and decreased glucose consumption, lactic acid, and ATP (P<0.05). The cell experiments showed that the expression and nuclear translocation of HIF-1α were reduced in all groups after treatment (P<0.05). The cell transfection efficiency was satisfactory (P<0.05). miR-34b-5p exhibited an effect comparable to that of XLHZ, effectively inhibiting glycolysis, whereas PFKFB1 promoted glycolysis and reversed the protective effect of XLHZ in CAG mice (P<0.05). ConclusionXLHZ could regulate the miR-34b-5p/PFKFB1 axis to inhibit glycolysis, thereby ameliorating MNNG-induced gastric mucosal atrophy.
4.Xianglian Huazhuo Prescription Regulates miR-34b-5p/PFKFB1 Signaling Pathway to Inhibit Glycolysis and Ameliorate Chronic Atrophic Gastritis
Yuxi GUO ; Pengli DU ; Ziqi JIN ; Yican LIN ; Yanru DU ; Haiyan BAI ; Xinran YANG ; Danyang ZHAO ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):29-38
ObjectiveTo investigate the mechanism by which Xianglian Huazhuo prescription (XLHZ) ameliorates chronic atrophic gastritis (CAG) through regulating glycolysis via the microRNA-34b-5p (miR-34b-5p)/6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 1 (PFKFB1) signaling pathway. MethodsBioinformatic screening was performed to identify the target genes of miR-34b-5p. In the animal experiments, a mouse model of CAG was established through a combination of N-methyl-N′-nitro-N-nitrosoguanidine (MNNG), ranitidine, and irregular feeding. The mice were randomized into the following groups: normal, model, Morodan group (2 g·kg-1), and high-, medium-, and low-dose XLHZ groups(7.2,3.8,1.9 g·kg-1). In the cell experiments, GES-1 cells were treated with MNNG for the modeling of CAG and grouped as follows: GES-1, MNNG+GES-1, MNNG+GES-1+XLHZ(10%), MNNG+GES-1+miR-34b-5p mimics, MNNG+GES-1+miR-34b-5p inhibitor, MNNG+GES-1+PFKFB1 inhibitor, and MNNG+GES-1+PFKFB1 mimics+XLHZ(10%). The general conditions of mice were observed. Real-time PCR was adopted to measure the expression levels of miRNA-34b-5p and PFKFB1 mRNA in the gastric mucosa of mice in each group. Dual luciferase reporter gene was used to verify the targeting interaction between miR-34b-5p and PFKFB1 in GES-1 cells exposed to MNNG. The cell-counting kit-8 (CCK-8) was used to screen the drug-containing serum concentration. Real-time PCR was employed to verify the transfection efficiency. Fluorescent probes were used to detect the expression and nuclear translocation of hypoxia-inducible factor-1α (HIF-1α) in each group of cells. The protein levels of HIF-1α, hexokinase 2 (HK2), PFKFB1, phosphofructokinase 1 (PFK1), and lactate dehydrogenase (LDHA) in the gastric mucosa of mice were determined by Western blot. The levels of glucose consumption and lactate in the serum and cells were measured by biochemical methods. Enzyme-linked immunosorbent assay (ELISA) was adopted to measure the content of adenosine triphosphate (ATP) in the gastric mucosa tissue and cells. ResultsThe animal experiments showed that compared with the normal group, the model group exhibited symptoms including mental fatigue, lethargy, sparse and dull fur, a tendency to curl up, sluggish responses, reduced food and water intake, and slow body weight gain. In addition, the model group showed decreased expression of miRNA-34b-5p (P<0.01), increased mRNA level of PFKFB1 (P<0.01), upregulated protein levels of HIF-1α, HK2, PFKFB1, PFK1, and LDHA (P<0.01), and increased glucose consumption, lactate content, and ATP content (P<0.01). Compared with the model group, the XLHZ group and Morodan group showed improved mental state, gradually improved fur, increased activity, food and water intake, and body weight. HE showed that each treatment group exhibited well arranged and increased gastric mucosal glands, reduced inflammatory cells, and recovered gastric pits. Transmission electron microscopy showed that the size of mitochondria in each treatment group returned to normal, with no obvious irregular shape, complete and clear cristae, and uniform matrix. Furthermore, each treatment group showed increased expression