Randomized controlled trials (RCTs), as the highest level of evidence and the gold standard in clinical research, occupy a central position in modern medical research due to their stringent variable control and high internal validity. However, their vacuum-like research environment and standardized treatment approaches face significant challenges in traditional Chinese medicine (TCM), which emphasizes Treatment Tailored to Individual and Treatment Based on Syndrome Differentiation, focusing on personalized treatment according to a patient’s constitution, age, gender, and lifestyle, and diagnosis based on specific syndromes. This approach lacks systematic modern clinical research and unified standards, conflicting with RCTs’ standardized design, thus limiting TCM trials and posing serious challenges to its modernization and internationalization. This study systematically collected and categorized data on the registration status, study type, design, interventions and control measures, research objectives, primary outcome measures of registered trials by searching the ClinicalTrials.gov using TCM-related keywords. It reveals the current status and distribution patterns of TCM clinical registration trials. Evidence suggests that TCM clinical trials urgently need to seek a balance between standardized research and individualized treatment to address the limitations of RCTs in the TCM field, like implementation difficulties and the neglect of individual differences. To address this, the paper proposes an innovative research framework centered on pragmatic RCTs, highlighting randomization based on patient preferences to gather real-world evidence. Additionally, it suggests constructing a multidimensional core information set for standardized diagnosis of TCM syndromes by integrating disease and syndrome data to enhance diagnostic scientificity and increase the credibility and international acceptance of TCM clinical trials. The introduction of this framework effectively integrates the traditional characteristics of TCM with modern scientific methods, providing essential theoretical support and innovative solutions for the design and implementation of TCM clinical research, thereby enhancing TCM’s role in global health.

The transition of alveolar type II epithelial cells into fibroblasts has been reported to cause and/or aggravate pulmonary fibrosis (PF), which is characterized by fibroblast proliferation, an enhanced production and accumulation of ECM (extracellular matrix), alveolar wall damage and functional capillary unit loss. Traditional Chinese medicine Emodin has been reported to inhibit TGF‐β‐induced epithelial‐mesenchymal transition (EMT) in alveolar epithelial cells through Notch signalling. In the present study, neutrophil elastase (NE, also known as ELA2) treatment promoted EMT, Notch1 cleavage (NICD/Notch1 ratio increase) and NICD nuclear translocation in RLE‐6TN cells and A549 cells. The promotive roles of NE treatment in these events were significantly reversed by Notch1 knockdown. Traditional Chinese medicine Emodin treatment remarkably inhibited the enzyme activity of NE, suppressed EMT, Notch1 cleavage and NICD nuclear translocation within RLE‐6TN and A549 cells, while NE treatment significantly reversed the effects of Emodin. Moreover, in RLE‐6TN, the effects of NE on EMT, Notch1 cleavage and NICD nuclear translocation were remarkably attenuated by Emodin treatment and more attenuated by the combination of Emodin and neutrophil elastase inhibitor Sivelestat or notch signal pathway inhibitor DAPT. In conclusion, we revealed the involvement of NE‐induced Notch1 cleavage in the functions of Emodin suppressing NE‐caused EMT in RLE‐6TN cells and A549 cells. This novel mechanism of Emodin inhibiting EMT might extend the application of Emodin in PF treatment.

To investigate the effect and mechanism of polydatin on bleomycin (BLM)‐induced pulmonary fibrosis in a mouse model. The lung fibrosis model was induced by BLM. The contents of TNF‐α, LPS, IL‐6 and IL‐1β in lung tissue, intestine and serum were detected by ELISA. Gut microbiota diversity was detected by 16S rDNA sequencing; R language was used to analyse species composition, α‐diversity, β‐diversity, species differences and marker species. Mice were fed drinking water mixed with four antibiotics (ampicillin, neomycin, metronidazole, vancomycin; antibiotics, ABx) to build a mouse model of ABx‐induced bacterial depletion; and faecal microbiota from different groups were transplanted into BLM‐treated or untreated ABx mice. The histopathological changes and collagen I and α‐SMA expression were determined. Polydatin effectively reduced the degree of fibrosis in a BLM‐induced pulmonary fibrosis mouse model; BLM and/or polydatin affected the abundance of the dominant gut microbiota in mice. Moreover, faecal microbiota transplantation (FMT) from polydatin‐treated BLM mice effectively alleviated lung fibrosis in BLM‐treated ABx mice compared with FMT from BLM mice. Polydatin can reduce fibrosis and inflammation in a BLM‐induced mouse pulmonary fibrosis model. The alteration of gut microbiota by polydatin may be involved in the therapeutic effect.