of miRNA-34b-5p (P<0.05), reduced mRNA level of PFKFB1 (P<0.05), downregulated protein levels of HIF-1α, HK2, PFKFB1, PFK1, and LDHA (P<0.05), and decreased glucose consumption, lactic acid, and ATP (P<0.05). The cell experiments showed that the expression and nuclear translocation of HIF-1α were reduced in all groups after treatment (P<0.05). The cell transfection efficiency was satisfactory (P<0.05). miR-34b-5p exhibited an effect comparable to that of XLHZ, effectively inhibiting glycolysis, whereas PFKFB1 promoted glycolysis and reversed the protective effect of XLHZ in CAG mice (P<0.05). ConclusionXLHZ could regulate the miR-34b-5p/PFKFB1 axis to inhibit glycolysis, thereby ameliorating MNNG-induced gastric mucosal atrophy.
5.Advances in the pathogenic mechanisms of anti-glutamic acid decarboxylase antibody-associated neuroimmune diseases
Lin BAI ; Yang YU ; Hongzhi GUAN
Chinese Journal of Neurology 2025;58(11):1221-1228
The pathogenic mechanisms underlying neuroimmune disorders associated with anti-glutamic acid decarboxylase (GAD) antibodies remain incompletely elucidated. This article systematically reviews the immunopathological mechanisms of this disease. In humoral immunity, anti-GAD antibodies target intracellular antigens and induce neuronal dysfunction, yet the mechanisms of antibody penetration across cell membranes remain undefined, and validated animal models confirming their pathogenicity are lacking. In cellular immunity, histopathological studies demonstrate T-lymphocyte infiltration in the central nervous system (CNS) of patients, while GAD antigen-specific T cells have been detected in peripheral blood and cerebrospinal fluid. However, the antigen specificity of CNS-infiltrating T cells and their potential association with GAD reactivity remain unclarified. Additionally, the CNS migration routes, functional phenotypes of these T cells, and their synergistic interplay with humoral immune responses require further investigation. Future research should focus on: (1) resolving the transmembrane mechanisms of anti-GAD antibodies; (2) defining the CNS trafficking pathways and functional roles of GAD antigen-specific T cells; (3) establishing reliable animal models to recapitulate disease-specific immune cascades. Elucidating these mechanisms will advance the development of precise diagnostic and therapeutic strategies.
6.Expert consensus on holistic integrative management of oral squamous cell carcinoma
Moyi SUN ; Zongxuan HE ; Haoyue XU ; Xiaoying LI ; Jie ZHANG ; Haijun LU ; Xiaohong ZHAN ; Dapeng HAO ; Shizhu BAI ; Wei GUO ; Zhangui TANG ; Guoxin REN ; Jian MENG ; Zhijun SUN ; Jichen LI ; Yue HE ; Chunjie LI ; Lizheng QIN ; Kai YANG ; Qing XI ; Lin KONG ; Bing HAN ; Lingxue BU ; Yuanyong FENG ; Kai SONG ; Hongyu HAN ; Jieying LI ; Qianwei NI ; Yun LI ; Juan CHAI ; Xiaochen YANG ; Man HU ; Mingjin XU ; Wei SHANG
Journal of Practical Stomatology 2025;41(4):437-449
Oral squamous cell carcinoma(OSCC)is a malignant lesion originating from the oral mucosal squamous epithelium,account-ing for over 80%of oral and maxillofacial malignancies.Key etiological factors include tobacco,alcohol abuse,and betel quid chewing.In China,its incidence has shown an overall upward trend,posing a significant threat to public health.OSCC exhibits high local invasive-ness,making early diagnosis critical for improving prognosis.Its clinical management requires close multidisciplinary collaboration among oral and maxillofacial surgery,head and neck surgery,radiation oncology,medical oncology,reconstructive surgery,radiology,patholo-gy,and nutritional support teams.Given the increasing disease burden of OSCC and rapid development of multidisciplinary collaborative models,an expert panel has formulated this integrated management consensus based on evidence-based medicine and extensive deliber-ation.Centered on the'Prevention-Screening-Diagnosis-Treatment-Rehabilitation'framework,the consensus provides comprehensive guidance for the entire disease course of OSCC patients,aiming to standardize clinical practice.
7.Consensus on informed consent for orthodontic treatment
Yang CAO ; Bing FANG ; Zuolin JIN ; Hong HE ; Yuxing BAI ; Lin WANG ; Haiping LU ; Zhihe ZHAO ; Tianmin XU ; Weiran LI ; Min HU ; Jinlin SONG ; Jun WANG ; Fang JIN ; Ding BAI ; Xianglong HAN ; Yuehua LIU ; Bin YAN ; Jie GUO ; Jiejun SHI ; Yongming LI ; Zhihua LI ; Xiuping WU ; Jiangtian HU ; Linyu XU ; Lin LIU ; Yi LIU ; Yanqin LU ; Wensheng MA ; Shuixue MO ; Liling REN ; Shuxia CUI ; Yongjie FAN ; Jianguang XU ; Lulu XU ; Zhijun ZHENG ; Peijun WANG ; Rui ZOU ; Chufeng LIU ; Lunguo XIA ; Li HU ; Weicai WANG ; Liping WU ; Xiaoxing KOU ; Jiali TAN ; Yuanbo LIU ; Bowen MENG ; Yuantao HAO ; Lili CHEN
Chinese Journal of Stomatology 2025;60(12):1327-1336
This consensus was developed by the Orthodontic Society of the Chinese Stomatological Association to provide a systematic, scientific, and practical guideline for informed consent in orthodontic care. Orthodontic treatment is typically lengthy, highly individualized, and involves multiple factors such as growth and development, occlusal function, and facial esthetics. Rapid technological advances and diverse risk profiles make the traditional reliance on orthodontist experience or institutional templates insufficient to ensure patients′ full understanding and autonomous decision-making. To address this, the expert panel conducted extensive reviews of domestic and international guidelines, analyzed representative dispute cases, and performed multicenter patient-clinician surveys. Using a multi-round Delphi method, the group established a standardized informed consent framework covering the initial consultation, treatment, and retention phases. The consensus emphasizes that informed consent is not only a fundamental legal and ethical requirement but also a key step in building trust, improving patient compliance, and enhancing treatment satisfaction. Orthodontists should clearly and comprehensively explain treatment plans, potential risks, uncertainties, and associated costs, while respecting the autonomy of patients or guardians, and maintain continuous communication and dynamic evaluation throughout the treatment process. The release of this consensus provides unified and authoritative guidance for clinical orthodontics, helping to standardize informed consent, enhance its transparency, safeguard patient rights, reduce medical risks, and promote high-quality, sustainable development of orthodontic practice.
8.Research of injury mapping relationship of lumbar spine in reclined occupants between anthropomorphic test devices and human body model.
Yu LIU ; Jing FEI ; Xin-Ming WAN ; Pei-Feng WANG ; Zhen LI ; Xiao-Ting YANG ; Lin-Wei ZHANG ; Zhong-Hao BAI
Chinese Journal of Traumatology 2025;28(2):130-137
PURPOSE:
To judge the injury mode and injury severity of the real human body through the measured values of anthropomorphic test devices (ATD) injury indices, the mapping relationship of lumbar injury between ATD and human body model (HBM) was explored.