Elderly people with acute respiratory failure (ARF) have prolonged length of hospital stay (LOS) and high mortality rates. Malnutrition is negatively correlated with these LOS and mortality. However, no tools have been used to detect the risk of malnutrition and assist in designing nutritional support for these patients. The geriatric nutritional risk index (GNRI) is reported as a novel tool for evaluating the risk of malnutrition. The aim of this study is to explore the relationship of the GNRI score with mortality and LOS in elderly patients with ARF. Data of elderly patients diagnosed with ARF were retrieved from the Medical Information Mart for Intensive Care III (MIMIC-III) database. A total of 1250 patients were divided into two groups based on their GNRI score: the malnutrition risk group (GNRI ≤ 98) and no risk group (GNRI > 98). The primary endpoints of this study were hospital mortality and hospital LOS. The higher GNRI score was associated with lower hospital mortality and shorter hospital LOS. Odds ratio (OR) for hospital mortality of patients with nutritional risk (GNRI ≤ 98) was 1.264 (95% CI:1.067-1.497) in the adjusted model. Patients with GNRI ≤98 had longer hospital LOS (adjusted OR: 1.142, 95%CI: 1.044-1.250) compared with those with GNRI > 98. Subgroup analysis showed that higher GNRI was only significantly associated with lower hospital mortality in the patients that did not undergo mechanical ventilator (MV) treatment (adjusted OR: 0.985, 95% CI: 0.977-0.992, P < 0.01). Kaplan-Meier curve analysis showed that the 90-day survival was significantly lower in the group with nutrition risk (GNRI≤98) compared with the no risk group (GNRI > 98, p < 0.05). These findings imply that GNRI is a useful prognostic tool in elderly patients with ARF.

Background: Traditional Chinese exercise as a new pulmonary rehabilitation technique has been increasingly used and achieved good results in pulmonary rehabilitation of chronic obstructive pulmonary disease (COPD). The aim of this study is to investigate the protective effects of Liuzijue on exercise tolerance, lung function, and quality of life in patients with COPD. Methods: This study is a multicenter, non-randomized, prospective study. Patients will be divided into a control group (CG) and a Liuzijue group (LG) based on their willingness to learn Liuzijue. None of the outcome assessors will know the grouping of patients. Participants in this study will be collected from stable COPD patients who are outpatients or inpatients in 3 centers in China since September 2021. Patients will meet the diagnostic criteria for GOLD stage I-II COPD (FEV₁% ≥ 0.5 and FEV₁/FVC < 0.7) and be aged 40 years or older. Patients voluntarily will take part in the clinical study and sign an informed consent form. All participants will follow their existing medication. For LG patients, Liuzijue training has been added. Patients will practice Liuzijue for more than 30 minutes a day, more than 5 days a week, and adhere to the training for 3 months. Outcome indicators are 6-minute walk test (6MWT), lung function (FEV₁%, FEV₁/FVC, MMEF, PEF), modified British Medical Research Council (mMRC) score, COPD assessment test score (CAT), acute exacerbations and changes in drug treatment. Discussion: This study quantified the effect of Liuzijue on the pulmonary rehabilitation of COPD patients in the stable phase of the disease, and provided a basis for the use of Liuzijue in COPD patients. Trial registration: Chinese clinical trial registry, ChiCTR2100048945. Date: 2021-07-19. http://www.chictr.org.cn/showproj.aspx?proj=129094