METHODS:
Through the ATD model and HBM simulation, the mapping relationship of lumbar injury between the 2 subjects was explored. The sled environment consisted of a semi-rigid seat with an adjustable seatback angle and a 3-point seat belt system with a seatback-mounted D-ring. Three seatback recline states of 25°, 45°, and 65° were designed, and the seat pan angle was maintained at 15°. A 23 g, 47 km/h pulse was used. The validity of the finite element model of the sled was verified by the comparison of ATD simulation and test results. ATD model was the test device for human occupant restraint for autonomous vehicles (THOR-AV) dummy model and HBM was the total human model for safety (THUMS) v6.1. The posture of the 2 models was adjusted to adapt to the 3 seat states. The lumbar response of THOR-AV and the mechanical and biomechanical data on L1 - L5 vertebrae of THUMS were output, and the response relationship between THOR-AV and THUMS was descriptive statistically analyzed.
RESULTS:
Both THOR-AV and THUMS were submarined in the 65° seatback angle case. With the change of seatback angle, the lumbar spine axial compression force (Fz) of THOR-AV and THUMS changed in the similar trend. The maximum Fz ratio of THOR-AV to THUMS at 25° and 45° seatback angle cases were 1.6 and 1.7. The flexion moment (My) and the time when the maximum My occurred in the 2 subjects were very different. In particular, the form of moment experienced by the L1 - L5 vertebrae of THUMS also changed. The changing trend of My measured by THOR-AV over time can reflect the changing trend of maximum stress of L1 and L2 of THUMS.
CONCLUSION
The Fz of ATD and HBM presents a certain proportional relationship, and there is a mapping relationship between the 2 subjects on Fz. The mapping function can be further clarified by applying more pulses and adopting more seatback angles. It is difficult to map My directly because they are very different in ATD and HBM. The My of ATD and stress of HBM lumbar showed a similar change trend over time, and there may be a hidden mapping relationship.
Humans
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Lumbar Vertebrae/injuries*
;
Finite Element Analysis
;
Biomechanical Phenomena
;
Manikins
;
Spinal Injuries/physiopathology*
9.Association between improved erectile function and dietary patterns: a systematic review and meta-analysis.
Bin YANG ; Chao WEI ; Yu-Cong ZHANG ; De-Lin MA ; Jian BAI ; Zhuo LIU ; Xia-Ming LIU ; Ji-Hong LIU ; Xiao-Yi YUAN ; Wei-Min YAO
Asian Journal of Andrology 2025;27(2):239-244
Erectile dysfunction (ED) is prevalent among men, but its relationship with dietary habits is uncertain. The aim of our study was to assess whether dietary patterns enhance erectile function by reviewing the literature published before August 1, 2022, via PubMed, Web of Science, and EMBASE databases. The data compiled included author details; publication dates, countries, treatments, patient numbers, ages, follow-ups, and clinical trial outcomes, such as ED cases, odds ratios (ORs), confidence intervals (CIs), and International Index of Erectile Function-5 (IIEF-5) scores with means and standard deviations. An analysis of 14 studies with 27 389 participants revealed that plant-based diets (OR = 0.71, 95% CI: 0.66-0.75; P < 0.00001), low-fat diets (OR = 0.27, 95% CI: 0.13-0.53; P = 0.0002), and alternative diets such as intermittent fasting and organic diets (OR = 0.54, 95% CI: 0.36-0.80; P = 0.002) significantly reduced ED risk. High-protein low-fat diets (hazard ratio [HR] = 1.38, 95% CI: 1.12-1.64; P < 0.00001) and high-carb low-fat diets (HR = 0.79, 95% CI: 0.55-1.04; P < 0.00001) improved IIEF-5 scores. Combined diet and exercise interventions decreased the likelihood of ED (OR = 0.49, 95% CI: 0.28-0.85; P = 0.01) and increased the IIEF-5 score (OR = 3.40, 95% CI: 1.69-5.11; P < 0.0001). Diets abundant in fruits and vegetables (OR = 0.97, 95% CI: 0.96-0.98; P < 0.00001) and nuts (OR = 0.54, 95% CI: 0.37-0.80; P = 0.002) were also correlated with lower ED risk. Our meta-analysis underscores a strong dietary-ED association, suggesting that low-fat/Mediterranean diets rich in produce and nuts could benefit ED management.
Humans
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Male
;
Erectile Dysfunction/epidemiology*
;
Diet
;
Diet, Fat-Restricted
;
Feeding Behavior
;
Penile Erection/physiology*
;
Diet, Vegetarian
10.Therapeutic Effect of Yu Melody Relaxation Training Combined with Jianpi Jieyu Decoction in Insomnia Patients: A Randomized Controlled Trial.
Hao-Yu PANG ; Xu CHEN ; Ling-Yun XI ; Qian-Lin JIA ; Yang BAI ; Jing CAO ; Xia HONG
Chinese journal of integrative medicine 2025;31(4):291-298
OBJECTIVE:
To evaluate the therapeutic effect of Yu Melody relaxation training (YMRT) combined with Jianpi Jieyu Decoction (JJD) in treating patients with insomnia disorders (ID).
METHODS:
In this randomized controlled study, 94 ID patients were included from Xiyuan Hospital, China Academy of Chinese Medical Sciences from September 2022 to January 2024. They were randomly assigned to the YMRT group (47 cases, YMRT plus JJD) and the control group (47 cases, oral JJD) using a random number table. Both treatment administrations lasted for 4 weeks, with a 2-week follow-up. The primary outcome was change in Insomnia Severity Index (ISI) scores from baseline to 4 weeks of intervention. Secondary outcomes included ISI response at week 4, as well as ISI, Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder 7-item (GAD-7) scores at baseline and weeks 1, 2, 3, 4, and 6. Additionally, Pittsburgh Sleep Quality Index (PSQI) scores were evaluated at baseline and weeks 4 and 6. Adverse events (AEs) were recorded and compared between groups.
RESULTS:
Five patients in each group did not complete the protocol requirements. The overall dropout rate was 10.64%. The full analysis set included all 47 cases in each group. The ISI score decreased significantly at week 4 from baseline in the YMRT group compared with the control group, with a between-group difference of -3.2 points [95% confidence interval (CI): -5.08 to -1.34; P<0.05]. The ISI response at week 4 in the YMRT group was significantly higher than that in the control group (85.11% vs. 51.06%), with a between-group difference of 34.05% (95% CI: 13.77% to 50.97%; P<0.05). At week 6, the YMRT group demonstrated greater reductions from baseline than the control group, with between-group differences of -2.1 points (-95% CI: -3.49 to -0.64; P<0.05) for PHQ-9 scores, -3.5 points (95% CI: -5.21 to -1.85; P<0.05) for PSQI scores, and -1.9 points (95% CI: -3.47 to -0.28; P<0.05) for GAD-7 scores. Moreover, at weeks 4 and 6, the ISI and PSQI scores in the YMRT group were significantly lower than those in the control group (P<0.05); and at week 6, the PHQ-9 score in the YMRT group was significantly lower (P<0.05). There was no significant difference in the incidence rates of AEs between the two groups (8.51% vs. 4.26%, P>0.05).
CONCLUSIONS
YMRT combined with oral JJD could improve sleep quality and alleviate depressive and anxiety symptoms in patients with ID. This combined therapy was effective and safe, and its effect was superior to oral JJD alone. (Registration No. ChiCTR2200063884).
Humans
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Sleep Initiation and Maintenance Disorders/drug therapy*
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Drugs, Chinese Herbal/therapeutic use*
;
Male
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Female
;
Relaxation Therapy/methods*
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Middle Aged
;
Adult
;
Treatment Outcome
;
Combined Modality Therapy

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